Carvedilol Tecnigen

Patient Information Leaflet

Carvedilolo TecniGen 6.25 mg tablets, 25 mg tablets

Carvedilolo
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any side effects, 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 taking 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 Carvedilolo TecniGen is and what it is used for

This medicine contains the active substance carvedilolo. 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 of the heart.
Carvedilolo TecniGen is used to treat the following conditions:
high blood pressure (essential arterial hypertension), either alone or in combination with other medicines
that lower blood pressure, especially thiazide diuretics;
chest pain caused by heart problems (angina pectoris);
heart failure, a condition characterized by the heart's inability to supply 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 to any of the other ingredients of this medicine (listed in section 6);
• if your heart function is inadequate to ensure sufficient blood supply to the body and is not stably controlled (unstable or decompensated heart failure, or heart failure unresponsive to standard therapy requiring treatment with intravenous inotropic medicines (medicines that increase the force of heart contraction));
• if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Pulmonary Disease) or if you have previously suffered from asthma or other obstructive respiratory disorders (bronchospasm);
• if your liver is not working properly (clinically evident hepatic dysfunction);
• if you have heart conduction problems (untreated second- or third-degree atrioventricular block, or sinoatrial node disorders, including sinoatrial block);
• if your heart rate is very slow (bradycardia), less than 50 beats per minute;
• if your blood pressure is very low (systolic pressure below 85 mmHg);
• if you have a severe heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• if you have an adrenal gland tumor called phaeochromocytoma, not controlled with alpha-blocking medicines;
• if your doctor has told you that the acidity level of your blood is higher than normal (metabolic acidosis);
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are in cardiogenic shock (a serious heart condition).

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

• if your heart function has long been inadequate and you suffer from fluid retention (chronic congestive heart failure);
• if your heart function is inadequate and you have low blood pressure (systolic pressure below 100 mmHg);
• if you have circulation problems or insufficient blood supply to the heart (ischaemic heart disease);
• if you have severe kidney problems (renal failure);
• if you recently had a heart attack;
• if you have breathing problems caused by a lung disease called COPD (Chronic Obstructive Pulmonary Disease);
• if you have diabetes or low blood sugar levels (hypoglycaemia);
• if you have circulation problems (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 or toes, which become painful and whitish;
• if you have thyroid problems (thyrotoxicosis);
• if you are undergoing surgery requiring anaesthetics;
• if your heart rate is very slow (bradycardia), less than 55 beats per minute;
• if you have previously experienced severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitisation therapy;
• if you suffer from an inflammatory skin disease called psoriasis;
• if you are taking other medicines to lower blood pressure and treat heart conditions containing verapamil or diltiazem, or if you are taking other antiarrhythmic medicines;
• if you have an adrenal gland tumor called phaeochromocytoma;
• if you suffer from a type of chest pain caused by poor blood flow to the heart (Prinzmetal's angina);
• if you wear contact lenses;
• if you experience sudden changes in blood pressure (labile hypertension) or have high blood pressure due to other diseases (secondary hypertension).

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
No data are available on the use of this medicine in children and adolescents under 18 years of age.
Other medicines and Carvedilolo TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, exercise caution and consult your doctor if you are taking:

• digoxin, used to treat heart rhythm disorders;
• insulin and oral hypoglycaemics, used to treat diabetes;
• rifampicin, used to treat tuberculosis;
• cimetidine, used to treat stomach problems;
• MAOIs (monoamine oxidase inhibitors), medicines used to treat depression;
• reserpine, used to treat high blood pressure;
• diltiazem and verapamil, antihypertensives (medicines used to lower blood pressure);
• antiarrhythmics, medicines used to treat heart problems;
• cyclosporine, used to prevent organ transplant rejection;
• clonidine, used to treat high blood pressure;
• medicines used to induce anaesthesia (see "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist 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 may cause fetal death, immature or premature births. Moreover, adverse reactions may occur in the fetus and newborn, especially hypoglycaemia (low blood sugar) and bradycardia (reduced heart rate). There may also be an increased risk of cardiac and pulmonary complications in the newborn.
The use of this medicine is not recommended if you are breastfeeding.

Driving and using machines
No studies have been conducted to determine the effect of this medicine on the ability to drive vehicles or operate machinery. However, if you experience dizziness or fatigue, avoid driving or operating machinery. This is particularly important at the beginning of treatment, after dose increases, when switching products, or if you consume alcohol.

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

3. How to take Carvedilolo TecniGen

Take this medicine exactly as directed by 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 food; however, if you suffer from heart failure, take the medicine with meals to reduce the occurrence of side effects.

Treatment of high blood pressure (essential arterial hypertension)
The recommended initial dose for adults is 12.5 mg once daily for the first two days.
Thereafter, the recommended dose is 25 mg once daily. If necessary, the dose may be gradually increased at intervals of no less than two weeks, up to the maximum recommended dose of 50 mg per day, taken as a single dose or divided into 25 mg twice daily.

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

Treatment of heart failure
Treatment must be carried out under close medical supervision, with the doctor adjusting the dose according to your individual needs until the appropriate dose is reached.
The recommended initial dose for adults is 3.125 mg (half a 6.25 mg tablet) twice daily for at least two weeks. Afterwards, the dose may be gradually increased at intervals of no less than two weeks: first to 6.25 mg twice daily, then to 12.5 mg twice daily, and finally to 25 mg twice daily. The dose should be increased up to the highest dose tolerated by your body.

Maximum recommended dose:

• 25 mg twice daily if you have severe heart failure;
• 25 mg twice daily if you have mild or moderate heart failure and weigh less than 85 kg;
• 50 mg twice daily if you have mild or moderate heart failure and weigh more than 85 kg.

If you stop treatment with this medicine for more than two weeks, therapy should be restarted with the lowest dose of 3.125 mg (half a 6.25 mg tablet) twice daily, which may then be gradually increased.

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

Use in elderly patients
The recommended initial dose for the treatment of high blood pressure (essential hypertension) is 12.5 mg once daily. The dose may then be increased at intervals of no less than two weeks, up to the maximum recommended dose of 50 mg per day, taken as two 25 mg doses.
The recommended initial dose for the treatment of angina pectoris is 12.5 mg twice daily. The dose may then be increased after an interval of at least two days, up to the maximum dose of 25 mg twice daily.

If you take more Carvedilolo than you should
If you accidentally ingest or take an excessive dose of Carvedilolo TecniGen, inform your doctor immediately or go to the nearest hospital.
In case of overdose, you may experience the following symptoms: severe drop in blood pressure (hypotension), slowed heart rate (bradycardia), inadequate heart function (heart failure, cardiogenic shock, and cardiac arrest), breathing difficulties, narrowing of the airways (bronchospasm), vomiting, disturbances of consciousness, and generalized seizures.

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 treatment with this medicine without first consulting your doctor.
Discontinuation of this medicine should be done gradually over a period of two weeks, especially if you suffer from heart circulation disorders (ischaemic heart disease).

If you have any questions about the use of this medicine, consult 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 (cephalalgia), dizziness
• heart problems (heart failure)
• low blood pressure (hypotension)
• feeling of tiredness (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
• decrease in the number of red blood cells (anaemia)
• weight gain
• increased levels of cholesterol in the blood (hypercholesterolaemia)
• changes in blood sugar levels in diabetic patients
• depression, depressed mood
• vision disturbances, reduced tear production (dry eyes), eye irritation
• decrease in the number of heartbeats (bradycardia)
• fluid retention causing general swelling of the body or of certain body parts (oedema), excess fluid
• increase in the amount of circulating blood (hypervolaemia)
• dizziness when standing up, due to a rapid drop in blood pressure (orthostatic hypotension)
• circulation problems in arms and legs causing cold sensation in hands and feet and pain in extremities
• tingling and pain in fingers, followed by sensation of heat and pain (Raynaud's phenomenon)
• difficulty in movement (intermittent claudication)
• shortness of breath (dyspnoea) and asthma (especially in patients predisposed to asthma)
• fluid accumulation in the lung (pulmonary oedema)
• nausea, diarrhoea, vomiting
• digestive problems (dyspepsia) and abdominal pain
• kidney problems (renal failure and changes in kidney function) in patients with widespread vascular disease and/or kidney failure
• urinary disorders
• pain

Uncommon (may affect up to 1 in 100 people)

• sleep disorders
• various skin reactions (e.g. allergic rash, dermatitis, urticaria, pruritus, psoriasiform skin lesions, lichen planus-like lesions)
• loss of hair and body hair (alopecia)
• erectile dysfunction (erectile dysfunction)
• heart conduction system disorders (atrioventricular block)
• chest pain caused by heart circulation problems (angina pectoris)
• feeling of fainting (pre-syncope), fainting (syncope), tingling in extremities (paraesthesia)

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

• stuffy nose (nasal congestion)
• decrease in the number of platelets in the blood (thrombocytopenia)

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

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

Following the instructions contained in this leaflet reduces the risk of side effects.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via 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 Carvedilol Tecnigen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month. The stated expiry date applies to the product in its original, unopened 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 via 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 substance is carvedilol. One 6.25 mg tablet contains 6.25 mg of carvedilol; one 25 mg tablet contains 25 mg of carvedilol.
• The other components are: lactose monohydrate, sucrose, povidone K25, crospovidone, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Carvedilolo TecniGen and contents of the pack
Carvedilolo TecniGen is available as scored tablets.
Box containing 28 scored tablets of 6.25 mg
Box containing 30 scored tablets of 25 mg

Marketing Authorization Holder
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 - Cinisello Balsamo (MI)

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