Nu-Seals 75

  • Name:

    Nu-Seals 75

  • Company:
    info
  • Active Ingredients:

    Aspirin

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/03/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 31/7/2019

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Alliance Pharmaceuticals Ireland

Alliance Pharmaceuticals Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Ametop 40 mg/g Gel Active Ingredients Tetracaine hydrochloride
Medicine Name Anbesol Anaesthetic Antiseptic Oromucosal Solution Active Ingredients Cetylpyridinium Chloride, Chlorocresol, Lidocaine Hydrochloride
Medicine Name Haemopressin 1 mg powder and solvent for solution for injection Active Ingredients Terlipressin acetate
Medicine Name Naseptin Nasal Cream Active Ingredients Chlorhexidine Dihydrochloride, Neomycin sulfate
Medicine Name Nu-Seals 300 Active Ingredients Aspirin
Medicine Name Nu-Seals 75 Active Ingredients Aspirin
Medicine Name Occlusal Active Ingredients Salicylic Acid
Medicine Name Quinoderm 10% w/w + 0.5% w/w Cream Active Ingredients Benzoyl Peroxide, hydrous, Potassium hydroxyquinoline sulfate
Medicine Name Quinoderm 5% w/w + 0.5% w/w Cream Active Ingredients Benzoyl Peroxide, hydrous, Potassium hydroxyquinoline sulfate
Medicine Name Ranitidine 50mg/2ml Solution for Injection and Infusion Active Ingredients Ranitidine Hydrochloride
Medicine Name Syntometrine injection Active Ingredients Ergometrine Maleate, Oxytocin
1 - 0 of 11 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 31 July 2019 SmPC

Reasons for updating

  • Change to MA holder contact details

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 31 July 2019 SmPC

Reasons for updating

  • Change to MA holder contact details

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 7 December 2018 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3 Contraindications

Hypoprothrombinaemia, haemophilia, haemorrhagic disease or a history of bleeding disorders, cerebral haemorrhage and active peptic ulceration.

Doses >100 mg/day during the third trimester of pregnancy.

4.4 Special warnings and precautions for use

High doses of aspirin may precipitate acute haemolytic anaemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency.

4.6 Fertility, Pregnancy and Lactation

Pregnancy: 

Low doses (up to 100 mg/day):

Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.

Doses of 100-500 mg/day:

There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendation below for doses of 500 mg/d and above apply also for this dose range.

Doses of 500 mg/day and above:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitor has been shown to results in increased pre- and post-implantation loss and embryo-foetal lethality.  In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

-cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

-renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

-possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

-inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is contraindicated during the third trimester of pregnancy.

4.8 Undesirable effects

System Organ Class: Hepatobiliary disorders Undesirable Effect: Transaminase increased

Updated on 20 July 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

File format update to PDF

Updated on 20 July 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

File format update to PDF

Updated on 10 April 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update section 4.8 to change IMB name to HPRA

Updated on 10 April 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 2 April 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 April 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 19 June 2014 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes are highlighted in red text below:

4.5       Interaction with other medicinal products and other forms of interaction

Salicylates inhibit the uricosuric effect of uricosuric drugs.

 

Antacids:  Patients using gastro-resistant enteric-coated aspirin should be advised against ingesting antacids simultaneously, to avoid premature drug release.

 

4.8       Undesirable effects

 

System Organ Class

Undesirable Effect

Frequency

Gastrointestinal disorders1

Peptic ulcers2

Unknown

GI Perforation2

Unknown

GI Bleeding2

Unknown

Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain,

Unknown

Melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis, exacerbation of Crohn’s disease, gastritis

Unknown

Blood and lymphatic system disorders

Not Known:

Bleeding disorders

Haemorrhages andhaematoma3

Anaemia14

Thrombocytopenia

Unknown

Unknown

Unknown

Unknown

Immune system disorders

Not Known:

Hypersensitivity reactions including skin rashes, urticaria, angioedema, asthma,

bronchospasm and anaphylaxis. 

Bullous reactions including Stevens-Johnson and toxic epidermal necrolysis syndrome

Unknown

Nervous system disorders

Not Known:

Cerebral haemorrhage

Unknown

Ear and labyrinth disorders

Not Known:

Tinnitus

Unknown

Respiratory thoracic  and mediastinal disorders

Asthma, epistaxis, haemoptysis

Unknown

Skin and subcutaneous tissue disorders

Purpura, ecchymoses

Unknown

Renal and urinary disorders

Haematuria, urate kidney stones

Unknown

Investigations

Bleeding time prolonged

Unknown

Vascular disorders

Hypertension

Unknown

General disorders and administration site disorders

Oedema

Unknown

Cardiovascular

Cardiac failure,

Unknown

Cardiac disorders

Not Known:

Cardiac failure

 

Vascular disorders

Not Known:

Hypertension Haemorrhages2 Haematoma2

 

Respiratory thoracic  and mediastinal disorders

Not Known:

Epistaxis

Haemoptysis

 

Gastrointestinal disorders3

Not Known:

Peptic ulcers4

GI Perforation4

GI Bleeding4

Nausea

Vomiting

Diarrhoea

Flatulence

Constipation

Dyspepsia

Abdominal pain

Melaena

Haematemesis

Ulcerative stomatitis Exacerbation of colitis Exacerbation of Crohn’s disease

Gastritis

Gastrointestinal ulcer

 

Skin and subcutaneous tissue disorders

Not Known:

Purpura

Ecchymoses

 

Renal and urinary disorders

Not Known:

Haematuria

Urate kidney stones

 

General disorders and administration site disorders

Not Known:

Oedema

 

Investigations

Not Known:

Bleeding time prolonged

 

1May occur following chronic GI blood loss or acute haemorrhage

2May occur in various organ systems and may be fatal

31The special coating of Nu-Seals helps to reduce the incidence of side effects resulting from gastric irritation.

42Sometimes fatal, particularly in the elderly

3May occur in various organ systems and may be fatal

4May occur following chronic GI blood loss or acute haemorrhage

 

 

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 IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie

 

4.9       Overdose

With the gastro-resistantenteric coated formulation, peak plasma levels may not occur for up to 12 hours.

 

5.1     Pharmacodynamic properties

Nu-Seals 75 tablets have an gastro-resistant enteric coat sandwiched between a sealing coat and a top coat.  The gastro-resistant enteric coat is intended to resist gastric fluid whilst allowing disintegration in the intestinal fluid.

 

Updated on 19 December 2013 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to the Summary of Product Characteristics highlighted red text below:

 

4.3       Contraindications

Hypersensitivity to aspirin (e.g.- bronchospasm, rhinitis, urticaria), or to non-steroidal anti-inflammatory drugs or to any of the excipients listed in Section 6.1

 

4.4       Special warnings and precautions for use

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin or, selective serotonin-reuptake inhibitors or anti-platelet agents such as clopidogrel and dipyridamole  aspirin (see section 4.5).

 

Aspirin can reduce uric acid excretions and so should be used with care in patients with gout or a history of gout.

 

Patients with hypertension should be carefully monitored.

 

Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

 

 

4.5       Interaction with other medicinal products and other forms of interaction

 

Concomitant use of alcohol with aspirin may increase the risk of gastrointestinal bleeding.

 

Gold: risk of increased hepatotoxicity with aspirin.

 

Thiopental - Aspirin may potentiate the effects of thiopental anaesthesia.

 

Aspirin can interfere, to varying degrees, with some urine tests for catecholamines, dopa, glucose, ketones, hippuric acid, homogentisic acid, homovallinic acid, 17-hydroxycorticosteroids, 5-hydroxyindoleacetic acid, urine pregnancy tests and with some serum or plasma tests for albumin, barbiturates, calcium, propylthiouracil, tyrosine and uric acid

 

4.6       Fertility, Pregnancy and Lactation

Fertility:  Women attempting to conceive should not use any NSAID, including aspirin, because of the findings in a variety of animal models that indicate these agents block blastocyst implantation.

 

Pregnancy: Although clinical and epidemiological evidence suggests the safety of aspirin for use in pregnancy, cCaution should be exercised when considering use in pregnant patients.  With high doses there may be premature closure of the ductus arteriosus and possible kernicterus or persistent pulmonary hypertension in the newborn.  Analgesic doses of aspirin should be avoided during the last trimester of pregnancy.

 

Numerous malformations have been reported following maternal use of aspirin during pregnancy, however with the exception of a possible risk of gastroschisis, no specific pattern of malformations has been observed and a causative role for aspirin has not been proven.

 

4.8       Undesirable effects

 

4.8.1    Summary of the safety profile

The most commonly observed adverse events are gastrointestinal in nature

4.8.2 Tabulated list of adverse reactions

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10

Common: ≥1/100 to <1/10

Uncommon: ≥1/1,000 to <1/100

Rare: ≥1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

 

 

 

Undesirable Effect

Frequency

Gastrointestinal disorders1

Peptic ulcers2

Unknown

GI Perforation2

Unknown

GI Bleeding2

Unknown

Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain,

Unknown

Melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis, exacerbation of Crohn’s disease, gastritis

Unknown

Blood and lymphatic system disorders

Bleeding disorders

Unknown

Haemorrhages and haematoma3

Unknown

Anaemia4

Unknown

Thrombocytopenia

Unknown

Immune system disorders

Hypersensitivity reactions including skin rashes, urticaria, angioedema, bronchospasm and anaphylaxis.  Bullous reactions including Stevens-Johnson and toxic epidermal necrolysis syndrome

Unknown

Nervous system disorders

Cerebral haemorrhage

Unknown

Ear and labyrinth disorders

Tinnitus

Unknown

Respiratory thoracic  and mediastinal disorders

Asthma, epistaxis, haemoptysis

Unknown

Skin and subcutaneous tissue disorders

Purpura, ecchymoses

Unknown

Renal and urinary disorders

Haematuria, urate kidney stones

Unknown

Investigations

Bleeding time prolonged

Unknown

Vascular disorders

Hypertension

Unknown

General disorders and administration site disorders

Oedema

Unknown

Cardiovascular

Cardiac failure,

Unknown

1The special coating of Nu-Seals helps to reduce the incidence of side effects resulting from gastric irritation.

2Sometimes fatal, particularly in the elderly

3May occur in various organ systems and may be fatal

4May occur following chronic GI blood loss or acute haemorrhage

 

 

 

1.1                 Undesirable effects

Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4 - Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed. The special coating of Nu-Seals 75 helps to reduce the incidence of side effects resulting from gastric irritation.

 

Blood & lymphatic system: Aspirin prolongs bleeding time, and bleeding disorders, have occasionally been reported.  Haemorrhages and haematoma in various organ systems may result, and fatalities have occurred.  Anaemia may occur following chronic gastrointestinal blood loss or acute haemorrhage. Very rarely, a reduction in platelet count (thrombocytopenia) may occur.

 

Immune system: Hypersensitivity reactions include skin rashes, urticaria, angioedema, bronchospasm and rarely, anaphylaxis.

 

Nervous system: Cerebral haemorrhage

 

Ear & labyrinth: Tinnitus

 

Respiratory: Asthma (see section 4.4 Special warnings and precautions), epistaxis, haemoptysis

 

Skin & subcutaneous tissue: Purpura, ecchymoses (see also Immune System)

 

Renal & urinary: Haematuria, urate kidney stones.

 

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

 

Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).

 

5.1       Pharmacodynamic properties

ATC code: N02B AB01A C06

 

Updated on 5 December 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation

Updated on 20 May 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes highlighted in red text below:

6.3 Shelf life
As packaged for sale: Blisters: Three years 
                                HDPE Containers: Two years.

Updated on 9 August 2012 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Please see amendments highlighted below in red

6.3 Shelf life
As packaged for sale: Two years.

After first opening of HDPE containers: Use within 8 weeks of opening

6.4 Special precautions for storage
Do not store above 25ºC.

Blister packs: Store in the original package in order to protect from moisture.

TabletHDPE containers: Keep the container tightly closed in order to protect from moisture. Store in the original package.

6.5 Nature and contents of container
UPVC/Aluminium foil blister packaging, pack sizes 28 and 56.
High-density polyethylene (HDPE) round plastic container with a plastic child-resistant tamper-evident screw cap, pack size 100. 
 

Updated on 2 August 2012 PIL

Reasons for updating

  • Change to packaging
  • Change to storage instructions

Updated on 31 July 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 December 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes/amendments highlighted in red text below:



2 Qualitative and Quantitative Composition





Each tablet contains:





Acetylsalicylic Acid Ph.Eur. (Aspirin) 300mg.



Excipients: also includes trace amounts of Ponceau 4R (E124)



For a full list of excipients see section 6.1.











6.1 List of Excipients







Maize Starch

Polyethlene Glycol 3350

Talc

Emulsion silicone

Hypromellose

Propylene Glycol

Benzyl alcohol

Methacrylic acid – ethyl acrylate (1:1) copolymer dispersion 30 per cent



Polyethylene glycol 3350

Propylene glycol

Benzyl alcohol

Emulsion silicone



Edible pPrinting ink containing Ponceau 4R (E124) shellac, iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide (E527) and simeticone









Updated on 2 December 2011 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 23 April 2009 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5 Now includes the following text

Ibuprofen: Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

 
 
Section 5.1 Now inlcudes the following text

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg vas taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

Updated on 23 April 2009 PIL

Reasons for updating

  • Change to drug interactions

Updated on 9 November 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 8 November 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 1 - trade name,
Change to section 2 - qualitative and quantitative composition,
Change to section 4.2 - Posology and Method of Administration,
Change to section 4.3 - Contra-indications,
Change to section 4.4 - Special Warnings and Precautions for Use,
Change to section 4.5 - Interactions with other Medicaments 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 5.1 - Pharmacodynamic Properties,
Change to section 6.1 - List of Excipients

Updated on 5 September 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1: Now reads, Nu-Seals 75 mg gastro-resistant tablets.
 
Section 2: Now reads

Each tablet contains:

            Aspirin (Acetylsalicylic Acid) 75mg.

 

            Excipients: also includes trace amounts of Ponceau 4R (E124)

            For a full list of excipients, see 6.1.

 

Section 6.1: Now reads

Edible printing ink containing ponceau 4R, E124.

 
Section 6.4: Now reads,

Do not store above 25ºC. Store in the original package. 

 
Section 6.6: Now reads

No special requirements

 
Section 7: Now reads

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

Updated on 6 March 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 28 November 2005 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 August 2004 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 22 July 2004 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)