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Xenical 120 mg capsules (orlistat) – not marketed in Serbia: information and available alternatives
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- Stock: Zabrana online prodaje
- Brand: ROCHE
- Model: BR-605162077654403
This medicine is currently not marketed in Serbia
- Xenical capsules currently have no valid marketing authorisation in Serbia according to the available ALIMS lists and cannot be obtained in pharmacies in Serbia, including ApotekaOnline.
- The last authorisations for Xenical 120 mg (packs of 42 and 84 capsules, nos. 515-01-02933-15-001 and 515-01-02934-15-001 of 21.04.2016, dispensing category: prescription-only) were valid for five years; no renewal was found in the ALIMS lists of new and renewed authorisations from 2021 to 2026. The medicine is still authorised in the European Union (EMA).
- For the treatment of obesity, consult a doctor – medicines with other active substances are authorised in Serbia, on prescription.
- This page is for information only and is not an offer to sell the medicine.
Xenical is a medicine in the form of hard capsules containing 120 mg of orlistat, a lipase inhibitor from the group of peripherally acting anti-obesity products (ATC A08AB01). In the intestine, orlistat reduces the breakdown and absorption of part of the dietary fat, so the unabsorbed fat is excreted in the stools.
According to the last summary of product characteristics approved in Serbia (ALIMS, 2016) and information from the European Medicines Agency (EMA), Xenical is used together with a mildly hypocaloric diet to treat obesity in adults. In the EU the marketing authorisation holder is CHEPLAPHARM Arzneimittel GmbH, and the medicine is prescription-only. All information on this page comes from the official documentation listed in the sources.
What is Xenical (orlistat), how is it used and what is available in Serbia?
Basic information about the medicine
| Name of the medicine | Xenical® 120 mg, hard capsules |
|---|---|
| Active substance | orlistat |
| Strength | 120 mg per capsule |
| Pharmaceutical form | hard capsule (blue, marked “XENICAL 120”) |
| Therapeutic group | peripherally acting anti-obesity products (A08AB01) |
| Pack | 42 or 84 capsules (blisters of 21) |
| Marketing authorisation holder | previously in Serbia: Roche d.o.o. Beograd (the National Medicines Register 2021 lists CHEPLAPHARM as manufacturer); in the EU: CHEPLAPHARM Arzneimittel GmbH |
| Status in Serbia | no valid authorisation found (previously: prescription-only medicine) |
What is Xenical used for?
According to the SmPC approved in Serbia, Xenical is indicated:
- in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) of 30 kg/m² or more
- in overweight patients (BMI ≥ 28 kg/m²) with associated risk factors
Treatment should be stopped after 12 weeks if the patient has not lost at least 5% of the body weight measured at the start of treatment.
How is it taken?
The official documentation describes, in adults, one 120 mg capsule immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose is skipped. The diet should be balanced and mildly hypocaloric, with about 30% of calories from fat distributed over three main meals, and rich in fruit and vegetables. Doses above 120 mg three times a day provide no additional benefit.
This information describes the official product information and is not an individual recommendation – the choice of obesity treatment is made by a doctor.
Important safety information from the official documentation
- The medicine must not be used in case of hypersensitivity to orlistat or the excipients, chronic malabsorption syndrome, cholestasis or during breast-feeding.
- Digestive side effects (fatty or oily stools, oily spotting, flatus with discharge, faecal urgency, abdominal pain) are very common and more likely with high-fat meals. Headache and upper respiratory tract infections are also very common.
- Orlistat may reduce the absorption of fat-soluble vitamins (A, D, E and K); if a multivitamin is recommended, it is taken at least two hours after orlistat or at bedtime.
- Concomitant use with ciclosporin is not recommended. Orlistat may reduce the absorption of levothyroxine, antiepileptics (with possible seizures), HIV medicines and amiodarone; with oral anticoagulants, clotting parameters should be monitored; in diabetes, treatment should be monitored.
- In severe diarrhoea, oral contraception may be unreliable – an additional method is recommended. Rectal bleeding, hyperoxaluria and oxalate nephropathy have been reported.
- Special caution is needed in pregnancy; it is contraindicated during breast-feeding. It has no effect on driving.
What is available in Serbia?
No valid authorised medicine containing orlistat is currently found in Serbia. For the treatment of obesity, medicines with other active substances appear in the ALIMS lists of new authorisations from 2022 to 2025 and are dispensed on prescription:
| Option | What it is | Note |
|---|---|---|
| Liraglutide – Saxenda® (authorisation from 12/2021–03/2022) | GLP-1 receptor agonist injection | a different medicine with a different route of administration; prescribed by a doctor |
| Semaglutide – Wegovy® (authorisation from 11–12/2023); tirzepatide – Mounjaro® (authorisation 20.05.2025) | injections acting on satiety hormones | different medicines; the indication, dose and monitoring are decided by a doctor |
| Naltrexone + bupropion – Mysimba® (authorisation 06.09.2023) | prolonged-release tablets | a different medicine with a different safety profile; prescribed by a doctor |
None of these medicines is the same as Xenical or can be used as a replacement without an examination – the doctor assesses body mass index, other conditions and other medicines.
A replacement medicine must always be chosen by a doctor. A pharmacist can help you choose suitable supportive products and care, but cannot replace the treatment prescribed by your doctor.
When to seek medical help immediately?
- rectal bleeding or severe, persistent abdominal symptoms
- severe pain in the upper right abdomen, yellowing of the skin or eyes, dark urine
- reduced urination or swelling (possible kidney damage)
- swelling of the face, lips or throat, difficulty breathing, hives
- seizures in people taking antiepileptics
Pharmacist’s advice
If you used Xenical, talk to your doctor about continuing treatment – other prescription medicines are available in Serbia, but they differ in how they work and how they are used. A weight-loss medicine is not a substitute for changes in diet and physical activity.
Weighing yourself regularly, always at the same time of day, helps you track progress. If your doctor recommends a multivitamin with orlistat, take it at least two hours after the capsule or in the evening at bedtime. Do not buy orlistat products online from unreliable sources.
Availability and price
Xenical is currently not marketed in Serbia and cannot be bought in pharmacies, including ApotekaOnline. No price is available because no valid authorisation was found for the medicine.
This page is for information only. For treatment, consult a doctor, and for scales, vitamins and other supportive products, ask your pharmacy.
Composition, pack and manufacturer
- Active substance: orlistat 120 mg per capsule.
- Appearance: blue two-piece gelatin capsules containing white to off-white pellets; “ROCHE” on the cap and “XENICAL 120” on the body.
- Pack: PVC/PVDC//Al blisters of 21 capsules; carton with 2 or 4 blisters (42 or 84 capsules).
- Marketing authorisation holder in the EU: CHEPLAPHARM Arzneimittel GmbH, Greifswald, Germany; previously in Serbia: Roche d.o.o. Beograd.
Storage
- According to the SmPC: store at a temperature up to 25 °C, in the original package to protect from moisture and light.
- Keep out of the reach of children.
Frequently asked questions
Can Xenical be bought in Serbia?
According to the available ALIMS lists, no – the last authorisations from 2016 were valid for five years, and no renewal was found. The medicine is authorised in the EU, but cannot be obtained in pharmacies in Serbia.
How much weight can be lost with Xenical?
The effect depends on diet and adherence. According to the SmPC, treatment should be stopped after 12 weeks if at least 5% of the initial body weight has not been lost.
Why does Xenical cause fatty stools?
Orlistat prevents the absorption of part of the dietary fat, so it is excreted in the stools. Digestive side effects are more likely with high-fat meals, so fat should be distributed evenly over three meals.
What is available in Serbia for the treatment of obesity?
In the ALIMS lists from 2022 to 2025, medicines with other substances (liraglutide, semaglutide, tirzepatide, naltrexone/bupropion) are authorised, all on prescription. Which one is suitable is assessed by a doctor.
Related information
For additional care and support with weight management, see also the Weight loss category – products in this category do not replace the medicine you have been prescribed.
Sources
- ALIMS – Sažetak karakteristika leka Xenical® 120 mg, kapsule, tvrde (dozvole 515-01-02933-15-001 i 515-01-02934-15-001 od 21.04.2016)
- ALIMS – Uputstvo za lek Xenical® 120 mg, kapsule, tvrde
- EMA – Xenical EPAR (centralizovana dozvola u EU, CHEPLAPHARM)
- ALIMS – Nacionalni registar lekova 2021
- ALIMS – Nove dozvole i obnove 21.12.2021–31.03.2022 (Saxenda)
- ALIMS – Nove dozvole i obnove 01.09.–31.10.2023 (Mysimba)
- ALIMS – Nove dozvole i obnove 01.11.–31.12.2023 (Wegovy)
- ALIMS – Nove dozvole i obnove 01.04.–31.05.2025 (Mounjaro)
Date sources were checked: 23 October 2026.
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