CARVEDILOLO 6.25 mg Film-coated tablets

Зміст інструкції

1. Carvedilolo Zentiva 6.25 mg film-coated tablets, 25 mg film-coated tablets
   1. What is Carvedilolo Zentiva and what is it used for
   2. What you need to know before you take Carvedilolo Zentiva
   3. How to take Carvedilolo Zentiva
   4. POSSIBLE SIDE EFFECTS
   5. How to store Carvedilolo Zentiva
   6. Package contents and other information

Carvedilolo Zentiva 6.25 mg film-coated tablets, 25 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicinebecause it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Carvedilolo Zentiva is and what it is used for
• 2. What you need to know before you take Carvedilolo Zentiva
• 3. How to take Carvedilolo Zentiva
• 4. Possible side effects
• 5. How to store Carvedilolo Zentiva
• 6. Contents of the pack and other information

1. What is Carvedilolo Zentiva and what is it used for

Carvedilolo Zentiva belongs to the group of medicines called alpha and beta blockers.
Carvedilolo Zentiva is indicated in the treatment of high blood pressure and
angina pectoris. Carvedilolo Zentiva is also indicated as an additional treatment
in heart failure, where it determines an improvement in cardiac function.

2. What you need to know before you take Carvedilolo Zentiva

Do not take Carvedilolo Zentiva:

• if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe heart failure for which you are being given certain medicines intravenously (administered in a vein);
• if you have an acute pulmonary embolism;
• if you suffer from weakness of the heart muscle following a respiratory disease (cor pulmonale);
• if you suffer from bronchial asthma or other respiratory diseases with a tendency to spasm such as airway constriction (e.g. chronic obstructive pulmonary disease);
• if you suffer from untreated heart failure or certain types of disturbances of the heart's conduction system (so-called AV block of 2nd and 3rd degree or sick sinus syndrome);
• if you suffer from severe impairment of cardiac function (cardiogenic shock);
• if you have a very weak pulse or very low blood pressure;
• if you suffer from severe alterations of acid-base balance (metabolic acidosis, acidemia);
• if you suffer from an unusual form of angina pectoris called Prinzmetal's angina caused by spasms of the coronary arteries;
• if you suffer from hyperactivity of the adrenal glands (pheochromocytoma) that is not being treated with medicines;
• if you have serious problems with poor circulation to the hands and feet that causes a feeling of cold, pain or intermittent claudication;
• if you suffer from a severe liver disease;
• if you are being treated at the same time with MAO inhibitors (exception: MAO B inhibitors);
• if you are currently being treated with intravenous medicines used for the treatment of high blood pressure or heart problems (verapamil or diltiazem) or other medicines for irregular heartbeats (antiarrhythmics);
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Carvedilolo Zentiva:

• if you have heart failure accompanied by
• low blood pressure (systolic blood pressure less than 100 mmHg);
• impaired blood and oxygen supply to the heart (ischemic heart disease) and hardening of the arteries (atherosclerosis);
• kidney problems. Your kidney function must be monitored. It may be necessary to reduce the dose.
• If you have recently had a heart attack;
• if you have diabetes. Treatment with Carvedilolo Zentiva may mask the revealing signs of a low blood sugar level and blood sugar control may worsen. Therefore, blood sugar levels should be regularly monitored.
• if you have serious breathing problems (chronic obstructive pulmonary disease) for which you are not taking any medicine, Carvedilolo Zentiva may worsen these breathing difficulties.
• if you have serious skin adverse reactions, such as toxic epidermal necrolysis and Stevens-Johnson syndrome.
• if you use contact lenses, Carvedilolo Zentiva may reduce tear production.
• if you have a decrease in the amount of blood and oxygen in the legs (chronic ischemia of the lower limbs) or suffer from peripheral circulatory disorders (such as Raynaud's phenomenon) The administration of Carvedilolo Zentiva may worsen the symptoms.
• if you have hyperactivity of the thyroid gland, with high production of thyroid hormone, Carvedilolo Zentiva may mask the symptoms.
• if you are taking Carvedilolo Zentiva and need to undergo an operation involving the use of an anesthetic. You should consult the anesthesiologist well in advance.
• if you have a very weak pulse (less than 55 beats per minute).
• if you have had a severe allergic reaction (e.g. due to an insect bite or food) or if you are being treated or are about to start therapy for desensitization, as Carvedilolo Zentiva may reduce the effectiveness of the medicine used to treat this type of allergic reaction.
• if you suffer from psoriasis.
• if you have a tumor of the adrenal glands;
• if you suffer from Prinzmetal's angina, or in patients with suspected presence of this disease;
• if you are currently being treated with calcium antagonists or other antiarrhythmics, the ECG and blood pressure should be monitored.
• the use of Carvedilolo Zentiva can lead to positive results in doping controls. The use of Carvedilolo Zentiva as a doping agent can endanger your health.

Children and adolescents
There is no experience with the use of Carvedilolo Zentiva in children (under 18 years of
age). Therefore, Carvedilolo Zentiva should not be given to children.
For athletes: the use of the drug without therapeutic need constitutes
doping and may still result in positive doping tests.

Other medicines and Carvedilolo Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
It is particularly important that your doctor knows that you are already being treated with:

• Digoxin (medicine for the treatment of heart failure).
• Rifampicin (antibiotic used in the treatment of tuberculosis).
• Cimetidine (medicine for the treatment of stomach ulcers, heartburn and acid reflux).
• Ketoconazole (medicine for the treatment of fungal infections).
• Fluoxetine and paroxetine (medicines for the treatment of depression).
• Haloperidol (medicine for the treatment of certain mental/psychiatric disorders).
• Erythromycin (an antibiotic).
• Cyclosporine (medicine used to suppress the immune system, to prevent organ rejection after transplantation and also, for example, for the treatment of some rheumatic or dermatological problems).
• Clonidine (medicine used to lower blood pressure or for the treatment of migraine).
• Verapamil, diltiazem, amiodarone (medicines for the treatment of irregular heartbeat).
• Quinidine, disopyramide, mexiletine, propafenone, flecainide (medicines for the treatment of irregular heartbeat).
• Other medicines to lower blood pressure. Carvedilol can potentiate the effects of other medicines that lower blood pressure administered simultaneously (e.g. alpha1 receptor antagonists) and of medicines that lower blood pressure as a side effect, e.g. barbiturates (in the treatment of epilepsy), phenothiazines (for treating psychoses), tricyclic antidepressants (used in the treatment of depression), vasodilators (medicines used to dilate blood vessels) and alcohol.
• Insulin or oral antidiabetics (agents that reduce blood sugar) as their action in reducing blood sugar may be intensified and symptoms attributable to a low blood sugar level may be masked.
• Inhalation anesthetics (medicines used in anesthesia).
• Sympathomimetics (medicines that increase the function of the sympathetic nervous system).
• Dihydropyridines (medicines for the treatment of high blood pressure and heart disease).
• Nitrates (medicines for the treatment of heart disease), as these drugs can suddenly reduce the antihypertensive effect of carvedilol.
• Preparations with neuromuscular blocking action (medicines that reduce muscle tension).
• Ergotamine (medicine for migraine).
• Some pain relievers in tablets (NSAIDs), estrogens (hormones) and corticosteroids (hormone produced by the adrenal glands) as these medicines can in some cases reduce the antihypertensive effect of carvedilol.
• Medicines containing reserpine, guanethidine, methyldopa, guanfacine and monoamine oxidase inhibitors (MAOIs) for the treatment of depression, as these medicines can lead to a further decrease in heart rate.
• Medicines used to treat asthma (beta-adrenergic bronchodilators).

Carvedilolo Zentiva with food, beverages and alcohol
Carvedilolo Zentiva may potentiate the effects of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.

Pregnancy
There is a risk of harmful effects to the unborn child. Carvedilolo Zentiva should be used during
pregnancy only if your doctor considers that you need to take Carvedilolo Zentiva.
Therefore, consult your doctor before taking Carvedilolo Zentiva during pregnancy.

Breastfeeding
It is not known whether Carvedilolo Zentiva passes into human breast milk and, therefore, it should not be used during
breastfeeding.

Driving and using machines
This medicine has a mild effect on the ability to drive and operate
machinery. Dizziness and fatigue may occur at the beginning of treatment or when
the treatment is changed. If you experience dizziness or feel weak while
taking the tablets, you should avoid driving or undertaking activities that
require careful attention.

Carvedilolo Zentiva contains lactose monohydrate
This medicine contains lactose monohydrate. If your doctor has diagnosed
an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Carvedilolo Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. If you think that the effects of Carvedilolo Zentiva are too strong or too weak, ask your doctor or pharmacist.
You must swallow the film-coated tablets with at least half a glass of water. You can take the film-coated tablets with or without food. However, patients with heart failure should take the film-coated tablets with food to reduce the risk of dizziness when getting up suddenly.

The film-coated tablets of Carvedilolo Zentiva are available in the following dosages:
6.25 mg and 25 mg.
High blood pressure
The usual dose is 12.5 mg of Carvedilolo Zentiva (corresponding to 12.5 mg of carvedilol) for the first two days and then 25 mg of Carvedilolo Zentiva (corresponding to 25 mg of carvedilol) once a day.

Angina pectoris
The usual dose is 12.5 mg of Carvedilolo Zentiva (corresponding to 12.5 mg of carvedilol) twice a day for two days and then 25 mg of Carvedilolo Zentiva (corresponding to 25 mg of carvedilol) twice a day.

Heart failure
The recommended initial dose of Carvedilolo Zentiva is half a tablet, which is 6.25 mg of Carvedilolo Zentiva (corresponding to 3.125 mg of carvedilol) twice a day for two weeks. The dose may be increased gradually, usually, at intervals of two weeks.
However, it may be necessary to increase or decrease the dose. Your doctor will advise you accordingly.

If you take more Carvedilolo Zentiva than you should:
If you take more Carvedilolo Zentiva than you should or if children accidentally take this medicine, contact your doctor, hospital or call the emergency services to find out about any risks and receive advice on what to do.
Symptoms of overdose may include feeling faint due to excessively low blood pressure, slowed heart rate and, in severe cases, occasional loss of heartbeat. Difficulty breathing, constriction of the airways, malaise, reduced level of consciousness and convulsions may occur.

If you forget to take Carvedilolo Zentiva:
If you forget a dose (or more doses), take the next dose at the usual time. Do not take a double dose (or higher) to make up for the forgotten dose(s).

If you stop taking Carvedilolo Zentiva:
Do not suddenly stop treatment or change the recommended dose without first consulting your doctor. If you need to stop treatment, you must do so gradually to avoid unwanted effects.
If you have any further questions on 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 everyone will experience them.
Most side effects are dose-dependent and disappear when the
dose is reduced or when treatment is stopped. Some side effects may
occur at the beginning of treatment and resolve spontaneously with continued
therapy.

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

• Dizziness, headache
• Heart problems that can cause shortness of breath or swelling of the ankles
• Low blood pressure
• Feeling weak or tired

Common (may affect up to 1 in 10 people)

• Bronchitis, pneumonia, upper respiratory tract infections
• Urinary tract infections
• Low number of red blood cells
• Weight gain
• Elevated cholesterol levels
• Loss of control of blood sugar levels in people with diabetes
• Depression, depressed mood
• Visual disturbances
• Reduced tear production, dry eyes, irritated eyes
• Slowed heartbeat
• Swelling of the body or parts of the body
• Fluid retention, increased blood volume in the body
• Drop in blood pressure when standing up causing dizziness, lightheadedness or fainting
• Feeling of fainting, fainting
• Problems with blood circulation (cold hands and feet)
• Worsening of symptoms in patients with Raynaud's disease (fingers or toes that turn first bluish, then whitish, and then reddish with pain) or claudication (leg pain that worsens when walking)
• Shortness of breath
• Fluid accumulation in the lungs
• Breathing problems in patients with asthma or chronic lung disease
• Feeling unwell
• Diarrhea
• Vomiting
• Indigestion
• Stomach pain
• Acute kidney failure and changes in kidney function in patients with hardening of the arteries and/or impaired kidney function
• Difficulty urinating
• Joint pain (e.g. in the arms and legs)

Uncommon (may affect up to 1 in 100 people):

• Difficulty sleeping, nightmares, hallucinations, confusion
• Tingling or numbness in the hands or feet
• Disturbances of the heart's conduction system
• Chest pain
• Skin reactions (allergic rash, skin inflammation, urticaria, itching, psoriasis-like rash, lichen-like rash)
• Sexual performance disorders
• Constipation

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

• Reduced platelets in the blood, which increases the risk of bleeding or bruising
• Blocked nose
• Dry mouth

Very rare (may affect up to 1 in 10,000 people):

• Low number of white blood cells
• Allergic reactions
• Psychosis
• Changes in liver function tests
• Involuntary loss of urine in women (urinary incontinence) that resolves with discontinuation of treatment

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

• severe skin rash with red spots or blisters on the skin, mouth, eyes and genitals (such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• hair loss

Dizziness, fainting, headache and fatigue are generally mild and are more likely
at the beginning of treatment.
Carvedilolo Zentiva may also worsen the signs of diabetes or cause the development of signs
of diabetes in people who have a very mild form of diabetes called "latent diabetes".

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Carvedilolo Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package or on the
bottle/ blister after EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Keep the blister or the plastic bottle in the outer packaging to protect the medicine
from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Carvedilolo Zentiva contains:
The active ingredient is carvedilol.
Each tablet contains 6.25 mg of carvedilol.
Each tablet contains 25 mg of carvedilol.
The other ingredients are:

• Microcrystalline cellulose
• Lactose monohydrate
• Crospovidone CL
• Povidone K30
• Colloidal anhydrous silica dioxide
• Magnesium stearate
• Hypromellose
• Titanium dioxide (E 171)
• Triethyl citrate
• Macrogol 8000
• Polydextrose (E 1200)

Description of the appearance of Carvedilolo Zentiva and package contents
Carvedilolo Zentiva 6.25 mg film-coated tablets: film-coated tablets
white, oval, with a fracture line on both sides and imprinted with “6.25” on one side. The
tablet can be divided into two equal halves.
Carvedilolo Zentiva 25 mg film-coated tablets: film-coated tablets white,
oval, with a fracture line on both sides and imprinted with “25” on one side. The tablet
can be divided into two equal halves.
Packs of
10, 14, 28, 30, 50, 56, 98 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Zentiva Italia S.r.l. – Via P. Paleocapa 7
20121 Milan

Manufacturers responsible for batch release:
Dragenopharm Apotheker Püschl GmbH - Göllstraße 1
84529 Tittmoning (Germany)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Spain: Carvedilol Zentiva comprimidos EFG
Germany: Carlich filmtabletten
Italy: Carvedilolo Zentiva
Greece: Carvedilen