Panaprex

PATIENT INFORMATION LEAFLET

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Leaflet attached to the packaging: patient information

Panaprex, 500 mg, coated tablets

Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

• 1. What is Panaprex and what is it used for
• 2. Important information before taking Panaprex
• 3. How to take Panaprex
• 4. Possible side effects
• 5. How to store Panaprex
• 6. Contents of the pack and other information

1. What is Panaprex and what is it used for

The active substance of the medicine is paracetamol, which belongs to the group of analgesic and antipyretic medicines. The medicine is indicated for the treatment of fever (in colds, flu) and symptomatic treatment of pain of various origins with mild to moderate intensity. Panaprex shows analgesic activity in the treatment of pains such as: headaches, migraines, bone and joint pains, muscle pains, back pains, toothaches, post-operative pains, painful menstruation, sore throat.
If after 3 days of treatment of pain or fever there is no improvement or the patient feels worse, they should consult a doctor.
The medicine is indicated for use in adults and adolescents over 12 years of age.

2. Important information before taking Panaprex

When not to take Panaprex

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe renal impairment,
• if the patient has severe hepatic impairment,
• in children under 12 years of age,
• if the patient has alcoholic liver disease.

Warnings and precautions

Before starting treatment with Panaprex, the patient should discuss it with their doctor or pharmacist if:

• the patient has liver or kidney disease. In chronic kidney failure, the doctor may recommend prolonging the intervals between consecutive doses of paracetamol,
• the patient is allergic to acetylsalicylic acid, as there is a greater risk of allergy to paracetamol as well,
• the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase or methemoglobin reductase (rare hereditary diseases).

The medicine contains paracetamol.The patient should not take other medicines containing paracetamol (e.g. some medicines used to alleviate the symptoms of colds and flu) due to the risk of overdose and potentially life-threatening liver damage. It is not recommended to take the medicine for a long time or frequently.
The patient should not exceed the recommended maximum daily dose.
The patient should use the lowest effective dose for the shortest possible time.
The tablets should be swallowed with water.
Children
Panaprex should not be used in children under 12 years of age.

Paracetamol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
In particular, the patient should inform their doctor or pharmacist about the use of:

• Rifampicin (a medicine used in infections), isoniazid (a medicine used in the treatment of tuberculosis), antiepileptic medicines (e.g. phenytoin, carbamazepine), barbiturates (medicines used as anticonvulsants, sedatives, or hypnotics, e.g. phenobarbital) - risk of liver damage.
• MAO inhibitors (medicines used in psychiatry and neurology, e.g. phenelzine). The use of these medicines with paracetamol may increase the risk of excitement and fever.
• Medicines that enhance peristalsis (movement of food and digestive products in the digestive tract) e.g. cisapride, domperidone, metoclopramide (medicines used in the treatment of nausea and vomiting). These medicines cause accelerated absorption of paracetamol.
• Medicines that inhibit peristalsis or absorption in the digestive tract, e.g. cholestyramine (a medicine used to reduce elevated lipid levels in the blood), ciprofloxacin (a medicine used in infections), levodopa (a medicine used in psychiatry and neurology). These medicines cause delayed absorption of paracetamol.
• Medicines that slow down the elimination of paracetamol from the body, e.g. probenecid (a medicine used in the treatment of gout), salicylamide (a medicine used in the treatment of fever and mild pain). These medicines cause an increase in paracetamol levels.
• Anticoagulant medicines from the coumarin group (e.g. warfarin). The use of these medicines with paracetamol may enhance the anticoagulant effect and increase the risk of bleeding.
• Zidovudine (an antiviral medicine). The use of zidovudine with paracetamol may enhance the toxic effect of zidovudine on the bone marrow.
• Non-steroidal anti-inflammatory medicines (NSAIDs, painkillers, anti-inflammatory and antipyretic medicines). The use of these medicines with paracetamol may increase the risk of kidney function disorders, especially with long-term concurrent use.
• Flucloxacillin (an antibiotic) due to the serious risk of blood and fluid disorders (metabolic acidosis), which must be treated urgently (see section 2).

Taking Panaprex with food, drink, and alcohol

Alcohol may increase the risk of toxic liver damage. The patient should not consume alcohol during treatment with paracetamol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Panaprex can be given to pregnant women if necessary. The patient should use the lowest effective dose that relieves pain or reduces fever and take the medicine for the shortest possible time. If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of taking the medicine, the patient should consult their doctor.
Breastfeeding
After oral administration, paracetamol is excreted in small amounts into breast milk. No adverse effects have been reported in breastfed infants. During breastfeeding, the patient can take the recommended doses specified in section 3 of the leaflet; however, like other medicines, this medicine should be used in the lowest effective dose and as rarely as possible.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

3. How to take Panaprex

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.
Recommended dose
Adults, elderly patients, and adolescents over 12 years of age (with a body weight over 50 kg):
Orally, 1 to 2 tablets. If necessary, the dose can be repeated at intervals of not less than 4 hours, up to 4 times a day. The maximum daily dose of paracetamol is 4 g (8 tablets).
Adults and adolescents over 12 years of age (with a body weight of 40-50 kg):
Orally, 1 tablet at a time. If necessary, the dose can be repeated at intervals of not less than 4 hours, up to 6 times a day. The maximum daily dose of paracetamol is 3 g (6 tablets).
The patient should not exceed the recommended maximum daily dose.
The patient should use the lowest effective dose for the shortest possible time.
The tablets should be swallowed with water.
Children
Panaprex should not be used in children under 12 years of age.

Taking a higher dose of Panaprex than recommended

If the patient has taken a higher dose of the medicine than recommended, they should immediately consult a doctor, even if they feel well. If it has been less than 1 hour since the overdose, the patient should induce vomiting. The patient should immediately consult a doctor, as specialized treatment in a hospital may be necessary.
Symptoms may include: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite the fact that liver damage is developing, which will later manifest as abdominal pain, return of nausea, and jaundice.
Other symptoms may also occur, such as tremors, restlessness, insomnia, increased blood pressure, significant acceleration of heart rate, pallor, urinary retention. Death may occur.

Missing a dose of Panaprex

The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Panaprex can cause side effects, although not everybody gets them.
The patient should stop taking the medicine and consult their doctor if they experience:

• an allergic reaction (hypersensitivity), which may include: skin rash, itching, urticaria, or peeling of the skin, mouth ulcers, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face
• anaphylactic shock (a severe allergic reaction characterized by dizziness, impaired consciousness, accelerated heart rate, decreased blood pressure)
• breathing difficulties, if the patient has experienced similar problems in the past when taking acetylsalicylic acid or other non-steroidal anti-inflammatory medicines
• liver function disorders.

These side effects are very rare (less than 1 in 10,000 treated patients), except for severe skin and allergic reactions (anaphylactic shock), whose frequency cannot be determined based on available data.
Other possible side effects are listed below by frequency of occurrence.
Rare (may affect 1 to 10 people in 10,000 treated patients)

• abdominal pain, diarrhea, nausea, vomiting, dyspepsia (indigestion).

Very rare (may affect less than 1 in 10,000 treated patients)

• drowsiness, dizziness, headaches,
• blood disorders (reduced platelet count, white blood cell count, and neutrophil count in the blood, methemoglobinemia).

Frequency not known (cannot be determined based on available data):

• a serious condition that can cause acidification of the blood (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; phone: +48 22 492 13 01; fax +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Panaprex

There are no special recommendations for storing the medicine.
The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging and blister (after the EXP symbol). The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Panaprex contains

• The active substance of the medicine is paracetamol. Each tablet contains 500 mg of paracetamol.
• Other ingredients (excipients) are: tablet core (microcrystalline cellulose, povidone K90, purified water, colloidal silica, sodium croscarmellose, sodium stearyl fumarate), coating Opadry 200 White (polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, methacrylic acid, and ethyl acrylate copolymer (1:1), sodium carbonate).

What Panaprex looks like and contents of the pack

The tablet is coated, oblong, biconvex, white or almost white.
PVC/Aluminum blister in a cardboard box.
The pack contains 12 or 50 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

OLIMP Laboratories Sp. z o.o.
Pustynia 84F
39-200 Dębica
+48 14 680 32 00
{logo OLIMP Laboratories}

Date of last revision of the leaflet: