Carbimazole 20 mg tablets

Patient Leaflet Updated 27-Sep-2023 | ADVANZ Pharma

Carbimazole 20 mg tablets

Package leaflet: Information for the user

Carbimazole 5 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 or pharmacist.
  • 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet:

1. What Carbimazole is and what it is used for
2. What you need to know before you take Carbimazole
3. How to take Carbimazole
4. Possible side effects
5. How to store Carbimazole
6. What Carbimazole 5 mg and 20 mg tablets contain

1. What Carbimazole is and what it is used for

The name of your medicine is Carbimazole 5 mg tablets or Carbimazole 20 mg tablets (called Carbimazole in this leaflet). This belongs to a group of medicines called 'anti-thyroid' medicines. Carbimazole is used for people with an over-active thyroid gland (called 'hyper-thyroidism')

  • It works by reducing the amount of thyroid hormones made in your thyroid gland.
  • It can be used on its own, or with other treatments for an over-active thyroid gland.
  • It can also be used before part of the thyroid gland has been removed by surgery. It helps the thyroid gland work properly before the surgery.

2. What you need to know before you take Carbimazole
Do not take Carbimazole:
  • if you are allergic to carbimazole or any of the other ingredients of this medicine (listed in Section 6).
  • if you have liver problems.
  • if you have problems with your blood cells.
  • if you had inflammation of the pancreas (acute pancreatitis) after administration of carbimazole or thiamazole in the past.

Do not take Carbimazole tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Carbimazole.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carbimazole

  • If you have a swelling in your neck called an 'intrathoracic goitre'.
  • If you are pregnant, think you may be pregnant or are trying to become pregnant.
  • If you have bone marrow depression.
  • If you have mild or moderate liver problems.
  • 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 unable to comply with the instructions for use or cannot be monitored regularly.
  • 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.
  • Carbimazole 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 not sure if the above applies to you, talk to your doctor or pharmacist before taking Carbimazole.

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

Tell your doctor or pharmacist if you are taking or have recently taken or might take 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:

  • Medicines to thin your blood or to stop clotting (Anticoagulants) e.g. warfarin
  • A medicine that helps to treat asthma or breathing problems called 'theophylline'.
  • Steroids such as prednisolone
  • An antibiotic called erythromycin
  • A medicine for heart failure called digitalis
  • Medicines for high blood pressure called beta-blockers
  • Any other medicine that could affect your white blood cell count.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Carbimazole.

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.

Pregnancy

Carbimazole can cause harm to an unborn baby. If you could get pregnant, use reliable contraception from the time you start treatment and during treatment. However, to reduce the possibility of any effects on your baby:

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

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.

Breast-feeding

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

Carbimazole tablet 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

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

  • Take this medicine by mouth.
  • Swallow the tablets whole with a drink of water.
  • You can take the tablets before, during or after meals.
  • The tablets you take each day may be split into two (morning and evening) or three (morning, afternoon and night). Ask your pharmacist if you are not sure.

How much to take at the start

The doctor will decide on a starting dose, and then see how well it works.

  • If needed, he or she will then change the dose.
  • This is to find a dose that suits you best.

Adults

The usual starting dose for the 5 mg tablets is between 4 and 12 tablets each day.

The usual starting dose for the 20 mg tablets is between 1 and 3 tablets each day.

Use in children

The usual starting dose is three 5 mg tablets each day.

How much to take after the starting dose

Your illness will usually start to improve within one to three weeks. However, it usually takes four to eight weeks to have full benefit from your treatment.

  • When your illness is controlled, your doctor will gradually lower your dose to one to three 5 mg tablets each day.
  • Do not change your dose without talking to your doctor first. You may need to keep taking Carbimazole for several months to keep control of your thyroid gland. Your doctor will decide when treatment can be stopped. Your doctor may ask you to have occasional blood tests to see how well your treatment is working.

Radio-iodine

Another treatment for an over-active thyroid is called "radio-iodine". If you need radio-iodine treatment your doctor will tell you to stop taking Carbimazole tablets for a while.

If you take more Carbimazole than you should

If you take more Carbimazole than you should, talk to a doctor or go to a hospital straight away.

Take the medicine pack or this leaflet and any remaining tablets with you.

If you forget to take Carbimazole

If you forget a dose, take it as soon as you remember. If it is time for your next dose, take both doses together.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects usually happen in the first eight weeks of your treatment. Do not be alarmed by this list of possible side effects. You may not get any of them.

Allergic reactions

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

Stop taking Carbimazole and see a doctor straight away, if you notice any of the following side effects:
  • Any infection such as a sore throat or mouth ulcers.
  • Fever.
  • Unusual bruising or bleeding.
  • Feeling unusually tired.
  • You are feeling generally unwell or think that you may have on infection
  • Angioedema, a serious allergic reaction with symptoms that may include swollen tongue, lips, face or throat
  • Stevens-Johnson syndrome, a serious illness with blistering of the skin, mouth, eyes and genitals

In addition, if you experience any of these symptoms while taking Carbimazole you should also contact your doctor immediately:

  • Liver problems such as yellowing of the skin or white of your eyes (jaundice).
  • Nerve pain
  • Muscle pain or weakness.
  • Swelling of lymph nodes.
  • Swelling of glands in your mouth.
  • Feeling faint (low blood sugar).
  • Kidney problems, with symptoms that include a reduction in the amount of urine passed, fluid retention and blood in the urine.

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 until you have consulted your doctor.

Carbimazole 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.

If you get any of the following side effects, they normally go away while you keep taking your medicine.

The following side effects are reported with a not known frequency (frequency cannot be estimated from the available data):

Other side effects include:

  • Feeling sick (nausea).
  • Headache or feeling dizzy.
  • Skin rashes, including urticaria (nettle rash)
  • Itching.
  • Stomach upset.
  • Painful joints.

The following side effects have also been reported:

  • Hair thinning.
  • Changes to your taste.
  • Inflammation of the pancreas (acute pancreatitis)
  • Lung problems, with symptoms that include shortness of breath or a cough

Reporting of side effects

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 Website: 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.

5. How to store Carbimazole
  • Keep Carbimazole out of the sight and reach of children.
  • Do not use Carbimazole after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
  • Do not store above 25°C.
  • Store Carbimazole in the original packaging.
  • 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. What Carbimazole 5 mg and 20 mg tablets contain
  • The active ingredient is carbimazole. Two tablet strengths are available. Each Carbimazole 5 mg tablet contains 5 mg of carbimazole. Each Carbimazole 20 mg tablet contains 20 mg of carbimazole.
  • The other ingredients are anhydrous lactose, magnesium stearate, croscarmellose sodium and the colourant red iron oxide (E172).

What Carbimazole 5 mg and 20 mg tablets look like and contents of the pack
  • The Carbimazole 5 mg tablets are round, pale pink and marked with Link C5 on one side and have a scoreline on the reverse side.
  • The Carbimazole 20 mg tablets are round, pink and marked with Link C20 on one side and have a scoreline on the reverse side.
  • Each carton contains 28, 56, 100 or 112 tablets in a blister pack (not all pack sizes will be marketed).

Marketing Authorisation Holder and Manufacturer
Amdipharm UK Limited
Dashwood House
69 Old Broad Street
London
EC2M 1QS
United Kingdom

Manufacturer:

Delpharm L’Aigle
Zone Industrielle No. 1
Route de Crulai
L’Aigle 61300
France

This leaflet was last revised in August 2023.

Company Contact Details
ADVANZ Pharma
Address

Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK

Medical Information Direct Line

+44 (0)208 588 9131

WWW

www.advanzpharma.com

Telephone

+44 (0)208 588 9131

Medical Information e-mail
Customer Care direct line

+44 (0)208 588 9273