Carvedilol-ratiopharm

Package Leaflet: Information for the User

Carvedilol-ratiopharm, 6.25 mg, tablets

Carvedilol-ratiopharm, 12.5 mg, tablets

Carvedilol-ratiopharm, 25 mg, tablets

Carvedilol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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. Contents of the pack 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 to treat heart failure.

2. Important information before taking Carvedilol-ratiopharm

When not to take Carvedilol-ratiopharm

If you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6),
if you have untreated or uncontrolled heart failure or a certain type of conduction disorder (so-called atrioventricular block of second or third degree in patients without a pacemaker or so-called sick sinus syndrome),
if you have clinically manifest liver dysfunction,
if you have a very slow heart rate (below 50 beats per minute)
or very low blood pressure,
if you have severe heart disorders (cardiogenic shock),
if you have 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 you have severe respiratory disorders (acute pulmonary embolism),
if you have atypical angina pectoris (Prinzmetal's angina),
if you have heart failure due to respiratory disease (pulmonary heart disease),
if you have untreated pheochromocytoma (a tumor of the adrenal gland),
if you are taking monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) (except for MAO-B inhibitors),
if you are receiving intravenous verapamil or diltiazem or other medicines used to treat heart rhythm disorders (antiarrhythmic agents),
if you are breastfeeding.

Warnings and precautions

Before taking Carvedilol-ratiopharm, discuss it with your doctor or pharmacist
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If you have heart failure with accompanying low blood pressure,
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reduced blood supply to the heart and oxygen (ischemic heart disease) and hardening of the arteries (atherosclerosis)
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and (or) kidney function disorder. In this case, your doctor will monitor your kidney function. It may be necessary to reduce the dose of the medicine. ­ In patients after myocardial infarction. The disease must be properly treated before starting Carvedilol-ratiopharm. ­ In patients with a certain type of conduction disorder (so-called atrioventricular block of first degree). ­ If you have secondary hypertension. ­ If you have diabetes. Treatment with Carvedilol-ratiopharm may mask the symptoms of low blood sugar. Therefore, you should regularly check your blood sugar levels. ­ In case of severe peripheral circulation disorders 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 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 you have Raynaud's phenomenon (fingers of the hands or feet turn blue, then pale, and then red, accompanied by pain). Carvedilol-ratiopharm may worsen these symptoms. ­ If you have hyperthyroidism with increased thyroid hormone secretion; Carvedilol-ratiopharm may mask the symptoms. ­ If you are taking Carvedilol-ratiopharm and are to undergo surgery under general anesthesia. In this case, you should inform the anesthesiologist about taking Carvedilol-ratiopharm. ­ If you have a very slow heart rate (below 55 beats per minute). ­ If you have ever had severe allergic reactions (e.g. after an insect bite or after eating food) or if you are undergoing (or planned) desensitization treatment, Carvedilol-ratiopharm may weaken the effect of medicines given in case of an allergic reaction.

• Psoriasis. Severe skin reactions (e.g. toxic epidermal necrolysis, TEN, or Stevens-Johnson syndrome, SJS).

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If you wear 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 your 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),
as 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 heart rhythm disorders (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, e.g. 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

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. You should limit your alcohol consumption while taking Carvedilol-ratiopharm, as alcohol may affect the action of Carvedilol-ratiopharm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
During treatment with Carvedilol-ratiopharm, there is a risk of harm to the fetus. Carvedilol-ratiopharm should only be used during pregnancy if your doctor considers it necessary. Therefore, you should always consult your 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 consumption of alcohol. 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, you should avoid driving or performing tasks that require increased attention.

Carvedilol-ratiopharm contains lactose.

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Carvedilol-ratiopharm

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
In case you feel that the effect of Carvedilol-ratiopharm is too strong or too weak, contact your doctor.
Swallow the tablets 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 carvedilol) once a day for the first two days, and then 2 tablets of Carvedilol-ratiopharm 12.5 mg (equivalent to 25 mg carvedilol) once a day.
To achieve the recommended dose, tablets of Carvedilol-ratiopharm with other strengths are available.
If necessary, your doctor may recommend further gradual dose increase, 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 carvedilol) once a day.
If necessary, your doctor may recommend further gradual dose increase, 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 carvedilol) twice a day for two days, and then 2 tablets of Carvedilol-ratiopharm 12.5 mg (equivalent to 25 mg carvedilol) twice a day.
To achieve the recommended dose, tablets of Carvedilol-ratiopharm with other strengths are available.
If necessary, your doctor may recommend further gradual dose increase, 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 carvedilol) twice a day for two days, and then 2 tablets of Carvedilol-ratiopharm 12.5 mg (equivalent to 25 mg carvedilol) twice a day.
The recommended maximum daily dose is 50 mg.

Heart failure

The usual initial dose is 3.125 mg carvedilol twice a day for two weeks. Your doctor may recommend gradual dose increase, usually every two weeks.
Your doctor may recommend both dose increase and decrease, and will inform you about it 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. The dose increase to 50 mg twice a day will be carried out under close medical supervision.

Taking a higher dose of Carvedilol-ratiopharm than recommended

In case of taking a higher dose of the medicine than recommended or accidental ingestion of any amount of the medicine by a child, contact your doctor immediately, 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 blood pressure lowering, 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 several doses) of the medicine, take the next dose at the usual time. Do not take a double dose (or larger) to make up for the missed dose(s).

Stopping treatment with Carvedilol-ratiopharm

Do not stop treatment or change the dose on your own, unless your doctor tells you to do so. The medicine should be discontinued gradually over a period of two weeks. Sudden discontinuation of the medicine may worsen the symptoms.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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.
Contact your doctor immediately if you 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), peeling of the top 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 coldness of the hands and feet), hardening of the arteries (atherosclerosis), worsening of symptoms in patients with Raynaud's phenomenon (initially bluish discoloration of the fingers of the hands or feet, then pallor, and then redness with accompanying pain) or intermittent claudication (pain in the legs that worsens during 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 disorder
• Urination disorders

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

• Sleep disorders
• Confusion, hallucinations
• Nightmares
• Sensory disturbances
• Conduction disorders, 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 membranes in 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 provoke latent diabetes.
Atrioventricular block (lack of impulse from the sinus 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, sinus node dysfunction, or atrioventricular block).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Carvedilol-ratiopharm

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging – Expiry date (EXP). The expiry date refers to the last day of the month.
Blisters (PVC/PVDC/Aluminum)
Carvedilol-ratiopharm 6.25 mg:
Do not store above 30°C.
Store in the original package to protect from light.
Carvedilol-ratiopharm 12.5 mg and 25 mg:
Store in the original package to protect from light.
No special storage temperature instructions for the medicinal product.
Blister (OPA/Aluminum/PVC/Aluminum)
Store in the original package to protect from light.
No special storage temperature instructions for the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 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.
Pack sizes: 30, 50, 60, 100 tablets.
Not all pack 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, please 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 tablets EFG
Carvedilol Teva-ratiopharm 25 mg tablets EFG

Poland, Portugal:

Carvedilol-ratiopharm

Date of last revision of the leaflet: January 2025