Dilatrend 6.25 mg, 12.5 mg and 25 mg tablets – carvedilol for heart failure, hypertension and angina

Dilatrend tablets contain carvedilol, a medicine which, according to the leaflet, causes non-selective blockade of beta1- and beta2-adrenergic receptors and selective blockade of alpha1-adrenergic receptors in the cardiovascular system. It is used to treat diseases of the heart and blood vessels.

In Serbia it is authorised in three strengths – 6.25 mg, 12.5 mg and 25 mg. It is important to know that the strengths differ in their approved indications: Dilatrend 6.25 mg is intended only for stable chronic heart failure, while 12.5 mg and 25 mg are also used for essential hypertension and chronic stable angina pectoris.

What is Dilatrend used for and how should it be taken correctly?

Key facts about the medicine

What is Dilatrend used for?

In heart failure the medicine is intended for patients with reduced left ventricular ejection fraction whose condition was clinically stable for 4 weeks before starting treatment (no change in symptoms or basic therapy and no hospitalisation for heart failure).

How is it taken and dosed?

Your doctor determines the dose carefully and increases it gradually. Examples from the leaflet:

• Swallow the tablets whole with enough liquid, in the morning or morning and evening, as your doctor has told you.
• Taking it with a meal is recommended, as the active substance is then absorbed more slowly and the risk of a drop in blood pressure on changing position is reduced.
• Treatment is usually long-term; it is stopped gradually over one to two weeks.

Special patient groups

• Children and adolescents under 18 years: there are insufficient data on efficacy and safety – the medicine should be avoided.
• Elderly patients: may be more sensitive to carvedilol and should be monitored carefully. For hypertension the starting dose is 12.5 mg in the morning and the maximum 25 mg twice daily; for angina a daily dose of 2 x 25 mg must not be exceeded.
• Liver impairment: contraindicated in severe liver impairment.
• Kidneys: in heart failure with low blood pressure, ischaemic disease or reduced kidney function, reversible worsening of kidney function has been observed.

Contraindications – when the medicine must not be used

Do not take Dilatrend:

• if you are allergic to carvedilol or any of the excipients;
• during cardiogenic shock or if heart failure is worsening (unstable/decompensated heart failure);
• in acute pulmonary embolism, Prinzmetal’s angina or cor pulmonale;
• if you have extremely low blood pressure (systolic below 85 mmHg) or a very slow heart rate (less than 50 beats per minute);
• in second- or third-degree AV block (without a permanent pacemaker) and sick sinus syndrome, including SA block;
• if you have asthma or another airway disease with a tendency to spasm (e.g. COPD);
• in untreated phaeochromocytoma, severe liver impairment or metabolic acidosis;
• in combination with MAO inhibitors (except MAO-B inhibitors) or with intravenous verapamil, diltiazem or other antiarrhythmics;
• during breast-feeding.

Warnings and precautions

Your doctor will take special precautions if:

• your condition worsens (shortness of breath, fluid accumulating in the legs);
• you have peripheral vascular disease or Raynaud’s disease, diabetes, psoriasis (also in the family) or an overactive thyroid;
• you have serious allergies or are undergoing hypo/desensitisation; in severe allergic reactions the response to adrenaline may be reduced;
• your heart rate is markedly slow (below 55/min), you have first-degree AV block, low or variable blood pressure, narrowing of heart valves or acute inflammatory heart disease;
• you take cardiac glycosides, verapamil, diltiazem or other blood pressure medicines;
• you are due to have anaesthesia or major surgery, or you wear contact lenses (reduced tear production);
• serious skin reactions occur (TEN, Stevens-Johnson syndrome).

Use of the medicine may result in a positive doping test. The tablets contain lactose and sucrose.

Interactions with other medicines, food and drink

Tell your doctor about all medicines you are taking. Interactions are possible with:

• digoxin and digitoxin; verapamil, diltiazem and amiodarone; dihydropyridines and other blood pressure medicines (reserpine, clonidine, alpha-methyldopa etc.);
• oral antidiabetic medicines and insulin – more frequent blood sugar monitoring is recommended;
• rifampicin and barbiturates (weaker effect), ciclosporin and tacrolimus, cimetidine and hydralazine;
• sedatives and sleeping pills, antidepressants (tricyclics, fluoxetine, paroxetine, MAO inhibitors) and alcohol;
• anaesthetics, sympathomimetics and parasympathomimetics, ergotamine, theophylline, aminophylline and beta-agonists;
• NSAIDs, corticosteroids, oestrogen-based hormone therapy and curare-like muscle relaxants.

Food and drink: during dose adjustment avoid grapefruit and grapefruit juice (they may increase carvedilol levels in the blood), as well as excessive alcohol.

Pregnancy and breast-feeding

• Pregnancy: because of insufficient data, the medicine may be taken during pregnancy only if the doctor considers it absolutely necessary. Beta-blocker treatment should be stopped 48–72 hours before the expected delivery; if this is not possible, the newborn is monitored for the first 48–72 hours.
• Breast-feeding: mothers must not breast-feed while taking Dilatrend.

Driving and using machines

Because of possible reactions such as dizziness or tiredness, the ability to drive and use machines may be reduced – especially at the start of treatment, when the dose is changed or increased, and with alcohol.

Possible side effects

Like all medicines, Dilatrend can cause side effects, although not everybody gets them. Their frequency does not depend on the dose, except for dizziness, visual disturbances and slow pulse.

• Very common (more than 1 in 10): dizziness, headache, heart failure, low blood pressure, tiredness.
• Common (up to 1 in 10): bronchitis, pneumonia, respiratory and urinary tract infections; anaemia; weight gain and raised cholesterol, impaired blood sugar control in diabetics; depression; fainting; visual disturbance, dry and irritated eyes; slow heart rate, fluid retention; drop in blood pressure on standing, cold extremities, worsening of claudication and Raynaud’s disease; difficulty breathing, pulmonary oedema, asthma; nausea, diarrhoea, vomiting, abdominal pain; pain in the limbs; impaired kidney function; oedema.
• Uncommon (up to 1 in 100): sleep disorders, nightmares, confusion, tingling, AV block, angina attacks, constipation, skin reactions and psoriasis, erectile dysfunction.
• Rare and very rare: reduced platelets and white blood cells, stuffy nose, dry mouth, allergic reactions, psychoses, raised liver enzymes, urinary incontinence in women; very rarely serious skin reactions (TEN, SJS).

Overdose, missed dose and stopping treatment

• Overdose: a marked drop in blood pressure, slow pulse, heart muscle weakness, cardiogenic shock, cardiac arrest, difficulty breathing, vomiting, impaired consciousness and seizures may occur. Tell your doctor immediately.
• Missed dose: do not take a double dose to make up for a missed one.
• Stopping treatment: do not change the dose or stop treatment without your doctor’s advice; the medicine is withdrawn gradually over 1–2 weeks.

Related information

For regular monitoring of blood pressure and pulse at home, see also the category Blood pressure monitors – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: carvedilol – 6.25 mg, 12.5 mg or 25 mg per tablet.
• Excipients: lactose monohydrate; sucrose; povidone K25; crospovidone type A; colloidal anhydrous silica; magnesium stearate; 6.25 mg additionally yellow iron oxide (E172); 12.5 mg additionally yellow and red iron oxide (E172).
• Appearance: 6.25 mg – round yellow tablets marked F1 and BM; 12.5 mg – round light brown tablets marked H3 and BM; 25 mg – round white to pale yellowish tablets marked D5 and BM; all scored on both sides.
• Marketing authorisation holder: Clinres Farmacija d.o.o. Beograd, Beogradskog bataljona 4, Belgrade. Manufacturer: Cheplapharm Arzneimittel GmbH, Greifswald, Germany.

Storage

• Store in the original package to protect from moisture and light – the tablets may change colour if exposed to light.
• Keep out of the sight and reach of children.
• Do not use after the expiry date; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

What is the difference between Dilatrend 6.25 mg, 12.5 mg and 25 mg?

Apart from the amount of carvedilol, the approved indications also differ: 6.25 mg is intended only for stable chronic heart failure, while 12.5 mg and 25 mg are also used for essential hypertension and chronic stable angina pectoris.

Is Dilatrend taken with food?

Yes, taking it with a meal is recommended, as the active substance is then absorbed more slowly, reducing the risk of dizziness and a drop in blood pressure on changing position.

Can I stop taking Dilatrend suddenly?

No. Treatment must not be stopped suddenly – the dose should be reduced gradually over one to two weeks as instructed by your doctor. This is especially important in coronary heart disease.

May I drink grapefruit juice with Dilatrend?

During the dose adjustment period, avoid grapefruit and grapefruit juice, as they can increase carvedilol levels in the blood and cause unpredictable side effects.

Sources

• ALIMS – Summary of Product Characteristics, Dilatrend® 25 mg tablets (SmPC, Serbian)
• ALIMS – Package leaflet, Dilatrend® 25 mg tablets (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Dilatrend® 12.5 mg tablets (SmPC, Serbian)
• ALIMS – Package leaflet, Dilatrend® 12.5 mg tablets (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Dilatrend® 6.25 mg tablets (SmPC, Serbian)
• ALIMS – Package leaflet, Dilatrend® 6.25 mg tablets (PIL, Serbian)

Sources checked on: 25 October 2026.