Skinoren Gel

  • Name:

    Skinoren Gel

  • Company:
    info
  • Active Ingredients:

    Azelaic Acid

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/12/19

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Summary of Product Characteristics last updated on medicines.ie: 10/10/2019

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LEO Pharma

LEO Pharma

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1 - 0 of 41 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 17 December 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Addition of information on alternative format leaflets
  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Additional changes in line with QRD

Updated on 10 October 2019 PIL

Reasons for updating

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

Updated on 10 October 2019 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)

Updated on 8 August 2019 PIL

Reasons for updating

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

Updated on 5 June 2019 SmPC

Reasons for updating

  • New SmPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

No previous SPC pdf document uploaded

Updated on 24 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 November 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 6.1 - List of excipients
  • 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

Summary of Changes

Deleted             Added

 4.2  Posology and method of administration

[…]

Geriatric patients

No targeted studies have been performed in patients aged 65 and over.

Patients with hepatic impairment

No targeted studies have been performed in patients with hepatic impairment.

Patients with renal impairment

No targeted studies have been performed in patients with renal impairment.

[…]

4.6     Fertility, pregnancy and lactation

Pregnancy

There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.

Animal studies do not indicate direct or indirect harmful the potential for effects with respect to pregnancy, embryonal-foetal development, parturition or postnatal development. However, the dose levels without observed adverse effects in animals ranged across studies from 3-32 times the maximum recommended human dose based on body surface area (see section 5.3 Preclinical safety data).

Caution should be exercised when prescribing azelaic acid to pregnant women.

[…]

Fertility

There are no data on the effect of Skinoren gel on human fertility. Results from animal studies showed no effect on fertility in male or female rats (see section 5.3 Preclinical safety data).

4.8     Undesirable effects

[…]

System Organ Class

Very common

Common

Uncommon

Rare1

Immune system disorders

 

 

 

hypersensitivity (which may occur with one or more of the following adverse reactions: angioedema, eye swelling, swelling face, dyspnoea) drug hypersensitivity, worsening of asthma (see section 4.4)

Skin and subcutaneous tissue disorders

 

 

contact dermatitis, acne*

skin irritation, urticaria

General disorders and administration site conditions

application site burning, application site pain, application site pruritus

application site rash, application site paraesthesia, application site dryness, application site oedema*

application site erythema, application site exfoliation**, application site warmth**, application site discolouration**, application site discomfort*, appplication site urticaria*

 

 

*   for indication Rosacea

** for indication Acne

1     These adverse reactions have been reported during post-approval use of Skinoren gel.

[…]

5.1     Pharmacodynamic properties

[…]

Rosacea:

While the pathophysiology of rosacea is not completely understood, there is increasing consensus that inflammation involving the elevation of several pro-inflammatory effector molecules such as kallikrein-5 and cathelicidin as well as reactive oxygen species (ROS), is a central process of this disease.

Azelaic acid has been demonstrated to modulate the inflammatory response in normal human keratinocytes by: a) activating the peroxisome proliferator-activated receptor γ (PPARγ); b) inhibiting the trans-activation of nuclear factor-kB (NF-kB); c) inhibiting the production of pro-inflammatory cytokines and d) inhibiting the release of ROS from neutrophils, as well as direct scavenging effects on existing ROS.

In addition, azelaic acid has been shown to directly inhibit kallikrein-5 and cathelicidin expression in three models: in vitro (human keratinocytes), in murine skin and in the facial skin of patients with rosacea.

These anti-inflammatory properties of azelaic acid may play a role in the treatment of rosacea.

While the clinical significance of these findings regarding kallikrein-5 and cathelicidin and their impact on the pathophysiology of rosacea has not yet been fully demonstrated in a large clinical study, initial studies in human facial skin appear to confirm the in vitro and murine findings.

The mechanism by which azelaic acid interferes with the pathogenic events in rosacea is unknown. Several in vitro and ex vivo investigations indicate that azelaic acid may exert an anti-inflammatory effect by reducing the formation of pro-inflammatory, reactive oxygen species.

[…]

5.2     Pharmacokinetic properties

[…]

A portion of the azelaic acid absorbed through the skin is excreted in unchanged form with in the urine. The remaining portion is broken down by b-oxidation into dicarboxylic acids with shorter chain length (C7, C5), which have likewise been found in the urine.

Steady-state plasma levels of azelaic acid in rosacea patients after 8 weeks twice daily treatment with Skinoren Gel were within the range also observed in volunteers and acne patients on normal diets. This indicates that the extent of percutaneous absorption of azelaic acid following twice daily application of Skinoren Gel does not alter the systemic burden of azelaic acid derived from dietary and endogenous sources in a clinically meaningful way.

5.3     Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.

Embryofetal developmental studies with oral administration of azelaic acid to rats, rabbits, and cynomolgus monkeys during the period of organogenesis revealed embryotoxicity at doses where some maternal toxicity was noted. No teratogenic effects were observed. The embryofetal NOAEL was 32 time the MRHD based on BSA in rats, 6.5 times the MRHD based on BSA in rabbits and 19 time the MRHD based on BSA in monkeys(see section 4.6 Fertility, pregnancy and lactation)

In a peri- and post-natal developmental study in rats where azelaic acid was administered orally from gestational day 15 to through day 21 postpartum slight disturbances in the post-natal development of fetuses were noted at oral doses that generated some maternal toxicity. The NOAEL was 3 times the MRHD based on BSA. No effects on sexual maturation of the fetuses were noted in this study

In vitro and in vivo studies with azelaic acid produced no evidence of mutagenic effects on germ and somatic cells.

Conventional long-term carcinogenicity studies with oral administration of azelaic acid have not been performed.

In a 26-week dermal carcinogenicity study using male and female transgenic (Tg.AC) mice, Skinoren Gel and the gel vehicle did increase the number of papillomas in male animals after twice daily application at the treatment site. This effect was not observed after single administration in male and female mice. This effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear, especially in the light of the doubtful validity of the Tg.AC test system.

If azelaic acid came into contact with the eyes of monkeys and rabbits, signs of moderate to severe irritation became evident. Therefore, contact with the eyes should be avoided.

Azelaic acid administered once intravenously had no effects on the nervous system (Irwin test), cardiovascular function, intermediary metabolism, smooth muscles and liver and kidney function.

6.1     List of excipients

Benzoic acid (E 210)

Carbomers

Disodium edetate

Lecithin

Triglycerides medium chain

Polysorbate 80

Propylene glycol

Purified water

Carbomers 980

Sodium hydroxide

Disodium edetate

Purified water

Benzoic acid (E 210)

Triglycerides medium chain

Updated on 8 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 November 2016 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 5 November 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 15 September 2014 PIL

Reasons for updating

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

Updated on 11 September 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

·         In section 4.8 on the reporting of adverse effects details were updated to include HPRA contact details instead of the IMB

·         In section 7 the MA holder has been changed to Bayer Limited, The atrium, Blackthorn Road, Dublin 18, Ireland

·         In section 8 the Marketing Authorisation Number has been changed from 1407/6/1 to 1410/72/2

·         In section 10 the Date of Revision has been updated to August 2014

Updated on 11 June 2014 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie;

e-mail: imbpharmacovigilance@imb.iethe national reporting system listed in Appendix V*

 

10 DATE OF REVISION OF THE TEXT

April 2013May 2014

Updated on 4 June 2014 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 13 March 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 31 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 29 April 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 - Date of revision of the text
  • 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

(Inserted text; Deleted text)



2        QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Excipients with known effect:

1 mg Benzoic acid/g Gel

0.12 g Propylene glycol/g Gel

 

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

 

 

4.2     Posology and method of administration

 

Skinoren 15 % Gel is intended for cutaneous use only.

 

Posology

 

Skinoren 15% Gel is intended for cutaneous use only. Skinoren Gel should be applied to the affected skin areas twice a day (in the morning and in the evening) and rubbed in gently. Approximately 0.5 g = 2.5 cm (1 inch) of gel is sufficient for the entire facial area.

 

Pediatric population

Use in adolescents (12‑18 years of age) for the treatment of acne vulgaris. Dose adjustment is not required when Skinoren Gel is administered to adolescents aged 12‑18 years.

The safety and efficacy of Skinoren Gel for the treatment of acne vulgaris in children below the age of 12 years have not been established.

The safety and efficacy of Skinoren Gel for the treatment of papulopustular rosacea in children below the age of 18 years have not been established.

Method of administration

Before Skinoren Gel is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used.

 

Pediatric population

Use in adolescents (12-18 years of age) for the treatment of acne vulgaris. Dose adjustment is not required when Skinoren Gel is administered to adolescents aged 12-18 years.

The safety and efficacy of Skinoren Gel for the treatment of acne vulgaris in children below the age of 12 years have not been established.

The safety and efficacy of Skinoren Gel for the treatment of papulopustular rosacea in children below the age of 18 years have not been established.

 

4.3     Contraindications

 

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

 

4.4     Special warnings and precautions for use

It is advisable to avoid the concomitant use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents when in patients using Skinoren Gel for treatment of papulopustular rosacea.

 

Worsening of asthma in patients treated with azelaic acid has been reported rarely during post-marketing surveillance.

 

4.6     Fertility, pPregnancy and lactation

 

Pregnancy

There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.

 

Lactation

 

Infants must not come into contact with treated skin/breast.

...

since aAzelaic acid is not concentrated in milk and systemic uptake of  less than 4 % of topically applied azelaic acid is systemically absorbed, did not increasinge endogenous azelaic acid exposure above physiological levels. However, caution should be exercised when Skinoren Gel is administered to a nursing woman.

Infants must not come into contact with treated skin/breast.

 

4.8     Undesirable effects

 

Only cutaneous treatment related adverse events were reported in clinical studies. In the great majority of cases the symptoms were mild or moderate; the frequency of irritative symptoms gradually decreased during the course of therapy.

In From clinical studies and post-marketing surveillance, the most frequently observed side effects included application site pruritus, application site burning and application site pain.

 

 

Frequencies of side-effects observed in clinical studies and post-marketing surveillance and given in the table below are defined according to the MedDRA frequency convention:

 

Very common (≥1/10),

Common (≥1/100, <1/10),

Uncommon (≥1/1,000; <1/100),

Rare (≥1/10,000, <1/1,000),

Very rare (<1/10,000),

Not known (cannot be estimated from the available data).

 

Acne:

 

System Organ Class

Very common (≥1/10)

Common (≥1/100 and <1/10)

Uncommon (≥1/1000 and <1/100)

Rare

Immune system disorders

 

 

 

drug hypersensitivity, worsening of asthma (see section 4.4)

Skin and subcutaneous tissue disorders

 

 

cContact dermatitis, acne*

 

General disorders and administration site conditions

aApplication site burning, aApplication site pain, aApplication site pruritus

aApplication site rash, aApplication site paraesthesia, aApplication site dryness, application site oedema*

aApplication site erythema, aApplication site exfoliation**, aApplication site warmth**, aApplication site discolouration**, application site discomfort*, appplication site urticaria*

 

*   for indication Rosacea

** for indication Acne

 

Rosacea:

System Organ Class

Very common (1/10)

Common (1/100 and <1/10)

Uncommon (1/1000 and <1/100)

Skin and subcutaneous tissue disorders

 

 

Acne, Contact dermatitis

General disorders and administration site conditions

Application site burning, Application site pain, Application site pruritus

Application site paraesthesia, Application site dryness, Application site rash, Application site oedema

Application site erythema, Application site urticarial, Application site discomfort

 

Hypersensitivity has been reported rarely in post-marketing surveillance. Generally, local skin irritation regresses in the course of the treatment.

Worsening of asthma in patients treated with azelaic acid has been reported rarely during post-marketing surveillance (the frequency is not known).

...

10      DATE OF REVISION OF THE TEXT

November 2010 April 2013

Updated on 3 December 2010 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 1 December 2010 SmPC

Reasons for updating

  • Change to paediatric information
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration

Re-wording of text

More complete information included re paediatric patients:

Pediatric population

Use in adolescents (12-18 years of age) for the treatment of acne vulgaris. Dose adjustment is not required when Skinoren Gel is administered to adolescents aged 12-18 years.

The safety and efficacy of Skinoren Gel for the treatment of acne vulgaris in children below the age of 12 years have not been established.

The safety and efficacy of Skinoren Gel for the treatment of papulopustular rosacea in children below the age of 18 years have not been established.

 

 

4.4     Special warnings and precautions for use

Editorial revision of text

Additional sentence included:

 

It is advisable to avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents when using Skinoren Gel for treatment of papulopustular rosacea.

 

 

4.6 Pregnancy and lactation

 

Current text:

Data on a limited number of exposed pregnancies (n=2) indicate no adverse effects of azelaic acid on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.

Caution should be exercised when prescribing azelaic acid to pregnant women.

 

Infants must not come into contact with treated skin/breast.

The amount of azelaic acid potentially transferred per day during breast-feeding is negligible and should not imply any risk to the infant.

 

Revised to:

Pregnancy

There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3 Preclinical safety data).

Caution should be exercised when prescribing azelaic acid to pregnant women.

 

Lactation

Infants must not come into contact with treated skin/breast.

 

It is not known if azelaic acid is secreted into human milk in vivo. However an in vitro equilibrium dialysis experiment demonstrated that passage of drug into maternal milk may occur. But the distribution of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk since azelaic acid is not concentrated in milk and systemic uptake of topically applied azelaic acid did not increase  endogenous azelaic acid exposure above physiological levels. However, caution should be exercised when Skinoren Gel is administered to a nursing woman.

 

4.8 Undesirable effects

 

Current text:

Only cutaneous treatment-related adverse events were reported in clinical trials comprising 269 acne patients treated with Skinoren 15% Gel for up to 4 months and 457 rosacea patients treated with Skinoren 15% Gel for up to 15 weeks. In the great majority of cases the symptoms were mild or moderate; the frequency of cutaneous adverse events gradually decreased during the course of therapy.

 

The spectrum of undesirable cutaneous effects related to Skinoren 15% Gel was similar in acne and rosacea.

 

Rosacea:

 

System Organ Class

Very common

(≥ 1/10)

Common

(≥ 1/100 and <1/10)

Uncommon

(≥ 1/1000 and < 1/100)

 Skin and subcutaneous tissue disorders

Pruritus

Skin exfoliation

Contact dermatitis

Facial oedema

General disorders and administration site conditions

Application site burning

Application site pain

Application site dryness

Application site rash

 

 

 

Acne:

 

System Organ Class

Very common

(≥ 1/10)

Common

(≥ 1/100 and <1/10)

Uncommon

(≥ 1/1000 and < 1/100)

Skin and subcutaneous tissue disorders

 

Pruritus,

Skin exfoliation

Contact dermatitis

 

General disorders and administration site conditions

Application site burning

Application site pain

Application site erythema,

Application site irritation,

Application site dryness

 

Application site discolouration

 

Revised to:

 

Only cutaneous treatment-related adverse events were reported in clinical studies. In the great majority of cases the symptoms were mild or moderate; the frequency of irritative symptoms gradually decreased during the course of therapy.

In clinical studies, the most frequently observed side effects included application site pruritus, application site burning and application site pain.

 

Acne:

 

System Organ Class

Very common
(
³ 1/10)

Common
(
³ 1/100 and < 1/10)

Uncommon
(
³ 1/1000 and <1/100)

Skin and subcutaneous tissue disorders

 

 

Contact dermatitis

General disorders and administration site conditions

Application site burning, Application site pain, Application site pruritus

Application site rash, Application site paraesthesia, Application site dryness

Application site erythema, Application site exfoliation, Application site warmth, Application site discolouration

 

Rosacea:

 

System Organ Class

Very common
(
³ 1/10)

Common
(
³ 1/100 and < 1/10)

Uncommon
(
³ 1/1000 and <1/100)

Skin and subcutaneous tissue disorders

 

 

Acne,

Contact dermatitis

General disorders and administration site conditions

Application site burning, Application site pain, Application site pruritus

 

Application site paraesthesia, Application site dryness, Application site rash, Application site oedema

Application site erythema, Application site urticaria, Application site discomfort

 

Hypersensitivity has been reported rarely in post-marketing surveillance.

Worsening of asthma in patients treated with azelaic acid has been reported rarely during post-marketing surveillance (the frequency is not known).

 

Pediatric population

Treatment of acne vulgaris in adolescents 12-18 years of age:

In 4 clinical phase II and II/III studies involving adolescents 12-17 years of age (120/383; 31%), the overall incidence of adverse events for Skinoren Gel was similar for the groups aged 12-17 years (40%), aged ³18 years (37%) and for the entire patient population (38%). This similarity also applied to the group aged 12-20 years (40%).

 

5.3 Preclinical safety data

 

Current text:

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

If azelaic acid came into contact with the eyes of monkeys and rabbits, signs of moderate to severe irritation became evident. Therefore, contact with the eyes should be avoided.

 

Revised to:

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.

If azelaic acid came into contact with the eyes of monkeys and rabbits, signs of moderate to severe irritation became evident. Therefore, contact with the eyes should be avoided.

 

6.5 Nature and contents of container

 

Current text:

Standard aluminium tube with membrane closure, internal coating with epoxide resin, white coloured outside, with screw cap made of high-density polyethylene.

Tubes of 5g, 30g, 50g.

Not all pack sizes may be marketed.

 

Revised text:

Aluminium tube with internal epoxide coating and polyethylene screw cap.

 

Tubes of 5, 30, 50, 2 x 50 g.

Not all pack sizes may be marketed.

 

10. Date of Revision of the Text

 

Revised to November 2010

Updated on 27 October 2009 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5
New pack size introduced: 2 x 50g

Section 10
New date of revision: October 2009

Updated on 22 October 2009 PIL

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 20 July 2009 SmPC

Reasons for updating

  • 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

In section 10, the date of revision of the text has been changed to May 2009

Updated on 29 March 2009 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 March 2009 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 2.2: additional excipient information
Section 4.2: additional information re duration of treatment and use in children
Section 4.2: editorial change
Section 4.4: additional excipient information
Section 4.5: editorial change
Section 4.7: addition of text re no influence on driving and using machinery
Section 4.8: revision of section
Section 5.1: editorial change
Section 5.3: editorial change
Section 6.4: editorial change
Section 6.5: editorial change
Section 9: revision of date of last renewal
Section 10: date of last revision changed to February 2009

Updated on 23 October 2007 PIL

Reasons for updating

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

Updated on 19 October 2007 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7: PA was transferred to Indentis GmbH.
 
Section 8: PA number is now 1407/6/1

Updated on 14 July 2006 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 14 July 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 26 October 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 January 2004 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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)

Updated on 8 July 2003 SmPC

Reasons for updating

  • New SPC for new product

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