BENALGIN 20 TABLETS

• Benalgin*x20 tablets - 500 mg/ 50 mg/ 38,75 mg tablets

Metamizole / caffeine / thiamine 

Please read the leaflet carefully before taking this medicine because it contains essential information. 

Always take this medicine as described in this leaflet or as your doctor or pharmacist has told you. Medicinal products require caution.

Ask your doctor or pharmacist in the following situations:

If you need further information or advice, ask your doctor or pharmacist;

If you get any side effects - it includes any possible side effects not listed in this leaflet;

You should seek medical attention if you do not feel better after 3-5 days or if your condition deteriorates. 

1. What is Benalgin, and what is it used for?

Benalgin is a complex product whose action is based on the interaction of its specific ingredients: metamizole, caffeine and vitamin B1 (also known as thiamine). Metamizole contributes to the analgesic properties as well as the ability to reduce fever.

Caffeine plays a role in stimulating the central nervous system and enhancing the effects of metamizole by aiding its passage into brain tissues. Vitamin B1 serves to boost metabolism and assists in the efficient transmission of nerve impulses in the body.

Benalgin is to be applied for the symptomatic treatment of pain:

Headache (migraine, tension headache); 

Inflammatory and degenerative diseases of the musculoskeletal system; 

Post-operative conditions; 

Diseases of the peripheral nervous system (radiculitis, pleksiti, neuritis, neuralgia, polyneuritis, polyneuropathy); 

Painful menstruation. 

You should seek medical attention if you do not feel better after 3-5 days or if your condition deteriorates. 

2. What do you need to know before taking Benalgin?

Regarding the active ingredients, it is essential to be aware that there are cases in which it is not recommended to take Benalgin.

Do not take Benalgin in the following cases:

• If you are allergic to metamizole, caffeine, vitamin B1, other pyrazolone derivatives or any of the other ingredients of this medicine; 
• Infringement in blood formation - low white blood cells (leukopenia), anaemia, low platelet count (thrombocytopenia); 
• If you have bronchial asthma; 
• In cases of severe liver and kidney disease; 
• If you have hepatic porphyria; 
• congenital glucose 6-phosphate dehydrogenase deficiency; 
• If you are under 12 years of age; 
• during pregnancy and lactation.

3. Warnings and Precautions 

It's recommended to seek medical advice if you have one or more of the following health conditions:

• Impaired kidney and/or liver function;
• An active peptic ulcer disease;
• Glaucoma;
• Heart rhythm disorders;
• Insomnia;
• A severe headache of unknown origin;
• Expressed allergies to food or drugs.

Suppose you use analgesics for a prolonged period, more than three months. In that case, it might lead to new headaches or worsening existing ones, mainly when using anaesthetics every other day or with higher frequency.

When facing headaches caused by excessive taking of analgesics, it's crucial not to attempt treating it by increasing the dosage. In such situations, it's advised to discontinue analgesic use after consulting a medical professional.

Note that caffeine can affect results of tests on adenosine or dipyridamole. Therefore, abstaining from taking Benalgin for at least 12 hours before the test is recommended.

Other medicines and Benalgin 

Concomitant use of Benalgin with other high-temperature pain relievers and anti-inflammatory drugs poses a higher risk of allergic reactions. 

Taking Benalgin with medicines that suppress blood formation increases the risk of a decrease in white blood cell count.

Taking Benalgin with medicines from the group of neuroleptics and tranquillisers may increase the analgesic effect of Benalgin, which also carries risks.

On the other hand, taking Benalgin together with chlorpromazine leads to a decrease in body temperature.

Use caution when combining Benalgin with antidepressants, contraceptive tablets and allopurinol. These drugs can slow the breakdown of metamizole, leading to high levels of Benalgin toxicity.

Additionally, it lowers the concentration of cyclosporine A in the blood and may threaten existing tissue transplantation.

Last but not least, the combination of drugs from the group of sympathomimetics can cause central nervous system excitation.

Do not administer Metamizole and other NSAIDs. 

Benalgin with food, drinks and alcohol 

There are no restrictions regarding the use and intake of Benalgin with foods and beverages. 

Pregnancy, lactation and fertility 

If you are pregnant or breastfeeding, you think you may be pregnant or are planning on becoming pregnant, consult your doctor or pharmacist before taking this medicine. 

Pregnancy 

Pregnant women should not use this product. 

Breastfeeding

If the intake of Benalgin during lactation is necessary, breastfeeding should be discontinued. 

Driving and operating machines 

The product does not affect your ability to drive and operate machines. 

Benalgin contains wheat starch, suitable for people with celiac disease (gluten enteropathy). Patients with a wheat allergy (different from celiac disease) should not take this product. 

4. How to take Benalgin 

Always take this medicine as described in the leaflet or as your doctor or pharmacist has told you. If you're not sure, ask your doctor or pharmacist. 

The recommended dosage is as follows:

Adults: It is advisable to take1 tablet three times a day. The daily dose should be at most six tablets. 

Children from 12 to 16 years: Taking 1/2 - 1 tablet three times a day is recommended. The daily dose should be at most 4 tablets. 

The maximum duration of the treatment course should be between 3 to 5 days without consulting a doctor. 

If you think that the effects of Benalgin are too strong or too weak, talk to your doctor or pharmacist. 

What to do if you used a higher than the recommended dose of Benalgin? 

If you've taken a higher than the recommended dose, immediately seek medical attention. The treatment must be done in a hospital setting. 

Symptoms of overdose include:

• Nausea
• Vomiting
• Agitation
• Insomnia
• Headache
• Vertigo
• Tinnitus
• Sometimes, it may occur blood in urine and faeces.

• In more severe cases, reducing or stopping the flow of urine, convulsions, anaemia, and a significant reduction in the number of white blood cells is possible.

What to do if you need to remember to use Benalgin?

If you miss a dose, administer the medicine at the next regular intake without increasing the dose. 

5. Possible side effects 

The medicine can cause side effects like all medicines. Note that only some get them. 

It is possible to experience the following side effects:

• Allergies of the skin, such as rashes, itching, and redness - they are most common;
• In rare cases, you can experience:
• Breathing difficulties;
• Allergic shock or other severe allergic reactions;
• Insomnia;
• Dizziness;
• Nervousness;
• Rapid heartbeat;
• Palpitations;
• Transient decrease in white blood cells and/or platelets;
• Anaemia;
• Skin pinpoint haemorrhages;
• Loss of appetite;
• Nausea;
• Vomiting;
• Cholestasis;
• Jaundice.

If you get any side effects, contact your doctor or pharmacist. It includes any possible effects not listed in this leaflet.

6. How to store Benalgin 

• Store at temperatures below 25° C; 
• Keep out of reach of children;
• Do not use this medicine after the expiry date stated on the packaging – the expiry date refers to the last day of that month;
• Do not dispose of medications in wastewater or as household waste – ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.