Carvedilol-ratiopharm

Leaflet attached to the packaging: information for the user

Carvedilol-ratiopharm, 6.25 mg, tablets

Carvedilol-ratiopharm, 12.5 mg, tablets

Carvedilol-ratiopharm, 25 mg, tablets

Carvedilol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Carvedilol-ratiopharm and what is it used for
• 2. Important information before taking Carvedilol-ratiopharm
• 3. How to take Carvedilol-ratiopharm
• 4. Possible side effects
• 5. How to store Carvedilol-ratiopharm
• 6. Package contents and other information

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

Carvedilol-ratiopharm belongs to a group of medicines called alpha- and beta-adrenergic blockers.
Carvedilol-ratiopharm is used to treat high blood pressure (hypertension) and angina pectoris. Carvedilol-ratiopharm is also used as an adjunct in the treatment of heart failure.

2. Important information before taking Carvedilol-ratiopharm

When not to take Carvedilol-ratiopharm

if the patient is allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6),
if the patient has untreated or uncontrolled heart failure or a certain type of conduction disorder in the heart (so-called atrioventricular block of second or third degree in patients without a pacemaker or so-called sick sinus syndrome),
if the patient has clinically significant liver dysfunction,
if the patient has a very slow heart rate (below 50 beats per minute)
or very low blood pressure,
if the patient has severe heart disorders (cardiogenic shock),
if the patient has severe acid-base balance disorders (metabolic acidosis),
in patients with asthma or other respiratory diseases with a tendency to bronchospasm (e.g. chronic obstructive pulmonary disease),
if the patient has severe respiratory disorders (acute pulmonary embolism),
if the patient has atypical angina pectoris (Prinzmetal's angina),
if the patient has heart failure due to respiratory disease (cor pulmonale),
if the patient has untreated pheochromocytoma (a tumor of the adrenal gland),
if the patient is taking MAO inhibitors (e.g. moclobemide) (except for MAO-B inhibitors),
if the patient is receiving intravenous verapamil, diltiazem, or other antiarrhythmic drugs,
if the patient is breastfeeding.

Warnings and precautions

Before starting to take Carvedilol-ratiopharm, the patient should discuss it with their doctor or pharmacist.
If the patient has heart failure with accompanying low blood pressure,
reduced blood supply to the heart and oxygen (ischemic heart disease) and hardening of the arteries (atherosclerosis)
and (or) kidney function disorder. In such a case, the doctor will monitor kidney function. It may be necessary to reduce the dose of the medicine. In the case of patients after a heart attack. The disease must be properly treated before starting to take Carvedilol-ratiopharm. In the case of a certain type of conduction disorder in the heart (so-called first-degree atrioventricular block). If the patient has secondary hypertension. If the patient has diabetes. Treatment with Carvedilol-ratiopharm may mask the symptoms of low blood sugar. Therefore, blood sugar levels should be regularly monitored. In the case of severe peripheral circulation disorders in the hands and feet. Concomitant treatment with medicines used to treat heart failure (digitalis glycosides) or arrhythmias (e.g. verapamil, diltiazem) Low blood pressure (orthostatic hypotension) Acute inflammatory heart disease Narrowing of the heart valves or outflow tracts End-stage peripheral arterial disease Uncontrolled or secondary hypertension Concomitant treatment with certain other blood pressure-lowering medicines (alpha1 receptor antagonists or alpha2 receptor agonists) If the patient has Raynaud's phenomenon (fingers or toes turn blue, then pale, and then red, accompanied by pain). Carvedilol-ratiopharm may worsen these symptoms. If the patient has hyperthyroidism with increased thyroid hormone secretion; Carvedilol-ratiopharm may mask the symptoms. If the patient is taking Carvedilol-ratiopharm and is to undergo surgery under general anesthesia. In such a case, the anesthesiologist should be informed about the use of Carvedilol-ratiopharm. If the patient has a very slow heart rate (below 55 beats per minute). If the patient has ever had severe allergic reactions (e.g. after an insect bite or after eating food) or if the patient is undergoing (or planned) desensitization treatment, Carvedilol-ratiopharm may weaken the effect of drugs administered in case of an allergic reaction. In the case of psoriasis. Severe skin reactions (e.g. toxic epidermal necrolysis, TEN, or Stevens-Johnson syndrome, SJS).

If the patient wears contact lenses. Carvedilol-ratiopharm may reduce tear secretion.

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-ratiopharm should not be used in this patient group.

Elderly

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

Carvedilol-ratiopharm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Other medicines taken at the same time may affect the action of Carvedilol-ratiopharm, and Carvedilol-ratiopharm may affect the action of other medicines.
It is especially important to inform the doctor about taking the following medicines:
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Digoxinor digitoxin(used to treat heart failure).
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Insulinor oral antidiabetic medicines(medicines that lower blood sugar levels),
because their antidiabetic effect may be enhanced, and the symptoms of low blood sugar may be masked.
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Rifampicin(an antibiotic used to treat tuberculosis).
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Carbamazepine(a medicine used to treat epilepsy).
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Fluconazole(an antifungal medicine).
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Paroxetine, fluoxetine, bupropion(medicines used to treat depression).
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Medicines containing reserpine, guanethidine, methyldopa, guanfacineand monoamine oxidase inhibitors(MAOIs) (used to treat depression and Parkinson's disease), as they may further slow down the heart rate.
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Cyclosporine or tacrolimus(a medicine used to weaken the immune response to prevent organ rejection, as well as to treat certain rheumatic or dermatological disorders).
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Medicines used to treat arrhythmias (e.g. verapamil, diltiazem, quinidine,
amiodarone).
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Clonidine(a medicine used to treat hypertension).
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Sympathomimetics(medicines that stimulate the sympathetic nervous system).
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Medicines used to treat respiratory disorders, such as salbutamol, formoterol.
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Dihydropyridine derivatives(medicines used to treat high blood pressure and heart diseases)
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Other blood pressure-lowering medicines. Carvedilol-ratiopharm may enhance the effect of other blood pressure-lowering medicines (e.g. alpha1-adrenergic receptor antagonists, nitrates) and medicines for which blood pressure lowering is an undesirable effect, e.g. barbiturates(medicines used to treat epilepsy), phenothiazines(medicines used to treat psychoses), tricyclic antidepressants(medicines used to treat depression), vasodilators
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Muscle relaxants(medicines that reduce muscle tension)
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Ergotamine(a medicine used to treat migraine)
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Anesthetics(medicines used for anesthesia)
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Certain painkillers(NSAIDs - nonsteroidal anti-inflammatory drugs), estrogens(hormones) and corticosteroids(adrenal hormones), as they may in some cases weaken the blood pressure-lowering effect of Carvedilol-ratiopharm.
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Cinacalcet(a medicine used to treat parathyroid gland disorders).

Carvedilol-ratiopharm with food, drink, and alcohol

The patient should avoid drinking grapefruit juice while taking Carvedilol-ratiopharm or immediately after taking the medicine. Grapefruit or its juice may increase the level of the active substance carvedilol in the blood and cause unexpected side effects. The patient should limit alcohol consumption while taking Carvedilol-ratiopharm, as alcohol may affect the action of Carvedilol-ratiopharm.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
During treatment with Carvedilol-ratiopharm, there is a risk of fetal harm. Carvedilol-ratiopharm may only be used during pregnancy if the doctor considers it necessary. Therefore, the patient should always consult their doctor before taking Carvedilol-ratiopharm during pregnancy.
It is not known whether Carvedilol-ratiopharm passes into 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 increasing the dose, after changing the medicine, or during concurrent alcohol consumption. It is not known whether carvedilol at therapeutic doses impairs the ability to drive or operate machinery. If dizziness or weakness occurs while taking the medicine, the patient should avoid driving or performing tasks that require increased attention.

Carvedilol-ratiopharm contains lactose.

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Carvedilol-ratiopharm

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. If the patient feels that the effect of Carvedilol-ratiopharm is too strong or too weak, they should consult their doctor.
The tablets should be swallowed, washed down with at least half a glass of water. Carvedilol-ratiopharm can be taken with or without food. However, patients with heart failure should take the tablets with food to reduce the risk of dizziness that may occur when standing up quickly.
The tablets can be divided into equal doses.
Carvedilol-ratiopharm tablets are available in the following strengths:
6.25 mg, 12.5 mg, and 25 mg.

Hypertension

Adults
The usual dose is 1 tablet of Carvedilol-ratiopharm 12.5 mg (equivalent to 12.5 mg of carvedilol) once a day for the first two days, and then 2 tablets of Carvedilol-ratiopharm 12.5 mg (equivalent to 25 mg of carvedilol) once a day.
To achieve the recommended dose, Carvedilol-ratiopharm tablets of other strengths are available.
If necessary, the doctor may recommend further gradual dose increases, at intervals of at least two weeks. The maximum recommended daily dose is 50 mg.
Elderly
The recommended dose is 1 tablet of Carvedilol-ratiopharm 12.5 mg (equivalent to 12.5 mg of carvedilol) once a day.
If necessary, the doctor may recommend further gradual dose increases, 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-ratiopharm 12.5 mg (equivalent to 12.5 mg of carvedilol) twice a day for two days, and then 2 tablets of Carvedilol-ratiopharm 12.5 mg (equivalent to 25 mg of carvedilol) twice a day.
To achieve the recommended dose, Carvedilol-ratiopharm tablets of other strengths are available.
If necessary, the doctor may recommend further gradual dose increases, at intervals of at least two weeks. The maximum recommended daily dose is 100 mg.
Elderly
The usual dose is 1 tablet of Carvedilol-ratiopharm 12.5 mg (equivalent to 12.5 mg of carvedilol) twice a day for two days, and then 2 tablets of Carvedilol-ratiopharm 12.5 mg (equivalent to 25 mg of carvedilol) twice a day.
The recommended maximum daily dose is 50 mg.

Heart failure

The usual initial dose is 3.125 mg of carvedilol twice a day for two weeks. The doctor may recommend gradual dose increases, usually every two weeks.
The doctor may recommend both increases and decreases in the dose, and will inform the patient about this in detail.
The recommended maximum daily dose is 25 mg twice a day in patients with a body weight below 85 kg and 50 mg twice a day in patients with a body weight above 85 kg, provided that heart failure is not severe. Increasing the dose to 50 mg twice a day will be done under close medical supervision.

Taking a higher dose of Carvedilol-ratiopharm than recommended

In case of taking a higher dose of Carvedilol-ratiopharm than recommended or accidental ingestion of any amount of the medicine by a child, the patient should immediately contact their doctor, go to the nearest hospital, or call the emergency services to get appropriate help.
Symptoms of overdose may include: feeling of fainting due to excessive lowering of blood pressure, slow heart rate, and in severe cases, cardiac arrest. Breathing disorders, bronchospasm, malaise, impaired consciousness, and seizures may occur.

Missing a dose of Carvedilol-ratiopharm

In case of missing a dose (or doses) of the medicine, the patient should take the next dose at the usual time. The patient should not take a double dose (or larger) to make up for the missed dose(s).

Stopping treatment with Carvedilol-ratiopharm

The patient should not suddenly stop treatment or change the dose without consulting their doctor. The medicine should be discontinued gradually over a period of two weeks. Abrupt discontinuation of the medicine may worsen the symptoms.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Carvedilol-ratiopharm can cause side effects, although not everybody gets them.
Most side effects are dose-dependent and disappear after dose reduction or discontinuation of treatment. Some side effects occur at the beginning of treatment and disappear spontaneously during continued treatment.
The patient should immediately contact their doctor if they experience any of the following side effects:

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

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

• Dizziness
• Headache
• Heart failure
• Low blood pressure
• Weakness

Common (may occur in up to 1 in 10 people)

• Bronchitis, pneumonia, upper respiratory tract infection
• Urinary tract infection
• Decreased red blood cell count
• Weight gain
• Increased cholesterol levels
• Worsening of blood sugar control in patients with diabetes
• Depression, low mood
• Visual disturbances
• Decreased tear secretion, eye irritation
• Slow heart rate
• Edema (swelling of the whole body or part of the body), fluid retention, increased blood volume in the body
• Dizziness when standing up quickly
• Fainting
• Circulatory disorders (which may manifest as cold hands and feet), hardening of the arteries (atherosclerosis), worsening of symptoms in patients with Raynaud's phenomenon (initially blue discoloration of the fingers or toes, then pale, and then red, accompanied by pain) or intermittent claudication (leg pain that worsens when walking)
• Asthma and breathing disorders
• Fluid accumulation in the lungs
• Diarrhea
• Malaise, nausea, vomiting, abdominal pain, indigestion
• Pain (e.g. in the hands and feet)
• Acute kidney failure and kidney function disorders in patients with atherosclerosis and (or) kidney function disorders
• Urination disorders

Uncommon (may occur in up to 1 in 100 people)

• Sleep disorders
• Confusion, hallucinations
• Nightmares
• Impaired sensation
• Conduction disorders in the heart, angina pectoris (associated with chest pain),
• Certain skin reactions (e.g. allergic dermatitis, urticaria, itching, and skin inflammation, increased sweating, skin changes resembling psoriasis or lichen planus)
• Constipation
• Impotence

Rare (may occur in up to 1 in 1000 people)

• Decreased platelet count (thrombocytopenia)
• Nasal congestion
• Dryness of the mucous membrane of the mouth

Very rare (may occur in up to 1 in 10,000 people, including single cases)

• Low white blood cell count
• Psychosis
• Allergic reactions
• Changes in liver function test results
• Uncontrolled urination in women (urinary incontinence)

Frequency not known (frequency cannot be estimated from the available data)

• Hair loss

Beta-adrenergic blockers may cause latent diabetes.
Atrioventricular block (lack of impulse from the sinoatrial node, the "pacemaker" of the heart, which controls heart contractions and regulates heart rhythm) in predisposed patients (e.g. elderly patients or patients with pre-existing bradycardia, sinoatrial node dysfunction, or atrioventricular block).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Carvedilol-ratiopharm

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging – after the Expiry Date (EXP). The expiry date refers to the last day of the month.
Blisters (PVC/PVDC/Aluminum)
Carvedilol-ratiopharm 6.25 mg:
The patient should not store the medicine at a temperature above 30°C.
The patient should store the medicine in its original packaging to protect it from light.
Carvedilol-ratiopharm 12.5 mg and 25 mg:
The patient should store the medicine in its original packaging to protect it from light.
There are no special recommendations for the storage temperature of the medicinal product.
Blister (OPA/Aluminum/PVC/Aluminum)
The patient should store the medicine in its original packaging to protect it from light.
There are no special recommendations for the storage temperature of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Carvedilol-ratiopharm contains

• The active substance of the medicine is carvedilol. Each tablet contains 6.25 mg or 12.5 mg or 25 mg of carvedilol.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate.

What Carvedilol-ratiopharm looks like and contents of the pack

6.25 mg: White, biconvex, capsule-shaped tablets with "C" embossed and a score line and "2" on one side and smooth on the other side
12.5 mg: White, biconvex, capsule-shaped tablets with "C" embossed and a score line and "3" on one side and smooth on the other side
25 mg: White, biconvex, capsule-shaped tablets with "C" embossed and a score line and "4" on one side and smooth on the other side.
The tablets can be divided into equal doses.
Package sizes: 30, 50, 60, 100 tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Manufacturer:

Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, Debrecen H-4042, Hungary
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
Phone: (22) 345 93 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Germany:
Carvedilol-ratiopharm 6.25/12.5/25 mg Tablets
Finland, Sweden:
Carveratio
Spain:
Carvedilol Teva-ratiopharm 6.25 mg EFG tablets
Carvedilol Teva-ratiopharm 25 mg EFG tablets
Poland, Portugal:
Carvedilol-ratiopharm

Date of last revision of the leaflet: January 2025