Zyban 150 mg prolonged release tablets

  • Name:

    Zyban 150 mg prolonged release tablets

  • Company:
    info
  • Active Ingredients:

    Bupropion Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/10/17

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Summary of Product Characteristics last updated on medicines.ie: 2/10/2017
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

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Medicine Name Imigran Ftab 100mg Film-Coated Tablets Active Ingredients Sumatriptan Succinate
Medicine Name Imigran Ftab 50mg Film-Coated Tablets Active Ingredients Sumatriptan Succinate
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Medicine Name Integrilin 2 mg/ml solution for injection Active Ingredients Eptifibatide
Medicine Name IPV-Boostrix suspension for injection in pre-filled syringe Active Ingredients Diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated) vaccine
Medicine Name IPV-Infanrix Active Ingredients Diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated) vaccine
Medicine Name Lamictal 100mg chewable/dispersible tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 100mg tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 200mg chewable/dispersible tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 200mg tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 25mg chewable/dispersible tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 25mg tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 2mg chewable/dispersible tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 50mg chewable/dispersible tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 50mg Tablets Active Ingredients Lamotrigine
Medicine Name Lamictal 5mg chewable/dispersible tablets Active Ingredients Lamotrigine
51 - 75 of 135 items.Total: 6 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 2 October 2017 PIL

Reasons for updating

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

Updated on 2 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 October 2017 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

section 4.8 of SPC updated to include urinary incontinence as an adverse reaction.

Updated on 2 October 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 4 May 2017 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

SmPC - Sec 4.8 addition of hyponatraemia with frequency not known

Updated on 2 May 2017 PIL

Reasons for updating

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

Updated on 29 July 2016 PIL

Reasons for updating

  • Change of contraindications
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 29 July 2016 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

4.5          Interaction with other medicinal products and other forms of interaction - Co-administration of digoxin with bupropion may decrease digoxin levels. Digoxin AUC 0–24 h was decreased and renal clearance was increased in healthy volunteers, based on a cross-study comparison. Clinicians should be aware that digoxin levels may rise on discontinuation of bupropion and the patient should be monitored for possible digoxin toxicity.

Updated on 16 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 26 January 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic 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

Description of change to SPC:

NAME OF THE MEDICINAL PRODUCT – removal of ‘film coated’

PHARMACEUTICAL FORM - removal of ‘film coated’

Posology and method of administration – QRD and layout of text changes

Special warnings and precautions for use – QRD and new text regarding inappropriate routes of administration

Undesirable effects – addition of anaemia, leuocpenia and thrombocytopenia with frequency of unknown. Contact information for reporting of AE.

Pharmacokinetic properties – QRD changes

 

Update to section 4.4 of SPC to include warnings on inappropriate routes of administration, non-oral for recreational purposes.

 

Updated on 23 January 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 11 August 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 11 August 2014 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 1 - update to pharmaceutical form and removal of "film-coated" from name of product.

Updated on 10 March 2014 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

Changes to:

Section 4.4 - Special warnings and precautions for use,
Section 4.6 - Pregnancy and lactation,
Section 5.1 - Pharmacodynamic properties,
Section 5.3 - Preclinical safety data,
Section 6.5 - Nature and contents of container

Updated on 28 February 2014 PIL

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 20 November 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 30 August 2012 SmPC

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 6.6 - Special precautions for disposal and other handling

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

For a the full list of excipients, see section 6.1.

4.2       Posology and method of administration

Zyban tablets should be swallowed whole. The tablets should not be cut, crushed or chewed as this may lead to an increased risk of adverse effects including seizures.

4.3       Contraindications

Zyban is contraindicated in patients with hypersensitivity to bupropion or any of the excipients listed in section 6.1.

4.4       Special warnings and precautions for use

Interference with urine testing

Having an amphetamine-like chemical structure, bupropion interferes with the assay used in some rapid urine drug screens, which can result in false positive readings, particularly for amphetamines. A positive result should usually be confirmed with a more specific method.

4.5       Interaction with other medicinal products and other forms of interaction

In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir 400 mg (Kaletra) twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by approximately 20 to 80% (see section 5.2). Similarly, efavirenz 600 mg once daily for two weeks reduced the exposure of bupropion by approximately 55% in healthy volunteers. Patients receiving any of these drugs with bupropion may need increased doses of bupropion but the maximum recommended dose of bupropion should not be exceeded.

6.6       Special precautions for disposal

No special requirements for disposal.

Updated on 12 May 2011 PIL

Reasons for updating

  • Change to drug interactions

Updated on 12 May 2011 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 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 THE MEDICINAL PRODUCT

Zyban 150 mg prolonged release film-coated tablets.

 

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

4.         CLINICAL PARTICULARS

4.3       Contraindications

 

Zyban should not be administered to patients being treated with any other medicinal product containing bupropion as the incidence of seizures is dose dependent and to avoid overdosage.

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

4.4       Special warnings and precautions for use

Interactions (see section 4.5)

Due to pharmacokinetic interactions plasma levels of bupropion or its metabolites may be altered, which may increase the potential for undesirable effects (e.g. dry mouth, insomnia, seizures).  Therefore care should be taken when bupropion is given concomitantly with medicinal products which can induce or inhibit the metabolism of bupropion.

Bupropion inhibits metabolism by cytochrome P450 2D6. Caution is advised when medicinal products metabolised by this enzyme are administered concomitantly.

In the literature it has been shown that medications that inhibit CYP2D6 may lead to reduced concentrations of endoxifen which is the active metabolite of tamoxifen. Therefore the use of bupropion, which is an inhibitor of CYP2D6, should whenever possible be avoided during tamoxifen treatment (see section 4.5).

 

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

4.5       Interaction with other medicinal products and other forms of interaction

The effect of bupropion on other medicinal products:

Although not metabolised by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2D6 pathway.  Co-administration of bupropion hydrochloride and desipramine to healthy volunteers known to be extensive metabolisers of the CYP2D6 isoenzyme resulted in large (2- to 5-fold) increases in the Cmax and AUC of desipramine.  Inhibition of CYP2D6 was present for at least 7 days after the last dose of bupropion hydrochloride.

Concomitant therapy with medicinal products with narrow therapeutic indices that are predominantly metabolised by CYP2D6 should be initiated at the lower end of the dose range of the concomitant medicinal product.  Such medicinal products include certain antidepressants (e.g. desipramine, imipramine, paroxetine), antipsychotics (e.g. risperidone, thioridazine), beta-blockers (e.g. metoprolol), and Type 1C antiarrhythmics (e.g. propafanone, flecainide). If Zyban is added to the treatment regimen of a patient already receiving such a medicinal product, the need to decrease the dose of the original medicinal product should be considered.  In these cases the expected benefit of treatment with Zyban should be carefully considered compared with the potential risks.

Drugs which require metabolic activation by CYP2D6 in order to be effective (e.g. tamoxifen), may have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion (see section 4.4).

Although citalopram is not primarily metabolised by CYP2D6, in one study, bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively.

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

4.6       Fertility, Ppregnancy and lactation

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

10.       DATE OF REVISION OF THE TEXT

December 2010May 2011

Updated on 12 January 2011 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

1.         NAME OF THE MEDICINAL PRODUCT

Zyban 150 mg prolonged release film-coated tablets.

 

 

 

4.         CLINICAL PARTICULARS

4.5       Interaction with other medicinal products and other forms of interaction

 

The effect of other medicinal products on bupropion:

Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the cytochrome P450 CYP2B6 (see section 5.2).  Co-administration of medicinal products that may affect the metabolism of bupropion via CYP2B6 isoenzyme (e.g. CYP2B6 substrates: cyclophosphamide, ifosfamide, and CYP2B6 inhibitors: orphenadrine, ticlopidine, clopidogrel), may result in increased bupropion plasma levels and lower levels of active metabolite hydroxy-bupropion. The clinical consequences of the inhibition of interaction with the metabolism of bupropion via CYP2B6 enzyme and the consequent changes in the bupropion-hydroxybupropion ratio are currently unknown.

Since bupropion is extensively metabolised, caution is advised when bupropion is co-administered with medicinal products known to induce metabolism (e.g. carbamazepine, phenytoin, ritonavir, efavirenz) or inhibit metabolism (e.g. valproate), as these may affect its clinical efficacy and safety.

In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir 400 mg (Kaletra®) twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by approximately 20 to 80% (see section 5.2). Similarly, efavirenz 600 mg once daily for two weeks reduced the exposure of bupropion by approximately 55% in healthy volunteers.  This effect is thought to be due to the induction of bupropion metabolism. Patients receiving ritonavir any of these drugs with bupropion may need increased doses of bupropion but the maximum recommended dose of bupropion should not be exceeded.

Nicotine, administered transdermally by patches, did not affect the pharmacokinetics of bupropion and its metabolites.

 

 

 

 

10.       DATE OF REVISION OF THE TEXT

February December 2010

Updated on 22 March 2010 PIL

Reasons for updating

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

Updated on 18 March 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 4.8 - 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

 

Section 4.4 Special warnings and precautions for use

Update to paragraph regarding the elderly under the subheading ‘Specific patient groups’, removing the statement regarding decreased renal function in elderly patients, i.e:

Elderly – Clinical experience with bupropion has not identified any differences in tolerability between elderly and other adult patients. However, greater sensitivity of some elderly individuals cannot be ruled out. Elderly patients are more likely to have decreased renal function, hence 150 mg once a day is the recommended dose in these patients (see sections 4.2 and 5.2).

 

Section 4.6 Pregnancy and lactation

Statement regarding use in breast feeding mothers updated from advising against using Zyban when breast feeding to a risk-benefit appraoch, i.e.

As bBupropion and its metabolites are excreted in human breast milk mothers should be advised not to breast feed while taking Zyban. A decision on whether to abstain from breast-feeding or to abstain from therapy with Zyban should be made taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Zyban therapy to the mother.

 

Section 4.8 Undesirable effects

Updated the description of the frequency categories from ‘greater than’ (>) to ‘great than and equal to’ (≥).

 

Included additional frequency category ‘not known (cannot be estimated from the available data).

 

Added ‘psychosis’ as an additional side effect, with unknown frequency and in system order class ‘psychiatric disorders’.

 

Updated on 26 May 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 August 2008 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Section changed is 4.9 as follows:

Ensure an adequate airway, oxygenation and ventilation. Gastric lavage may be indicated if performed soon after ingestion. The use of activated charcoal is also recommended. No specific antidote for bupropion is known. Further management should be as clinically indicated

Updated on 25 July 2008 PIL

Reasons for updating

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

Updated on 28 May 2008 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

New wording in relation to suicidal ideation, warnings regarding crushing or chewing tablets and interactions with Ritonavir

Updated on 15 November 2006 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company


4.5. Interaction with Other Medicinal Products and Other Forms of Interaction

In patients receiving medicinal products known to lower the seizure threshold, Zyban must only be used if there is a compelling clinical justification for which the potential medical benefit of smoking cessation outweighs the increased risk of seizure (see 4.4 Special Warnings and Precautions for use).

The effect of bupropion on other medicinal products:

Although not metabolised by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2D6 pathway. Co-administration of bupropion hydrochloride and desipramine to healthy volunteers known to be extensive metabolisers of the CYP2D6 isoenzyme resulted in large (2- to 5-fold) increases in the Cmax and AUC of desipramine. Inhibition of CYP2D6 was present for at least 7 days after the last dose of bupropion hydrochloride.

Although not formally studied, cConcomitant therapy with medicinal products with narrow therapeutic indices that are predominantly metabolised by CYP2D6 should be initiated at the lower end of the dose range of the concomitant medicinal product. Such medicinal products include certain antidepressants (e.g. desipramine, imipramine, paroxetine), antipsychotics (e.g. risperidone, thioridazine), beta-blockers (e.g. metoprolol), and Type 1C antiarrhythmics (e.g. propafanone, flecainide). If Zyban is added to the treatment regimen of a patient already receiving such a medicinal product, the need to decrease the dose of the original medicinal product should be considered. In these cases the expected benefit of treatment with Zyban should be carefully considered compared with the potential risks.

Although citalopram is not primarily metabolised by CYP2D6, in one study, bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively.

The effect of other medicinal products on bupropion:

In vitro findings indicate that bBupropion is metabolised to its major active metabolite hydroxybupropion primarily by the cytochrome P450 CYP2B6 (see 5.2 Pharmacokinetic Properties). Care should therefore be exercised when Zyban is co-administered with Co-administration of medicinal products that may affect the CYP2B6 isoenzyme (e.g.: CYP2B6 substrates: orphenadrine, cyclophosphamide, ifosfamide, and CYP2B6 inhibitors: orphenadrine, ticlopidine, clopidogrel),. may result in increased bupropion plasma levels and lower levels of active metabolite hydroxy-bupropion. The clinical consequences of the interaction with CYP2B6 enzyme and the consequent changes in the bupropion-hydroxybupropion ratio are currently unknown.

Since bupropion is extensively metabolised, caution is advised when bupropion is co-administered with medicinal products known to induce metabolism (e.g. carbamazepine, phenytoin) or inhibit metabolism (e.g. valproate), as these may affect its clinical efficacy and safety.

In a healthy volunteer study, ritonavir at a dose of 600mg twice daily for 20 days decreased the AUC(0-inf) and the Cmax of bupropion by approximately 65% and 60% respectively. The plasma levels of the active metabolites also decreased significantly after long-term use of ritonavir. This effect is thought to represent induction of metabolism, however ritonavir has also been shown to inhibit metabolism by CYP2B6 in vitro. Therefore, the recommended dose of bupropion should not be exceeded. In contrast to long-term administration of ritonavir, there was no significant interaction with bupropion after short-term administration of low doses of ritonavir (200 mg twice daily for 2 days). However, the effects of long-term low-dose ritonavir ("booster-dose") treatment on bupropion metabolism remains to be investigated.

Nicotine, administered transdermally by patches, did not affect the pharmacokinetics of bupropion and its metabolites.

.....ETC

Updated on 28 September 2006 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose

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

The safety of Zyban for use in human pregnancy has not been established.

In a retrospective study, there was no greater proportion of congenital malformations or cardiovascular malformations amongst more than a thousand first trimester exposures to bupropion compared with the use of other antidepressants.

Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri-natal or post-natal development. Exposure in animals was, however, similar to the systemic exposure achieved in humans at the maximum recommended dose. The potential risk in humans is unknown.

.....etc.

4.9. Overdose

Acute ingestion of doses in excess of 10 times the maximum therapeutic dose has been reported. In addition to those events reported as Undesirable Effects, overdose has resulted in symptoms including drowsiness, loss of consciousness and/or ECG changes such as conduction disturbances (including QRS prolongation), arrhythmias and tachycardia. QTc prolongation has also been reported but was generally seen in conjunction with QRS prolongation and increased heart rate. Experimental and clinical data do not rule out potential for QT prolongation and widening of QRS at supra-therapeutic levels. Although most patients recovered without sequelae, deaths associated with overdoses of bupropion have been reported rarely in patients ingesting massive large overdoses of the drug.

Treatment: In the event of overdose, hospitalisation is advised. ECG and vital signs should be monitored.

.....etc

Updated on 13 February 2006 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 6 January 2006 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 1 June 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 April 2005 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 4.3 - Contraindications
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients

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

Updated on 3 March 2004 SmPC

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)

Updated on 2 March 2004 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 20 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 3 July 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 19 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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