Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 16363/0627.
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 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. Contents of the pack and other information
1. What Carbimazole is and what it is used for
Carbimazole is a sulfur-containing imidazole derivative which belongs to a group of medicines called anti-thyroid agents. Carbimazole is used to reduce the formation of thyroid hormones in adults and children with an over active thyroid gland. The condition is called hyperthyroidism. Carbimazole 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 like therapy prior to and post radio-iodine treatment.
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 a serious blood disorder.
If you have a severe liver disorder.
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 or pharmacist before taking Carbimazole
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 unable to comply with the instructions for use or cannot be monitored regularly.
If you are pregnant, think you may be pregnant or are trying to become pregnant.
If 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.
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, 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:
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.
Any other medicine that could affect your white blood cell count.
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 straight away 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 dose possible.
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
You should not breast-feed if you are using Carbimazole. 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, but do not drive until you know how it affects you.
Carbimazole contains lactose monohydrate
Carbimazole tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Carbimazole tablet contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Carbimazole
Always take this medicine exactly as your doctor or pharmacist has told you. 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 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 score line is only there to help you break the tablet if you have difficulty swallowing it whole.
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 (I-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.
If you take more Carbimazole than you should
If you take more Carbimazole 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
If you forget to take Carbimazole 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, this medicine can cause side effects, although not everybody gets 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 in breathing.
Stop taking Carbimazole 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 an infection
Stevens-Johnson syndrome, a serious illness with blistering of the skin, mouth, eyes and genitals
Angioedema, a serious allergic reaction with symptoms that may include swollen tongue, lips, face or throat
In addition, if you experience any of these symptoms while taking Carbimazole you should also contact your doctor immediately:
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
Kidney problems, with symptoms that include a reduction in the amount of urine passed, fluid retention, 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 marrow depression which causes a reduction in number of blood cells and reduces the ability to fight against 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.
The following side effects are reported with a not known frequency (frequency cannot be estimated from the available data):
Feeling sick
Headache
Skin rashes, including urticaria (nettle rash)
Itching
Stomach upset
Painful joints
Hair loss
Loss of 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 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not use this medicine if you notice any change in the appearance of the tablets.
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 to protect the environment.
6. Contents of the pack and other information
What Carbimazole contains
The active substance is Carbimazole. Carbimazole 5 mg tablets Each tablet contains 5 mg Carbimazole. Carbimazole 20 mg tablets Each tablet contains 20 mg Carbimazole.
The other ingredients are: Lactose monohydrate, croscarmellose sodium, Iron oxide red (E172) and magnesium stearate.
What Carbimazole looks like and contents of the pack
Carbimazole 5 mg tablets
Pink colored, mottled, uncoated, circular [diameter 5 mm], biconvex tablets debossed with “C5” on one side “break line” on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Carbimazole 20 mg tablets
Pink colored, mottled, uncoated, circular [diameter 8.3 mm], biconvex tablets debossed with “C 20” on one side and “break line” on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Carbimazole tablets are available in blister packs.
Pack sizes
Blister packs: 100 tablets.
Marketing Authorisation Holder
Milpharm Limited 1 Roundwood Avenue Stockley Park Uxbridge UB11 1AF United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26 Hal Far Industrial Estate Hal Far Birzebbugia BBG 3000 Malta
or
Milpharm Limited 1 Roundwood Avenue Stockley Park Uxbridge UB11 1AF United Kingdom
or
Generis Farmaceutica, S.A. Rua João de Deus n. o 19 Venda Nova 2700-487 Amadora Portugal
This leaflet was last revised in 10/2025.
P1540071
Aurobindo Pharma - Milpharm Ltd.
Address
Milpharm Limited, 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF, UK