CARAVEL 6.25 mg Coated tablet

Зміст інструкції

1. CARAVEL 6.25 mg tablets, 25 mg tablets
   1. What is CARAVEL and what is it 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

CARAVEL 6.25 mg tablets, 25 mg tablets

carvedilol
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is CARAVEL and what is it used for

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

• essential hypertension (high blood pressure). It can be used alone or in combination with other medicines for the treatment of high blood pressure, especially with thiazide diuretics;
• angina pectoris (heart disease that causes chest pain);
• heart failure (inability of the heart to provide an adequate amount of blood to the body).

2. What you need to know before taking CARAVEL

Do not take CARAVEL

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• if you have unstable/decompensated heart failure or severe heart failure (serious conditions in which the body is unable to balance the reduction in the heart's contractile activity);
• if you have severe liver problems;
• if you are breastfeeding (see “Pregnancy and breastfeeding”);
• if you have heart rhythm disturbances (atrioventricular block of 2nd and 3rd degree) unless you have been fitted with a permanent pacemaker;
• if you suffer from severe bradycardia (have less than 50 beats per minute);
• in case of sinus node disease, including sinoatrial block (severe reduction in heart rate);
• if you suffer from severe hypotension (very low blood pressure);
• in case of cardiogenic shock (decreased blood flow reaching the organs and tissues of the body, due to a decrease in heart activity);
• if you suffer from bronchial asthma (narrowing and inflammation of the bronchi) or other respiratory diseases with a bronchospastic component (e.g. chronic obstructive pulmonary disease (COPD), a disease that makes it difficult to empty the air from the lungs);
• in case of pheochromocytoma (a tumor that affects the adrenal gland) not controlled by certain medications;
• if you suffer from metabolic acidosis (alteration of blood acidity);
• if you are being treated with medications used to treat high blood pressure or heart rhythm disturbances such as verapamil or diltiazem intravenously (see section “Other medicines and CARAVEL”).

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

• you suffer from chronic congestive heart failure (a condition in which the heart is unable to pump blood efficiently) as worsening of heart failure or fluid retention may occur. If your condition worsens during therapy, your doctor will consider reducing the dose or alternative therapy;
• you suffer from chronic heart failure with low blood pressure, ischemic heart disease (heart suffering due to reduced oxygen supply) and widespread vascular disease (narrowing of the arteries) as carvedilol treatment may worsen kidney function. In such circumstances, your doctor will assess the need to discontinue treatment or reduce the dosage;
• you suffer from left ventricular dysfunction (a portion of the heart is unable to contract effectively or fill adequately) after acute myocardial infarction (death of heart cells due to prolonged lack of oxygen supply). In this case, your doctor will prescribe appropriate treatment before starting CARAVEL;
• you are diabetic and are being treated with medications that lower blood glucose (amount of sugar in the blood), as taking CARAVEL may be associated with worsening blood glucose control, or the initial signs and symptoms of acute hypoglycemia (sudden drop in blood sugar), such as tachycardia (fast heartbeat), blurred vision, dizziness, sweating, restlessness, may be masked or attenuated. Regular blood glucose monitoring is necessary during treatment to adjust medication dosages;
• you suffer from peripheral vasculopathy (reduced blood flow to the arteries due to obstruction or narrowing of the latter at the level of the limbs) as it may worsen with carvedilol treatment;
• you have hyperthyroidism (excess of hormones produced by the thyroid gland), as taking CARAVEL may mask its symptoms (e.g. tachycardia). Do not suddenly stop treatment with CARAVEL as it may alter thyroid function;
• you are going to undergo surgery requiring the use of anesthetics (medicines that induce sedation, reduce sensitivity to pain and muscle relaxation) as carvedilol may increase the effect of muscle contractility;
• you have bradycardia (reduction in heart rate), with values below 55 beats per minute;
• you have had a severe hypersensitivity reaction (allergy) in the past or are currently undergoing desensitization therapy (taking progressively increasing doses of a drug to which you are hypersensitive, in order to be able to take it at effective and safe doses), as increased sensitivity may occur;
• you suffer from psoriasis (an inflammatory skin disease characterized by thickened and reddened patches covered with gray scales) or if you are affected by pheochromocytoma (a tumor that causes high blood pressure), as your doctor will prescribe CARAVEL only after making a risk/benefit assessment;
• you suffer from Prinzmetal's angina (chest pain of cardiac origin, because taking CARAVEL may increase it;
• you have a first-degree heart block (an alteration of the heartbeat) because carvedilol can reduce the speed of conduction of the heart's electrical impulse;
• you are elderly or have heart rhythm disturbances such as bradycardia (slow heart rate), sinus node dysfunction or atrioventricular block (types of arrhythmias), as sinus arrest (a temporary pause in the heartbeat) may occur, see “Possible side effects”;
• you use contact lenses, as CARAVEL may reduce tear production.

The treatment with CARAVEL must not be stopped abruptly. Discontinuation of carvedilol must occur gradually (over a period of two weeks). During treatment with CARAVEL, very rare cases of severe skin and mucous membrane 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 because the intake of CARAVEL must be stopped.

Other medicines and CARAVEL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pay particular attention and tell your doctor if you are taking:

• digoxin, a medicine used to treat heart disease;
• cyclosporine and tacrolimus, medicines used to prevent organ rejection after transplantation;
• antiarrhythmics, such as amiodarone, medicines used to regulate the heartbeat;
• fluoxetine and paroxetine, medicines used to treat depression;
• rifampicin, an antibiotic, used to treat infections caused by bacteria;
• cimetidine, a medicine used to treat ulcers and heartburn;
• insulin and oral hypoglycemic agents (medicines for the treatment of diabetes);
• antihypertensives, such as reserpine and clonidine (medicines used to lower blood pressure);
• anesthetics and neuromuscular blocking agents, medicines that induce sedation, reduce sensitivity to pain and muscle relaxation;
• non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for pain and inflammation and fever;
• bronchodilators, medicines used to treat breathing problems.

CARAVEL with alcohol
Alcohol can enhance the hypotensive effect of carvedilol (lowers blood pressure).

CARAVEL and grapefruit juice
It is recommended to avoid drinking grapefruit juice during treatment with carvedilol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The administration of CARAVEL during pregnancy should be considered only if the expected benefit for the mother outweighs the risk to the fetus or child.
If you are taking the medicine, stop 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
CARAVEL should not be used during breastfeeding (see section “Do not take CARAVEL”).

Driving and operating machinery
Studies have not been conducted on the effects of carvedilol on the ability to drive and operate machinery.
CARAVEL may cause dizziness and visual disturbances, therefore the ability to drive and operate machinery may be impaired. These effects may occur predominantly at the beginning of treatment, after dose increases, when switching from another medicine and with the concomitant intake of alcohol.

For athletes
The use of this medicine without therapeutic need constitutes doping and may in any case result in positive doping tests.

CARAVEL 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 CARAVEL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Treatment of essential hypertension

Dosage

Adults
The recommended initial dose is 12.5 mg once a day, for the first 2 days. Subsequently
the recommended dose is 25 mg once a day. If necessary the dosage may be increased
gradually, at intervals of not less than 2 weeks, up to reaching the maximum recommended
dose of 50 mg per day to be taken in a single administration or divided into 25 mg
twice a day.

Elderly
The recommended dose for the start of therapy is 12.5 mg once a day. If necessary, the
doctor may increase the dose at intervals of at least 2 weeks, up to the maximum
recommended dose of 50 mg, to be taken in two doses of 25 mg twice a day.

Treatment of angina pectoris

Dosage

Adults
The recommended initial dose is 12.5 mg twice a day, for the first 2 days.
Subsequently, the recommended dose is 25 mg, twice a day.
Do not exceed the maximum recommended daily dose.

Elderly
The recommended dose for the start of therapy is 12.5 mg twice a day. Subsequently the
dose may be increased, after an interval of at least 2 days, to 25 mg twice a day.
Do not exceed the maximum recommended daily dose.

Treatment of heart failure

Dosage
The doctor will prescribe the appropriate dose to be taken, and will carefully follow you during the period of
time necessary to reach the dosage suitable for you.
The recommended dose for the start of therapy is 3.125 mg (half a 6.25 mg tablet) twice
a day, for at least 2 weeks. After 2 weeks, if this dosage is well tolerated, the
dosage may be increased, at intervals of not less than 2 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 must be increased up to the highest tolerated dose.
The maximum recommended dose is 25 mg twice a day in case of severe heart failure and
of mild or moderate heart failure with a body weight less than 85 kg. In case of mild or moderate
heart failure with a body weight greater than 85 kg, the maximum recommended dose is
50 mg twice a day.
Before each increase in the dose, the doctor will examine any signs of worsening
of heart failure or vasodilation and will assess, if necessary, the interruption of
treatment. If treatment with CARAVEL is interrupted for more than two
weeks, therapy must be restarted with the administration of 3.125 mg (half
a 6.25 mg tablet) twice a day, and subsequently the dosage must be
increased taking into account 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 can be divided into equal parts.
The tablets must be taken with a sufficient amount of liquid, independently
of meals.
Taking with meals is recommended in case of heart failure (inability of the heart to provide
an adequate amount of blood to the body), to slow down the absorption of the medicine and
reduce the incidence of orthostatic hypotension (lowering of blood pressure when you
stand up).

If you take more CARAVEL than you should
In case of accidental ingestion/taking of an excessive dose of CARAVEL, immediately warn
your doctor or go to the nearest hospital.
In case of overdose, the following may occur: severe hypotension (low blood pressure), bradycardia
(reduction in heart rate), heart failure (inability of the heart to
pump blood efficiently), cardiogenic shock (decrease in blood flow that
reaches the organs and tissues of the body, due to a decrease in heart activity) and
cardiac arrest. Respiratory problems, bronchospasm (constriction
of the bronchi), vomiting, altered consciousness and generalized convulsive seizures (involuntary, sudden and uncontrolled movements) can also occur.
The doctor will institute a treatment appropriate to your clinical conditions, if necessary,
will monitor and correct your vital parameters in intensive care conditions.

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

If you stop taking CARAVEL
CARAVEL must be discontinued gradually, over a period of 2 weeks, and under the control of
the doctor.

If you have any further questions on 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 everyone will experience them.
The following side effects may occur:

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

• dizziness (vertigo), giddiness, 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 pneumonia (inflammation of the bronchi and lungs), upper respiratory tract infections;
• urinary tract infections;
• anemia (decrease in the amount of hemoglobin, a protein found in red blood cells that carries oxygen in the blood);
• weight gain, hypercholesterolemia (increase in the amount of cholesterol, a type of fat in the blood), hyperglycemia or hypoglycemia (increase or decrease in blood glucose), in people suffering from diabetes;
• depression, depressed mood;
• syncope, pre-syncope (loss of consciousness, feeling of loss of consciousness);
• impaired vision, decreased lacrimation (dry eyes), eye irritation;
• bradycardia (reduction in heart rate);
• hypertension (high blood pressure);
• hypervolemia (increase in circulating blood volume), fluid retention;
• orthostatic hypotension (lowering of blood pressure when standing up), peripheral circulation disorders (cold hands and feet, problems with peripheral blood vessels), worsening of leg pain during physical exertion (intermittent claudication) and Raynaud's phenomenon (constriction of blood vessels in the hands and feet causing pain and skin color changes);
• dyspnea (difficulty breathing), pulmonary edema (fluid accumulation in the lungs), asthma (narrowing and inflammation of the bronchi, in patients predisposed to this condition);
• nausea, diarrhea, vomiting, dyspepsia (indigestion), abdominal pain;
• pain in the extremities (hands and feet);
• renal insufficiency and altered renal function in patients with widespread vascular disease and/or underlying renal insufficiency;
• pain;
• edema (fluid retention). Uncommon(may affect up to 1 in 100 people)
• sleep disorders;
• confusion;
• paresthesia (sensation of numbness or tingling in the hands and feet);
• atrioventricular block (disorders in the conduction of the cardiac impulse between atrium and ventricle), angina pectoris (chest pain);
• constipation;
• skin reactions, e.g. allergic rash (allergic skin rash), dermatitis (skin irritation), urticaria, pruritus, psoriasiform skin lesions (raised, red and scaly patches) and lichen planus-like skin lesions (red, rough and scaly patches), alopecia (hair loss);
• erectile dysfunction (erection disorders). Rare(may affect up to 1 in 1000 people)
• thrombocytopenia (decrease in the number of platelets in the blood);
• nasal congestion (stuffy nose);
• dry mouth;
• urinary disorders (retention of urine or difficulty in its emission). Very rare(may affect up to 1 in 10,000 people)
• leukopenia (decrease in the number of white blood cells in the blood);
• hypersensitivity (allergic reaction);
• increased levels of liver enzymes  proteins that increase in case of liver damage (ALT, AST and GGT)  ;
• severe skin reactions with blisters, bubbles and vesicles (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Not known(frequency cannot be estimated based on available data)

• manifestation of diabetes symptoms with alteration of blood sugar levels (glycemia), worsening of diabetes, changes in blood glucose;
• sinus arrest (temporary pause in heartbeat);
• hyperhidrosis (excessive sweating);
• urinary incontinence (difficulty retaining urine) in women, which resolves with discontinuation of treatment;
• hallucinations (perception of things that do not exist in reality).

Reporting of side effects
If you experience any side effects, including 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 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 which is stated on the packaging after
“Expiry”. The expiry date refers to the last day of that month.
Store at a temperature below 25°C. Store in the original packaging to protect the
medicine from light and moisture.
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. Contents of the pack and other information

What CARAVEL contains
CARAVEL 6.25 mg tablets

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

CARAVEL 25 mg tablets

• The active ingredient is carvedilol. Each tablet contains 25 mg of carvedilol.
• The other ingredients are: sucrose, lactose monohydrate, polyvinylpyrrolidone, anhydrous colloidal silica, crospovidone, magnesium stearate.

Description of the appearance of CARAVEL and contents of the pack
CARAVEL 6.25 mg tablets
Round tablets of light yellow colour, with a break line. Pack of 28 divisible tablets.
CARAVEL 25 mg tablets
Round tablets of white colour, with a break line. Pack of 30 divisible tablets.

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

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