Milenol 12.5 mg and 25 mg tablets – carvedilol for high blood pressure, angina and heart failure

Milenol contains carvedilol, a medicine that blocks beta1 and beta2 adrenergic receptors (a beta-blocker) and also alpha1 receptors in the blood vessels. It slows the heart, reduces its workload and widens the blood vessels, so blood pressure falls.

In Serbia it is authorised as Milenol®, 12.5 mg and 25 mg, tablets (Hemofarm AD Vršac), in packs of 30 tablets. It is used for essential hypertension, chronic stable angina pectoris and stable chronic heart failure in addition to standard therapy.

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

Key facts about the medicine

What is Milenol used for?

According to the package leaflet, Milenol is used to treat:

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

How is it taken and dosed?

Take the tablets with plenty of liquid. Your doctor decides the dose; according to the leaflet:

• Milenol is not intended for doses below 6.25 mg – for lower doses (e.g. the initial 3.125 mg in heart failure) another authorised carvedilol medicine of suitable strength is used.
• If more than one week has passed since stopping treatment, contact your doctor – treatment will need to be restarted at the initial dose.

Special patient groups

• Elderly patients: may be more sensitive to carvedilol and should be monitored carefully.
• Heart failure and kidneys: with low blood pressure, ischaemic heart disease or reduced kidney function, the doctor frequently checks kidney function during dose adjustment.
• Liver impairment: the medicine must not be taken in severe impairment.
• Diabetes: signs of low blood sugar (especially a fast heartbeat) may be masked – check your blood sugar regularly at the start and when the dose changes.
• Children and adolescents: insufficient data – use should be avoided.

Contraindications – when the medicine must not be used

Do not take Milenol:

• if you are allergic to carvedilol or any excipient;
• during cardiogenic shock or with worsening (unstable/decompensated) heart failure;
• with acute pulmonary embolism or Prinzmetal angina;
• with extremely low blood pressure (systolic below 85 mmHg) or a very slow heart rate (below 50/min);
• with second- or third-degree AV block (without a pacemaker), sick sinus syndrome or SA block;
• with cor pulmonale, asthma or other lung disease with a tendency to airway narrowing (e.g. COPD);
• with untreated phaeochromocytoma, severe liver impairment or metabolic acidosis;
• together with MAO inhibitors (except MAO-B inhibitors) or intravenous verapamil, diltiazem or other antiarrhythmics;
• while breast-feeding.

Warnings and precautions

Heart failure treatment is started only when the condition is stabilised, with standard therapy unchanged for at least 4 weeks. A sudden fall in blood pressure after the first dose or a dose increase is more likely in severe heart failure, salt or fluid depletion (high-dose diuretics), in people aged 70 or over and with low initial blood pressure – such patients are monitored for about 2 hours. Heart failure may worsen or fluid may be retained during dose increases.

Caution is needed with first-degree AV block, unstable angina, diabetes, Raynaud’s disease and other peripheral vascular diseases, an overactive thyroid (symptoms may be masked), surgery and anaesthesia, a tendency to severe allergic reactions or desensitisation therapy, and psoriasis related to beta-blockers. If the pulse falls below 55/min, the dose is reduced. In severe skin reactions (SJS, TEN) the medicine is stopped permanently. Contact lens wearers may notice reduced eye moistening. The medicine may give a positive doping test.

Interactions with other medicines, food and drink

• digoxin – increased digoxin levels and slowed AV conduction; monitoring needed;
• other blood pressure medicines, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators – greater fall in blood pressure;
• clonidine, reserpine, guanethidine, methyldopa, guanfacine, MAO inhibitors – additional lowering of blood pressure and slow heart rate; when stopping, Milenol is withdrawn first and clonidine gradually a few days later;
• verapamil, diltiazem, amiodarone and other antiarrhythmics – risk of conduction disorders; ECG and blood pressure monitoring needed;
• ciclosporin – level monitoring; anaesthetics – increased effect on the heart and blood pressure;
• NSAIDs – may raise blood pressure and weaken its control;
• insulin and oral antidiabetics – increased effect and masked signs of hypoglycaemia;
• cimetidine, hydralazine, fluoxetine, paroxetine – may increase carvedilol levels; rifampicin reduces them;
• beta-agonist bronchodilators – Milenol weakens their effect.

Do not drink alcohol during treatment – Milenol may enhance its blood-pressure-lowering effect, and alcohol increases the availability of the medicine.

Pregnancy and breast-feeding

• Pregnancy: the medicine may be taken only if the doctor considers it absolutely necessary. Beta-blockers 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 Milenol.

Driving and using machines

Dizziness or tiredness may occur, especially at the start of treatment, when the dose is changed or increased, and with alcohol. If this happens, do not drive or use machines.

Possible side effects

Contact a doctor immediately in case of sudden swelling of the face, lips, tongue or throat; chest pain with breathlessness and sweating; passing less urine with swelling; symptoms of low blood sugar; severe skin reactions with blisters.

• Very common (more than 1 in 10): dizziness, headache, weakness and tiredness, heart failure, low blood pressure (mostly mild symptoms at the start of treatment).
• Common (up to 1 in 10): respiratory and urinary tract infections, anaemia, weight gain, raised cholesterol, impaired blood sugar control in diabetics, depression, visual disturbances and dry eyes, slow heart rate, fall in blood pressure on standing, fluid retention and swelling, cold hands and feet, claudication, Raynaud’s phenomenon, breathing problems, nausea, diarrhoea, abdominal pain, pain in the arms and legs, kidney and urination problems.
• Uncommon (up to 1 in 100): sleep disturbances, nightmares, confusion, hallucinations, angina attacks, AV block, tingling of hands and feet, skin rash, itching, erectile dysfunction, constipation.
• Rare and very rare: low platelet or white blood cell counts, runny nose, dry mouth, allergic reactions, liver function disorders, involuntary urination in women; not known – hair loss and severe skin reactions.

Report any suspected side effect to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: a marked fall in blood pressure, slow pulse, heart muscle weakness, cardiogenic shock, bronchospasm, vomiting, impaired consciousness and seizures may occur – inform a 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 without your doctor; withdrawal is gradual, over two weeks.

Related information

For home monitoring of blood pressure and pulse during treatment, see also the category Blood pressure monitors – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: carvedilol – 12.5 mg or 25 mg per tablet.
• Excipients: silicified microcrystalline cellulose; pregelatinised starch; sodium starch glycolate (type A); sodium lauryl sulfate; magnesium stearate.
• Pack: carton with 3 PVC/PVDC-Al blisters of 10 tablets (30 in total).
• Marketing authorisation holder and manufacturer: Hemofarm AD Vršac, Beogradski put bb, Vršac, Republic of Serbia.

Storage

• Do not store above 30 °C; keep in the original package to protect from 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

Why must I not stop Milenol suddenly?

The leaflet states that treatment must not be stopped abruptly, especially in coronary artery disease – the dose is reduced gradually over two weeks, as instructed by your doctor.

Can heart failure treatment be started with the 12.5 mg tablet?

No. The starting dose in heart failure is 3.125 mg twice daily, and Milenol is not intended for doses below 6.25 mg – another carvedilol medicine of suitable strength is used to start.

May I take Milenol if I have asthma?

No – asthma and other lung diseases with a tendency to airway narrowing (e.g. COPD) are contraindications, as the medicine can cause bronchospasm.

Why have my eyes become dry since I started Milenol?

A feeling of dry eyes due to reduced tear production is a common side effect, and contact lens wearers may notice reduced eye moistening. If the symptoms persist, tell your doctor.

Sources

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

Date sources checked: 25.10.2026.