Carbimazole 5mg Tablets
Packaging leaflet: Information for the patient
NeoMercazole® 5mg 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. 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.
The name of your medicine is NeoMercazole 5mg tablets but will be referred to as NeoMercazole throughout this leaflet. Please note that this leaflet also contains information about the other strength, NeoMercazole 20mg tablets.
In this leaflet:
1. What NeoMercazole is and what it is used for
2. What you need to know before you take NeoMercazole
3. How to take NeoMercazole
4. Possible side effects
5. How to store NeoMercazole
6. Contents of the pack and other information
1. WHAT NEOMERCAZOLE IS AND WHAT IT IS USED FOR
NeoMercazole contains the active substance carbimazole. NeoMercazole belongs to a group of medicines called antithyroid agents. NeoMercazole is used to reduce the formation of thyroid hormones in adults and children with an overactive thyroid gland. The condition is called hyperthyroidism. NeoMercazole 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 NEOMERCAZOLE
Do not take NeoMercazole
• If you are allergic (hypersensitive) to carbimazole or any of the ingredients of NeoMercazole.
• If you are allergic (hypersensitive) to other anti-thyroid 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 NeoMercazole
• 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 NeoMercazole
• 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 NeoMercazole.
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 NeoMercazole
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 NeoMercazole can affect the way some medicines work. Also, some medicines can affect the way NeoMercazole 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 NeoMercazole 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 NeoMercazole. This is because small amounts may pass into the mother's milk.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
You can drive when taking NeoMercazole, but do not drive until you know how it affects you.
NeoMercazole contains 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. HOW TO TAKE NEOMERCAZOLE
Always take NeoMercazole 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 20mg tablets, or four to twelve 5mg tablets daily. Once control is achieved your doctor will gradually reduce your dose to one to three 5mg tablets each day.
Use in children: The recommended starting dose is three 5mg 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 (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 NeoMercazole 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 NeoMercazole temporarily.
If you take more NeoMercazole than you should
If you take more NeoMercazole 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 NeoMercazole
If you forget to take NeoMercazole 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, NeoMercazole can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction, stop taking NeoMercazole and see a doctor straight away. The signs may include: sudden rash, swelling or difficulty breathing.
Stop taking NeoMercazole 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 NeoMercazole 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.
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 NeoMercazole until you have consulted your doctor.
NeoMercazole 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.
If at any time you are concerned about these or any other unwanted effects, talk to your doctor 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 NEOMERCAZOLE
Keep out of the sight and reach of children.
Do not store your tablets above 25°C.
Store in the original container.
Do not use NeoMercazole after the expiry date which is stated on the carton and bottle labels 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.
If tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What NeoMercazole contains
The active ingredient in NeoMercazole is carbimazole.
Each tablet contains 5mg carbimazole.
The other ingredients are lactose, corn starch, gelatin, magnesium stearate, sucrose, acacia, talc and red iron oxide (E172).
What NeoMercazole looks like and contents of the pack
NeoMercazole is round, pink coloured tablet marked with 'Neo 5' on one side and plain on the other.
NeoMercazole is available in plastic bottle of 100 tablets.
Manufactured by: Cenexi SAS, 52 rue Marcel a Jacques Gaucher, 94120 Fontenay-sous-Bois, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
NeoMercazole® 5mg tablets, PL 18799/2897
POM I
Leaflet date: 12.04.2016
Packaging leaflet: Information for the patient
Carbimazole 5mg 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.
The name of your medicine is Carbimazole 5mg tablets but will be referred to as Carbimazole throughout this leaflet. Please note that this leaflet also contains information about the other strength, Carbimazole 20mg tablets.
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 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBIMAZOLE
Do not take Carbimazole
• If you are allergic (hypersensitive) to carbimazole or any of the ingredients of Carbimazole.
• If you are allergic (hypersensitive) to other anti-thyroid 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
• 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
• 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.
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 medicines.
Driving and using machines
You can drive when taking Carbimazole, but do not drive until you know how it affects you.
Carbimazole contains 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. 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 20mg tablets, or four to twelve 5mg tablets daily. Once control is achieved your doctor will gradually reduce your dose to one to three 5mg tablets each day.
Use in children: The recommended starting dose is three 5mg 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 (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, 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 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 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.
If at any time you are concerned about these or any other unwanted effects, talk to your doctor 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
Keep out of the sight and reach of children.
Do not store your tablets above 25°C.
Store in the original container.
Do not use Carbimazole after the expiry date which is stated on the carton and bottle labels 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.
If tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Carbimazole contains
The active ingredient in Carbimazole is carbimazole.
Each tablet contains 5mg carbimazole.
The other ingredients are lactose, corn starch, gelatin, magnesium stearate, sucrose, acacia, talc and red iron oxide (E172).
What Carbimazole looks like and contents of the pack
Carbimazole is round, pink coloured tablet marked with 'Neo 5' on one side and plain on the other.
Carbimazole is available in plastic bottle of 100 tablets.
Manufactured by: Cenexi SAS, 52 rue Marcel a Jacques Gaucher, 94120 Fontenay-sous-Bois, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Carbimazole 5mg tablets, PL 18799/2897
POM I
Leaflet date: 12.04.2016