CARBIMAZOLE 5 MG TABLETS - patient leaflet, side effects, dosage

1. what carbimazole is and what it is used for

The name of your medicine is Carbimazole 5 mg tablets or Carbimazole 10 mg tablets or Carbimazole 15 mg tablets or Carbimazole 20 mg tablets (it will be referred to as Carbimazole throughout the leaflet). Carbimazole contains the active substance carbimazole. Carbimazole belongs to a group of medicines called antithyroid 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 (listed in section 6).
• if you have had a serious allergy to other anti-thyroid medications such as thiamazole, methimazole or propylthiouracil.
• 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 are pregnant, think you may be pregnant or are trying to become pregnant.
• If you have mild or moderate liver problem.
• If you have bone marrow depression. Bone marrow depression causes a reduction in the number of blood cells and reduces the ability to fight infection.
• 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, 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 (digoxin)
• Medicine 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 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 taking Carbimazole. This is because small amount may pass into the mother's milk.

Driving and using machine

You can drive when taking Carbimazole, but do not drive until you know how it affects you.

Carbimazole 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The tablets are to be taken by mouth.
• You can take the tablets before, after or during meals.
• The dosage will be decided by your doctor according to your individual needs, and may be changed at intervals during treatment.
• Your doctor may decide to add an additional tablet (l-thyroxine), to help control your condition.
• Each day's tablets may be divided into two (morning and evening) or three daily doses (morning, noon and night).
• Do not change the dosage without consulting your doctor first.
• Some improvement is usually felt within one to three weeks. However, full beneficial effects usually take four to eight weeks.
• If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or the nearest hospital straight away.
• 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. 4----

_____________­_________■fflffl_______

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.

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 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.

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.
• itching
• increased bruising or bleeding tendency.
• you are feeling generally unwell or think that you may have an 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: muscle pain or weakness.
• nerve pain.
• swelling of lymph nodes.
• swelling of glands in your mouth.
• feeling faint (low blood sugar).
• kidney problems, with symptoms that include a reduction of the amount of urine passed, fluid retention, blood in the urine and yellowing of your skin or whites of your eyes.

These could be signs of muscle problems, jaundice or inflammation of the liver and your doctor may want you to stop taking Carbimazole and carry out some blood tests on you.

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 can become life-threatening.

Carbimazole can also affect the liver (causing jaundice and inflammation of the liver) or the muscles. If you experience muscle aches or pains or notice yellowing of your skin or the whites of your eyes consult your doctor immediately as, under medical supervision, the drug should be stopped and blood tests performed.

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.
• feeling unusually tired
• headache.
• skin rashes, including urticaria (nettle rash).
• itching.
• stomach upset.
• painful joints.
• hair thining.
• 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 the Yellow card scheme at 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.

Store below 30°C

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

The product is used within 100 days after opening of container.

Do not throw away this medicine via waste water or household waste. Ask your pharmacist how to throw away this medicine you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Carbimazole Tablet contains

• The active substance is carbimazole. Each tablet contains 5mg or 10mg or 15mg or 20 mg of carbimazole.

What Carbimazole Tablet looks like and contents of the pack

1. what carbimazole is and what it is used for

The name of your medicine is Carbimazole 5 mg tablets or Carbimazole 10 mg tablets or Carbimazole 15 mg tablets or Carbimazole 20 mg tablets (it will be referred to as Carbimazole throughout the leaflet). Carbimazole contains the active substance carbimazole. Carbimazole belongs to a group of medicines called antithyroid 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 (listed in section 6).
• if you have had a serious allergy to other anti-thyroid medications such as thiamazole, methimazole or propylthiouracil.
• 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 are pregnant, think you may be pregnant or are trying to become pregnant.
• If you have mild or moderate liver problem.
• If you have bone marrow depression. Bone marrow depression causes a reduction in the number of blood cells and reduces the ability to fight infection.
• 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, 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 (digoxin)
• Medicine 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 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 taking Carbimazole. This is because small amount may pass into the mother's milk.

Driving and using machine

You can drive when taking Carbimazole, but do not drive until you know how it affects you.

Carbimazole 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The tablets are to be taken by mouth.
• You can take the tablets before, after or during meals.
• The dosage will be decided by your doctor according to your individual needs, and may be changed at intervals during treatment.
• Your doctor may decide to add an additional tablet (l-thyroxine), to help control your condition.
• Each day's tablets may be divided into two (morning and evening) or three daily doses (morning, noon and night).
• Do not change the dosage without consulting your doctor first.
• Some improvement is usually felt within one to three weeks. However, full beneficial effects usually take four to eight weeks.
• If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or the nearest hospital straight away.
• 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. 4----

_____________­_________■fflffl_______

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.

se in children: The recommended starting dose is three 5 mg tablets daily.

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 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.

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.
• itching
• increased bruising or bleeding tendency.
• you are feeling generally unwell or think that you may have an 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: muscle pain or weakness.
• nerve pain.
• swelling of lymph nodes.
• swelling of glands in your mouth.
• feeling faint (low blood sugar).
• kidney problems, with symptoms that include a reduction of the amount of urine passed, fluid retention, blood in the urine and yellowing of your skin or whites of your eyes.

These could be signs of muscle problems, jaundice or inflammation of the liver and your doctor may want you to stop taking Carbimazole and carry out some blood tests on you.

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 can become life-threatening.

Carbimazole can also affect the liver (causing jaundice and inflammation of the liver) or the muscles. If you experience muscle aches or pains or notice yellowing of your skin or the whites of your eyes consult your doctor immediately as, under medical supervision, the drug should be stopped and blood tests performed.

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.
• feeling unusually tired
• headache.
• skin rashes, including urticaria (nettle rash).
• itching.
• stomach upset.
• painful joints.
• hair thining.
• 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 the Yellow card scheme at 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.

Store below 30°C

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

The product is used within 100 days after opening of container.

Do not throw away this medicine via waste water or household waste. Ask your pharmacist how to throw away this medicine you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Carbimazole Tablet contains

• The active substance is carbimazole. Each tablet contains 5mg or 10mg or 15mg or 20 mg of carbimazole.

What Carbimazole Tablet looks like and contents of the pack

Carbimazole 5mg: Pink, mottled, round, biconvex uncoated tablets, debossed with „5“ on one side and plain on other side.

Carbimazole 10mg: Pink, mottled, round, biconvex uncoated tablets, debossed with „10“ on one side and plain on other side.

Carbimazole 15mg: Pink, mottled, round, biconvex uncoated tablets, debossed with „15“ on one side and plain on other side.

Carbimazole 20mg: Pink, mottled, round, biconvex uncoated tablets, debossed with „2 and 0“ separated by breakline on one side and plain on other side.

Blister packs: Blister pack comprises of White Opaque 250g PVC as a forming material and Plain 25 g Aluminium foil/ 6–8 gsm HSL as the lidding material.

Pack sizes: 20, 30, 50, 100 tablets.

Container Pack: Container pack comprises of round white HDPE bottle, Child resistant closure with pulp & liner and polyester coil.

Pack size: 100 tablets.

Not all pack sizes may be marketed.

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Marketing Authorisation Holder

Macleods Pharma UK Limited

Wynyard Park House, Wynyard Avenue, Wynyard,

Billingham, TS22 5TB, United Kingdom

Manufacturer

Synoptis Industrial Sp. z o.o ul. Rabowicka 15, Swarz^dz, 62–020, Poland !

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PL 34771/0197–0200 § I

This leaflet was last revised in {06/2021}

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