Gemipar 125
PolandTable of Contents
Read the 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 medical assistance. However, to achieve effective treatment, the medicine should be used carefully and in accordance with the information 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 further information. If symptoms worsen or do not improve, contact a doctor.
GEMIPAR 125
125 mg, suppositories
Paracetamolum
MEDICINAL PRODUCT CONTAINING PARACETAMOL
Composition:
One suppository contains 125 mg of paracetamol (Paracetamolum)
and excipients: liquid paraffin, neutral fat (Vitepsol H15).
Available pack sizes:
10 suppositories
Marketing Authorization Holder:
Biofaktor Sp. z o.o.
ul. Podmiejska 15 C
66-400 Gorzów Wielkopolski
Leaflet contents:
- What GEMIPAR 125 is and what it is used for
- Before you use GEMIPAR 125
- How to use GEMIPAR 125
- Possible side effects
- How to store GEMIPAR 125
- Further information
1. What GEMIPAR 125 is and what it is used for
GEMIPAR 125 is a suppository containing paracetamol. Paracetamol has analgesic and antipyretic properties. This medicine is intended for children aged 1 to 6 years.
Indications:
Short-term treatment of mild to moderate pain, such as headache, toothache, joint, muscle and bone pain, postoperative and post-dental procedure pain. Fever, for example, occurring during colds or influenza, in patients who cannot take paracetamol orally, e.g. due to nausea or vomiting.
2. Before using GEMIPAR 125
Do not use the medicine if you have: hypersensitivity to any component of the medicine, severe renal insufficiency, severe hepatic insufficiency, congenital glucose-6-phosphate dehydrogenase deficiency and methemoglobin reductase deficiency, alcohol-related disease, first trimester of pregnancy.
Exercise special caution when using GEMIPAR 125
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 insufficiency. Alcohol should not be consumed during treatment with paracetamol due to the risk of severe liver damage. The risk of liver damage is particularly high in fasting individuals and those who regularly consume alcohol.
Use of GEMIPAR 125 in children
The medicine is indicated for use in children from 1 to 6 years of age.
Pregnancy. Breastfeeding
The medicine, due to its dosage, is intended for use in children.
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 if clearly necessary and after consultation with a physician.
Before using any medicine, consult a physician.
Driving and operating machinery
The medicine, due to its dosage, is intended for use in children.
Paracetamol does not affect psycho-physical performance.
Use with other medicines
Paracetamol enhances the effect of oral anticoagulants from 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 enhance hepatic metabolism, e.g. rifampicin, antiepileptic drugs, 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. Concurrent administration of paracetamol and non-steroidal anti-inflammatory drugs increases the risk of renal function disorders. Use of paracetamol with 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. Consumption of alcohol during paracetamol treatment may lead to liver failure caused by hepatocyte necrosis. Paracetamol use may cause false results in certain laboratory tests (e.g. glucose concentration measurements). Do not use with other medicines containing paracetamol.
Inform your doctor about all medicines you have recently taken, including those available without a prescription.
3. How to use GEMIPAR 125
Use in children under 2 years of age should be prescribed by a doctor.
Children aged 1 to 3 years: 1 suppository rectally, single dose; children aged 4 to 6 years: 1 to 2 suppositories rectally, single dose.
If necessary, the dose may be repeated every 4 hours, no more frequently than 4 times daily.
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.
In case of an overdose of GEMIPAR 125
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 take 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 in case of concomitant oral intake of paracetamol.
Treatment of oral paracetamol overdose includes inducing vomiting if less than one hour has passed since ingestion, and administration of activated charcoal.
In case of ingestion of very large doses of the drug, antidotes should be administered: methionine, followed by continued treatment with acetylcysteine.
If you forget to take a dose of GEMIPAR 125
The medicine is used for immediate treatment. If you miss a dose and symptoms persist, take the next dose as soon as possible. Do not take a double dose to make up for a missed dose.
4. Possible adverse reactions
Like all medicines, GEMIPAR 125 can cause adverse reactions, although not everyone experiences them.
Rare:
- Hypersensitivity reactions: skin redness, rash, angioedema, dyspnoea, bronchospasm attacks, hypotension up to shock symptoms.
- Gastrointestinal disorders: nausea, vomiting.
- Hepatic disorders: signs 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).
Other adverse reactions not listed in this leaflet may occur in some individuals during treatment with GEMIPAR 125. If any other adverse symptoms occur, the doctor should be informed.
5. Storage of the medicinal product GEMIPAR 125
Keep the medicinal product out of the sight and reach of children.
Do not use GEMIPAR 125 after the expiry date stated on the packaging.
Store below 25°C. Store in the original packaging.
6. Other information
For more detailed information, please contact the responsible entity:
Biofaktor Sp. z o.o.
ul. Podmiejska 15 C
66-400 Gorzów Wielkopolski
e-mail: [email protected]
Date of leaflet preparation: