Carbimazole

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–      If you have any further questions ask your doctor or your pharmacist.

–      This medicine was prescribed for you personally and you should not pass it on to others. It can be harmful, even when their symptoms are the same as yours.

Composition:

Active substance: Carbimazole

Excipients: Microcrystalline Cellulose, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Hypromellose, Macrogol 400, Titanium Dioxide, Ponceau 4R E124.

Marketing Licence Holder & Manufacturer:

Remedica Ltd, Limassol Industrial Estate,

Limassol, Cyprus, Europe.

Marketing Licence Number:

1.      WHAT IS CARBIMAZOLE AND WHAT ARE ITS PROPERTIES

Carbimazole, the active substance of Carbimazole tablets, belongs to the group of medicines that are named antithyroids.

Carbimazole blocks the formation or the excretion of the hormone thyroxine from the thyroid gland and therefore it treats the excess hormone of the thyroid gland in the blood as well as the symptoms that it causes (thyreotoxicosis). Treatment may either be prolonged on a maintenance base or it may just be preliminary before the surgical removal of the thyroid gland.

Indications

Carbimazole is indicated in all states that a reduction of the function of the thyroid is needed such as:

• Hyperthyroidism
• Preparation for thyroidectomy in hyperthyroidism
• Preparation and concomitant therapy with radio-iodine therapy.

2.      WHAT SHOULD YOU KNOW BEFORE YOU TAKE CARBIMAZOLE

Be particularly careful with Carbimazole:

Please inform your doctor,

• if you are allergic to carbimazole or to any excipients of the product
• if you are pregnant, intend to get pregnant or if you are breast feeding
• if you suffer from liver impairment (the excretion of the drug with the usual rate could be delayed therefore increasing the possibility of undesirable effects.

Interactions

A number of medicines interact with Carbimazole and should not be used concomitantly. However, a few of them can be used concomitantly under special precautions. In this case, your doctor can change the posology or take other cautions if needed. It is important to inform your doctor or pharmacist if you are taking other medications and particularly any of the following: Amiodarone, potassium iodide, anticoagulants, digoxin, sulphonylurea.

Special Precautions

Carbimazole should not be administered to patients with obstruction of the upper respiratory system. It should be administered with caution to patients with hepatic disorders.

Administration of Carbimazole should be stopped temporarily at the time of administration of radio-iodide.

The administration to women that are possibly pregnant, the risk / benefit ratio should be taken into account.

Pregnancy

Carbimazole should be administered with special caution during pregnancy. The lowest possible dose should be used, and this should be discontinued 3-4 weeks before labour, in order to reduce the risk of neonatal complications.

Consult your doctor or pharmacist before taking any medication.

Lactation

Carbimazole is secreted in breast milk, and if treatment is continued, breast-feeding should be interrupted.

Consult your doctor or pharmacist before taking any medication.

Effects on ability to drive or operate machinery

Carbimazole is unlikely to affect the ability to drive or operate machinery.

3. HOW SHOULD CARBIMAZOLE BE TAKEN

Follow your doctor’s instructions.

Adults: The initial dose is in the range of 20-60mg per day as divided doses, every 6-8 hours.

Maintenance regimen: 5-15mg per day, as single or divided doses. Treatment should last 6-18 months.

Blocking-replacement regimen: 20-60mg per day, and supplemental thyroxine, 50-150μg per day. Thyroxine should be administered concomitantly in order to prevent hypothyroidism. Therapy should last 6-18 months.

Children: The usual initial daily dose is 15mg per day.

Elderly: No special dosage regimen, but care should be taken to observe the contra-indications and warnings.

Do not discontinue the medication unless you first consult your doctor.

If you take a larger dose of Carbimazole than that recommended

In case of overdose contact your doctor or the nearest hospital immediately.

What should you know if you forget to take Carbimazole

If you forget to take a dose, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a missed one.

4. POSSIBLE UNDESIRABLE EFFECTS

As with all medicines, Carbimazole can cause undesirable effects.

The most frequently occurring reactions are: nausea, headache, arthralgia, mild gastric distress, skin rashes and pruritus.

• Blood system disorders: bone marrow depression that can lead to agranulocytosis. Rare cases

of aplastic anaemia, pancytopenia and thrombocytopenia have been reported.

• Nervous System disorders: headache.
• Gastro-intestinal system disorders: nausea, mild gastric distress.
• Hepatic system disorders: hepatic disorders jaundice. In these cases the use of the medicine should be withdrawn.
• Skin disorders: skin rashes, pruritus, urticaria. Hair loss has been occasionally reported.
• Musculoskeletal system disorders: myopathy, myalgia.

If you have undesirable effects that are not mentioned above, please inform your doctor.

5. SHELF LIFE AND STORAGE OF CARBIMAZOLE

Product expiry date:

Shown on the inner and outer packaging. In case the expiry date has lapsed, do not use.

Special precautions for storage of the product:

Keep below 25° C, in a safe, cool, dry place, away from light and moisture and out of the reach of children.

6. OTHER INFORMATION

For any information regarding this pharmaceutical product, contact the Marketing Licence Holder.

Date of last revision of leaflet

October 2004

Dispensing

This medicine is dispensed only by medical prescription.