Paracetamol 500 mg (20 tablets)
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Paracetamol 500 mg (20 tablets)






20 tablets


0.02 kg


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Paracetamol of the pharmaceutical company Sopharma is an analgesic and antipyretic drug used to treat mild to moderate migraine pain, neuralgia, toothache, sore throat, ear pain, symptomatic relief of rheumatic pain, mild and moderate postoperative and pain; fever, headache. The mechanism of action is associated with inhibition of prostaglandin synthesis (of biologically active substances) in the brain and spinal cord.

Available in a pack of 20 tablets.


 Composition:in 1 tablet: 
 Paracetamol500 mg
 Excipients: wheat starch, povidone K25, talc,
milk sugar, magnesium stearate


Method of administration: Paracetamol tablets are taken orally with water.

Adults and children over 12 years: 1-2 tablets 3-4 times a day. Maximum daily dose – 8 tablets. It is recommended that the interval between two doses be 4-6 hours. The duration of the treatment course should not exceed 10 days.

Children from 6 to 12 years: 1 / 2-1 tablet 3-4 times a day. The duration of the treatment course should not exceed 5 days. The dosage form is unsuitable for children under 6 years of age.

If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor.

More Information

You should not use Paracetamol Sopharma tablets in the following cases:

If you are allergic to the drug or any of the excipients, If you have severe liver disease.

Pregnancy and breast-feeding:

Tell your doctor if you are pregnant or planning to become pregnant. Be sure to talk to your doctor before taking any medication during pregnancy.

Paracetamol can be taken in therapeutic doses during pregnancy. When administered in therapeutic doses, paracetamol passes into small, clinically insignificant amounts in breast milk. The available data show that there is no harmful effect on the infant.

Side effects:

Paracetamol is generally well tolerated by patients. In rare cases, manifestations of hypersensitivity may be observed – itching, skin rash; in very rare cases there are shortness of breath, lowering of blood pressure, malaise, jaundice, blood in the urine, urinary disorders.

If you get side effects, including those not mentioned in this leaflet, please inform your doctor.

Patient Leaflet

PARACETAMOL tablets 500 mg * 20 SOPHARMA

Package leaflet: information for the user

Paracetamol Sopharma 500 mg tablets

Paracetamol Sopharma 500 mg tablets


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may have to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

If after 3 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet

1. What Paracetamol Sopharma is and what it is used for

2. What you need to know before you take Paracetamol Sopharma

3. How to take Paracetamol Sopharma

4. Possible side effects

5. How to store Paracetamol Sopharma

6. Contents of the pack and other information

1. What Paracetamol Sopharma is and what it is used for

Paracetamol Sopharma tablets contains the active substance paracetamol, which has a pronounced analgesic and temperature-lowering effect.

Paracetamol Sopharma tablets are used to treat mild to moderate pain in headache, migraine, toothache, rheumatic and muscular pain, menstrual pain, sore throat, as well as to relieve discomfort in fever and cold pain.

If after 3 days you do not feel better or your condition worsens, you should seek medical attention.

2. What you need to know before you take Paracetamol Sopharma

Do not take Paracetamol Sopharma

  • if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
  • if you have severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before using Paracetamol Sopharma: if you have liver or kidney disease.

When the pain or fever persists for more than 3 days, or symptoms worsen or any other symptoms develop, do not continue treatment before consulting a doctor.

This medicine contains paracetamol. Other drugs also contain this active substance. Do not combine such drugs, so as not to exceed the recommended daily dose. Use with caution in chronic alcoholism.

Other medicines and Paracetamol Sopharma

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

With prolonged use of high doses of paracetamol, treatment may be affected and the risk of side effects increased if you take at the same time:

coumarin anticoagulants (medicines that reduce blood clotting), acetylsalicylic acid (aspirin) and other non-steroidal anti-inflammatory drugs (NSAIDs),

  • • anti-vomiting medicines (metoclopramide, domperidone),
  • • antiepileptic medicines (phenantoin, carbamazepine, phenobarbital),
  • antibacterial drugs (isoniazid, rifampicin, chloramphenicol),
  • • medicines affecting gastric acidity
  • medicines to lower cholesterol.

If the doctor orders a uric acid or blood sugar test, you should inform him that you are taking paracetamol.

Paracetamol Sopharma with food and drinks

During treatment with paracetamol, alcohol use is not recommended due to an increased risk of liver damage.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Paracetamol Sopharma can be used during pregnancy. You should use the lowest possible dose that reduces pain and/or lowers the temperature and for the shortest possible time. Contact your doctor or midwife if your pain and/or fever has not decreased, or if you need to take the medicine more often.

Paracetamol passes in negligible amounts into breast milk when administered in healing doses. There is no evidence to prove a harmful effect on the infant. In the period of breastfeeding, it can be administered with strict adherence to the daily treatment dose and the duration of the treatment course.

Driving and using machines

There was no evidence of adverse influence on active attention, ability to drive and use machines.
Paracetamol Sopharma contains wheat starch. The wheat starch in this medicine contains only very small amounts of gluten and is unlikely to cause problems if you have celiac disease (gluten intolerance). One tablet contains no more than 3.6 micrograms of gluten.

If you have an allergy to wheat (a condition other than celiac disease), you should not take this medicine.

Paracetamol Sopharma contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Paracetamol Sopharma

Always take Paracetamol Sopharma exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Tablets are taken orally with enough water. The tablet can be divided into equal doses.

The recommended dose is:

Adults and adolescents over 12 years: 1-2 tablets 3-4 times a day.

Maximum daily dose for adults – 8 tablets.

In adolescents over 12 years, do not take more than 6 tablets in 24 hours.

Use in children

Children from 6 to 12 years: 1/2-1 tablet 3-4″ times a day.

Children under 6 years: the dosage form is not suitable for children under 6 years of age. It is recommended that the interval between 2 receptions is 4-6 hours. If necessary, the medicinal product can be taken every 4 hours, but not more than 4 times in 24 hours. The course of treatment without consulting a doctor should not be longer than 3 days.

If you take more Paracetamol Sopharma than you should

If you take a dose greater than necessary, the early signs of poisoning with the drug may appear – heaviness and abdominal pain, nausea, vomiting, lack of appetite, anxiety, general malaise.

If you suspect taking a larger dose of paracetamol, ask your doctor immediately, even if you feel well.

If you forget to take Paracetamol Sopharma

If you miss a dose, take it as soon as possible. If it’s almost time for your next dose, take it as usual. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In rare cases (between 1 and 10 patients in 10,000), there may be mild manifestations of the gastrointestinal tract (nausea, vomiting, abdominal pain, diarrhoea).

Very rarely (in less than 1 in 10,000 patients) may be observed: decreased number of platelets in the blood, decreased number of leukocytes with an increase in the possibility of developing infections, anemia, severe allergic reactions with difficulty breathing and dizziness, manifestations of hypersensitivity on the part of the skin – itching and rashes of a different nature, urticaria. On the part of the respiratory system – difficulty breathing in predisposed patients, with a manifested allergy to acetylsalicylic acid (aspirin) and other NSAIDs. Prolonged administration of high doses can lead to liver damage, with early symptoms being nausea, vomiting, sweating and general malaise. At high doses, a violation of renal function is possible. Very rarely, serious skin reactions have been reported.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Sopharma

Store in the original package at a temperature below 25°C. Keep out of the reach of children.

Do not use Paracetamol Sopharma after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Paracetamol Sopharma contains

– The active substance is paracetamol 500 mg per tablet.

– The other ingredients are: povidone K30, lactose monohydrate, wheat starch, magnesium stearate, talc.

What Paracetamol Sopharma looks like and contents of the pack

Flat tablets, white to off-white, odorless, of regular round shape, with a score line and a diameter of 13 mm.
10 tablets in a blister of solid, colourless, transparent PVC foil and aluminium foil; 1, 2 or 40 blisters per cardboard box, together with a leaflet. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer


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