Karvileks 12.5 mg tablets (carvedilol) – for high blood pressure, angina pectoris and heart failure

Karvileks is a medicine for diseases of the heart and blood vessels containing carvedilol – a blocker of beta1 and beta2 adrenergic receptors that also blocks alpha1 receptors in blood vessels. In this way it slows the heart and widens the blood vessels.

In Serbia it is authorised as a 12.5 mg tablet with a score line (30 tablets). It is used in essential hypertension, chronic stable angina pectoris and stable chronic heart failure. The dose is introduced gradually and treatment must not be stopped abruptly.

What is Karvileks used for and how should it be taken?

Key facts about the medicine

What is Karvileks used for?

• essential hypertension – high blood pressure not caused by another disease;
• chronic stable angina pectoris;
• stable, symptomatic chronic heart failure of any grade, of ischaemic or non-ischaemic origin, in addition to standard treatment (ACE inhibitors, diuretics, with or without digoxin) – in patients with reduced ejection fraction whose condition was stable for 4 weeks before starting treatment.

How is Karvileks taken and dosed?

• The tablets are taken with plenty of liquid, usually in the morning or morning and evening, with a meal – this reduces the drop in blood pressure on changing position.
• The tablets can be divided into equal doses (½ tablet = 6.25 mg).
• In heart failure the dose is increased only if the condition is stable, with frequent check-ups (kidneys, body weight, blood pressure, pulse). If treatment has been interrupted for more than 1 week, it is resumed at lower doses; after a break of more than 2 weeks it starts again at 3.125 mg twice daily.
• The duration of treatment is decided by the doctor; treatment is usually long-term.

Special patient groups

• Children and adolescents under 18: the medicine should be avoided – there are insufficient data on efficacy and safety.
• Elderly patients: may be more sensitive and should be monitored carefully; special doses for hypertension and angina (see table).
• Heart failure and kidney disease: the dose is set individually; with low blood pressure, ischaemic disease and impaired kidneys a reversible worsening of kidney function is possible.
• Severe liver impairment: the medicine must not be taken.
• Diabetes: beta-blockers may mask or worsen blood sugar disorders – more frequent monitoring is needed.

Contraindications – when the medicine must not be used

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

Warnings and precautions

• worsening of the condition (shortness of breath, fluid retention in the legs);
• severe circulatory disorders in the limbs or Raynaud's disease – symptoms may worsen;
• diabetes; severe allergies and hypo-/desensitisation; psoriasis (also in the family);
• pulse below 55 beats per minute; first-degree AV block; orthostatic hypotension; labile or secondary hypertension;
• acute inflammatory heart disease, narrowed heart valves, end-stage peripheral arterial disease, hyperthyroidism;
• forthcoming anaesthesia or major surgery; reduced tear production in contact lens wearers;
• severe skin reactions (TEN, SJS) – stop the medicine;
• the medicine may give a positive doping test; contains lactose.

Interactions with other medicines, food and drink

• digoxin, digitoxin; verapamil, diltiazem, amiodarone and other antiarrhythmics; dihydropyridines;
• oral antidiabetics and insulin – closer blood sugar monitoring;
• rifampicin and barbiturates – may reduce the effect; ciclosporin, tacrolimus – their dose may need to be reduced;
• medicines acting on the CNS (sedatives, sleeping pills, antidepressants, MAO inhibitors), other blood pressure medicines (clonidine, alpha-methyldopa, nitrates, alpha-blockers);
• anaesthetics, sympathomimetics and parasympathomimetics, ergotamine, aminophylline, theophylline, beta-agonists;
• NSAIDs, corticosteroids, oestrogens, muscle relaxants, cimetidine, hydralazine;
• grapefruit and grapefruit juice – avoid; alcohol – do not drink (enhances the fall in blood pressure).

Pregnancy and breast-feeding

• Pregnancy: only if the doctor considers it absolutely necessary; beta-blocker treatment should be stopped 48–72 hours before delivery, otherwise the newborn is monitored for the first 48–72 hours.
• Breast-feeding: mothers must not breast-feed while taking Karvileks.

Driving and using machines

• Dizziness and tiredness are possible, especially at the start of treatment, when the dose is changed or increased and with alcohol. Then do not drive, use machines or work without secure support.

Possible side effects

• Very common (more than 1 in 10): dizziness, headache, heart failure, low blood pressure, weakness.
• Common (up to 1 in 10): bronchitis, pneumonia, respiratory and urinary tract infections, anaemia, weight gain and raised cholesterol, blood sugar disorders in diabetics, depression, fainting, vision disorders and dry eye, slow pulse, fluid retention, drop in blood pressure on standing, cold limbs, difficulty breathing, nausea, diarrhoea, vomiting, stomach and joint pain, kidney problems, oedema.
• Uncommon (up to 1 in 100): sleep disorders, nightmares, hallucinations, confusion, paraesthesia, 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, raised transaminases, involuntary urination in women, severe skin reactions (TEN, SJS).

Overdose, missed dose and stopping treatment

• Overdose: marked drop in blood pressure, slow pulse, heart weakness, cardiogenic shock, cardiac arrest, difficulty breathing and bronchospasm, vomiting, impaired consciousness and seizures. Contact a doctor or go to hospital immediately and take the pack with you.
• Missed dose: take it as soon as you remember; if it is nearly time for the next one, skip it. Do not take a double dose.
• Stopping treatment: do not stop without your doctor; the dose is reduced gradually over 1–2 weeks.

Related information

For additional care and support with high blood pressure (home blood pressure and pulse monitoring), see also the category Blood pressure devices – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: carvedilol – each tablet contains 12.5 mg.
• Excipients: lactose monohydrate; povidone K30; colloidal anhydrous silica; crospovidone; magnesium stearate.
• Appearance: round, flat, white tablets with a score line; PVC/Al blister, box with 3 blisters of 10 tablets (30 tablets).
• Marketing authorisation holder: Actavis d.o.o. Belgrade, Đorđa Stanojevića 12; manufacturer: Zdravlje AD Leskovac.
• Authorisation number: 515-01-02073-21-001 of 10.05.2022 (renewal).

Storage

• Store below 25 °C, in the original package, to protect from light and moisture.
• Shelf life: 2 years.
• Keep out of the sight and reach of children.

Frequently asked questions

Why is the dose of Karvileks increased gradually?

Carvedilol lowers blood pressure and slows the heart. Gradual increases, at intervals of at least 2 weeks, reduce the risk of a drop in blood pressure, dizziness and worsening of heart failure.

Can I start heart failure treatment with the 12.5 mg tablet?

No. The starting dose in heart failure is 3.125 mg twice daily for 2 weeks, which is achieved with tablets from other manufacturers; Karvileks 12.5 mg is used in the later dosing steps.

What if I stop taking the medicine suddenly?

Abrupt stopping can worsen angina and the heart condition, especially in coronary disease. The dose is reduced gradually over 1–2 weeks, as advised by the doctor.

May I drink alcohol with Karvileks?

You should not. The medicine enhances the blood-pressure-lowering effect of alcohol, and dizziness and tiredness are more likely. Also avoid grapefruit and grapefruit juice.

Sources

• ALIMS – Package leaflet Karvileks 12.5 mg (PIL, in Serbian)
• ALIMS – Summary of product characteristics Karvileks 12.5 mg (SmPC, in Serbian)

Date sources were checked: 25.10.2026.