CARVEDILOL TEVA-RATIOPHARM 25 mg TABLETS

2. What you need to know before you take 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 or decompensated heart failureor certain types of conduction disorders(so-called AV block type II and III unless you have a pacemaker, or so-called sick sinus syndrome),
• if you have liver diseasethat causes problems,
• if you have a very slow heart rate (less than 50 beats per minute)or very low blood pressure,
• if you have severely impaired heart function(cardiogenic shock),
• if you have a severe disturbance in the body's acid-base balance(metabolic acidosis, acidemia),
• if you have asthmaor other respiratory diseaseswith a tendency to throat constriction caused by spasms (e.g. chronic obstructive pulmonary disease),
• if you have severe respiratory problems(acute pulmonary embolism),
• if you have a rare form of angina pectoris(Prinzmetal's angina),
• if you have heart failure as a result of a lung disease (cor pulmonale),
• if you have an overactive adrenal gland(phaeochromocytoma) and are not being treated with medication,
• if you are taking monoamine oxidase inhibitors (MAOIs)(e.g. moclobemide) (except MAO-B inhibitors),
• if you are receiving intravenous treatment with verapamil, diltiazemor other medicines used to treat heart rhythm disorders (antiarrhythmics),
• if you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Carvedilol Teva-ratiopharm

• if you have heart failureaccompanied by

• low blood pressure,
• impaired blood and oxygen supply to the heart(ischaemic heart disease) and hardening of the arteries(arteriosclerosis)
• and/or kidney problems,

Your kidney function should then be monitored. It may be necessary to reduce your dose.

• if you have had a heart attack. This should be treated before taking carvedilol,

• if you have a certain type of conduction disorder(so-called AV block type I),
• if you have high blood pressure due to organic causes,

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

• if you have severely impaired circulation in your 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 the heart valves or the outlet tract,
• terminal peripheral arteriopathy,
• labile or secondary hypertension,
• concomitant treatment with other blood pressure-lowering medicines (alpha-1 receptor antagonists or alpha-2 receptor agonists),
• if you have Raynaud's phenomenon(your fingers or toes turn blue, then white and then red along with pain). Carvedilol Teva-ratiopharm may worsen the symptoms,
• if you have an overactive thyroid gland, with increased production of thyroid hormone, Carvedilol Teva-ratiopharm may mask the symptoms,
• if you are going to have an operationwith an anaesthetic. You should discuss this with the doctor responsible for the anaesthesia well in advance,
• if you have a very slow heart rate (less than 55 beats per minute),
• if you have a severe allergic reaction(e.g. to an insect bite or food) or if you are undergoing or are going to undergo allergen desensitisation therapy because Carvedilol Teva-ratiopharm may weaken the effect of the medicines used to treat such allergic reactions,
• if you have psoriasis,
• severe skin reactions (e.g. toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome [SJS]),
• if you use contact lenses. Carvedilol may reduce tear production.

Children and adolescents

There is only limited data available 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 with greater care.

Other medicines and Carvedilol Teva-ratiopharm

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

It is especially importantthat your doctor knows if you are already being treated with:

• Digoxin or digitoxin(for the treatment of heart failure).
• Insulinor oral antidiabetics(medicines that lower blood sugar) as the reduction in blood sugar may be increased and the symptoms of hypoglycaemia may be masked.
• Rifampicin(an antibiotic used in the treatment of tuberculosis).
• Carbamazepine(a medicine used to treat epilepsy).
• Fluconazole(a medicine used to treat fungal infections).
• Paroxetine, fluoxetine, bupropion(medicines used to treat depression).
• Medicines that contain reserpine, guanethidine, methyldopa, guanfacine and monoamine oxidase inhibitors (MAOIs)(medicines used to treat depression and Parkinson's disease), as they may lead to a greater reduction in heart rate.
• Ciclosporin or tacrolimus(medicines that suppress the immune system, to prevent rejection reactions after organ transplantation, also used for certain rheumatic or dermatological problems).
• Medicines used to treat irregular heartbeat (e.g. verapamil, diltiazem, quinidine, amiodarone).
• Clonidine(a medicine used to lower blood pressure).
• Sympathomimetics(medicines that increase the function of the nerves of the sympathetic nervous system).
• Medicines used to treat respiratory problems (e.g. salbutamol, formoterol).
• Dihydropyridines(medicines used to treat high blood pressure and heart disease).
• Other medicines that lower blood pressure. Carvedilol may enhance the effect of other blood pressure-lowering medicines given concomitantly (e.g. alpha-1 receptor antagonists, nitrates) and medicines in which the reduction in blood pressure occurs as a side effect, e.g. barbiturates(in the treatment of epilepsy), phenothiazines(to treat psychosis), tricyclic antidepressants(to treat depression) vasodilator medicines (medicines that widen blood vessels).
• Neuromuscular blocking agents(medicines that reduce muscle tension).
• Ergotamine(a medicine for migraine).
• Anaesthetics(medicines used in anaesthesia).
• Certain pain-relieving tablets(NSAIDs), oestrogens(hormones) and corticosteroids(adrenal hormone), as they may sometimes lower blood pressure, reducing the effect of Carvedilol Teva-ratiopharm.
• Cinacalcet(a medicine used to treat problems with the parathyroid gland).

Carvedilol Teva-ratiopharm with food, drinks and alcohol

It is recommended to avoid taking carvedilol at the same time or near grapefruit or grapefruit juice during the initiation of treatment. Grapefruit and grapefruit juice may cause an increase in the amount of the active substance 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 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.

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 should not be used during breast-feeding.

Driving and using machines

Dizziness and fatigue may occur at the start of treatment after a dose increase, when changing treatment or in combination with alcohol. At the correct dose levels, it is not known whether carvedilol reduces the ability to drive or use machines. If you feel dizzy or weak when taking the tablets, you should avoid driving or work that requires great attention.

Carvedilol Teva-ratiopharm 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-ratiopharm

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask your doctor or pharmacist. If you feel that the effects of Carvedilol Teva-ratiopharm are too strong or too weak, talk to your doctor or pharmacist.

You should swallow the tablets with at least half a glass of water. You can 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 can 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 and 2 tablets of Carvedilol 12.5 mg tablets (corresponding to 25 mg of carvedilol) once daily thereafter. For this dosing, other strengths of carvedilol are available.

If necessary, the dose can 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 can be gradually increased at intervals of at least two weeks up to a 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 and 2 tablets of Carvedilol 12.5 mg tablets (corresponding to 25 mg of carvedilol) twice daily thereafter. For this dosing, other strengths of Carvedilol Teva-ratiopharm are available.

If necessary, the dose can 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 and 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 can be increased incrementally, usually at intervals of two weeks.

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

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

If you take more Carvedilol Teva-ratiopharm than you should

If you take more Carvedilol Teva-ratiopharm than you should, or if children have taken the medicine by accident, contact your doctor, hospital or call the emergency services for advice on the risk and the actions to be taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

Symptoms of overdose may include feeling faint due to excessively low blood pressure, slow heart rate, and in severe cases, pauses in heart rhythm. Difficulty breathing, narrowed airways, discomfort, decreased level of consciousness and convulsions may occur.

If you forget to take Carvedilol Teva-ratiopharm

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

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

If you stop taking Carvedilol Teva-ratiopharm

Do not stop your treatment suddenly or change the dose unless your doctor tells you to. Your treatment should be withdrawn gradually over a period of two weeks. Sudden interruption may worsen your symptoms.

If you have any further questions on 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 all people suffer from them.

Most adverse effects are related to the dose 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 difficulty breathing, sweating, and nausea (may affect up to 1 in 100 people).
• Severe 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 top layer of the skin from the lower layers of the 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,
• decrease in the number of red blood cells in the blood,

• weight gain,
• high cholesterol levels,
• loss of blood sugar control in people with diabetes,
• depression, depressive mood,
• visual disturbances,
• decreased tear production, eye irritation,
• low heart rate,
• edema (inflammation of the body or parts of the body), fluid overload, increased blood volume in the body,
• dizziness when standing up suddenly,
• 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 turn blue, then white, and then reddish along with pain) or claudication (pain in the legs that worsens when walking),
• asthma and respiratory problems,
• fluid accumulation in the lungs,
• diarrhea,
• discomfort, nausea, vomiting, stomach pain, indigestion,
• pains, (e.g., in arms and legs),

• acute kidney failure and disorders of renal function in patients with hardened arteries and/or altered renal function,
• difficulty urinating.

Uncommon (may affect up to 1 in 100 people)

• sleep disturbance,
• confusion, hallucinations,
• nightmares,

• abnormal sensation,
• disorders of the heart conduction system, angina pectoris (including chest pain),
• certain skin reactions (e.g., allergic dermatitis, urticaria, itching, and skin inflammation, increased sweating, psoriatic or lichen planus-like skin lesions),
• constipation,
• impotence.

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

• decrease in platelet count (thrombocytopenia),

• nasal congestion,
• dry mouth.

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

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

Frequency Not Known (cannot be estimated from the available data)

• hair loss.

The pharmacological class of beta-blocker receptor blockers may trigger hidden diabetes.

Sinoatrial arrest (lack of impulse from the sinus node, the "pacemaker" of the heart that controls heart contractions and regulates heart rate) in predisposed patients (e.g., elderly patients or patients with pre-existing bradycardia, sinoatrial 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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Carvedilol Teva-ratiopharm

Keep this medicine out of sight and reach of children.

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

PVC/PVdC/Aluminum Blisters

Store in the original packaging to protect it from light.

This medicine does not require special temperature storage conditions.

OPA/Aluminum/PVC/Aluminum Blisters

Store in the original packaging to protect it from light.

This medicine does not require special temperature storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Carvedilol Teva-ratiopharm 25 mg tablets

• The active ingredient 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 Package Contents

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

The tablets can be divided into equal doses.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

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 medicine is authorized in the Member States of the European Economic Area with 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 Last Revision of this Prospectus:April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). 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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