Andriol Testocaps 40 mg capsules (testosterone undecanoate) – no longer authorised in Serbia
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- Stock: Zabrana online prodaje
- Brand: OSTALO
- Model: BR-60551162
This medicine is currently not marketed in Serbia
- Andriol Testocaps capsules have no valid marketing authorisation in Serbia. Authorisation 515-01-04303-14-001 ceased by ALIMS decision 515-01-00187-20-001 of 11 August 2020.
- The medicine cannot be obtained in pharmacies in Serbia, including ApotekaOnline.
- There is no registered oral medicine with testosterone undecanoate in Serbia. Other forms of testosterone therapy are decided by a doctor (endocrinologist, andrologist or urologist).
- This page is for information only and is not an offer to sell the medicine.
Andriol Testocaps was a medicine in soft capsules containing testosterone undecanoate, 40 mg per capsule (equivalent to 25.3 mg of testosterone). The marketing authorisation holder was Merck Sharp & Dohme d.o.o. Belgrade, and the medicine was available on prescription.
According to the last summary of product characteristics approved in Serbia, Andriol Testocaps was intended for testosterone replacement therapy in men with hypogonadism. All information on this page comes from the official documents listed in the sources.
What was Andriol Testocaps, what was it used for and whom should you consult today?
Key facts about the medicine
| Medicine name | Andriol® Testocaps, 40 mg, soft capsule |
|---|---|
| Active substance | testosterone undecanoate (40 mg = 25.3 mg testosterone) |
| Pharmaceutical form | soft capsule (orange, oil-filled) |
| Therapeutic group | androgens |
| Pack | 3 blisters of 10 capsules (30 capsules) |
| Former marketing authorisation holder | Merck Sharp & Dohme d.o.o. Belgrade |
| Former supply status | on medical prescription |
| Status in Serbia | no valid authorisation – termination decision of 11 August 2020 |
What was Andriol Testocaps used for?
According to the summary of product characteristics, Andriol Testocaps was indicated for testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
The leaflet stated that the capsules were taken with a meal, because food enables the absorption of testosterone undecanoate. The dose was determined by a doctor with regular monitoring of testosterone levels; this page does not give recommendations for using a medicine that is no longer on the market.
Important safety information from the official documents
- The medicine must not be used in case of prostate or breast cancer (or suspicion of them), hypersensitivity to its ingredients, or during pregnancy.
- Before and during treatment, the doctor monitored testosterone levels and other laboratory parameters, every three months in the first year and then once a year.
- Androgens may raise blood pressure, so caution was needed in men with hypertension.
- Androgens may enhance the effect of anticoagulants and affect glucose tolerance in people with diabetes.
- The capsules contained castor oil (may cause stomach upset and diarrhoea) and the colouring Sunset Yellow (E110).
What is available in Serbia?
Since the authorisation ceased in 2020, no oral medicine with testosterone undecanoate has been registered in Serbia. Treatment of testosterone deficiency is managed by a specialist, who assesses whether another form of testosterone therapy is suitable and which one – other forms are not a 1:1 replacement and have different dosing and monitoring.
| Option | What it is | Note |
|---|---|---|
| Examination by an endocrinologist, andrologist or urologist | confirmation of the diagnosis and choice of treatment | essential before any testosterone therapy |
| Other registered forms of testosterone | prescription medicines with a different route of administration | choice and dose are decided solely by a doctor |
| Regular check-ups | testosterone level, blood count, prostate, blood pressure | an integral part of any androgen therapy |
When to seek medical help immediately?
- chest pain, sudden shortness of breath, or swelling and pain in one leg
- severe headache or very high blood pressure
- yellowing of the skin or eyes
- a painful erection lasting for hours
Pharmacist's advice
Testosterone products are not something to buy on your own – testosterone therapy requires a confirmed diagnosis and regular checks of the prostate, blood count and blood pressure.
If you used Andriol Testocaps before, bring your latest test results to your doctor – this makes it easier to choose how to continue treatment.
Availability and price
Andriol Testocaps is not marketed in Serbia and cannot be bought in pharmacies, including ApotekaOnline. No price is available because the medicine has no valid authorisation.
Medicines containing testosterone are prescribed by a doctor. This page is for information only.
Related information
For additional care and support with men's reproductive health, you can also browse the category Prostate and sperm function – products in this category do not replace a medicine prescribed for you.
Composition, packaging and manufacturer
- Active substance: testosterone undecanoate 40 mg in one soft capsule (equivalent to 25.3 mg of testosterone).
- Excipients with known effect: Sunset Yellow FCF (E110), castor oil, lecithin.
- Pack: carton with 3 aluminium sachets, each containing a blister of 10 capsules.
- Marketing authorisation holder: Merck Sharp & Dohme d.o.o., Omladinskih brigada 90a/1400, Belgrade.
Storage
- According to the summary of product characteristics: store below 30 °C in the original package to protect from light; do not refrigerate or freeze.
Frequently asked questions
Can Andriol Testocaps be bought in Serbia?
No. The authorisation ceased on 11 August 2020 (ALIMS decision 515-01-00187-20-001), and no new authorisation has been issued.
Is oral testosterone available in Serbia?
The ALIMS lists reviewed up to 2026 contain no registered oral medicine with testosterone undecanoate. Other forms of treatment are decided by a doctor.
Who was not allowed to use Andriol Testocaps?
According to the official documents: men with prostate or breast cancer (or suspicion of them) and people hypersensitive to its ingredients; the medicine was not used in pregnancy.
Can supplements replace testosterone therapy?
No. Food supplements are not medicines and cannot make up for a confirmed testosterone deficiency.
Sources
- ALIMS – Summary of product characteristics for Andriol® Testocaps, 40 mg, kapsule, meke (515-01-04303-14-001)
- ALIMS – Patient information leaflet for Andriol® Testocaps, 40 mg, kapsule, meke (515-01-04303-14-001)
- ALIMS – List of medicines whose authorisation ceased (11.07.–31.08.2020)
- ALIMS – National Register of Medicines 2019
- ALIMS – National Register of Medicines 2021
Sources checked on: 25 October 2026.
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