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Carbimazole 20 Mg Tablets

Document: leaflet MAH BRAND_PLPI 39467-0158 change

Package leaflet: Information for the user

Carbimazole 20 mg tablets

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 or pharmacist.

-    This medicine has been prescribed for you. Do not pass it onto 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

In this leaflet:

1.    What Carbimazole 20mg tablets is and what it is used for

2.    What you need to know before you take Carbimazole 20mg tablets

3.    How to take Carbimazole 20mg tablets

4.    Possible side effects

5.    How to store Carbimazole 20mg tablets

6.    Contents of the pack and other information.

1.    WHAT CARBIMAZOLE 20MG TABLETS IS AND WHAT IT IS USED FOR

The name of your medicine is Carbimazole 20mg tablets. Carbimazole 20mg tablets contains the active substance carbimazole. Carbimazole 20mg tablets belongs to a group of medicines called anti-thyroid agents.

Carbimazole 20mg tablets is used to reduce the formation of thyroid hormones in adults and children with on overactive thyroid gland. The condition is called hyperthyroidism. Carbimazole 20mg tablets is also used in more serious cases, for example, to restore the normal function of the thyroid before its partial removal by surgery. It may also be used together with other treatments for hyperthyroidism.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBIMAZOLE 20MG TABLETS

Do not take Carbimazole 20mg tablets

•    If you are allergic (hypersensitive) to carbimazole or any of the ingredients of Carbimazole 20mg tablets.

•    If you are allergic (hypersensitive) to other antithyroid medications such as thiamazole, methimazole or propylthiouracil.

•    If you are breast-feeding.

•    If you have a serious blood disorder.

•    If you have a severe liver disorder.

Warnings and precautions

Take special care with Carbimazole 20mg tablets

•    If you have a swelling in your neck called an 'intrathoracic goitre'.

•    If you have bone marrow depression.

•    If you are receiving radio-iodine (for thyroid problems).

•    If you are of child-bearing potential.

•    If you are allergic to thiamazole, methimazole or propylthiouracil (other thyroid medications).

•    If you are lactose intolerant or have any other lactose deficiency.

•    If you are sucrose intolerant or have any other sucrose deficiency.

•    If you are unable to comply with the instructions for use or cannot be monitored regularly.

Talk to your doctor or pharmacist before taking Carbimazole 20mg tablets

•    If you are pregnant, think you may be pregnant or are trying to become pregnant.

•    If you have mild or moderate liver problems.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Carbimazole 20mg tablets.

Children

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

Other medicines and Carbimazole 20mg tablets

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 20mg tablets can affect the way some medicines work. Also, some medicines can affect the way Carbimazole 20mg tablets 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 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.

Your Carbimazole 20mg tablets treatment is important for you and may need to be continued during pregnancy but very rarely it can cause harm to a developing foetus. However, 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.

•    You should not breast-feed if you are using Carbimazole 20mg tablets. This is because small amounts may pass into the mother's milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You can drive when taking Carbimazole 20mg tablets, but do not drive until you know how it affects you.

Carbimazole 20mg tablets contains lactose and sucrose

If your doctor has told you that you have on intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE CARBIMAZOLE 20MG TABLETS

Always take Carbimazole 20mg tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    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 ta 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 20mg 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 radio-iodine treatment, your doctor will tell you to stop taking Carbimazole 20mg tablets temporarily.

If you take more Carbimazole 20mg tablets than you should

If you take more Carbimazole 20mg tablets than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Carbimazole 20mg tablets

If you forget to take Carbimazole 20mg tablets take the next dose as soon as you remember. If your next dose is due, take both doses together.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Carbimazole 20mg tablets can cause side effects, although not everybody gets them.

Allergic reactions

If you have an allergic reaction, stop taking Carbimazole 20mg tablets and see a doctor straight away. The signs may include: sudden rash, swelling or difficulty breathing.

Stop taking Carbimazole 20mg tablets and see a doctor straight away if you notice any of the following side effects:

•    Sore throat.

•    Mouth ulcers.

•    High temperature or fever.

•    Significant tiredness.

•    Increased bruising or bleeding tendency.

•    You are feeling generally unwell or think that you may have on infection.

In addition, if you experience any of these symptoms while taking Carbimazole 20mg tablets you should also contact your doctor i mmediately:

•    Muscle pain or weakness.

•    Nerve pain.

•    Swelling of lymph nodes.

•    Swelling of glands in your mouth.

•    Feeling faint (low blood sugar).

•    Yellowing of your skin or whites of your eyes

These could be signs of muscle problems, jaundice or inflammation of the liver and under medical supervision your doctor may want you to stop taking the medicine and carry out some blood tests on you.

Do not stop taking Carbimazole 20mg tablets until you have consulted your doctor:

Carbimazole 20mg tablets can sometimes cause bone morrow depression which causes a reduction in the number of blood cells and reduces the ability to fight infection. If it is not treated as soon as it is detected the condition can become life threatening. Your doctor should carry out tests to check for bone marrow depression before restarting your treatment.

Other side effects include:

•    Feeling sick.

•    Headache.

•    Skin rashes, including urticaria (nettle rash).

•    Itching.

•    Stomach upset.

•    Painful joints.

The following side effects have also been reported:

•    Hair loss.

•    Loss of taste.

•    Angioedema, a serious allergic reaction with symptoms that may include swollen tongue, lips, face or throat.

•    Lung problems, with symptoms that include shortness of breath or a cough.

•    Kidney problems, with symptoms that include a reduction in the amount of urine passed, fluid retention and blood in the urine.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NEOMEICAZOLE

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original container.

Do not use after the expiry date which is printed on the label after Exp. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Carbimazole 20 mg tablets contains

•    The active substance is carbimazole. Each tablet contains 20 mg of the carbimazole.

•    The other ingredients are sucrose, lactose monohydrate, acacia, talc, maize starch, magnesium stearate, gelatin, red iron oxide E172 and microcrystalline cellulose.

What Carbimazole 20 mg tablets looks like and the contents of the pack

The Carbimazole 20 mg tablets are round, pale pink tablets and marked with 'Neo 20' on one side and plain on the reverse.

Each carton contains 100 tablets in a plastic bottle.

Procured from within the EU by PL holder

PilsCo Ltd, 10-16 Colvilles Place, East Kilbride, G75 0SN

Manufacturer

Amdipharm PLC, Regency House, Miles Gray Road, Basildon, Essex, SS14 3AF, UK Cenexi SAS, 52 rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France

PL 39467/0158 Carbimazole 20 mg tablets

This leaflet was last revised 17/03/2016.

POM