CARVEDILOLO 6.25 mg Tablet

Зміст інструкції

1. CARVEDILOLO PENSA 6.25 mg tablets, 25 mg tablets
   1. What is CARVEDILOLO PENSA and what is it used for
   2. What you need to know before taking CARVEDILOLO PENSA
2. CARVEDILOL PENSA may mask its symptoms (e.g. tachycardia). Do not discontinue
   1. How to take CARVEDILOLO PENSA
   2. Possible side effects
   3. How to store CARVEDILOLO PENSA
   4. Contents of the pack and other information

CARVEDILOLO PENSA 6.25 mg tablets, 25 mg tablets

Carvedilol

Generic medicine

Read this leaflet carefully before 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 they have the same symptoms as you, as it may 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 CARVEDILOLO PENSA is and what it is used for
• 2. What you need to know before you take CARVEDILOLO PENSA
• 3. How to take CARVEDILOLO PENSA
• 4. Possible side effects
• 5. How to store CARVEDILOLO PENSA
• 6. Contents of the pack and other information

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

This medicine contains the active ingredient carvedilol which, by lowering blood pressure, reduces the
workload on the heart.
CARVEDILOLO PENSA 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 CARVEDILOLO PENSA

Do not take CARVEDILOLO PENSA

• if you are allergic to carvedilol or 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 fails to balance the reduction in the heart's contractile activity) if you suffer from severe liver problems
• if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• 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, who are not taking medicines orally or by inhalation)
• in case of pheochromocytoma (tumor affecting the adrenal gland) not controlled by certain medicines
• if you suffer from metabolic acidosis (alteration of blood acidity)
• if you are being treated with medicines used to treat high blood pressure or heart rhythm disturbances such as verapamil or diltiazem intravenously (see section “Other medicines and CARVEDILOLO PENSA”)

Warnings and precautions
Talk to your doctor or pharmacist before taking CARVEDILOLO PENSA 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, during therapy, your condition should worsen, the doctor will evaluate a dose reduction 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 worsening of kidney function may occur during treatment with carvedilol. In such circumstances, the doctor will evaluate 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, the doctor will prescribe appropriate treatment before starting CARVEDILOLO PENSA.
• You are diabetic and are being treated with medicines that lower blood sugar (glucose levels), as taking CARVEDILOLO PENSA may be associated with worsening blood sugar 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 sugar monitoring is necessary during treatment to adjust dosages of medicines.
• 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 thyrotoxicosis (excess of hormones produced by the thyroid) as taking

CARVEDILOL PENSA may mask its symptoms (e.g. tachycardia). Do not discontinue

treatment with CARVEDILOL PENSA abruptly as it may alter thyroid function.

• You must undergo surgery that requires the use of anesthetic drugs (drugs that induce sedation, reduce sensitivity to pain and muscle relaxation) as carvedilol may increase muscle contractility.
• You have bradycardia (reduced 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 have a pheochromocytoma (a tumor that causes high blood pressure), as your doctor will only prescribe CARVEDILOL PENSA after performing a risk/benefit assessment.
• You suffer from Prinzmetal's angina or use contact lenses (chest pain of cardiac origin), because taking CARVEDILOL PENSA 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, e.g. 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 Undesirable Effects.
• You use contact lenses because CARVEDILOL PENSA may reduce tear production. Treatment with CARVEDILOL PENSA must not be discontinued abruptly. Discontinuation of carvedilol must occur gradually (over a period of two weeks). During treatment with CARVEDILOL PENSA, very rare cases of severe skin and mucous membrane reactions, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) have been reported (see paragraph 4 “Possible undesirable effects”). In such cases, contact your doctor immediately because the intake of CARVEDILOL PENSA must be stopped.

Other medicines and CARVEDILOL PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
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;
• Antiarrhythmics, such as amiodarone, medicines used to regularize 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 or 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, drugs 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.

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

CARVEDILOL PENSA and grapefruit juice
It is recommended to avoid taking grapefruit juice during treatment with
carvedilol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The administration of CARVEDILOL PENSA during pregnancy should only be considered 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
CARVEDILOL PENSA should not be used during breastfeeding (see
paragraph “Do not take CARVEDILOL PENSA”).

Driving and using machines
No studies have been conducted on the effects of carvedilol on the ability to drive vehicles and
operate machinery. CARVEDILOL PENSA may cause dizziness and visual disturbances, therefore the
ability to drive vehicles and use machinery may be impaired. These effects
may occur predominantly at the beginning of treatment, after dose increases, in case of
replacement with another medicine containing carvedilol and with the simultaneous intake of
alcohol.

CARVEDILOL PENSA contains lactose and sucrose
This medicine contains lactose and sucrose, two types of sugars. If your doctor has
diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

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

3. How to take CARVEDILOLO PENSA

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

Treatment of essential hypertension

Dosage

Adults
The recommended initial dose is 12.5 mg once a day, for the first two days. Subsequently,
the recommended dose is 25 mg once a day. If necessary, the dosage may be
gradually increased at intervals of no less than two 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 two 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 two 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 two 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 monitor 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 two weeks, if this dosage is well tolerated, the
dosage may be increased, at intervals of no 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 50 mg twice a day in case of severe heart failure and
of mild or moderate heart failure with a body weight of 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 dose increase, the doctor will examine any signs of worsening
of heart failure or vasodilation and will assess, if necessary, the interruption of
treatment.
If the treatment with CARVEDILOLO PENSA is interrupted for more than two
weeks, the therapy must be restarted by taking 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 CARVEDILOLO PENSA in children and adolescents have not been
established yet.

How to take
The tablet can be divided into equal doses.
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 CARVEDILOLO PENSA than you should
In case of accidental ingestion/taking of an excessive dose of this medicine, 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 reaching
the organs and tissues of the body, due to a decrease in heart activity) and cardiac arrest.
You may also experience breathing problems, bronchospasm (constriction of the
bronchi), vomiting, altered consciousness and generalized convulsive seizures (involuntary, sudden and uncontrolled movements).
The doctor will institute appropriate treatment for your clinical conditions, if necessary,
will monitor and correct your vital parameters in 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 must be discontinued gradually, over a period of two weeks, and under
the control of your doctor.
If you have any doubts 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 will experience them.
At the beginning of treatment, dizziness (vertigo), syncope (loss of consciousness), headache, and asthenia (weakness) may be more likely to occur.
These effects are generally mild.
The following side effects may manifest:

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). 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 and hypoglycemia (increase or decrease in blood glucose) in patients suffering from diabetes;
• depression, depressed mood;
• impaired vision, decreased lacrimation (dry eyes), eye irritation;
• bradycardia (reduction in heart rate);
• hypertension (high blood pressure);
• hypervolemia (increased circulating blood volume), fluid retention;
• orthostatic hypotension (lowering of blood pressure when standing up), peripheral circulatory 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);
• syncope, pre-syncope (loss of consciousness, feeling of loss of consciousness);
• 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 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 10000 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);
• urinary incontinence (difficulty retaining urine) in women, which resolves with discontinuation of treatment;
• severe skin reactions with blisters, bubbles and vesicles (e.g. erythema multiforme, Stevens-Johnson syndrome and 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, alterations of glycemia;
• sinus arrest (temporary pause in heartbeat);
• hyperhidrosis (excessive sweating);
• 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 contribute to providing more information about
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 which is stated on the packaging after “Exp.”.
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 CARVEDILOLO PENSA contains
CARVEDILOLO PENSA 6.25 mg tablets

• The active ingredient is carvedilol.
• The other ingredients are: sucrose, lactose monohydrate, polyvinylpyrrolidone, anhydrous colloidal silica, crospovidone, magnesium stearate, yellow iron oxide (E 172). CARVEDILOLO PENSA 25 mg tablets
• The active ingredient is carvedilol.
• The other ingredients are: sucrose, lactose monohydrate, polyvinylpyrrolidone, anhydrous colloidal silica, 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 Authorisation Holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milan

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 (Milan)