Nadolol 80mg Tablets
I
1.
Warnings and precautions Take special care with Corgard
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Corgard® 80mg tablets
(nadolol)
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.
The name of your medicine is Corgard 80mg tablets but will be referred to as Corgard throughout this leaflet.
In this leaflet:
1. What Corgard is and what it is used for
2. What you need to know before you take Corgard
3. How to take Corgard
4. Possible side effects
5. How to store Corgard
6. Content of the pack and other information
What Corgard is and what they are used for
Corgard contains 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 is 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
Do not take Corgard if:
x You are allergic (hypersensitive) to nadolol or any of the other ingredients of Corgard (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 x You have or have had asthma, or wheezing x You have a very slow heart beat x 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.
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 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.
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 if you are going to have an anaesthetic or an operation (including dental surgery).
Other medicines and Corgard
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 can affect the way some other medicines work. Also some medicines can affect the way Corgard 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. 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. If this happens, do not drive or use any tools or machines.
3. How to take Corgard
Always take Corgard 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 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 if necessary.
Children
Corgard should not be given to children.
If you take more Corgard than you should
If you take more Corgard 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.
If you forget to take Corgard
Do not take a double dose to make up for a forgotten dose.
If you stop taking Corgard
Keep taking Corgard 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, you need to do this gradually. Your doctor will help you do this.
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.
If you have any further questions on the use of this medicine, ask you doctor or pharmacist.
5. How to store Corgard
4. Possible side effects
Like all medicines, Corgard can cause side effects, although not everybody gets them.
Stop taking Corgard 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)
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take your medicine after the expiry date which is stated on the carton and blister label after ‘Exp'. The expiry date refers to the last day of that month.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
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. Content of the pack and other information
What Corgard contain:
The active ingredient in Corgard is nadolol.
Each tablet contains 80mg of nadolol.
The other ingredients are microcrystalline cellulose and magnesium stearate
What Corgard 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 by: Sanofi-aventis Sp. z.o.o. Drug Production and Distribution Plant ul. Lubelska 52, 35-233 Rzeszow, Poland.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Coargard® 80mg tablets;
PL 18799/2849 POM |
Leaflet date: 15.02.2016
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Nadolol 80mg tablets
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.
The name of your medicine is Nadolol 80mg tablets but
will be referred to as Nadolol throughout this leaflet.
In this leaflet:
1. What Nadolol is and what it is used for
2. What you need to know before you take Nadolol
3. How to take Nadolol
4. Possible side effects
5. How to store Nadolol
6. Content of the pack and other information
1. What Nadolol is and what they are used for
Nadolol contains 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 is 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
Do not take Nadolol if:
x You are allergic (hypersensitive) to nadolol or any of the other ingredients of Nadolol (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 x You have or have had asthma, or wheezing x You have a very slow heart beat x 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.
Warnings and precautions Take special care with Nadolol
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 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.
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 Nadolol.
Operations or anaesthetics
Tell your doctor or dentist you are taking Nadolol if you are going to have an anaesthetic or an operation (including dental surgery).
Other medicines and Nadolol
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 can affect the way some other medicines work. Also some medicines can affect the way Nadolol 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. 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. If this happens, do not drive or use any tools or machines.
3. How to take Nadolol
Always take Nadolol 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 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 if necessary.
Children
Nadolol should not be given to children.
If you take more Nadolol than you should
If you take more Nadolol 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.
If you forget to take Nadolol
Do not take a double dose to make up for a forgotten dose.
If you stop taking Nadolol
Keep taking Nadolol 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, you need to do this gradually. Your doctor will help you do this.
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.
If you have any further questions on the use of this medicine, ask you doctor or pharmacist.
5. How to store Nadolol
4. Possible side effects
Like all medicines, Nadolol can cause side effects, although not everybody gets them.
Stop taking Nadolol 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)
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take your medicine after the expiry date which is stated on the carton and blister label after ‘Exp'. The expiry date refers to the last day of that month.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
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. Content of the pack and other information
What Nadolol contain:
The active ingredient in Nadolol is nadolol.
Each tablet contains 80mg of nadolol.
The other ingredients are microcrystalline cellulose and magnesium stearate
What Nadolol 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 by: Sanofi-aventis Sp. z.o.o. Drug Production and Distribution Plant ul. Lubelska 52, 35-233 Rzeszow, Poland.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 oNu, UK.
Nadolol 80mg tablets;
PL 18799/2849 POM |
Leaflet date: 15.02.2016