Carbimazole 20mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

1. What Carbimazole tablets are and what they are used for
2. What you need to know before you take Carbimazole tablets
3. How to take Carbimazole tablets
4. Possible side effects
5. How to store Carbimazole tablets
6. Contents of the pack and other information

• You are allergic to Carbimazole or any of the other ingredients of Carbimazole tablets (listed in Section 6) or to other anti-thyroid medicines such as thiamazole, methimazole or propylthiouracil
• You are breast-feeding
• You have a severe liver disorder
• You have a serious blood disorder.
• You had inflammation of the pancreas (acute pancreatitis) after taking carbimazole or thiamazole in the past.

Talk to your doctor or pharmacist before taking Carbimazole if:

• You have a swelling in your neck called an 'intrathoracic goitre'.
• You have bone marrow depression.
• You are receiving radio-iodine (for thyroid problems).
• You cannot follow the instructions for use or you cannot be monitored regularly by your doctor.
• You have mild or moderate liver problems.

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

If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Carbimazole.

Do not give this medicine to children under the age of two years because it may not be safe or effective.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Carbimazole can affect the way some medicines work. Also some medicines can affect the way Carbimazole works.

In particular tell your doctor or pharmacist if you are taking any of the following:

• Theophylline used to treat asthma or breathing problems
• Medicines called anticoagulants, which are used to thin the blood e.g. warfarin
• Steroids such as prednisolone
• An antibiotic called erythromycin
• A medicine for heart failure called digitalis
• Medicines for high blood pressure called beta-blockers

Pregnancy

Carbimazole can cause harm to an unborn baby. You should use reliable contraception from the time you start treatment and during treatment.

Tell your doctor if you are pregnant, think you may be pregnant or are trying to become pregnant.

Your treatment with Carbimazole may need to be continued during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.

To reduce the possibility of any effects on your baby:

• Your doctor should prescribe the lowest dose possible.
• Your treatment may be discontinued three to four weeks before you are due to give birth.

Breast-feeding

You should not breast-feed if you are using Carbimazole. This is because small amounts may pass into the mother's milk.

You can drive when taking Carbimazole, but do not drive until you know how it affects you.

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

• The tablets should be taken by mouth.
• You can take the tablets before, after or during meals.
• Each day's tablets may be divided into two (morning and evening) or three daily doses (morning, noon and night).

Adults and the elderly: The recommended starting dose is one to three 20 mg tablets, or four to twelve 5 mg tablets daily. Once control is achieved your doctor will gradually reduce your dose to one to three 5 mg tablets each day.

Use in children: The recommended starting dose is three 5 mg tablets daily.

The dosage will be decided by your doctor according to your individual needs, and may be changed at intervals during treatment.

Do not change the dosage without consulting your doctor first.

Your doctor may decide to add an additional tablet (L-thyroxine), to help control your condition.

Some improvement is usually felt within one to three weeks. However, full beneficial effects usually take four to eight weeks.

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

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

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

Take the next dose as soon as you remember. If your next dose is due, take both doses together.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is carbimazole. Each tablet contains 5 mg or 20 mg of carbimazole.
• The other ingredients are lactose monohydrate, copovidone, citric acid monohydrate, croscarmellose sodium and magnesium stearate

Carbimazole 5mg Tablets are white to off-white coloured, circular, flat beveled edge tablets, approximately 4.50 mm in size with “Y” debossed on one side and “11” on other side.

Carbimazole 20mg Tablets are white to off-white coloured, circular, flat beveled edge tablets, approximately 7.50 mm in size with “G” debossed on one side and “111” on other side.

Carbimazole 5mg and 20mg Tablets are available in PVC/PVDC/Alu foil blister packs and HDPE bottle pack containing 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer