CARVEDILOLO 6.25 мг Коированная таблетка

Содержание инструкции

1. CARVEDILOLO ALMUS 6.25 mg tablets, 25 mg tablets
   1. What is CARVEDILOLO ALMUS and what it is used for
   2. What you need to know before taking CARVEDILOLO ALMUS
   3. How to take CARVEDILOLO ALMUS
   4. Possible side effects
   5. How to store CARVEDILOLO ALMUS
   6. Contents of the pack and other information

CARVEDILOLO ALMUS 6.25 mg tablets, 25 mg tablets

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

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

This medicine contains the active ingredient carvedilol, belonging to the class of medicines called
“alpha and beta-adrenergic receptor blockers”, medicines that relax and dilate blood vessels,
lowering blood pressure and reducing the workload on the heart.
CARVEDILOLO ALMUS 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 (chest pain caused by heart problems);
• 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 ALMUS

Do not take CARVEDILOLO ALMUS

• 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 (decreased heart activity);
• if you have heart failure in Class IV NYHA (New York Heart Association classification) severe heart failure, which requires the administration of drugs with action on the contractility of the heart muscle intravenously (inotropic drugs);
• if you have clinically manifest liver dysfunction (liver problems);
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if you have a second or third degree atrioventricular block (unless a permanent pacemaker has been implanted);
• if you have severe bradycardia (very slow heart rate);
• in case of sino-nodal disease (including sino-atrial block);
• if you suffer from severe hypotension (very low systolic 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 or have suffered from bronchial asthma or other respiratory diseases with a bronchospastic component;
• in case of pheochromocytoma (tumor affecting the medulla of the adrenal gland) not controlled with alpha-blockers;
• if you suffer from metabolic acidosis (build-up of acids in the body);

Warnings and precautions
Talk to your doctor or pharmacist before taking CARVEDILOLO ALMUS.
In particular, pay attention and talk to your doctor if:

• You suffer from chronic congestive heart failure as worsening of heart failure or fluid retention may occur. If you have heart failure and are taking drugs based on digitalis, diuretics and/or ACE inhibitors, take CARVEDILOLO ALMUS with caution as both digitalis and carvedilol slow atrioventricular conduction. If, during therapy, worsening of heart failure occurs, your doctor will indicate an alternative therapy.
• If you have chronic heart failure with low blood pressure, widespread vascular disease and insufficient blood supply to the heart (ischemic heart disease), and/or underlying kidney failure. Your doctor will monitor you.
• You have left ventricular dysfunction after acute myocardial infarction.
• You have chronic obstructive bronchopneumopathy (COPD) with bronchospastic component and are not taking specific medications orally or by inhalation. In this case, do not take carvedilol, as respiratory distress may occur. Your doctor will monitor you carefully.
• You suffer from diabetes mellitus, as taking CARVEDILOLO ALMUS may be associated with worsening of blood sugar control, or the initial signs and symptoms of acute hypoglycemia may be masked or attenuated. Regular blood sugar monitoring is necessary and hypoglycemic therapy should be adjusted accordingly.
• You suffer from peripheral vasculopathy (alteration of blood vessels) as symptoms of arterial insufficiency may worsen.
• You have Raynaud's phenomenon (disease characterized by brief episodes of constriction of blood vessels, and which manifests predominantly on the fingertips and toes, with sensations of pain, numbness or tingling, and a change in skin color).
• You have thyrotoxicosis (excess of hormones produced by the thyroid gland in the body) as taking CARVEDILOLO ALMUS may mask its symptoms.
• You are to undergo general surgery requiring the use of anesthetic drugs.
• You have bradycardia (reduction of heart rate), with values below 55 beats per minute.
• You have had a severe hypersensitivity reaction in the past or are currently undergoing desensitization therapy, as increased sensitivity to substances that induce hypersensitivity reactions and their severity may occur. Very rare cases of severe skin adverse reactions such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) have been reported during treatment with CARVEDILOLO ALMUS (see section 4 “Possible side effects”). In such cases, taking CARVEDILOLO ALMUS should be discontinued.
• You suffer from psoriasis (inflammatory skin disease characterized by thickened and reddened patches covered with gray scales). In this case, you should take CARVEDILOLO ALMUS with caution.
• You are taking calcium antagonists (drugs used to treat high blood pressure). In this case, careful electrocardiographic (ECG) and blood pressure monitoring will be necessary.
• You are taking other medicines (see section “Other medicines and CARVEDILOLO ALMUS”).
• You are affected by a pheochromocytoma;
• You suffer from a form of angina pectoris known as “Prinzmetal's angina”, also called “variant angina”. Taking CARVEDILOLO ALMUS may cause chest pain.
• You use contact lenses. A reduction in tear production may occur during treatment with CARVEDILOLO ALMUS.
• You have rapidly fluctuating blood pressure (labile hypertension) or suffer from high blood pressure caused by an underlying medical condition (secondary hypertension).

Treatment with CARVEDILOLO ALMUS must be discontinued gradually (over two
weeks).

Children and adolescents
The safety and efficacy of CARVEDILOLO ALMUS in children and adolescents under the age of 18
years have not yet been established.

Other medicines and CARVEDILOLO ALMUS
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:

• Insulin or oral hypoglycemic agents (drugs for the treatment of diabetes). Signs of hypoglycemia may be masked or attenuated (especially tachycardia). If you are taking such drugs, it is recommended to check your blood sugar regularly (see section “Warnings and precautions”).
• Agents that reduce catecholamines (drugs such as reserpine or monoamine oxidase inhibitors): if you are taking such drugs during treatment with CARVEDILOLO ALMUS, you should be carefully monitored for signs of hypotension and/or severe bradycardia.
• Digoxin: The combined use of beta-blockers and digoxin can cause a further prolongation of atrioventricular (AV) conduction time.
• Calcium antagonists, in particular diltiazem or verapamil orally, amiodarone and other antiarrhythmics. Monitoring of the electrocardiogram (ECG) and blood pressure is recommended.
• Clonidine (medicine mainly used for the treatment of high blood pressure): the concomitant administration of clonidine and CARVEDILOLO ALMUS may potentiate the effects of reducing blood pressure and heart rate. If you discontinue treatment, gradually discontinue treatment with CARVEDILOLO ALMUS first and then, after a few days, with clonidine.
• Antihypertensive drugs: CARVEDILOLO ALMUS may potentiate the effect of other medicines administered in association with drugs for the treatment of high blood pressure.
• Medicines used to induce anesthesia (see section “Warnings and precautions”)
• Non-steroidal anti-inflammatory drugs (NSAIDs): concomitant use with CARVEDILOLO ALMUS may cause an increase in blood pressure levels and insufficient control of blood pressure.
• Beta-agonist bronchodilators (used for the treatment of chest tightness and shortness of breath caused by asthma or other chest diseases); careful monitoring is recommended (see section “Warnings and precautions”).
• Cyclosporine, a medicine used to prevent transplant rejection.
• Fluoxetine and paroxetine, medicines for the treatment of depression.
• Rifampicin, a medicine used against tuberculosis.
• Cimetidine, a medicine used to treat stomach problems. The administration of carvedilol in association with inotropic drugs has not been studied.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take this medicine during pregnancy unless your doctor has assessed that the
potential benefits outweigh the potential risks.

Breastfeeding
The use of this medicine is not recommended if you are breastfeeding.

Driving and using machines
There is no data available to establish the effect of the medicine on the ability to drive vehicles and operate
machinery. However, if you experience dizziness or fatigue, avoid driving vehicles and operating
machinery, especially at the beginning of treatment, after dose increases, following a
change of product and if you drink alcohol.

For those who play sports
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
doping tests.

CARVEDILOLO ALMUS 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 him before taking this medicine.

3. How to take CARVEDILOLO ALMUS

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Take the tablets with a sufficient amount of liquid, independently of meals. However, if you suffer
from heart failure, take the medicine during meals, to reduce the manifestation of side
effects such as a decrease in blood pressure when getting up (orthostatic
hypotension).
The tablet can be divided into equal parts.

Treatment of essential hypertension
The recommended initial dose is 12.5 mg once a day, for the first 2 days. Subsequently the dose
recommended is 25 mg once a day. Afterwards, the dosage may be gradually increased, at
intervals of no less than 2 weeks, up to reaching the maximum recommended dose of 50 mg per
day to be taken in one or two doses of 25 mg.

Treatment of angina pectoris
The recommended initial dose is 12.5 mg twice a day, for the first 2 days, subsequently the
dosage may be increased up to the maximum recommended dose of 25 mg, twice a day.

Treatment of heart failure
Treatment is carried out under strict medical supervision, who will adjust the dosage according to your needs
until reaching the adequate dosage.
The recommended initial dose is 3.125 mg twice a day, for at least 2 weeks. Subsequently, if
necessary, the dosage may be gradually increased, at intervals of no less than 2 weeks, and brought
first to 6.25 mg twice a day, then to 12.5 mg twice a day up to a maximum of 25 mg twice a
day. If the patient has heart problems (mild or moderate heart failure) and has a body weight
greater than 85 kg, the maximum recommended dose is 50 mg twice a day. If the patient has heart problems
(mild or moderate heart failure) and has a body weight less than 85 kg, the maximum
recommended dose is 25 mg twice a day.
The maximum recommended dose is 25 mg twice a day in all patients with severe heart failure.
The doctor will have to monitor the patient and check their health status before each increase in
dosage of the medicine. If you experience a worsening of heart failure or fluid retention,
a dose adjustment will be necessary, including diuretics.
If you interrupt the treatment with this medicine for more than two weeks, the therapy must be
started again by taking the minimum dose of 3.125 mg twice a day which
may then be increased.

Use in the elderly
Treatment of essential hypertension
The recommended initial dose is 12.5 mg once a day. Subsequently, if the response should be
inadequate the dosage may be increased, at intervals of no less than 2 weeks, up to the maximum
recommended dose of 50 mg to be taken in two doses of 25 mg per day.

Treatment of angina pectoris
The recommended initial dose in the treatment of angina pectoris is 12.5 mg twice a day which may be
increased after an interval of at least 2 days, up to the maximum dose of 25 mg twice a day (maximum
dose not to be exceeded).

If you take more CARVEDILOLO ALMUS than you should
In case of ingestion/taking of an excessive amount of this medicine, immediately contact
your doctor or the nearest hospital.
In case of taking an excessive dose of this medicine, you may experience the following symptoms:
slowing of the heartbeat (bradycardia), decrease in blood pressure (hypotension),
insufficient heart function (heart failure), cardiogenic shock and cardiac arrest. You may
also experience breathing problems, bronchospasm, vomiting, altered consciousness and convulsions.
In addition to normal intervention protocols, the doctor will monitor and correct your vital parameters, if
necessary, in intensive care conditions and will assess the most appropriate treatment.

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

If you stop taking CARVEDILOLO ALMUS
Do not stop the treatment with this medicine without consulting your doctor.
Treatment with carvedilol should not be stopped abruptly. It is necessary that the interruption of
treatment with this medicine takes place gradually, over a period of 2 weeks, especially if
you suffer from disorders of the blood circulation of the heart (ischemic heart disease).

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 everybody 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 (hypotension);
• feeling tired (asthenia).

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)

• airway infections (bronchitis), lungs (pneumonia), nose and throat (upper airways);
• urinary tract infections;
• decreased number of red blood cells (anemia);
• weight gain;
• increased cholesterol levels in the blood (hypercholesterolemia);
• alteration of blood sugar levels (hyperglycemia, hypoglycemia) in patients with diabetes;
• depression, depressed mood;
• pre-syncope and syncope (feeling of loss of consciousness, loss of consciousness);
• vision problems, dry eyes (reduced lacrimation) and eye irritation;
• decreased heart rate (bradycardia);
• hypertension;
• fluid overload;
• increased blood volume in circulation (hypervolemia);
• feeling dizzy when standing up due to a rapid drop in blood pressure (orthostatic hypotension);
• fluid retention causing swelling (edema);
• circulation problems in the arms and legs causing cold hands and feet and pain;
• exacerbation of Raynaud's phenomenon (tingling, color changes and pain in the fingers)
• exacerbation of intermittent claudication (difficulty moving);
• shortness of breath (dyspnea), asthma especially in predisposed patients;
• fluid accumulation in the lung (pulmonary edema);
• nausea, diarrhea, vomiting;
• abdominal pain and digestive problems;
• pain in the extremities;
• kidney problems (renal failure, changes in kidney function in patients with widespread vascular disease and/or underlying renal failure);
• pain.

Uncommon(may affect up to 1 in 100 people)

• sleep disturbances;
• tingling of the extremities (paresthesia);
• heart block (atrioventricular block);
• constipation;
• severe chest pain (angina pectoris);
• skin reactions such as rash, dermatitis, urticaria, itching, skin lesions (psoriatic lesions, lichen planus);
• hair loss (alopecia);
• erectile dysfunction (erectile dysfunction).

Rare(may affect up to 1 in 1000 people)

• decreased platelets in the blood (thrombocytopenia);
• blocked nose (nasal congestion).
• dry mouth;
• urination disorders

Very rare(may affect up to 1 in 10000 people)

• decreased white blood cells (leukopenia);
• allergic reactions (hypersensitivity);
• increased levels of liver enzymes (ALT, AST, GGT);
• severe skin reactions (e.g. erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).

Carvedilol may cause urinary incontinence in women, which resolves with discontinuation of treatment.
Carvedilol may also cause the manifestation of symptoms of diabetes in patients who have a mild form of diabetes called ‘latent diabetes’.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 CARVEDILOLO ALMUS

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 “Scad.”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from light and humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CARVEDILOLO ALMUS contains
CARVEDILOLO ALMUS 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).

CARVEDILOLO ALMUS 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 CARVEDILOLO ALMUS and contents of the pack
Pack of 28 tablets of 6.25 mg.
Pack of 30 tablets of 25 mg.

Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genova – Italy
E-mail: [email protected]

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) - Italy