ACARDEN 6.25 мг Таблетка

Содержание инструкции

1. ACARDEN 6.25 mg tablets
   1. What is ACARDEN and what is it used for
   2. What you need to know before taking ACARDEN
   3. How to take ACARDEN
   4. Possible side effects
   5. How to store ACARDEN
   6. Contents of the pack and other information
2. ACARDEN 12,5 mg tablets
   1. What is ACARDEN and what is it used for
   2. What you need to know before taking ACARDEN
   3. How to take ACARDEN
   4. Possible side effects
   5. How to store ACARDEN
   6. Contents of the pack and other information
3. ACARDEN 25 mg tablets
   1. What ACARDEN is and what it is used for
   2. What you need to know before taking ACARDEN
   3. How to take ACARDEN
   4. Possible side effects
   5. How to store ACARDEN
   6. Contents of the pack and other information

ACARDEN 6.25 mg tablets

Carvedilol
Generic medicine

Read this leaflet carefully before you start 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 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 ACARDEN is and what it is used for
• 2. What you need to know before you take ACARDEN
• 3. How to take ACARDEN
• 4. Possible side effects
• 5. How to store ACARDEN
• 6. Contents of the pack and other information

1. What is ACARDEN and what is it used for

This medicine contains the active ingredient carvedilol, belonging to a group of
medicines called alpha and beta-blockers, which relax and dilate blood vessels, lowering
blood pressure and reducing the workload on the heart.
ACARDEN is indicated for:

• the treatment of high blood pressure (hypertension), even in association with other medicines to treat high blood pressure, such as thiazide diuretics;
• the treatment of chest pain caused by heart problems (angina pectoris);
• the treatment of a condition characterized by the heart's inability to provide an adequate amount of blood to the body (heart failure).

2. What you need to know before taking ACARDEN

Do not take ACARDEN:

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• if you have severe heart failure, (class IV) requiring the administration of specific medicines (inotropes) intravenously to help the heart function;
• if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Bronchopneumopathy) or have previously suffered from asthma or other obstructive respiratory problems (bronchospasm);
• if you have liver problems;
• if you are breastfeeding with breast milk;
• if your heart function is insufficient to ensure adequate blood supply to the body (unstable or decompensated heart failure);
• if you have problems with heart conduction (untreated 2nd or 3rd degree atrioventricular block, a disease of the sinoatrial node called “Sick Sinus Syndrome”);
• if you have a very slow heartbeat (bradycardia), less than 50 beats per minute;
• if you have very low blood pressure (systolic pressure less than 85 mmHg);
• if you have a serious heart problem known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• if you have a tumor of the adrenal gland called pheochromocytoma that has not been treated;
• if your doctor has told you that the level of acidity in your blood is higher than normal (metabolic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACARDEN.
Pay particular attention and talk to your doctor before taking this medicine:

• if your heart function is insufficient and you suffer from fluid retention (congestive heart failure);
• if you have sudden changes in pressure (labile hypertension) or have high blood pressure due to other diseases (secondary hypertension);
• if your heart function is insufficient and you have low blood pressure (systolic pressure less than 100 mmHg);
• if you have problems with blood circulation or have insufficient blood supply to the heart (ischemic heart disease);
• if you have severe kidney problems (renal insufficiency);
• if you have recently had a heart attack (acute myocardial infarction);
• if you have breathing problems caused by a lung disease called COPD (Chronic Obstructive Bronchopneumopathy);
• if you have diabetes or have low blood sugar levels (hypoglycemia). Carvedilol may mask or attenuate the initial signs and symptoms of acute hypoglycemia, especially the increase in heart rate (tachycardia); If you suffer from insulin-dependent diabetes mellitus, alternative medicines are preferable;
• if you suffer from disorders of blood circulation (peripheral vascular disease);
• if you have problems with blood circulation in the limbs or if you are affected by a condition called Raynaud's phenomenon, characterized by poor blood circulation to the fingers or toes that become painful and whitish;
• if you have thyroid problems (thyrotoxicosis), because carvedilol may hide the symptoms;
• if you are going to undergo surgery that requires the use of anesthetics. Tell the anesthesiologist that you are taking ACARDEN;
• if you have a very slow heartbeat (bradycardia), less than 55 beats per minute;
• if you have previously suffered from severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitization therapy;
• if you suffer from an inflammatory skin disease called psoriasis;
• if you are taking other medicines to lower blood pressure based on verapamil or diltiazem, or if you are taking antiarrhythmic medicines, in these cases you should have your blood pressure and heart rate checked periodically, verapamil and diltiazem should not be administered together intravenously;
• if you have a tumor of the adrenal gland called pheochromocytoma;
• if you suffer from a type of chest pain caused by poor blood circulation to the heart (Prinzmetal's angina);
• if you wear contact lenses, as a reduction in tear production may occur.

If, during the treatment of heart problems (heart failure), you experience a
worsening of your condition or a worsening compared to the previous visit, your doctor
will indicate an alternative therapy.
For those who play sports: the use of this medicine without a therapeutic need constitutes
doping and may still result in a positive doping test.

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

• medicines used to treat heart rhythm disturbances (digoxin and other digitalis glycosides);
• medicines used to treat diabetes such as insulin and oral hypoglycemic agents; in these cases, periodic monitoring of blood sugar levels (glycemia) is recommended;
• rifampicin, a medicine used against tuberculosis;
• antidepressant medicines called monoamine oxidase inhibitors (MAOIs, fluoxetine);
• medicines used to treat high blood pressure, such as reserpine, diltiazem, verapamil, amiodarone and antiarrhythmic medicines (see section Warnings and precautions); cyclosporine, a medicine used to prevent rejection after a transplant;
• clonidine, a medicine used to treat high blood pressure. If the two medicines are administered simultaneously, clonidine must be discontinued a few days after discontinuation of carvedilol;
• medicines used to induce anesthesia (see section Warnings and precautions);
• medicines used to treat inflammation (NSAIDs);
• medicines used to treat breathing problems, such as asthma (beta-agonist bronchodilators).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy, consult your doctor who will assess whether the benefits
for you outweigh the potential risks.
The use of this medicine is not indicated if you are breastfeeding with breast milk.

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

3. How to take ACARDEN

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

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

Treatment of chest pain caused by heart problems (angina pectoris)
The recommended initial dose is 12.5 mg (two tablets) twice a day, for the first 2 days,
afterwards the dosage may be increased up to the maximum recommended dose of 25
mg, twice a day. It is recommended not to exceed this dose.

Treatment of heart failure
Treatment is carried out under strict medical supervision, who will adjust the dosage according to
your needs until reaching the appropriate dosage. Take the tablets during meals with
some liquid.
The recommended initial dose is 3.125 mg (half a tablet) 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, up to a maximum of 25 mg twice a day. If the patient
has a body weight greater than 85 kg, the maximum recommended dose is 50 mg twice a day.
The doctor must monitor the patient and check their health status before
increasing the dosage of the medicine. If you experience a worsening of heart failure or
fluid retention, a dose adjustment will be necessary.
If you stop treatment with this medicine for more than two weeks, therapy should be
started again by taking the minimum dose of 3.125 mg (half a tablet)
twice a day, which may then be increased.

Use in children
No data are available regarding the use of this medicine in children and patients under
18 years of age.

Use in the elderly
The recommended initial dose for the treatment of essential hypertension is 12.5 mg (two
tablets) once a day, which 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.
The recommended initial dose in the treatment of angina pectoris is 12.5 mg (two tablets) twice
a day, which may be increased after an interval of at least 2 days, up to a maximum dose of 25
mg twice a day.

If you take more ACARDEN than you should
In case of ingestion/taking of an excessive amount of this medicine, contact
immediately 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) and difficulty breathing (bronchospasm), vomiting, altered consciousness and
convulsions.

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

If you stop taking ACARDEN
Do not stop treatment with this medicine without consulting your doctor.
It is necessary that the interruption of treatment with this medicine occurs gradually, over 2 weeks, especially if you suffer from disorders of the blood circulation of the
heart (ischemic heart disease).
If you have any doubts about 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):

• dizziness, vertigo and headache;
• heart problems (heart failure);
• low blood pressure (hypotension);
• feeling tired (asthenia).

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

• airway infections (bronchitis), lungs (pneumonia), nose and throat (upper respiratory tract);
• urinary tract infections;
• decreased number of red blood cells (anemia);
• weight gain;
• increased cholesterol levels in the blood (hypercholesterolemia);
• altered blood sugar levels in people with diabetes;
• depression;
• vision problems, dry eyes and eye irritation;
• decreased heart rate (bradycardia);
• fluid retention causing general swelling of the body or certain parts of the body, such as hands, feet, ankles and legs (edema) and an increase in the amount of blood in circulation (hypervolemia);
• feeling dizzy when getting up due to a rapid drop in blood pressure (postural hypotension), which may be associated with fainting;
• circulation problems in the arms and legs causing cold hands and feet and pain;
• tingling and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• difficulty walking (intermittent claudication);
• difficulty breathing, especially in patients who suffer or have suffered from asthma;
• fluid accumulation in the lungs (pulmonary edema);
• nausea, diarrhea, vomiting;
• abdominal pain and digestive problems;
• kidney problems and difficulty urinating;
• pain.

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

• sleep disturbances;
• feeling of fainting (pre-syncope), fainting (syncope), tingling of the extremities (paresthesia);
• heart block (atrioventricular block);
• chest pain caused by heart circulation problems (angina pectoris);
• worsening of heart problems (heart failure) during dose increase;
• constipation;
• skin reactions such as rash, dermatitis, urticaria, itching, skin lesions, psoriasis or worsening of psoriasis;
• hair loss (alopecia);
• increased sweating;
• erection problems (erectile dysfunction).

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

• decreased platelets in the blood (thrombocytopenia);
• blocked nose (nasal congestion).

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

• decreased white blood cells in the blood (leukopenia);
• allergic reactions;
• alteration of liver function and increased levels of liver enzymes (ALT, AST, GGT);
• dry mouth.

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

• urinary incontinence in women, which resolves with discontinuation of treatment;
• the use of this medicine may promote the onset of latent diabetes, worsening of diabetes if already suffering from it and problems with blood sugar regulation.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ACARDEN

Keep this medicine out of 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 ACARDEN contains

• The active ingredient is carvedilol. Each tablet contains 6.25 mg of carvedilol.
• The other ingredients are: microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate.

Description of the appearance of ACARDEN and contents of the pack
Pack of 14, 28 or 56 divisible tablets containing 6.25 mg.

Marketing Authorisation Holder
SO.SE.PHARM S.R.L.
VIA DEI CASTELLI ROMANI, 22, 00071 - POMEZIA – ROMA

Manufacturer
Hameln rds a.s., Horná 36, 90001 Modra, Slovakia

ACARDEN 12,5 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 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 ACARDEN is and what it is used for
• 2. What you need to know before you take ACARDEN
• 3. How to take ACARDEN
• 4. Possible side effects
• 5. How to store ACARDEN
• 6. Contents of the pack and other information

1. What is ACARDEN and what is it used for

This medicine contains the active ingredient carvedilol, belonging to a group of
medicines called alpha and beta-blockers, which relax and dilate blood vessels, lowering
blood pressure and reducing the workload on the heart.
ACARDEN is indicated for:

• the treatment of high blood pressure (hypertension), even in association with other medicines to treat high blood pressure, such as thiazide diuretics;
• the treatment of chest pain caused by heart problems (angina pectoris);
• the treatment of a condition characterized by the heart's inability to provide an adequate amount of blood to the body (heart failure).

2. What you need to know before taking ACARDEN

Do not take ACARDEN:

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• if you have severe heart failure (class IV) requiring the administration of specific medicines (inotropes) intravenously to help the heart function;
• if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Bronchopneumopathy) or have previously suffered from asthma or other obstructive respiratory problems (bronchospasm);
• if you have liver problems;
• if you are breastfeeding with breast milk;
• if your heart function is insufficient to ensure adequate blood supply to the body (unstable or decompensated heart failure);
• if you have heart conduction problems (untreated 2nd or 3rd degree atrioventricular block, sinus node disease called “Sick Sinus Syndrome”);
• if you have a very slow heartbeat (bradycardia), less than 50 beats per minute;
• if you have very low blood pressure (systolic pressure less than 85 mmHg);
• if you have a serious heart problem known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• if you have an adrenal gland tumor called pheochromocytoma that has not been treated;
• if your doctor has told you that the level of acidity in your blood is higher than normal (metabolic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACARDEN.
Pay particular attention and talk to your doctor before taking this medicine:

• if your heart function is insufficient and you suffer from fluid retention (congestive heart failure);
• if you have sudden changes in blood pressure (labile hypertension) or have high blood pressure due to other diseases (secondary hypertension);
• if your heart function is insufficient and you have low blood pressure (systolic pressure less than 100 mmHg);
• if you have problems with blood circulation or have insufficient blood supply to the heart (ischemic heart disease);
• if you have severe kidney problems (renal insufficiency);
• if you have recently had a heart attack;
• if you have breathing problems caused by a lung disease called COPD (Chronic Obstructive Bronchopneumopathy);
• if you have diabetes or low blood sugar levels (hypoglycemia). Carvedilol may mask or attenuate the initial signs and symptoms of acute hypoglycemia, especially the increase in heart rate (tachycardia); If you suffer from insulin-dependent diabetes mellitus, alternative medicines are preferable;
• if you suffer from circulatory disorders (peripheral vascular disease);
• if you have problems with blood circulation in the limbs or if you are affected by a condition called Raynaud's phenomenon, characterized by poor blood circulation to the fingers of the hands or feet that become painful and white;
• if you have thyroid problems (thyrotoxicosis), because carvedilol may hide the symptoms;
• if you are going to undergo surgery that requires the use of anesthetics. Tell the anesthesiologist that you are taking ACARDEN;
• if you have a very slow heartbeat (bradycardia), less than 55 beats per minute;
• if you have previously had severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitization therapy;
• if you suffer from an inflammatory skin disease called psoriasis;
• if you are taking other medicines to lower blood pressure based on verapamil or diltiazem, or if you are taking antiarrhythmic medicines, in these cases you should have your blood pressure and heart rate checked periodically, verapamil and diltiazem should not be administered together intravenously;
• if you have an adrenal gland tumor called pheochromocytoma;
• if you suffer from a type of chest pain caused by poor blood circulation to the heart (Prinzmetal's angina);
• if you use contact lenses, because a reduction in tear production may occur.

If during the treatment of heart problems (heart failure) you experience a
worsening of your condition or a worsening compared to the previous visit, your doctor
will indicate an alternative therapy.
For those who play sports: the use of this medicine without a therapeutic need constitutes
doping and may still result in a positive doping test.

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

• medicines used to treat heart rhythm disturbances (digoxin and other digitalis glycosides);
• medicines used to treat diabetes such as insulin and oral hypoglycemic agents; in these cases, periodic monitoring of blood sugar levels (glycemia) is recommended;
• rifampicin, a medicine used against tuberculosis;
• antidepressant medicines called monoamine oxidase inhibitors (MAOIs, fluoxetine);
• medicines used to treat high blood pressure, such as reserpine, diltiazem, verapamil, amiodarone and antiarrhythmic medicines (see section Warnings and precautions);
• cyclosporine, a medicine used to prevent rejection after a transplant;
• clonidine, a medicine used to treat high blood pressure. If the two medicines are administered simultaneously, clonidine must be discontinued a few days after stopping carvedilol;
• medicines used to induce anesthesia (see section Warnings and precautions);
• medicines used to treat inflammation (NSAIDs);
• medicines used to treat breathing problems, such as asthma (beta-agonist bronchodilators).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy, consult your doctor who will assess whether the benefits
for you outweigh the potential risks.
The use of this medicine is not indicated if you are breastfeeding with breast milk.

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

3. How to take ACARDEN

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Take the tablets with a sufficient amount of liquid, regardless of meals.
However, if you suffer from heart failure, take the medicine during meals, to reduce the
manifestation of undesirable effects.

Treatment of high blood pressure (essential hypertension)
The recommended initial dose is 12.5 mg (1 tablet) once a day, for the first 2 days.
Subsequently the recommended dose is 25 mg (2 tablets) once a day. Afterwards, the
dosage may be gradually increased, at intervals of not less than 2 weeks, up to
reaching the maximum recommended dose of 50 mg per day to be taken in one or two
doses.

Treatment of chest pain caused by heart problems (angina pectoris)
The recommended initial dose is 12.5 mg (1 tablet) twice a day, for the first 2 days,
subsequently the dosage may be increased up to the recommended maximum dose of 25 mg
(2 tablets), twice a day. It is recommended not to exceed this dose.

Treatment of heart failure
Treatment is carried out under strict medical supervision, which will adjust the dosage according to
your needs until the appropriate dosage is reached. Take the tablets during meals with
some liquid.
The recommended initial dose is 3.125 mg (half a 6.25 mg tablet) twice a day, for at least
2 weeks. Subsequently, if necessary, the dosage may be gradually increased,
at intervals of not less than 2 weeks, up to a maximum of 25 mg (2 tablets) twice a
day. If the patient has a body weight greater than 85 kg, the recommended maximum dose is 50 mg
twice a day.
The doctor must monitor the patient and check his state of health before
increasing the dosage of the medicine. If you experience a worsening of heart failure or
fluid retention, a dose adjustment will be necessary.
If you stop treatment with this medicine for more than two weeks, therapy must be
started again by taking the minimum dose of 3.125 mg (half a
6.25 mg tablet) twice a day, which may subsequently be increased.

Use in children
No data are available regarding the use of this medicine in children and patients under
18 years of age.

Use in the elderly
The recommended initial dose for the treatment of essential hypertension is 12.5 mg (1 tablet)
once a day, which may be increased, at intervals of not less than 2 weeks, up to the
maximum recommended dose of 50 mg to be taken in two doses of 25 mg (2 tablets) per day.
The recommended initial dose in the treatment of angina pectoris is 12.5 mg (1 tablet) twice
a day, which may be increased after an interval of at least 2 days, up to a maximum dose of
25 mg (2 tablets) twice a day.

If you take more ACARDEN than you should
In case of ingestion/taking of an excessive amount of this medicine, contact
your doctor or the nearest hospital immediately.
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) and difficulty breathing (bronchospasm), vomiting, altered consciousness and
convulsions.

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

If you stop taking ACARDEN
Do not stop treatment with this medicine without consulting your doctor.
It is necessary that the interruption of treatment with this medicine occurs gradually, over 2 weeks, especially if you suffer from disorders of blood circulation of the
heart (ischemic heart disease).
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 everybody gets them.
The following side effects may occur:

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

• dizziness, vertigo and headache;
• heart problems (heart failure);
• low blood pressure (hypotension);
• feeling tired (asthenia).

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

• airway infections (bronchitis), lungs (pneumonia), nose and throat (upper respiratory tract);
• urinary tract infections;
• decreased number of red blood cells (anemia);
• weight gain;
• increased levels of cholesterol in the blood (hypercholesterolemia);
• alteration of blood sugar levels in people with diabetes;
• depression;
• vision problems, dry eyes and eye irritation;
• decreased heart rate (bradycardia);
• fluid retention causing a general swelling of the body or some parts of the body, such as hands, feet, ankles and legs (peripheral and extremities edema), genital edema and an increase in the amount of blood in circulation (hypervolemia);
• feeling dizzy when getting up due to a rapid drop in blood pressure (postural hypotension), which may be associated with fainting;
• circulation problems in the arms and legs causing a feeling of coldness in the hands and feet and pain;
• tingling and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• difficulty walking (intermittent claudication);
• difficulty breathing, especially in patients who suffer or have suffered from asthma;
• fluid accumulation in the lung (pulmonary edema);
• nausea, diarrhea, vomiting;
• abdominal pain and digestive problems;
• kidney problems and difficulty urinating;
• pain.

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

• sleep disorders;
• feeling of fainting (pre-syncope), fainting (syncope), tingling of the extremities (paresthesia);
• heart block (atrioventricular block);
• chest pain caused by problems with blood circulation to the heart (angina pectoris);
• worsening of heart problems (heart failure) during dose increase;
• constipation;
• skin reactions such as rash, dermatitis, urticaria, itching, skin lesions, psoriasis or worsening of psoriasis;
• hair loss (alopecia);
• increased sweating;
• erection problems (erectile dysfunction).

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

• decreased platelets in the blood (thrombocytopenia);
• nasal congestion.

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

• decreased white blood cells in the blood (leukopenia);
• allergic reactions;
• alteration of liver function and increased levels of liver enzymes (ALT, AST, GGT);
• dry mouth.

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

• urinary incontinence in women, which resolves with discontinuation of treatment;
• the use of this medicine may favor the appearance of latent diabetes, worsening of diabetes if already suffering from it and problems with blood sugar regulation.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACARDEN

Keep this medicine out of 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 humidity.
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 ACARDEN contains

• The active ingredient is carvedilol. Each tablet contains 12.5 mg of carvedilol.
• The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of ACARDEN and contents of the pack
Pack of 28 or 56 divisible tablets containing 12.5 mg.

Marketing Authorisation Holder
SO.SE.PHARM S.R.L.
VIA DEI CASTELLI ROMANI, 22, 00071 - POMEZIA – ROMA

Manufacturer
Hameln rds a.s., Horná 36, 90001 Modra, Slovakia

ACARDEN 25 mg tablets

Carvedilol
Generic medicine

Read this leaflet carefully before you start 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 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 ACARDEN is and what it is used for
• 2. What you need to know before you take ACARDEN
• 3. How to take ACARDEN
• 4. Possible side effects
• 5. How to store ACARDEN
• 6. Contents of the pack and other information

1. What ACARDEN is and what it is used for

This medicine contains the active ingredient carvedilol, belonging to a group of
medicines called alpha and beta-blockers, which relax and dilate blood vessels, lowering
blood pressure and reducing the workload on the heart.
ACARDEN is indicated for:

• the treatment of high blood pressure (hypertension), even in association with other medicines to treat high blood pressure, such as thiazide diuretics;
• the treatment of chest pain caused by heart problems (angina pectoris).

2. What you need to know before taking ACARDEN

Do not take ACARDEN:

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6);
• if you have severe heart failure (class IV) requiring the administration of specific medicines (inotropic agents) intravenously to help the heart function;
• if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Bronchopneumopathy) or have previously suffered from asthma or other obstructive respiratory problems (bronchospasm);
• if you have liver problems;
• if you are breastfeeding;
• if your heart function is insufficient to ensure adequate blood supply to the body (unstable or decompensated heart failure);
• if you have heart conduction problems (untreated 2nd or 3rd degree atrioventricular block, sinus node disease called “Sick Sinus Syndrome”);
• if you have a very slow heartbeat (bradycardia), less than 50 beats per minute;
• if you have very low blood pressure (systolic pressure less than 85 mmHg);
• if you have a serious heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• if you have an untreated tumor of the adrenal gland called pheochromocytoma;
• if your doctor has told you that the acidity of your blood is higher than normal (metabolic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACARDEN.
Pay particular attention and talk to your doctor before taking this medicine:

• if your heart function is insufficient and you suffer from fluid retention (congestive heart failure);
• if you have sudden changes in blood pressure (labile hypertension) or have high blood pressure due to other diseases (secondary hypertension);
• if your heart function is insufficient and you have low blood pressure (systolic pressure less than 100 mmHg);
• if you have problems with blood circulation or have insufficient blood supply to the heart (ischemic heart disease);
• if you have severe kidney problems (renal insufficiency);
• if you have recently had a heart attack;
• if you have breathing problems caused by a lung disease called COPD (Chronic Obstructive Bronchopneumopathy);
• if you have diabetes or low blood sugar levels (hypoglycemia). Carvedilol may mask or attenuate the initial signs and symptoms of acute hypoglycemia, especially the increase in heart rate (tachycardia); If you suffer from insulin-dependent diabetes mellitus, alternative medicines are preferable;
• if you suffer from blood circulation disorders (peripheral vascular disease);
• if you have problems with blood circulation in the limbs or are affected by a condition called Raynaud's phenomenon, characterized by poor blood circulation to the fingers of the hands or feet that become painful and white;
• if you have thyroid problems (thyrotoxicosis), because carvedilol may hide the symptoms;
• if you are going to undergo surgery requiring the use of anesthetics. Tell the anesthesiologist that you are taking ACARDEN;
• if you have a very slow heartbeat (bradycardia), less than 55 beats per minute;
• if you have previously suffered from severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitization therapy;
• if you suffer from an inflammatory skin disease called psoriasis;
• if you are taking other medicines to lower blood pressure based on verapamil or diltiazem, or if you are taking antiarrhythmic medicines, in these cases you should have your blood pressure and heart rate checked periodically; verapamil and diltiazem should not be administered in association intravenously;
• if you have a tumor of the adrenal gland called pheochromocytoma;
• if you suffer from a type of chest pain caused by poor blood circulation to the heart (Prinzmetal's angina);
• if you wear contact lenses, as a reduction in tear production may occur.

If, during the treatment of heart problems (heart failure), you experience a
worsening of your condition or a worsening compared to the previous visit, your doctor
will indicate an alternative therapy.
For those who play sports: the use of this medicine without a therapeutic need constitutes
doping and may still result in a positive doping test.

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

• medicines used to treat heart rhythm disturbances (digoxin and other digitalis glycosides);
• medicines used to treat diabetes such as insulin and oral hypoglycemic agents; in these cases, periodic monitoring of blood sugar levels (glycemia) is recommended;
• rifampicin, a medicine used to treat tuberculosis;
• antidepressant medicines called monoamine oxidase inhibitors (MAOIs, fluoxetine);
• medicines used to treat high blood pressure, such as reserpine, diltiazem, verapamil, amiodarone and antiarrhythmic medicines (see section Warnings and precautions);
• cyclosporine, a medicine used to prevent rejection after a transplant;
• clonidine, a medicine used to treat high blood pressure. If the two medicines are administered simultaneously, clonidine must be discontinued a few days after stopping carvedilol;
• medicines used to induce anesthesia (see section Warnings and precautions);
• medicines used to treat inflammation (NSAIDs);
• medicines used to treat breathing problems, such as asthma (beta-agonist bronchodilators).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy, consult your doctor who will assess whether the benefits
for you outweigh the potential risks.
The use of this medicine is not indicated if you are breastfeeding.

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

3. How to take ACARDEN

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

Treatment of high blood pressure (essential hypertension)
The recommended initial dose is 12.5 mg (half a tablet) once a day, for the first 2 days.
Subsequently the recommended dose is 25 mg (1 tablet) once a day. Afterwards, the
dosage may be gradually increased, at intervals of not less than 2 weeks, up to the
achievement of the maximum recommended dose of 50 mg per day to be taken in one or two
doses.

Treatment of chest pain caused by heart problems (angina pectoris)
The recommended initial dose is 12.5 mg (half a tablet) twice a day, for the first 2
days, subsequently the dosage may be increased up to the maximum recommended dose of
25 mg (1 tablet), twice a day. It is recommended not to exceed this dose.

Use in children
No data are available regarding the use of this medicine in children and patients under
18 years of age.

Use in the elderly
The recommended initial dose for the treatment of essential hypertension is 12.5 mg (half
tablet) once a day which may be increased, at intervals of not less than 2 weeks,
up to the maximum recommended dose of 50 mg to be taken in two doses of 25 mg per day.
The recommended initial dose in the treatment of angina pectoris is 12.5 mg (half tablet) 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.

If you take more ACARDEN than you should
In case of ingestion/taking of an excessive amount of this medicine, contact
immediately 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) and difficulty breathing (bronchospasm), vomiting, altered consciousness and
convulsions.

If you forget to take ACARDEN
Do not take a double dose to make up for the forgotten tablet.

If you stop taking ACARDEN
Do not stop treatment with this medicine without consulting your doctor.
It is necessary that the interruption of treatment with this medicine occurs 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 doubts about 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):

• dizziness, vertigo and headache;
• heart problems (heart failure);
• low blood pressure (hypotension);
• feeling tired (asthenia).

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

• airway infections (bronchitis), lungs (pneumonia), nose and throat (upper respiratory tract);
• urinary tract infections;
• decrease in the number of red blood cells (anemia);
• weight gain;
• increased cholesterol levels in the blood (hypercholesterolemia);
• alteration of blood sugar levels in people with diabetes;
• depression;
• vision problems, dry eyes and eye irritation;
• decreased heart rate (bradycardia);
• fluid retention which causes general swelling of the body or some parts of the body, such as hands, feet, ankles and legs (peripheral and lower limb edema), genital edema and an increase in the amount of blood circulating (hypervolemia);
• feeling dizzy when getting up due to a rapid drop in blood pressure (postural hypotension), which may be associated with fainting;
• circulation problems in the arms and legs that cause cold hands and feet and pain;
• numbness and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• difficulty walking (intermittent claudication);
• difficulty breathing, especially in patients who suffer or have suffered from asthma;
• fluid accumulation in the lung (pulmonary edema);
• nausea, diarrhea, vomiting;
• abdominal pain and digestive problems;
• kidney problems and difficulty urinating;
• pain.

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

• sleep disorders;
• feeling faint (pre-syncope), fainting (syncope), numbness of the extremities (paresthesia);
• heart block (atrioventricular block);
• chest pain caused by heart circulation problems (angina pectoris);
• worsening of heart problems (heart failure) during dose increase;
• constipation;
• skin reactions such as rash, dermatitis, urticaria, itching, skin lesions, psoriasis or worsening of psoriasis;
• hair loss (alopecia);
• increased sweating;
• erectile dysfunction (erectile dysfunction).

Rare(may affect up to 1 in 1000 people):

• decrease in platelets in the blood (thrombocytopenia);
• blocked nose (nasal congestion).

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

• decrease in white blood cells (leukopenia);
• allergic reactions;
• alteration of liver function and increased levels of liver enzymes (ALT, AST, GGT);
• dry mouth.

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

• urinary incontinence in women, which resolves with discontinuation of treatment;
• the use of this medicine may promote the onset of latent diabetes, worsening of diabetes if already suffering from it and problems with blood sugar regulation.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACARDEN

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 ACARDEN contains

• The active ingredient is carvedilol. Each tablet contains 25 mg of carvedilol.
• The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of ACARDEN and contents of the pack
Pack of 30 or 56 divisible tablets containing 25 mg.

Marketing Authorisation Holder
SO.SE.PHARM S.R.L.
VIA DEI CASTELLI ROMANI, 22, 00071 - POMEZIA – ROMA

Manufacturer
Hameln rds a.s., Horná 36, 90001 Modra, Slovakia