Carbimazole 20mg Tablets
CARBIMAZOLE 5MG & 20MG TABLETS
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 on to others. It may harm them, even if their symptoms 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. This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What are Carbimazole tablets and what are they used for.
2. Before you take Carbimazole tablets
3. How to take Carbimazole tablets
4. Possible side effects
5. How to store Carbimazole tablets
6. Further Information
1. WHAT ARE CARBIMAZOLE TABLETS AND WHAT ARE THEY USED FOR?
Carbimazole belongs to a group of medicines called anti-thyroid agents. It is used for the following:
• Hyperthyroidism, which is a condition where in the thyroid gland is hyperactive. Carbimazole is used to reduce the formation of thyroid hormones
• Treatment in more serious cases, for example, to restore the normal function of the thyroid before its partial removal by surgery.
• It is also used together with other treatments for overactive thyroid.
2. BEFORE YOU TAKE CARBIMAZOLE TABLETS
Do not take Carbimazole tablets if you:
• are allergic to carbimazole or any other ingredients in the products.
• have a serious blood disorder
• have a severe liver disorder.
Take special care with Carbimazole tablets and consult your doctor if you:
• have mild or moderate liver problems
• have swelling in your neck called an 'intrathoracic goitre'.
Your doctor may ask you for occasional blood tests to help him determine how you are responding to treatment.
Taking other medicine
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines including medicines obtained without a prescription, or the following:
• Theophylline used to treat asthma or breathing problems
• Medicines called anticoagulants, which are used to thin the blood e.g. warfarin
• Other thyroid medicines like carbimazole, thiamazole and propylthiouracil which may cause cross allergy.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, as your doctor of pharmacist for advice before taking this medicine
Carbimazole 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 3 to 4 weeks before you are due to give birth.
• You should not breast feed if you are using Carbimazole.
Ask your doctor or pharmacist for advice before taking any medicine
Driving and using machines
The effects of Carbimazole on the ability to drive and operate machinery have not been established. Hence do not drive or use machinery when you are on Carbimazole tablets unless you are sure your judgement and co-ordination are not affected.
Carbimazole tablets contain 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 TABLETS
Always take Carbimazole tablets exactly as your doctor has told you. Do not increase or decrease the dose on your own. You should check with your doctor or pharmacist if you are not sure.
Adults and elderly: The usual starting dose for adults is one to three 20mg tablets or four to twelve 5mg tablets.
Use in children: For children the usual starting dose is three 5mg tablets.
Carbimazole tablets may be taken with or without food
Once control is achieved your doctor will gradually reduce your dose to one to three 5mg tablets each day.
You may be given an additional L-thyroxine tablet, to help control your condition. Each day's tablets may be divided into two or three daily doses.
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. He may ask you to have occasional blood tests to help him 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 temporarily.
If you have the impression that the effect of Carbimazole tablets is too strong or too weak, talk to you doctor or pharmacist.
If you take more Carbimazole tablets than you should
It is important to stick to the dose on the label of the medicine. If you or someone else swallows several of these tablets all together, contact your doctor or nearest hospital emergency department immediately Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets.
If you forget to take Carbimazole tablets
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before.
If you stop taking Carbimazole tablets
In order to maintain control of the thyroid gland, you may need to continue to take Carbimazole tablets for several months.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Carbimazole tablets can have side effects although not everybody gets them.
Stop taking Carbimazole tablets and tell your doctor immediately if you experience any of the following symptoms:
• 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 cough
• kidney problems, with symptoms that include a reduction in the amount of urine passed, fluid retention and blood in the urine
• 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
• Deadly skin disease (TENS or Stevens-Johnson Syndrome). Symptoms of these will include cough, aching, headaches, feverishness, red rash across the face and the trunk of the body
Some tests should be performed to check for bone marrow depression before restarting your treatment. Bone marrow depression 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 could become life-threatening.
Tell your doctor immediately if you experience:
Carbimazole can also affect your muscles or the liver (causing jaundice and inflammation of the liver). Under medical supervision, the drug should be stopped and blood tests performed. Symptoms of these will include the following:
• muscle aches or pains
• notice yellowing of your skin or the whites of your eyes
• nerve pain
• swollen lymph nodes or swelling of the glands in your mouth
• feeling faint (low blood sugar)
The following side effects have also been reported:
• feeling sick
• headache
• skin rashes, including urticaria (nettle rash)
• itching
• stomach upset
• painful joints
• hair loss
• loss of taste
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist as soon as possible.
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). By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CARBIMAZOLE TABLETS
• Keep out of the sight and reach of children.
• Do not use Carbimazole tablets after the expiry date, which is stated on the label and carton. The expiry date refers to the last day of the month.
• Store your tablets in the original container. Keep the container tightly closed. Do not store above 25°C.
• 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 tablets contain
The name of your medicine is Carbimazole 5mg or 20mg Tablets.
The active substance in your tablet is carbimazole. Each tablet contains 5mg or 20mg of carbimazole. Other ingredients are lactose monohydrate, maize starch, citric acid monohydrate and magnesium stearate.
What Carbimazole tablets look like and contents of the pack
Carbimazole 5mg Tablets are white, round, biconvex, uncoated tablets with a score line on one side and embossed 'F1' on the other.
Carbimazole 20mg Tablets are white, round, biconvex, uncoated tablets with a score line on one side and plain on the other.
Carbimazole 5mg or 20mg Tablets are supplied in bottles of 100 tablets.
Marketing Authorisation Holder:
The Marketing Authorisation holder of these is Lime Pharma Ltd, Whiddon Valley, Barnstaple,
North Devon, EX32 8NS, UK.
Manufacturer
Tiofarma B.V, Benjamin Franlinstraat 7-9,
3261 LW Oud-Beijerland, The Netherlands.
This leaflet was last revised in July 2016
®Lime
Pharma