Baralgetas tablets (metamizole, pitofenone, fenpiverinium) – no longer authorised in Serbia
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- Stock: Zabrana online prodaje
- Brand: OSTALO
- Model: BR-6051962162
This medicine is currently not marketed in Serbia
- Baralgetas tablets have no valid marketing authorisation in Serbia. The last renewal of the authorisation was on 9 March 2017 (for five years), and no further renewal appears in the ALIMS lists of authorisations and renewals from the end of 2021 to May 2026.
- The medicine cannot be obtained in pharmacies in Serbia, including ApotekaOnline.
- There is no registered medicine with the same combination of substances in Serbia. For severe cramping pain, please see a doctor.
- This page is for information only and is not an offer to sell the medicine.
Baralgetas was a combination medicine in tablet form made by Union-Medic d.o.o. Novi Sad. It contained three active substances: metamizole sodium (a painkiller), pitofenone hydrochloride and fenpiverinium bromide (substances that relax spasms of smooth muscle). It was available on prescription.
According to the last summary of product characteristics approved in Serbia (2017), Baralgetas was indicated only for short-term use in severe cramping pain when other non-opioid painkillers had not been effective. All information on this page comes from the official documents listed in the sources.
What was Baralgetas, what was it used for and what is important to know about metamizole?
Key facts about the medicine
| Medicine name | Baralgetas®, tablets |
|---|---|
| Active substances | metamizole sodium 500 mg, pitofenone hydrochloride 5 mg, fenpiverinium bromide 0.1 mg |
| Pharmaceutical form | tablet |
| Therapeutic group | spasmoanalgesic (painkiller combined with antispasmodics) |
| Pack | blister with 10 tablets |
| Former marketing authorisation holder | Union-Medic d.o.o. Novi Sad |
| Status in Serbia | no valid authorisation – last renewal 9 March 2017, no later renewal |
What was Baralgetas used for?
According to the summary of product characteristics, Baralgetas was intended only for short-term use, when treatment with other non-opioid painkillers had failed, in:
- severe acute pain due to spasm of smooth muscle – cramps in the digestive tract, biliary and renal colic
- severe pain with spasms in gynaecological surgery
- spastic dysmenorrhoea (painful periods) with severe pain
Dosing was determined by a doctor; 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 hypersensitivity to pyrazolones (metamizole, propyphenazone, etc.) or pyrazolidine derivatives, asthma or hives caused by painkillers, impaired bone marrow function or blood disorders, acute intermittent porphyria, or congenital glucose-6-phosphate dehydrogenase deficiency.
- Very rarely, metamizole can cause agranulocytosis – a severe, life-threatening drop in white blood cells.
- The medicine can cause a drop in blood pressure (hypotensive reaction).
- The tablets contained lactose and sodium.
What is available in Serbia?
There is no registered medicine in Serbia with the combination of metamizole, pitofenone and fenpiverinium. Medicines with metamizole alone and other painkillers and antispasmodics exist, but they are not the same combination and are dispensed with a doctor's advice or prescription. Severe cramping abdominal pain and biliary or renal colic require a medical examination.
| Option | What it is | Note |
|---|---|---|
| Medical examination | finding the cause of cramping pain | essential for colic, severe pain or pain with fever |
| Registered painkillers and antispasmodics | medicines with a different composition | choice and dose according to the advice of a doctor or pharmacist |
| Products for menstrual complaints | food supplements | not a medicine; may be a complement for milder complaints |
When to seek medical help immediately?
- high fever, sore throat or mouth ulcers after taking metamizole (a possible sign of agranulocytosis)
- swelling of the face, lips or throat, difficulty breathing, hives
- dizziness, fainting or cold sweat (drop in blood pressure)
- severe abdominal pain that does not ease, with vomiting or yellowing of the skin
Pharmacist's advice
If you used Baralgetas in the past for painful periods or colic, tell your doctor or pharmacist whether you have ever had a reaction to metamizole or other painkillers – this is essential for choosing new treatment.
Recurrent severe menstrual pain needs a gynaecological examination, not just a stronger painkiller.
Availability and price
Baralgetas is 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.
Related information
For additional care and support with menstrual pain, you can also browse the category Menstrual pains – products in this category do not replace a medicine prescribed for you.
Composition, packaging and manufacturer
- Active substances in one tablet: pitofenone hydrochloride 5 mg, fenpiverinium bromide 0.1 mg, metamizole sodium monohydrate 500 mg.
- Excipients with known effect: lactose monohydrate and sodium.
- Pack: carton with one blister of 10 tablets.
- Marketing authorisation holder: Union-Medic d.o.o., Arhimandrita Jovana Rajića 2, Novi Sad.
Storage
- According to the summary of product characteristics: store below 25 °C in the original package to protect from light and moisture.
Frequently asked questions
Can Baralgetas be bought in Serbia?
No. The last renewal of the authorisation was in 2017, and there is no further renewal in the ALIMS lists of authorisations and renewals up to May 2026, so the medicine is not marketed.
Is there a medicine with the same composition?
There is no registered medicine in Serbia with the same combination of metamizole, pitofenone and fenpiverinium.
Why is caution needed with metamizole?
According to the official documents, metamizole can very rarely cause agranulocytosis and a drop in blood pressure. Fever, sore throat or mouth ulcers during use require urgent medical attention.
What can be used for painful periods?
The choice of painkiller should be agreed with a pharmacist or doctor, and severe or recurrent pain requires a gynaecological examination.
Sources
- ALIMS – Summary of product characteristics for Baralgetas®, tablets (515-01-01639-16-001, renewal 09.03.2017)
- ALIMS – Patient information leaflet for Baralgetas®, tablets (515-01-01639-16-001, renewal 09.03.2017)
- ALIMS – National Register of Medicines 2019
- ALIMS – National Register of Medicines 2021
Sources checked on: 25 October 2026.
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