Escitalpro 5 mg, 10 mg, 15 mg & 20 mg film-coated tablets

  • Name:

    Escitalpro 5 mg, 10 mg, 15 mg & 20 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Escitalopram Oxalate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/02/18

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Summary of Product Characteristics last updated on medicines.ie: 25/9/2019

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Gerard Laboratories

Gerard Laboratories

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1 - 0 of 117 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 25 September 2019 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 10 - Date of revision of the text

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

Updated on 21 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 February 2018 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 11 December 2017 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

Opaque PVC/PVdC/Aluminium blisters with an outer carton; 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 100, 180, 200, tablets
Opaque PVC/PVdC/Aluminium perforated unit dose blisters with an outer carton; 28 x 1, 56 x 1 tablets Polypropylene tablet container: 28, 49, 100, 200, 250, 500 tablets
Not all pack sizes may be marketed.


10. DATE OF REVISION OF THE TEXT

December 2016September 2017


Updated on 11 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 December 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 7 June 2017 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

Opaque PVC/PVdC/Aluminium blisters with an outer carton; 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 100, 180, 200, tablets
Opaque PVC/PVdC/Aluminium perforated unit dose blisters with an outer carton: ; 28 x 1 tablets (not 5 mg tablets).
Polypropylene tablet container: 28, 49, 100, 200, 250, 500 tablets
Not all pack sizes may be marketed.

10. DATE OF REVISION OF THE TEXT

May 2016December 2016

Updated on 6 June 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 7 July 2016 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

3. PHARMACEUTICAL FORM

Film-coated tablet.
Escitalpro 5 mg film-coated tablets: round, white, film-coated tablet marked with "EC 5" on one side and “G” on the other. The tablets are circular with a diameter of 5.5 mm.                                                                                                                 
Escitalpro 10 mg film-coated tablets: oblong, white, scored, film-coated tablet marked with "EC|10" on one side and “G” on the other. The tablets are oblong with dimensions of 9.5 mm x 5.5 mm. The tablet can be divided into equal doses.

Escitalpro 15 mg film-coated tablets: oblong, white, scored, film-coated tablet marked with "EC|15" on one side and “G” on the other. The tablets are oblong with dimensions of 10.5 mm x 6.0 mm. The tablet can be divided into equal doses.

Escitalpro 20mg film-coated tablets: oblong, white, scored, film-coated tablet marked with "EC|20" on one side and “G” on the other. The tablets are oblong with dimensions of 12.5 mm x 7 mm. The tablet can be divided into equal doses.

4.2 Posology and method of administration

Obsessive-Compulsive disorderDisorder
Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily.
As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free. Treatment benefits and dose should be re-evaluated at regular intervals (see section 5.1).

Paediatric population
Escitalpro should not be used in the treatment of Children children and Adolescents adolescents under 18 years of age (see Section section 4.4).


4.3 Contraindications

Hypersensitivity to escitalopram the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Diabetes
In patients with diabetes, treatment with an SSRI may alter glycaemic control (hypoglaycaemia hypoglycaemia or hyperglycaemia). Insulin and/or oral hypoglycaemic dosage may need to be adjusted.

Discontinuation symptoms seen when stopping treatment
Discontinuation symptoms when stopping treatment are common, particularly if discontinuation is abrupt (see section 4.8). In clinical trials adverse events seen on treatment discontinuation occurred in approximately 25% of patients treated with escitalopram and 15% of patients taking placebo.

The risk of discontinuation 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 and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. Generally these symptoms are mild to moderate; however, in some patients they may be severe in intensity.

4.6 Fertility, pregnancy and lactation

Pregnancy
For escitalopram only limited clinical data are available regarding exposed pregnancies.

Animal studies have shown reproductive toxicity (see section 5.3). In reproductive toxicity studies performed in rats with escitalopram, embryo-fetotoxic effects, but no increased incidence of malformations, were observed (see section 5.3). The risk for humans is unknown. Therefore, Escitalpro tablets should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit.

4.8 Undesirable effect

 

Very common

Common

Uncommon

Rare

Very rare

Not known

Blood and lymphatic system disorders

 

 

 

 

 

Thrombocytopenia

Immune system disorders

 

 

 

Anaphylactic reaction

 

 

Endocrine disorders

 

 

 

 

 

Inappropriate ADH secretion

Metabolism and nutrition disorders

 

 

Decreased appetite, increased appetite Weight increased

Weight decreased

 

 

Hyponatraemia, anorexia2 anorexia1

Psychiatric disorders

 

 

Anxiety, restlessness, abnormal dreams

Female and male: libido decreased

female: anorgasmia

Bruxism, agitation, nervousness, panic attack, confusional state

Aggression, depersonalisation hallucination

 

Mania, suicidal ideation, suicidal behaviour2behaviour1

Nervous system disorders

 

Headache

Insomnia, somnolence, dizziness, paraesthesia, tremor

Taste disturbance, sleep disorder, syncope

Serotonin syndrome

 

Dyskinesia, movement disorder, convulsion, psychomotor restlessness/akathisia1akathisia2

Eye disorders

 

 

Mydriasis, visual disturbance

 

 

 

Ear and labyrinth disorders

 

 

Tinnitus

 

 

 

Cardiac disorders

 

 

Tachycardia

Bradycardia

 

Electrocardiogram QT prolonged, ventricular arrhythmia including torsade de pointes

Vascular disorders

 

 

 

 

 

Orthostatic hypotension

Respiratory, thoracic and mediastinal disorders

 

 

Sinusitis, yawning

Epistaxis

 

 

 

Gastro-instestinal disorders

Nausea

 

Diarrhoea, constipation, vomiting, dry mouth

 

Gastrointestinal haemorrhages (including rectal haemorrhage)

 

 

 

Hepatobiliary disorders

 

 

 

 

 

Hepatitis, Liver function test abnormal

Skin and subcutaneous tissue disorders

 

 

Sweating increased

 

Urticaria, alopecia, rash, pruritus

 

 

Ecchymosis, angioedemas

Musculo-skeletal and connective tissue disorders

 

Arthralgia, myalgia

 

 

 

 

Renal and urinary disorders

 

 

 

 

 

Urinary retention

Reproductive system and breast disorders

 

 

Male: ejaculation disorder, impotence

Female: metrorrhagia, menorrhagia

 

 

Galactorrhoea Male: priapism,

 

General disorders and administration site conditions

 

 

Fatigue, pyrexia

Oedema

 

 

 

1 These events have been reported for the therapeutic class of SSRIs.
1 2 Cases of suicidal ideation and suicidal behaviours have been reported during escitalopram therapy or early after treatment discontinuation (see section 4.4)
2 These events have been reported for the therapeutic class of SSRIs.

QT interval prolongation
Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT interval prolongation or other cardiac diseases (see sections 4.3, 4.4, 4.5, 4.9 and 5.1).

Class effects
Epidemiological 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.

Discontinuation symptoms seen when stopping treatment
Discontinuation of SSRIs/SNRIs (particularly when abrupt) commonly leads to discontinuation symptoms. Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. 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 escitalopram treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).

QT interval prolongation
Cases
of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT interval prolongation or other cardiac diseases (see sections 4.3, 4.4, 4.5, 4.9 and 5.1).


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 HPRA Pharmacovigilance

5.1  Pharmacodynamic properties

Generalised Anxiety anxiety Disorderdisorder
Escitalopram in doses of 10 and 20 mg/day was effective in four out of four placebo-controlled studies.

5.2 Pharmacokinetic properties

Linearity
There is linear pharmacokinetics. Steady-state plasma levels are achieved in about 1 week. Average steady-state concentrations of 50 nmol/L (range 20 to 125 nmol/L) are achieved at a daily dose of 10 mg.

5.3 Preclinical safety data

No complete conventional battery of preclinical studies was performed with escitalopram since the bridging toxicokinetic and toxicological studies conducted in rats with escitalopram and citalopram showed a similar profile. Therefore, all the citalopram information are expected can to be extrapolated to escitalopram.

In comparative toxicological studies in rats, escitalopram and citalopram caused cardiac toxicity, including congestive heart failure, after treatment for some weeks, when using dosages that caused general toxicity. The cardiotoxicity seemed to correlate with peak plasma concentrations rather than to systemic exposures (AUC). Peak plasma concentrations at no-effect-level were in excess (8-fold) of those achieved in clinical use, while AUC for escitalopram was only 3- to 4-fold higher than the exposure achieved in clinical use. For citalopram AUC values for the S-enantiomer were 6- to 7-fold higher than exposure achieved in clinical use. The findings are probably related to an exaggerated influence on biogenic amines i.e. secondary to the primary pharmacological effects, resulting in hemodynamic effects (reduction in coronary flow) and ischemia. However, the exact mechanism of cardiotoxicity in rats is not clear. Clinical experience with citalopram, and escitalopram, together with the clinical trial experience with escitalopram, do not indicate that these findings have a clinical correlate.

 

Updated on 5 July 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 25 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

In section 6.5, clear to opaque blisters:

ClearOpaque PVC/PVdC/Aluminium blisters with an outer carton; 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 100, 180, 200, tablets.

ClearOpaque PVC/PVdC/Aluminium perforated unit dose blisters with an outer carton: 28 x 1 tablets (not 5 mg tablets).

Updated on 20 February 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Sections 4.1, 4.2 and 5.1 updated to include information relating to the indication "Treatment of generalized anxiety disorder".

Updated on 20 February 2015 PIL

Reasons for updating

  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 4 July 2014 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 4 July 2014 PIL

Reasons for updating

  • New PIL for new product