1. What Carvedilol Tablets are and what they are used for

This medicine contains an active substance called Carvedilol. Carvedilol belongs to a group of medicines called beta-blockers. Carvedilol is used to treat the following:

• Chronic heart failure.
• High blood pressure (hypertension).
• Angina (chest pain or discomfort that happens when your heart isn’t getting enough oxygen). Carvedilol works by making your blood vessels relax and widen.
• This helps to lower your blood pressure.
• If you have chronic heart failure, this makes it easier for your heart to pump blood around your body.
• If you have angina, this will help stop the chest pain.

Your doctor may give you other medicines as well as Carvedilol to help treat your condition.

|               2. What you need to know before you take Carvedilol Tablets ~|

DO NOT take Carvedilol Tablets if:

• You are allergic (hypersensitive) to carvedilol or any of the other ingredients of this medicine (listed in Section 6).
• You have ever had wheezing due to asthma.
• You have severe heart failure (swelling of your hands, ankles and feet) which is being treated by medicines given into one of your veins (intravenously).
• You have problems with your liver.
• You have problems with your heart (for example ‘heart block’ or slow heart beat). Carvedilol is not suitable for some people with certain types of heart problem.
• You have very low blood pressure.

If you are not sure, talk to your doctor or pharmacist before taking Carvedilol.

Warnings and precautions

Check with your doctor or pharmacist before taking Carvedilol Tablets if you:

• have problems with your lungs
• have problems with your kidneys
• are diabetic (high blood sugar)
• wear contact lenses
• have problems with your blood vessels (peripheral vascular disease)
• have ever had problems with your thyroid
• have ever had a serious allergic reaction (for example, sudden swelling, causing difficulty breathing or swallowing, swelling of the hands, feet and ankles or a severe rash)
• have an allergy and are having treatment to desensitize you
• have problems with the blood circulation in your fingers and toes (Raynaud’s phe­nomenon)
• have had a skin disorder called ‘psoriasis’ after taking beta-blocker medicines
• have a type of angina (chest pain) called ‘Prinzmetal’s va­riant angina’
• have phaeochromocytoma (tumors of adrenal gland)

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

Other medicines and Carvedilol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes medicines that you buy without a prescription and herbal medicines. This is because Carvedilol can affect the way some medicines work. Also some other medicines can affect the way Carvedilol works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines for your heart or blood pressure, including water tablets (diuretics), ‘calcium channel blockers’ (for example diltiazem or verapamil), medicines to control an irregular heartbeat (for example digoxin and amiodarone).
• Catecholamine-depleting agents (for example reserpine and Monoamine oxidase inhibitors (MAOIs, such as isocarboxide and phenelzine (used to treat depression)).
• Fluoxetine and Paroxetine (used to treat depression).
• Medicines for diabetes, such as insulin or metformin.
• Clonidine (used to treat high blood pressure, migraine and flushing in the menopause).
• Rifampicin (used to treat infections).
• Ciclosporin (used after an organ transplant).
• Non-steroidal anti-inflammatory drugs (NSAIDs, for example aspirin, indomethacin and ibuprofen).
• Beta-agonist bronchodilators (used to treat chest tightness and wheezing due to asthma or other chest conditions (for example salbutamol and terbutaline sulphate)).

Operations

If you are going to have an operation, tell the doctor that you are taking Carvedilol. This is because some anaesthetics can lower your blood pressure, and it may become too low.

Pregnancy, breast-feeding and fertility

• 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.

Driving and using machines

• You may feel dizzy while taking Carvedilol. This is more likely when you start treatment or if your treatment is changed, and when you drink alcohol. If this happens to you, do not drive or use any tools or machines.
• Talk to your doctor if you notice any other problems that might affect driving, using tools or machines while you are taking Carvedilol.

Carvedilol Tablets contain Lactose

• If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine

3. How to take Carvedilol Tablets

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Swallow each tablet with a drink. The scoreline is not intended for breaking the tablet

Chronic heart failure:

When used for heart failure, treatment with Carvedilol should be started by a specialist doctor.

• You should take your tablets at the same time as eating some food.
• The usual starting dose is one 3.125 mg tablet twice a day for two weeks.
• Your doctor will then increase the dose slowly, over several weeks, up to 25 mg twice a day.
• If you weigh more than 85 kg (187 lb) the dose may be increased up to 50 mg twice a day.
• If you have stopped taking Carvedilol for more than two weeks you should talk to your doctor. They will need you to go back to the starting dose again (see section ‘If you stop taking Carvedilol’).

High blood pressure:

• The usual starting dose is 12.5 mg once a day for two days.
• After two days the dose is usually 25 mg, once a day.
• If your blood pressure is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg a day.
• If you are older people, you may not need any more than 12.5 mg a day to control your blood pressure.

Angina:

Adults

• The usual starting dose is 12.5 mg twice a day for two days.
• After two days the dose is usually 25 mg, twice a day.
• If your angina is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg twice a day.

Older people

• Your doctor will decide both your starting dose and the best dose for you to take in the longer term.
• The usual maximum dose is 50 mg each day, taken in smaller amounts (divided doses).

Use in children and adolescents

• Carvedilol is not suitable for children under the age of 18 years.

If you take more Carvedilol Tablets than you should

• If you take more Carvedilol than you should or someone else takes your Carvedilol, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
• The following effects may happen if you have taken more tablets than you should: a slow heart beat, feeling dizzy or light headed, becoming breathless, wheezy or extremely tired. IXXXXXX

If you forget to take Carvedilol Tablets

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Carvedilol Tablets

Do not stop taking this medicine without talking to your doctor. They may want you to stop taking Carvedilol slowly 1 to 2 weeks.

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.

• Stop taking this medicine and tell your doctor immediately if you suffer from any of the following: Severe allergic reactions signs may include sudden swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow.
• Chest pains accompanied by shortness of breath, sweating and feeling sick.
• Passing water (urinating) less often with swelling of legs, indicating problems with your kidneys.
• Very low blood sugar (hypoglycaemia) which might cause seizures or unconsciousness.
• Skin reactions – Very rarely, severe skin conditions (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur. Redness, often associated with blisters may appear on the skin or mucous membranes, such as the inside of the mouth, the genital areas or the eyelids. These can appear initially as circular patches often with central blisters, which may progress to widespread peeling of the skin and can be life threatening. These serious skin reactions are often preceded by headache, fever and body aches (flu-like symptoms).

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• Feeling weak and tired
• Feeling dizzy
• Headache
• Low blood pressure. The signs include feeling dizzy or light-headed.
• Problems with your heart. The signs include chest pains, tiredness, shortness of breath and swelling of your arms and legs.

Feeling dizzy, having a headache and feeling weak and tired are usually mild and more likely to happen at the beginning of your treatment.

Common (may affect up to 1 in 10 people):

• Infections of the airway (bronchitis), lung (pneumonia), nose and throat (upper respiratory tract). The signs include wheezing, shortness of breath, chest tightness and sore throat.
• Infections of the urinary tract which can cause problems in passing water.
• Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, a fluttering sensation in your heart (palpitations) and being short of breath.
• Increase in weight.
• Increase in cholesterol levels (shown by a blood test).
• Loss of control of blood sugar in people with diabetes.
• Feeling depressed.
• Problems with your sight, sore or dry eyes due to fewer tears being made.
• A slow heart beat.
• Feeling dizzy or light-headed after standing up.
• Fluid retention. The signs include: overall swelling of your body, swelling of parts of your body for example your hands, feet, ankles and legs and an increase in how much blood you have in your body.
• Problems with blood circulation in your arms and legs. The signs include cold hands and feet, whiteness, tingling and pain in your fingers and a pain in your leg which gets worse when you walk.
• Breathing problems
• Feeling sick or being sick.
• Diarrhoea.
• Stomach upset / indigestion.
• Pain, possibly in your hands and feet.

Uncommon (may affect up to 1 in 100 people):

• Disturbed sleep.
• Fainting.
• Tingling or numbness of your hands or feet.
• Problems with your skin, including skin rashes which may cover a lot of your body, a lumpy rash (hives), feeling itchy and dry skin patches.
• Increased sweating.
• Hair loss.
• Being unable to get an erection (erectile dysfunction).
• Constipation.

Rare (may affect up to 1 in 1,000 people):

• Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds.
• A stuffy nose, wheezing and flu-like symptoms.
• A dry mouth.

Very rare (may affect up to 1 in 10,000 people):

• Low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat and lungs.
• Kidney problems which show up in a blood test.
• Some women may have difficulty with bladder control when they pass water (urinary incontinence). This normally will get better when treatment is stopped.

Carvedilol can also cause development of the signs of diabetes in people who have a very mild form of diabetes called ‘latent diabetes’.

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: yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

|                             5. How to store Carvedilol Tablets                            ~|

• Keep this medicine out of the sight and reach of the children.
• Blister carton: Do not store above 250C. Store in the original package to protect from moisture. Keep the blister in outer carton to protect from light.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to last date of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Carvedilol Tablets contain:

• The active substance is Carvedilol. Carvedilol Tablets come in four strengths. Each tablet contains either 3.125mg or 6.25mg or 12.5mg or 25mg of active ingredient Carvedilol
• The other ingredients are: lactose, sodium starch glycollate, microcrystalline cellulose, colloidal silicon dioxide, polysorbate 80, maize starch and magnesium stearate. In addition the tablets contain colouring agents. The 3.125mg tablets contain ferric oxide red (E172), the 6.25mg tablets contain ferric oxide yellow (E172) and the 12.5mg tablets contain the colouring agent ferric oxide red (E172) and ferric oxide yellow (E172).

What Carvedilol Tablets look like and contents of the pack:

1. What Carvedilol Tablets are and what they are used for

This medicine contains an active substance called Carvedilol. Carvedilol belongs to a group of medicines called betablockers. Carvedilol is used to treat the following:

• Chronic heart failure.
• High blood pressure (hypertension).
• Angina (chest pain or discomfort that happens when your heart isn’t getting enough oxygen). Carvedilol works by making your blood vessels relax and widen.
• This helps to lower your blood pressure.
• If you have chronic heart failure, this makes it easier for your heart to pump blood around your body.
• If you have angina, this will help stop the chest pain.

Your doctor may give you other medicines as well as Carvedilol to help treat your condition.

2. What you need to know before you take Carvedilol Tablets                    |

DO NOT take Carvedilol Tablets if:

• You are allergic (hypersensitive) to carvedilol or any of the other ingredients of this medicine (listed in Section 6).
• You have ever had wheezing due to asthma.
• You have severe heart failure (swelling of your hands, ankles and feet) which is being treated by medicines given into one of your veins (intravenously).
• You have problems with your liver.
• You have problems with your heart (for example ‘heart block’ or slow heart beat). Carvedilol is not suitable for some people with certain types of heart problem.
• You have very low blood pressure.

If you are not sure, talk to your doctor or pharmacist before taking Carvedilol.

Warnings and precautions

Check with your doctor or pharmacist before taking Carvedilol Tablets if you:

• have problems with your lungs
• have problems with your kidneys
• are diabetic (high blood sugar)
• wear contact lenses
• have problems with your blood vessels (peripheral vascular disease)
• have ever had problems with your thyroid
• have ever had a serious allergic reaction (for example, sudden swelling, causing difficulty breathing or swallowing, swelling of the hands, feet and ankles or a severe rash)
• have an allergy and are having treatment to desensitize you
• have problems with the blood circulation in your fingers and toes (Raynaud’s phe­nomenon)
• have had a skin disorder called ‘psoriasis’ after taking beta-blocker medicines
• have a type of angina (chest pain) called ‘Prinzmetal’s va­riant angina’
• have phaeochromocytoma (tumors of adrenal gland)

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

Other medicines and Carvedilol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes medicines that you buy without a prescription and herbal medicines. This is because Carvedilol can affect the way some medicines work. Also some other medicines can affect the way Carvedilol works.

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

• Other medicines for your heart or blood pressure, including water tablets (diuretics), ‘calcium channel blockers’ (for example diltiazem or verapamil), medicines to control an irregular heartbeat (for example digoxin and amiodarone).
• Catecholamine-depleting agents (for example reserpine and Monoamine oxidase inhibitors (MAOIs, such as isocarboxide and phenelzine (used to treat depression)).
• Fluoxetine and Paroxetine (used to treat depression).
• Medicines for diabetes, such as insulin or metformin.
• Clonidine (used to treat high blood pressure, migraine and flushing in the menopause).
• Rifampicin (used to treat infections).
• Ciclosporin (used after an organ transplant).
• Non-steroidal anti-inflammatory drugs (NSAIDs, for example aspirin, indomethacin and ibuprofen).
• Beta-agonist bronchodilators (used to treat chest tightness and wheezing due to asthma or other chest conditions (for example salbutamol and terbutaline sulphate)).

Operations

If you are going to have an operation, tell the doctor that you are taking Carvedilol. This is because some anaesthetics can lower your blood pressure, and it may become too low.

Pregnancy, breast-feeding and fertility

• 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.

Driving and using machines

• You may feel dizzy while taking Carvedilol. This is more likely when you start treatment or if your treatment is changed, and when you drink alcohol. If this happens to you, do not drive or use any tools or machines.
• Talk to your doctor if you notice any other problems that might affect driving, using tools or machines while you are taking Carvedilol.

Carvedilol Tablets contain Lactose

• If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine

3. How to take Carvedilol Tablets

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Swallow each tablet with a drink. The scoreline is not intended for breaking the tablet

Chronic heart failure:

When used for heart failure, treatment with Carvedilol should be started by a specialist doctor.

• You should take your tablets at the same time as eating some food.
• The usual starting dose is one 3.125 mg tablet twice a day for two weeks.
• Your doctor will then increase the dose slowly, over several weeks, up to 25 mg twice a day.
• If you weigh more than 85 kg (187 lb) the dose may be increased up to 50 mg twice a day.
• If you have stopped taking Carvedilol for more than two weeks you should talk to yourdoctor. They will need you to go back to the starting dose again (see section ‘If you stop taking Carvedilol’).

High blood pressure:

• The usual starting dose is 12.5 mg once a day for two days.
• After two days the dose is usually 25 mg, once a day.
• If your blood pressure is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg a day.
• If you are older people, you may not need any more than 12.5 mg a day to control your blood pressure.

Angina:

Adults

• The usual starting dose is 12.5 mg twice a day for two days.
• After two days the dose is usually 25 mg, twice a day.
• If your angina is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg twice a day.

Older people

• Your doctor will decide both your starting dose and the best dose for you to take in the longer term.
• The usual maximum dose is 50 mg each day, taken in smaller amounts (divided doses).

Use in children and adolescents

• Carvedilol is not suitable for children under the age of 18 years.

If you take more Carvedilol Tablets than you should

• If you take more Carvedilol than you should or someone else takes your Carvedilol, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

IXXXXXX

• The following effects may happen if you have taken more tablets than you should: a slow heart beat, feeling dizzy or light headed, becoming breathless, wheezy or extremely tired.

If you forget to take Carvedilol Tablets

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Carvedilol Tablets

Do not stop taking this medicine without talking to your doctor. They may want you to stop taking Carvedilol slowly 1 to 2 weeks.

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.

Stop taking this medicine and tell your doctor immediately if you suffer from any of the following:

• Severe allergic reactions signs may include sudden swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow.
• Chest pains accompanied by shortness of breath, sweating and feeling sick.
• Passing water (urinating) less often with swelling of legs, indicating problems with your kidneys.
• Very low blood sugar (hypoglycaemia) which might cause seizures or unconsciousness.
• Skin reactions – Very rarely, severe skin conditions (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur. Redness, often associated with blisters may appear on the skin or mucous membranes, such as the inside of the mouth, the genital areas or the eyelids. These can appear initially as circular patches often with central blisters, which may progress to widespread peeling of the skin and can be life threatening. These serious skin reactions are often preceded by headache, fever and body aches (flu-like symptoms).

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• Feeling weak and tired
• Feeling dizzy
• Headache
• Low blood pressure. The signs include feeling dizzy or light-headed.
• Problems with your heart. The signs include chest pains, tiredness, shortness of breath and swelling of your arms and legs.
• Feeling dizzy, having a headache and feeling weak and tired are usually mild and more likely to happen at the beginning of your treatment.

Common (may affect up to 1 in 10 people):

• Infections of the airway (bronchitis), lung (pneumonia), nose and throat (upper respiratory tract). The signs include wheezing, shortness of breath, chest tightness and sore throat.
• Infections of the urinary tract which can cause problems in passing water.
• Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, a fluttering sensation in your heart (palpitations) and being short of breath.
• Increase in weight.
• Increase in cholesterol levels (shown by a blood test).
• Loss of control of blood sugar in people with diabetes.
• Feeling depressed.
• Problems with your sight, sore or dry eyes due to fewer tears being made.
• A slow heart beat.
• Feeling dizzy or light-headed after standing up.
• Fluid retention. The signs include: overall swelling of your body, swelling of parts of your body for example your hands, feet, ankles and legs and an increase in how much blood you have in your body.
• Problems with blood circulation in your arms and legs. The signs include cold hands and feet, whiteness, tingling and pain in your fingers and a pain in your leg which gets worse when you walk.
• Breathing problems
• Feeling sick or being sick.
• Diarrhoea.
• Stomach upset / indigestion.
• Pain, possibly in your hands and feet.

Uncommon (may affect up to 1 in 100 people):

• Disturbed sleep.
• Fainting.
• Tingling or numbness of your hands or feet.
• Problems with your skin, including skin rashes which may cover a lot of your body, a lumpy rash (hives), feeling itchy and dry skin patches.
• Increased sweating.
• Hair loss.
• Being unable to get an erection (erectile dysfunction).
• Constipation.

Rare (may affect up to 1 in 1,000 people):

• Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds.
• A stuffy nose, wheezing and flu-like symptoms.
• A dry mouth.

Very rare (may affect up to 1 in 10,000 people):

• Low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat and lungs.
• Kidney problems which show up in a blood test.
• Some women may have difficulty with bladder control when they pass water (urinary incontinence).

This normally will get better when treatment is stopped.

Carvedilol can also cause development of the signs of diabetes in people who have a very mild form of diabetes called ‘latent diabetes’.

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:. By reporting side effects you can help provide more information on the safety of this medicine.

|                                    5. How to store Carvedilol Tablets                                    |

• Keep this medicine out of the sight and reach of the children.
• Blister carton: Do not store above 250C. Store in the original package to protect from moisture. Keep the blister in outer carton to protect from light.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to last date of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Carvedilol Tablets contain:

• The active substance is Carvedilol. Carvedilol Tablets come in four strengths. Each tablet contains either 3.125mg or 6.25mg or 12.5mg or 25mg of active ingredient Carvedilol
• The other ingredients are: lactose, sodium starch glycollate, microcrystalline cellulose, colloidal silicon dioxide, polysorbate 80, maize starch and magnesium stearate. In addition the tablets contain colouring agents. The 3.125mg tablets contain ferric oxide red (E172), the 6.25mg tablets contain ferric oxide yellow (E172) and the 12.5mg tablets contain the colouring agent ferric oxide red (E172) and ferric oxide yellow (E172).

What Carvedilol Tablets look like and contents of the pack:

• The 3.125mg tablets are pink coloured, circular, biconvex uncoated tablets with ‘C’ breakline ‘1’ embossed on one side and plain on the other
• The 6.25mg tablets are cream coloured, circular, biconvex uncoated tablets with ‘C’ breakline ‘2’ embossed on one side and plain on the other
• The 12.5mg tablets are light pink coloured, circular, biconvex uncoated tablets with ‘C’ breakline ‘3’ embossed on one side and plain on the other
• The 25mg tablets are white to off white, circular, biconvex uncoated tablets with ‘C’ breakline ‘4’ embossed on one side and plain on the other
• They are available in blister packs of 14, 28, 56, or 84 tablets. Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

E-mail:

Manufacturer

Wave Pharma Limited,

4th Floor, Cavendish House, 369 Burnt Oak Broadway,

Edgware, HA8 5AW, United Kingdom

Carvedilol 3.125mg Tablets; PL 17907/0097

Carvedilol 6.25mg Tablets; PL 17907/0098

Carvedilol 12.5mg Tablets; PL 17907/0099

Carvedilol 25mg Tablets; PL 17907/0100

This leaflet was last revised in November 2017

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V4 20–11–17 D0

SAME SIZE ARTWORK 370 × 150 mm

Back

PACKAGE LEAFLET: INFORMATION FOR THE USER

CARVEDILOL 3.125MG TABLETS

CARVEDILOL 6.25MG TABLETS

CARVEDILOL 12.5MG TABLETS

CARVEDILOL 25MG 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

What is in this leaflet:

• 1. What Carvedilol Tablets are and what they are used for

• 2. What you need to know before you take Carvedilol Tablets.

• 3. How to take Carvedilol Tablets

• 4. Possible side effects

• 5. How to store Carvedilol Tablets

• 6. Contents of the pack and other information.

1. What Carvedilol Tablets are and what they are used for

This medicine contains an active substance called Carvedilol. Carvedilol belongs to a group of medicines called betablockers. Carvedilol is used to treat the following:

• Chronic heart failure.
• High blood pressure (hypertension).
• Angina (chest pain or discomfort that happens when your heart isn’t getting enough oxygen). Carvedilol works by making your blood vessels relax and widen.
• This helps to lower your blood pressure.
• If you have chronic heart failure, this makes it easier for your heart to pump blood around your body.
• If you have angina, this will help stop the chest pain.

Your doctor may give you other medicines as well as Carvedilol to help treat your condition.

2. What you need to know before you take Carvedilol Tablets |

DO NOT take Carvedilol Tablets if:

• You are allergic (hypersensitive) to carvedilol or any of the other ingredients of this medicine (listed in Section 6).
• You have ever had wheezing due to asthma.
• You have severe heart failure (swelling of your hands, ankles and feet) which is being treated by medicines given into one of your veins (intravenously).
• You have problems with your liver.
• You have problems with your heart (for example ‘heart block’ or slow heart beat). Carvedilol is not suitable for some people with certain types of heart problem.
• You have very low blood pressure.

If you are not sure, talk to your doctor or pharmacist before taking Carvedilol.

Warnings and precautions

Check with your doctor or pharmacist before taking Carvedilol Tablets if you:

• have problems with your lungs
• have problems with your kidneys
• are diabetic (high blood sugar)
• wear contact lenses
• have problems with your blood vessels (peripheral vascular disease)
• have ever had problems with your thyroid
• have ever had a serious allergic reaction (for example, sudden swelling, causing difficulty breathing or swallowing, swelling of the hands, feet and ankles or a severe rash)
• have an allergy and are having treatment to desensitize you
• have problems with the blood circulation in your fingers and toes (Raynaud’s phe­nomenon)
• have had a skin disorder called ‘psoriasis’ after taking beta-blocker medicines
• have a type of angina (chest pain) called ‘Prinzmetal’s va­riant angina’
• have phaeochromocytoma (tumors of adrenal gland)

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

Other medicines and Carvedilol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes medicines that you buy without a prescription and herbal medicines. This is because Carvedilol can affect the way some medicines work. Also some other medicines can affect the way Carvedilol works.

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

• Other medicines for your heart or blood pressure, including water tablets (diuretics), ‘calcium channel blockers’ (for example diltiazem or verapamil), medicines to control an irregular heartbeat (for example digoxin and amiodarone).
• Catecholamine-depleting agents (for example reserpine and Monoamine oxidase inhibitors (MAOIs, such as isocarboxide and phenelzine (used to treat depression)).
• Fluoxetine and Paroxetine (used to treat depression).
• Medicines for diabetes, such as insulin or metformin.
• Clonidine (used to treat high blood pressure, migraine and flushing in the menopause).
• Rifampicin (used to treat infections).
• Ciclosporin (used after an organ transplant).
• Non-steroidal anti-inflammatory drugs (NSAIDs, for example aspirin, indomethacin and ibuprofen).
• Beta-agonist bronchodilators (used to treat chest tightness and wheezing due to asthma or other chest conditions (for example salbutamol and terbutaline sulphate)).

Operations

If you are going to have an operation, tell the doctor that you are taking Carvedilol. This is because some anaesthetics can lower your blood pressure, and it may become too low.

Pregnancy, breast-feeding and fertility

• 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.

Driving and using machines

• You may feel dizzy while taking Carvedilol. This is more likely when you start treatment or if your treatment is changed, and when you drink alcohol. If this happens to you, do not drive or use any tools or machines.
• Talk to your doctor if you notice any other problems that might affect driving, using tools or machines while you are taking Carvedilol.

Carvedilol Tablets contain Lactose

• If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine

• 3. How to take Carvedilol Tablets

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Swallow each tablet with a drink. The scoreline is not intended for breaking the tablet

Chronic heart failure:

When used for heart failure, treatment with Carvedilol should be started by a specialist doctor.

• You should take your tablets at the same time as eating some food.
• The usual starting dose is one 3.125 mg tablet twice a day for two weeks.
• Your doctor will then increase the dose slowly, over several weeks, up to 25 mg twice a day.
• If you weigh more than 85 kg (187 lb) the dose may be increased up to 50 mg twice a day.
• If you have stopped taking Carvedilol for more than two weeks you should talk to yourdoctor. They will need you to go back to the starting dose again (see section ‘If you stop taking Carvedilol’).

High blood pressure:

• The usual starting dose is 12.5 mg once a day for two days.
• After two days the dose is usually 25 mg, once a day.
• If your blood pressure is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg a day.
• If you are older people, you may not need any more than 12.5 mg a day to control your blood pressure.

Angina:

Adults

• The usual starting dose is 12.5 mg twice a day for two days.
• After two days the dose is usually 25 mg, twice a day.
• If your angina is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg twice a day.

Older people

• Your doctor will decide both your starting dose and the best dose for you to take in the longer term.
• The usual maximum dose is 50 mg each day, taken in smaller amounts (divided doses).

Use in children and adolescents

• Carvedilol is not suitable for children under the age of 18 years.

If you take more Carvedilol Tablets than you should

• If you take more Carvedilol than you should or someone else takes your Carvedilol, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

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• The following effects may happen if you have taken more tablets than you should: a slow heart beat, feeling dizzy or light headed, becoming breathless, wheezy or extremely tired.

If you forget to take Carvedilol Tablets

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Carvedilol Tablets

Do not stop taking this medicine without talking to your doctor. They may want you to stop taking Carvedilol slowly 1 to 2 weeks.

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.

Stop taking this medicine and tell your doctor immediately if you suffer from any of the following:

• Severe allergic reactions signs may include sudden swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow.
• Chest pains accompanied by shortness of breath, sweating and feeling sick.
• Passing water (urinating) less often with swelling of legs, indicating problems with your kidneys.
• Very low blood sugar (hypoglycaemia) which might cause seizures or unconsciousness.
• Skin reactions – Very rarely, severe skin conditions (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur. Redness, often associated with blisters may appear on the skin or mucous membranes, such as the inside of the mouth, the genital areas or the eyelids. These can appear initially as circular patches often with central blisters, which may progress to widespread peeling of the skin and can be life threatening. These serious skin reactions are often preceded by headache, fever and body aches (flu-like symptoms).

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• Feeling weak and tired
• Feeling dizzy
• Headache
• Low blood pressure. The signs include feeling dizzy or light-headed.
• Problems with your heart. The signs include chest pains, tiredness, shortness of breath and swelling of your arms and legs.
• Feeling dizzy, having a headache and feeling weak and tired are usually mild and more likely to happen at the beginning of your treatment.

Common (may affect up to 1 in 10 people):

• Infections of the airway (bronchitis), lung (pneumonia), nose and throat (upper respiratory tract). The signs include wheezing, shortness of breath, chest tightness and sore throat.
• Infections of the urinary tract which can cause problems in passing water.
• Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, a fluttering sensation in your heart (palpitations) and being short of breath.
• Increase in weight.
• Increase in cholesterol levels (shown by a blood test).
• Loss of control of blood sugar in people with diabetes.
• Feeling depressed.
• Problems with your sight, sore or dry eyes due to fewer tears being made.
• A slow heart beat.
• Feeling dizzy or light-headed after standing up.
• Fluid retention. The signs include: overall swelling of your body, swelling of parts of your body for example your hands, feet, ankles and legs and an increase in how much blood you have in your body.
• Problems with blood circulation in your arms and legs. The signs include cold hands and feet, whiteness, tingling and pain in your fingers and a pain in your leg which gets worse when you walk.
• Breathing problems
• Feeling sick or being sick.
• Diarrhoea.
• Stomach upset / indigestion.
• Pain, possibly in your hands and feet.

Uncommon (may affect up to 1 in 100 people):

• Disturbed sleep.
• Fainting.
• Tingling or numbness of your hands or feet.
• Problems with your skin, including skin rashes which may cover a lot of your body, a lumpy rash (hives), feeling itchy and dry skin patches.
• Increased sweating.
• Hair loss.
• Being unable to get an erection (erectile dysfunction).
• Constipation.

Rare (may affect up to 1 in 1,000 people):

• Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds.
• A stuffy nose, wheezing and flu-like symptoms.
• A dry mouth.

Very rare (may affect up to 1 in 10,000 people):

• Low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat and lungs.
• Kidney problems which show up in a blood test.
• Some women may have difficulty with bladder control when they pass water (urinary incontinence).

This normally will get better when treatment is stopped.

Carvedilol can also cause development of the signs of diabetes in people who have a very mild form of diabetes called ‘latent diabetes’.

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:. By reporting side effects you can help provide more information on the safety of this medicine.

| 5. How to store Carvedilol Tablets |

• Keep this medicine out of the sight and reach of the children.
• Blister carton: Do not store above 250C. Store in the original package to protect from moisture. Keep the blister in outer carton to protect from light.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to last date of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

• 6. Contents of the pack and other information

What Carvedilol Tablets contain:

• The active substance is Carvedilol. Carvedilol Tablets come in four strengths. Each tablet contains either 3.125mg or 6.25mg or 12.5mg or 25mg of active ingredient Carvedilol
• The other ingredients are: lactose, sodium starch glycollate, microcrystalline cellulose, colloidal silicon dioxide, polysorbate 80, maize starch and magnesium stearate. In addition the tablets contain colouring agents. The 3.125mg tablets contain ferric oxide red (E172), the 6.25mg tablets contain ferric oxide yellow (E172) and the 12.5mg tablets contain the colouring agent ferric oxide red (E172) and ferric oxide yellow (E172).

What Carvedilol Tablets look like and contents of the pack:

• The 3.125mg tablets are pink coloured, circular, biconvex uncoated tablets with ‘C’ breakline ‘1’ embossed on one side and plain on the other
• The 6.25mg tablets are cream coloured, circular, biconvex uncoated tablets with ‘C’ breakline ‘2’ embossed on one side and plain on the other
• The 12.5mg tablets are light pink coloured, circular, biconvex uncoated tablets with ‘C’ breakline ‘3’ embossed on one side and plain on the other
• The 25mg tablets are white to off white, circular, biconvex uncoated tablets with ‘C’ breakline ‘4’ embossed on one side and plain on the other
• They are available in blister packs of 14, 28, 56, or 84 tablets. Not all pack sizes may be marketed