Gemipar 50

1. What is GEMIPAR 50 and what is it used for

GEMIPAR 50 are suppositories that contain paracetamol. Paracetamol has analgesic and antipyretic effects. The medicine is intended for infants.

Indications for use:

Short-term treatment of mild to moderate pain, e.g. pain associated with teething.
Fever, e.g. in the course of childhood diseases in patients who cannot take paracetamol orally, e.g. due to nausea or vomiting.

2. Before using GEMIPAR 50

Do not use the medicine if:there is hypersensitivity to any component of the medicine, severe renal failure, severe liver failure, congenital lack of glucose-6-phosphate dehydrogenase and methemoglobin reductase, alcoholism, first trimester of pregnancy.

Use GEMIPAR 50 with caution

The medicine contains paracetamol. To avoid overdose, check if other medicines being taken do not contain paracetamol. Do not use doses higher than recommended. Use with caution in elderly patients. Use with caution in patients with liver or kidney failure.
During paracetamol treatment, do not consume alcohol due to the risk of severe liver damage. Particular risk of liver damage exists in starving people and those who regularly drink alcohol.

Using the medicine GEMIPAR 50 in children:

The medicine is indicated for infants from 3 to 12 months.

Pregnancy. Breast-feeding:

The medicine is intended for use in infants due to the dose.
The medicine is contraindicated in the first three months of pregnancy. Paracetamol may be used in the second and third trimester of pregnancy and during breastfeeding in case of urgent need and after consulting a doctor.
Before using any medicine, consult a doctor.

Driving vehicles and operating machinery:

The medicine is intended for use in infants due to the dose.
Paracetamol does not affect psychophysical fitness.

Using other medicines

Paracetamol enhances the effect of oral anticoagulant medicines from the coumarin group, prolonging bleeding time and increasing the risk of bleeding. Using paracetamol with zidovudine (AZT) may enhance the toxic effect of zidovudine on the bone marrow. Concurrent use of paracetamol and medicines that increase liver metabolism, e.g. rifampicin, antiepileptic medicines, barbiturates, increases the risk of liver damage, even when using recommended paracetamol doses. Paracetamol prolongs the half-life of chloramphenicol and increases its toxicity. Concurrent administration of paracetamol and non-steroidal anti-inflammatory medicines increases the risk of kidney function disorders. Using paracetamol with MAO inhibitors may cause excitement and high fever (a 14-day interval should be maintained). Metoclopramide accelerates, and propanteline delays the absorption of paracetamol from the gastrointestinal tract. Consuming alcohol during paracetamol treatment may lead to liver failure caused by liver cell necrosis. Using paracetamol may be the cause of false results of some laboratory tests (e.g. glucose concentration measurement). Do not use with other medicines containing paracetamol.
Inform your doctor about all medicines taken recently, even those available without a prescription.

3. How to use GEMIPAR 50

Use in children under 2 years of age should be recommended by a doctor.
Infants from 3 to 6 months, rectally 1 suppository at a time, from 7 to 12 months, rectally 1 to 2 suppositories at a time.
If necessary, the dose can be repeated every 4 hours, but no more than 4 times a day.
The medicine should not be used for more than 3 days without consulting a doctor.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

In case of using a higher dose of the medicine GEMIPAR 50 than recommended:

The following may occur: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite the fact that liver damage is starting to develop, which will then manifest as abdominal distension, return of nausea, and jaundice.
In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.
Due to the pharmaceutical form (suppositories), overdose of the medicine is unlikely, but it cannot be ruled out in the event of concurrent oral administration of paracetamol.
Treatment of paracetamol overdose given orally involves inducing vomiting if it has not been more than an hour since administration, and administering activated charcoal.
In case of taking very high doses of the medicine, antidotes are given: methionine and acetylcysteine treatment is continued.

In case of missing a dose of the medicine GEMIPAR 50:

The medicine is used for emergency treatment. If a dose is missed and the symptoms persist, take the next dose of the medicine. Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, GEMIPAR 50 can cause side effects, although they will not occur in everyone.
Rarely

• Hypersensitivity reactions: skin redness, rash, angioedema, dyspnea, asthma attacks, decreased blood pressure up to shock symptoms.
• Gastrointestinal disorders: nausea, vomiting
• Liver disorders - symptoms of liver damage.
• Kidney and urinary tract disorders: renal colic, renal papillary necrosis, acute kidney failure. Very rarely.
• Blood disorders: granulocytopenia (decreased granulocyte count in the blood), agranulocytosis (lack of granulocytes in the blood), thrombocytopenia (decreased platelet count). In some people, during the use of the medicine GEMIPAR 50, other side effects may occur. If other side effects occur that are not listed in this leaflet, inform your doctor.

5. Storage of the medicine GEMIPAR 50

Keep the medicine out of the reach and sight of children.
Do not use the medicine GEMIPAR 50 after the expiry date stated on the packaging.
Store at a temperature below 25°C. Store in the original packaging.

6. Other information

To obtain more detailed information, contact the responsible entity:
Biofaktor Sp. z o...
ul. Podmiejska 15 C
66-400 Gorzów Wielkopolski
e-mail: [email protected]
Date of leaflet preparation: