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National Drug Formulary

AVEXA ADUTAS SOFT CAPSULE 0.5MG [SIN17296P]

Active ingredients: AVEXA ADUTAS SOFT CAPSULE 0.5MG

View product's general information
Last updated 24 April 2026

Product Info

AVEXA ADUTAS SOFT CAPSULE 0.5MG

[SIN17296P]

Product information

Active Ingredient and Strength

DUTASTERIDE - 0.5 MG

Dosage Form

CAPSULE, LIQUID FILLED

Manufacturer and Country

CYNDEA PHARMA, S.L - SPAIN

Registration Number

SIN17296P

Licence Holder

APEX PHARMA MARKETING PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

G04CB02

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1. Therapeutic indications
Monotherapy
Adutas is indicated for the treatment and control of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery.

Combination With Alpha-Blocker
Adutas in combination with the alpha-blocker tamsulosin is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.

Dosing

4.2. Posology and method of administration
Adult males (including elderly):
Capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.

Adutas may be taken with or without food.

The recommended dose of Adutas is one capsule (0.5 mg) taken orally once a day.

Although an improvement may be observed at an early stage, treatment for at least 6 months may be necessary in order to assess objectively whether a satisfactory response to the treatment can be achieved.

For the treatment of BPH, dutasteride can be administered alone or in combination with the alpha-blocker tamsulosin (0.4 mg).

Renal Impairment:
The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment (see “5.2 Pharmacokinetic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment:
The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment (see “4.4 Special warnings and precautions for use” and “5.2 Pharmacokinetic properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In patients with severe hepatic impairment, the use of dutasteride is contraindicated (see “4.3 Contraindications”).

Contraindications

4.3. Contraindications
Adutas is contraindicated in:

  • women and children and adolescents (see “4.6 Fertility, pregnancy and lactation” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  • patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or any of the other excipients.

  • patients with severe hepatic impairment.