Imuger 25 mg & 50 mg Film-coated Tablets

  • Name:

    Imuger 25 mg & 50 mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Azathioprine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/02/18

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 28/2/2018
print

Print ViewKeyword Search SmPC

Gerard Laboratories

Gerard Laboratories

Company Products

Medicine NameActive Ingredients
Medicine Name Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets Active Ingredients Abacavir hydrochloride, Lamivudine
Medicine Name Agerdex 1mg Film Coated Tablets Active Ingredients Anastrozole
Medicine Name Agomelatine Mylan 25 mg film-coated tablets Active Ingredients Agomelatine
Medicine Name Amisulpride 50mg & 200mg Tablets Active Ingredients Amisulpride
Medicine Name Amlodipine Mylan 5mg & 10mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine/Valsartan Mylan 5mg/80mg, 5mg/160mg, 10mg/160mg film-coated tablets Active Ingredients Amlodipine besilate, Valsartan
Medicine Name Areloger 7.5mg & 15mg Tablets Active Ingredients Meloxicam
Medicine Name Aripil 5mg & 10mg Film-coated Tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Atenetic 50/12.5mg & 100/25mg Film - coated Tablets Active Ingredients Atenolol, Chlortalidone
Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets Active Ingredients Atovaquone, Proguanil Hydrochloride
Medicine Name Azromax 250mg Film-coated tablets Active Ingredients Azithromycin monohydrate
Medicine Name Baclopar Tablets 10 mg Active Ingredients Baclofen
Medicine Name Bisoprolol Mylan Active Ingredients Bisoprolol Fumarate
Medicine Name Brabio 20mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Brabio 40mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Cifloxager 250 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Cifloxager 500 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciprager 10mg & 20mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprager 40mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprofloxacin Mylan 2mg/1ml solution for infusion Active Ingredients Ciprofloxacin
Medicine Name Clopidogrel Mylan 75 mg film-coated tablets Active Ingredients clopidogrel hydrochloride
Medicine Name Darunavir Mylan 800 mg film-coated tablets Active Ingredients darunavir ethanolate
Medicine Name Depreger 50mg & 100mg Film-Coated Tablets Active Ingredients sertraline hydrochloride
Medicine Name Diaclide MR 30 mg Modified-release Tablets Active Ingredients Gliclazide
1 - 0 of 117 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 28 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 28 February 2018 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

3. PHARMACEUTICAL FORM
 
Film-coated tablet

Pale-yellow, film-coated, round,  biconvex tablet, marked ‘AE’ over ‘25’ on one side and ‘G’ on the reverse.

Pale- yellow, film-coated, round, biconvex tablet, marked ‘AE’ over ‘50’ on one side and breakline on the reverse. The tablet can be divided into equal doses.

4.1 Therapeutic indications

Azathioprine is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung, or pancreas transplants. Azathioprine is usually indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression).

Azathioprine is indicated in severe cases of the following diseases, in patients who are intolerant to steroids or who are dependent on steroids and in whom the therapeutic response is inadequate despite treatment with high doses of steroids:
• severe active rheumatoid arthritis that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic drugs (DMARDs))
• severe or moderately severe inflammatory intestinal disease (Crohn’s disease or ulcerative colitis)
• systemic lupus erythematosus
• dermatomyositis
• autoimmune hepatitis
• polyarteritis nodosa
• refractory warm auto-immune autoimmune haemolytic anaemia
• chronic refractory idiopathic thrombocytopenic purpura

4.2  Posology and method of administration

Posology

Use in patients with renal and/ or hepatic impairment
In patients with renal and/ or mild to moderate hepatic dysfunction, dosages should be given at the lower end of the normal range. Azathioprine is contraindicated in severe hepatic impairment (see section 4.3).

Paediatric population:
There are insufficient data to recommend the use of azathio¬prine for the treatment of juvenile idiopathic arthritis, systemic lupus erythematosus, dermatomyositis, and polyar-teriitis polyarteritis nodosa (in children and adolescents < 18 years).
 
Concerning the other indications, the given dose recommendations apply for children and adolescents as well as for adults.

Use in the elderly: 
There is no specific information on how elderly patients tolerate azathioprine.  It is advisable to monitor renal and hepatic functions and consider a dose reduction if there is a functional impact (see section 4.2). It is recommended that the dosages used should be at the lower end of the normal range (for monitoring of blood count see section 4.4).

Drug interactions:
When allopurinol, oxipurinol or thiopurinol is given conco¬mitantly with azathioprine, the dose of azathioprine must be reduced to a quarter of the original dose (see sections 4.4 and 4.5).

It can take weeks or months before a therapeutic effect is seen.

The medicinal product may be given over the long term unless the patient cannot tolerate the preparation.

Use in TPMT-deficient patients:
Patients with rare hereditary problems of small or non-existent thiopurine S methyltransferase (TPMT) activity are at an increased risk of severe azathioprine toxicity from conventional doses of azathioprine, and usually require a significant dose reduction. The optimal starting dose for homozygous patients with TPMT deficiency has not been established (see sections 4.4 and. 5.2).

Most patients with heterozygous TPMT deficiency tolerate the recommended azathioprine doses, but some of them may require dose reduction. Tests of genotype and phenotype of TPMT are available (see sections 4.4 and 5.2).

Patients with NUDT15 variant:
Patients with an inherited, mutated NUDT15 gene have an increased risk of serious azathioprine toxicity (see section 4.4). These patients generally require a dose reduction, particularly those patients who are homozygous for the NUDT15 variant (see section 4.4). Genotypical testing of NUDT15 variants may be considered before starting treatment with azathioprine. In every case it is necessary to monitor the blood count carefully.

4.4 Special warnings and precautions for use

Immunisation with live vaccines is not recommended as they may cause infection in immunocompromised hosts (see section 4.5).

Patients with NUDT15 variant:
Patients with an inherited mutated NUDT15 gene have an increased risk of serious azathioprine toxicity, such as early leukopenia and alopecia, from conventional doses in thiopurine treatment. A dose reduction is generally required, particularly for those patients who are homozygous for the NUDT15 variant (see section 4.2). The frequency of NUDT15 c.415C>T has an ethnic variability: approx. 10% in Asians, 4% in Latin Americans, 0.2% in Europeans and 0% in Africans. In every case it is necessary to monitor the blood count carefully.

Fertility:
Contraceptive measures must be used by both male and female patients of reproductive age during azathioprine therapy and for at least three months thereafter. This also applies to patients with impaired fertility due to chronic uraemia, since fertility usually returns to normal after transplantation.

Relief of chronic renal insufficiency by renal transplantation involving the administration of azathioprine has been accompanied by increased fertility in both male and female transplant recipients.

Azathioprine has been reported to interfere with the effectiveness of intrauterine contraceptive devices. It is therefore recommended that alternative or additional contraceptive measures be used.

4.6 Fertility, pregnancy and lactation

This also applies to patients with impaired fertility due to chronic uraemia, since that fertility usually returns to normal after transplantation. Azathioprine has been reported to interfere with the effectiveness of intrauterine contraceptive devices. It is therefore recommended that alternative or additional contraceptive measures be used.

4.8 Undesirable effects

Infections and infestations
Patients treated with azathioprine alone or in combination with other immunesuppressants immunosuppressants, primarily corticosteroids, have shown increased susceptibility to viral, fungal and bacterial infections, including severe and atypical varicella, herpes zoster and other infectious agents (see section 4.4).

5.1 Pharmacodynamic properties
 
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents. Immunosuppressants. Other immunosuppressants, ATC code: L04 AX 01

Azathioprine is used as an immunosuppressive antimetabolite either alone or

Updated on 27 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 February 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 25 November 2016 PIL

Reasons for updating

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

Updated on 5 August 2016 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

1. NAME OF THE MEDICINAL PRODUCT

Imuger 25 mg Film-coated Tablets film-coated tablets
Imuger 50 mg Film-coated Tablets film-coated tablets

4.4 Special warnings and precautions for use

Carcinogenicity:
Patients receiving immunosuppressive therapy, including azathioprine are at an increased risk of developing non-Hodgkin's lymphomas lymphoproliferative disorders and other malignancies, notably mainly skin cancers (melanoma and non-melanoma), sarcomas (Kaposi’s and non-Kaposi’s) and uterine cervical cancer carcinoma in situ. The increased risk appears to be is probably related to the degree intensity and duration of immunosuppression.treatment, and not the individual product. It has been reported that reduction or discontinuation of immunosuppression immunosuppressive therapy may provide result in partial or complete regression of the lymphoproliferative disorder non-Hodgkin's lymphoma and Kaposi's sarcoma.

A treatment regimen containing multiple immunosuppressants (including thiopurines) should therefore be used with caution as this could lead to lymphoproliferative disorders, some with reported fatalities. A combination of multiple immunosuppressants, given concomitantly, increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders.

Macrophage activation syndrome:
Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of azathioprine. If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with azathioprine should be discontinued. Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.

4.8 Undesirable effects

 

 

Very common

(>1/10)

 

Common

(>1/100to <1/10)

 

Uncommon

(>1/1000to <1/100)

 

Rare

(>1/10000to <1/1000)

Very rare

(<1/10000),

 

Not known (cannot be estimated from the available data)

Infections and infestations

Viral, fungal and bacterial infections in transplant patients receiving azathioprine in combination with other immunosuppressants. In 20% of kidney transplant patients.

Susceptibility to infection in patients with inflammatory bowel disease

Viral, fungal and bacterial infections in other patient populations.

In <1% of rheumatoid arthritis (RA) patients

 

Cases of PML associated with JC virus has been reported following use of azathioprine in combination with other immunosuppressive agents (see section 4.4).

 

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

 

 In up to 2.8% of kidney transplant patients, significantly fewer cases (or none at all) in other indications (in decreasing frequency): squamous cell carcinoma of the skin, non-Hodgkin lymphomas, cervical cancer, Kaposi’s sarcoma, vulval cancer.

Post-transplantation lymphoproliferative disease.

Neoplasms including lymphoproliferative disorders, skin cancers (melanomas and non-melanomas), sarcomas (Kaposi’s and non-Kaposi’s) and uterine cervical cancer in situ (see section 4.4)

Acute myeloid leukaemia and myelo-dysplastic syndromes.

 

Blood and lymphatic system disorders

Depression of bone marrow function; leukopenia

 

- in >50% of kidney transplant patients (significant in 16%),

- in 28% of RA patients,

- in 15% of Crohn’s disease patients.

Thrombocytopenia. Significant leukopenia in 5.3% in RA patients.

Anaemia

Agranulocytopenia, pancytopenia and aplastic anaemia, megaloblastic anaemia, ery­throid hypoplasia.

 

Haemolytic anaemia

 

Immune system disorders

 

 

Hypersensitivity reac­tions including general malaise, hypotension, dizziness, leukocytosis, exanthema, severe nau­sea and vomiting, di­arrhoea, fever, rigors, chills, rash, myalgia, arthra­lgia, vasculitis, renal dysfunction, elevations in liver enzymes.

 

Hypersensitivity reactions with lethal outcome.

 

Nervous system disorders

 

 

 

 

 

Meningism

Respiratory, thoracic and mediastinal disorders

 

 

 

Interstitial pneumonitis (reversible).

 

 


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.

Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6767836
Website:
www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

6.6  Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Updated on 26 July 2016 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
  • Addition of information on reporting a side effect.

Updated on 13 January 2015 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 6.5, additional pack size of 90 for blisters

PVC/Aluminium foil blister packs – 20, 30, 50,

90, 100

 

Updated on 13 January 2015 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 4 March 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Extensive updates to the SPC in line with the brand leader and QRD template.

Updated on 12 February 2014 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 26 May 2010 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3: description chanaged from...
25mg: Pale yellow, film coated, biconvex tablet approximately 6mm in diameter             marked “AE 25” on one side and “G” on reverse. Pale-yellow, film-coated, biconvex tablets marked ‘AE over 25’ on one side and ‘G’ on the reverse.

50mg: Pale yellow, film coated, biconvex tablet approximately 8mm in diameter             marked “AE 50” on one side and breakline on reverse.Pale- yellow, film-coated, round, biconvex tablets marked “AE over 50” on one side and breakline on the reverse.

Updated on 3 July 2007 PIL

Reasons for updating

  • Change of special precautions for disposal
  • Change to date of revision

Updated on 3 July 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

 
Section 1: amended name to read 'Imuger 25mg/50mg Film-coated Tablets'
Section 3: Included statement 'The tablet can be divided into equal halves' for 50mg only.
Section 4.2: 'juvenile chronic arthritis' amended to 'juvenile idiopathic arthritis'.
Section 4.7: amended text to QRD
Section 4.8: amended types of adverse effects to QRD.
Section 6.1: amended 'Stearylfumarate sodium' to read 'Sodium stearyl fumarate'.
Section 6.4: amended statement to QRD.
Section 6.5: included QRD statement.
Section 6.6: included QRD statement.
Section 9: new renewal date.
Section 10: new revision date.

Updated on 1 September 2006 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 26 May 2005 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation

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

Updated on 25 May 2005 PIL

Reasons for updating

  • Change to date of revision
  • Change to storage instructions

Updated on 16 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 August 2003 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)

Updated on 17 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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