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Carvedilol 6.25mg Tablets

Document: leaflet ACTAVIS_PL 36390-0123 change

Package Leaflet: Information for the user



Carvedilol 3.125 mg tablets Carvedilol 6.25 mg tablets Carvedilol 12.5 mg tablets Carvedilol 25 mg tablets

carvedilol

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:

_T| What Carvedilol tablet is and what it is used for

~2| What you need to know before you take Carvedilol tablets ^3| How to take Carvedilol tablets ^ Possible side effects

How to store Carvedilol tablets "6| Contents of the pack and other information

T| What Carvedilol tablet is and what it is used for

Carvedilol tablets contain the active ingredient carvedilol. Carvedilol belongs to a group of medicines called beta-blocker. Beta-blockers make your blood vessels relax and widen and slows your heart rate, thus causing the heart to beat more calmly and lower blood pressure.

Carvedilol tablets is used to:

•    treat angina

•    control high blood pressure

•    Carvedilol tablets can also be used in combination with other therapies to treat heart failure.

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 a history of asthma or other lung diseases unless you have consulted your doctor or pharmacist first

•    you have liver problems

•    you have problems with your heart (for example 'heart block' or unstable heart failure), as Carvedilol tablet is not suitable for some people with certain types of heart problem

•    you have an unusually slow heart beat (<50 bpm) or very low blood pressure (systolic blood pressure below 85 mmHg) sometimes causing dizziness, faintness or lightheadness on standing

•    you have a problem with the acid levels in your blood ('metabolic acidosis')

•    you are receiving verapamil or diltiazem by injection or as an infusion (with a drip).

Do not take Carvedilol tablets if any of the above applies to you. If you are not sure consult your doctor or pharmacist first. Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

•    you have kidney problems

•    you have diabetes, as your low blood sugar (hypo) warning sign may be less obvious than usual

•    you wear contact lenses, as Carvedilol tablets may cause dry eyes

•    you have thyroid problem

•    you have previously suffered from serious allergic reactions or you are undergoing desensitisation therapy to prevent allergy e. g. to wasp or bee stings

•    you have Raynaud's syndrome or peripheral vascular disease causing cold hands and feet or pins-and-needles

•    you have psoriasis (patches of thickened and sore skin)

•    you have a certain type of chest pain called 'Prinzmetal's angina'

•    you have a phaeochromocytoma (a growth on one of your adrenal glands) unless adequately controlled by medication

•    severe bradycardia (<50 bpm).

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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 tablets can affect the way some medicines work. Also some other medicines can affect the way Carvedilol tablets works.

Talk to your doctor or pharmacist if you are taking any of the following medicines:

•    Other medicines for your heart or high blood pressure particularly;

•    antiarrhythmics e. g. amiodarone,

•    calcium channel blockers e.g. amlodipine, diltiazem, verapamil, nifedipine,

•    digitalis drugs e. g. digoxin,

•    nitrates e.g. glyceryl trinitrate,

•    guanethidine, reserpine, methyldopa,

•    clonidine

•    Monoamine oxidase inhibitors (used to treat depression) e.g. moclobemide

•    Insulin or tablets to treat diabetes

•    Rifampicin (used to treat tuberculosis)

•    Cimetidine (used to treat ulcers)

•    Cyclosporin (used following an organ transplant)

•    barbiturates e.g. amylobarbitone (sleeping drug)

•    phenothiazines e.g. prochlorperazine (to help stop vomiting and nausea)

•    antidepressants e.g. amitriptyline, fluoxetine (used to treat depression)

•    non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen (used for pain, stiffness and inflammation of painful bones, joints and muscles)

•    corticosteroids (used to reduce inflammation) e.g. beclometasone

•    oestrogen therapies (used as contraception or hormone replacement therapy)

•    ketoconazole (used to treat fungal infections)

•    haloperidol (used in mental illness)

•    erythromycin (an antibiotic used for bacterial infections)

•    sympathomimetics (used for the nervous system) e.g. ephedrine, or beta agonist bronchodilators

•    ergotamine (used to treat migraine)

•    neuromuscular blocking agents (muscle relaxants used in anaesthesia) e.g. atracurium besilate

•    vasodilating agents (these drugs open blood vessels)

•    guanfacine (used to treat high blood pressure).

Operations

Tell your hospital or dentist you are taking Carvedilol tablets if you are going to have an operation needing an anaesthetic.

Carvedilol tablets with food and drink

Do not drink alcohol while you are taking Carvedilol tablets.

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

Do not take Carvedilol tablets if you are pregnant, trying to get pregnant or breast-feeding, unless your doctor has told you to.

Driving and using machines

Carvedilol tablets may reduce your alertness and you may feel dizzy while taking Carvedilol tablets. This is more likely when you start treatment or if your treatment is changed and when you drink alcohol. If affected do not drive or operate machinery.

Carvedilol tablets contains lactose

This medicinal product contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

_3| How to take Carvedilol tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

•    The tablets should be swallowed preferably with a glass of water.

Your doctor may monitor you at the start of treatment or if your dose is increased. This may involve urine and blood tests.

The recommended dose is:

Heart failure:

The tablets should be taken with food to reduce the risk of a fall in blood pressure when standing up, which causes dizziness, light-headedness or fainting

   Adults: The usual starting dose is 3.125 mg twice a day for 2 weeks. Your doctor may gradually increase your dose to 25 mg twice a day. The maximum dose is 25 mg twice a day for patients with a body weight of less than 85 kg. For patients with a body weight above 85 kg, a maximum dose of 50 mg twice a day can be taken.

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High blood pressure:

   Adults: The usual starting dose is 12.5 mg once a day for the first two days after which the recommended dose is 25 mg once a day. If necessary your doctor may gradually increase your dose. The maximum dose taken at one time is 25 mg and the maximum dose taken in one day is 50 mg.

   Elderly: The usual starting dose is 12.5 mg once a day. If necessary your doctor may increase your dose.

Angina:

   Adults: The usual starting dose is 12.5 mg twice a day for two days after which the recommended dose is 25 mg twice a day. If necessary your doctor may gradually increase your dose. The maximum daily dose is 50 mg twice a day.

   Elderly: The usual starting dose is 12.5 mg twice a day for two days after which the recommended dose is 25 mg twice a day, which is the maximum daily dose.

Liver or kidney problems

If you have either liver or kidney problems your doctor may prescribe a lower dose.

Elderly

Your doctor may want to monitor you more closely if you are elderly.

Use in Children and adolescents (under 18 years old)

Carvedilol tablets is not recommended for use in children and adolescents under 18 years old.

If you take more Carvedilol tablets than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose can cause low blood pressure (leading to feeling faint, shaky and weak), wheezing, vomiting, fits, very slow heartbeat, heart failure/attack, breathing problems and loss of consciousness.

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 your tablets, even if you are feeling well, unless your doctor tells you. They may want you to stop taking Carvedilol tablets slowly over 1 to 2 weeks.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are less likely if you are being treated for angina or hypertension than if you are being treated for heart failure..

If you think you may have any of the following side effects contact your doctor or go to your nearest hospital emergency room immediately:

Allergic reactions signs may include difficulty breathing or swallowing caused by sudden swelling of the throat, or face or swelling of your hands, feet and ankles.

Breathing problems signs may include wheezing, shortness of breath and chest tightness.

Low numbers of all types of white blood cells signs may include infections of the mouth, gums, throat and lungs. blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome: rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals), or severe blistering and peeling of large areas of the skin (toxic epidermal necrolysis: severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell , or erythema multiforme: severe condition of the skin that may affect the mouth and other parts of the body. It is seen as red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body. The spots may blister or may progress to form raised, red, pale-centred marks. Those affected may have fever, sore throat, headache and/or diarrhea.

Possible side effects in patients being treated for heart failure:

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

•    Low blood pressure. The signs include feeling dizzy or lightheaded, in particular after you stand up.

•    Headache (this is usually mild and happens at the start of your treatment)

•    Feeling weak and tired

•    Dizziness

•    Problems with your heart.

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

•    Increase in weight

•    Increase in cholesterol levels (shown by a blood test)

•    Loss of control of blood sugar in people with diabetes

•    A slow heart beat

•    Feeling sick or being sick, upset stomach, vomiting

•    Diarrhoea

•    infection of the airway (bronchitis), lungs (pneumonia), nose and throat

•    urinary infections

•    anaemia

•    Feeling depressed

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•    Problems with vision, sore or dry eyes, eye irritation

•    swelling of hands, ankles or feet

•    problems with circulation, fluid retention

•    worsening of cold extremities in patients who have Raynaud's disease or circulation problems

•    Problems with breathing

•    Pain in your hands, feet

•    Problems with your kidney, including changes in passing urine.

•    faintness or dizziness on standing up (due to lowered blood pressure)

Uncommon (may affect up to 1 in 100 people)

•    Fainting, feeling faint

•    problems with sleeping

•    tingling or numbness

•    problems with heart, chest pain

•    problems with your skin (skin rashes, itchiness, dry skin patches)

•    loss of hair

•    impotence (difficulty getting or maintaining an erection).

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

•    decreased number of platelets in your blood (causing unusual bleeding or unexplained bruising)

•    stuffy nose

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

•    low number of white blood cells in your blood

•    allergic reactions

•    changes in liver function (detected by tests)

•    problems keeping urine (incontinence in women)

Changes in blood sugar levels and a worsening of blood sugar control in patients with diabetes can occur.

You should report to your doctor if your symptoms or condition worsen, as the dose of your other medications or Carvedilol tablets may need to be changed.

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.

5| How to store Carvedilol tablets

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after "Exp". The expiry date refers to the last day of that month.Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waster. 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 contains

•    The active substance is carvedilol

•    Each 3.125mg tablet contains 3.125mg of the active ingredient carvedilol.

•    Each 6.25mg tablet contains 6.25mg of the active ingredient carvedilol.

•    Each 12.5mg tablet contains 12.5mg of the active ingredient carvedilol.

•    Each 25mg tablet contains 25mg of the active ingredient carvedilol.

•    The other ingredients are lactose monohydrate, microcrystalline cellulose (Avicel PH 102), low-substituted hydroxypropyl cellulose (E463), maize starch, yellow iron oxide (E172), colloidal anhydrous silica, purified talc, magnesium stearate (E572)

What Carvedilol tablets looks like and contents of the pack

Carvedilol 3.125 mg tablets are cream coloured, circular, biconvex tablets, marked 'C3' on one face and plain on the reverse face.

Carvedilol 6.25 mg tablets are cream coloured, circular, biconvex tablets, marked 'C6' on one face and plain on the reverse face.

Carvedilol 12.5 mg tablets are cream coloured, circular, biconvex tablets, marked 'C12' on one face and plain on the reverse face.

Carvedilol 25 mg tablets are cream coloured, circular, biconvex tablets, marked 'C25' on one face and plain on the reverse face.

Carvedilol 3.125 mg and 6.25 mg tablets are available in packs of 28 and 56 tablets.

Carvedilol 12.5 mg and 25 mg tablets are available in packs of 14, 28, 30, 56 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher,

Surrey, KT10 9NW, United Kingdom.

Manufacturer:

Cipla (EU) Limited, 20 Balderton Street, London, W1K 6TL, United Kingdom

Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium

Distributed by:

Actavis, Barnstaple, EX32 8NS, UK This leaflet was last revised in 07/2015.

Actavis

Barnstaple, EX32 8NS, UK