PANACIT 500 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Panacit, 500 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Panacit and what is it used for
4. Important information before taking Panacit
   1. When not to take Panacit
   2. Warnings and precautions
   3. Children
   4. Panacit and other medicines
   5. Panacit with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Panacit contains sodium
5. How to take Panacit
   1. Use in children and adolescents
   2. Taking a higher dose of Panacit than recommended
   3. Missing a dose of Panacit
6. Possible side effects
   1. Reporting side effects
7. How to store Panacit
8. Contents of the pack and other information
   1. What Panacit contains
   2. What Panacit looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 03/2025

Package Leaflet: Information for the Patient

Panacit, 500 mg, Tablets

Paracetamol

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

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 5 days for pain and 3 days for fever, consult a doctor.

Table of Contents of the Leaflet:

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

1. What is Panacit and what is it used for

The active substance of Panacit is paracetamol, which belongs to a group of pain-relieving and fever-reducing medicines. Panacit is used for the symptomatic treatment of mild to moderate pain, such as headache, toothache, back pain, menstrual pain, muscle and joint pain associated with flu and/or fever. If there is no improvement or if you feel worse after 5 days for pain and 3 days for fever, consult a doctor.

2. Important information before taking Panacit

When not to take Panacit

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver failure, acute liver inflammation.
• if you have severe hemolytic anemia (abnormal breakdown of red blood cells).

Warnings and precautions

Before starting to take the medicine, discuss it with your doctor or pharmacist:

• if you have kidney or liver disease (including Gilbert's syndrome or acute liver inflammation),
• if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase,
• if you have hemolytic anemia (abnormal breakdown of red blood cells)
• if you regularly consume large amounts of alcohol; never take more than 2 grams of paracetamol (4 x 500 mg tablets) per day.
• if you have asthma and are sensitive to acetylsalicylic acid and/or non-steroidal anti-inflammatory drugs (NSAIDs)
• in case of dehydration or prolonged malnutrition.

During treatment with Panacit, immediately inform your doctor: If you have severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism or when you are also taking flucloxacillin (an antibiotic). There have been reports of a serious disease called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. Do not take Panacit at the same time as other medicines containing paracetamol.

Children

Panacit should not be taken by children under 6 years of age.

Panacit and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take. There are several medicines that may interact with paracetamol. You should talk to your doctor before starting to take paracetamol if you are taking one of the following medicines:

• barbiturates (a group of sleeping pills and anesthetics)
• certain antidepressants
• probenecid (used in gout)
• chloramphenicol (an antibiotic)
• metoclopramide or domperidone (used to treat nausea and vomiting)
• cholestyramine (a cholesterol-lowering medicine)
• warfarin and other coumarins (blood-thinning medicines)
• zidovudine (a medicine used to treat AIDS)
• salicylamide or non-steroidal anti-inflammatory drugs (NSAIDs) (pain-relieving medicines)
• isoniazid (used to treat tuberculosis)
• lamotrigine (an antiepileptic medicine)
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).
• 2).

Paracetamol may affect the results of various laboratory tests (e.g., blood sugar test, urine analysis).

Panacit with food and drink

Caution should be exercised when taking paracetamol if you regularly consume large amounts of alcohol. In this case, do not take more than 2 grams of paracetamol (4 x 500 mg tablets) per day. Do not drink alcohol during treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before taking this medicine. Panacit can be used during pregnancy. Use the lowest possible dose that reduces pain and/or fever and use it for the shortest possible time. If pain and/or fever do not improve or if you need to take the medicine more often than recommended, consult your doctor. Although paracetamol passes into breast milk in small amounts, no adverse effects have been observed in breastfed infants. At recommended doses, paracetamol can be used for a short period by breastfeeding women.

Driving and using machines

Paracetamol does not affect the ability to drive and use machines.

Panacit contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Panacit

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. Recommended dosage: Adults and adolescents over 15 years: 1-2 tablets, up to four times a day, with at least a 4-hour interval between doses. 1 tablet is suitable for people weighing 34-60 kg; 2 tablets for people over 60 kg. The maximum single dose is 1 gram (2 tablets), the maximum daily dose is 4 grams (8 tablets).

Use in children and adolescents

12-15 years: 1 tablet, 4-6 times in 24 hours. The maximum daily dose is 3 grams (6 tablets). 6-12 years: 250-500 mg of paracetamol (½ to 1 tablet). A single dose of ½ tablet is intended for children weighing 21-32 kg; and 1 tablet for children weighing 33 kg or more. The interval between doses should be 4-6 hours. The maximum daily dose for children weighing 21-24 kg is 1.25 grams (2 ½ tablets); the maximum daily dose for children weighing 25-32 kg is 1.5 grams (3 tablets); the maximum daily dose for children weighing 33-40 kg is 2 grams (4 tablets). Tablets should be swallowed with a large amount of water or dissolved in a large amount of water, well mixed and drunk. Panacit should not be taken by children under 6 years of age. The interval between doses must be at least 4 hours. The medicine should not be combined with other products containing paracetamol. Do not exceed the recommended daily dose. The tablet can be divided into equal doses. If pain persists for more than 5 days or fever persists for more than 3 days, or symptoms worsen or if other symptoms occur, treatment should be discontinued and a doctor consulted. The effective daily dose should not be higher than 60 mg of paracetamol/kg body weight per day (up to 2 grams of paracetamol/day) in the following cases:

• adults with a body weight of less than 50 kg,
• mild or moderate liver failure, Gilbert's syndrome (familial non-hemolytic jaundice),
• dehydration,
• prolonged malnutrition.

If you feel that the effect of Panacit is too strong or too weak, consult a doctor or pharmacist.

Taking a higher dose of Panacit than recommended

In case of taking too much paracetamol, immediately consult a doctor or pharmacist, due to the risk of delayed, serious liver damage. In case of taking more than the recommended amount of the medicine, nausea, vomiting, sweating, and loss of appetite may occur. In most cases, there is no loss of consciousness. However, immediate medical attention should be sought. If help comes too late, liver damage may be irreversible.

Missing a dose of Panacit

Take the missed dose as soon as possible, unless it is almost time for the next dose. In this case, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose. If you have any further doubts about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects are listed below: Rare (may affect up to 1 in 1,000 people):

• certain blood diseases, including agranulocytosis, thrombocytopenia, neutropenia, thrombocytopenic purpura, hemolytic anemia, leukopenia
• allergic reactions (except for angioedema)
• liver disorders, liver failure, liver cirrhosis, and jaundice
• itching (pruritus), rash, sweating, purpura, and urticaria
• overdose and poisoning
• depression, confusion, and hallucinations
• seizures and headaches
• blurred vision
• edema
• bleeding, abdominal pain, diarrhea, nausea, vomiting
• dizziness, fever, and drowsiness

Very rare (may affect up to 1 in 10,000 people):

• pancytopenia (reduction in the number of all blood cells)
• allergic reactions, which should be discontinued, including angioedema, breathing difficulties, sweating, nausea, drop in blood pressure,

anaphylactic shock

• bronchospasm (bronchial constriction) in people allergic to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)
• liver poisoning
• skin rash
• hypoglycemia (low blood sugar)
• dark urine (sterile pyuria) and kidney disorders
• severe skin reactions

Frequency not known (cannot be estimated from the available data):

• a serious disease that can make the blood more acidic (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Long-term use of 3 to 4 grams of paracetamol (6 to 8 tablets) per day may also damage the liver. If you take 6 grams of paracetamol (12 tablets) per day, the liver may be damaged.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Panacit

Keep out of sight and reach of children. There are no special precautions for storage. Do not take this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Panacit contains

• The active substance of Panacit is paracetamol; each tablet contains 500 mg of paracetamol.
• Other ingredients of the medicine are: povidone K30, corn starch, sodium carboxymethyl starch type A, stearic acid 50.

What Panacit looks like and contents of the pack

Panacit is a white capsule-shaped tablet with the inscription 500 on one side and a dividing line on the reverse, packaged in PVC/Aluminum blisters, in a cardboard box. Tablets can be divided into equal doses. Pack sizes: 10, 12, 16, 20, 24, 30, or 50 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o. Na Florenci 2116/15 110 00 Prague Czech Republic tel.: (+420) 516 770 199

Manufacturer:

MEDIS INTERNATIONAL a.s. Výrobní závod Bolatice, Průmyslová 961/16, 747 23 Bolatice Czech Republic Qualimetrix S.A. 579 Mesogeion Avenue Agia Paraskevi 15343 Athens Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland Panacit Czech Republic Parapyrex Slovakia Parapyrex

Date of last revision of the leaflet: 03/2025