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Nadolol 80mg Tablets

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Document: leaflet MAH BRAND_PLPI 15184-1035 change

Ref: 1035/230715/1/F

Corgard 80mg Tablets

(nadolol)

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

*    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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

Your medicine is called Corgard 80mg Tablets but will be referred to as Corgard Tablets throughout this leaflet.

In this leaflet:

,1^ What Corgard Tablets are and what they are used for

,2^ What you need to know before you take Corgard Tablets

,3^ How to take Corgard Tablets

.4^ Possible side effects

.5^ How to store Corgard Tablets

Content of the pack and other information

What Corgard Tablets are and what they are used for

Corgard Tablets contain a medicine called nadolol.

This belongs to a group of medicines called beta-blockers. It works by slowing your heart rate or lowering your blood pressure.

Corgard tablets are used for:

*    Chest pain (angina)

*    High blood pressure

*    Uneven or unusually fast heart beats (arrhythmia)

*    Symptoms of an overactive thyroid gland

*    Stopping migraine attacks happening

[2) What you need to know before you take Corgard Tablets

Do not take Corgard Tablets if:

*    You are allergic (hypersensitive) to nadolol or any of the other ingredients of Corgard Tablets (see Section 6: Further information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

*    You have or have had asthma, or wheezing

*    You have a very slow heart beat

*    You have heart problems - where you have difficulty breathing and swollen ankles

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Corgard Tablets.

Warnings and precautions

Take special care with Corgard Tablets Check with your doctor or pharmacist before taking your medicine if:

*    You have any heart problems

*    You have breathing problems due to long term lung problems (called ‘bronchitis' or ‘emphysema')

*    You have diabetes.

Corgard Tablets may cause low blood sugar levels even in patients who are not diabetic such as children, the elderly and those who are fasting

*    You have liver problems

*    You have an overactive thyroid gland

*    You have kidney problems

*    You have a history of severe allergies

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Corgard Tablets.

Stress tests

The accuracy of all stress tests (used by your doctor to find out whether you have a decrease in blood flow to your heart muscle) is affected by the use of Beta blockers including Corgard.

Operations or anaesthetics

Tell your doctor or dentist you are taking Corgard Tablets if you are going to have an anaesthetic or an operation (including dental surgery).

Other medicines and Corgard Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without prescription, including herbal medicines. This is because Corgard Tablets can affect the way some other medicines work. Also some medicines can affect the way Corgard Tablets work.

In particular, tell your doctor if you are taking any of the following:

*    Water tablets (diuretics) such as amiloride

*    Insulin or tablets to treat diabetes

*    Medicines for high blood pressure (such as guanethidine or hydralazine)

*    Medicines for depression (mono-amine oxidase inhibitors) such as phenelzine

*    Medicines used for migraine (such as clonidine, ergotamine or methysergide)

*    Medicines used for asthma, bowel problems or Parkinson's disease (such as atropine, ipratropium and benzatropine)

*    Medicines for chest pain (angina) - such as verapamil, nifedipine, and diltiazem

*    Medicines used for heart problems - such as lidocaine (also used as a local anaesthetic), procainamide, isoprenaline, verapamil, adrenaline (also used for severe allergies), noradrenaline, amiodarone, disopyramide and quinidine

*    Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) - used to relieve pain (such as ibuprofen, naproxen, diclofenac, indometacin and piroxicam)

*    Medicines used for mental problems (antipsychotic medicines) - such as chlorpromazine, fluphenazine and haloperidol

*    Medicines used to raise blood pressure (vasoconstrictors - used to narrow blood vessels) - such as ephedrine and phenylephrine

*    Fingolimod - a medicine used for multiple sclerosis

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

You should not breast-feed if you are taking Corgard Tablets. This is because small amounts may pass into the mothers milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel tired or dizzy whilst taking Corgard Tablets. If this happens, do not drive or use any tools or machines.

How to take Corgard Tablets

Always take Corgard Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

   Take this medicine by mouth

   Swallow the tablets with a drink of water

   If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

The usual dose:

The dose of Corgard Tablets depends on your needs and the illness being treated. Your doctor will advise you.

Chest pain (angina)

•    40mg (half a tablet) to 160mg (2 tablets) each day High blood pressure

•    80mg (1 tablet) to 240mg (3 tablets) each day

Uneven or unusually fast hearts beats (arrhythmias)

•    40mg (half a tablet) to 160mg (2 tablets) each day

Stop migraine attacks happening

•    40mg (half a tablet) to 160mg (2 tablets) each day

Overactive thyroid gland

•    80mg (1 tablet) to 160mg (2 tablets) each day

Elderly patients and patients with kidney problems

Your doctor may decide to lower your dose of Corgard Tablets if necessary.

Children

Corgard Tablets should not be given to children.

If you take more Corgard Tablets than you should

If you take more Corgard Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctors know what you have taken. The following effects may happen: feeling dizzy or weak, difficulty in breathing or wheezing.

(nadolol)

Patient Information Leaflet (continued)

If you forget to take Corgard Tablets

Do not take a double dose to make up for a forgotten dose.

If you stop taking Corgard tablets

Keep taking Corgard Tablets until your doctor tells you to stop. If you stop treatment suddenly your illness may get worse. When your doctor says that you can stop taking Corgard Tablets, you need to do this gradually. Your doctor will help you do this.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Corgard Tablets can cause side effects, although not everybody gets them.

Stop taking Corgard Tablets and see a doctor or go to a hospital straight away if:

*    You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Tell your doctor as soon as possible if you have any of the following side effects:

Common reported side effects

(may affect up to 1 in 10 people)

*    Pain in your chest and feeling weak or dizzy. These could be signs of heart problems.

*    Slow heart rate

*    Feeling dizzy or weak. These could be signs of low blood pressure

Uncommon reported side effects

(may effect up to 1 in 100 people)

*    Stomach pain, stomach feels full or tight (bloating), wind (flatulence), constipation, diarrhoea, indigestion and loss of appetite

*    Changes in behaviour

*    Slurred speech

*    Cough and blocked nose

*    Ringing in the ears

*    Headache

*    Feeling or being sick

*    Breathing problems such as asthma

*    Dry mouth, eyes or skin

*    Weight gain

*    Sweating

*    Difficulty in getting or maintaining an erection, or in ejaculating (impotence)

*    Lack of interest in sexual activities (libido)

Other side effects with frequency not known

(frequency cannot be estimated from available data)

*    Feeling nervous, anxious, shaky or sweaty. These could be signs of low blood sugar levels (hypoglycaemia)

*    Inflammation, irritation or swelling caused by blood flow to the stomach

*    Difficulty sleeping (insomnia)

*    Seeing or hearing things that are not there (hallucinations), confusion, blurred vision

*    Depression and short term memory loss

*    High temperature and sore throat

*    A cold or numb feeling on your fingers or toes

*    Unusual skin sensation such as numbness, tingling, picking, burning or creeping on the skin

*    Hair loss (usually grows back when you stop using the medicine)

*    Changes in your blood cell count shown up on blood tests. This can lead to skin rashes or feeling weak

[a How to store Corgard Tablets

Expiry Date

Do not use this medicine after the expiry date shown on the carton label or blister label. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

Storage

*    Keep out of the sight and reach of children

*    Do not store above 25°C

[£) Content of the pack and other information

What Corgard Tablets contain

Each tablet contains 80mg of Nadolol as the active ingredient.

Your medicine also contains the following inactive ingredients: microcrystalline cellulose and magnesium stearate.

What Corgard Tablets look like and contents of the pack

Corgard tablets are white, biconvex, capsule-shaped tablets, with a score line on one side and engraved with ‘80' on the other.

They are available in blister packs of 28 tablets.

Manufacturer and Licence Holder

Corgard are manufactured by Sanofi-Aventis sp. z.o.o., Rzeszow, Poland and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM PL Number: 15184/1035 Leaflet revision date: 23/07/15

Corgard is a registered trademark of E.R Squibb & Son Limited.

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Blood tests

The results of some blood tests may show higher levels of liver enzymes than normal. The blood test may also show higher levels of white blood cells than normal.

If you get any side effects or if any of the side effects get serious or last longer than a few days, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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.

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

*    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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

Your medicine is called Nadolol 80mg Tablets, but will be referred to as Nadolol Tablets thoroughout this leaflet.

In this leaflet:

What Nadolol Tablets are and what they are used for What you need to know before you take Nadolol Tablets How to take Nadolol Tablets [4) Possible side effects

How to store Nadolol Tablets

Content of the pack and other information

What Nadolol Tablets are and what they are used for

Nadolol Tablets contain a medicine called nadolol.

This belongs to a group of medicines called beta-blockers. It works by slowing your heart rate or lowering your blood pressure.

Nadolol tablets are used for:

*    Chest pain (angina)

*    High blood pressure

*    Uneven or unusually fast heart beats (arrhythmia)

*    Symptoms of an overactive thyroid gland

*    Stopping migraine attacks happening

[2) What you need to know before you take Nadolol Tablets

Do not take Nadolol Tablets if:

*    You are allergic (hypersensitive) to nadolol or any of the other ingredients of Nadolol Tablets (see Section 6: Further information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

*    You have or have had asthma, or wheezing

*    You have a very slow heart beat

*    You have heart problems - where you have difficulty breathing and swollen ankles

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Nadolol Tablets.

Warnings and precautions

Take special care with Nadolol Tablets Check with your doctor or pharmacist before taking your medicine if:

*    You have any heart problems

*    You have breathing problems due to long term lung problems (called ‘bronchitis' or ‘emphysema')

*    You have diabetes.

Nadolol Tablets may cause low blood sugar levels even in patients who are not diabetic such as children, the elderly and those who are fasting

*    You have liver problems

*    You have an overactive thyroid gland

*    You have kidney problems

*    You have a history of severe allergies

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Nadolol Tablets.

Stress tests

The accuracy of all stress tests (used by your doctor to find out whether you have a decrease in blood flow to your heart muscle) is affected by the used of Beta blockers including Nadolol.

Operations or anaesthetics

Tell your doctor or dentist you are taking Nadolol Tablets if you are going to have an anaesthetic or an operation (including dental surgery).

Other medicines and Nadolol Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without prescription, including herbal medicines. This is because Nadolol Tablets can affect the way some other medicines work. Also some medicines can affect the way Nadolol Tablets work.

In particular, tell your doctor if you are taking any of the following:

*    Water tablets (diuretics) such as amiloride

*    Insulin or tablets to treat diabetes

*    Medicines for high blood pressure (such as guanethidine or hydralazine)

*    Medicines for depression (mono-amine oxidase inhibitors) such as phenelzine

*    Medicines used for migraine (such as clonidine, ergotamine or methysergide)

*    Medicines used for asthma, bowel problems or Parkinson's disease (such as atropine, ipratropium and benzatropine)

*    Medicines for chest pain (angina) - such as verapamil, nifedipine, and diltiazem

*    Medicines used for heart problems - such as lidocaine (also used as a local anaesthetic), procainamide, isoprenaline, verapamil, adrenaline (also used for severe allergies), noradrenaline, amiodarone, disopyramide and quinidine

*    Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) - used to relieve pain (such as ibuprofen, naproxen, diclofenac, indometacin and piroxicam)

*    Medicines used for mental problems (antipsychotic medicines) - such as chlorpromazine, fluphenazine and haloperidol

*    Medicines used to raise blood pressure (vasoconstrictors - used to narrow blood vessels) - such as ephedrine and phenylephrine

*    Fingolimod - a medicine used for multiple sclerosis

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

You should not breast-feed if you are taking Nadolol Tablets. This is because small amounts may pass into the mothers milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel tired or dizzy whilst taking Nadolol Tablets. If this happens, do not drive or use any tools or machines.

^ How to take Nadolol Tablets

Always take Nadolol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

   Take this medicine by mouth

   Swallow the tablets with a drink of water

   If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

The usual dose:

The dose of Nadolol Tablets depends on your needs and the illness being treated. Your doctor will advise you.

Chest pain (angina)

•    40mg (half a tablet) to 160mg (2 tablets) each day High blood pressure

•    80mg (1 tablet) to 240mg (3 tablets) each day

Uneven or unusually fast hearts beats (arrhythmias)

•    40mg (half a tablet) to 160mg (2 tablets) each day

Stop migraine attacks happening

•    40mg (half a tablet) to 160mg (2 tablets) each day

Overactive thyroid gland

•    80mg (1 tablet) to 160mg (2 tablets) each day

Elderly patients and patients with kidney problems

Your doctor may decide to lower your dose of Nadolol Tablets if necessary.

Children

Nadolol Tablets should not be given to children.

If you take more Nadolol Tablets than you should

If you take more Nadolol Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctors know what you have taken. The following effects may happen: feeling dizzy or weak, difficulty in breathing or wheezing.

Patient Information Leaflet (continued)

If you forget to take Nadolol Tablets

Do not take a double dose to make up for a forgotten dose.

If you stop taking Nadolol tablets

Keep taking Nadolol Tablets until your doctor tells you to stop. If you stop treatment suddenly your illness may get worse. When your doctor says that you can stop taking Nadolol Tablets, you need to do this gradually. Your doctor will help you do this.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

[5) How to store Nadolol Tablets

Expiry Date

Do not use this medicine after the expiry date shown on the carton label or blister label. If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

Storage

*    Keep out of the sight and reach of children

*    Do not store above 25°C

[£) Content of the pack and other information

What Nadolol Tablets contain

Each tablet contains 80mg of Nadolol as the active ingredient.

Your medicine also contains the following inactive ingredients: microcrystalline cellulose and magnesium stearate.

What Nadolol Tablets look like and contents of the pack

Nadolol tablets are white, biconvex, capsule-shaped tablets, with a score line on one side and engraved with ‘80' on the other.

They are available in blister packs of 28 tablets.

Manufacturer and Licence Holder

Nadolol are manufactured by Sanofi-Aventis sp. z.o.o., Rzeszow, Poland and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.


Possible side effects

Like all medicines, Nadolol Tablets can cause side effects, although not everybody gets them.

Stop taking Nadolol Tablets and see a doctor or go to a hospital straight away if:

*    You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Tell your doctor as soon as possible if you have any of the following side effects:

Common reported side effects

(may affect up to 1 in 10 people)

*    Pain in your chest and feeling weak or dizzy. These could be signs of heart problems.

*    Slow heart rate

*    Feeling dizzy or weak. These could be signs of low blood pressure

Uncommon reported side effects

(may effect up to 1 in 100 people)

*    Stomach pain, stomach feels full or tight (bloating), wind (flatulence), constipation, diarrhoea, indigestion and loss of appetite

*    Changes in behaviour

*    Slurred speech

*    Cough and blocked nose

*    Ringing in the ears

*    Headache

*    Feeling or being sick

*    Breathing problems such as asthma

*    Dry mouth, eyes or skin

*    Weight gain

*    Sweating

*    Difficulty in getting or maintaining an erection, or in ejaculating (impotence)

*    Lack of interest in sexual activities (libido)

Other side effects with frequency not known

(frequency cannot be estimated from available data)

*    Feeling nervous, anxious, shaky or sweaty. These could be signs of low blood sugar levels (hypoglycaemia)

*    Inflammation, irritation or swelling caused by blood flow to the stomach

*    Difficulty sleeping (insomnia)

*    Seeing or hearing things that are not there (hallucinations), confusion, blurred vision

*    Depression and short term memory loss

*    High temperature and sore throat

*    A cold or numb feeling on your fingers or toes

*    Unusual skin sensation such as numbness, tingling, picking, burning or creeping on the skin

*    Hair loss (usually grows back when you stop using the medicine)

*    Changes in your blood cell count shown up on blood tests. This can lead to skin rashes or feeling weak

Blood tests

The results of some blood tests may show higher levels of liver enzymes than normal. The blood test may also show higher levels of white blood cells than normal.

If you get any side effects or if any of the side effects get serious or last longer than a few days, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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.

POM PL Number: 15184/1035 Leaflet revision date: 23/07/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.