CARVEDILOLO 6.25 mg Коированные таблетки

Содержание инструкции

1. Carvedilolo TecniGen 6,25 mg tablets, 25 mg tablets
   1. What is Carvedilolo TecniGen and what is it used for
   2. What you need to know before taking Carvedilolo TecniGen
   3. How to take Carvedilolo TecniGen
   4. Possible side effects
   5. How to store Carvedilolo Tecnigen
   6. Package Contents and Other Information

Carvedilolo TecniGen 6,25 mg tablets, 25 mg tablets

Carvedilolo

Generic medicine

Read this leaflet carefully before 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

This medicine contains the active ingredient carvedilol. This substance belongs to a group of
medicines called alpha and beta-blockers which relax and dilate blood vessels, lower blood
pressure and reduce the workload on the heart.
Carvedilolo TecniGen is used for the treatment of the following conditions:
high blood pressure (essential arterial hypertension), alone or in combination with other medicines
that lower blood pressure, especially with thiazide diuretics;
chest pain caused by heart problems (angina pectoris);
heart failure, a disease characterized by the heart's inability to provide an adequate amount
of blood to the body.

2. What you need to know before taking Carvedilolo TecniGen

Do not take Carvedilolo TecniGen

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• if your heart function is insufficient to ensure adequate blood supply to the body and is not stably controlled (unstable or decompensated heart failure or cardiac decompensation that does not respond to standard therapy and requires therapy with inotropic drugs (medicines that increase the force of heart contraction) via intravenous injection);
• if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Bronchopneumopathy) or if you have previously suffered from asthma or other obstructive respiratory problems (bronchospasm);
• if your liver is not functioning properly (clinically manifest hepatic dysfunction);
• if you have problems with heart conduction (untreated 2nd and 3rd degree atrioventricular block or sinoatrial node disease, including sinoatrial block);
• if you have a very slow heartbeat (bradycardia), less than 50 beats per minute;
• if you have very low blood pressure (systolic pressure less than 85 mmHg);
• if you have a serious heart problem known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• if you have a tumor of the adrenal gland, called pheochromocytoma, not controlled with medicines called alpha blockers;
• if your doctor has told you that the level of acidity in your blood is higher than normal (metabolic acidosis);
• if you are pregnant or during the breastfeeding period with breast milk (see “Pregnancy and breastfeeding”).
• if you are in a state of cardiogenic shock (serious heart problem)

Warnings and precautions
Talk to your doctor before taking Carvedilolo TecniGen.
Pay particular attention and talk to your doctor before taking this medicine:

• if your heart function has been insufficient for a long time and you suffer from fluid retention (chronic congestive heart failure);
• if your heart function is insufficient and you have low blood pressure (systolic pressure less than 100 mmHg);
• if you have problems with blood circulation or have insufficient blood supply to the heart (ischemic heart disease);
• if you have serious kidney problems (renal insufficiency);
• if you have recently had a heart attack;
• if you have breathing problems caused by a lung disease called COPD (Chronic Obstructive Bronchopneumopathy);
• if you have diabetes or low blood sugar levels (hypoglycemia);
• if you have problems with blood circulation (widespread vascular disease) in the limbs (peripheral vascular disease) or if you suffer from a condition called “Raynaud’s phenomenon”, characterized by poor blood circulation to the fingers of the hands or feet that become painful and whitish;
• if you have problems with your thyroid gland (thyrotoxicosis);
• if you are going to undergo surgery due to the use of anesthetics;
• if you have a very slow heartbeat (bradycardia), less than 55 beats per minute;
• if you have previously suffered from severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitization therapy;
• if you suffer from an inflammatory skin disease called psoriasis;
• if you are taking other medicines to lower blood pressure and treat heart problems based on verapamil or diltiazem, or if you are taking other antiarrhythmic medicines;
• if you have a tumor of the adrenal gland called pheochromocytoma;
• if you suffer from a type of chest pain caused by poor blood circulation to the heart (Prinzmetal’s angina);
• if you use contact lenses;
• if you have sudden changes in blood pressure (labile hypertension) or have high blood pressure due to other diseases (secondary hypertension).

For athletes:the use of the medicine without therapeutic necessity constitutes doping and may
still result in positive anti-doping tests.

Children and adolescents
No data are available regarding the use of this medicine in children and adolescents under
18 years of age.

Other medicines and Carvedilolo TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Be particularly careful and talk to your doctor if you are taking:

• digoxin, used for the treatment of heart rhythm disturbances;
• insulin and oral hypoglycemic agents, used for the treatment of diabetes;
• rifampicin, used to treat tuberculosis;
• cimetidine, used to treat stomach problems;
• MAOIs (monoamine oxidase inhibitors), medicines used to treat depression;
• reserpine, used for the treatment of high blood pressure;
• diltiazem and verapamil, antihypertensives (medicines used to lower blood pressure);
• antiarrhythmics, medicines used to treat heart problems:
• cyclosporine, used to prevent rejection after an organ transplant;
• clonidine, used for the treatment of high blood pressure;
• medicines used to induce anesthesia (see “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Carvedilolo TecniGen during pregnancy, unless your doctor considers it strictly
necessary for your health.
Beta-blockers reduce placental perfusion and can cause fetal death, premature and
premature births. In addition, adverse reactions can occur in the fetus and newborn, especially hypoglycemia
(reduced blood sugar) and bradycardia (reduced heart rate). There may be an
increased risk of cardiac and pulmonary complications in the newborn.
The use of this medicine is not recommended if you are breastfeeding with breast milk.

Driving and using machines
No studies have been conducted to establish the effect of the medicine on the ability to drive vehicles and
use machinery. However, if you experience dizziness or fatigue, avoid driving vehicles and
using machinery. This is particularly true at the beginning of treatment, after increasing the dose, following
a change in the product or if you drink alcohol.

Carvedilolo TecniGen contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Carvedilolo TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the tablets with a sufficient amount of liquid. It is not necessary to take the tablets with
meals; however, if you suffer from heart failure, take the medicine during meals, to reduce the
manifestation of undesirable effects.

Treatment of high blood pressure (essential hypertension)
The recommended initial dose in adults is 12.5 mg once a day, for the first two days.
Subsequently, the recommended dose is 25 mg once a day. If necessary, the dosage may
be gradually increased at intervals of not less than two weeks, up to reaching the
recommended maximum dose of 50 mg per day, to be taken in a single administration or divided
into 25 mg twice a day.

Treatment of chest pain caused by heart problems (angina pectoris)
The recommended initial dose in adults is 12.5 mg twice a day, for the first two days.
Subsequently, the recommended dosage is 25 mg twice a day.

Treatment of heart failure
The treatment must be carried out under strict medical supervision, who will adjust the dosage based on
your needs until reaching the adequate dosage.
The recommended initial dose in adults is 3.125 mg (half a 6.25 mg tablet) twice a day, for at least two weeks. Afterwards, the dose may be gradually increased, at intervals
of not less than two weeks, and first brought to 6.25 mg twice a day, then to 12.5 mg twice a day and finally to 25 mg twice a day. The dosage should be increased up to the highest dose
tolerated by your body.
Recommended maximum dose:

• 25 mg twice a day if you suffer from severe heart failure;
• 25 mg twice a day if you suffer from mild or moderate heart failure and have a body weight less than 85 kg;
• 50 mg twice a day if you suffer from mild or moderate heart failure and have a body weight greater than 85 kg.

If you stop the treatment with this medicine for more than two weeks, the therapy must be
started again with the administration of the minimum dose of 3.125 mg (half a 6.25 mg tablet) twice a day, which may subsequently be increased.

Use in children and adolescents
The tolerability and efficacy of this medicine in children and adolescents under 18 years of age
have not been established.

Use in the elderly
The recommended initial dose for the treatment of high blood pressure (essential hypertension) is
12.5 mg once a day. Subsequently, the dose may be increased at intervals of not less than 2
weeks, up to the recommended maximum dose of 50 mg per day, taken in two doses of 25 mg.
The recommended initial dose in the treatment of angina pectoris is 12.5 mg twice a day.
Subsequently, the dose may be increased after an interval of at least 2 days, up to the maximum
dose of 25 mg twice a day.

If you take more Carvedilolo than you should
In case of accidental ingestion/taking of an excessive dose of Carvedilolo TecniGen, immediately
inform your doctor or go to the nearest hospital.
In case of overdose, you may experience the following symptoms: severe reduction of blood pressure
(hypotension), slowing of the heartbeat (bradycardia), insufficient heart function
(heart failure, cardiogenic shock and cardiac arrest), difficulty breathing, narrowing of the
bronchi (bronchospasm), vomiting, altered consciousness and generalized convulsions.

If you forget to take Carvedilolo TecniGen
Do not take a double dose to make up for the missed tablet.

If you stop taking Carvedilolo TecniGen
Do not stop the treatment with this medicine without first consulting your doctor.
It is necessary that the interruption of the treatment with this medicine takes place gradually, over a period
of 2 weeks, especially if you suffer from disorders of the blood circulation of the heart (ischemic heart disease).
If you have any doubts 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.

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

• headache, dizziness
• heart problems (heart failure)
• low blood pressure (hypotension)
• feeling tired (asthenia)

Common(may affect up to 1 in 10 people)

• airway infections of the bronchi (bronchitis), lungs (pneumonia), nose and throat (upper respiratory tract)
• urinary tract infections
• decreased number of red blood cells (anemia)
• weight gain
• increased cholesterol levels in the blood (hypercholesterolemia)
• changes in blood sugar levels in patients with diabetes
• depression, depressed mood
• impaired vision, reduced tear production (dry eyes), eye irritation
• decreased heart rate (bradycardia)
• fluid retention causing general swelling of the body or parts of the body (edema), excess fluid
• increased amount of blood in circulation (hypervolemia)
• feeling dizzy when standing up due to a rapid drop in blood pressure (orthostatic hypotension)
• circulation problems in the arms and legs causing cold hands and feet and pain in the extremities
• numbness and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon)
• difficulty walking (intermittent claudication)
• difficulty breathing (dyspnea) and asthma (especially in patients predisposed to asthma)
• fluid accumulation in the lungs (pulmonary edema)
• nausea, diarrhea, vomiting
• digestive problems (dyspepsia) and abdominal pain
• kidney problems (renal failure and altered kidney function) in patients with widespread vascular disease and/or renal failure
• urination disorders
• pain

Uncommon(may affect up to 1 in 100 people)

• sleep disorders
• skin reactions of various types (e.g. allergic rash, dermatitis, urticaria, itching, psoriasis-like skin lesions, lichen planus-like)
• hair loss (alopecia)
• erectile dysfunction
• heart conduction system disorders (atrioventricular block)
• chest pain caused by heart circulation problems (angina pectoris)
• feeling of fainting (presyncope), fainting (syncope), tingling in the extremities (paresthesia) Rare(may affect up to 1 in 1000 people)
• nasal congestion
• decreased number of platelets in the blood (thrombocytopenia)

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

• decreased number of white blood cells in the blood (leukopenia)
• allergic reactions (hypersensitivity)
• increased levels of liver enzymes (ALT, AST, GGT)
• urinary incontinence in women

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

5. How to store Carvedilolo Tecnigen

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 packaging after “Exp”. The expiry date refers to the last day of that month. The expiry date indicated refers to the product in
intact packaging, correctly stored.
Store the medicine in its original packaging to protect it from moisture and light and at a temperature
not exceeding 25 °C.
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 contains

• The active ingredient is carvedilol. A 6.25 mg tablet contains 6.25 mg of carvedilol; a 25 mg tablet contains 25 mg of carvedilol.
• The other ingredients are: lactose monohydrate, sucrose, povidone K25, crospovidone, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Carvedilolo TecniGen and package contents
Carvedilolo TecniGen is available as divisible tablets.
Pack of 28 divisible tablets of 6.25 mg
Pack of 30 divisible tablets of 25 mg

Marketing Authorisation Holder
Tecnigen S.r.l.
Via Galileo Galilei, 40

• 20092 - Cinisello Balsamo (MI)

Manufacturer
KRKA, d.d. – Šmarješka cesta, 6 – Novo Mesto (Slovenia)