Entocort CR 3mg Capsules

  • Name:

    Entocort CR 3mg Capsules

  • Company:
    info
  • Active Ingredients:

    Budesonide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/09/17

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Summary of Product Characteristics last updated on medicines.ie: 4/3/2020

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Tillotts Pharma GmbH

Tillotts Pharma GmbH

Company Products

Medicine NameActive Ingredients
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Medicine Name Asacolon 400 mg Gastro-Resistant Tablet Active Ingredients Mesalazine
Medicine Name Asacolon 500 mg Suppositories Active Ingredients Mesalazine
Medicine Name Asacolon 800 mg Gastro-Resistant Tablets Active Ingredients Mesalazine
Medicine Name Entocort CR 3mg Capsules Active Ingredients Budesonide
Medicine Name Vistaprep Powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
1 - 0 of 6 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 4 March 2020 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Updated on 29 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 September 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 11 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 11 April 2017 SmPC

Reasons for updating

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

4.1 Therapeutic indications
Crohn’s disease: Entocort CR Capsules are indicated for the induction of remission in patients with mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon and for long-term use, to prolong remission.
The full effect is usually achieved within 2-4 weeks.
Microscopic colitis: Entocort CR Capsules are indicated for the induction of remission in patients with active microscopic colitis.

4.2 Posology and method of administration
...
Active Microscopic colitis: The recommended dose is 9 mg once daily in the morning (corresponding to 3 capsules), for up to eight weeks.
When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy. In line with general corticosteroid prescribing, the lowest effective dose should be given as clinically indicated.

...

5.1 Pharmacodynamic properties
...

Microscopic colitis

Evidence for the indication microscopic (collagenous colitis and lymphocytic colitis) is presented below.

Collagenous colitis:

Two randomised, double-blind, placebo-controlled induction studies of six and eight weeks duration investigated the clinical and histological effect of Entocort 9 mg/day in the treatment of collagenous colitis. In the first study, 23 patients were randomised to Entocort 9 mg/day and 22 patients to placebo for 6 weeks. The rate of clinical remission was significantly higher (p<0.001) in the Entocort group than in the placebo group 86.9% vs. 13.6%. Histologic improvement was observed in 14 patients of the Entocort group (60.9%) and in one patient of the placebo group (4.5%; p<0.001). In the second study, 10 patients were randomised to Entocort for 8 weeks (9 mg/day 4 weeks, 6 mg/day 2 weeks, and 3 mg/day 2 weeks) and ten to placebo. All 10 patients receiving Entocort had a clinical response compared with two in the placebo group (p<0.001).

Two open-label studies (run-in phase of randomised, double-blind, placebo-controlled maintenance studies) investigated the efficacy of Entocort 9 mg/day during 6 weeks. In the first study, 46 patients (96%) achieved clinical remission within 2–30 (mean 6.4) days, with marked improvements in stool consistency. In the second study, of the 42 patients who commenced the study, 34 patients (81%) were in clinical remission (mean stool frequency of three or fewer per day) at week 6.

 

Lymphocytic colitis:

Evidence for this indication is limited to one randomised, double-blind placebo-controlled study in 15 lymphocytic colitis patients. Eleven subjects were treated with Entocort 9 mg/day and four patients received placebo for 8 weeks. A clinical response (defined as at least 50% improvement in the frequency of bowel movements) was seen in 25% of the placebo group vs. 91% in the Entocort group (p=0.03).

...

Updated on 10 April 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 7 February 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

4.1 Therapeutic indications

Entocort CR Capsules are indicated for the induction of remission in patients with mild to moderate Crohn`s disease affecting the ileum and/or the ascending colon and for long-term use, to prolong remission.

4.4  Special Warnings and precautions for use
...
Co-treatment with CYP3A inhibitors, including ketoconazole and cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. Concomitamt use of ketoconazole or other potent CYP3A4-inhibitors should be avoided.  If this is not possible, the period between treatments should be as long as possible and a reduction of the budesonide dose could also be considered (see also section 4.5).

Updated on 2 February 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 20 September 2016 SmPC

Reasons for updating

  • Change to paediatric information

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

Free text change information supplied by the pharmaceutical company

Section 4.8 UndesiSection
...

Paediatric population
Systemic and inhaled corticosteroids, including Entocort CR Capsules, may cause a reduction of growth velocity in paediatric patients. No long-term studies have been performed in paediatric patients treated with Entocort CR Capsules. Based on the available data from short-term studies (see section 5.1), the overall observed safety profile of Entocort CR Capsules in paediatric patients is consistent with the safety profile in adults.
...

Section 5.1 Pharmacodynamic properties
...
Study D9422C0001 was an open-label, uncontrolled study designed to evaluate Entocort in 108 pediatric patients (children and adolescents aged 5 to 17 years) diagnosed with mild to moderate Crohn’s disease of the ileum and/or ascending colon. The median duration of treatment exposure of Entocort of 58 days (range: 5 days to 90 days). Patients were dosed with oral Entocort once daily according to bodyweight, patients weighing ≤25 kg received 6 mg once daily for 8 weeks; patients weighing >25 kg received 9 mg once daily for 8 weeks. During the 8 weeks of treatment there was a reduction in the mean (±SD) PCDAI score from 19.1 (±10.1) to 9.1 (±8.5), indicating an improvement in disease activity; with an improvement in mean (±SD) IMPACT 3 score from 132.1 (±18.8) to 140.9 (±16.9). AEs were observed at a similar frequency and severity as seen in adults, and were mostly related to Crohn’s disease, puberty and possible GCS related side effects.

Study D9422C00002 was an open-label, un-comparative study designed to evaluate Entocort 6 mg once daily as maintenance treatment in 50 pediatric patients (children and adolescents aged 5 to 17 years) with a diagnosis of mild to moderate Crohn’s disease of the ileum and/or ascending colon who were in clinical remission (PCDAI ≤10). Treatment consisted of a 12-week maintenance treatment phase of 6 mg once daily, a 2-week taper phase to 3 mg once daily. The median duration of treatment exposure of Entocort was 98.5 days (range: 11 days to 135 days). Most patients remained in the clinical remission stage, as there were no major changes in the mean PCDAI composite score or IMPACT 3 score. Mean (SD) PCDAI was 4.85 (3.62) at baseline and 6.89 (8.08) after 12 weeks of maintenance treatment with Entocort 6 mg daily. At the same points in time the mean IMPACT3 score was 145.62 (12.43) and 146.98 (15.48), respectively. AEs were observed at a similar frequency and severity as seen in adults, and were mostly related to Crohn’s disease, puberty and possible GCS related side effects.
....

Updated on 15 September 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 4 August 2016 SmPC

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
  • 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

4.5       Interaction with other medicinal products and other forms of interaction

 

Concomitant treatment with CYP3A4 inducers such as carbamazepine may reduce budesonide exposure, which may require a dose increase.

Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).











4.8       Undesirable effects

The following definitions apply to the incidence of undesirable effects: 

very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot estimate from the available data).

 

Adverse drug reactions by frequency and system organ class (SOC)

SOC

Frequency

Reaction

Immune system disorders

Very rare

Anaphylactic reaction

Endocrine disorders

Common

Cushingoid features

 

Very rare

Growth retardation

Metabolism and nutrition disorders

Common

Hypokalemia

Psychiatric disorders

Common

Behavioural changes such as nervousness, insomnia, and mood swings and depression

 

Uncommon

Anxiety

 

Rare

Aggression

Nervous system disorders

Uncommon

Tremor, , psychomotor hyperactivity

Eye disorders

Common

Not known

Blurred vision

Glaucoma

 

Rare

Glaucoma, cataract including subcapsular cataract

Cardiac disorders

Common

Palpitations

Gastrointestinal disorders

Common

Dyspepsia

Skin and subcutaneous tissue disorders

Common

Skin reactions (urticaria, exanthema)

 

Rare

Ecchymosis

Musculoskeletal and connective tissue disorders

Common

Muscle cramps

Reproductive system and breast disorders

Common

Menstrual disorders

 

Most of the adverse events mentioned in this SmPC can also be expected for other treatments with glucocorticoids.




































10.       DATE OF REVISION OF THE TEXT

 

April 2016August 2016

Updated on 18 July 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

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

Free text change information supplied by the pharmaceutical company

Updated on 18 July 2016 PIL

Reasons for updating

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

Updated on 19 April 2016 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

In section 7 the marketing authorisation holder has changed from AstraZeneca UK Ltd to Tillotts Pharma GmbH. The MAH address has been updated consequently.
In section 8 the marketing authorisation number was updated to PA2018/003/001.
In section 10 the date of revision of text was updated to April 2016.

Updated on 18 April 2016 PIL

Reasons for updating

  • Change of licence holder

Updated on 13 April 2015 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 4.6 - Pregnancy and lactation
  • 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 6.3 - Shelf life
  • 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– Changes relating to QRD update

Section 4.2 – Changes relating to QRD update

Section 4.3 – Changes relating to QRD update

Section 4.4 – Changes relating to QRD update

Section 4.6 – Changes relating to QRD update

Section 4.7 – Changes relating to QRD update

Section 4.8 – Changes relating to QRD update

Section 5.1 – Changes relating to QRD update

Section 6.3 – Changes relating to QRD update

Section 9 – Changes relating to QRD update

Section 10 – Update to Date of Revision

Updated on 7 April 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 8 May 2014 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 Addition of ADR Wording
Section 10 Updated date of revision

Updated on 6 May 2014 PIL

Reasons for updating

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

Updated on 27 April 2012 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 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 5.2 - Pharmacokinetic properties
  • 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

Sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, & 5.2

 

All changes are following implementation of paediatric work sharing text and an updated CSP resulting from a PSUR work sharing procedure

 

 

Section 10

 

Date of revision changed to:   25th April 2012

 

Updated on 26 April 2012 PIL

Reasons for updating

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

Updated on 23 September 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 16 September 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4

Additional text:

This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

 

Additional text in last paragraph

When Entocort CR Capsules are used chronically in excessive doses, systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression may appear, and very rarely a wide range of psychiatric/behavioural effects may also occur (see section 4.8).

 

Section 4.8

Additional text in first paragraph

Very rarely a wide range of psychiatric/behavioural effects may occur, when systemic steroids are prescribed at high doses and for prolonged periods (see section 4.4).

Section 10

Revision date of text: 21 July 2010

Updated on 9 December 2009 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.6

Replacement of last paragraph with:

Budesonide is excreted in breast milk. However, based on data from inhaled budesonide, at therapeutic doses of Entocort exposure to the suckling child is anticipated to be low.

Section 10

Change of date to:

20th November 2009

Updated on 4 December 2009 PIL

Reasons for updating

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

Updated on 6 October 2009 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8

Side effect moved from uncommon to common in table:

Skin and subcutaneous tissue disorders-        Skin reactions (urticaria, exanthema)


Addition of very-rare side-effect to table:

Immune system disorders-                              Anaphylactic reaction


Section 10

Change of date to:

14th September 2009

Updated on 17 April 2009 PIL

Reasons for updating

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

Updated on 7 October 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 - BOLD text new text and strike through deleted:
 

Treatment with Entocort CR Capsules results in lower systemic steroid levels than conventional oral steroid therapy. Special care is needed when transferring from other steroid therapy as disturbances in hypothalamic-pituitary-adrenal axis can be expected in these patients.

Use with caution in patients with bacterial, fungal or viral infections, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts or with a family history of diabetes or glaucoma or with any other condition where the use of glucocorticosteroids may have unwanted effects.

Treatment with Entocort CR Capsules results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy. When patients are transferred from systemic glucocorticosteroid treatment with higher systemic effect to Entocort CR Capsules, they may have adrenocortical suppression. Therefore, monitoring of adrenocortical function may be considered in these patients and their dose of systemic steroid should be reduced cautiously.

Replacement of systemic glucocorticosteroid treatment with higher systemic effect with Entocort CR Capsules, sometimes unmasks allergies, e.g. rhinitis and eczema, which were previously controlled by the systemic drug.

 

Chicken pox and measles may follow a more serious course in patients on oral glucocorticosteroids. Particular care should be taken to avoid exposure in patients who have not previously had these diseases. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chicken pox develops, treatment with antiviral agents may be considered.

GlucocCorticosteroids may cause suppression of the HPA axis and reduce the stress response. Where patients are subject to surgery or other stresses, supplementary systemic glucocorticoid treatment is recommended.

As with all glucocorticosteroids the possibility of local or systemic infections should be borne in mind when using this product, particularly in view of the possible absence of systemic response thereto.

In patients with compromised liver function, blood levels of glucocorticosteroid may increase, as with other drugs which are metabolised via the liver.Reduced liver function may affect the elimination of glucocorticosteroids. The pharmacokinetics after oral ingestion of budesonide was affected by compromised liver function as evidenced by increased systemic availability. The intravenous pharmacokinetics of budesonide however was similar in cirrhotic patients and in healthy subjects.

When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy. Some patients may feel unwell in a non-specific way during the withdrawal phase, e.g. pain in muscles and joints. In some instances withdrawal symptoms may involve or resemble a clinical relapse of the disease for which the patient has been undergoing treatment. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of systemic glucocorticosteroids is sometimes necessary.

In vivo studies have shown that oral administration of ketoconazole (a known inhibitor of CYP3A activity in the liver and in the intestinal mucosa), caused a several fold increase of the systemic exposure to oral budesonide. If treatment with ketoconazole together with budesonide is indicated, reduction of the budesonide dose should be considered if side effects typical of systemic glucocorticosteroids occur.

After extensive intake of grapefruit juice (which inhibits CYP3A activity predominantly in the intestinal mucosa), the systemic exposure for oral budesonide increased about two times. As with other drugs primarily being metabolised through CYP3A, regular ingestion of grapefruit or juice of it, should be avoided in connection with budesonide administration (other juices such as orange juice or apple juice do not inhibit CYP3A). See also section 4.5 Interactions.

When Entocort CR Capsules are used chronically in excessive doses, systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression may appear.
 
 
Section 4.9 - BOLD text new text and strike through deleted:
 

Reports of acute toxicity and/or death following overdosage of glucocorticosteroids are rare. Acute overdosage with Entocort CR Capsules, even at very high doses, is not expected to lead to an acute clinical crisis. In the event of acute overdosage, no specific antidote is available. Treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy.Use supportive therapy as required.

Chronic overdosage may lead to systemic corticosteroid effects, such as Cushingoid features. If such changes occur, the dose of Entocort CR Capsules should be gradually reduced until treatment is discontinued, in accordance with normal procedures for the discontinuation of prolonged oral glucocorticosteroid therapy.
 
 
Section 5.2 BOLD text new text and strike through deleted:
 

Absorption

Budesonide has a high volume of distribution (about 3 L/kg) and a high systemic clearance (about 1.2 L/min). Plasma protein binding averages 85-90%. After oral dosing of plain micronised compound, absorption is rapid and seems to be complete. A large proportion of the drug is absorbed from the ileum and ascending colon. Systemic availability in healthy subjects is approximately 9–12% for Entocort CR Capsules, similar to the systemic availability of plain micronised budesonide, indicating complete absorption. In patients with active Crohn's disease systemic availability is approximately 12–20%.

Distribution

Budesonide has a high volume of distribution (about 3 L/kg). Plasma protein binding averages 85–90%. In healthy volunteers mean maximal plasma concentrations of 5–10 nmol/L were seen at 3–5 hours following a single oral dose of Entocort CR Capsules 9 mg.

Biotransformation

Budesonide then undergoes extensive biotransformation in the liver (approximately 90%) to metabolites of low glucocorticosteroid activity. The glucocorticosteroid activity of the major metabolites, 6b-hydroxybudesonide and 16a-hydroxy-prednisolone, is less than 1% of that of budesonide. The metabolism of budesonide is primarily mediated by CYP3A, a subfamily of cytochrome P450.

In healthy volunteers mean maximal plasma concentrations of 5-10 nmol/L were seen at 3-5 hours following a single oral dose of Entocort CR Capsules 9 mg.

Systemic availability in healthy subjects is approximately 9-12% for Entocort CR Capsules, similar to the systemic availability of plain micronised budesonide, indicating complete absorption.

In patients with active Crohn's disease systemic availability is approximately 12‑20%.

A large proportion of the drug is absorbed from the ileum and ascending colon.
 
Elimination
                Elimination is rate-limited by absorption. The average terminal half-life is 4 hours. Budesonide has a high systemic clearance (about 1.2 L/min).
 
 
 
Section 10
 
Date changed to 15th September 2008

Updated on 24 May 2007 PIL

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use

Updated on 22 May 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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

Current text

Each capsule also contains up to 295 mg sucrose

 

New Text

Excipients; not more than 295 mg

 

 

Section 4.5

Addition of the letter “P” in front of 450 in 4th paragraph

 

Section 6.1

Current text

Methacrylic acid-ethyl acrylate copolymer (1:1)

 

New text

Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent

 

Section 6.4

Current text

Do not store above 30°C. Store in the original. Keep the container tightly closed.

 

New text

Do not store above 30°C. Store in the original package. Keep the container tightly closed.

 

Section 9

Addition of text

Date of last renewal: 24th September 2006

 

Section 10

New Date of revision 12th January 2007

 

 

 

Updated on 2 February 2006 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 21 October 2005 SmPC

Reasons for updating

  • 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)

Updated on 7 March 2005 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 22 February 2005 SmPC

Reasons for updating

  • 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)

Updated on 10 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 July 2004 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 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

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

Updated on 4 June 2003 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)

Updated on 22 May 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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