GEMIPAR 50

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 medical assistance. However, to achieve successful treatment, the medicine should be used carefully and in accordance with the information provided in this leaflet.

• Keep this leaflet, as you may need to read it again.
• Consult a doctor or pharmacist if you need advice or additional information. If symptoms worsen or do not improve, contact a doctor.

GEMIPAR 50
50 mg, suppositories
Paracetamolum
MEDICINAL PRODUCT CONTAINS PARACETAMOL
Composition:
Each suppository contains 50 mg of paracetamol (Paracetamolum)
and excipients: liquid paraffin, neutral fat (Vitepsol H15).
Available pack sizes:
10 suppositories
Marketing Authorisation Holder:
Biofaktor Sp. z o.o.
ul. Podmiejska 15 C
66-400 Gorzów Wielkopolski
Leaflet Contents:

1. What GEMIPAR 50 is and what it is used for
2. Before you use GEMIPAR 50
3. How to use GEMIPAR 50
4. Possible side effects
5. How to store GEMIPAR 50
6. Other information

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

GEMIPAR 50 is a suppository containing paracetamol. Paracetamol has analgesic and antipyretic properties. This medicine is intended for infants.
Indications:
Short-term treatment of mild to moderate pain, e.g. pain associated with teething.
Fever, for example, in childhood illnesses, 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 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, alcoholism, first trimester of pregnancy.
Exercise special caution when using GEMIPAR 50
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 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 50 in children:
The medicine is indicated for infants from 3 to 12 months of age.
Pregnancy and breastfeeding:
Due to its dosage, the medicine is intended for use in infants.
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 doctor.
Driving and operating machinery:
Due to its dosage, the medicine is intended for use in infants.
Paracetamol 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 toxic effect of zidovudine on bone marrow. 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. Concurrent administration of paracetamol and nonsteroidal 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. Alcohol consumption during paracetamol treatment may lead to liver failure caused by necrosis of liver cells. 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 are currently taking, including those available without a prescription.

3. How to use GEMIPAR 50

Use in children under 2 years of age should be prescribed by a doctor.
Infants from 3 to 6 months: 1 suppository rectally, as a single dose.
Infants from 7 to 12 months: 1 to 2 suppositories rectally, as a single dose.
If necessary, the dose may be repeated every 4 hours, no more than 4 times per day.
The medicine should not be used for longer than 3 days without consulting a doctor.
If the effect of the medicine appears too strong or too weak, consult a doctor.

If more GEMIPAR 50 medicine has been used than recommended:
Symptoms may include nausea, vomiting, excessive sweating, drowsiness, and general weakness.
These symptoms may subside the following day, even though liver damage may have begun to develop,
which later becomes evident as upper abdominal discomfort, recurrence of nausea, and jaundice.
If more medicine than recommended has been used, seek immediate advice from a doctor or pharmacist.

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

If a dose of GEMIPAR 50 has been missed:
The medicine is used for immediate treatment. If a dose has been missed and symptoms persist, the
next dose should be taken as soon as possible. Do not use a double dose to make up for the missed dose.

4. Possible adverse reactions

Like any medicine, GEMIPAR 50 may cause adverse reactions, although not everyone will experience them.

Rare:

• Hypersensitivity reactions: skin redness, rash, angioedema, dyspnoea, bronchial asthma attacks, hypotension 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 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 not listed in this leaflet may occur during treatment with GEMIPAR 50. If any adverse reactions occur which are not mentioned in this leaflet, they should be reported to a physician.

5. Storage of the medicinal product GEMIPAR 50

Keep this medicine out of the sight and reach of children.
Do not use the medicinal product GEMIPAR 50 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 marketing authorisation holder:
Biofaktor Sp. z o...
ul. Podmiejska 15 C
66-400 Gorzów Wielkopolski
e-mail: [email protected]
Date of leaflet preparation: