Carvedilol Doc Generici

Patient Information Leaflet

CARVEDILOLO DOC Generici 6.25 mg scored tablets, 25 mg scored tablets

Generic medicine
Please read all of this leaflet carefully before you take 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 give it to other people, even if they have the same symptoms as yours, because it may 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 DOC Generici is and what it is used for
2. What you need to know before taking CARVEDILOLO DOC Generici
3. How to take CARVEDILOLO DOC Generici
4. Possible side effects
5. How to store CARVEDILOLO DOC Generici
6. Contents of the pack and other information

1. What CARVEDILOLO DOC Generici is and what it is used for

This medicinal product contains the active substance carvedilol, which belongs to a group of medicines called beta-blockers, that relax and widen blood vessels, lowering blood pressure and reducing the workload of the heart.
CARVEDILOLO DOC Generici is indicated for:

• the treatment of high blood pressure (hypertension), either alone or in combination with other medicines used to treat high blood pressure, such as thiazide diuretics;
• the treatment of chest pain caused by heart problems (angina pectoris);
• the treatment of a condition characterized by the heart's inability to deliver sufficient blood to the body (heart failure).

2. What you should know before taking CARVEDILOLO DOC Generici

Do not take CARVEDILOLO DOC Generici

• if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6);
• if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Pulmonary Disease) or have previously suffered from asthma or other obstructive respiratory problems (bronchospasm);
• if you have liver problems;
• if your heart function is insufficient to ensure adequate blood supply to the body (unstable or decompensated heart failure);
• if you have heart conduction problems (untreated second- or third-degree atrioventricular block, sinoatrial node disease);
• if you have a very slow heart rate (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 untreated tumor of the adrenal gland called pheochromocytoma;
• if your doctor has told you that the acidity level of your blood is higher than normal (metabolic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking CARVEDILOLO DOC Generici.
Pay special attention and consult your doctor before taking this medicine:

• if your heart function is insufficient and you suffer from fluid retention (congestive heart failure);
• if your heart function is insufficient and you have low blood pressure (systolic pressure below 100 mmHg);
• if you have problems with blood circulation or inadequate blood supply to the heart (ischemic heart disease);
• if you have severe kidney problems (renal failure);
• if you have recently had a heart attack;
• if you have respiratory problems caused by a lung disease called COPD (Chronic Obstructive Pulmonary Disease);
• if you have diabetes or low blood sugar levels (hypoglycemia). Carvedilol may mask or reduce the signs and symptoms of acute hypoglycemia, especially increased heart rate (tachycardia);
• if you have circulation problems in the limbs or suffer from a condition called Raynaud's phenomenon, characterized by poor blood flow to the fingers or toes, which become painful and whitish;
• if you have thyroid problems (thyrotoxicosis), because carvedilol may hide the symptoms;
• if you are undergoing surgery requiring anesthesia. Inform the anesthesiologist that you are taking CARVEDILOLO DOC Generici;
• if you have a very slow heart rate (bradycardia), less than 55 beats per minute;
• if you have previously experienced severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitization therapy;
• if you suffer from a skin inflammatory disease called psoriasis;
• if you are taking other medicines to lower blood pressure containing verapamil or diltiazem, or antiarrhythmic medicines; in these cases, you should have your blood pressure and heart rate monitored regularly; verapamil and diltiazem must not be administered intravenously in combination;
• if you have sudden changes in blood pressure (labile hypertension) or high blood pressure due to other conditions (secondary hypertension);
• if you have a tumor of the adrenal gland called pheochromocytoma;
• 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, as reduced tear production may occur.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Other medicines and CARVEDILOLO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pay special attention and consult your doctor if you are taking:

• medicines used to treat heart rhythm disorders (digoxin and other digitalis glycosides);
• medicines used to treat diabetes such as insulin and oral hypoglycemics;
• rifampicin, a medicine used to treat tuberculosis;
• cimetidine, a medicine used to treat stomach lesions and heartburn (ulcers);
• antidepressant medicines called monoamine oxidase inhibitors (MAOIs);
• medicines used to treat high blood pressure, such as reserpine, diltiazem, verapamil, and antiarrhythmic medicines (see section Warnings and precautions);
• medicines used to treat pain and inflammation (NSAIDs) such as ibuprofen, ketoprofen, acetylsalicylic acid, or other analgesics, as they may in some cases reduce the blood pressure-lowering effect of carvedilol;
• cyclosporine, a medicine used to prevent organ rejection after transplantation;
• medicines used to treat heart conditions and high blood pressure (calcium channel blockers and antihypertensives);
• clonidine, a medicine used to treat high blood pressure. If both medicines are administered together, clonidine should be discontinued several days after stopping carvedilol;
• amiodarone or other medicines used to control heart rhythm;
• fluoxetine, a medicine used to treat depression;
• beta-agonist bronchodilator medicines (used to treat chest tightness and shortness of breath caused by asthma or other chest conditions, such as salbutamol and terbutaline);
• medicines used to induce anesthesia (see section Warnings and precautions).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary.
The use of this medicine is not recommended if you are breastfeeding.

Driving and using machines
There are no data available 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 vehicles or operating machinery. This is particularly important at the beginning of treatment, after dose increases, when switching products, or if you consume alcohol.

CARVEDILOLO DOC Generici contains lactose and sucrose
This medicine contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take CARVEDILOLO DOC Generici

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, regardless of meals. However, if you suffer
from heart failure, take the medicine during meals to reduce the occurrence of
undesirable effects.

Treatment of high blood pressure (essential arterial hypertension)
The recommended starting dose is 12.5 mg once daily for the first 2 days. Subsequently, the recommended dose
is 25 mg once daily. Afterwards, the dosage may be gradually increased at intervals of no less than 2 weeks, up to
the maximum recommended dose of 50 mg per day, taken as either one or two doses.

Treatment of chest pain caused by heart problems (angina pectoris)
The recommended starting dose is 12.5 mg twice daily for the first 2 days; thereafter, the dosage may be increased up to the maximum recommended dose of 25 mg twice daily.

Treatment of heart failure
Treatment must be carried out under close medical supervision, with the doctor adjusting the dosage according to your individual needs until the appropriate dosage is reached. Take the tablets during meals with some liquid.
The recommended starting dose is 3.125 mg twice daily for at least 2 weeks. Afterwards, if necessary, the dosage may be gradually increased at intervals of no less than 2 weeks, up to a maximum of 25 mg twice daily. If the patient weighs more than 85 kg, the maximum recommended dose is 50 mg twice daily.
Your doctor must monitor your condition and assess your health status before increasing the dosage of this medicine. If you experience worsening heart failure or fluid retention, dosage adjustment will be required.
If you discontinue treatment with this medicine for more than two weeks, therapy should be restarted with the lowest dose of 3.125 mg twice daily, which may then be gradually increased.

Use in children
There are no data available on the use of this medicine in children under 18 years of age.

Use in the elderly
The recommended starting dose for the treatment of essential hypertension is 12.5 mg once daily, which may be increased at intervals of no less than 2 weeks, up to the maximum recommended dose of 50 mg per day, divided into two 25 mg doses.
The recommended starting dose for the treatment of angina pectoris is 12.5 mg twice daily, which may be increased after an interval of at least 2 days up to the maximum dose of 25 mg twice daily.

If you take more CARVEDILOLO DOC Generici than you should
If you have taken or ingested too much of this medicine, contact your doctor or the nearest hospital immediately.
Overdose may cause the following symptoms:
slowing of the heartbeat (bradycardia), low blood pressure (hypotension),
impaired heart function (heart failure, cardiogenic shock, and cardiac arrest), breathing difficulties (bronchospasm), vomiting, altered consciousness, and seizures.

If you forget to take CARVEDILOLO DOC Generici
Do not take a double dose to make up for the forgotten tablet.

If you stop taking CARVEDILOLO DOC Generici
Do not stop treatment with this medicine without consulting your doctor.
Discontinuation of treatment with this medicine should be gradual over a period of 2 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 everyone gets them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

• headache and dizziness;
• heart problems (heart failure);
• low blood pressure;
• feeling of fatigue (asthenia).

Common (may affect up to 1 in 10 people)

• airway infections (bronchitis), lungs (pneumonia), nose and throat (upper respiratory tract);
• urinary tract infections;
• decrease in the number of red blood cells (anaemia);
• weight gain;
• increased blood cholesterol levels (hypercholesterolaemia);
• changes in blood sugar levels in people with diabetes;
• depression;
• vision problems, dry eyes and eye irritation;
• decrease in heart rate (bradycardia);
• fluid retention causing general swelling of the body or certain parts of the body, for example hands, feet, ankles and legs (oedema), and an increase in blood volume (hypervolaemia);
• dizziness when standing up due to a rapid drop in blood pressure (orthostatic hypotension), which may be associated with fainting;
• circulation problems in arms and legs causing cold hands and feet and pain;
• tingling and pain in fingers, followed by a sensation of heat and pain (Raynaud's phenomenon);
• difficulty in movement (intermittent claudication);
• breathing difficulties, especially in patients who have or have had asthma;
• fluid accumulation in the lung (pulmonary oedema);
• nausea, diarrhoea, vomiting;
• abdominal pain and digestive problems;
• kidney problems and difficulty urinating;
• pain.

Uncommon (may affect up to 1 in 100 people)

• sleep disorders;
• feeling faint, fainting, tingling in the extremities (paraesthesia);
• heart block (atrioventricular block);
• chest pain caused by circulation problems in the heart (angina pectoris);
• constipation;
• skin reactions such as rash, dermatitis, urticaria, itching, skin lesions;
• increased sweating;
• hair loss (alopecia);
• erectile problems (erectile dysfunction).

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

• decrease in platelets in the blood;
• blocked nose (nasal congestion);
• dry mouth.

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

• decrease in white blood cells in the blood (leucopenia);
• allergic reactions;
• alteration of liver function and increased levels of liver enzymes (ALT, AST, GGT);
• urinary incontinence in women, which resolves upon discontinuation of treatment;
• severe skin disorders characterised by skin lesions (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 CARVEDILOLO DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging to protect the medicine from light and moisture.
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 DOC Generici contains
CARVEDILOLO DOC Generici 6.25 mg, divisible tablets

• The active substance is carvedilolo. Each tablet contains 6.25 mg of carvedilolo.
• The other components are: sucrose, monohydrate lactose, polyvinylpyrrolidone, anhydrous colloidal silicon dioxide, crospovidone, magnesium stearate, yellow iron oxide (E 172).

CARVEDILOLO DOC Generici 25 mg, divisible tablets

• The active substance is carvedilolo. Each tablet contains 25 mg of carvedilolo.
• The other components are: sucrose, monohydrate lactose, polyvinylpyrrolidone, anhydrous colloidal silicon dioxide, crospovidone, magnesium stearate.

Description of the appearance of CARVEDILOLO DOC Generici and contents of the pack
Box containing 28 divisible tablets of 6.25 mg in PVC/Al blisters.
Box containing 30 divisible tablets of 25 mg in PVC/Al blisters.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan.
Manufacturer
Lachifarma S.r.l. - Laboratorio Chimico Salentino, S.S. 16 Zona Industriale, 73010 Zollino (LE)
SPL - Special Product’s Line S.p.A. - Strada Paduni, 240 - 03012 Anagni (FR)