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Lexapro 20 mg tablets

*
Pharmacy Only: Prescription

  • Company:

    Lundbeck (Ireland) Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Escitalopram Oxalate

    *Additional information is available within the SPC or upon request to the company

Updated on 07 February 2024

File name

IE Lexapro fct_PIL clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 07 February 2024

File name

IE Lexapro 20 mg fct_SPC clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

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

Updated on 02 June 2022

File name

IE Lexapro 20 mg fct_SPC clean.pdf

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

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

Updated on 02 June 2022

File name

IE Lexapro fct_PIL clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 09 April 2021

File name

IE Lexapro 20 mg - SPC - Clean.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Typing error correction in section 4.2 Method of administration: Correction to product name "Lexapro" instead of Cipralex.

Updated on 27 January 2021

File name

1-3-1 PL IE Lexapro 5 10 15 20 mg FCT - REG_013031.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

PRAC Recommendation - update to sections 2 and 4 (post partum haemorrhage)

Updated on 27 January 2021

File name

1-3-1 IE Lexapro 20 mg - REG_013800.pdf

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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

PRAC Recommendation - change to sections 4.4, 4.6 and 4.8 (post partum haemorrhage)

Updated on 20 July 2020

File name

1-3-1 IE Lexapro 20 mg - REG_013800.pdf

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

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

Updated on 08 July 2020

File name

1-3-1 IE Lexapro 20 mg - REG_013800.pdf

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

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

Updated on 08 July 2020

File name

1-3-1 PL IE Lexapro 5 10 15 20 mg FCT - REG_013031.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect

Updated on 30 April 2020

File name

REG_013031.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 30 April 2020

File name

REG_013800 spc 20 mg.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 27 April 2020

File name

REG_013031.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Section 2. What you need to know before you take Lexapro
xxx
Driving and using machines
You are advised not to drive a car or operate machinery until you know how
Lexapro affects you.
Lexapro contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is
to say essentially ‘sodium-free’.

Updated on 27 September 2019

File name

1-3-1 IE Lexapro 20 mg.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 27 September 2019

File name

1-3-1 PL IE Lexapro 5 10 15 20 mg FCT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 12 August 2019

File name

1-3-1 PL IE Lexapro 5 10 15 20 mg FCT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 12 August 2019

File name

1-3-1 IE Lexapro 20 mg.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 09 May 2019

File name

1-3-1 PL IE Lexapro 5 10 15 20 mg FCT.pdf

Reasons for updating

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

Updated on 08 May 2019

File name

1-3-1 IE Lexapro 20 mg.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 28 July 2015

File name

PIL_8312_56.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 27 July 2015

Reasons for updating

  • New SPC for new product

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

Updated on 27 July 2015

Reasons for updating

  • 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

Section 4.8: Change in HPRA name and details.

Updated on 08 November 2013

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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company

In section 4.3, the statement regarding hypersensitivity has been updated.
In section 4.4, information regarding Angle-Closure Glaucoma has been added.
In section 4.5, information regarding medicinal products inducing hypokalaemia/hypomagnesaemia has been included.
In section 4.6, the information relating to pregnancy has been updated and the heading Lactation has been changed to Breast-feeding.
In section 4.8, headache has been added to the table of undesirable effects, the warning regarding QT interval prolongation has been moved and information regarding reporting of suspected adverse reactions to the IMB has been added.
In section 5.2, the heading Linearity has been included.
In section 6.4, the precautions for storage statement has been updated.
In section 7, the address of the MAH has been updated.
In section 10, the date of the revision of the text has been updated.


Updated on 06 November 2013

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 date of revision
  • Change due to harmonisation of PIL
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 18 October 2012

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Section 4.6. The following text has been added:

Fertility

Animal data have shown that citalopram may affect sperm quality (see section 5.3).

Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far.

Section 5.3. The following text has been added:
Animal data have shown that citalopram induces a reduction of fertility index and pregnancy index, reduction in number in implantation and abnormal sperm at exposure well in excess of human exposure. No animal data related to this aspect are available for escitalopram.

Section 10. Changed date to October 2012

Updated on 17 October 2012

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 31 January 2012

Reasons for updating

  • Change to side-effects

Updated on 18 January 2012

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 4.2 Elderly changed from:
Elderly patients (> 65 years of age)
Initial treatment with half the usually recommended dose and a lower maximum dose should be considered(see section 5.2).
The efficacy of Lexapro in social anxiety disorder has not been studied in elderly patients.

to:
Elderly patients (> 65 years of age)
Initial dosage is 5 mg once daily. Depending on individual patient response the dose may be increased to 10 mg daily (see section 5.2).
The efficacy of Lexapro in social anxiety disorder has not been studied in elderly patients.

Section 4.3 New paragraphs:

Escitalopram is contraindicated in patients with known QT interval prolongation or congenital long QT syndrome. 

 

Escitalopram is contraindicated together with medicinal products that are known to prolong the QT interval (see section 4.5).


Section 4.4 Hyponatraemia
'the' placed before 'elderly'

Section 4.4 New paragraphs:
QT interval prolongation
Escitalopram has been found to cause a dose-dependent prolongation of the QT interval. 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, 4.5, 4.8, 4.9 and 5.1).

Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure.

Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for malignant arrhythmias and should be corrected before treatment with escitalopram is started.

If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started.

If signs of cardiac arrhythmia occur during treatment with escitalopram, the treatment should be withdrawn and an ECG should be performed.

Section 4.5 New paragraph
QT interval prolongation
Pharmacokinetic and pharmacodynamic studies of escitalopram combined with other medicinal products that prolong the QT interval have not been performed. An additive effect of escitalopram and these medicinal products cannot be excluded. Therefore, co-administration of escitalopram with medicinal products that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine), is contraindicated.

Section 4.5
Cimetidine paragraph:
Caution is advised when administering escitalopram in combination with cimetidine. Dose adjustment may be warranted.

Section 4.8
≤ 1/10,000 changed to <1/10,000

New warning in cardiac section (Not known):
ventricular arrhythmia including Torsade de Pointes

Section deleted:
Cases of QT-prolongation have been reported during the post-marketing period, predominantly in patients with pre-existing cardiac disease. In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTc (Fridericia-correction) was 4.3 msec at the 10 mg/day dose and 10.7 msec at the 30 mg/day dose.

Section added:
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).

Section 4.9
'interval' placed before 'prolongation' in Symptoms section

Treatment heading changed to Management
Extra paragraph:
ECG monitoring is advised in case of overdose in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT interval, or in patients with altered metabolism, e.g. liver impairment.

Section 5.1 extra paragraph
Pharmacodynamic effects
In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTc (Fridericia-correction) was 4.3 ms (90% CI: 2.2, 6.4) at the 10 mg/day dose and 10.7 ms (90% CI: 8.6, 12.8) at the supratherapeutic dose 30 mg/day (see section 4.3, 4.4, 4.5, 4.8 and 4.9).

Section 7
Address changed from 7-9 from 9
Valby placed before Copenhagen

Updated on 09 November 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4

Seizures

Escitalopram The medicinal product should be discontinued if a patient in any patient who develops seizures for the first time, or if there is an increase in seizure frequency (in patients with a previous diagnosis of epilepsy). SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be closely carefully monitored. SSRIs should be discontinued if there is an increase in seizure frequency.


Hyponatraemia

Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of SSRIs and generally resolves on discontinuation of therapy. Caution should be exercised in patients at risk, such as elderly, or patients with cirrhosis, or if used in combination with other medications which maytic patients or patients concomitantly treated with medications known to cause hyponatraemia.

Haemorrhage

Altered anti-coagulant effects may occur when escitalopram is combined with oral anticoagulants. Patients receiving oral anticoagulant therapy should receive careful coagulation monitoring when escitalopram is started or stopped (see section 4.4).

Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase bleeding-tendency (see section 4.4).

Section 4.8

System organ class

Frequency

Undesirable Effect

 

Blood and lymphatic system disorders

Not known

Thrombocytopenia

Immune system disorders

Rare

Anaphylactic reaction

Endocrine disorders

Not known

Inappropriate ADH secretion

Metabolism and nutrition disorders

Common

Decreased appetite, increased appetite, weight increased

Uncommon

Weight decreased

Not known

Hyponatraemia, anorexia2

Psychiatric disorders

Common

Anxiety, restlessness, abnormal dreams

Female and male: libido decreased

Female: anorgasmia

Uncommon

Bruxism, agitation, nervousness, panic attack, confusional state

Rare

Aggression, depersonalisation, hallucination

Not known

Mania, suicidal ideation, suicidal behaviour1

Nervous system disorders

Common

Insomnia, somnolence, dizziness, paraesthesia, tremor

Uncommon

Taste disturbance, sleep disorder, syncope

Rare

Serotonin syndrome

Not known

Dyskinesia, movement disorder, convulsion, psychomotor restlessness/akathisia2

Eye disorders

Uncommon

Mydriasis, visual disturbance

Ear and labyrinth disorders

Uncommon

Tinnitus

Cardiac disorders

Uncommon

Tachycardia

Rare

Bradycardia

Not known

Electrocardiogram QT prolonged

Vascular disorders

Not known

Orthostatic hypotension

Respiratory, thoracic and mediastinal disorders

Common

Sinusitis, yawning

Uncommon

Epistaxis

Gastrointestinal disorders

Very common

Nausea

Common

Diarrhoea, constipation, vomiting, dry mouth

Uncommon

Gastrointestinal haemorrhages (including rectal haemorrhage)

Hepatobiliary disorders

Not known

Hepatitis, liver function test abnormal

Skin and subcutaneous tissue disorders

Common

Sweating increased

Uncommon

Urticaria, alopecia, rash, pruritus

Not known

Ecchymosis, angioedemas

Musculoskeletal and connective tissue disorders

Common

Arthralgia, myalgia

Renal and urinary disorders

Not known

Urinary retention

Reproductive system and breast disorders

Common

Male: ejaculation disorder, impotence

Uncommon

Female: metrorrhagia, menorrhagia

Not known

Galactorrhoea

Male: priapism

General disorders and administration site conditions

Common

Fatigue, pyrexia

Uncommon

Oedema


2 These events have been reported for the therapeutic class of SSRIs.

 

The following adverse drug reactions have been reported for the therapeutic class of SSRIs: psychomotor restlessness/akathisia (see section 4.4) and anorexia.

 

Cases of QT-prolongation have been reported during the post-marketing period, predominantly in patients with pre-existing cardiac disease. No causal relationship has been established. In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTc (Fridericia-correction) was 4.3 msec at the 10 mg/day dose and 10.7 msec at the 30 mg/day dose.



Updated on 08 November 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability

Updated on 23 September 2010

Reasons for updating

  • Improved electronic presentation

Updated on 06 September 2010

Reasons for updating

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

Updated on 03 September 2010

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

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in 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.

 

4. 8 Undesirable 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.

Updated on 31 August 2010

Reasons for updating

  • Introduction of new pack/pack size

Updated on 13 August 2010

Reasons for updating

  • 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



High Density Polyethylene (HDPE) container; 100 (5, 10, 15 and 20 mg), 200 (5 and 10 mg) tablets

Updated on 25 August 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 12 August 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 19 May 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4


or clinical worsening added to title

 

Text added:

 

'known to be'

 

A meta analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.

 

'any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour'

 

Text deleted:

 

In addition, there is a possibility of an increased risk of suicidal behaviour in young adults.

 

the emergence of such events

 

Section 4.8

 

Text added to Pschiatric disorder section:

 

suicidal ideation, suicidal behaviour[1]

Updated on 19 May 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 19 December 2007

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 December 2007

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

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 4.8 - Undesirable Effects, Change to section 7 - Marketing Authorisation Holder, Change to section 10 (date of (partial) revision of the text

Updated on 29 August 2007

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 16 August 2007

Reasons for updating

  • Correction of spelling/typing errors

Updated on 16 May 2007

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder

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
56x1 & 98x1 added to Transparent blister pack size
 
Section 7
Address changed from 7-9 to 9

Updated on 16 May 2007

Reasons for updating

  • Change to marketing authorisation holder
  • Change due to harmonisation of patient information leaflet

Updated on 28 February 2007

Reasons for updating

  • Change to, or new use for medicine

Updated on 12 February 2007

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

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wet[ojwe[tojwertwetwetwqet

Updated on 09 February 2007

Reasons for updating

  • Improved electronic presentation
  • Correction of spelling/typing errors

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

Updated on 01 February 2007

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation

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

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Due to detailed changes to this SPC, please copy and paste the following url into your web browser to view the change details:
 
 

Updated on 29 September 2006

Reasons for updating

  • Change to marketing authorisation holder
  • Correction of spelling/typing errors

Updated on 05 May 2006

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Improved electronic presentation

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

Updated on 28 November 2005

Reasons for updating

  • Change to, or new use for medicine

Updated on 22 November 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 11 October 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 11 October 2005

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 04 August 2005

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
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 04 August 2005

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 09 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 06 August 2004

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Updated on 05 March 2004

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 28 January 2004

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 13 August 2003

Reasons for updating

  • Change to joint SPC covering all presentations

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

Updated on 25 June 2003

Reasons for updating

  • New SPC for medicines.ie

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