GEMIPAR 500

Please read this entire leaflet carefully, as it contains important information for the patient.
This medicine is available without a prescription so that certain conditions can be treated without the need for a doctor's visit. However, to achieve successful treatment, the medicine must be used carefully and in accordance with the information provided in this leaflet.

• Keep this leaflet so that you can read it again if necessary.
• Consult a doctor or pharmacist if you need advice or additional information. If symptoms worsen or do not improve, consult a doctor.

GEMIPAR 500
500 mg, suppositories
Paracetamolum
MEDICINAL PRODUCT CONTAINING PARACETAMOL
Composition:
Each suppository contains 500 mg of paracetamol (Paracetamolum)
and excipients: liquid paraffin, neutral fat (Vitepsol H15).
Pack sizes available:
10 suppositories
Marketing Authorization Holder:
Biofaktor Sp. z o.o.
ul. Podmiejska 15 C
66-400 Gorzów Wielkopolski
Leaflet Contents:

1. What GEMIPAR 500 is and what it is used for
2. Before you use GEMIPAR 500
3. How to use GEMIPAR 500
4. Possible side effects
5. How to store GEMIPAR 500
6. Other information

1. What GEMIPAR 500 is and what it is used for

GEMIPAR 500 is a suppository formulation containing paracetamol. Paracetamol has analgesic and antipyretic properties. The medicine is intended for adults and adolescents over 12 years of age.
Indications:
Short-term treatment of mild to moderate pain, such as headache, toothache, joint, muscle or bone pain, and postoperative pain following surgical or dental procedures. Fever, for example, associated with colds or influenza in patients who cannot take paracetamol orally due to nausea or vomiting.

2. Before using GEMIPAR 500.

Do not use the medicine if you have: hypersensitivity to any component of the medicine, severe renal failure, severe hepatic failure, congenital deficiency of glucose-6-phosphate dehydrogenase and methemoglobin reductase, alcoholic liver disease, first trimester of pregnancy.
Exercise special caution when using GEMIPAR 500:
The medicine contains paracetamol. To avoid overdose, check whether other medicines being taken also contain paracetamol.
Do not use doses higher than recommended. Use with caution in elderly patients. Use with caution in patients with hepatic or renal impairment. Alcohol must not be consumed during paracetamol treatment due to the risk of severe liver damage.
The risk of liver damage is particularly high in fasting patients and in those who regularly consume alcohol.
Use of GEMIPAR 500 in children:
Do not use in children under 12 years of age.
Pregnancy and breastfeeding:
The medicine is contraindicated during the first three months of pregnancy. Paracetamol may be used during the second and third trimesters of pregnancy and during breastfeeding only if clearly necessary and after consultation with a physician.
Before using any medicine, consult a physician.
Driving and operating machinery:
The medicine does not affect psychomotor performance.
Use with other medicines:
Paracetamol enhances the effect of oral anticoagulants of the coumarin group, prolonging bleeding time and increasing the risk of hemorrhage. Concurrent use of paracetamol with zidovudine (AZT) may intensify the myelotoxic effect of zidovudine. Simultaneous use of paracetamol and drugs that increase hepatic metabolism, such as rifampicin, antiepileptic drugs, and barbiturates, increases the risk of liver damage, even when recommended doses of paracetamol are used. Paracetamol prolongs the half-life of chloramphenicol and enhances its toxicity. Concomitant administration of paracetamol and nonsteroidal anti-inflammatory drugs increases the risk of renal function disorders. Use of paracetamol with monoamine oxidase inhibitors (MAO inhibitors) may cause states of excitation and high fever (a 14-day interval should be observed). Metoclopramide accelerates, while propantheline delays, the absorption of paracetamol from the gastrointestinal tract. Alcohol consumption during paracetamol treatment may lead to liver failure caused by hepatocellular necrosis. Paracetamol use may lead to false results in certain laboratory tests (e.g. glucose concentration measurement). Do not use with other medicines containing paracetamol.
Inform your physician about all medicines you are currently taking, including those available without a prescription.

3. How to use GEMIPAR 500

Adults and adolescents over 12 years of age: 1 suppository rectally, once. If necessary,
the dose may be repeated every 4 hours, but no more than 4 times a day.
Do not use the medicine for longer than 3 days without consulting a doctor.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

If you use more GEMIPAR 500 than recommended:
Symptoms may include nausea, vomiting, excessive sweating, drowsiness, and general weakness.
These symptoms may subside the next day, even though liver damage may have already begun to develop,
later manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.
If you have used more medicine than recommended, contact your doctor or pharmacist immediately.

Due to the pharmaceutical form (suppositories), overdose is unlikely; however, such a possibility
cannot be excluded if paracetamol is simultaneously taken orally.
Treatment of oral paracetamol overdose includes inducing vomiting if less than one hour has passed
since ingestion, and administration of activated charcoal.
In cases of ingestion of very large doses of the medicine, antidotes should be administered: methionine,
followed by continued treatment with acetylcysteine.

If you forget to use a dose of GEMIPAR 500:
The medicine is used for immediate relief. If you miss a dose and symptoms persist, take the next dose
as soon as possible. Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, GEMIPAR 500 may cause adverse reactions, although not everybody gets them.

Rare:

• Hypersensitivity reactions: skin redness, rash, angioedema, dyspnoea, bronchial asthma attacks, reduction in blood pressure up to shock symptoms.
• Gastrointestinal disorders: nausea, vomiting.
• Hepatic disorders: symptoms of liver damage.
• Renal and urinary disorders: renal colic, renal papillary necrosis, acute renal failure.

Very rare:

• Blood disorders: granulocytopenia (reduced number of granulocytes in the blood), agranulocytosis (absence of granulocytes in the blood), thrombocytopenia (reduced number of platelets in the blood).

In some individuals, other adverse reactions may occur during treatment with GEMIPAR 500. If any adverse reactions not listed in this leaflet occur, they should be reported to a physician.

5. Storage of the medicinal product GEMIPAR 500

Keep the medicinal product out of the reach and sight of children.
Do not use GEMIPAR 500 after the expiry date stated on the packaging.
Store below 25°C. Keep in the original packaging.

6. Other information

For more detailed information, please contact the marketing authorisation holder:
Biofaktor Sp. z o.o.
ul. Podmiejska 15 C
66-400 Gorzów Wielkopolski
e-mail: [email protected]
Date of leaflet preparation: