Caravel

Package leaflet: Information for the patient

CARAVEL 6.25 mg tablets, 25 mg tablets

carvedilol
Equivalent 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 may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CARAVEL is and what it is used for

CARAVEL contains the active substance carvedilol, which lowers blood pressure and reduces the heart's workload.
CARAVEL is indicated for the treatment of:

• essential arterial hypertension (high blood pressure). It may be used alone or in combination with other antihypertensive medicines, 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 CARAVEL

Do not take CARAVEL

• if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6);
• if you have unstable/compensated heart failure or severe heart failure (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 and breastfeeding");
• if you have heart rhythm disorders (second- or third-degree atrioventricular block), unless you have a permanent pacemaker implanted;
• if you have severe bradycardia (less than 50 beats per minute);
• if you have sinoatrial disease, including sinoatrial block (severe slowing of heart rate);
• if you have severe hypotension (very low blood pressure);
• if you are experiencing cardiogenic shock (reduced blood flow to 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);
• if you have uncontrolled phaeochromocytoma (a tumor of the adrenal gland) not controlled by medication;
• if you have metabolic acidosis (alteration 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 CARAVEL”).

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

• you have chronic congestive heart failure (a condition in which the heart cannot pump blood efficiently), as heart failure or fluid retention may worsen. If your condition worsens during treatment, your doctor will consider reducing the dose or switching to an alternative therapy;
• you have chronic heart failure with low blood pressure, ischemic heart disease (heart damage 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 acute myocardial infarction (death of heart cells due to prolonged lack of oxygen). In this case, your doctor will prescribe appropriate treatment before starting CARAVEL;
• you are diabetic and are being treated with glucose-lowering medicines (medicines that reduce blood sugar levels), as taking CARAVEL may impair blood glucose control, or mask or reduce the initial signs and symptoms of acute hypoglycemia (sudden drop in blood sugar), such as tachycardia (fast heartbeat), blurred vision, dizziness, sweating, restlessness. Regular blood glucose monitoring is necessary during treatment to adjust medication dosages;
• 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 CARAVEL may mask its symptoms (e.g. tachycardia). Do not stop CARAVEL treatment suddenly, as this may affect thyroid function;
• you are scheduled for surgery requiring anesthetics (medicines that induce sedation, reduce pain sensitivity, and cause muscle relaxation), as carvedilol may enhance the effects 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 desensitization therapy (receiving gradually increasing doses of a drug to which you are hypersensitive, to achieve safe and effective dosing), as increased sensitivity may occur;
• you have psoriasis (an inflammatory skin disease characterized by thickened, red patches covered with grey scales), or have phaeochromocytoma (a tumor causing high blood pressure), as your doctor will prescribe CARAVEL only after assessing the risk-benefit ratio;
• you have Prinzmetal's angina (chest pain of cardiac origin), as taking CARAVEL may worsen it;
• 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 “Possible side effects”;
• you wear contact lenses, as CARAVEL may reduce tear production.

Treatment with CARAVEL must not be stopped abruptly. Discontinuation of carvedilol should be gradual (over a period of two weeks). During treatment with CARAVEL, very rare cases of serious skin and mucosal reactions have been reported, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see section 4 “Possible side effects”). In such cases, contact your doctor immediately, as CARAVEL must be discontinued.

Other medicines and CARAVEL
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 and oral hypoglycemics (medicines for treating diabetes);
• antihypertensives, such as reserpine and clonidine (medicines used to lower blood pressure);
• anesthetics 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.

CARAVEL and alcohol
Alcohol may enhance the hypotensive effect of carvedilol (lowering blood pressure).

CARAVEL 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 a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of CARAVEL during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus or newborn.
If you take this medicine, discontinue treatment 2–3 days before the expected delivery date. If this is not possible, the newborn must be monitored for the first 2–3 days of life.

Breastfeeding
CARAVEL must not be used during breastfeeding (see section “Do not take CARAVEL”).

Driving and using machines
No studies have been conducted on the effects of carvedilol on the ability to drive and operate machinery.
CARAVEL may cause dizziness and visual disturbances; therefore, your ability to drive or operate machinery may be impaired. These effects may occur mainly at the beginning of treatment, after dose increases, when switching to another medicine, or when alcohol is consumed concurrently.

For athletes
The use of this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

CARAVEL contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine.

3. How to take CARAVEL

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Treatment of essential arterial hypertension
Dosage
Adults
The recommended starting dose is 12.5 mg once daily for the first 2 days. Subsequently, the recommended dose is 25 mg once daily. If necessary, the dose may be gradually increased at intervals of no less than 2 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 2 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 2 days. Subsequently, 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. Subsequently, the dose may be increased after an interval of at least 2 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 2 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 dosage should be increased up to the highest dose tolerated.

The maximum recommended dose is 25 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 assess any signs of worsening heart failure or vasodilation and, if necessary, evaluate whether to interrupt treatment. If treatment with CARAVEL is discontinued 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 CARAVEL in children and adolescents have not yet been established.

Method of administration
The tablet may be divided into equal parts.
Tablets should be taken with a sufficient amount of liquid, regardless of meals.
However, taking the tablets with meals is recommended in cases of heart failure (inability of the heart to supply an adequate amount of blood to the body), in order to slow down the absorption of the medicine and reduce the incidence of orthostatic hypotension (a drop in blood pressure upon standing).

If you take more CARAVEL than you should
In case of accidental ingestion/overdose of CARAVEL, contact your doctor immediately or go to the nearest hospital.
In case of overdose, the following may occur: 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 bronchi), vomiting, disturbances in consciousness, and generalized convulsive seizures (sudden, involuntary, uncontrolled movements) may also occur.
Your doctor will initiate treatment appropriate to your clinical condition and, if necessary, monitor and correct your vital parameters under intensive care conditions.

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

If you stop taking CARAVEL
CARAVEL must be discontinued gradually over a period of 2 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 everybody gets them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

• dizziness, vertigo, headache;
• heart failure (inability of the heart to pump blood efficiently);
• hypotension (low blood pressure);
• asthenia (weakness). Dizziness, syncope, headache and asthenia are generally mild and are more likely to occur at the beginning of treatment. Common (may affect up to 1 in 10 people)
• bronchitis and pneumonitis (inflammation of the bronchi and lungs), upper respiratory tract infections;
• urinary tract infections;
• anaemia (reduction in the amount of 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 or hypoglycaemia (increased or decreased blood glucose levels) in people with diabetes;
• depression, depressed mood;
• syncope, pre-syncope (loss of consciousness, feeling of impending loss of consciousness);
• visual disturbances, decreased lacrimation (dry eyes), eye irritation;
• bradycardia (reduced heart rate);
• hypertension (high blood pressure);
• hypervolaemia (increased volume of circulating blood), fluid accumulation;
• 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 the 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 diffuse vascular disease and/or pre-existing renal failure;
• 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 (disturbances in the conduction of the cardiac impulse between atrium and ventricle), angina pectoris (chest pain);
• constipation;
• skin reactions, e.g. allergic rash (allergic skin eruption), dermatitis (skin irritation), urticaria, pruritus, psoriatic skin lesions (raised, red, scaly patches), and lichen planus-like skin lesions (rough, scaly red 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 urination). 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) ;
• severe skin reactions with wheals, blisters and vesicles (e.g. erythema multiforme, Stevens-Johnson syndrome, 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 blood glucose;
• sinus arrest (temporary pause in the heartbeat);
• hyperhidrosis (excessive sweating);
• urinary incontinence (difficulty in retaining urine) in women, which resolves upon discontinuation of treatment;
• hallucinations (perception of things not present in reality).

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 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 CARAVEL

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 "Expiry". 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. Contents of the pack and other information

What CARAVEL contains
CARAVEL 6.25 mg tablets

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

CARAVEL 25 mg tablets

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

Description of the appearance of CARAVEL and contents of the pack
CARAVEL 6.25 mg tablets
Light yellow, round tablets with a score line. Box containing 28 divisible tablets.
CARAVEL 25 mg tablets
White, round tablets with a score line. Box containing 30 divisible tablets.

Marketing Authorization Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 Milan.

Manufacturers
DOPPEL Farmaceutici S.r.l. – Via Volturno, 48 – 20089 Quinto De’ Stampi - Rozzano (MI).
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. - Via di Fossignano, 2 - 04011 APRILIA (LT).