Carvedilol Teva-Ratiopharm 25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Carvedilol Teva-ratiopharm 25 mg tablets EFG

carvedilol

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Carvedilol Teva-ratiopharm is and what it is used for
2. What you need to know before taking Carvedilol Teva-ratiopharm
3. How to take Carvedilol Teva-ratiopharm
4. Possible adverse effects
5. How to store Carvedilol Teva-ratiopharm
6. Contents of the pack and other information

1. What Carvedilol Teva-ratiopharm is and what it is used for

Carvedilol Teva-ratiopharm belongs to the group of alpha and beta-blocking medicines. Carvedilol is used in the treatment of high blood pressure and in the treatment of angina pectoris. Carvedilol is also used as a complementary treatment in heart failure.

2. What you need to know before taking Carvedilol Teva-ratiopharm

Do not take Carvedilol Teva-ratiopharm

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6),
• if you have unstable/decompensated heart failure or certain types of heart conduction disorders (so-called AV block type II or III unless you have a pacemaker, or the so-called sick sinus syndrome),
• if you have a liver disease causing problems,
• if you have a very slow pulse (less than 50 beats per minute) or very low blood pressure,
• if you have severely impaired cardiac function (cardiogenic shock),
• if you have a severe disturbance in the body's acid-base balance (metabolic acidosis, acidemia),
• if you have asthma or other respiratory diseases with a tendency to throat constriction due to spasms (e.g., chronic obstructive pulmonary disease),
• if you have severe respiratory problems (acute pulmonary embolism),
• if you have an unusual form of chest pain (Prinzmetal's angina),
• if you have heart failure due to a respiratory disease (cor pulmonale),
• if you have overactivity of the adrenal gland (pheochromocytoma) and are not being treated with medication,
• if you are taking MAO inhibitors (e.g., moclobemide) (except MAO-B inhibitors),
• if you are receiving intravenous treatment with verapamil, diltiazem, or another medicine used to treat heart rhythm disorders (antiarrhythmics),
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carvedilol Teva-ratiopharm

• if you have heart failure accompanied by

• low blood pressure,

• impaired blood and oxygen supply to the heart (ischaemic heart disease) and hardening of the arteries (atherosclerosis),

• and/or kidney problems,

Your kidney function should then be monitored. A dose reduction may be necessary.

• if you have had a heart attack. This must be treated before starting carvedilol,

• if you have a certain type of heart conduction disorder (called first-degree AV block),

• if you have hypertension due to organic causes,

• if you have diabetes. Treatment with Carvedilol Teva-ratiopharm may mask the signs of low blood sugar. Therefore, your blood sugar should be monitored regularly,

• if you have severely reduced circulation in the hands and feet,

• concomitant treatment with medicines used to treat heart failure (digitalis glycosides) or heart rhythm disorders (e.g., verapamil, diltiazem),

• low blood pressure (orthostatic hypotension),

• acute inflammatory heart disease,

• narrowing of heart valves or the outflow tract,

• terminal peripheral arterial disease,

• labile or secondary hypertension,

• concomitant treatment with other antihypertensive medicines (alpha-1 receptor antagonists or alpha-2 receptor agonists),

• if you have Raynaud's phenomenon (fingers or toes first turn blue, then white, then red, accompanied by pain). Carvedilol Teva-ratiopharm may worsen the symptoms,

• if you have overactive thyroid gland with increased production of thyroid hormone, Carvedilol Teva-ratiopharm may mask the symptoms,

• if you are taking Carvedilol Teva-ratiopharm and are scheduled for surgery with anaesthesia. You must discuss this with the anaesthetist well in advance,

• if you have a very slow pulse (less than 55 beats per minute),

• if you have a severe allergic reaction (e.g., to an insect sting or food) or if you are undergoing or are about to undergo allergen desensitisation therapy. Carvedilol may increase your sensitivity to allergens and the risk of severe anaphylactic reactions. In addition, while taking Carvedilol, the medicines used to treat allergic (anaphylactic) reactions, such as adrenaline (epinephrine), may be less effective.

• if you have psoriasis,

• severe skin reactions (e.g., toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome [SJS]),

• if you wear contact lenses. Carvedilol may reduce tear production.

Children and adolescents

There is insufficient data on the efficacy and safety of carvedilol in children and adolescents under 18 years of age. Therefore, carvedilol should not be used in this patient group.

Elderly patients

Elderly patients may be more sensitive to carvedilol and should be monitored more closely.

Other medicines and Carvedilol Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Other treatments may affect or be affected by carvedilol.

It is especially important that your doctor knows if you are already taking:

• Digoxin or digitoxin (to treat heart failure).
• Insulin or oral antidiabetic medicines (medicines that lower blood sugar), as the blood sugar-lowering effect may be enhanced and symptoms of hypoglycaemia may be masked.
• Rifampicin (an antibiotic used to treat tuberculosis).
• Carbamazepine (a medicine to treat epilepsy).
• Fluconazole (a medicine to treat fungal infections).
• Paroxetine, fluoxetine, bupropion (medicines to treat depression).
• Medicines containing reserpine, guanethidine, methyldopa, guanfacine, or monoamine oxidase inhibitors (MAOIs) (medicines to treat depression and Parkinson's disease), as they may cause a greater reduction in heart rate.
• Cyclosporine or tacrolimus (medicines to suppress the immune system, to prevent organ transplant rejection, also used for, e.g., certain rheumatological or dermatological conditions).
• Medicines to treat irregular heartbeat (e.g., verapamil, diltiazem, quinidine, amiodarone).
• Clonidine (a medicine to lower blood pressure).
• Sympathomimetics (medicines that increase the activity of the sympathetic nervous system).
• Medicines used to treat respiratory problems (e.g., salbutamol, formoterol).
• Dihydropyridines (medicines to treat high blood pressure and heart conditions).
• Other medicines that lower blood pressure. Carvedilol may enhance the effect of other antihypertensive medicines taken concomitantly (e.g., alpha-1 receptor antagonists, nitrates) and medicines in which blood pressure reduction occurs as an adverse effect, e.g., barbiturates (used in epilepsy treatment), phenothiazines (to treat psychosis), tricyclic antidepressants (to treat depression), vasodilators (medicines to widen blood vessels).
• Neuromuscular blocking agents (drugs that reduce muscle tension).
• Ergotamine (a medicine for migraine).
• Anaesthetics (medicines used in anaesthesia).
• Certain painkillers (NSAIDs), estrogens (hormones), and corticosteroids (adrenal hormones), as they may occasionally reduce blood pressure, thereby reducing the effect of Carvedilol Teva-ratiopharm.
• Cinacalcet (a medicine used to treat parathyroid gland problems).

Carvedilol Teva-ratiopharm with food, drinks, and alcohol

You should avoid taking carvedilol at the same time or close to grapefruit or grapefruit juice during initiation of treatment. Grapefruit and grapefruit juice may cause an increase in the amount of the active ingredient carvedilol in the blood and possibly unpredictable side effects. During treatment with carvedilol, alcohol consumption should be limited, as alcohol may affect how carvedilol works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

There is a risk of harm to the fetus. Carvedilol Teva-ratiopharm should only be used during pregnancy if your doctor considers it necessary. Therefore, always consult your doctor before using Carvedilol Teva-ratiopharm during pregnancy.

It is not known whether Carvedilol Teva-ratiopharm passes into human breast milk and therefore it should not be used during breastfeeding.

Driving and using machines

Dizziness and fatigue may occur at the beginning of treatment, after dose increases, when changing treatment, or in combination with alcohol. At correct dose levels, it is not known whether carvedilol impairs the ability to drive or use machines. If you feel dizzy or weak while taking the tablets, you should avoid driving or tasks requiring high concentration.

Carvedilol Teva-ratiopharm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Carvedilol Teva-ratiopharm

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist. If you feel that the effects of Carvedilol Teva-ratiopharm are too strong or too weak, speak to your doctor or pharmacist.

You should swallow the tablets with at least half a glass of water. You may take the tablets with or without food. However, patients with heart failure should take the tablets with food to reduce the risk of dizziness when standing up suddenly.

The tablets may be divided into equal doses.

Carvedilol Teva-ratiopharm tablets are available in the following strengths: 6.25 mg and 25 mg.

High blood pressure

Adults

The usual dose is 1 tablet of Carvedilol 12.5 mg tablets (corresponding to 12.5 mg of carvedilol) for the first two days, followed by 2 tablets of Carvedilol 12.5 mg tablets (corresponding to 25 mg of carvedilol) once daily thereafter. Other carvedilol strengths are available for this dosing regimen.

If necessary, the dose may be gradually increased at intervals of at least two weeks. The maximum recommended daily dose is 50 mg.

Elderly patients

The recommended dose is 1 tablet of Carvedilol 12.5 mg tablets (corresponding to 12.5 mg of carvedilol) once daily.

If necessary, the dose may be gradually increased at intervals of at least two weeks up to the maximum daily dose of 50 mg.

Angina pectoris

Adults

The usual dose is 1 tablet of Carvedilol 12.5 mg tablets (corresponding to 12.5 mg of carvedilol) twice daily for two days, followed by 2 tablets of Carvedilol 12.5 mg tablets (corresponding to 25 mg of carvedilol) twice daily thereafter. Other strengths of Carvedilol Teva-ratiopharm are available for this dosing regimen.

If necessary, the dose may be gradually increased at intervals of at least two weeks. The maximum recommended daily dose is 100 mg.

Elderly patients

The usual dose is 1 tablet of Carvedilol 12.5 mg tablets (corresponding to 12.5 mg of carvedilol) twice daily for two days, followed by 2 tablets of Carvedilol 12.5 mg tablets (corresponding to 25 mg of carvedilol) twice daily thereafter. The maximum recommended daily dose is 50 mg.

Heart failure

The usual initial dose is 3.125 mg of carvedilol twice daily for two weeks. The dose may be increased incrementally, usually at two-week intervals.

However, it may be necessary to increase or reduce the dose. Your doctor will advise you accordingly.

The maximum recommended dose is 25 mg twice daily in patients weighing less than 85 kg, and 50 mg twice daily in patients weighing more than 85 kg, provided that heart failure is not severe. Dose increases up to 50 mg twice daily should be carried out carefully with close medical supervision.

If you take more Carvedilol Teva-ratiopharm than you should

If you take more Carvedilol Teva-ratiopharm than prescribed, or if children have accidentally taken the medicine, contact your doctor, go to the hospital, or call emergency services to obtain advice on the risk and what action should be taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include feeling faint due to excessively low blood pressure, slow heart rate, and in severe cases, pauses in heartbeat. Breathing difficulties, narrowed airways, discomfort, decreased level of consciousness, and seizures may also occur.

If you forget to take Carvedilol Teva-ratiopharm

If you miss a dose (or more doses), take the next dose at the usual scheduled time.

Do not take a double dose to make up for missed doses.

If you stop taking Carvedilol Teva-ratiopharm

Do not stop your treatment suddenly or change the dose unless instructed by your doctor. Your treatment should be gradually withdrawn over a period of two weeks. Stopping treatment suddenly may worsen your symptoms.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Most adverse effects are dose-related and disappear when the dose is reduced or treatment is discontinued. Some adverse effects may occur at the beginning of treatment and resolve spontaneously as treatment continues.

Contact your doctor immediately if you experience any of the following adverse effects:

• Chest pain with simultaneous shortness of breath, sweating, and nausea (may affect up to 1 in 100 people).
• Serious skin reactions, such as skin rash, redness, blisters on the lips, around the eyes or in the mouth, scaly skin (symptoms of erythema multiforme), sores in the mouth, lips and skin (signs of Stevens-Johnson syndrome), peeling of the upper layer of skin from the lower layers of skin all over the body (signs of toxic epidermal necrolysis) (very rare frequency).

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

• dizziness,
• headache,
• heart failure,
• low blood pressure,
• weakness.

Common (may affect up to 1 in 10 people)

• bronchitis, pneumonia, upper respiratory tract infection,

• urinary tract infections,

• decreased number of red blood cells in blood,

• weight gain,

• elevated cholesterol levels,

• loss of blood sugar control in people with diabetes,

• depression, depressed mood,

• visual disturbances,

• decreased tear production, eye irritation,

• low heart rate,

• edema (swelling of the body or parts of the body), fluid overload, increased blood volume in the body,

• dizziness upon sudden standing,

• fainting,

• problems with blood circulation (signs include cold hands and feet), hardening of the arteries (atherosclerosis), worsening of symptoms in patients with Raynaud's disease (fingers and toes first turn blue, then white, then red, accompanied by pain), or claudication (leg pain that worsens with walking),

• asthma and breathing problems,

• fluid accumulation in the lungs,

• diarrhea,

• discomfort, nausea, vomiting, stomach pain, indigestion,

• pain (e.g. in arms and legs),

• acute kidney failure and kidney function disorders in patients with hardening of the arteries and/or impaired kidney function,

• difficulty urinating.

Uncommon (may affect up to 1 in 100 people)

• sleep disturbances,

• confusion, hallucinations,

• nightmares,

• abnormal sensation,

• disturbances in the heart's conduction system, angina (including chest pain),

• certain skin reactions (e.g. allergic dermatitis, urticaria, itching and skin inflammation, increased sweating, psoriasiform or lichen planus-like skin lesions),

• constipation,

• impotence.

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

• decreased platelet count (thrombocytopenia),

• nasal congestion,

• dry mouth.

Very rare (may affect up to 1 in 10,000 people, including isolated cases)

• decreased number of white blood cells in blood,
• psychosis,
• allergic reactions,
• abnormal liver function test,
• involuntary loss of urine in women (urinary incontinence).

Frequency not known (cannot be estimated from available data)

• hair loss.

The pharmacological class of beta-receptor blockers may unmask latent diabetes.

Sinoatrial block (lack of impulse from the sinus node, the heart's "pacemaker" that controls heart contractions and regulates heart rhythm) in predisposed patients (e.g. elderly patients or patients with pre-existing bradycardia, sinoatrial node dysfunction or AV block).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carvedilol Teva-ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation CAD. The expiry date refers to the last day of that month.

PVC/PVdC/Aluminum blisters

Store in the original packaging to protect from light.

This medicine does not require any special storage conditions regarding temperature.

OPA/Aluminum/PVC/Aluminum blisters

Store in the original packaging to protect from light.

This medicine does not require any special storage conditions regarding temperature.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Carvedilol Teva-ratiopharm 25 mg tablets

• The active substance is: Carvedilol

Each tablet contains 25 mg of carvedilol.

• The other components are:

• microcrystalline cellulose

• lactose monohydrate

• crospovidone

• povidone

• colloidal anhydrous silica

• magnesium stearate

Appearance of the product and contents of the container

Tablets, white, biconvex, capsule-shaped, engraved with “C” with a score line and “4” on one side and smooth on the other.

The tablets may be divided into equal doses.

Pack sizes: 10, 14, 28, 30, 50, 56, 60, 98, 100 and 105 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig Merckle Strasse 3

89143 Blaubeuren

Germany

Or

Teva Operations Poland Sp. z o.o.

Mogilska 80 Str.

31-546 Krakow

Poland

Or

Teva Pharmaceutical Works Private Limited

Pallagi út 13

Debrecen H-4042

Hungary

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany, Austria: Carvedilol-ratiopharm 25 mg Tabletten

Finland, Sweden: Carveratio

Spain: Carvedilol Teva-ratiopharm 25 mg tablets EFG

Poland, Portugal: Carvedilol-ratiopharm

Date of the most recent review of this leaflet: December 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70697/P_70697.html

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