Lipantil Micro 200mg capsules, hard

  • Name:

    Lipantil Micro 200mg capsules, hard

  • Company:
    info
  • Active Ingredients:

    Fenofibrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/06/17

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Summary of Product Characteristics last updated on medicines.ie: 5/7/2017
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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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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 5 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 July 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

7.  MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

BGP Products Ireland Limited

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER

 

PA 2010/15/2 2007/12/2

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 30 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 June 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 28 March 2017 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 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2: Additional info added re: posology in Elderly patients and patients with Renal impairment.

Section 4.3: Contra-indications: Severe renal dysfunction deleted and 'Severe Renal Insufficiency' added

Section 4.4: Renal Function section: Additional information added regarding precautions for use

Section 4.6: Additional info. added re: Fertility

Section 4.8 Undesirable effects: UEs deleted and added

Section 5.3: Pre-clinical safety data: Additional information added re: non clinical study in rat species and a repeat dose toxicity study

Updated on 27 March 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 6 October 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 9 July 2015 PIL

Reasons for updating

  • Change of manufacturer
  • Change to further information section

Updated on 18 June 2015 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Section 3 - Update capsu;le colour to ochre
Section 6.1 - Update to colourants in excipients list

Updated on 17 June 2015 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to appearance of the medicine

Updated on 15 June 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

Section 4.8 - addition of information regarding reporting of side effects

Updated on 12 June 2015 PIL

Reasons for updating

  • Change of manufacturer
  • Addition of information on reporting a side effect.

Updated on 8 April 2015 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Section 7: Marketing authorisation holder changed from Abbott Healthcare Products Ltd. to BGP Products Ltd.
Section 8: PA number updated

Updated on 31 March 2015 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 23 October 2014 SmPC

Reasons for updating

  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Cahnge in address from Shampton to Maidenhead

Updated on 9 October 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to further information section
  • Change to MA holder contact details

Updated on 15 August 2013 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

- section 4.6 : amendment to lactation statement
- section 4.8: addition of reference to ' skin and subcutaneous tissue disorders' in undesirable effects 

Updated on 13 August 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 11 June 2013 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Significant updates to sections 4.2, 4.3, 4.4, 4.6, 4.8, 5.1 & 5.2

Updated on 15 May 2013 PIL

Reasons for updating

  • Change to drug interactions
  • Change to improve clarity and readability

Updated on 24 July 2012 PIL

Reasons for updating

  • Change of contraindications
  • Change to dosage and administration

Updated on 23 July 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

Section 4.2: the following information was added re: Paediatric population:


Paediatric population:

The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established.  No data are available.  Therefore, the use of fenofibrate is not recommended in paediatric subjects under 18 years.



Section 4.3:  deletion of contraindication re: children

Updated on 23 December 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 4 July 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

4.1.      Therapeutic Indications

In the adult, hyperlipidaemia when modifications to diet have been insufficient.

It is always essential to continue the diet.

At the present time, no results of long-term controlled clinical trials are available to demonstrate the efficacy of fenofibrate in the primary or secondary prevention of atherosclerotic complications.

LipantilÒ Micro 200mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.

- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

- Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

Section5.1

At the present time, no results of long-term controlled clinical trials are available to demonstrate the efficacy of fenofibrate in the primary or secondary prevention of atherosclerotic complications.

There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin. Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%). In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (≤34 mg/dl or 0.88 mmol/L) and highest tertile of TG (≥204 mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p = 0.03; absolute risk reduction: 4.95%). Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p = 0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069). This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.

Updated on 18 March 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.1: Has been updated as follows;

 

From:

 

In the adult, hyperlipidaemia when modifications to diet have been insufficient.

It is always essential to continue the diet.

 

At the present time, no results of long-term controlled clinical trials are available to demonstrate the efficacy of fenofibrate in the primary or secondary prevention of atherosclerotic complications.

To:

 

LipantilÒ Micro 200mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.

- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

- Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

Section 5.1: Has been updated as follows;

 

At the present time, no results of long-term controlled clinical trials are available to demonstrate the efficacy of fenofibrate in the primary or secondary prevention of atherosclerotic complications.

 

There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.

 

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin. Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%). In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (34 mg/dl or 0.88 mmol/L) and highest tertile of TG (204 mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p = 0.03; absolute risk reduction: 4.95%). Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p = 0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069). This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.

Updated on 25 January 2011 SmPC

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

The following additions/updates to the Lipantil Micro 200mg SPC have been made and are highlighted in bold and italics.

Section 2: addition of the following;

Excipients: each capsule contains 101 mg of lactose monohydrate.

Section 4.2: as well as an update of the subheadings the following information has been included;

Method of administration: Capsules should be swallowed whole with water.


Section 4.3: Bullet points have been introduced for clarity and the following have been updated;

hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality e.g. persistent elevations in serum transaminases)
• - children (age below 18 years)


Section 4.4: As well as an update to the subheadings the following have been introduced/modified;


Liver Function: Moderately elevated levels of serum transaminases may be found in some patients but rarely interfere with treatment. However, it is recommended that serum transaminases should be monitored every three months during the first twelve months of treatment and thereafter periodically. Treatment should be discontinued if ASAT (SGOT) and ALAT (SGPT) levels increase to more than 3 times the upper limit of the normal range. When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus), and are confirmed by laboratory testing, fenofibrate therapy should be discontinued.


Renal function: In renal dysfunction, the dose of fenofibrate may need to be reduced, depending on the rate of creatinine clearance (see Section 4.2). Dose reduction should be considered in elderly patients with impaired renal function. Treatment should be interrupted in case of an increase in creatinine levels > 50% ULN (upper limit of normal). It is recommended that creatinine is measured during the first three months after initiation of treatment and thereafter periodically (for dose recommendations, see section 4.2 Posology and method of administration).

Section 4.5:

Oral Anti-coagulants: Fenofibrate enhances oral anti-coagulant effect and may increase risk of bleeding. It is recommended that the dose of anti-coagulant is reduced by about one-third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring. Therefore, this combination is not recommended.

Glitazones: Some cases of reversible paradoxical reduction of HDL-cholesterol have been reported during concomitant administration of fenofibrate and glitazones. Therefore, it is recommended to monitor HDL-cholesterol if one of these components is added to the other and stopping of either therapy if HDL-cholesterol is too low.

Cytochrome P450 enzymes: In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6, and mild-to-moderate inhibitors of CYP2C9 at therapeutic concentrations.

Patients co-administered fenofibrate and CYP2C19, CYP2A6, and especially CYP2C9 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.

Section 4.7:

Lipantil Micro 200 mg, capsules have no or negligible influence on the ability to drive and use machines.


Section 4.8: This section has been updated with the SPC guidelines and the undesirable effects tabulated according to the MedDRA system organ class and ranked under headings of frequency. ADRs noted in clinical trails are tabulated with information on post marketing ADRs (frequency not known) also included.


Section 4.9:

No case of overdosage has been reported. Only anecdotal cases of fenofibrate overdosage have been received. In the majority of cases no overdose symptoms were reported.
No specific antidote is known. If an overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

Section 5.1:

During clinical trials with fenofibrate total cholesterol is reduced by 20 to 25%, triglycerides by 40-55% and HDL cholesterol is increased by 10 to 30%.
In hypercholesterolaemic patients, where LDL cholesterol levels are reduced by 20 to 35%, the overall effect on cholesterol results in a decrease in the ratios of total cholesterol to HDL cholesterol, LDL cholesterol to HDL cholesterol, or Apo B to Apo A-I, all of which are markers of atherogenic risk.

Section 6.4:

Store in the original package in order to protect from moisture.

This medicinal product does not require any special temperature storage conditions.

Updated on 23 September 2010 SmPC

Reasons for updating

  • 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

Name of the Marketing Authorisation Holder has been changed to Abbott Healthcare Products Ltd.

Updated on 21 September 2010 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 9 April 2009 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 7 April 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

 

Section 2: Updated to include the excipient Lactose monohydrate. Further, standard comment added to refer to section 6.1 of the SPC

section 3: "s" removed from capsules to read capsule

section 6.1: each excipient is now listed on a separate line.

section 6.5: asterix removed

section 6.6: heading updated to be in line with current SPC guidelines. Following additonal sentence added; "Any unused product or waste material should be disposed of in accordance with local requirements."

section 4.8:frequency of hepatitis changed from very rare to rare.

section 9: date of last renewal changed to 13th July 2008

section 10: last revision of text changed to March 2009

Updated on 27 August 2008 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

  Section 4.3; Now reads as follows: 

Lipantil Micro 200mg is contra-indicated in children, in patients with severe liver or renal dysfunction, gallbladder disease, biliary cirrhosis, in patients hypersensitive to fenofibrate or any component of this medication, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, and in patients with chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.

Section 4.4:

 Under renal impairment the following additional has been made:

Treatment should be interrupted in case of an increase in creatinine levels > 50% ULN (upper limit of normal). It is recommended that creatinine measurement should be considered during the first three months after initiation of treatment.

Myopathy section: changed from

 Patients with pre-disposing factors for rhabdomyolysis, including renal impairment, hypothyroidism and high alcohol intake, may be at an increased risk of developing rhabdomyolysis.

 To read as follows:

 Patients with pre-disposing factors for myopathy and/or rhabdomyolysis, including age above 70 years old, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may be at an increased risk of developing rhabdomyolysis. For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighed up.

 Also the following is now stated:

 This medicinal product contains lactose. Therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 Section 4.8

 ADRs are now ranked under headings of frequency

 Pancreatitis is now added

 Section 6.4: Now stated as follows:

 Store in the original package, in order to protect from moisture.

Section 9: Modified to read as follows;

 Date of first authorisation: 13th July 1998

Date of last renewal: 13th July 2003

Updated on 22 February 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 April 2007 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

7.                  MARKETING AUTHORIsATION HOLDER

FOURNIER Pharmaceuticals Ltd

19-20 Progress Business Center,

Whittle Parkway

SLOUGH SL1 6DQ

BERKSHIRE

United Kingdom

8.         MARKETING AUTHORISATION NUMBER (S)

PA 810/1/2

9.                   DATE OF REVISION OF THE TEXT

August 2003

 

7.                   MARKETING AUTHORIsATION HOLDER

 

Solvay Healthcare Limited,

Mansbridge Road,

West End,

Southampton, SO18 3JD

United Kingdom

8.         MARKETING AUTHORISATION NUMBER

PA 108/30/3

10.               DATE OF REVISION OF THE TEXT

January 2007

Updated on 22 March 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Change to marketing authorisation holder address
  • Change to date of revision

Updated on 21 April 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 August 2004 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Updated on 1 September 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 30 June 2003 SmPC

Reasons for updating

  • New SPC for new product

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