Leaflet TWINPROS 0.5mg / 0.4mg capsules

Product code:
W67129001
Quantity:
7
Indicated for:
benign prostatic hyperplasia
Route of administration:
oral
Substance:
dutasteride + tamsulosin (enzyme inhibitor + alpha-1 blocker)
ATC
G04CA52 — Genito urinary system and sex hormones | Drugs used in benign prostatic hypertrophy | Alpha-adrenoreceptor antagonists

Precautions:

Contraindicated during pregnancy

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Teratogenic / fetal risk

Teratogenic / fetal risk

This medicine may affect fetal development.

Dutasteride and tamsulosin are used together to treat benign prostatic hyperplasia (BPH), a condition characterized by the non-cancerous enlargement of the prostate, which can cause urinary difficulties. This combination is indicated for men with moderate to severe symptoms, helping to reduce prostate size, improve urine flow, and prevent complications such as acute urinary retention or the need for surgery.

Dutasteride is a 5-alpha-reductase inhibitor that blocks the conversion of testosterone into dihydrotestosterone (DHT), a hormone responsible for prostate growth. By reducing DHT levels, dutasteride shrinks the prostate and alleviates symptoms. Tamsulosin is an alpha-1 adrenergic receptor antagonist that relaxes the smooth muscles in the prostate and bladder neck, facilitating urination and reducing obstructive symptoms.

While this combination is effective, its use may cause side effects. Dutasteride may lead to decreased libido, erectile dysfunction, or breast tenderness. Tamsulosin may cause dizziness, orthostatic hypotension (a drop in blood pressure upon standing), abnormal ejaculation, or nasal congestion. In rare cases, allergic reactions or more severe symptoms, such as priapism (prolonged and painful erection), may occur.

This combination should be used as directed by a doctor, and patients should be regularly monitored to assess their response to treatment. It is important for patients to inform their doctor of any pre-existing conditions or concurrent medications. Additionally, alcohol consumption and activities requiring focus, such as driving, should be avoided until the patient knows how the medication affects them.

General data about TWINPROS 0.5mg / 0.4mg

Substance:
dutasteride + tamsulosin
Date of latest medicines list:
01-12-2020
Product code:
W67129001
Concentration:
0.5mg / 0.4mg
Pharmaceutical form:
capsules
Quantity:
7
Product type:
Generic medicine
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
LABORATORIOS LEON FARMA, S.A. - SPANIA
Holder:
KRKA, D.D., NOVO MESTO - SLOVENIA
Number:
12851/2019/01
Shelf life:
2 years