Methyldopa (Methyldopa HF) 250 mg film-coated tablets – methyldopa for the treatment of high blood pressure

Methyldopa is authorised in Serbia as Methyldopa HF 250 mg film-coated tablets (Hemofarm AD Vršac), the only authorised medicine with this active substance. It contains methyldopa and belongs to the group of antihypertensives – medicines that lower blood pressure.

The doctor prescribes it for the treatment of high blood pressure (hypertension). Each film-coated tablet contains 250 mg methyldopa (anhydrous, as methyldopa sesquihydrate). The pack contains 20 tablets.

How does Methyldopa HF lower blood pressure and how is it taken correctly?

Key facts about the medicine

What is Methyldopa HF used for?

According to the patient leaflet, Methyldopa HF is used for the treatment of high blood pressure (hypertension). According to the summary of product characteristics, methyldopa is also used, under medical supervision, to treat hypertension in pregnancy.

How is Methyldopa HF taken and dosed?

The dose depends on your condition and response to treatment; take the medicine exactly as prescribed by your doctor and for as long as prescribed.

• Adults: the usual starting dose is 250 mg 2 to 3 times daily for the first two days; the doctor then adjusts the dose (at intervals of no less than 2 days). The maximum daily dose is 3000 mg.
• Many patients experience drowsiness for 2–3 days at the start of treatment or after a dose increase; therefore, when the dose is increased, the evening dose is increased first.
• In patients already on other antihypertensives, the starting dose of methyldopa is limited to 500 mg daily.
• Children: the dose is based on body weight – the usual starting daily dose is 10 mg/kg divided into 2–4 doses; at most 65 mg/kg or 3000 mg daily (whichever is lower).
• Elderly: the doctor sets the dose; the lowest effective dose reduces the risk of fainting.
• The tablet is taken by mouth.

Special patient groups

• Elderly patients: a tendency to faint (syncope) may be related to increased sensitivity and atherosclerosis – lower doses are used.
• Kidney impairment: lower doses are needed because methyldopa is mainly excreted by the kidneys. Dialysis removes methyldopa, so blood pressure may rise afterwards.
• Liver disease: active liver disease is a contraindication; with previous liver disease the medicine is used with caution.
• Children: dosing by body weight, as instructed by the doctor.

Contraindications – when the medicine must not be used

• allergy to methyldopa (including liver disease caused by previous use of methyldopa) or to the excipients;
• active liver disease (acute hepatitis, cirrhosis);
• depression;
• phaeochromocytoma or paraganglioma (catecholamine-secreting tumours);
• treatment with MAO inhibitors;
• porphyria.

Warnings and precautions

• Haemolytic anaemia (rare) – if signs of anaemia appear, the doctor checks the blood count; a positive Coombs test occurs in 10–20% of patients on long-term treatment, which is important for blood transfusions.
• Fever, abnormal liver function or jaundice, usually within the first 2–3 months – treatment is stopped and the medicine is not used again.
• Caution in previous liver disease, after stroke or heart attack and with involuntary movements.
• Tell your doctor if you need dialysis, surgery (including dental procedures under anaesthesia) or a blood transfusion.
• Tolerance to the medicine may develop.
• Methyldopa may affect the results of some blood and urine tests (uric acid, creatinine, AST, urinary catecholamines) – say that you are taking this medicine.
• Rarely, urine may darken after exposure to air.
• The medicine contains lactose and azo colourings (E110, E122, E151), which may cause allergic reactions.

Interactions with other medicines, food and drink

• MAO inhibitors – must not be taken at the same time.
• Other blood pressure medicines and alcohol – increase the blood-pressure-lowering effect.
• Lithium – possible lithium toxicity, monitoring required.
• Phenothiazines (e.g. chlorpromazine), tricyclic antidepressants, haloperidol and sympathomimetics, including cough/cold medicines with decongestants – may weaken the effect of methyldopa or cause interactions.
• Iron and iron-containing products, including multivitamins with minerals – reduce the absorption of methyldopa and may worsen blood pressure control.
• Anaesthetics – lower doses may be needed; tell your surgeon and dentist.
• Alcohol – do not drink during treatment.

Pregnancy and breast-feeding

• Pregnancy: according to the summary of product characteristics, methyldopa is used under medical supervision to treat hypertension in pregnancy; it crosses the placenta, so use requires a benefit–risk assessment. Consult your doctor before taking it.
• Breastfeeding: methyldopa passes into breast milk; the doctor decides on breastfeeding or treatment.

Driving and using machines

• Methyldopa HF may cause drowsiness (sedation) or light-headedness, especially at the start of treatment or when the dose is increased. In that case, do not drive or operate machinery.

Possible side effects

The frequency of side effects is not known (cannot be estimated from the available data). Reported effects include:

• Nervous system: drowsiness and tiredness (usually transient, at the start or after a dose increase), headache, weakness, pins and needles, involuntary movements, signs of parkinsonism, paralysis of one side of the face, confusion, dizziness and fainting, especially on standing up quickly.
• Heart and blood vessels: slow heartbeat, worsening angina, AV block, inflammation of the heart muscle or pericardium, low blood pressure on standing.
• Blood: anaemia (including haemolytic), low white blood cell and platelet counts, positive Coombs test.
• Liver and pancreas: hepatitis and jaundice, pancreatitis.
• Stomach and bowel: nausea, vomiting, bloating, constipation, wind, diarrhoea, colitis, dry mouth, sore or discoloured tongue.
• Other: blocked nose, rash, joint and muscle pain, swelling and weight gain due to fluid retention, fever, inflammation of the salivary glands, raised prolactin, breast enlargement, absence of periods, milk secretion, erection and ejaculation disorders, reduced libido, nightmares, depression, delusions and paranoia (resolving when the medicine is stopped).

Overdose, missed dose and stopping treatment

• Overdose: if you have taken more than the recommended dose, contact a doctor or the nearest healthcare facility immediately.
• Missed dose: simply continue with the prescribed schedule; do not take a double dose.
• Stopping treatment: do not stop without consulting your doctor – after stopping, blood pressure usually rises again within 48 hours.

Related information

For additional care and support with home blood pressure 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: methyldopa, anhydrous (as methyldopa sesquihydrate), 250 mg per film-coated tablet.
• Tablet core: povidone K30; maize starch; lactose monohydrate; magnesium stearate; colloidal anhydrous silica; talc.
• Film coating: hypromellose; triacetin; titanium dioxide (E171); talc; colourings E104, E110, E122 and E151.
• Appearance: pale yellow, round, biconvex film-coated tablets, white in cross-section.
• Pack: PVC/PVdC-Al blister with 10 tablets; carton with 2 blisters (20 film-coated tablets).
• Marketing authorisation holder and manufacturer: Hemofarm AD Vršac, Beogradski put bb, Vršac, Serbia.
• Authorisation number and date: 000457486 2023 of 29 July 2024.

Storage

• Store below 25 °C in the original package to protect from light and moisture.
• Keep out of the sight and reach of children.

Frequently asked questions

May methyldopa be taken during pregnancy?

According to the summary of product characteristics, methyldopa is used under medical supervision to treat high blood pressure in pregnancy. The medicine crosses the placenta, so the decision is always made by the doctor after weighing benefits and risks.

Why does my doctor ask for blood tests while I take Methyldopa HF?

Methyldopa can rarely cause haemolytic anaemia and liver damage, most often in the first weeks and months of treatment. Liver tests and blood counts are therefore recommended before starting and periodically during the first 6–12 weeks, and also in case of unexplained fever.

May I take iron or multivitamins with this medicine?

Not without agreeing it with your doctor. Iron (and multivitamins with minerals) reduce the absorption of methyldopa, which can weaken blood pressure control.

Why has my urine turned dark?

Rarely, after exposure to air, urine may darken due to the breakdown of methyldopa or its metabolites. However, if dark urine comes with yellowing of the skin or eyes and pale stools, contact your doctor immediately.

Sources

• ALIMS – Patient information leaflet (PIL): Methyldopa HF 250 mg film-coated tablets
• ALIMS – Summary of product characteristics (SmPC): Methyldopa HF 250 mg film-coated tablets

Date sources were checked: 25.10.2026.