Carbimazole 5mg Tablets
Ref: LTT0197/121015/1/F
Carbimazole 5mg Tablets
Patient Information Leaflet
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 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. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Carbimazole 5mg Tablets and will be referred to as Carbimazole throughout the rest of this leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Carbimazole 20mg Tablets
In this leaflet:
^ What Carbimazole is and what it is used for ^ What you need to know before you take Carbimazole ^ How to take Carbimazole ^ Possible side effects ^ How to store Carbimazole ^ Contents of the pack and other information
^ 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). Carbimazole contains the active substance carbimazole. Carbimazole 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 overactive 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.
Other medicines and Carbimazole
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 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 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. 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 tablets contain lactose and sucrose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 What you need to know before you take Carbimazole
Do not take Carbimazole
* You are allergic (hypersensitive) to carbimazole or any of the other ingredients of Carbimazole tablets.
* You are allergic (hypersensitive) 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.
Warnings and precautions Take special care with 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 lactose intolerant or have any other lactose deficiency.
* If you are unable to comply with instructions for use or cannot be monitored regularly.
* If you are sucrose intolerant or have any other sucrose deficiency.
Talk to your doctor or pharmacist before taking Carbimazole
* 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.
Children
Do not give this medicine to children under the age of two years because it may not be safe or effective.
How to take Carbimazole
Always take Carbimazole 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 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 doasge 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 treatment.
Radio-iodine is another treatment for hyperthyroidism. If you need radioiodine treatment, your doctor will tell you to stop taking Carbimazole temporarily.
Patient Information Leaflet (continued)
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.
Q Possible side effects
Like all medicines, Carbimazole 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 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.
In addition, if you experience any of these symptoms while taking Carbimazole you should also contact your doctor immediately:
* Muscle aches or weaskness.
** 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 until you have consulted your doctor.
Carbimazole can sometimes cause bone marrow 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 Carbimazole
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Store in the original container.
Do not use this medicine after the expiry date which is printed on the carton. If your doctor tells you to stop taking the medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.
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.
[£) Contents of the pack and other information
What this medicine contains:
The active substance is carbimazole.
Each tablet contains 5mg of carbimazole.
The other ingredients are: sucrose, lactose monohydrate, acacia, talc, maize starch, magnesium stearate, gelatin and red iron oxide (E172).
What this medicine looks like and contents of the pack
Carbimazole 5mg tablets are pink, circular biconvex tablets with Neo 5 printed on one side and plain on the reverse.
Carbimazole is available in bottles of 100 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Amdipharm UK Limited, Capital House,
85 King William Street, London EC4N 7BL, UK and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, Redditch B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
[POMl PL 33723/0197 Carbimazole 5mg Tablets Revision date: 12/10/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Patient Information Leaflet
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 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. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Carbimazole 5mg Tablets and will be referred to as Carbimazole throughout the rest of this leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Carbimazole 20mg Tablets
In this leaflet:
^ What Carbimazole is and what it is used for ^ What you need to know before you take Carbimazole ^ How to take Carbimazole ^ Possible side effects ^ How to store Carbimazole ^ Contents of the pack and other information
^ 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). Carbimazole contains the active substance carbimazole. Carbimazole 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 overactive 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.
Other medicines and Carbimazole
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 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 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. 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 tablets contain lactose and sucrose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 What you need to know before you take Carbimazole
Do not take Carbimazole
* You are allergic (hypersensitive) to carbimazole or any of the other ingredients of Carbimazole tablets.
* You are allergic (hypersensitive) 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.
Warnings and precautions Take special care with 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 lactose intolerant or have any other lactose dificiency.
* If you are unable to comply with instructions for use or cannot be monitored regularly.
* If you are sucrose intolerant or have any other sucrose deficiency.
Talk to your doctor or pharmacist before taking Carbimazole
* 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.
Children
Do not give this medicine to children under the age of two years because it may not be safe or effective.
How to take Carbimazole
Always take Carbimazole 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 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 doasge 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 treatment.
Radio-iodine is another treatment for hyperthyroidism. If you need radioiodine treatment, your doctor will tell you to stop taking Carbimazole temporarily.
Patient Information Leaflet (continued)
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.
^ Possible side effects
Like all medicines, Carbimazole can cause side effects, although not everybody gets them.
Allergic reations
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:
* 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.
In addition, if you experience any of these symptoms while taking Carbimazole you should also contact your doctor immediately:
* Muscle aches or weaskness.
** 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 until you have consulted your doctor.
Carbimazole can sometimes cause bone marrow 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 Carbimazole
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Store in the original container.
Do not use this medicine after the expiry date which is printed on the carton. If your doctor tells you to stop taking the medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.
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.
[£) Contents of the pack and other information
What this medicine contains:
The active substance is carbimazole.
Each tablet contains 5mg of carbimazole.
The other ingredients are: sucrose, lactose monohydrate, acacia, talc, maize starch, magnesium stearate, gelatin and red iron oxide (E172).
What this medicine looks like and contents of the pack
Carbimazole 5mg tablets are pink, circular biconvex tablets with Neo 5 printed on one side and plain on the reverse.
Carbimazole is available in bottles of 100 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Cenexi SAS, 52 rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, Redditch B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
[POMl PL 33723/0197 Carbimazole 5mg Tablets Revision date: 12/10/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.