Carvedilolo PensA: detailed information

Package leaflet: Information for the patient

CARVEDILOLO PENSA 6.25 mg tablets, 25 mg tablets

Carvedilolo
Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CARVEDILOLO PENSA is and what it is used for
What you need to know before taking CARVEDILOLO PENSA
How to take CARVEDILOLO PENSA
Possible side effects
How to store CARVEDILOLO PENSA
Contents of the pack and other information

1. What CARVEDILOLO PENSA is and what it is used for

This medicinal product contains the active substance carvedilolo, which reduces the workload of the heart by lowering blood pressure.
CARVEDILOLO PENSA is indicated for the treatment of:

essential arterial hypertension (high blood pressure). It may be used alone or in combination with other antihypertensive medicinal products, particularly thiazide diuretics;
angina pectoris (heart disease causing chest pain);
heart failure (the heart's inability to supply sufficient blood to the body).

2. What you should know before taking CARVEDILOL PENSA

Do not take CARVEDILOL PENSA

if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6);
if you have severe unstable / decompensated heart failure or severe cardiac decompensation (serious conditions in which the body is unable to compensate for reduced cardiac contractile function);
if you have severe liver problems;
if you are breastfeeding (see "Pregnancy, breastfeeding and fertility");
if you have heart rhythm disorders (second- or third-degree atrioventricular block) unless you have a permanently implanted pacemaker;
if you have severe bradycardia (less than 50 beats per minute);
in case of sinoatrial node dysfunction, including sinoatrial block (severe reduction in heart rate);
if you have severe hypotension (very low blood pressure);
in case of cardiogenic shock (reduced blood flow to the body's organs and tissues due to decreased heart function);
if you have bronchial asthma (narrowing and inflammation of the bronchi) or other respiratory diseases with a bronchospastic component (e.g. chronic obstructive pulmonary disease (COPD), a condition that makes it difficult to empty air from the lungs), and you are not receiving oral or inhaled medication for these conditions;
in case of uncontrolled phaeochromocytoma (a tumour affecting the adrenal gland) not adequately managed with medication;
if you have metabolic acidosis (a disturbance in blood acidity);
if you are being treated with medicines used to treat high blood pressure or heart rhythm disorders such as intravenous verapamil or diltiazem (see section "Other medicines and CARVEDILOL PENSA").

Warnings and precautions
Talk to your doctor or pharmacist before taking CARVEDILOL PENSA if:

You have chronic congestive heart failure (a condition in which the heart is unable to pump blood efficiently), as heart failure or fluid retention may worsen. If your condition deteriorates during treatment, your doctor will consider reducing the dose or switching to an alternative therapy.
You have chronic heart failure with low blood pressure, ischaemic heart disease (heart impairment due to reduced oxygen supply), or diffuse vascular disease (narrowing of arteries), as treatment with carvedilol may worsen kidney function. In such cases, your doctor will assess whether treatment should be discontinued or the dose reduced.
You have left ventricular dysfunction (a part of the heart unable to contract effectively or fill adequately) following an acute myocardial infarction (death of heart cells due to prolonged lack of oxygen). In this case, your doctor will prescribe appropriate treatment before initiating CARVEDILOL PENSA.
You have diabetes and are being treated with glucose-lowering medicines (medicines that reduce blood sugar levels), as taking CARVEDILOL PENSA may impair blood glucose control. Additionally, early signs and symptoms of acute hypoglycaemia (sudden drop in blood sugar), such as tachycardia (rapid heartbeat), blurred vision, dizziness, sweating, and restlessness, may be masked or diminished. Regular blood glucose monitoring is necessary during treatment to adjust medication doses appropriately.
You have peripheral vascular disease (reduced blood flow to arteries due to obstruction or narrowing in the limbs), as this may worsen with carvedilol treatment.
You have thyrotoxicosis (excess thyroid hormones), as CARVEDILOL PENSA may mask symptoms (e.g. tachycardia). Do not stop treatment abruptly, as this may worsen thyroid function.
You are scheduled for surgery requiring anaesthetic medicines (medicines that induce sedation, reduce pain sensitivity, and cause muscle relaxation), as carvedilol may enhance the effects of anaesthetics on myocardial contractility.
You have bradycardia (reduced heart rate) with values below 55 beats per minute.
You have previously experienced a severe hypersensitivity reaction (allergy) or are currently undergoing desensitisation therapy (receiving gradually increasing doses of a drug to which you are hypersensitive, to enable safe and effective dosing), as increased sensitivity may occur.
You have psoriasis (an inflammatory skin disease characterised by thickened, red patches covered with grey scales) or have a tumour of the adrenal gland called phaeochromocytoma (a tumour causing high blood pressure), as your doctor will prescribe CARVEDILOL PENSA only after assessing the risk-benefit balance.
You have Prinzmetal's angina (a type of chest pain of cardiac origin), as taking CARVEDILOL PENSA may worsen it.
You wear contact lenses, as CARVEDILOL PENSA may reduce tear production.
You have first-degree heart block (a disturbance in heart rhythm), as carvedilol may reduce the speed of electrical impulse conduction in the heart.
You are elderly or have heart rhythm disorders such as bradycardia (slow heart rate), sinoatrial dysfunction, or atrioventricular block (types of arrhythmias), as sinus arrest (a temporary pause in heartbeat) may occur (see section 4 "Possible side effects").
You use contact lenses, as CARVEDILOL PENSA may reduce tear production.

Do not stop CARVEDILOL PENSA treatment suddenly.
Discontinuation of carvedilol must be gradual (over a period of two weeks). Very rare cases of severe skin and mucous membrane reactions, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported during treatment with CARVEDILOL PENSA (see section 4 "Possible side effects"). In such cases, contact your doctor immediately, as treatment with CARVEDILOL PENSA must be discontinued.

Other medicines and CARVEDILOL PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking:

Digoxin, a medicine used to treat heart conditions;
Cyclosporine and tacrolimus, medicines used to prevent organ transplant rejection;
Antiarrhythmics such as amiodarone, medicines used to regulate heart rhythm;
Fluoxetine and paroxetine, medicines used to treat depression;
Rifampicin, an antibiotic used to treat bacterial infections;
Cimetidine, a medicine used to treat ulcers and heartburn;
Insulin or oral hypoglycaemics (medicines for diabetes treatment);
Antihypertensives such as reserpine and clonidine (medicines used to lower blood pressure);
Anaesthetics and neuromuscular blocking agents, medicines that induce sedation, reduce pain sensitivity, and cause muscle relaxation;
Non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for pain, inflammation, and fever;
Bronchodilators, medicines used to treat respiratory problems.

CARVEDILOL PENSA and alcohol
Alcohol may enhance the hypotensive effect of carvedilol (lowering blood pressure).
CARVEDILOL PENSA and grapefruit juice
It is recommended to avoid consuming grapefruit juice during treatment with carvedilol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Administration of CARVEDILOL PENSA during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus or newborn.
If the medicine is taken, discontinue treatment 2–3 days before the expected delivery. If this is not possible, the newborn must be monitored for the first 2–3 days of life.
Breastfeeding
CARVEDILOL PENSA must not be used during breastfeeding (see section "Do not take CARVEDILOL PENSA").
Driving and using machines
No studies have been conducted on the effects of carvedilol on the ability to drive or operate machinery. CARVEDILOL PENSA may cause dizziness and visual disturbances; therefore, your ability to drive or use machinery may be impaired. These effects may occur mainly at the beginning of treatment, after dose increases, when switching to another medicine containing carvedilol, or when alcohol is consumed concurrently.
CARVEDILOL PENSA 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.
For those engaged in sports activities
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take CARVEDILOLO PENSA

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The tablets can be divided into equal doses.

Treatment of essential arterial hypertension
Dosage
Adults
The recommended starting dose 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 daily, taken as a single dose or divided into 25 mg twice daily.

Elderly
The recommended starting dose is 12.5 mg once daily. If necessary, your doctor may increase the dose at intervals of at least two weeks, up to the maximum recommended dose of 50 mg daily, taken as 25 mg twice daily.

Treatment of angina pectoris
Dosage
Adults
The recommended starting dose is 12.5 mg twice daily for the first two days.
Thereafter, the recommended dose is 25 mg twice daily.
Do not exceed the maximum recommended daily dose.

Elderly
The recommended starting dose is 12.5 mg twice daily. Thereafter, the dose may be increased after an interval of at least two days to 25 mg twice daily.
Do not exceed the maximum recommended daily dose.

Treatment of heart failure
Dosage
Your doctor will prescribe the appropriate dose for you and will closely monitor you during the period required to reach the dosage suitable for you.
The recommended starting dose is 3.125 mg (half a 6.25 mg tablet) twice daily for at least 2 weeks. After two weeks, if this dose is well tolerated, the dosage may be increased at intervals of no less than 2 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 that is tolerated.

The maximum recommended dose is 50 mg twice daily in cases of severe heart failure and in mild to moderate heart failure with body weight below 85 kg. In cases of mild to moderate heart failure with body weight above 85 kg, the maximum recommended dose is 50 mg twice daily.

Before each dose increase, your doctor will check for any signs of worsening heart failure or vasodilation and, if necessary, will consider discontinuing treatment.

If treatment with CARVEDILOLO PENSA is interrupted for more than two weeks, therapy should be restarted with 3.125 mg (half a 6.25 mg tablet) twice daily, and the dosage should then be increased according to the previous recommendations.

Use in children and adolescents
The safety and efficacy of CARVEDILOLO PENSA in children and adolescents have not yet been established.

Instructions for administration
The tablet can be divided into equal doses.
The tablets should be taken with a sufficient amount of liquid, regardless of meals.
Taking the tablets with meals is recommended in patients with heart failure (inability of the heart to supply adequate blood flow to the body), in order to slow down the absorption of the medicine and reduce the incidence of orthostatic hypotension (low blood pressure upon standing up).

If you take more CARVEDILOLO PENSA than you should
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
Overdose may cause: severe hypotension (low blood pressure), bradycardia (reduced heart rate), heart failure (inability of the heart to pump blood efficiently), cardiogenic shock (reduced blood flow to organs and tissues due to decreased heart function), and cardiac arrest. Respiratory problems, bronchospasm (constriction of the airways), vomiting, disturbances in consciousness, and generalized convulsive seizures (sudden, uncontrolled, involuntary movements) may also occur.
Your doctor will initiate treatment appropriate to your clinical condition and, if necessary, monitor and correct your vital signs under intensive care conditions.

If you forget to take CARVEDILOLO PENSA
Do not take a double dose to make up for the missed dose.

If you stop taking CARVEDILOLO PENSA
CARVEDILOLO PENSA should be discontinued gradually over a period of two weeks and under medical supervision.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
At the beginning of treatment, dizziness, fainting (syncope), headache, and asthenia (weakness) may occur more frequently. These effects are generally mild.

The following side effects may occur:
Very common (may affect more than 1 in 10 people):

dizziness, headache;
heart failure (inability of the heart to pump blood efficiently);
hypotension (low blood pressure);
asthenia (weakness).

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

bronchitis and pneumonia (inflammation of the bronchi and lungs), upper respiratory tract infections;
urinary tract infections;
anaemia (reduction in haemoglobin, a protein found in red blood cells that carries oxygen in the blood);
weight gain, hypercholesterolaemia (increased levels of cholesterol, a type of fat in the blood), hyperglycaemia and hypoglycaemia (increased or decreased blood glucose levels) in patients with diabetes;
depression, depressed mood;
visual disturbances, decreased lacrimation (dry eyes), eye irritation;
bradycardia (reduced heart rate);
hypertension (high blood pressure);
hypervolaemia (increased volume of circulating blood), fluid retention;
orthostatic hypotension (drop in blood pressure upon standing), peripheral circulatory disorders (cold hands and feet, problems with peripheral blood vessels), worsening of leg pain during physical activity (intermittent claudication), and Raynaud's phenomenon (constriction of blood vessels in hands and feet causing pain and skin colour changes);
dyspnoea (difficulty breathing), pulmonary oedema (fluid accumulation in the lungs), asthma (narrowing and inflammation of the bronchi in patients predisposed to this condition);
nausea, diarrhoea, vomiting, dyspepsia (indigestion), abdominal pain;
extremity pain (in hands and feet);
renal failure and altered kidney function in patients with widespread vascular disease and/or pre-existing renal insufficiency;
pain;
oedema (fluid accumulation).

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

sleep disorders;
confusion;
paraesthesia (tingling or numbness sensations in hands and feet);
atrioventricular block (disturbance in the conduction of the cardiac impulse between atrium and ventricle), angina pectoris (chest pain);
syncope, pre-syncope (fainting, feeling faint);
constipation;
skin reactions, e.g. allergic rash (allergic skin eruption), dermatitis (skin irritation), urticaria, pruritus, psoriasiform skin lesions (raised, red, scaly patches), lichen planus-like skin lesions (rough, red, scaly patches), alopecia (hair loss);
erectile dysfunction (erection disorders).

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

thrombocytopenia (decreased number of platelets in the blood);
nasal congestion (stuffy nose);
dry mouth;
urinary disorders (urine retention or difficulty in passing urine).

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

leucopenia (decreased number of white blood cells in the blood);
hypersensitivity (allergic reaction);
increased levels of liver enzymes, proteins that rise in case of liver damage (ALT, AST and GGT);
urinary incontinence (difficulty holding urine) in women, which resolves upon discontinuation of treatment;
severe skin reactions with wheals, blisters and vesicles (e.g. erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the available data):

onset of diabetes symptoms with altered blood sugar levels (glycaemia), worsening of diabetes, changes in glycaemia;
sinus arrest (temporary pause in the heartbeat);
hyperhidrosis (excessive sweating);
hallucinations (perception of non-existent things).

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 the website
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 PENSA

Keep this medicine out of the 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.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What CARVEDILOLO PENSA contains
CARVEDILOLO PENSA 6.25 mg tablets

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

CARVEDILOLO PENSA 25 mg tablets

The active substance is carvedilolo.
The other components are: sucrose, monohydrate lactose, polyvinylpyrrolidone, anhydrous colloidal silicon dioxide, crospovidone, magnesium stearate.

Description of the appearance of CARVEDILOLO PENSA and contents of the pack
CARVEDILOLO PENSA 6.25 mg tablets
Pack of 28 tablets in PVC/Al blisters.
CARVEDILOLO PENSA 25 mg tablets
Pack of 30 tablets in PVC/Al blisters.

Marketing Authorization Holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milano

Manufacturers
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. - Via di Fossignano, 2 - 04011 APRILIA (LT)
Doppel Farmaceutici S.r.l. - Via Volturno, 48 – Quinto De’ Stampi – Rozzano (Milano)