Betamsal 0.4 mg modified-release capsules – tamsulosin for urinary symptoms of benign prostatic enlargement

Betamsal is a medicine containing the active substance tamsulosin, an alpha-1A and alpha-1D adrenergic receptor blocker. It relaxes the smooth muscle of the prostate and urethra, making it easier for urine to pass, and also reduces the urge to urinate frequently.

This page refers to Betamsal 0.4 mg modified-release hard capsules (30 capsules) made by Hemofarm. The medicine is intended only for men with symptoms caused by benign enlargement of the prostate and is available on prescription.

What is Betamsal (tamsulosin) used for and how should it be taken correctly?

Key facts about the medicine

What is Betamsal used for?

According to the official leaflet, Betamsal is used in men to treat the functional symptoms of benign prostatic hyperplasia (BPH, benign enlargement of the prostate). These symptoms include:

• difficulty starting to urinate;
• a thin or interrupted urine stream;
• an urgent need to urinate;
• frequent urination during the day and night.

The medicine relieves urinary symptoms, while the condition of the prostate is monitored by your doctor through regular check-ups.

How is it used and dosed?

• Recommended dose for adult and elderly men: one capsule a day.
• Take the capsule after breakfast or the first meal of the day.
• Swallow the capsule whole with enough water – do not open, crush or chew it, as this would affect the modified release.

Take the medicine for as long as your doctor has prescribed, even when the symptoms improve. This is the general dosing from the leaflet – your doctor will decide on your treatment.

Special patient groups

• Elderly patients: the dose does not change.
• Kidney impairment: no dose adjustment is needed; in severe impairment (creatinine clearance below 10 mL/min) great caution is required as there are no data.
• Liver impairment: no dose change in mild to moderate impairment; the medicine must not be taken in severe impairment.
• Children and adolescents under 18 years: the medicine is not intended for this population.
• Women: the medicine is not indicated for use in women.

Contraindications – when the medicine must not be used

• allergy to tamsulosin or any of the excipients (may appear as sudden swelling of the throat or tongue, difficulty breathing, itching and rash – angioedema);
• severe liver impairment;
• a history of fainting or dizziness due to low blood pressure on standing up quickly (orthostatic hypotension).

Warnings and precautions

• Regular medical check-ups are needed to monitor the prostate.
• Dizziness or weakness, and even fainting, may rarely occur – sit or lie down until the symptoms pass.
• Tell your doctor if you have severe kidney disease.
• Before any surgery, especially cataract or glaucoma surgery, tell your eye doctor that you are taking, have taken or plan to take tamsulosin; the doctor will decide whether treatment should be temporarily stopped or postponed.

Interactions with other medicines, food and drink

• Other alpha-1 adrenergic receptor blockers: together they may lower blood pressure and cause dizziness or fainting.
• Diclofenac (a medicine for pain and inflammation) and warfarin (a blood-thinning medicine): may speed up the elimination of tamsulosin and shorten its effect.
• Ketoconazole (an antifungal) and erythromycin (an antibiotic): may slow down the elimination of tamsulosin – be sure to tell your doctor.
• Food: take the medicine after breakfast or the first meal of the day.

Pregnancy, breast-feeding and fertility

Betamsal is not indicated for use in women. In men, ejaculation disorders have been reported – semen flows back into the bladder (retrograde ejaculation), its volume is reduced or ejaculation is absent. According to the leaflet, this effect is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive, but some patients experience dizziness. In that case, do not drive or operate machinery until the symptoms pass.

Possible side effects

• Common (up to 1 in 10): dizziness, especially on standing up; ejaculation disorders (retrograde ejaculation, reduced volume or absence of ejaculation).
• Uncommon (up to 1 in 100): headache, palpitations, a drop in blood pressure on standing up quickly (sometimes with fainting), runny or blocked nose, diarrhoea, nausea, vomiting, constipation, weakness, rash, itching, hives.
• Rare (up to 1 in 1,000): brief loss of consciousness (syncope), angioedema.
• Very rare (up to 1 in 10,000): priapism (a painful, prolonged erection requiring urgent medical help), Stevens-Johnson syndrome.
• Floppy iris syndrome (IFIS) may occur during cataract and glaucoma surgery; irregular heartbeat and breathing difficulties have also been reported after marketing.

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

Overdose, missed dose and stopping treatment

• Overdose: a sudden fall in blood pressure and heart rhythm disturbance with dizziness and weakness may occur – contact a doctor or emergency service immediately.
• Missed dose: take it the same day as soon as you remember; if the day has passed, continue as usual the next day. Do not take a double dose.
• Stopping: symptoms may return – do not stop treatment without consulting your doctor.

Related information

For additional care and support with enlarged prostate symptoms, see also the Preparations for an enlarged prostate and urination problems category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: tamsulosin hydrochloride 0.4 mg per capsule.
• Capsule contents (pellets): microcrystalline cellulose; methacrylic acid–ethyl acrylate copolymer (1:1) dispersion 30% (polysorbate 80, sodium lauryl sulfate); talc; triethyl citrate.
• Capsule shell: gelatin; red, yellow and black iron oxide (E172); titanium dioxide (E171); indigo carmine (E132).
• Pack: PVC/PE/PVDC//Al blister of 10 capsules; carton with 3 blisters (30 capsules).
• Marketing authorisation holder and manufacturer: Hemofarm AD Vršac, Beogradski put bb, Vršac, Serbia.

Storage

• Store in the original package.
• Shelf life: 3 years.
• Keep out of the sight and reach of children.

Frequently asked questions

When is the best time to take Betamsal?

Once a day, after breakfast or the first meal of the day. Swallow the capsule whole with water.

Why is there less ejaculate after taking Betamsal?

Tamsulosin can cause retrograde ejaculation – semen flows back into the bladder instead of out of the body. The leaflet states that this is common and harmless.

Should I stop Betamsal before cataract surgery?

Your doctor will decide. It is important that the eye surgeon knows that you are taking or have taken tamsulosin, as floppy iris syndrome (IFIS) may occur during surgery.

Can Betamsal lower blood pressure?

Yes, especially on standing up quickly (orthostatic hypotension). Caution is needed with other alpha-blockers; if you feel dizzy, sit or lie down until it passes.

Sources

• ALIMS – Summary of Product Characteristics, Betamsal®, 0.4 mg, modified-release capsules, hard (Serbian)
• ALIMS – Package leaflet, Betamsal® (July 2024, Serbian)

Date sources were checked: 24.10.2026.