Package Leaflet: Information for the Patient Carbimazole Orifarm 5 Mg

Package leaflet: Information for the patient

Carbimazole Orifarm 5 mg, 10 mg, 15 mg and 20 mg tablets

carbimazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet 1. What Carbimazole Orifarm is and what it is used for 2. What you need to know before you take Carbimazole Orifarm 3. How to take Carbimazole Orifarm 4. Possible side effects 5. How to store Carbimazole Orifarm 6. Contents of the pack and other information

1. What Carbimazole Orifarm is and what it is used for

Carbimazole Orifarm contains the active substance carbimazole. It belongs to a group of medicines called anti-thyroid agents which is used to prevent the formation of thyroid hormones in the thyroid gland. It is used when the thyroid gland produces too much thyroid hormon (hyperthyroidism).

This medicine is used for treatment of the following: - Thyrotoxicosis (another type of overactive thyroid gland) - Graves' disease (immune disorder resulting in overproduction of thyroid hormones) - To restore the normal function of the thyroid before surgery.

Carbimazole Orifarm can also be used for radio-iodine treatment.

Carbimazole Orifarm is used to treat adults, children and adolescents.

2. What you need to know before you take Carbimazole Orifarm

Do not take Carbimazole Orifarm: - if you are allergic to carbimazole or any of the other ingredients of this medicine (listed in section 6) - if you have a severe blood disorder - if you have a severe liver disorder - if you are breast-feeding. - if you had inflammation of the pancreas (acute pancreatitis) after administration of carbimazole or thiamazole in the past.

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Carbimazole Orifarm. - if you feel unwell, tend to have infections, especially a sore throat and fever. This may be due to changes in blood (too few white blood cells). Contact your doctor

- if you have a condition called agranulocytosis (low white blood cell count) - if you have a mild to moderate liver disease or develop jaundice (symptoms includes yellowing of the eyes) or if you experience upper abdominal pain, loss of appetite or itching all over the body, stop treatment and talk to your doctor - if you have been told by a doctor that you have an inappropriate iodine level - if you have swelling in your neck called an ‘intrathoracic goitre’ or if your thyroid gland growth in volume during treatment (goitre) and you develop breathing difficulties - if you are going to have a surgery, as Carbimazole Orifarm may make you more prone to bleedings - if you are unable to comply with the instructions for use or cannot be monitored regularly due to poor memory - if you have muscle weakness - if you are of childbearing age - if you are taking other medicines for increased metabolism (propylthiouracil, thiamazole).

Carbimazole Orifarm can cause harm to an unborn baby. If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.

Tell your doctor straight away if you develop fever or abdominal pain, which may be signs of inflammation of the pancreas (acute pancreatitis). Carbimazole Orifarm may need to be discontinued.

Children and adolescents Carbimazole Orifarm is not recommended to children under the age of 2 years.

Other medicines and Carbimazole Orifarm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Talk to your doctor if you are taking the following medicines: - medicines used to thin the blood (anticoagulants) such as warfarin - theophylline used to treat asthma or breathing problems - steroids such as prednisolone - antibiotics such as erythromycin - medicines for heart diseases such as digitalis glycosides or beta-blockers (e.g. propranolol).

It is especially important that you talk to your doctor if you are in iodine treatment or have taken iodine in recent years.

Carbimazole Orifarm with food and drink Carbimazole Orifarm can be taken with food, but it is not necessary. You must take Carbimazole Orifarm with a glass of water.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Carbimazole Orifarm can cause harm to an unborn baby.

If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away. Your treatment with Carbimazole Orifarm may need to be continued during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.

Do not breast-feed if you are taking Carbimazole Orifarm since the medicine is excreted into breast milk. Talk to your doctor.

Driving and using machines

It is not known if carbimazole affects your ability to drive and use machines. You must be aware of how the medicine affects you.

Carbimazole Orifarm contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Carbimazole Orifarm

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dosage will be decided by your doctor. The recommended dose is:

Adults: Severe cases: The initial dose is 20-60 mg daily, taken as 2-3 divided doses.

Mild cases: The initial dose is 20 mg daily.

Maintenance regimen: 5-20 mg daily. Therapy should be continued for at least 6 months and up to 18 months.

If you have an enlarged thyroid gland or you have been treated with iodine, your doctor may prescribe very large doses at the start of treatment (e.g. 120 mg).

Use in children and adolescents 3-17 years of age: The recommended initial dose ranges from 0.2-0.5 mg/kg body weight per day divided into two doses and adjusted based on the level of thyroid hormones in the blood.

The 5 mg tablets are not suitable for children with a body weight below 20 kg. For children weighing 20-50 kg, the suitability of the 5 mg tablets depends of the dose needed.

The 10 mg, 15 mg and 20 mg tablets is not suitable for small children.

The maximum recommended dose of carbimazole in children is 30 mg/day.

Method of administration The tablets must be taken with a glass of water. The 20 mg tablet can be divided into equal doses.

Duration of treatment Therapy should be continued for at least 6 months and up to 18 months with routine control of thyroxine (T4) in the blood. Some improvement is usually felt within 1-3 weeks. However, full beneficial effects usually take 4-8 weeks. Once control is achieved your doctor can gradually reduce your dose. Do not change the dosage without consulting your doctor first.

In order to maintain control of the thyroid gland, you may need to continue to take Carbimazole Orifarm tablets for several months. Your doctor will decide when treatment can be stopped. Your doctor may ask you to have occasional blood tests to determine how you are responding to treatment.

Radio-iodine treatment Radio-iodine is another treatment for hyperthyroidism. If you need radio-iodine treatment, your doctor will tell you to stop taking Carbimazole Orifarm temporarily.

If you take more Carbimazole Orifarm than you should You may get enlargement of the thyroid gland (goitre) and a slower metabolism if you take too much Carbimazole Orifarm for a long time.

If you forget to take Carbimazole Orifarm If you have forgotten to take a dose, skip the forgotten dose. Do not take a double dose to make up for a forgotten dose. Continue with the next dose as usual.

If you stop taking Carbimazole Orifarm You should only pause or stop the treatment in agreement with your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects If you experience any serious side effects, contact your doctor or healthcare professional immediately.

- Agranulocytosis (changes in blood picture leading to fatigue, bleeding from skin and mucosa, infections (throat infection) and fever). - Severe blood disorders (anemia) leading to fatigue, mouth ulcers and pale skin. - Rapid swelling of various parts of the body caused by an accumulation of fluid (angioedema) with symptoms like swelling of the tongue, lips, face or throat. Call the emergency department. - Side effects produced by the normal immune system in several organs, the symptoms may be; skin rash, shortness of breath, fever, muscle pain, decreased urination and malaise. - Life-threatening skin disease (Stevens-Johnson syndrome) with bladder-shaped rash and skin inflammation, especially on the hands and feet and in and around the mouth accompanied by fever or peeling of the skin on large parts of the body. Call the emergency department. - Liver disease with jaundice. - Faintness, cold sweat, hunger, confusion, possibly unconsciousness and convulsions due to low blood sugar (blood glucose). In case of shortness of breath call the emergency department. - Sensory disturbances and paralysis mainly in the arms and legs, but breathing can also be affected. - Fatigue, loss of appetite, nausea, vomiting, lower back pain, fever, foaming or bloody urine due to inflammation of the kidneys, possibly with swelling of hands, feet and face. Call the doctor or the emergency department.

Other side effects

Common side effects: may affect up to 1 in 10 people - Headache, dizziness - Prickly, tingling sensations or numbness - Nerve pain, decreased sensation - Nausea, indigestion - Painful joints (especially in the joint of the thumb) - Allergic reactions such as skin rashes, pruritus, nettle rash (urticaria) - Stomach upset.

Uncommon side effects: may affect up to 1 in 100 people - Loss of taste sensation - Hair loss.

Rare side effects: may affect up to 1 in 1,000 people - Pain or a sore throat (sialoadenitis).

Very rare side effects: may affect up to 1 in 10,000 people - Muscle weakness.

Not known: frequency cannot be estimated from the available data - Enlargement of the thyroid gland (goitre) - Bulging of the eyes - Mouth ulcers - Vomiting - Decreased activity of the thyroid gland resulting in delayed growth and mental development in children and adults - Muscle pain - Fever - General malaise - Weakness - Liver function abnormal - Creatine phosphokinase levels abnormal, an enzyme found in the heart, brain, skeletal muscle and other tissues. Increased amounts of creatine phosphokinase are released into the blood following muscle damage. - Inflammation of the pancreas (acute pancreatitis).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Carbimazole Orifarm

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions

Container: After first opening, discard the polyester filling.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Carbimazole Orifarm contains - The active substance is carbimazole. - The other ingredients are lactose monohydrate, ferric oxide red (E172), croscarmellose sodium, magnesium stearate.

What Carbimazole Orifarm looks like and contents of the pack Appearance 5 mg: pink, mottled, round, biconvex uncoated tablets, debossed with "5" on one side and plain on the other side. Diameter 5 mm.

10 mg: pink, mottled, round, biconvex uncoated tablets, debossed with "10" on one side and plain on the other side. Diameter 6.5 mm.

15 mg: pink, mottled, round, biconvex uncoated tablets, debossed with "15" on one side and plain on the other side. Diameter 7.4 mm.

20 mg: pink, mottled, round, biconvex uncoated tablets, debossed with "2 and 0" separated by a score line on one side and plain on the other side. Diameter 8 mm.

Contents of the pack Container with child resistant closure, aluminum seal and polyester filling: 100 tablets.

Marketing Authorisation Holder and Manufacturer [To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names: DK, NO, IS: Carbimazole Orifarm

This leaflet was last revised in [To be completed nationally]