- Home
- Automated
- List of product information
- ARIPSA SOFT CAPSULES 0.5MG [SIN16476P]
ARIPSA SOFT CAPSULES 0.5MG [SIN16476P]
Active ingredients: ARIPSA SOFT CAPSULES 0.5MG
Last updated 26 October 2025
On this page
Product Info
ARIPSA SOFT CAPSULES 0.5MG
[SIN16476P]
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 | SIN16476P |
Licence Holder | NOVEM HEALTHCARE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | G04CB02 |
4.1. Therapeutic Indications
ARIPSA is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce prostate size, reduce the risk of acute urinary retention, and reduce the need for BPH-related surgery.
In addition, ARIPSA in combination with the alpha-blocker tamsulosin is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
4.2. Posology and Method of Administration
Adult males (including elderly):
ARIPSA can be administered alone or in combination with the alpha-blocker tamsulosin (0.4 mg).
The recommended dose of ARIPSA is one capsule (0.5 mg) taken orally once a day. The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.
ARIPSA may be taken with or without food.
Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the elderly.
Renal impairment
The effect of renal impairment on dutasteride pharmacokinetics has not been studied. 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 Special 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 section 4.3 Contraindications).
4.3. Contraindications
ARIPSA is contraindicated for use in women, children and adolescents (see 4.6 Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
ARIPSA is contraindicated in patients with hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, or any of the excipients.
ARIPSA is contraindicated in patients with severe hepatic impairment.