Carvedilolo Zentiva

Italy
Brand name Carvedilolo Zentiva
Form tablets, film-coated
Active substance / Dosage
CARVEDILOL
Prescription type Prescription only
ATC code
C07AG02
Registration number 037144
Manufacturer ZENTIVA ITALIA S.R.L.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 may be harmful to them.
  • If you experience any side effect, including 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 Carvedilolo Zentiva is and what it is used for

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

2. What you should know before taking 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 have severe heart failure for which you are receiving certain medicines intravenously (administered via a vein);
  • if you have acute pulmonary embolism;
  • if you have heart muscle weakness due to respiratory disease (cor pulmonale);
  • if you have bronchial asthma or other respiratory diseases with a tendency to spasm, such as airway constriction (e.g. chronic obstructive pulmonary disease);
  • if you have untreated heart failure or certain types of heart conduction disorders (so-called second- or third-degree AV block or sick sinus syndrome);
  • if you have severe impairment of heart function (cardiogenic shock);
  • if your pulse is very weak or your blood pressure is very low;
  • if you have severe disturbances in acid-base balance (metabolic acidosis, acidemia);
  • if you have an unusual form of angina pectoris called Prinzmetal's angina, caused by spasms of the coronary arteries;
  • if you have overactivity of the adrenal glands (pheochromocytoma) that is not being treated with medication;
  • if you have serious circulatory problems in the hands and feet causing coldness, pain or intermittent claudication;
  • if you have 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 high blood pressure or heart problems (verapamil or diltiazem) or other medicines for heart rhythm disorders (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 below 100 mmHg);
  • reduced blood and oxygen supply to the heart (ischaemic heart disease) and hardening of the arteries (atherosclerosis);
  • kidney problems. Your kidney function should be monitored. A dose reduction may be necessary.
  • if you have recently had a heart attack;
  • if you have diabetes. Treatment with Carvedilolo Zentiva may mask the warning signs of low blood sugar levels, and blood glucose control may worsen. Therefore, your blood sugar levels should be regularly monitored.
  • if you have severe respiratory problems (chronic obstructive pulmonary disease) for which you are not taking any medication, Carvedilolo Zentiva may worsen these breathing difficulties.
  • if you have had severe skin reactions, such as toxic epidermal necrolysis or Stevens-Johnson syndrome.
  • if you wear contact lenses, Carvedilolo Zentiva may reduce tear production.
  • if you have reduced blood flow and oxygen supply to the legs (chronic lower limb ischemia) or suffer from peripheral circulatory disorders (such as Raynaud's phenomenon). Treatment with Carvedilolo Zentiva may worsen these symptoms.
  • if you have overactivity of the thyroid gland with increased production of thyroid hormone, Carvedilolo Zentiva may mask the symptoms.
  • if you are taking Carvedilolo Zentiva and are scheduled for surgery requiring anesthesia. You must consult your anaesthetist well in advance.
  • if you have a very weak pulse (less than 55 beats per minute).
  • if you have experienced a severe allergic reaction (e.g. due to insect bites or food) or if you are undergoing or about to start desensitization therapy, as Carvedilolo Zentiva may reduce the effectiveness of the medicine used to treat such allergic reactions.
  • if you have psoriasis.
  • if you have a tumour of the adrenal glands;
  • if you have Prinzmetal's angina, or if this condition is suspected;
  • if you are currently being treated with calcium antagonists or other antiarrhythmics, ECG and blood pressure monitoring are required.
  • use of Carvedilolo Zentiva may lead to positive results in doping tests. The use of Carvedilolo Zentiva as a doping agent may endanger health.

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

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 if you are already being treated with:

  • Digoxin (a medicine used to treat heart failure).
  • Rifampicin (an antibiotic used to treat tuberculosis).
  • Cimetidine (a medicine used to treat gastric ulcers, heartburn and acid reflux).
  • Ketoconazole (a medicine used to treat fungal infections).
  • Fluoxetine and paroxetine (medicines used to treat depression).
  • Haloperidol (a medicine used to treat certain mental/psychiatric disorders).
  • Erythromycin (an antibiotic).
  • Cyclosporine (a medicine used to suppress the immune system, to prevent organ transplant rejection, and also, for example, to treat certain rheumatological or dermatological conditions).
  • Clonidine (a medicine used to lower blood pressure or to treat migraine).
  • Verapamil, diltiazem, amiodarone (medicines used to treat irregular heartbeat).
  • Quinidine, disopyramide, mexiletine, propafenone, flecainide (medicines used to treat irregular heartbeat).
  • Other medicines to lower blood pressure. Carvedilol may enhance the effects of other blood pressure-lowering medicines taken concomitantly (e.g. alpha1-receptor antagonists) and of medicines that lower blood pressure as an adverse effect, e.g. barbiturates (used to treat epilepsy), phenothiazines (to treat psychosis), tricyclic antidepressants (used to treat depression), vasodilators (medicines used to dilate blood vessels) and alcohol.
  • Insulin or oral antidiabetic agents (agents that reduce blood sugar levels), as their blood sugar-lowering effect may be intensified and symptoms of low blood sugar may be masked.
  • Inhaled anaesthetics (medicines used in anaesthesia).
  • Sympathomimetics (medicines that increase the activity of the sympathetic nervous system).
  • Dihydropyridines (medicines used to treat high blood pressure and heart conditions).
  • Nitrates (medicines used to treat heart conditions), as these medicines may suddenly reduce the antihypertensive effect of carvedilol.
  • Neuromuscular blocking agents (medicines that reduce muscle tension).
  • Ergotamine (a medicine used for migraine).
  • Certain oral painkillers (NSAIDs), estrogens (hormones) and corticosteroids (hormones produced by the adrenal glands), as these medicines may in some cases reduce the antihypertensive effect of carvedilol.
  • Medicines containing reserpine, guanethidine, methyldopa, guanfacine and monoamine oxidase inhibitors (MAOIs) used to treat depression, as these medicines may further decrease heart rate.
  • Medicines used to treat asthma (beta-adrenergic bronchodilators).

Carvedilolo Zentiva with food, drinks and alcohol
Carvedilolo Zentiva may enhance the effects of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is a risk of harmful effects on the unborn child. Carvedilolo Zentiva should be used during pregnancy only if your doctor considers it necessary for you 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 Carvedilolo Zentiva must not be used during breastfeeding.

Driving and using machines
This medicine has a minor influence on the ability to drive and use machines. Dizziness and fatigue may occur at the beginning of treatment or when treatment is changed. If you feel dizzy or weak while taking the tablets, you should avoid driving or performing activities that require alertness.

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

3. How to take Carvedilolo Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. If you think the effect of Carvedilolo Zentiva is too strong or too weak, ask your doctor or pharmacist for advice.

You should swallow the film-coated tablets with at least half a glass of water. You may 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 standing up suddenly.

Carvedilolo Zentiva film-coated tablets are available in the following strengths:
6.25 mg and 25 mg.

High blood pressure
The usual dose is 12.5 mg of Carvedilolo Zentiva (equivalent to 12.5 mg of carvedilolo) for the first two days, followed by 25 mg of Carvedilolo Zentiva (equivalent to 25 mg of carvedilolo) once daily.

Angina pectoris
The usual dose is 12.5 mg of Carvedilolo Zentiva (equivalent to 12.5 mg of carvedilolo) twice daily for two days, followed by 25 mg of Carvedilolo Zentiva (equivalent to 25 mg of carvedilolo) twice daily.

Heart failure
The recommended starting dose of Carvedilolo Zentiva is half a tablet, i.e. 6.25 mg of Carvedilolo Zentiva (equivalent to 3.125 mg of carvedilolo), twice daily for two weeks. The dose may then be gradually increased, 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 ingest this medicine, contact your doctor, hospital, or call emergency services to assess any risks and receive advice on necessary measures.

Symptoms of overdose may include feeling faint due to excessively low blood pressure, slowed heart rate, and in severe cases, occasional loss of heartbeat. Breathing difficulties, airway constriction, malaise, reduced level of consciousness, and seizures may also occur.

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

If you stop taking Carvedilolo Zentiva:
Do not stop treatment abruptly or change the recommended dose without first consulting your doctor. If you need to stop treatment, it should be done gradually to avoid unwanted effects.

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Most of the adverse effects are dose-dependent and disappear when the dose is reduced or when treatment is discontinued. Some adverse effects may occur at the beginning of treatment and resolve spontaneously as therapy continues.

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

  • Dizziness, headache
  • Heart problems that may cause shortness of breath or swelling of the ankles
  • Low blood pressure
  • Feeling of weakness or fatigue

Common (may affect up to 1 in 10 people):

  • Bronchitis, pneumonia, upper respiratory tract infections
  • Urinary tract infections
  • Low red blood cell count
  • 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 heart rate
  • Swelling of the body or parts of the body
  • Fluid retention, increased blood volume in the body
  • Drop in blood pressure upon standing causing dizziness, lightheadedness or fainting
  • Feeling faint, fainting
  • Circulatory problems (cold hands and feet)
  • Worsening of symptoms in patients with Raynaud's disease (fingers or toes turning first bluish, then pale, then red, 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 ache
  • 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 arms and legs)

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

  • Difficulty sleeping, nightmares, hallucinations, confusion
  • Tingling or numbness in hands or feet
  • Heart conduction disorders
  • Chest pain
  • Skin reactions (allergic skin 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 platelet count in the blood, increasing the risk of bleeding or bruising
  • Nasal congestion
  • Dry mouth

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

  • Low white blood cell count
  • Allergic reactions
  • Psychosis
  • Changes in liver function tests
  • Involuntary loss of urine in women (urinary incontinence), which resolves upon discontinuation of treatment

Frequency not known (frequency cannot be estimated from the 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 usually mild and more likely at the beginning of treatment.
Carvedilolo Zentiva may also worsen 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 adverse effects
If you experience any adverse effect, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse 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 box and on the
bottle/blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister or plastic bottle in the outer packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

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

  • Microcrystalline cellulose
  • Lactose monohydrate
  • Crospovidone CL
  • Povidone K30
  • Anhydrous colloidal silicon dioxide
  • Magnesium stearate
  • Hypromellose
  • Titanium dioxide (E 171)
  • Triethyl citrate
  • Macrogol 8000
  • Polidextrose (E 1200)

Description of the appearance of Carvedilolo Zentiva and pack sizes
Carvedilolo Zentiva 6.25 mg film-coated tablets: white, oval, film-coated tablets with a break line on both sides and engraved "6.25" on one side. The tablet can be divided into two equal halves.
Carvedilolo Zentiva 25 mg film-coated tablets: white, oval, film-coated tablets with a break line on both sides and engraved "25" on one side. The tablet can be divided into two equal halves.
Pack sizes:
10, 14, 28, 30, 50, 56, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Zentiva Italia S.r.l. – Via P. Paleocapa 7
20121 Milano
Responsible manufacturers for batch release:
Dragenopharm Apotheker Püschl GmbH - Göllstraße 1
84529 Tittmoning (Germany)

This medicinal product is authorised in the European Economic Area countries under the following names:
Spain: Carvedilol Zentiva comprimidos EFG
Germany: Carlich filmtabletten
Italy: Carvedilolo Zentiva
Greece: Carvedilen

This leaflet was last approved on: