Acarden

Italy
Brand name Acarden
Form tablets
Active substance / Dosage
CARVEDILOL
Prescription type Prescription only
ATC code
C07AG02
Registration number 035987
Manufacturer SO.SE.PHARM S.R.L. SOCIETA' DI SERVIZIO PER L'INDUSTRIA FARMACEUTICA ED AFFINI

Table of Contents

Patient Information Leaflet

ACARDEN 6.25 mg tablets

Carvedilol
Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, inform 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 taking 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 substance carvedilol, which belongs to a group of
medicines called alpha and beta-blockers, that relax and widen blood vessels, lowering
blood pressure and reducing the workload of the heart.
ACARDEN is indicated for:

  • the treatment of high blood pressure (hypertension), either alone or in combination with other medicines used 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 supply sufficient blood to the body (heart failure).

2. What you should know before taking ACARDEN

Do not take ACARDEN:

  • if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6);
  • if you have severe heart failure (class IV) requiring intravenous administration of specific medicines (inotropes) to help support heart function;
  • if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Pulmonary Disease), or if you have previously suffered from asthma or other obstructive respiratory disorders (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 disorders (second- or third-degree atrioventricular block not treated with a permanent pacemaker, or sinoatrial node disease known as "sick sinus syndrome");
  • if you have a very slow heart rate (bradycardia), less than 50 beats per minute;
  • if you have very low blood pressure (systolic pressure below 85 mmHg);
  • if you have a serious heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood to the body;
  • if you have an untreated tumour of the adrenal gland called phaeochromocytoma;
  • if your doctor has told you that the acidity level of your blood is higher than normal (metabolic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACARDEN.
Be especially cautious and consult your doctor before taking this medicine:

  • if you have heart failure with fluid retention (congestive heart failure);
  • if you have sudden fluctuations in blood pressure (labile hypertension) or high blood pressure due to other diseases (secondary hypertension);
  • if you have heart failure and low blood pressure (systolic pressure below 100 mmHg);
  • if you have circulatory problems or insufficient blood supply to the heart (ischaemic heart disease);
  • if you have severe kidney problems (renal failure);
  • if you recently had a heart attack (acute myocardial infarction);
  • if you have respiratory problems caused by a lung disease called COPD (Chronic Obstructive Pulmonary Disease);
  • if you have diabetes or low blood sugar levels (hypoglycaemia). Carvedilol may mask or reduce the early signs and symptoms of acute hypoglycaemia, especially increased heart rate (tachycardia); if you have insulin-dependent diabetes mellitus, alternative medicines are preferred;
  • if you suffer from circulatory disorders (peripheral vascular disease);
  • if you have poor blood circulation in the limbs or suffer from a condition called Raynaud's phenomenon, characterized by poor blood flow to the fingers or toes, which become painful and pale;
  • if you have thyroid problems (thyrotoxicosis), as carvedilol may mask its symptoms;
  • if you are scheduled for surgery requiring anaesthetics. Inform the anaesthetist that you are taking ACARDEN;
  • if you have a very slow heart rate (bradycardia), less than 55 beats per minute;
  • if you have previously experienced severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitisation therapy;
  • if you suffer from a skin inflammatory disease called psoriasis;
  • if you are taking other blood pressure-lowering medicines containing verapamil or diltiazem, or antiarrhythmic medicines; in such cases, regular monitoring of blood pressure and heart rate is required; verapamil and diltiazem must not be administered intravenously in combination;
  • if you have a tumour of the adrenal gland called phaeochromocytoma;
  • if you suffer from a type of chest pain caused by poor blood flow to the heart (Prinzmetal's angina);
  • if you wear contact lenses, as reduced tear production may occur.

If, during treatment for heart problems (heart failure), your condition worsens or deteriorates compared to your previous medical assessment, your doctor will recommend an alternative therapy.
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and ACARDEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be especially cautious and consult your doctor if you are taking:

  • medicines used to treat heart rhythm disorders (digoxin and other digitalis glycosides);
  • medicines used to treat diabetes, such as insulin and oral hypoglycaemic agents; in these cases, periodic monitoring of blood sugar levels (glycaemia) 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 organ transplant rejection;
  • clonidine, a medicine used to treat high blood pressure. If both medicines are administered together, clonidine should be discontinued several days after stopping carvedilol;
  • medicines used to induce anaesthesia (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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy. Consult your doctor, who will assess whether the benefits to you outweigh the potential risks.
This medicine should not be used if you are breastfeeding.

Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive vehicles or operate machinery. However, if you experience dizziness or fatigue, avoid driving and operating machinery. This is particularly important at the beginning of treatment, after dose increases, when switching products, and if you consume alcohol.

3. How to take ACARDEN

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any 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 occurrence of unwanted effects.

Treatment of high blood pressure (essential arterial hypertension)
The recommended initial dose is 12.5 mg (two tablets) once daily for the first 2 days.
Subsequently, the recommended dose is 25 mg once daily. Afterwards, the dosage may be gradually increased at intervals of no less than 2 weeks, up to the maximum recommended dose of 50 mg daily, taken as either 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 daily for the first 2 days.
Thereafter, the dosage may be increased up to the maximum recommended dose of 25 mg twice daily. It is recommended not to exceed this dose.

Treatment of heart failure
Treatment must be carried out under strict medical supervision, with the doctor adjusting the dosage according to your individual needs until the appropriate dose is reached. Take the tablets during meals with some liquid.
The recommended initial dose is 3.125 mg (half a tablet) twice daily for at least 2 weeks. Thereafter, if necessary, the dosage may be gradually increased at intervals of no less than 2 weeks, up to a maximum of 25 mg twice daily. If the patient weighs more than 85 kg, the maximum recommended dose is 50 mg twice daily.
Your doctor must monitor your condition and assess your health status before increasing the dosage of this medicine. If you experience worsening heart failure or fluid retention, dosage adjustment will be required.
If you stop treatment with this medicine for more than two weeks, therapy should be restarted with the lowest dose of 3.125 mg (half a tablet) twice daily, which may subsequently be increased.

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

Use in elderly patients
The recommended initial dose for the treatment of essential hypertension is 12.5 mg (two tablets) once daily, which may be increased at intervals of no less than 2 weeks, up to the maximum recommended dose of 50 mg daily, administered as two 25 mg doses.
The recommended initial dose for the treatment of angina pectoris is 12.5 mg (two tablets) twice daily, which may be increased after an interval of at least 2 days, up to the maximum dose of 25 mg twice daily.

If you take more ACARDEN than you should
In case of ingestion/overdose of this medicine, contact your doctor or the nearest hospital immediately.
Symptoms of overdose may include: slowing of the heartbeat (bradycardia), low blood pressure (hypotension), inadequate heart function (heart failure, cardiogenic shock, cardiac arrest), breathing difficulties (bronchospasm), vomiting, altered consciousness, and seizures.

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.
Discontinuation of treatment with this medicine should occur gradually over a period of 2 weeks, especially if you suffer from heart circulation disorders (ischaemic heart disease).

If you have any questions 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 will experience 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 of fatigue (asthenia).

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

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

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

  • sleep disorders;
  • feeling of fainting (pre-syncope), fainting (syncope), tingling in extremities (paraesthesia);
  • heart block (atrioventricular block);
  • chest pain caused by circulation problems in 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;
  • erectile dysfunction.

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

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

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

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

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

  • urinary incontinence in women, which resolves upon discontinuation of treatment;
  • use of this medicine may promote the onset of latent diabetes, worsening of existing diabetes, and problems with blood sugar level regulation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 below 25°C. Keep in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ACARDEN contains

  • The active substance is carvedilol. Each tablet contains 6.25 mg of carvedilol.
  • The other components are: microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

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

Patient information leaflet

ACARDEN 12.5 mg tablets

Carvedilol
Equivalent medicine
Please 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 doubts, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, consult 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 taking ACARDEN
  3. How to take ACARDEN
  4. Possible side effects
  5. How to store ACARDEN
  6. Package contents and other information

1. What ACARDEN is and what it is used for

This medicinal product contains the active substance carvedilol, which belongs to a group of medicines called alpha and beta-blockers. These medicines relax and widen blood vessels, lowering blood pressure and reducing the workload of the heart.
ACARDEN is indicated for:

  • the treatment of high blood pressure (hypertension), either alone or in combination with other medicines used 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 supply 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 to any of the other ingredients of this medicine (listed in section 6);
  • if you have severe heart failure (class IV) requiring intravenous administration of specific medications (inotropes) to support heart function;
  • if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Pulmonary Disease), or if you have previously suffered from asthma or other obstructive respiratory disorders (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 disorders (untreated second- or third-degree atrioventricular block, sinoatrial node disease known as "sick sinus syndrome");
  • if you have a very slow heart rate (bradycardia), less than 50 beats per minute;
  • if you have very low blood pressure (systolic pressure below 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 adrenal gland tumor called phaeochromocytoma;
  • if your doctor has told you that the acidity level of your blood is higher than normal (metabolic acidosis).

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

  • if your heart function is impaired and you suffer from fluid retention (congestive heart failure);
  • if you have sudden fluctuations in blood pressure (labile hypertension) or high blood pressure due to other diseases (secondary hypertension);
  • if your heart function is impaired and you have low blood pressure (systolic pressure below 100 mmHg);
  • if you have problems with blood circulation or insufficient blood supply to the heart (ischaemic heart disease);
  • if you have severe kidney problems (renal failure);
  • if you recently had a heart attack;
  • if you have respiratory problems caused by a lung disease called COPD (Chronic Obstructive Pulmonary Disease);
  • if you have diabetes or low blood sugar levels (hypoglycaemia). Carvedilol may mask or reduce the signs and symptoms of acute hypoglycaemia, especially increased heart rate (tachycardia); if you have insulin-dependent diabetes mellitus, alternative medicines are preferred;
  • if you suffer from circulatory disorders (peripheral vascular disease);
  • if you have poor blood circulation in the limbs or suffer from a condition called Raynaud's phenomenon, characterized by poor blood flow to the fingers or toes, causing them to become painful and pale;
  • if you have thyroid problems (thyrotoxicosis), as carvedilol may mask their symptoms;
  • if you are undergoing surgery requiring anaesthetics. Inform the anaesthetist that you are taking ACARDEN;
  • if you have a very slow heart rate (bradycardia), less than 55 beats per minute;
  • if you have previously experienced severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitization therapy;
  • if you suffer from a skin inflammatory disease called psoriasis;
  • if you are taking other blood pressure-lowering medicines containing verapamil or diltiazem, or antiarrhythmic medicines; in such cases, regular monitoring of blood pressure and heart rate is required; verapamil and diltiazem must not be administered intravenously in combination;
  • if you have an adrenal gland tumor called phaeochromocytoma;
  • if you suffer from a type of chest pain caused by poor blood flow to the heart (Prinzmetal's angina);
  • if you wear contact lenses, as reduced tear production may occur.

If, during treatment for heart problems (heart failure), your condition worsens or deteriorates compared to your previous medical evaluation, your doctor will recommend an alternative therapy.
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

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

  • medicines used to treat heart rhythm disorders (digoxin and other digitalis glycosides);
  • medicines used to treat diabetes, such as insulin and oral hypoglycaemics; in these cases, periodic monitoring of blood sugar levels (glycaemia) 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 transplant rejection;
  • clonidine, a medicine used to treat high blood pressure. If both medicines are administered together, clonidine should be discontinued several days after stopping carvedilol;
  • medicines used to induce anaesthesia (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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy; consult your doctor, who will assess whether the benefits to you outweigh the potential risks.
This medicine should not be used if you are breastfeeding.

Driving and using machines
There are no available data on the effect of this medicine on the ability to drive vehicles or operate machinery. However, if you experience dizziness or fatigue, avoid driving or operating machinery, especially at the beginning of treatment, after dose increases, when switching products, or if consuming alcohol.

3. How to take ACARDEN

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any 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 occurrence of unwanted effects.

Treatment of high blood pressure (essential arterial hypertension)
The recommended starting dose is 12.5 mg (1 tablet) once daily for the first 2 days.
Subsequently, the recommended dose is 25 mg (2 tablets) once daily. Afterwards, the dosage may be gradually increased at intervals of no less than 2 weeks, up to the maximum recommended dose of 50 mg daily, taken as either 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 daily for the first 2 days. Subsequently, the dose may be increased up to the maximum recommended dose of 25 mg (2 tablets) twice daily. It is recommended not to exceed this dose.

Treatment of heart failure
Treatment must be carried out under strict medical supervision, with the doctor adjusting the dosage according to your individual 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 daily for at least 2 weeks. Afterwards, if necessary, the dosage may be gradually increased at intervals of no less than 2 weeks, up to a maximum of 25 mg (2 tablets) twice daily. If the patient weighs more than 85 kg, the maximum recommended dose is 50 mg twice daily.
Your doctor must monitor your condition and assess your health status before increasing the dosage of this medicine. If you experience worsening heart failure or fluid retention, dosage adjustment will be required.
If you stop treatment with this medicine for more than two weeks, therapy should be restarted with the minimum dose of 3.125 mg (half a 6.25 mg tablet) twice daily, which may subsequently be increased.

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

Use in the elderly
The recommended starting dose for the treatment of essential hypertension is 12.5 mg (1 tablet) once daily, which may be increased at intervals of no less than 2 weeks up to the maximum recommended dose of 50 mg daily, administered as two doses of 25 mg (2 tablets) per day.
The recommended initial dose for the treatment of angina pectoris is 12.5 mg (1 tablet) twice daily, which may be increased after an interval of at least 2 days up to the maximum dose of 25 mg (2 tablets) twice daily.

If you take more ACARDEN than you should
If you ingest/absorb an excessive amount of this medicine, contact your doctor or the nearest hospital immediately.
Symptoms of overdose may include: slowing of the heartbeat (bradycardia), low blood pressure (hypotension), inadequate heart function (heart failure, cardiogenic shock, and cardiac arrest), breathing difficulties (bronchospasm), vomiting, altered consciousness, and seizures.

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.
Discontinuation of treatment with this medicine should be done gradually over a period of 2 weeks, especially if you suffer from heart circulation disorders (ischemic heart disease).

If you have any questions 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 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 of tiredness (asthenia).

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

  • airway infections (bronchitis), lungs (pneumonia), nose and throat (upper airways);
  • urinary tract infections;
  • decrease in the number of red blood cells (anaemia);
  • weight gain;
  • increase in blood cholesterol levels (hypercholesterolaemia);
  • changes in blood sugar levels in people with diabetes;
  • depression;
  • vision problems, dry eyes, and eye irritation;
  • decrease in heart rate (bradycardia);
  • fluid retention causing general swelling of the body or certain parts of the body, such as hands, feet, ankles, and legs (peripheral and extremity oedema), genital oedema, and an increase in blood volume (hypervolaemia);
  • sensation of dizziness when standing up due to a rapid drop in blood pressure (postural hypotension), which may be associated with fainting;
  • circulation problems in arms and legs causing cold hands and feet and pain;
  • tingling and pain in fingers, followed by a sensation of heat and pain (Raynaud's phenomenon);
  • difficulty in movement (intermittent claudication);
  • breathing difficulties, especially in patients who have or have had asthma;
  • fluid accumulation in the lungs (pulmonary oedema);
  • nausea, diarrhoea, 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 in the extremities (paraesthesia);
  • heart block (atrioventricular block);
  • chest pain caused by circulation problems in the heart (angina pectoris);
  • worsening of heart problems (heart failure) when increasing the dose;
  • constipation;
  • skin reactions such as rash, dermatitis, urticaria, itching, skin lesions, psoriasis, or worsening of psoriasis;
  • hair loss (alopecia);
  • increased sweating;
  • erection disorders (erectile dysfunction).

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

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

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

  • decrease in white blood cells in the blood (leucopenia);
  • allergic reactions;
  • alteration in liver function and increase in liver enzyme levels (ALT, AST, GGT);
  • dry mouth.

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

  • urinary incontinence in women, which resolves upon discontinuation of treatment;
  • use of this medicine may promote the onset of latent diabetes, worsening of existing diabetes, and problems with blood sugar level regulation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ACARDEN contains

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

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

Patient Information Leaflet: Information for the Patient

ACARDEN 25 mg tablets

Carvedilol
Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 medicinal product contains the active substance carvedilol, which belongs to a group of
medicines called alpha and beta-blockers, that relax and dilate blood vessels, lowering
blood pressure and reducing the workload of the heart.
ACARDEN is indicated for:

  • the treatment of high blood pressure (hypertension), either alone or in combination with other medicines used 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 to any of the other ingredients of this medicine (listed in section 6);
  • if you have severe heart failure (class IV) requiring intravenous administration of specific medicines (inotropes) to help support heart function;
  • if you have breathing problems due to a lung disease (COPD - Chronic Obstructive Pulmonary Disease), or if you have previously had asthma or other obstructive respiratory disorders (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 second- or third-degree atrioventricular block, sinoatrial node disease known as "sick sinus syndrome");
  • if you have a very slow heart rate (bradycardia), less than 50 beats per minute;
  • if you have very low blood pressure (systolic pressure below 85 mmHg);
  • if you have a serious heart condition known as cardiogenic shock, which occurs when your heart cannot pump enough blood throughout the body;
  • if you have an untreated tumour of the adrenal gland called phaeochromocytoma;
  • if your doctor has told you that the acidity level in your blood is higher than normal (metabolic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACARDEN.
Be particularly careful and consult your doctor before taking this medicine:

  • if your heart function is impaired and you suffer from fluid retention (congestive heart failure);
  • if you have sudden fluctuations in blood pressure (labile hypertension) or high blood pressure due to other diseases (secondary hypertension);
  • if your heart function is impaired and you have low blood pressure (systolic pressure below 100 mmHg);
  • if you have circulation problems or inadequate blood supply to the heart (ischaemic heart disease);
  • if you have severe kidney problems (renal failure);
  • if you have recently had a heart attack;
  • if you have breathing problems caused by a lung disease called COPD (Chronic Obstructive Pulmonary Disease);
  • if you have diabetes or low blood sugar levels (hypoglycaemia). Carvedilol may mask or reduce the early signs and symptoms of acute hypoglycaemia, especially increased heart rate (tachycardia); if you have insulin-dependent diabetes mellitus, alternative medicines are preferred;
  • if you suffer from circulation disorders (peripheral vascular disease);
  • if you have poor blood circulation in the limbs or suffer from a condition called Raynaud's phenomenon, characterized by poor blood flow to the fingers or toes, causing them to become painful and pale;
  • if you have thyroid problems (thyrotoxicosis), as carvedilol may mask its symptoms;
  • if you are undergoing surgery requiring anaesthetics. Inform the anaesthetist that you are taking ACARDEN;
  • if you have a very slow heart rate (bradycardia), less than 55 beats per minute;
  • if you have previously experienced severe allergic reactions (anaphylactic reactions) or if you are undergoing desensitization therapy;
  • if you suffer from a skin inflammatory disease called psoriasis;
  • if you are taking other blood pressure-lowering medicines containing verapamil or diltiazem, or antiarrhythmic medicines; in such cases, regular monitoring of blood pressure and heart rate is required; verapamil and diltiazem must not be administered concomitantly by intravenous route;
  • if you have a tumour of the adrenal gland called phaeochromocytoma;
  • if you suffer from a type of chest pain caused by poor blood flow to the heart (Prinzmetal's angina);
  • if you wear contact lenses, as reduced tear production may occur.

If, during treatment for heart problems (heart failure), your condition worsens or deteriorates compared to your previous visit, your doctor will recommend an alternative therapy.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Other medicines and ACARDEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be particularly careful and consult your doctor if you are taking:

  • medicines used to treat heart rhythm disorders (digoxin and other digitalis glycosides);
  • medicines used to treat diabetes, such as insulin and oral hypoglycaemics; in these cases, periodic monitoring of blood sugar levels (glycaemia) is recommended;
  • rifampicin, a medicine used to treat tuberculosis;
  • antidepressants 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 transplant rejection;
  • clonidine, a medicine used to treat high blood pressure. If both medicines are taken together, clonidine should be discontinued several days after stopping carvedilol;
  • medicines used to induce anaesthesia (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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless advised by your doctor, who will assess whether the benefits outweigh the potential risks.
The use of this medicine is not recommended if you are breastfeeding.

Driving and using machines
There are no available data on the effect of this medicine on the ability to drive vehicles or operate machinery. However, if you experience dizziness or fatigue, avoid driving or operating machinery. This is especially important at the beginning of treatment, after dose increases, when switching products, or if consuming alcohol.

3. How to take ACARDEN

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any 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 occurrence of undesirable effects.

Treatment of high blood pressure (essential arterial hypertension)
The recommended starting dose is 12.5 mg (half a tablet) once daily for the first 2 days.
The recommended dose is then 25 mg (1 tablet) once daily. Afterwards, the dosage may be gradually increased at intervals of no less than 2 weeks, up to the maximum recommended dose of 50 mg daily, taken as either one or two doses.

Treatment of chest pain caused by heart problems (angina pectoris)
The recommended starting dose is 12.5 mg (half a tablet) twice daily for the first 2 days. Subsequently, the dose may be increased up to the maximum recommended dose of 25 mg (1 tablet) twice daily. Exceeding this dose is not recommended.

Use in children
There are no data available on the use of this medicine in children and patients under 18 years of age.

Use in the elderly
The recommended starting dose for the treatment of essential hypertension is 12.5 mg (half a tablet) once daily, which may be increased at intervals of no less than 2 weeks up to the maximum recommended dose of 50 mg daily, divided into two 25 mg doses.
The recommended starting dose for the treatment of angina pectoris is 12.5 mg (half a tablet) twice daily, which may be increased after an interval of at least 2 days up to the maximum dose of 25 mg twice daily.

If you take more ACARDEN than you should
If you have taken or ingested too much of this medicine, contact your doctor or the nearest hospital immediately.
In case of overdose, you may experience the following symptoms: slowing of the heartbeat (bradycardia), low blood pressure (hypotension), inadequate heart function (heart failure, cardiogenic shock, and cardiac arrest), breathing difficulties (bronchospasm), vomiting, altered consciousness, and seizures.

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.
Treatment with this medicine should be discontinued gradually over a period of 2 weeks, especially if you suffer from heart circulation disorders (ischemic heart disease).

If you have any questions 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 of fatigue (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 (anaemia);
  • weight gain;
  • increased levels of cholesterol in the blood (hypercholesterolaemia);
  • changes in blood sugar levels in people with diabetes;
  • depression;
  • vision problems, dry eyes, and eye irritation;
  • decrease in heart rate (bradycardia);
  • fluid retention causing general swelling of the body or certain body parts, such as hands, feet, ankles and legs (peripheral and lower limb oedema), genital oedema, and an increase in circulating blood volume (hypervolaemia);
  • dizziness when standing up due to a rapid drop in blood pressure (postural hypotension), which may be associated with fainting;
  • circulation problems in arms and legs causing cold sensation in hands and feet and pain;
  • tingling and pain in fingers, followed by sensation of heat and pain (Raynaud's phenomenon);
  • difficulty in movement (intermittent claudication);
  • breathing difficulties, especially in patients who have or have had asthma;
  • fluid accumulation in the lung (pulmonary oedema);
  • nausea, diarrhoea, 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 in extremities (paraesthesia);
  • heart block (atrioventricular block);
  • chest pain caused by circulation problems in 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;
  • erectile dysfunction.

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

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

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

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ACARDEN contains

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

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