Package leaflet: Information for the patient

Dilatrend 6.25 mg tablets

Carvedilol
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dilatrend is and what it is used for
What you need to know before taking Dilatrend
How to take Dilatrend
Possible side effects
How to store Dilatrend
Contents of the pack and other information

1. What Dilatrend is and what it is used for

Dilatrend contains the active substance carvedilolo, which lowers blood pressure and reduces the workload of the heart.
Dilatrend is indicated for the treatment of:

essential arterial hypertension (high blood pressure). It may be used alone or in combination with other antihypertensive medicines, particularly thiazide diuretics;
angina pectoris (heart disease causing chest pain);
heart failure (the heart's inability to supply sufficient blood to the body).

2. What you should know before taking Dilatrend

Do not take Dilatrend

if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6)
if you have unstable/compensated heart failure or severe heart failure (serious conditions in which the body cannot compensate for reduced cardiac contractile function)
if you have severe liver problems
if you are breastfeeding (see "Pregnancy, breastfeeding and fertility")
if you have heart rhythm disorders (second- or third-degree atrioventricular block unless you have a permanently implanted pacemaker)
if you have severe bradycardia (less than 50 beats per minute)
if you have sinoatrial node disease, including sinoatrial block (severe reduction in heart rate)
if you have severe hypotension (very low blood pressure)
if you are in cardiogenic shock (reduced blood flow to organs and tissues due to decreased heart function)
if you have bronchial asthma (narrowing and inflammation of the bronchi) or other respiratory diseases with a bronchospastic component (e.g. chronic obstructive pulmonary disease (COPD), a condition that makes it difficult to empty air from the lungs), not treated with oral or inhaled medications
if you have uncontrolled phaeochromocytoma (a tumor affecting the adrenal gland) not controlled by medication
if you have metabolic acidosis (a disturbance in blood acidity)
if you are being treated with medicines used to treat high blood pressure or heart rhythm disorders such as verapamil or diltiazem administered intravenously (see section "Other medicines and Dilatrend")

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

You have chronic congestive heart failure (a condition in which the heart cannot pump blood efficiently), as heart failure or fluid retention may worsen. If your condition deteriorates during treatment, your doctor will consider reducing the dose or switching to an alternative therapy.
You have chronic heart failure with low blood pressure, ischemic heart disease (heart damage due to reduced oxygen supply), or diffuse vascular disease (narrowing of arteries), as treatment with carvedilol may worsen kidney function. In such cases, your doctor will assess whether treatment should be discontinued or the dose reduced.
You have left ventricular dysfunction (a part of the heart unable to contract effectively or fill adequately) following an acute myocardial infarction (death of heart cells due to prolonged lack of oxygen). In this case, your doctor will prescribe appropriate treatment before starting Dilatrend.
You have diabetes and are being treated with glucose-lowering medicines (medicines that reduce blood sugar levels), as taking Dilatrend may impair blood sugar control. Additionally, early signs and symptoms of acute hypoglycemia (sudden drop in blood sugar), such as tachycardia (fast heartbeat), blurred vision, dizziness, sweating, restlessness, may be masked or diminished. Regular blood sugar monitoring is necessary during treatment to adjust medication dosages appropriately.
You have peripheral vascular disease (reduced blood flow to arteries due to obstruction or narrowing in the limbs), as this may worsen with carvedilol treatment.
You have thyrotoxicosis (excess thyroid hormones), as Dilatrend may mask its symptoms (e.g. tachycardia). Do not stop Dilatrend treatment suddenly, as this may worsen thyroid function.
You are scheduled for surgery requiring anesthetic medicines (medicines inducing sedation, reducing pain sensitivity and causing muscle relaxation), as carvedilol may enhance the depressant effects of anesthetics on myocardial contractility.
You have bradycardia (reduced heart rate) with values below 55 beats per minute.
You have previously experienced a severe hypersensitivity reaction (allergy) or are currently undergoing desensitization therapy (receiving gradually increasing doses of a drug to which you are hypersensitive, to achieve safe and effective dosing), as increased sensitivity may occur.
You have psoriasis (an inflammatory skin disease characterized by thickened, red patches covered with grayish scales) or phaeochromocytoma (a tumor causing high blood pressure), as your doctor will prescribe Dilatrend only after assessing the risk/benefit ratio.
You have Prinzmetal's angina (chest pain of cardiac origin), as taking Dilatrend may worsen it.
You have first-degree heart block (an abnormality in heart rhythm), as carvedilol may reduce the speed of electrical impulse conduction in the heart.
You are elderly or have heart rhythm disorders such as bradycardia (slow heart rate), sick sinus syndrome, or atrioventricular block (types of arrhythmias), as sinus arrest (temporary pause in heartbeat) may occur—see section "Undesirable effects".
You wear contact lenses, as Dilatrend may reduce tear production.
Treatment with Dilatrend must not be stopped abruptly. Discontinuation of carvedilol should occur gradually (over a two-week period). During treatment with Dilatrend, very rare cases of serious skin and mucosal reactions have been reported, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see section 4 "Possible side effects"). In such cases, contact your doctor immediately, as Dilatrend must be discontinued.

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

Digoxin, a medicine used to treat heart conditions;
Cyclosporine and tacrolimus, medicines used to prevent organ transplant rejection;
Antiarrhythmics such as amiodarone, medicines used to regulate heart rhythm;
Fluoxetine and paroxetine, medicines used to treat depression;
Rifampicin, an antibiotic used to treat bacterial infections;
Cimetidine, a medicine used to treat ulcers and heartburn;
Insulin or oral hypoglycemics (medicines for diabetes treatment);
Antihypertensives such as reserpine and clonidine (medicines used to lower blood pressure);
Anesthetics and neuromuscular blocking agents, medicines inducing sedation, reducing pain sensitivity and causing muscle relaxation;
Non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for pain, inflammation, and fever;
Bronchodilators, medicines used to treat respiratory problems.

Dilatrend and alcohol
Alcohol may enhance the hypotensive effect of carvedilol (lowering blood pressure).
Dilatrend and grapefruit juice
It is recommended to avoid consuming grapefruit juice during treatment with carvedilol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Dilatrend should be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus or newborn.
If you take this medicine, discontinue treatment 2–3 days before the expected delivery date. If this is not possible, the newborn must be monitored during the first 2–3 days of life.
Breastfeeding
Dilatrend must not be used during breastfeeding (see section "Do not take Dilatrend").
Driving and using machines
No studies have been conducted on the effects of carvedilol on the ability to drive or operate machinery.
Dilatrend may cause dizziness and visual disturbances; therefore, your ability to drive or operate machinery may be impaired. These effects may occur mainly at the beginning of treatment, after dose increases, when switching to another carvedilol-containing medicine, or when alcohol is consumed concurrently.
For athletes
Using this medicine without medical need constitutes doping and may result in a positive anti-doping test.
Dilatrend contains sucrose and lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Dilatrend

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Treatment of essential arterial hypertension
Dosage
Adults
The recommended starting dose is 12.5 mg once daily for the first two days.
Subsequently, the recommended dose is 25 mg once daily. If necessary, the dose may be gradually increased at intervals of no less than two weeks, up to the maximum recommended dose of 50 mg per day, taken as a single dose or divided into 25 mg twice daily.

Elderly
The recommended starting dose is 12.5 mg once daily. If necessary, your doctor may increase the dose at intervals of at least two weeks, up to the maximum recommended dose of 50 mg per day, taken as 25 mg twice daily.

Treatment of angina pectoris
Dosage
Adults
The recommended starting dose is 12.5 mg twice daily for the first two days.
Subsequently, the recommended dose is 25 mg twice daily.
Do not exceed the maximum recommended daily dose.

Elderly
The recommended starting dose is 12.5 mg twice daily. Subsequently, the dose may be increased, after an interval of at least two days, to 25 mg twice daily. Do not exceed the maximum recommended daily dose.

Treatment of heart failure
Dosage
Your doctor will prescribe the appropriate dose for you and will monitor you closely during the period required to reach the dose best suited to you.
The recommended starting dose is 3.125 mg (half a 6.25 mg tablet) twice daily for at least two weeks. After two weeks, if this dose is well tolerated, the dosage may be increased at intervals of no less than two weeks: first to 6.25 mg twice daily, then to 12.5 mg twice daily, and finally to 25 mg twice daily. The dose should be increased up to the highest dose tolerated.

The maximum recommended dose is 25 mg twice daily in cases of severe heart failure and in cases of mild to moderate heart failure with body weight below 85 kg. In cases of mild to moderate heart failure with body weight above 85 kg, the maximum recommended dose is 50 mg twice daily.

Before each dose increase, your doctor will assess any signs of worsening heart failure or vasodilation and, if necessary, may consider discontinuing treatment.

If treatment with Dilatrend is interrupted for more than two weeks, therapy should be restarted with 3.125 mg (half a 6.25 mg tablet) twice daily, and the dose should then be increased according to the previous recommendations.

Use in children and adolescents
The safety and efficacy of Dilatrend in children and adolescents have not yet been established.

Method of administration
The tablet may be divided into equal doses.
Tablets should be taken with a sufficient amount of liquid, regardless of meals.
However, taking the tablets with meals is recommended in cases of heart failure (inability of the heart to supply adequate blood to the body) to slow the absorption of the medicine and reduce the incidence of orthostatic hypotension (a drop in blood pressure upon standing).

If you take more Dilatrend than you should
In case of accidental ingestion or overdose of Dilatrend, contact your doctor immediately or go to the nearest hospital.
Overdose may cause: severe hypotension (low blood pressure), bradycardia (reduced heart rate), heart failure (inability of the heart to pump blood efficiently), cardiogenic shock (reduced blood flow to organs and tissues due to decreased heart function), and cardiac arrest. Respiratory problems, bronchospasm (constriction of the airways), vomiting, disturbances in consciousness, and generalized convulsions (sudden, involuntary, uncontrolled movements) may also occur.
Your doctor will initiate treatment appropriate to your clinical condition and, if necessary, monitor and correct your vital parameters in an intensive care setting.

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

If you stop taking Dilatrend
Dilatrend must be discontinued gradually over a period of two weeks and under medical supervision.

If you have any doubts about how to use 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, headache;
heart failure (inability of the heart to pump blood efficiently);
hypotension (low blood pressure);
asthenia (weakness). Dizziness, syncope, headache and asthenia are generally mild and are more likely to occur at the beginning of treatment. Common (may affect up to 1 in 10 people)
bronchitis and pneumonia (inflammation of the bronchi and lungs), upper respiratory tract infections;
urinary tract infections;
anaemia (reduction in the amount of haemoglobin, a protein found in red blood cells that carries oxygen in the blood);
weight gain, hypercholesterolaemia (increased levels of cholesterol, a type of fat in the blood), hyperglycaemia and hypoglycaemia (increased or decreased blood glucose levels) (in patients with diabetes);
depression, depressed mood;
syncope, pre-syncope (loss of consciousness, feeling faint);
visual disturbances, decreased lacrimation (dry eyes), eye irritation;
bradycardia (reduced heart rate);
hypertension (high blood pressure);
hypervolaemia (increased circulating blood volume), fluid accumulation;
orthostatic hypotension (drop in blood pressure upon standing), peripheral circulatory disorders (cold hands and feet, problems with peripheral blood vessels), worsening of leg pain during physical activity (intermittent claudication) and Raynaud's phenomenon (constriction of blood vessels in hands and feet causing pain and skin colour changes);
dyspnoea (difficulty breathing), pulmonary oedema (fluid accumulation in the lungs), asthma (narrowing and inflammation of the bronchi in patients predisposed to this condition);
nausea, diarrhoea, vomiting, dyspepsia (indigestion), abdominal pain;
extremity pain (in hands and feet);
renal failure and altered kidney function in patients with widespread vascular disease and/or baseline renal impairment;
pain;
oedema (fluid accumulation). Uncommon (may affect up to 1 in 100 people)
sleep disorders;
confusion;
paraesthesia (numbness or tingling sensation in hands and feet);
atrioventricular block (disturbance in the conduction of the cardiac impulse between atrium and ventricle), angina pectoris (chest pain);
constipation;
skin reactions, e.g. allergic rash (allergic skin eruption), dermatitis (skin irritation), urticaria, pruritus, psoriasiform skin lesions (raised, red, scaly patches), lichen planus-like skin lesions (rough, scaly red patches), alopecia (hair loss);
erectile dysfunction (erection disorders) Rare (may affect up to 1 in 1,000 people)
thrombocytopenia (decreased number of platelets in the blood);
nasal congestion (stuffy nose);
dry mouth;
urinary disorders (urine retention or difficulty in passing urine). Very rare (may affect up to 1 in 10,000 people)
leucopenia (decreased number of white blood cells in the blood);
hypersensitivity (allergic reaction);
increased liver enzyme levels [
proteins that increase in case of liver damage [(ALT, AST) and GGT)];
severe skin reactions with blisters, bullae and vesicles (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis); Not known (frequency cannot be estimated from the available data)
onset of diabetes symptoms with changes in blood sugar levels (glycaemia), worsening of diabetes, changes in glycaemia;
sinus arrest (temporary pause in the heartbeat);
hyperhidrosis (excessive sweating);
urinary incontinence (inability to hold urine) in women, which resolves upon discontinuation of treatment;
hallucinations (perception of things that do not exist in reality).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please consult your doctor or pharmacist. You may also report side effects directly
through the national reporting system at the following website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dilatrend

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original intact packaging, stored correctly.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Dilatrend 6.25 mg contains

The active substance is carvedilol 6.25 mg
The other components are sucrose, lactose monohydrate, povidone K25, colloidal anhydrous silica, crospovidone type A, magnesium stearate, yellow iron oxide (E 172).

Description of the appearance of Dilatrend and package contents
Dilatrend 6.25 mg are round, yellow tablets with a break line and the imprint BM on one side and F1 on the other.
Pharmaceutical form and contents
Tablets of 25 mg in packages containing 14, 28 and 56 tablets
Marketing Authorization Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Package leaflet: information for the patient

Dilatrend 12.5 mg tablets

Carvedilol
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dilatrend is and what it is used for
What you need to know before taking Dilatrend
How to take Dilatrend
Possible side effects
How to store Dilatrend
Contents of the pack and other information

1. What Dilatrend is and what it is used for

Dilatrend contains the active substance carvedilolo, which lowers blood pressure and reduces the workload of the heart.
Dilatrend is indicated for the treatment of:

essential arterial hypertension (high blood pressure). It may be used alone or in combination with other medicines for the treatment of high blood pressure;
angina pectoris (heart disease causing chest pain);
heart failure (the heart's inability to supply sufficient blood to the body).

2. What you need to know before taking Dilatrend

Do not take Dilatrend

if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6)
if you have unstable/compensated heart failure or severe heart failure (serious conditions in which the body cannot compensate for reduced cardiac contractile function)
if you have severe liver problems
if you are breastfeeding (see "Pregnancy, breastfeeding and fertility")
if you have heart rhythm disorders (second- or third-degree atrioventricular block), unless you have had a permanent pacemaker implanted
if you have severe bradycardia (less than 50 beats per minute)
in case of sinoatrial node disease, including sinoatrial block (severe reduction in heart rate)
if you have severe hypotension (very low blood pressure)
in case of cardiogenic shock (reduced blood flow to organs and tissues due to decreased heart function)
if you have bronchial asthma (narrowing and inflammation of the bronchi) or other respiratory diseases with a bronchospastic component (e.g. chronic obstructive pulmonary disease (COPD), a disease that makes it difficult to empty air from the lungs, not treated with oral or inhaled medications)
in case of uncontrolled phaeochromocytoma (a tumor affecting the adrenal gland) not controlled by medication
if you have metabolic acidosis (altered blood acidity)
if you are being treated with medicines used to treat high blood pressure or heart rhythm disorders such as verapamil or diltiazem administered intravenously (see section “Other medicines and Dilatrend”)

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

You suffer from chronic congestive heart failure (a condition in which the heart cannot pump blood efficiently), as heart failure or fluid retention may worsen. If your condition worsens during treatment, your doctor may consider reducing the dose or switching to an alternative therapy. If you have chronic heart failure with low blood pressure, ischemic heart disease (heart damage due to reduced oxygen supply), or widespread vascular disease (narrowing of arteries), kidney function may deteriorate during treatment with carvedilol. In such cases, your doctor will assess whether treatment should be discontinued or the dosage reduced.
You have left ventricular dysfunction (a part of the heart unable to contract effectively or fill adequately) following an acute myocardial infarction (heart cell death due to prolonged lack of oxygen). In this case, your doctor will prescribe appropriate treatment before starting Dilatrend.
You are diabetic and are being treated with medications that lower blood glucose (blood sugar levels), as taking Dilatrend may impair blood glucose control. Additionally, early signs and symptoms of acute hypoglycemia (sudden drop in blood sugar), such as tachycardia (fast heartbeat), blurred vision, dizziness, sweating, restlessness, may be masked or reduced. Regular blood glucose monitoring is necessary during treatment to adjust medication dosages appropriately.
You have peripheral vascular disease (reduced blood flow to arteries due to obstruction or narrowing in the limbs), as this may worsen with carvedilol treatment.
You have thyrotoxicosis (excess thyroid hormones), as Dilatrend may mask symptoms (e.g. tachycardia). Do not stop treatment with Dilatrend abruptly, as this may disrupt thyroid function.
You are scheduled for surgery (medications inducing sedation, pain relief, and muscle relaxation), as carvedilol may enhance the effects on myocardial contractility.
You have bradycardia (reduced heart rate) with values below 55 beats per minute.
You have previously experienced a severe hypersensitivity reaction (allergy), or are currently undergoing desensitization therapy (receiving gradually increasing doses of a drug to which you are hypersensitive, to achieve safe and effective dosing), as increased sensitivity may occur.
You suffer from psoriasis (an inflammatory skin disease characterized by thickened, red patches covered with grayish scales) or have phaeochromocytoma (a tumor causing high blood pressure), as your doctor will prescribe Dilatrend only after assessing the risk-benefit ratio.
You suffer from Prinzmetal's angina (chest pain of cardiac origin), as taking Dilatrend may worsen it.
You have first-degree heart block (an abnormality in heart rhythm), as carvedilol may reduce the speed of electrical impulse conduction in the heart.
You are elderly or have heart rhythm disorders such as bradycardia (slow heart rate), sinoatrial node dysfunction, or atrioventricular block (types of arrhythmias), as sinus arrest (temporary pause in heartbeat) may occur; see section on "Undesirable effects".
You wear contact lenses, as Dilatrend may reduce tear production.

Treatment with Dilatrend must not be stopped suddenly but should be discontinued gradually. Discontinuation of carvedilol should occur gradually over a period of two weeks. During treatment with Dilatrend, very rare cases of severe skin and mucosal reactions have been reported, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see section 4 “Possible side effects”). In such cases, contact your doctor immediately, as Dilatrend must be discontinued.

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

Digoxin, a medicine used to treat heart conditions;
Cyclosporine and tacrolimus, medicines used to prevent organ transplant rejection;
Antiarrhythmics such as amiodarone, medicines used to regulate heart rhythm;
Fluoxetine and paroxetine, medicines used to treat depression;
Rifampicin, an antibiotic used to treat bacterial infections;
Cimetidine, a medicine used to treat ulcers and heartburn;
Insulin or oral antidiabetics (medicines for treating diabetes);
Antihypertensives such as reserpine and clonidine (medicines used to lower blood pressure);
Anesthetics and neuromuscular blocking agents, medicines inducing sedation, pain relief, and muscle relaxation;
Non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for pain, inflammation, and fever;
Bronchodilators, medicines used to treat respiratory problems.

Dilatrend and alcohol
Alcohol may enhance the hypotensive effect of carvedilol (lowers blood pressure).
Dilatrend and grapefruit juice
It is recommended to avoid consuming grapefruit juice during treatment with carvedilol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Dilatrend should only be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus or newborn.
If you take this medicine, discontinue treatment 2–3 days before the expected delivery. If this is not possible, the newborn must be monitored during the first 2–3 days of life.
Breastfeeding
Dilatrend must not be used during breastfeeding (see section “Do not take Dilatrend”).
Driving and using machines
No studies have been conducted on the effects of carvedilol on the ability to drive or operate machinery.
Dilatrend may cause dizziness and visual disturbances; therefore, your ability to drive or use machinery may be impaired. These effects are more likely at the beginning of treatment, after dose increases, when switching to another carvedilol-containing medicine, or when alcohol is consumed concurrently.
For athletes
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Dilatrend contains sucrose and lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Dilatrend

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Treatment of essential arterial hypertension
Dosage
Adults
The recommended starting dose is 12.5 mg once daily for the first two days.
Thereafter, the recommended dose is 25 mg once daily. If necessary, the dose may be gradually increased at intervals of no less than two weeks, up to the maximum recommended dose of 50 mg daily, taken as a single dose or divided into 25 mg twice daily.

Treatment of angina pectoris
Dosage
Adults
The recommended starting dose is 12.5 mg twice daily for the first two days.
Thereafter, the recommended dose is 25 mg twice daily.
Do not exceed the maximum recommended daily dose.

Elderly
The recommended starting dose is 12.5 mg twice daily.
Thereafter, the dose may be increased, after an interval of at least two days, to 25 mg twice daily. Do not exceed the maximum recommended daily dose.

Treatment of heart failure
Dosage
Your doctor will prescribe the appropriate dose for you and will closely monitor you during the period required to reach the optimal dosage regimen for you.

The recommended starting dose is 3.125 mg (half a 6.25 mg tablet) twice daily for at least two weeks. After two weeks, if this dose is well tolerated, the dosage may be increased at intervals of no less than two weeks, first to 6.25 mg twice daily, then to 12.5 mg twice daily, and finally to 25 mg twice daily. The dose should be increased up to the highest dose that is tolerated.

The maximum recommended dose is 25 mg twice daily in cases of severe heart failure or mild to moderate heart failure with body weight below 85 kg. In cases of mild to moderate heart failure with body weight above 85 kg, the maximum recommended dose is 50 mg twice daily.

Before each dose increase, your doctor will evaluate any signs of worsening heart failure or vasodilation and, if necessary, will consider discontinuing treatment.

If treatment with Dilatrend is interrupted for more than two weeks, therapy should be restarted with 3.125 mg (half a 6.25 mg tablet) twice daily, and the dosage should then be increased according to the previous recommendations.

Use in children and adolescents
The safety and efficacy of Dilatrend in children and adolescents have not yet been established.

Method of administration
The tablet may be divided into equal doses.
Tablets should be taken with a sufficient amount of liquid, regardless of meals.
Taking the tablets with meals is recommended in cases of heart failure (inability of the heart to supply adequate blood to the body) to slow down the absorption of the medicine and reduce the incidence of orthostatic hypotension (drop in blood pressure upon standing).

If you take more Dilatrend than you should
In case of accidental ingestion or overdose of Dilatrend, inform your doctor immediately or go to the nearest hospital.

Symptoms of overdose may include: severe hypotension (low blood pressure), bradycardia (reduced heart rate), heart failure (inability of the heart to pump blood effectively), cardiogenic shock (reduced blood flow to organs and tissues due to decreased heart function), and cardiac arrest. Respiratory problems, bronchospasm (constriction of the airways), vomiting, disturbances in consciousness, and generalized convulsive seizures (sudden, uncontrolled, involuntary movements) may also occur.

Your doctor will initiate appropriate treatment based on your clinical condition and, if necessary, will monitor and correct your vital parameters under intensive care conditions.

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

If you stop taking Dilatrend
Dilatrend must be discontinued gradually over a period of two weeks and under medical supervision.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur:

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

dizziness, headache;
heart failure (inability of the heart to pump blood efficiently);
hypotension (low blood pressure);
asthenia (weakness). Dizziness, syncope, headache, and asthenia are generally mild and are more likely to occur at the beginning of treatment.

Common (may affect up to 1 in 10 people)

bronchitis and pneumonia (inflammation of the bronchi and lungs), upper respiratory tract infections;
urinary tract infections;
anaemia (reduction in haemoglobin, a protein found in red blood cells that carries oxygen in the blood);
weight gain, hypercholesterolaemia (increased blood cholesterol levels, a type of fat in the blood), hyperglycaemia and hypoglycaemia (increased or decreased blood glucose levels) (in patients with diabetes);
depression, depressed mood;
syncope, pre-syncope (loss of consciousness, feeling of fainting);
visual disturbances, decreased lacrimation (dry eyes), eye irritation;
bradycardia (reduced heart rate);
hypertension;
hypervolaemia (increased circulating blood volume), fluid accumulation;
orthostatic hypotension (drop in blood pressure upon standing), peripheral circulatory disorders (cold hands and feet, problems with peripheral blood vessels), worsening of leg pain during physical activity (intermittent claudication), and Raynaud's phenomenon (constriction of blood vessels in hands and feet causing pain and skin colour changes);
dyspnoea (difficulty breathing), pulmonary oedema (fluid accumulation in the lungs), asthma (narrowing and inflammation of the bronchi, in patients predisposed to this condition);
nausea, diarrhoea, vomiting, dyspepsia (indigestion), abdominal pain;
extremity pain (hands and feet);
renal failure and altered kidney function in patients with widespread vascular disease and/or pre-existing renal failure;
pain;
oedema (fluid accumulation).

Uncommon (may affect up to 1 in 100 people)

sleep disorders;
confusion;
paraesthesia (tingling or numbness sensations in hands and feet);
atrioventricular block (disturbance in the conduction of the cardiac impulse between atrium and ventricle), angina pectoris (chest pain);
constipation;
skin reactions, e.g. allergic rash (allergic skin eruption), dermatitis (skin irritation), urticaria, pruritus, psoriatic skin lesions (raised, red, scaly patches), and lichen planus-like skin lesions (rough, scaly red patches), alopecia (hair loss);
erectile dysfunction (erectile disorders).

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

thrombocytopenia (decreased platelet count);
nasal congestion (stuffy nose);
dry mouth;
urinary disorders (urine retention or difficulty in urination).

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

leucopenia (decreased white blood cell count);
hypersensitivity (allergic reaction);
increased liver enzyme levels [proteins that rise in case of liver damage (ALT, AST) and GGT)];
severe skin reactions with wheals, blisters, and vesicles (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

onset of diabetes symptoms with altered blood sugar levels (glycaemia), worsening of diabetes, changes in blood glucose;
sinus arrest (temporary pause in heartbeat);
hyperhidrosis (excessive sweating);
urinary incontinence (difficulty in holding urine) in women, which resolves upon discontinuation of treatment;
hallucinations (perception of things not present in reality).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dilatrend

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.
The expiry date applies to the product in its original, unopened packaging stored
correctly.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Dilatrend 12.5 mg contains

The active substance is carvedilolo 12.5 mg
The other components are sucrose, lactose monohydrate, povidone K25, anhydrous colloidal silica, crospovidone type A, magnesium stearate, yellow iron oxide (E 172), red iron oxide (E 172).

Description of the appearance of Dilatrend and package contents
Dilatrend 12.5 mg are round, light brown tablets with a break line and the imprint BM on one side and H3 on the other.
Pharmaceutical form and contents
Tablets of 125 mg in packages containing 28 and 56 tablets
Marketing Authorization Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Package leaflet: information for the patient

Dilatrend 25 mg tablets

Carvedilol
Please read this leaflet carefully before 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 give it to other people, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dilatrend is and what it is used for
What you need to know before taking Dilatrend
How to take Dilatrend
Possible side effects
How to store Dilatrend
Contents of the pack and other information

1. What Dilatrend is and what it is used for

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

essential arterial hypertension (high blood pressure). It may be used alone or in combination with other medicines for the treatment of high blood pressure;
angina pectoris (heart disease causing chest pain);
heart failure (the heart’s inability to supply sufficient blood to the body).

2. What you need to know before taking Dilatrend

Do not take Dilatrend

if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6)
if you have unstable/decompensated heart failure or severe heart failure (serious conditions in which the body cannot compensate for reduced contractile function of the heart)
if you have severe liver problems
if you are breastfeeding (see "Pregnancy, breastfeeding and fertility")
if you have heart rhythm disorders (second- or third-degree atrioventricular block), unless you have a permanent pacemaker implanted
if you have severe bradycardia (less than 50 beats per minute)
in case of sinus node disease, including sinoatrial block (severe reduction in heart rate)
if you have severe hypotension (very low blood pressure)
in case of cardiogenic shock (reduced blood flow to the body's organs and tissues due to decreased heart function)
if you have bronchial asthma (narrowing and inflammation of the airways) or other respiratory diseases with a bronchospastic component (e.g. chronic obstructive pulmonary disease (COPD), a condition that makes it difficult to expel air from the lungs, not treated with oral or inhaled medications)
in case of uncontrolled phaeochromocytoma (a tumor affecting the adrenal gland) not managed by medication
if you have metabolic acidosis (alteration of blood acidity)
if you are being treated with medicines used to treat high blood pressure or heart rhythm disorders such as intravenous verapamil or diltiazem (see section "Other medicines and Dilatrend")

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

You have chronic congestive heart failure (a condition in which the heart is unable to pump blood efficiently), as heart failure or fluid retention may worsen. If your condition deteriorates during treatment, your doctor will consider reducing the dose or switching to an alternative therapy.
You have chronic heart failure with low blood pressure, ischemic heart disease (heart damage due to reduced oxygen supply), or diffuse vascular disease (narrowing of arteries), as treatment with carvedilol may worsen kidney function. In such cases, your doctor will assess whether treatment should be discontinued or the dose reduced.
You have left ventricular dysfunction (a portion of the heart is unable to contract effectively or fill adequately) following an acute myocardial infarction (heart cell death due to prolonged lack of oxygen). In this case, your doctor will prescribe appropriate treatment before starting Dilatrend.
You have diabetes and are being treated with glucose-lowering medicines (medicines that reduce blood sugar levels), as taking Dilatrend may be associated with impaired blood glucose control. Additionally, early signs and symptoms of acute hypoglycemia (sudden drop in blood sugar), such as tachycardia (fast heartbeat), blurred vision, dizziness, sweating, restlessness, may be masked or reduced. Regular blood glucose monitoring is required during treatment to adjust medication dosages appropriately.
You have peripheral vascular disease (reduced blood flow to arteries due to obstruction or narrowing in the limbs), as this condition may worsen with carvedilol treatment.
You have thyrotoxicosis (excess thyroid hormones), as Dilatrend may mask symptoms (e.g. tachycardia). Do not stop Dilatrend treatment abruptly, as this may disrupt thyroid function.
You are scheduled for surgery requiring anesthetics (medicines that induce sedation, reduce pain sensitivity, and cause muscle relaxation), as carvedilol may enhance the effects of anesthetics on myocardial contractility.
You have bradycardia (reduced heart rate) with values below 55 beats per minute.
You have previously experienced a severe hypersensitivity reaction (allergy) or are currently undergoing desensitization therapy (receiving gradually increasing doses of a drug to which you are hypersensitive, to achieve safe and effective dosing), as increased sensitivity may occur.
You have psoriasis (an inflammatory skin disease characterized by thickened, red patches covered with grayish scales) or phaeochromocytoma (a tumor causing high blood pressure), as your doctor will prescribe Dilatrend only after evaluating the risk-benefit ratio.
You have Prinzmetal's angina (chest pain of cardiac origin), as Dilatrend may worsen it.
You have first-degree heart block (an alteration in heart rhythm), as carvedilol may reduce the speed of electrical impulse conduction in the heart.
You are elderly or have heart rhythm disorders such as bradycardia (slow heart rate), sinus node dysfunction, or atrioventricular block (types of arrhythmias), as sinus arrest (a temporary pause in heartbeat) may occur; see section 4 "Possible side effects".
You wear contact lenses, as Dilatrend may reduce tear production.

Do not stop Dilatrend treatment abruptly. Discontinuation of carvedilol should be gradual (over a period of two weeks). During treatment with Dilatrend, very rare cases of serious skin and mucous membrane reactions have been reported, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see section 4 "Possible side effects"). In such cases, contact your doctor immediately, as Dilatrend must be discontinued.

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

Digoxin, a medicine used to treat heart conditions;
Cyclosporine and tacrolimus, medicines used to prevent organ transplant rejection;
Antiarrhythmics, such as amiodarone, medicines used to regulate heart rhythm;
Fluoxetine and paroxetine, medicines used to treat depression;
Rifampicin, an antibiotic used to treat bacterial infections;
Cimetidine, a medicine used to treat ulcers and heartburn;
Insulin or oral hypoglycemics (medicines for the treatment of diabetes);
Antihypertensives, such as reserpine and clonidine (medicines used to lower blood pressure);
Anesthetics and neuromuscular blocking agents, medicines that induce sedation, reduce pain sensitivity, and cause muscle relaxation;
Non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for pain, inflammation, and fever;
Bronchodilators, medicines used to treat respiratory problems.

Dilatrend and alcohol
Alcohol may enhance the hypotensive effect of carvedilol (lowers blood pressure).
Dilatrend and grapefruit juice
It is recommended to avoid consuming grapefruit juice during treatment with carvedilol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Dilatrend during pregnancy should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus or newborn.
If the medicine is taken, discontinue treatment 2–3 days before the expected delivery date. If this is not possible, the newborn must be monitored for the first 2–3 days of life.
Breastfeeding
Dilatrend must not be used during breastfeeding (see section "Do not take Dilatrend").
Driving and using machines
No studies have been conducted on the effects of carvedilol on the ability to drive or operate machinery.
Dilatrend may cause dizziness and visual disturbances; therefore, your ability to drive or use machines may be impaired. These effects are more likely to occur at the beginning of treatment, after dose increases, when switching to another carvedilol-containing medicine, or when alcohol is consumed concurrently.
For athletes
Using this medicine without a therapeutic indication constitutes doping and may lead to a positive anti-doping test.
Dilatrend contains sucrose and lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Dilatrend

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Treatment of essential arterial hypertension
Dosage
Adults
The recommended initial dose is 12.5 mg once daily for the first two days.
Thereafter, the recommended dose is 25 mg once daily. If necessary, the dose may be gradually increased at intervals of no less than two weeks, up to the maximum recommended dose of 50 mg per day, taken as a single dose or divided into 25 mg twice daily.
Elderly
The recommended starting dose is 12.5 mg once daily. If necessary, your doctor may increase the dose at intervals of at least two weeks, up to the maximum recommended dose of 50 mg, taken as 25 mg twice daily.
Treatment of angina pectoris
Dosage
Adults
The recommended initial dose is 12.5 mg twice daily for the first two days.
Thereafter, the recommended dose is 25 mg twice daily. Do not exceed the maximum recommended daily dose.
Elderly
The recommended starting dose is 12.5 mg twice daily.
Thereafter, the dose may be increased, after an interval of at least two days, to 25 mg twice daily. Do not exceed the maximum recommended daily dose.
Treatment of heart failure
Dosage
Your doctor will prescribe the appropriate dose for you and will closely monitor you during the period required to reach the dose suitable for you.
The recommended starting dose is 3.125 mg (half a 6.25 mg tablet) twice daily for at least two weeks. After two weeks, if this dose is well tolerated, the dose may be increased at intervals of no less than two weeks, first to 6.25 mg twice daily, then to 12.5 mg twice daily, and finally to 25 mg twice daily. The dose should be increased up to the highest dose that is tolerated.
The maximum recommended dose is 25 mg twice daily in cases of severe heart failure and in mild to moderate heart failure with body weight below 85 kg. In cases of mild to moderate heart failure with body weight above 85 kg, the maximum recommended dose is 50 mg twice daily.
Before each dose increase, your doctor will assess for any signs of worsening heart failure or vasodilation and, if necessary, will consider discontinuing treatment.
If treatment with Dilatrend is interrupted for more than two weeks, therapy should be restarted with 3.125 mg (half a 6.25 mg tablet) twice daily, and the dose should then be increased according to the previous recommendations.
Use in children and adolescents
The safety and efficacy of Dilatrend in children and adolescents have not yet been established.
Method of administration
The tablet may be divided into equal doses.
Tablets should be taken with a sufficient amount of liquid, regardless of meals.
Taking the tablets with food is recommended in cases of heart failure (inability of the heart to supply adequate blood to the body), to slow down the absorption of the medicine and reduce the incidence of orthostatic hypotension (low blood pressure upon standing).
If you take more Dilatrend than you should
In case of accidental ingestion/overdose of Dilatrend, contact your doctor immediately or go to the nearest hospital.
Overdose may cause: severe hypotension (low blood pressure), bradycardia (reduced heart rate), heart failure (inability of the heart to pump blood efficiently), cardiogenic shock (reduced blood flow to organs and tissues due to decreased heart function), and cardiac arrest. Respiratory problems, bronchospasm (constriction of the airways), vomiting, disturbances of consciousness, and generalized convulsive seizures (sudden, uncontrolled, involuntary movements) may also occur.
Your doctor will initiate treatment appropriate to your clinical condition and, if necessary, monitor and correct your vital parameters under intensive care conditions.
If you forget to take Dilatrend
Do not take a double dose to make up for a missed dose.
If you stop taking Dilatrend
Dilatrend must be discontinued gradually over a period of two weeks and under medical supervision.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

dizziness, headache;
heart failure (inability of the heart to pump blood efficiently);
hypotension (low blood pressure);
asthenia (weakness); dizziness, syncope, headache and asthenia are generally mild and are more likely to occur at the beginning of treatment.

Common (may affect up to 1 in 10 people)

bronchitis and pneumonia (inflammation of the bronchi and lungs), upper respiratory tract infections;
urinary tract infections;
anaemia (reduction in the amount of haemoglobin, a protein found in red blood cells that carries oxygen in the blood);
weight gain, hypercholesterolaemia (increased level of cholesterol, a type of fat in the blood), hyperglycaemia and hypoglycaemia (increased or decreased blood glucose) (in patients with diabetes);
depression, depressed mood;
syncope, pre-syncope (loss of consciousness, feeling of fainting);
visual disturbances, decreased lacrimation (dry eyes), eye irritation;
bradycardia (reduced heart rate);
hypertension (high blood pressure);
hypervolaemia (increased volume of circulating blood), fluid accumulation;
orthostatic hypotension (drop in blood pressure upon standing), peripheral circulatory disorders (cold hands and feet, problems with peripheral blood vessels), worsening of leg pain during physical activity (intermittent claudication), and Raynaud's phenomenon (constriction of blood vessels in the hands and feet causing pain and skin colour changes);
dyspnoea (difficulty breathing), pulmonary oedema (fluid accumulation in the lungs), asthma (narrowing and inflammation of the bronchi in patients predisposed to this condition);
nausea, diarrhoea, vomiting, dyspepsia (indigestion), abdominal pain;
extremity pain (hands and feet);
renal failure and altered kidney function in patients with diffuse vascular disease and/or pre-existing renal failure;
pain;
oedema (fluid accumulation).

Uncommon (may affect up to 1 in 100 people)

sleep disorders;
confusion;
paraesthesia (tingling or numbness in hands and feet);
atrioventricular block (disturbance in the conduction of the cardiac impulse between atrium and ventricle), angina pectoris (chest pain);
constipation;
skin reactions, e.g. allergic rash (allergic skin eruption), dermatitis (skin irritation), urticaria, pruritus, psoriasiform skin lesions (raised, red, scaly patches), and lichen planus-like skin lesions (rough, scaly red patches), alopecia (hair loss);
erectile dysfunction (erection disorders).

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

thrombocytopenia (decrease in the number of platelets);
nasal congestion (stuffy nose);
dry mouth;
urinary disorders (urine retention or difficulty in passing urine).

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

leucopenia (decrease in the number of white blood cells);
hypersensitivity (allergic reaction);
increased liver enzyme levels [proteins that rise in case of liver damage (ALT, AST, and GGT)];
severe skin reactions with redness, blisters and vesicles (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

onset of diabetes symptoms with altered blood sugar levels (glycaemia), worsening of diabetes, changes in glycaemia;
sinus arrest (temporary pause in heartbeat);
hyperhidrosis (excessive sweating);
urinary incontinence (difficulty in holding urine) in women, which resolves upon discontinuation of treatment;
hallucinations (perception of things that do not exist in reality).

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dilatrend

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 pack after
"Exp". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging,
correctly stored.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Dilatrend 25 mg contains

The active substance is carvedilol 25 mg
The other components are sucrose, monohydrate lactose, povidone K25, anhydrous colloidal silica, crospovidone type A, magnesium stearate.

Description of the appearance of Dilatrend and package contents
Dilatrend 25 mg are round tablets, white to slightly yellowish beige in colour, with a break line and imprint BM on one side and D5 on the other.
Pharmaceutical form and pack size
25 mg tablets in packages containing 30 and 56 tablets.
Marketing Authorization Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany