CARVEDILOL TEVA 6.25 mg TABLETS

2. What you need to know before you take Carvedilol Teva

Do not take Carvedilol Teva 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 first consulted your doctor or pharmacist
• you have heart problems (e.g. "heart block" or unstable heart failure), as Carvedilol is not suitable for some people with certain types of heart problems
• you have a heart with an unusually slow rhythm (<50 bpm) or very low blood pressure (systolic below 85 mmhg) which sometimes causes dizziness, fainting dizziness when standing up< li>
• you are taking verapamil or diltiazem by injection or as an infusion (with a drip).
• you have problems with acid levels in your body (metabolic acidosis)
• you have liver problems.

Warnings and precautions

Consult your doctor before starting to take this medicine if:

• you have diabetes, as it may mask the usual symptoms of low blood sugar.
• you have kidney problems
• you have Raynaud's syndrome or peripheral vascular disease which causes cold hands and feet
• you have thyroid problems
• you have previously suffered from severe allergic reactions or are undergoing desensitization therapy to prevent allergies, for example to bee or wasp stings
• you have psoriasis (thickened skin plaques)
• you wear contact lenses, as carvedilol may cause dry eyes
• you have had problems taking debrisoquine (used to treat high blood pressure).
• you have a phaeochromocytoma (a tumour of one of your adrenal glands) unless it is adequately controlled with medication
• you have a type of angina pectoris called Prinzmetal's angina
• severe bradycardia (<50 bpm)< li>

Using Carvedilol Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines without a prescription and herbal medicines. This is because carvedilol can affect the way some medicines work. Also, some medicines can affect the way carvedilol works.

Tell your doctor if you are taking any of the following medicines:

• other medicines used especially for the heart or for high blood pressure:
• • anti-arrhythmics, e.g. amiodarone
  • calcium channel blockers, e.g. amlodipine, diltiazem, verapamil, nifedipine.
  • digitalis, e.g. digoxin
  • nitrates, e.g. glyceryl trinitrate
  • guanethidine, reserpine, methyldopa
  • clonidine

• monoamine oxidase inhibitors (used to treat depression), e.g. moclobemide
• barbiturates, e.g. amylobarbitone (for insomnia)
• phenothiazines, e.g. prochlorperazine (to help stop nausea and vomiting)
• antidepressants, e.g. amitriptyline, fluoxetine (used to treat depression)
• cyclosporin (used to prevent organ rejection after a transplant)
• insulin or tablets for diabetes
• non-steroidal anti-inflammatory medicines (NSAIDs), e.g. ibuprofen (for pain, stiffness and painful inflammation of the bones, joints and muscles)
• corticosteroids (used to reduce inflammation), e.g. beclometasone
• hormone replacement therapy (used as contraceptives or hormone replacement therapy)
• rifampicin (used to treat tuberculosis)
• cimetidine (used to treat ulcers)
• ketoconazole (used to treat fungal infections)
• haloperidol (used in mental illness)
• erythromycin (an antibiotic used in 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 besylate
• vasodilators (these medicines open up blood vessels)
• guanfacine (used to treat high blood pressure)

If you have to be anaesthetized for surgery, tell your hospital doctor or dentist that you are taking Carvedilol tablets.

Carvedilol with food and drinks

Do not drink alcohol while taking Carvedilol.

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. You should not take this medicine unless your doctor has told you to.

Driving and using machines

Carvedilol may reduce your alertness and you may feel dizzy during treatment with carvedilol. This is more likely to happen when you first start treatment or if you change your treatment and when you drink alcohol. If you are affected, do not drive or operate machinery.

Carvedilol Teva contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Carvedilol Teva

Take Carvedilol Teva exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• The tablets should be taken preferably with a glass of water.
• Your doctor may monitor you at the start of treatment or if your dose is increased. This may affect your urine and blood tests.

The normal dose is:

Hypertension

• Adults:The usual starting dose is 12.5 mg once daily for the first two days, after which the recommended dose is 25 mg once daily. If necessary, your doctor may gradually increase the dose. The maximum single dose is 25 mg and the maximum daily dose is 50 mg.
• Elderly patients:The usual starting dose is 12.5 mg once daily. If necessary, your doctor may increase the dose.

Angina pectoris

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

Heart failure

The tablets should be taken with food to reduce the risk of a drop in blood pressure when standing up, which can cause dizziness, fainting or dizziness.

• Adults: The initial dose is 3.125 mg twice daily for 2 weeks. Your doctor may gradually increase the dose to 25 mg twice daily. The maximum dose is 25 mg twice daily for patients weighing less than 85 kg. Patients weighing more than 85 kg may take a maximum dose of 50 mg twice daily.

Liver or kidney problems

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

Elderly patients

Your doctor may monitor you if you are elderly.

Use in children and adolescents (under 18 years)

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

If you take more Carvedilol Teva than you should

If you (or someone else) swallow too many tablets or think a child has swallowed some, contact your doctor or go to the nearest hospital casualty department immediately. An overdose may cause a drop in blood pressure (leading to feeling weak and shaky), wheezing, vomiting, very slow heart rate, heart failure, breathing problems and loss of consciousness. You can also contact the National Poison Information Service on 020 7188 0200 for advice.

If you forget to take Carvedilol Teva

If you forget to take a dose, take another as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Carvedilol Teva

Do not stop treatment abruptly, as side effects may occur. If treatment needs to be stopped, your doctor will reduce your dose gradually.

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

4. 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 pectoris or high blood pressure than if you are being treated for heart failure.

Possible side effects in patients treated for heart failure:

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

• dizziness
• headache
• heart problems
• feeling tired or weak
• low blood pressure (feeling dizzy or lightheaded)
• slow heart rate, dizziness, weakness when standing up (due to low blood pressure)

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

• respiratory tract infections (bronchitis), lungs (pneumonia), nose and throat
• urinary tract infections
• anaemia
• weight gain
• increased cholesterol (fat) in the blood
• loss of control of blood sugar levels in people with diabetes
• feeling depressed
• vision problems, eye pain or dryness, eye irritation
• slow heart rate
• swelling of hands, ankles or feet
• circulation problems, fluid retention
• feeling faint or dizzy when standing up (due to low blood pressure)
• worsening of Raynaud's disease or circulation problems in patients who have these conditions
• breathing problems

• feeling sick, stomach upset, vomiting
• diarrhoea
• pain in hands or feet
• kidney problems, including changes in urination

Uncommon (may affect up to 1 in 100 people)

• sleeping problems
• feeling weak or faint
• tingling or numbness
• heart problems, chest pain
• skin problems (rash, itching, dry skin patches)
• hair loss
• impotence (difficulty getting or keeping an erection)

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

• low platelet count in the blood (causing unusual bleeding or bruising)
• stuffy nose

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

• low white blood cell count in the blood
• allergic reactions
• changes in liver function (detected by blood tests)
• problems controlling urination (incontinence in women)
• skin blistering (including Stevens-Johnson syndrome, a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals), or severe skin blistering (toxic epidermal necrolysis, a rare skin condition with severe blisters and peeling of large areas of skin, accompanied by fever and chills, muscle pain and general feeling of being unwell), or erythema multiforme: a serious skin condition that can affect the mouth and other parts of the body. It appears as red patches, often with itching, similar to measles, starting on the extremities and sometimes on the face and the rest of the body. The patches can turn into blisters or can progress to form red, pale, centred marks. Those affected may have fever, sore throat, headache and/or diarrhoea.

Changes in blood sugar levels and worsening of glucose control in patients with diabetes may occur.

You should tell your doctor if your symptoms get worse, as you may need to have your dose of other medicines or Carvedilol 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. Storing Carvedilol Teva

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

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.

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. Contents of the pack and other information

What Carvedilol Teva 6.25 mg Tablets contain

The active substance is Carvedilol.

Each 6.25 mg tablet contains 6.25 mg of the active substance Carvedilol.

The other ingredients are: lactose monohydrate, povidone, crospovidone, colloidal anhydrous silica and magnesium stearate. The tablets contain the following colourants:

• 6.25 mg tablets: yellow iron oxide (E172).

Appearance and packaging

Carvedilol tablets are round, flat, scored on one side and engraved on the other side with "CVL" on the top. Additionally:

6.25 mg tablets are light yellow in colour and have "T2" on the bottom.

They are available in packs of 14, 28, 30, 50, 56 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11. Edificio B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Teva Operatios Poland Sp. Z.o.o.,

Mogilska 80 Str, 31-546 Kraków

Poland

Or

Pharmachemie B.V.

Swensweg 5, PO Box 552, 2003 RN, Haarlem,

Netherlands

Or

Teva Pharmaceutical Works Private Limited Company

Pallagi Street 13 Debrecen

H-4042, Hungary

Or

TEVA PHARMACEUTICALS CR S.R.O

Sokolovska 651/136A.Business park Futurama (Prague)

18000 - Czech Republic

This medicine is authorised in the Member States of the EEA under the following names:

Germany: Carvedilol-Teva 6,25mg Tabletten

Belgium: Carvedilol Teva 6.25mg Tabletten

Denmark: Carvedilol Teva 6.25 mg Tabletter

Slovakia: Carvedilol-Teva 6.25 mg

Spain: Carvedilol Teva 6,25mg comprimidos EFG

Hungary: Carvol 6,25mg tabletta

Italy: Carvedilolo Ratiopharm compresse 6.25 mg

Portugal: Carvedilol Teva 6.25mg Comprimidos

Date of last revision of this leaflet:June 2014