Package Insert: Information for the User

Carvedilol Teva 25 mg TabletsEFG

Carvedilol belongs to a group of medicines known as beta blockers. Beta blockers cause blood vessels to relax and widen and slow down heart rate, resulting in a slower heart beat and lower blood pressure.

Carvedilol is used for:

• Treating chest pain.
• Controlling high blood pressure.
• Carvedilol may also be used in combination with other therapies to treat heart failure.

Do not take Carvedilol Teva if

• you are allergic (hypersensitive) to carvedilol or any of the other components of this medication (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 heart problems (for example, "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)
• you are taking verapamil or diltiazem by injection or as an infusion (with a drip)
• you have problems with the levels of acids in your body (metabolic acidosis)
• you have liver problems

Warnings and precautions

Consult your doctor before starting to take this medication 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 that causes cold hands and feet
• you have thyroid problems
• you have previously had severe allergic reactions or are undergoing desensitization therapy to prevent allergies, for example, to bee or wasp stings
• you have psoriasis (thickened skin patches)
• you wear contact lenses, as carvedilol may cause dry eyes
• you have had problems taking debrisoquine (used to treat high blood pressure)
• you have phaeochromocytoma (a tumor of one of the adrenal glands) unless it is adequately controlled by medication

• you have a type of chest pain called Prinzmetal's angina
• severe bradycardia (<50)

Use of Carvedilol Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications and herbal remedies. This is because carvedilol may affect the functioning of some medications. Also, some medications may affect the functioning of carvedilol.

Inform your doctor if you are taking any of the following medications:

• other medications used particularly for the heart or for high blood pressure:
• • antiarrhythmics, for example amiodarone
  • calcium channel blockers, for example amlodipine, diltiazem, verapamil, nifedipine
  • digitalis, for example digoxin
  • nitrates, for example glyceryl trinitrate
  • guanetidine, reserpine, methyldopa
  • clonidine

• monoamine oxidase inhibitors (used to treat depression), for example moclobemide
• barbiturates, for example amobarbital (to treat insomnia)
• phenothiazines, for example prochlorperazine (to help stop nausea and vomiting)
• antidepressants, for example amitriptyline, fluoxetine (used to treat depression)
• ciclosporin (used to prevent rejection after an organ transplant)
• insulin or tablets to treat diabetes
• non-steroidal anti-inflammatory drugs (NSAIDs), for example ibuprofen (used to treat pain, stiffness, and inflammatory joint and muscle disorders)
• corticosteroids (used to reduce inflammation), for example 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 to treat bacterial infections)

• sympathomimetics (used for the nervous system), for example ephedrine or beta-agonist bronchodilators

• ergotamine (used to treat migraine)
• neuromuscular blocking agents (muscle relaxants used in anesthesia), for example atracurium besylate
• vasodilators (these medications open blood vessels)
• guanfacine (used to treat high blood pressure)

If you need to be anesthetized for surgery, inform the hospital doctor or dentist that you are taking Carvedilol tablets.

Carvedilol with food and drinks

Do not drink alcohol while taking Carvedilol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Do not take this medication unless your doctor has told you to.

Driving and operating machines

Carvedilol may reduce your alertness and may cause dizziness during treatment with carvedilol. This is more likely to occur at the start of treatment or if you change your treatment and when you drink alcohol. If you are affected, do not drive or operate machines.

Carvedilol Teva contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for Carvedilol Teva as indicated by your doctor. In case of doubt, consult your doctor or pharmacist if you have any questions.

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

The normal dose is:

Hypertension

• Adults:The initial normal dose is 12.5 mg once a day for the first two days, after that, the recommended dose is 25 mg once a day. If necessary, your doctor may increase the dose gradually. The maximum dose taken at one time is 25 mg and the maximum daily dose is 50 mg.
• Older adults:The initial normal dose is 12.5 mg once a day. If necessary, your doctor may increase the dose.

Angina pectoris

• Adults:The initial normal dose is 12.5 mg twice a day for two days, after that, the recommended dose is 25 mg twice a day. If necessary, your doctor may increase the dose gradually. The maximum daily dose is 50 mg twice a day.
• Older adults:The initial normal dose is 12.5 mg twice a day for two days, after that, the recommended dose is 25 mg twice a day, 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, which may cause dizziness, fainting, or drowsiness.

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

Liver or kidney problems

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

Older adults

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) have taken too many tablets or think a child has taken some tablets, contact your doctor immediately or go to the nearest hospital emergency department. A overdose may cause a drop in blood pressure (causing weakness and trembling), wheezing, vomiting, very slow heart rate, heart failure, respiratory problems, and loss of consciousness. You can also contact the Toxicology Information Service; Phone 91 562 04 20.

If you forget to take Carvedilol Teva

If you forget to take a dose, take another one as soon as you remember, as long as it is not almost time for your next dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Carvedilol Teva

Do not stop treatment abruptly, as this may cause adverse effects. If you need to stop, your doctor will gradually reduce your dose.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects are less likely if you are being treated for angina 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 faint)
• slow heart rate, dizziness, weakness when standing (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
• anemia
• weight gain
• increased cholesterol (fat) in the blood
• loss of control of blood sugar 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 (due to low blood pressure)
• worsening of coldness in extremities in patients with Raynaud's disease or circulation problems
• breathing problems

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

Uncommon (may affect up to 1 in 100 people)

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

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

• decrease in the number of platelets 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
• allergic reactions
• changes in liver function (detected by tests)
• difficulty controlling urine (incontinence in women)
• formation of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome: a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals) or severe blisters and peeling of large areas of the skin (toxic epidermal necrolysis: a severe skin reaction that starts with painful red areas, followed by large blisters, and ends with peeling of the skin layers. This is accompanied by fever and chills, muscle pain, and general discomfort), or Multiform Erythema: a severe skin disease that can affect the mouth and other parts of the body. It appears as red patches, often with itching, similar to measles rash, that starts on the extremities and sometimes on the face and the rest of the body. The patches may turn into blisters or progress to form pale, centered marks. Affected individuals may have fever, sore throat, headache, and/or diarrhea.

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

You should inform your doctor if your symptoms worsen, as you may need to change the dose of other medications or Carvedilol.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated. An expiration date abbreviation (for example, CAD) may appear on the blister pack and the box.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Carvedilol Teva 25 mg tablets

The active ingredient is Carvedilol.

Each 25 mg tablet contains 25 mg of the active ingredient Carvedilol.

The other components (excipients) are: lactose monohydrate, povidone, crospovidone, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

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

25 mg tablets are white or almost white and have “T4” on the bottom.

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11. Edificio B, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer

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

Mogilska 80 Str, 31-546 Kraków

Poland

Ó

Pharmachemie B.V.

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

Netherlands

Ó

Teva Pharmaceutical Works Private Limited Company

Pallagi Street 13 Debrecen

H-4042, Hungary

Ó

TEVA PHARMACEUTICALS CR S.R.O

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

18000 - Czech Republic

This medicine is authorized in the EEA member states with the following names:

Germany: Carvedilol-Teva 25mg Tabletten

Belgium: Carvedilol Teva 25 mg tabletten

Denmark: Carvedilol Teva 25 mg Tabletter

Slovakia: Carvedilol-Teva 25mg

Spain: Carvedilol Teva 25mg comprimidos EFG

Hungary: Carvol 25mg tabletta

Italy: Carvedilolo Ratiopharm compresse 25 mg

Portugal: Carvedilol Teva 25mg Comprimidos

Last review date of this leaflet:June 2014