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Qlaira film-coated tablets (estradiol valerate and dienogest) – not marketed in Serbia: information and alternatives
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- Stock: Zabrana online prodaje
- Brand: BAYER products
- Model: BR-16415054
This medicine is currently not marketed in Serbia
- Qlaira film-coated tablets currently have no valid marketing authorisation in Serbia (ALIMS) and cannot be obtained in pharmacies in Serbia, including ApotekaOnline.
- The authorisation for Qlaira (Bayer d.o.o. Beograd, no. 515-01-00909-20-001 of 10.02.2021, dispensing category: prescription-only) ceased to be valid by an ALIMS decision from the July–August 2024 period.
- If you used Qlaira, always consult a gynaecologist about continuing contraception. Until your appointment, use additional barrier protection (condom).
- This page is for information only and is not an offer to sell the medicine.
Qlaira is a combined hormonal contraceptive in the form of film-coated tablets containing estradiol valerate (an oestrogen) and dienogest (a progestogen) in four different combinations, plus two hormone-free tablets – a total of 28 tablets taken without a break.
According to the last summary of product characteristics approved in Serbia (ALIMS), Qlaira is intended for oral contraception and for the treatment of heavy menstrual bleeding in women without organic pathology who wish to use oral contraception. All information on this page comes from the official documentation listed in the sources.
What is Qlaira, what was it used for and what is available in Serbia?
Basic information about the medicine
| Name of the medicine | Qlaira®, film-coated tablets |
|---|---|
| Active substances | estradiol valerate and dienogest |
| Pack contents | 2 dark yellow (3 mg estradiol valerate), 5 pink (2 mg dienogest + 2 mg estradiol valerate), 17 light yellow (3 mg dienogest + 2 mg estradiol valerate), 2 dark red (1 mg estradiol valerate) and 2 white hormone-free tablets |
| Pharmaceutical form | film-coated tablet |
| Therapeutic group | sex hormones – progestogens and oestrogens, sequential preparations (combined hormonal contraceptive) |
| Pack | 28 film-coated tablets in a wallet-type carton |
| Marketing authorisation holder | previously in Serbia: Bayer d.o.o. Beograd (manufacturer Bayer Weimar GmbH und Co. KG, Germany) |
| Status in Serbia | no valid authorisation since 2024 (previously: prescription-only medicine) |
What was Qlaira used for?
According to the SmPC approved in Serbia, Qlaira is intended for:
- oral contraception
- treatment of heavy menstrual bleeding in women without organic pathology who wish to use oral contraception
When deciding to prescribe it, the doctor assesses each woman’s risk factors, especially the risk of venous thromboembolism (blood clots), and the differences in risk between Qlaira and other combined hormonal contraceptives.
How was it taken?
The tablets are taken in the order marked on the pack, every day at about the same time, one a day for 28 consecutive days, without a break between packs. When starting without previous hormonal contraception, the first tablet is taken on the first day of menstrual bleeding. In certain situations (e.g. missed tablets in particular phases of the pack) the official information requires additional barrier protection, usually for the next 9 days.
This information describes the official product information and is not an individual recommendation – the choice of contraceptive and how to take it are decided by a gynaecologist according to the official information for the specific medicine.
Important safety information from the official documentation
- The medicine must not be used in current or past venous thromboembolism (deep vein thrombosis, pulmonary embolism), hereditary or acquired predisposition to thrombosis, arterial thromboembolism (heart attack, stroke, angina pectoris, TIA), migraine with focal neurological symptoms, or other conditions listed in the SmPC (e.g. severe liver disease, sex-hormone-dependent tumours).
- Combined hormonal contraceptives increase the risk of blood clots in veins and arteries; the overall risk is small but higher in smokers, obese people, after major surgery and during prolonged immobility.
- Some medicines and the herbal preparation St John’s wort (Hypericum perforatum) may reduce contraceptive efficacy; additional protection is then needed according to the doctor’s advice.
- The most commonly reported side effects are acne, breast discomfort, headache, bleeding between periods, nausea and weight gain; serious side effects are arterial and venous thromboembolism.
- Qlaira must not be taken during pregnancy; if pregnancy occurs, it must be stopped. It is generally not recommended during breast-feeding. No effect on driving has been observed.
What is available in Serbia?
No other authorised medicine with the combination of estradiol valerate and dienogest was found in the National Medicines Register or in the ALIMS lists of new and renewed authorisations up to 2026, so there is currently no direct replacement for Qlaira in Serbia.
| Option | What it is | Note |
|---|---|---|
| Other combined hormonal contraceptives authorised in Serbia | tablets with other combinations of oestrogen and progestogen, prescription-only | they differ in composition, regimen and risk of thrombosis; the choice is made by a gynaecologist |
| Non-hormonal or other hormonal methods | condom, intrauterine device and other methods as assessed by a gynaecologist | a condom also protects against sexually transmitted infections |
| Heavy menstrual bleeding | requires an examination and determination of the cause | treatment is decided by a gynaecologist |
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?
- swelling, pain or tenderness of one leg, warmth or discoloration of the skin of the leg (possible deep vein thrombosis)
- sudden shortness of breath, rapid breathing, coughing up blood, sharp chest pain (possible pulmonary embolism)
- chest pain or pressure spreading to the arm, jaw or back (possible heart attack)
- sudden weakness or numbness of the face, arm or leg, difficulty speaking, vision disturbances, severe headache (possible stroke)
- sudden loss or blurring of vision in one eye
Pharmacist’s advice
If you used Qlaira, book a gynaecologist appointment before you finish your last pack, so that switching to another contraceptive happens without a gap in protection. Switching from one contraceptive to another has its own rules, which are set by the doctor.
Until your appointment and during the switch, use condoms as additional protection. If you have missed tablets or had vomiting or severe diarrhoea and had unprotected intercourse, ask a pharmacist or doctor in good time; a pregnancy test gives a reliable result only from the day your period is due. At every visit, tell your doctor whether you smoke and whether anyone in your family has a tendency to thrombosis.
Availability and price
Qlaira is currently not marketed in Serbia and cannot be bought in pharmacies, including ApotekaOnline. No price is available because the medicine has no valid authorisation.
This page is for information only. For the choice of contraception, consult a gynaecologist, and for the availability of other products (condoms, pregnancy tests), ask your pharmacy.
Further information
For additional care and support with contraception, see also the Condoms category – products in this category do not replace the medicine you have been prescribed.
Composition, pack and manufacturer
- Active substances: estradiol valerate and dienogest, in four different combinations according to the phases of the pack, and 2 hormone-free tablets.
- Excipient with known effect: lactose monohydrate (no more than 50 mg per film-coated tablet).
- Pack: PVC/Alu blister with 28 film-coated tablets in a wallet-type carton.
- Previously in Serbia: marketing authorisation holder Bayer d.o.o. Beograd; manufacturer Bayer Weimar GmbH und Co. KG, Germany.
Storage
- According to the SmPC: the medicine does not require any special storage conditions; shelf life 5 years.
- Keep out of the reach of children.
Frequently asked questions
Can Qlaira be bought in Serbia?
No. The authorisation for Qlaira ceased to be valid by an ALIMS decision from July–August 2024, so the medicine cannot be obtained in pharmacies in Serbia.
What can replace Qlaira?
No other medicine with estradiol valerate and dienogest is authorised in Serbia. A gynaecologist may suggest another combined hormonal contraceptive or another method of contraception, depending on your health and risk factors.
Why does Qlaira have tablets of different colours?
Qlaira contains four types of tablets with different doses of estradiol valerate and dienogest and two hormone-free tablets. That is why the tablets must be taken exactly in the order marked on the pack, every day without a break.
What should I do until I see a gynaecologist?
If you have run out of tablets, use condoms as additional protection and book an appointment as soon as possible. Emergency contraception is not a substitute for regular contraception, and switching to another product is decided by the doctor.
Sources
- ALIMS – Sažetak karakteristika leka Qlaira®, film tablete (dozvola 515-01-00909-20-001 od 10.02.2021)
- ALIMS – Uputstvo za lek Qlaira®, film tablete
- ALIMS – Rešenja o prestanku važenja dozvole 01.07.–31.08.2024 (Qlaira)
- ALIMS – Nacionalni registar lekova 2021
Date sources were checked: 23 October 2026.
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Additional information
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Shipping cost
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For goods ordered up to 5.000,00 RSD, delivery charge is 350.00 RSD (VAT included). For goods over 5.000,00 RSD, shipping is free of charge.
For international delivery:
For the export of goods abroad through the PostExport service of Post of Serbia, the shipping price is for:
- Zone I (Slovenia, Croatia, Bosnia and Herzegovina, Montenegro, Northern Macedonia) - 1,280.00 RSD
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- Zone III (Asia, Africa, America, Australia and other countries) - 2,650.00 RSD
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