Seroxat Tablets

  • Name:

    Seroxat Tablets

  • Company:
    info
  • Active Ingredients:

    Paroxetine hydrochloride hemihydrate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/09/19

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Summary of Product Characteristics last updated on medicines.ie: 16/9/2019

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 136 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 16 September 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to further information section

Free text change information supplied by the pharmaceutical company

Section 2 - addition of sexual disfunction warning

Updated on 16 September 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 - addition of sexual disfunction warning

Updated on 5 November 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 5 November 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of section 4.8 (‘Undesirable effects’) of the SmPC to add ‘Bruxism’ with a frequency not known in ‘Psychiatric disorders’

Updated on 3 November 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 November 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

For Seroxat 30mg Tablets only:

Section 6.5 – addition of child resistant packs and changes to the material components.

Updated on 2 November 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 November 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 7 August 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.5 – addition of child resistant packs and changes to the material components.

Updated on 6 August 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Improved electronic presentation

Updated on 15 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 - change to Ireland MAH address

Updated on 15 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 3 June 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 – addition of aggression as an AE under psychiatric disorders

Section 5.1 – minor editorial changes

Updated on 1 June 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 10 February 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.5         Nature and contents of container – following text has been added:

20     mg tablet - Child-resistant blister packs comprising opaque polyvinyl chloride (PVC) backed with aluminium foil laminated with paper.

Updated on 10 February 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of manufacturer
  • Change to improve clarity and readability
  • Change to product name

Updated on 23 January 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update section 4.4, 4.5 and 4.8 of the SPC in order to include warnings of:

·         gynaecological bleeding/menstrual period disorders

·         interactions between pravastatin and paroxetine

·         AE information updated for the following: Immune system disorders, Metabolism and nutrition disorders, Skin and subcutaneous tissue disorders, Reproductive system and breast disorders

Updated on 22 January 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 2 September 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

2 QUALITATIVE AND QUANTITATIVE COMPOSITION – minor editorial changes

3.         PHARMACEUTICAL FORM – additional information on break bar and minor editorial changes

4.2       Posology and method of administration – change of layout and minor editorial changes

4.3      Contraindications – minor editorial changes

4.4      Special warnings and precautions for use – minor editorial changes

4.5     Interaction with other medicinal products and other forms of interaction - SSRIs may reduce plasma cholinesterase activity resulting in a prolongation of the neuromuscular blocking action of mivacurium and suxamethonium.

4.6 Fertility, pregnancy and lactation – minor editorial changes and a change in layout

4.8 Undesirable effects – addition of HPRA contact details

Updated on 1 September 2014 PIL

Reasons for updating

  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 23 January 2014 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC UPDATES

 

3. PHARMACEUTICAL FORM

Specifically for the 30 mg tablet, a the following statement regarding breaking:

The tablet must only be broken to ease swallowing.

 

4.2 Posology and Method of Administration

Minor editorial change under the subheading ‘Special Populations’:

Changed the term ‘elderly’ to ‘older people’

 

4.6   Undesirable Effects

Added the details of the IMB Pharmacovigilance department, required for the reporting of adverse events:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie).  A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.

 

FREEPOST

Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2. Tel: +353 1 676497. Fax: +353 1 6762517. Website: www.imb.ie. e-mail: imbpharmacovigilance@imb.ie

 

5.2      Pharmacokinetic properties

Minor editorial changes:

Changed the term ‘Metabolism’ to ‘Biotransformation’.

 

Under the subheading ‘Special Populations’:

Changed the term ‘elderly’ to ‘older people’

 

 

Updated on 22 January 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change due to harmonisation of PIL
  • Change due to user-testing of patient information

Updated on 11 January 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 22 November 2012 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.6        Pregnancy and Lactation

 

 

Fertility

Animal data have shown that paroxetine may affect sperm quality (see section 5.3).  In vitro data with human material may suggest some effect on sperm quality, however, human case reports with some  SSRIs (including paroxetine) have shown that an effect on sperm quality appears to be reversible.

Impact on human fertility has not been observed so far. Some clinical studies have shown that SSRIs (including paroxetine) may affect sperm quality. This effect appears to be reversible following discontinuation of treatment.  These studies have not examined impact on fertility but changes in sperm quality may affect fertility in some men.

 

5.3     Preclinical safety data

 

Reproduction toxicity studies in rats have shown that paroxetine affects male and female fertility. In rats, increased pup mortality and delayed ossification were observed. The latter effects were likely related to maternal toxicity and are not considered a direct effect on the foetus/neonate.

Reproduction toxicity studies in rats have shown that paroxetine affects male and female fertility by reducing fertility index and pregnancy rate. In rats, increased pup mortality and delayed ossification were observed. The latter effects were likely related to maternal toxicity and are not considered a direct effect on the foetus/neonate.

Updated on 16 November 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 7 December 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4       Special Warnings and Special Precautions for use

Under the subheading ‘Interaction with tamoxifen’, updated warning from:

Paroxetine may lead to reduced efficacy of tamoxifen (see section 4.5). It is recommended that prescribers consider using an alternative antidepressant with minimal CYP2D6 activity.

to read:

Paroxetine, a potent inhibitor of CYP2D6, may lead to reduced concentrations of endoxifen, one of the most important active metabolites of tamoxifen. Therefore, paroxetine should whenever possible be avoided during tamoxifen treatment (see Section 4.5).

 

4.5       Interactions with other medicinal products and other forms of interaction

Under the subheading ‘CYP2D6 inhibitory potency of paroxetine’, updated the statement from:

Tamoxifen is a pro‑drug requiring metabolic activation by CYP2D6.  Inhibition of CYP2D6 by paroxetine may lead to reduced plasma concentrations of an active metabolite and hence reduced efficacy of tamoxifen, especially in extensive metabolisers. It is recommended that prescribers consider using an alternative antidepressant with minimal CYP2D6 activity.

to read:

Pharmacokinetic interaction between CYP2D6 inhibitors and tamoxifen, showing a 65-75% reduction in plasma levels of one of the more active forms of tamoxifen, i.e. endoxifen, has been reported in the literature. Reduced efficacy of tamoxifen has been reported with concomitant usage of some SSRI antidepressants in some studies. As a reduced effect of tamoxifen cannot be excluded, co-administration with potent CYP2D6 inhibitors (including paroxetine) should whenever possible be avoided (see section 4.4).

 

4.8          Undesirable Effects

Under the subheading ‘Nervous system disorders’ added the common undesirable effect:

Concentration impaired

 

Updated on 29 November 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 9 May 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

1.       NAME OF MEDICINAL PRODUCT

 

SEROXAT 10 mg film‑coated tablets.

SEROXAT 20 mg film‑coated tablets.

SEROXAT 30 mg film‑coated tablets.

SEROXAT 20 mg/10 ml oral suspension.

 

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

10mg Tablets:

Each film‑coated tablet contains 10 mg paroxetine (as paroxetine hydrochloride hemihydrate).

 

20mg Tablets:

Each film‑coated tablet contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate).

 

30mg Tablets:

Each film‑coated tablet contains 30 mg paroxetine (as paroxetine hydrochloride hemihydrate).

 

Oral Suspension:

Each 10 ml of oral suspension contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate).

Excipient – each 10 ml of oral suspension contains:

-          20 mg methyl parahydroxybenzoate

-          6 mg propyl parahydroxybenzoate

-          0.9 mg FD&C Yellow No. 6 (sunset yellow, FCF (EEEC No. 110)

-          4 g sorbitol (E420).

 

For a full list of excipients, see section 6.1.

*************************************************************************

 

4.3    Contraindications

 

Known hypersensitivity to paroxetine or any of the excipients.

 

Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs).  In exceptional circumstances, linezolid (an antibiotic which is a reversible non‑selective MAOI) can be given in combination with paroxetine provided that there are facilities for close observation of symptoms of serotonin syndrome and monitoring of blood pressure (see section 4.5).    

Treatment with paroxetine can be initiated:

-           two weeks after discontinuation of an irreversible MAOI, or

-        at least 24hrs after discontinuation of a reversible MAOI (e.g. moclobemide, linezolid, methylthioninium chloride (methylene blue; a preoperative visualizing agent which is a reversible non-selective MAOI)).

At least one week should elapse between discontinuation of paroxetine and initiation of therapy with any MAOI.

 

*************************************************************************

 

4.5     Interactions with other medicinal products and other forms of interaction

 

Serotonergic drugs

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5‑HT associated effects (serotonin syndrome: see Section 4.4 Special Warnings and Special Precautions for Use). Caution should be advised and a closer clinical monitoring is required when serotonergic drugs (such as L‑tryptophan, triptans, tramadol, linezolid, methylthioninium chloride (methylene blue), SSRIs, lithium, pethidine and St. John's Wort – Hypericum perforatum – preparations) are combined with paroxetine. Caution is also advised with fentanyl used in general anaesthesia or in the treatment of chronic pain. Concomitant use of paroxetine and MAOIs is contraindicated because of the risk of serotonin syndrome (see Section 4.3 Contraindications).

*************************************************************************

 

4.8  Undesirable Effects

 

Skin and subcutaneous tissue disorders
Common:  sweating.
Uncommon:  skin rashes, pruritus
Very rare:  severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), photosensitivity reactions.

 

*************************************************************************

 

6.4     Special precautions for storage

 

10/20/30 mg tablet

Do not store above 30ºC.

Store in the original package in order (to protect from light).

 

Oral suspension

Do not store above 25ºC.

*************************************************************************

 

9   DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation:

SEROXAT 10 mg film‑coated tablets.                           5th March 2004

SEROXAT 20 mg film‑coated tablets.                           19th March 1991

SEROXAT 30 mg film‑coated tablets.                           19th March 1991

SEROXAT 20 mg/10 ml oral suspension.                     6th May 1998

 

Date of last renewal: 27th September 201005.

 

*************************************************************************

 

10    DATE OF REVISION OF THE TEXT

 

September 2010March 2011

Updated on 28 April 2011 PIL

Reasons for updating

  • Change to drug interactions

Updated on 10 January 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 21 October 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.4     Special Warnings and Special Precautions for use

 

 

 

Mania
As with all antidepressants, paroxetine should be used with caution in patients with a history of mania. Paroxetine should be discontinued in any patient entering a manic phase.

 

Bone fracture

Epidemiological studies show an increased risk of bone fractures in patients receiving certain antidepressants, including SSRIs, such as paroxetine. The risk occurs during treatment and is greatest in the first months of therapy.

 

 

Renal/hepatic impairment
Caution is recommended in patients with severe renal impairment or in those with hepatic impairment.  (see section 4.2 Posology and Method of Administration)

 

 

 

 

Oral Suspension:

Warnings for excipients

Parabens

Paroxetine oral suspension contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (parabens), which are known to cause urticaria; generally delayed type reactions, such as contact dermatitis, but rarely immediate reaction with bronchospasm.

 

Sunset Yellow Colouring Agent

Paroxetine oral suspension contains the colouring agent FD&C Yellow No. 6 (sunset yellow, FCF (E110), which may cause allergic reactions.

 

Sorbitol E420

Paroxetine oral suspension contains sorbitol (E420).  Patients with rare hereditary problems of fructose intolerance should not take this medicine.

 

 

 

 

4.6        Pregnancy and Lactation

 

Fertility

Some clinical studies have shown that SSRIs (including paroxetine) may affect sperm quality. This effect appears to be reversible following discontinuation of treatment. These studies have not examined impact on fertility but changes in sperm quality may affect fertility in some men.

 

Pregnancy

Some epidemiological studies suggest an increased risk of congenital malformations, particularly cardiovascular (e.g. ventricular and atrial septum defects), associated with the use of paroxetine during the first trimester. The mechanism is unknown. The data suggest that the risk of having an infant with a cardiovascular defect following maternal paroxetine exposure is less than 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population.

 

 

4.7  Undesirable Effects

 

 

 

Musculoskeletal and connective tissue disorders

Rare: arthralgia, myalgia

 

Epidemological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

 

General disorder and administration site conditions
Common:  asthenia, body weight gain
Very rare:  peripheral oedema.

 

WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF PAROXETINE TREATMENT

 

Common:  dizziness, sensory disturbances, sleep disturbances, anxiety, headache.
Uncommon:  agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhoea, irritability.

Discontinuation of paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia, electric shock sensations and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances have been reported.

Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged.  It is therefore advised that when paroxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and Method of Administration and section 4.4 Special Warnings and Special Precautions for use).

Adverse Events from Paediatric Clinical Trials

In short-term (up to 10-12 weeks) clinical trials in children and adolescents, the following adverse events were observed in paroxetine treated patients at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility.  Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder.  Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age.  Additional events that were more often seen in the paroxetine compared to placebo group were: decreased appetite, tremor, sweating, hyperkinesia, agitation, emotional lability (including crying and mood fluctuations).

 

In studies that used a tapering regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special Warnings and Special Precautions for use).

 

The following adverse events were observed:

Increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility. Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder. Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age.

Additional events that were seen are: decreased appetite, tremor, sweating, hyperkinesias, agitation, emotional lability (including crying and mood fluctuations), bleeding related adverse events, predominately of the skin and mucous membranes.

Events seen after discontinuation/tapering of paroxetine are: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special Warnings and Special Precautions for Use).

See section 5.1 for more information on paediatric clinical trials.

 

 

 

 

5.1     Pharmacodynamic Properties

 

 

 

 

Long-term efficacy

The long-term efficacy of paroxetine in depression has been demonstrated in a 52 week maintenance study with relapse prevention design: 12% of patients receiving paroxetine (20-40mg daily) relapsed, versus 28% of patients on placebo.

 

The long-term efficacy of paroxetine in treating obsessive compulsive disorder has been examined in three 24 week maintenance studies with relapse prevention design. One of the three studies achieved a significant difference in the proportion of relapsers between paroxetine (38%) compared to placebo (59%).

 

The long-term efficacy of paroxetine in treating panic disorder has been demonstrated in a 24 week maintenance study with relapse prevention design: 5% of patients receiving paroxetine (10-40mg daily) relapsed, versus 30% of patients on placebo. This was supported by a 36 week maintenance study.

 

The long-term efficacy of paroxetine in treating social anxiety disorder and generalised anxiety disorder and Post-traumatic Stress Disorder has not been sufficiently demonstrated.

 

Adverse Events from Paediatric Clinical Trials

In short-term (up to 10-12 weeks) clinical trials in children and adolescents, the following adverse events were observed in paroxetine treated patients at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility. Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder. Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age. Additional events that were more often seen in the paroxetine compared to placebo group were: decreased appetite, tremor, sweating, hyperkinesias, agitation, emotional lability (including crying and mood fluctuations).

 

In studies that used a tapering regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special Warnings and Special Precautions for use).

 

In five parallel group studies with a duration of eight weeks up to eight months of treatment, bleeding related adverse events, predominately of the skin and mucous membranes, were observed in paroxetine treated patients at a frequency of 1.74% compared to 0.74% observed in placebo treated patients.

 

 

 

 

 

6.       Pharmaceutical Particulars

 

6.1     List of Excipients

 

10 mg tablet

Tablet core:

Dibasic calcium phosphate dihydrate (E314)

Sodium starch glycolate (Type A)

Magnesium stearate (E470b)

 

Tablet coating:

Hypromellose (E464)

Macrogol 400

Polysorbate 80 (E433)

Titanium dioxide (E171)

Iron oxide red (E172)

 

20 mg tablet

Tablet core:

Dibasic calcium phosphate dihydrate (E431)

Sodium starch glycolate (Type A)

Magnesium stearate (E470b).

 

Tablet coating:

Hypromellose (E464)

Macrogol 400

Polysorbate 80 (E433)

Titanium dioxide (E171)

 

30 mg tablet

Tablet core:

Dibasic calcium phosphate dihydrate (E341)

Sodium starch glycolate (Type A)

Magnesium stearate (E470b)

 

Tablet coating:

Hypromellose (E464)

Macrogol 400

Polysorbate 80 (E433)

Titanium dioxide (E171)

Indigo carmine (E132)

 

Oral suspension

Polacrilin potassium

Dispersible cellulose (E460)

Propylene glycol

Glycerol (E422)

Sorbitol (E420)

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Sodium citrate dihydrate (E331)

Citric acid anhydrate (E330)

Sodium saccharin (E954)

Natural orange flavour

Natural lemon flavour

Yellow colouringColouring agent sunset yellow FCF (E110)

Simethicone emulsion

Purified water

 

 

 

 

7.            DATE OF REVISION OF THE TEXT

 

December 2009September 2010

Updated on 18 March 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Section 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Minor change to the SPC for Oral Suspension, adding quantitative description of excipients, i.e. added:

Excipient – each 10 ml of oral suspension contains:

-          20 mg methyl parahydroxybenzoate

-          6 mg propyl parahydroxybenzoate

-          0.9 mg FD&C Yellow No. 6 (sunset yellow, EEC No. 110)

-          4 g sorbitol (E420).

 

SPECIFIC TO SEROXAT 30 mg film‑coated tablets (PA 1077/97/3)

Section 3 PHARMACEUTICAL FORM

Updated the description of the tablet marking to include the alternative marking ‘30’, i.e. from ‘debossed with “SEROXAT 30” on one side and a break bar on the other’ to ‘debossed with “SEROXAT 30” or ‘30’on one side and a break bar on the other.

 

Section 4.4 Special Warnings and Special Precautions for use

Added the following warning regarding bone fracture:

Bone fracture

Epidemiological studies show an increased risk of bone fractures in patients receiving certain antidepressants, including SSRIs, such as paroxetine. The risk occurs during treatment and is greatest in the first months of therapy.

 

Section 4.5 Interactions with other medicinal products and other forms of interaction

Under the subheading ‘Serotonergic drugs’, added pethedine to the list of serotonergic drugs and added the following warning regarding fenanyl:

Caution is also advised with fentanyl used in general anaesthesia or in the treatment of chronic pain.

 

Section 4.6 Pregnancy and Lactation

Under the subheading ‘Pregnancy’, added the following statement regarding the increased risk of persistent pulmonary hypertension of the newborn:

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may have an increased risk of persistent pulmonary hypertension of the newborn (PPHN).  The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.

 

Section 4.8 Undesirable Effects

Under the category ‘Psychiatric disorders’ added the side effect (frequency common) abnormal dreams (including nightmares).

 

Under the category ‘Nervous system disorders’ added the side effect (frequency rare) restless legs syndrome (RLS).

 

Under the category ‘Gastrointestinal disorders’ disorders’ added the side effect (frequency common) vomiting

 

Section 4.9 Overdose

Under the subheading ‘Symptoms and Signs’, removed the side effect vomiting.

 

Under the subheading ‘Treatment’, updated the instructions to include the following:

·         Administration of 20-30 g activated charcoal may be considered if possible within a few hours after overdose intake to decrease absorption of paroxetine.

·         Patient management should be as clinically indicated.

 

Section 5.2 Pharmacokinetic properties

Under the subheading ‘Distribution’, removed the statement:

Transfer to human breast milk, and to the foetuses of laboratory animals, occurs in small amounts.

 

 

 

 

 

 

Updated on 18 January 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to appearance of the medicine
  • Change to name of manufacturer
  • Change to warnings or special precautions for use
  • Change to instructions about overdose

Updated on 14 May 2009 PIL

Reasons for updating

  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 15 April 2009 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 New text highlighted in Red:

 

3.       PHARMACEUTICAL FORM

 

20 mg Tablet:

White, film‑coated tablet, oval shaped biconvex tablets debossed with SEROXAT 20 or 20 on one side and a break bar on the other

Updated on 12 December 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.4

Additional Text:

Interaction with tamoxifen

Paroxetine may lead to reduced efficacy of tamoxifen (see section 4.5). It is recommended that prescribers consider using an alternative antidepressant with minimal CYP2D6 activity.

 

4.5

Additional Text:

Tamoxifen is a pro‑drug requiring metabolic activation by CYP2D6.  Inhibition of CYP2D6 by paroxetine may lead to reduced plasma concentrations of an active metabolite and hence reduced efficacy of tamoxifen, especially in extensive metabolisers. It is recommended that prescribers consider using an alternative antidepressant with minimal CYP2D6 activity.

 

4.6

Nature of Change:

Amendment of pregnancy text as a result of updated meta-analysis

Updated on 26 June 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 2 May 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type II variation to implement PhVWP/CMD(h) agreed core wording on suicidal thoughts and behaviour for antidepressive therapies - Change to Section 4.8 - Adverse Events

Updated on 19 February 2008 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

 

4.3    Contraindications

 

Known hypersensitivity to paroxetine or any of the excipients.

 

Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs).  In exceptional circumstances, linezolid (an antibiotic which is a reversible non‑selective MAOI) can be given in combination with paroxetine provided that there are facilities for close observation of symptoms of serotonin syndrome and monitoring of blood pressure (see section 4.5).    

Treatment with paroxetine can be initiated:

-           two weeks after discontinuation of an irreversible MAOI, or

-           at least 24hrs after discontinuation of a reversible MAOI (e.g. moclobemide, linezolid).

At least one week should elapse between discontinuation of paroxetine and initiation of therapy with any MAOI.

 

Paroxetine should not be used in combination with thioridazine, because, as with other drugs which inhibit the hepatic enzyme CYP450 2D6, paroxetine can elevate plasma levels of thioridazine (see section 4.5 Interactions with other medicinal products and other forms of interaction). Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death.

 

Paroxetine should not be used in combination with pimozide (see section 4.5 Interactions with other medicinal products and other forms of interaction).

 

 

4.4     Special Warnings and Special Precautions for use

……………………………….

 

Glaucoma
As with other SSRIs, paroxetine can cause mydriasis and should be used with caution in patients with narrow angle glaucoma or history of glaucoma.

 

…………………………

 

Parabens

Paroxetine oral suspension contains methyl and propyl parahydroxybenzoate (parabens), which are known to cause urticaria; generally delayed type reactions, such as contact dermatitis, but rarely immediate reaction with bronchospasm.

 

 

4.5     Interactions with other medicinal products and other forms of interaction

 

Serotonergic drugs

As with other SSRIs, co-administration with serotonergic drugs preparations)may lead to an incidence of 5‑HT associated effects (serotonin syndrome: see Section 4.4 Special Warnings and Special Precautions for Use). Caution should be advised and a closer clinical monitoring is required when serotonergic drugs (such as L‑tryptophan, triptans, tramadol, linezolid, SSRIs, lithium and St. John's Wort – Hypericum perforatum – preparations) are combined with paroxetine. Concomitant use of paroxetine and MAOIs is contraindicated because of the risk of serotonin syndrome (see Section 4.3 Contraindications).

 

Pimozide

Increased pimozide levels of on average 2.5 times have been demonstrated in a study of a single low dose pimozide (2 mg) when co‑administered with 60 mg paroxetine. This may be explained by the known CYP2D6 inhibitory properties of paroxetine. Due to the narrow therapeutic index of pimozide and its known ability to prolong QT interval, concomitant use of pimozide and paroxetine is contraindicated (see Section 4.3 Contraindications).

 

 

4.8       Undesirable Effects

 

……………………………..

 

Nervous system disorders
Common:  dizziness, tremor, headache.
Uncommon:  extrapyramidal disorders.  

Rare:  convulsions.
Very rare:  serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia and tremor).

Reports of extrapyramidal disorder including oro-facial dystonia have been received in patients sometimes with underlying movement disorders or who were using neuroleptic medication. 

 

Eye disorders
Common: blurred vision.
Uncommon: mydriasis (see section 4.4 Special Warnings and Special Precautions for Use). 
Very rare:  acute glaucoma.

 

Ear and labyrinth disorders

Frequency not known:  tinnitus.

 

Cardiac disorders
Uncommon:  sinus tachycardia.
Rare: bradycardia.

 

Vascular disorders
Uncommon:  transient increases or decreases in blood pressure, postural hypotension.

Transient increases or decreases of blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension or anxiety.

 

 

4.9              Overdose

 

Symptoms and Signs

A wide margin of safety is evident from available overdose information on paroxetine.

Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned under section 4.8 "Undesirable Effects", vomiting, fever and involuntary muscle contractions have been reported.  Patients have generally recovered without serious sequelae even when doses of up to 2000 mg have been taken alone.  Events such as coma or ECG changes have occasionally been reported and, very rarely with a fatal outcome, but generally when paroxetine was taken in conjunction with other psychotropic drugs, with or without alcohol.

 

………………………………

 

 

6.1     List of Excipients

 

10 mg Tablet:

Tablet core:

Dibasic calcium phosphate dihydrate

Sodium starch glycolate (Type A)

Magnesium stearate.

 

Tablet coating:

Hypromellose

Macrogol 400

Polysorbate 80

Titanium dioxide (E171)

Iron oxide red (E172).

 

20 mg Tablet:

Tablet core:

Dibasic calcium phosphate dihydrate

Sodium starch glycolate (Type A)

Magnesium stearate.

 

Tablet coating:

Hypromellose

Macrogol 400

Polysorbate 80

Titanium dioxide (E171).

 

30 mg tablet:

Tablet core:

Dibasic calcium phosphate dihydrate

Sodium starch glycolate (Type A)

Magnesium stearate.

 

Tablet coating:

Hypromellose

Macrogol 400

Polysorbate 80

Titanium dioxide (E171)

Indigo carmine (E132).

 

Oral suspension:

Polacrilin potassium

Dispersible cellulose

Propylene glycol

Glycerol

Sorbitol (E420)

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Sodium citrate dihydrate

Citric acid anhydrate

Sodium saccharin

Natural orange flavour

Natural lemon flavour

Yellow colouring (E110)

Simethicone emulsion

Purified water.

 

 

  1. Date of Revision of the Text

 

06 December 2007.

 

Updated on 16 October 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 3 September 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 12 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 December 2006 PIL

Reasons for updating

  • Change to side-effects

Updated on 13 December 2006 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.6 Pregnancy and Lactation

Pregnancy

etc.......

Lactation

Small amounts of paroxetine are excreted into breast milk. In published studies, serum concentrations in breast-fed infants were undetectable (<2 ng/ml) or very low (<4 ng/ml) and Nno signs of drug effects were observed in these infants. Nevertheless, paroxetine should not be used during lactation unless the expected benefits to the mother justify the potential risks for the infant. Since no effects are anticipated, breast-feeding can be considered.

4.8 Undesirable Effects

etc.....

Metabolism and nutrition disorders

Common: increases in cholesterol levels, decreased appetite.

Rare: hyponatraemia.

Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH).

etc......

Updated on 9 November 2006 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 3 - The following text has been added:

The 20 mg film-coated tablet has a break-line, and can be divided into equal halves if required.

Section 4.4 - The following text has been added (highlighted in red):

Akathisia/psychomotor restlessness

The use of paroxetine has been associated with the development of akathisia, which is characterized by an inner sense of restlessness.....

Drugs affecting gastric pH (Oral Suspension only)

In patients receiving oral suspension, the paroxetine plasma concentration may be influenced by gastric pH. In vitro data have shown that an acidic environment is required for release of the active drug from the suspension, hence absorption may be reduced in patients with a high gastric pH or achlorhydria, such as after the use of certain drugs (antacid drugs, histamine H2-receptor antagonists, proton pump inhibitors), in certain disease states (e.g. atrophic gastritis, pernicious anemia, chronic Helicobacter pylori infection), and after surgery (vagotomy, gastrectomy). The pH dependency should be taken into account when changing paroxetine formulation (e.g. the plasma paroxetine concentration may decrease after changing from tablet to oral suspension in patients with a high gastric pH). Caution is therefore recommended in patients when initiating or ending treatment with drugs increasing gastric pH. Dose adjustments may be necessary in such situations.

Withdrawal symptoms seen on discontinuation of paroxetine treatment

Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects). In clinical trials adverse events seen on treatment discontinuation occurred in 30% of patients treated with paroxetine compared to 20% of patients treated with placebo. The occurrence of withdrawal symptoms is not the same as the drug being addictive or dependence producing. The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.Dizziness, sensory disturbances (including paraesthesia, electric shock sensations and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability,

and visual disturbances have been reported........

Warnings for excipients (Oral Suspension only)

Parabens

Paroxetine oral suspension contains methyl and propyl hydroxybenzoate (parabens), which are known to cause urticaria; generally delayed type reactions, such as contact dermatitis, but rarely immediate reaction with bronchospasm.

Sunset Yellow Colouring Agent

Paroxetine oral suspension contains the colouring agent FD&C Yellow No. 6 (sunset yellow, EEC No. 110), which may cause allergic reactions.

Sorbitol E420

Paroxetine oral suspension contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Section 4.5 - The following text has been added (highlighted in red):

Drug metabolising enzymes

The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug metabolising enzymes.

When paroxetine is to be co-administered with a known drug metabolising enzyme inhibitor, consideration should be given to using paroxetine doses at the lower end of the range.

No initial dosage adjustment is considered necessary when the drug is to be co-administered with known drug metabolising enzyme inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin) or with fosamprenavir/ritonavir. Any paroxetine dosage adjustment (either after initiation or following discontinuation of an enzyme inducer) should be guided by clinical effect (tolerability and efficacy).

Fosamprenavir/ritonavir: Co-administration of fosamprenavir/ritonavir 700/100 mg twice daily with paroxetine 20 mg daily in healthy volunteers for 10 days significantly decreased plasma levels of paroxetine by approximately 55%. The plasma levels of fosamprenavir/ritonavir during co-administration of paroxetine were similar to reference values of other studies, indicating that paroxetine had no significant effect on metabolism of fosamprenavir/ritonavir. There are no data available about the effects of long-term co-administration of paroxetine and fosamprenavir/ritonavir exceeding 10 days.

Drugs affecting gastric pH (Oral Suspension only)

In vitro data have shown that dissociation of paroxetine from the oral suspension is pH-dependant. Therefore, drugs that alter gastric pH (such as antacid drugs, proton pump inhibitors or histamine H2-receptor antagonists) may affect plasma paroxetine concentrations in patients taking the oral suspension (see section 4.4).

Section 4.8 - The following text has been added (highlighted in red):

Ear and labyrinth disorders

Frequency not known: tinnitus.

Renal and urinary disorders

Uncommon: urinary retention, urinary incontinence.

WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF PAROXETINE TREATMENT

Common: dizziness, sensory disturbances, sleep disturbances, anxiety, headache.

Uncommon: agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhoea, irritability.

Discontinuation of paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia,electric shock sensations and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances have been reported.

Section 6.5 - The following text has been added (highlighted in red):

Oral suspension:

Amber glass bottle sealed with polypropylene child-resistant cap lined with a polyethylene wad. A polypropylene measuring cup is included.

Pack size: 150 ml.

Updated on 8 November 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 25 August 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 29 May 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 November 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 6 July 2005 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 July 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 February 2004 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)