Myleran Tablets 2mg

  • Name:

    Myleran Tablets 2mg

  • Company:
    info
  • Active Ingredients:

    Busulfan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/11/17

files-icon(Click to Download)

XPIL

Summary of Product Characteristics last updated on medicines.ie: 8/11/2017
print

Print ViewKeyword Search SmPC

Aspen

Aspen

Company Products

Medicine NameActive Ingredients
Medicine Name Aldomet Tablets 250 mg Active Ingredients Methyldopa
Medicine Name Aldomet tablets 500 mg Active Ingredients Methyldopa
Medicine Name Alkeran 2 mg Film-coated Tablets Active Ingredients Melphalan
Medicine Name Alkeran 50 mg, Powder and Solvent for Solution for Infusion Active Ingredients Melphalan
Medicine Name Anectine 50 mg/ml Solution for Injection or Infusion Active Ingredients Suxamethonium Chloride
Medicine Name Arixtra Fondaparinux sodium solution for injection 1,5 mg/ 0,3 ml Active Ingredients Fondaparinux sodium
Medicine Name Arixtra Fondaparinux sodium solution for injection 10 mg/ 0,8 ml Active Ingredients Fondaparinux sodium
Medicine Name Arixtra Fondaparinux sodium solution for injection 2,5 mg/ 0,5 ml Active Ingredients Fondaparinux sodium
Medicine Name Arixtra Fondaparinux sodium solution for injection 5 mg/ 0,4 ml Active Ingredients Fondaparinux sodium
Medicine Name Arixtra Fondaparinux sodium solution for injection 7,5 mg/ 0,6 ml Active Ingredients Fondaparinux sodium
Medicine Name Dexamethasone 2mg Tablets Active Ingredients Dexamethasone
Medicine Name Diprivan 1% w/v Emulsion for Injection or Infusion, Pre-filled Syringe (50ml) Active Ingredients Propofol
Medicine Name Emla Cream 5% Active Ingredients Lidocaine, Prilocaine
Medicine Name Fludrocortisone acetate 0.1mg Tablets Active Ingredients Fludrocortisone Acetate
Medicine Name Imuran Powder for Solution for Injection or Infusion 50mg Active Ingredients azathioprine sodium
Medicine Name Imuran Tablets 25mg Active Ingredients Azathioprine
Medicine Name Imuran Tablets 50mg Active Ingredients Azathioprine
Medicine Name Kemadrin Tablets Active Ingredients Procyclidine Hydrochloride
Medicine Name Lanoxin 250 microgram tablets Active Ingredients Digoxin
Medicine Name Lanoxin Injection Active Ingredients Digoxin
Medicine Name Lanoxin PG 50 micrograms/ml Elixir Active Ingredients Digoxin
Medicine Name Lanoxin PG Tablets Active Ingredients Digoxin
Medicine Name Lanvis 40 mg tablets Active Ingredients Tioguanine
Medicine Name Leukeran 2mg Film-coated Tablets Active Ingredients Chlorambucil
Medicine Name Marcain 0.25% with Adrenaline (5 micrograms per ml) 1:200,000 Active Ingredients Adrenaline tartrate, Bupivacaine Hydrochloride
1 - 0 of 54 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 8 November 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 8 November 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - 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

Text in red = new text

Text strikethrough = deleted text

 

 

4.4       Special warnings and precautions for use

 

Conventional dose Treatment

 

Patients co-administered who are concurrently treated with the conventional dose of busulfan and itraconazole or metronidazole with conventional dose busulfan should be closely monitored closely for signs of busulfan toxicity. At concomitant use of these agents with busulfan Weekly measurements of blood counts are recommended when co-administering these drugs (see section 4.5).

 

 

4.5       Interaction with other medicinal products and other forms of interaction

 

In patients receiving high-dose busulfan it has been reported that co-administration of itraconazole decreases clearance of busulfan by approximately 20 % with corresponding increases in plasma busulfan levels. In combination with metronidazole (1200 mg, given as 400 mg three times daily) busulfan values are increased in approximately 80% (see section 4.4). Metronidazole has been reported to increase trough levels of busulfan by approximately 80 %. Fluconazole had no effect on busulfan clearance. Consequently, high-dose busulfan in combination with itraconazole or metronidazole is reported to be associated with an increased risk of busulfan toxicity (see section 4.4).

 

4.8       Undesirable effects

 

The following convention has been utilised for the classification of frequency:  Very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10,000 and < 1/1000) and, very rare (< 1/10,000) and not known (cannot be estimated from the available data).

 

 

Not known        Tooth hypoplasia

 

 

 

10.       DATE OF  REVISION OF THE TEXT

 

January November  2017

Updated on 7 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 November 2017 PIL

Reasons for updating

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

Updated on 31 January 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 5 January 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

Text in red = new text
Text strikethrough = deleted text

 

 

 4.2      Posology and method of administration

 

Obese patients

 

4.4       Special warnings and precautions for use

 

Hepatic veno-occlusive disease is a major complication that can occur during treatment with busulfan. Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk (see section 4.8).

 

 

Oogenesis and spermatogenesis

 

Busulfan interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes. Men treated with busulfan should be informed about sperm preservation prior to treatment (section 4.6 and 4.8).

 

4.5       Interaction with other medicinal products and other forms of interaction

 

Vaccinations with live organism vaccines are not recommended in immunocompromised individuals (see section 4.4).

 

The effects of other cytotoxics producing pulmonary toxicity may be additive (see section 4.8).

 

In the paediatric population, for the combined Busulfan-Melphalan (BuMel) regimen it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities. 

 

 

4.6       Fertility, pregnancy and lactation

 

Fertility

 

Myleran can lead to suppression of ovarian function and amenorrhoea in women and suppression of spermatogenesis in men. It may cause sterility in both sexes. In women busulfan may cause severe and persistent ovarian failure, including failure to achieve puberty after administration to young girls and pre-adolescents at high-dose. It may also cause male infertility, azoospermia and testicular atrophy in male patients receiving busulfan (see section 4.8 and 5.3).

 

 

4.8       Undesirable effects

 

Nervous system disorders           Rare      At high-dose:seizure convusion (see section 4.4 and 4.5)

 

Musculoskeletal and connective tissue disorders               Rare      Sjögren’s syndrome

Injury, poisoning and procedural complications   Rare      Radiation skin injury is increased in patients receiving radiotherapy soon after high-dose busulfan

 

Uncommon      Ovarian disorder and amenorrhoea with menopausal symptoms in pre-menopausal patients at conventional dose. In very rare cases, recovery of ovarian function has been reported with continuing treatment

 

 

4.9       Overdose

 

Treatment:

There is no known antidote. Dialysis should be considered in the management of overdose as there is one report of successful dialysis of busulfan.

 

Appropriate supportive treatment should be given during the period of haematological toxicity.

 

Since, busulfan is metabolised through conjugation with glutathione, administration of glutathione might be considered.

 

 

10.       DATE OF  REVISION OF THE TEXT

 

January 2017 November 2015

Updated on 4 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 17 November 2016 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 15 November 2016 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 24 November 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)

Free text change information supplied by the pharmaceutical company

Text in red = new text
Text strikethrough = deleted text



2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 2 mg of the active substance busulfan.

Excipient with known effect:

Each tablet also contains 92.5 mg of lactose.


3. Pharmaceutical Form

Film-coated tablet.

White, film-coated, biconvex tablets engraved 'GX EF3' on one side and 'M' on the other.

. CLINICAL PARTICULARS

4.1 Therapeutic Indications

Myleran is indicated for the palliative treatment of the chronic phase of chronic granulocytic myeloid leukaemia.

Myleran is effective in producing prolonged remission in polycythaemia vera, particularly in cases with marked thrombocytosis.

4.2 Posology and method of administration

General Posology

The relevant literature should be consulted for full details of treatment schedules.

Use in the elderly

No special comment.

Chronic granulocyticmyeloid leukaemia



The usual maintenance dosage is 0.5‑2 mg/day, but individual requirements may be much less. The aim is to maintain a leucocyte count of 1015 x 109 per litre and blood counts must be performed at least every 4 weeks. Should a patient require an average daily dose of less than the content of one tablet, the maintenance dose may also be adjusted by reducing the number of treatment days per week.

Note: Lower doses of Myleran should be used if it is administered with other cytotoxic agents.

Paediatric population:

Chronic granulocyticmyeloid leukaemia is very rare in the paediatric age group. Myleran may be used to treat Philadelphia chromosome positive (Ph' positive) disease, but the Ph' negative juvenile variant responds poorly.

4.4 Special warnings and precautions for use

Hyperuricaemia and/or hyperuricosuria are not uncommon in patients with chronic granulocytic myeloid leukaemia and should be corrected before starting treatment with Myleran. During treatment, hyperuricaemia and the risk of uric acid nephropathy should be prevented by adequate prophylaxis, including adequate hydration and the use of allopurinol.

Studies in renally impaired patients have not been conducted, however, as busulfan is moderately excreted in the urine, dose modification is not recommended in these patients. However, caution is recommended.

Myleran has not been studied in patients with hepatic impairment. Since busulfan is mainly metabolized through the liver, caution should be observed when busulfan is used in patients with pre existing impairment of liver function, especially in those with severe hepatic impairment.

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

Conventional dose Treatment

Patients co-administered itraconazole or metronidazole with conventional dose busulfan should be monitored closely for signs of busulfan toxicity. Weekly measurements of blood counts are recommended when co-administering these drugs (see section 4.5).

High-dose Treatment (used for Haemopoietic Stem Cell Transplantation)

If high-dose Myleran is prescribed (see section 4.9), patients should be given prophylactic anticonvulsant therapy with preferably a benzodiazepine rather than phenytoin (see section 4.5 and 4.8).

Concomitant administration of itraconazole or metronidazole with high-dose busulfan has been reported to be associated with an increased risk of busulfan toxicity (see section 4.5). Co administration of metronidazole and high-dose busulfan is not recommended. Co administration of itraconazole with high-dose busulfan should be at the discretion of the prescribing physician and should be based on a risk/benefit assessment.

Mutagenicity

Various chromosome aberrations have been noted in cells from patients receiving bulsulpha busulfan.

Very careful consideration should be given to the use of Myleran for the treatment of polycythaemia vera and essential thrombocythaemia in view of the drug's carcinogenic potential (see section 5.3). The use of Myleran for these indications should be avoided in younger or asymptomatic patients. If the drug is considered necessary treatment courses should be kept as short as possible.

Paracetamol is described to decrease glutathione levels in blood and tissues, and may therefore decrease busulfan clearance when used in combination.

4.6 Fertility, pregnancy and lactation

Fertility

Myleran can lead to suppression of ovarian function and amenorrhoea in women and suppression of spermatogenesis in men (see section 4.8 and 5.3).

 

The use of Myleran should be avoided whenever possible during pregnancy, particularly during the first trimester. In every individual case the expected benefit of treatment to the mother must be weighed against the possible risks to the foetus.

It is not known whether Myleran or its metabolites are excreted in human breast milk. Mothers receiving Myleran should not breast-feed their infants.

Breastfeeding


 

4.8 Undesirable effects

For this product there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on the dose received and also when given in combination with other therapeutic agents.

The following convention has been utilised for the classification of frequency: Very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1000 and < 1/100), rare (≥ 1/10,000 and < 1/1000) and very rare (< 1/10,000).

The following table of adverse reactions originated from the use of busulfan, or busulfan in combination with other therapeutic agents.

System organ class

Frequency

Side effects

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Common

Leukaemia secondary to oncology chemotherapy (see section 4.4)

Blood and lymphatic system disorders *

Very common

Dose-related bone marrow failure, manifesting as leukopenia and particularly thrombocytopenia

Rare

Aplastic anaemia (see section 4.9)

Nervous system disorders

Rare

At high-dose:convulsion (see section 4.4 and 4.5)

Very rare

Myasthenia gravis

Eye disorders

Rare

Lens disorder and cataract (which may be bilateral) corneal thinning (reported after bone marrow transplantation preceded by high-dose busulfan treatment)

Cardiac disorders

Common

At high-dose: cardiac tamponade in patients with thalassaemia

Respiratory, thoracic and mediastinal disorders *

Very common

At high-dose: idiopathic pneumonia syndrome

Common

Interstitial lung disease following long term conventional dose use

Gastrointestinal disorders

Very common

At high-dose: nausea, vomiting, diarrhoea, mouth ulceration (see section 4.9)

Rare

At conventional dose: nausea, vomiting, diarrhoea, mouth ulceration, which may possibly be ameliorated by usingdivided doses. Dry mouth

Hepatobiliary disorders *

Very common

At high-dose: hyperbilirubinaemia, jaundice, venoocclusive liver disease (see section 4.4 and 4.5) and biliary fibrosis with hepatic atrophy and necrosis

Rare

Jaundice and abnormal hepatic function, at conventional dose. Biliary fibrosis

Skin and subcutaneous tissue disorders *

Common

Alopecia at high-dose. Skin hyperpigmentation (see also General disorders and administration site conditions)

Rare

Alopecia at conventional dose, skin reactions including urticaria, erythema multiforme, erythema nodosum, porphyria non-acute, rash, dry skin and fragility of the skin with complete anhydrosis cheilosis, Sjögren’s syndrome. An increased radiation skin injury in patients receiving radiotherapy soon after high-dose busulfan

Renal and urinary disorders

Common

At high-dose: in combination with cyclophosphamide cystitis haemorrhagic

Reproductive system and breast disorders *

Very common

Ovarian disorder and amenorrhoea with menopausal symptoms in pre-menopausal patients at high-dose; severe and persistent ovarian failure, including failure to achieve puberty after administration to young girls and pre-adolescents at high-dose. Male infertility, azoospermia and testicular atrophy in male patients receiving busulfan

Uncommon

Ovarian disorder and amenorrhoea with menopausal symptoms in pre-menopausal patients at conventional dose. In very rare cases, recovery of ovarian function has been reported with continuing treatment

Very rare

Gynaecomastia

General disorders and administration site conditions *

Rare

Dysplasia

* Description of selected adverse events

 

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:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

5. Pharmacological Properties

5.1 Pharmacodynamic properties

Group and ATC code: Antineoplastic and Immunomodulating agents, alkyl sulfonates: L01AB01.

Mechanism of action

Busulfan (1,4-butanediol dimethanesulfonate) is a bifunctional alkylating agent. Binding to DNA is believed to play a role in its mode of action, and di-guanyl derivatives have been isolated, but interstrand crosslinking has not been conclusively demonstrated.

The basis for the uniquely selective effect of busulfan on granulocytopoiesis is not fully understood. Although not curative, Myleran is very effective in reducing the total granulocyte mass, relieving the symptoms of disease and improving the clinical state of the patient. Myleran has been shown to be superior to splenic irradiation when judged by survival times and maintenance of haemoglobin levels and is as effective in controlling spleen size.

5.2 Pharmacokinetic properties

Absorption

The bioavailability of oral busulfan shows large intraindividual variation ranging from 47 % to 103 % (mean 80 %) in adults.

Following oral administration of high-dose busulfan (1 mg/kg every 6 h for 4 days), AUC and Cmax in adults are highly variable but have been reported to be 8260 nanograms.h/ml (range 2484 to 21090)

Distribution

Busulfan is reported to have a volume of distribution of 0.64 ± 0.12 L/kg in adults.

Busulfan given in high doses has been shown to enter the cerebrospinal fluid (CSF) in concentrations comparable to those found in plasma, with a mean CSF:plasma ratio of 1.3 : 1. The saliva:plasma distribution of busulfan was 1.1 : 1.

Biotransformation

Busulfan metabolism involves a reaction with glutathione, which occurs via the liver and is mediated by glutathione-S­transferase.

The urinary metabolites of busulfan have been identified as 3-hydroxysulpholane, tetrahydrothiophene 1-oxide and sulpholane, in patients treated with high-dose busulfan.

Elimination


 

Special patient populations

Paediatric population

The bioavailability of oral busulfan shows large intra-individual variation ranging from 22 % to 120 % (mean 68 %) in children.

 

Fertility

Busulfan interferes with spermatogenesis in experimental animals. Limited studies in female animals indicate busulfan has a marked and irreversible effect on fertility via oocyte depletion.

6.6 Special precautions for disposal and other handling

Safe handling of Myleran tablets

 

8. Marketing Authorisation Number

PA 1691/008/001

9. Date of First Authorisation/Renewal of THE Authorisation

Date of first authorisation: 1 April 1979

Date of last renewal: 1 April 2009

10. Date of Revision of THE Text

November 2015 April 2014

Updated on 23 November 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 14 April 2014 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

Text in red = new text
Text strikethrough = deleted text

7 MARKETING AUTHORISATION HOLDER

12/13 Exchange Place

I.F.S.C Dublin 1

3016 Lake Drive,

Citywest Business Campus

Dublin 24

10 DATE OF REVISION OF THE TEXT

February April 20143

Updated on 8 April 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 17 January 2014 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Text in red = new text
Text strikethrough = deleted text

7.    marketing AUTHORISATION holder

Aspen Europe GmbH

Industriestrasse 32-36,

D-23843 Bad Oldesloe

Germany

 

Aspen Pharma Trading Limited

12/13 Exchange Place

I.F.S.C Dublin 1,

Ireland

 

8.    marketing authoriSation number

PA 1568/9/1

 

PA 1691/8/1

 

10.  date of (PARTIAL) REVision of the Text

March 2010

 

November 2010

Updated on 5 May 2011 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
  • SPC retired pending re-submission

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

Free text change information supplied by the pharmaceutical company

Product ownership changed from GSK to Aspen

Updated on 3 May 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 20 April 2010 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 20 April 2010 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Change in spelling:

busulphan to busulfan

Updated on 4 January 2010 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 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Myleran Changes in red

1.   name of the medicinal product

Myleran 2mg Film-coated Tablets

2.   qualitative and QUantitative composition

Each tablet contains 2mg of the active substance busulphan.

Each tablet also contains 92.5mg of Lactose

 

For a full list of excipients, see Section 6.1.

3.   pharmaceutical form

White, film-coated round biconvex tablets engraved ‘GX EF3’ on one side and ‘M’ on the other.

9.   date of first authoriSation/renewal of the AUTHORISATION

1st April 1979 / 1st April 2009

10. date of (PARTIAL) REVision of the Text

October 2009

 

Updated on 4 September 2009 SmPC

Reasons for updating

  • 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 10:

Change of Date:

August 2004 changed to Sept 2004

Updated on 17 November 2008 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 4 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 October 2004 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 11 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 August 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Updated on 29 January 2004 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 4 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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