Gemipar 125

1. What is GEMIPAR 125 and what is it used for

GEMIPAR 125 are suppositories that contain paracetamol. Paracetamol has analgesic and antipyretic effects. The medicine is intended for children from 1 to 6 years old.

Indications for use:

Short-term treatment of mild to moderate pain, e.g. headaches, toothaches, joint, muscle and bone pain, pain after surgical and dental procedures. Fever, e.g. in the course of a cold or flu 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:there is hypersensitivity to any component of the medicine, severe renal impairment, severe hepatic impairment, congenital lack of glucose-6-phosphate dehydrogenase and methemoglobin reductase, alcoholism, first trimester of pregnancy.

Use GEMIPAR 125 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 impairment. During paracetamol treatment, do not consume alcohol due to the risk of severe liver damage.
There is a special risk of liver damage in people who are starving and regularly drinking alcohol.

Using the medicine GEMIPAR 125 in children

The medicine is indicated for children from 1 to 6 years old.

Pregnancy. Breast-feeding

The medicine is intended for use in children 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 children 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. The use of 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 the recommended doses of paracetamol. Paracetamol prolongs the half-life of chloramphenicol and increases its toxicity. Simultaneous administration of paracetamol and non-steroidal anti-inflammatory medicines increases the risk of kidney function disorders. The use of 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 due to liver cell necrosis. The use of paracetamol may be the cause of false results of some laboratory tests (e.g. glucose concentration determination). 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 125

Use in children under 2 years of age should be recommended by a doctor.
Children from 1 to 3 years old, rectally 1 suppository at a time, children from 4 to 6 years old, 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 125 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, however, it cannot be ruled out in the event of simultaneous 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 the case of very high doses of the medicine, antidotes are given: methionine and the treatment is continued with acetylcysteine.

In case of missing a dose of the medicine GEMIPAR 125

The medicine is used for emergency treatment. If a dose of the medicine 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 125 can cause side effects, although they do 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 renal 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 125, 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 125

Keep the medicine out of the reach and sight of children.
Do not use the medicine GEMIPAR 125 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.o.
ul. Podmiejska 15 C
66-400 Gorzów Wielkopolski
e-mail: [email protected]
Date of preparation of the leaflet: