Paracetamol Dr.max

Leaflet attached to the packaging: patient information

Paracetamol Dr.Max, 500 mg, 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 the patient leaflet or as directed by a doctor or pharmacist.

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

Table of contents of the leaflet:

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

1. What is Paracetamol Dr.Max and what is it used for

Paracetamol, the active substance of Paracetamol Dr.Max, has analgesic and antipyretic effects.
Paracetamol Dr.Max is used to relieve mild to moderate pain, such as headache, migraine, back pain, toothache, or menstrual pain. It provides relief from symptoms of flu and colds, such as muscle pain, joint pain, and sore throat, and reduces fever.
Only on the advice of a doctor can the medicine be used to relieve pain in certain rheumatic conditions, such as osteoarthritis and neuralgia (pain felt in the area of the nerve).
Paracetamol Dr.Max is intended for adults, adolescents, and children over 6 years old (or children with a body weight of at least 21 kg).
If after 3 days the patient does not feel better or feels worse, they should talk to their doctor.
Without a doctor's recommendation, Paracetamol Dr.Max should not be taken for more than 7 days in adults and 3 days in children.

2. Important information before taking Paracetamol Dr.Max

When not to take Paracetamol Dr.Max

Warnings and precautions

Paracetamol Dr.Max should not be taken simultaneously with other medicinal products containing paracetamol.

Paracetamol Dr.Max should not be taken without consulting a doctor if the patient has liver or kidney disease.

Before starting treatment with Paracetamol Dr.Max, the patient should discuss it with their doctor or pharmacist if:

• the patient has kidney function disorders (in this case, the medicine can be taken only on the advice of a doctor, as smaller doses are necessary),
• the patient has a lack of glucose-6-phosphate dehydrogenase (a hereditary disease that reduces the number of red blood cells),
• the patient has liver function disorders,
• the patient has a very low BMI (body mass index),
• the patient has been taking higher doses of paracetamol for a longer period; regular monitoring of liver function is necessary; the risk of overdose is higher in patients with liver disease who are already taking other medicines containing paracetamol,
• the patient consumes alcoholic beverages for a longer period; long-term alcohol consumption significantly increases the risk of liver damage from paracetamol.

If the patient is unsure whether any of the above situations apply to them, they should immediately contact their doctor.

During treatment with Paracetamol Dr.Max, the patient should immediately inform their doctor:

If the patient has severe diseases, including severe kidney or liver disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Severe metabolic acidosis (a blood and fluid disorder) has been reported in patients who take paracetamol in regular doses 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.
This medicine contains paracetamol. Do not exceed the recommended dose.Taking higher doses than recommended may lead to severe liver damage. The liver-damaging effect of paracetamol can occur even during short-term treatment with therapeutic doses without prior liver function impairment.
During paracetamol treatment, life-threatening skin reactions have been reported. If such symptoms occur (e.g., progressive skin rash, often with blisters or mucosal lesions), the patient should stop taking Paracetamol Dr.Max and immediately go to the hospital.

Children

Due to the content of paracetamol, Paracetamol Dr.Max is not intended for children under 6 years old (or children with a body weight below 21 kg).

Paracetamol Dr.Max and other medicines

The patient should tell their doctor or pharmacist if they are taking, have recently taken, or might take any other medicines.
The medicine contains paracetamol.Do not take this medicine with other medicines containing paracetamol.

Before starting treatment with Paracetamol Dr.Max, the patient should discuss it with their doctor or pharmacist if they are taking:

• medicines used to treat nausea and vomiting or stomach ulcers (metoclopramide, domperidone, and propanteline),
• warfarin or other medicines that prevent blood clotting; long-term use of higher doses of paracetamol may enhance the effect of these medicines; occasional concurrent use of these medicines does not have a significant effect,
• certain medicines used to treat epilepsy or sleep (glutethimide, phenobarbital, phenytoin, carbamazepine, lamotrigine),
• medicines for depression from the group of monoamine oxidase inhibitors or tricyclic antidepressants,
• sleeping pills, sedatives, or other medicines that have a depressant effect on the central nervous system (barbiturates),
• medicines for tuberculosis (isoniazid),
• zydovudine (treatment for HIV and AIDS),
• certain antibiotics (rifampicin, chloramphenicol),
• medicines used to treat gout (probenecid),
• medicines that lower blood fat levels (cholestyramine),
• medicines containing acetylsalicylic acid or other medicines used to treat pain and fever from the group of nonsteroidal anti-inflammatory drugs (nonsteroidal anti-rheumatic drugs); (concomitant long-term use with paracetamol may lead to kidney damage),
• medicines or dietary supplements containing St. John's Wort,
• flucloxacillin (an antibiotic), due to the serious risk of a disorder affecting blood and body fluids (called metabolic acidosis), which requires urgent treatment (see section 2).

The effect of Paracetamol Dr.Max and the effect of other medicines taken at the same time may interact. Therefore, the doctor should be informed about all medicines the patient is taking or will take, prescription and non-prescription medicines. Before taking any non-prescription medicines with Paracetamol Dr.Max, the patient should consult their doctor.

Paracetamol Dr.Max with food, drink, and alcohol

The patient should not drink alcohol during treatment due to the increased risk of liver damage.
Patient with alcohol problems should consult their doctor before starting treatment.

Pregnancy, breastfeeding, and fertility

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 the medicine.
Paracetamol Dr.Max can be given to pregnant women if necessary. The patient should use the smallest effective dose that relieves pain or reduces fever and take the medicine for as short a time as possible. 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 women can take Paracetamol Dr.Max for a short time; longer treatment is possible only after consulting a doctor.

Driving and using machines

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

Paracetamol Dr.Max contains sodium

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

3. How to take Paracetamol Dr.Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
Paracetamol Dr.Max can be taken regardless of meals.
The medicine is intended for internal use. The tablets should be swallowed with water.
The patient should always take the smallest effective dose for the shortest time necessary to relieve symptoms.
The time interval between doses must be at least 4 hours.
Do not exceed the recommended dose.Taking higher doses than recommended may lead to a risk of severe liver damage.

Adults and adolescents over 15 years old

The recommended dose is 1-2 tablets several times a day, with an interval of at least 4 hours between doses.
One tablet is intended for persons weighing 34-60 kg, and 2 tablets are intended for persons weighing over 60 kg.
The maximum daily dose is 8 tablets. In long-term treatment (over 10 days), do not exceed 5 tablets per day.

Adolescents 12-15 years old

The recommended dose is 1 tablet several times a day, with an interval of at least 4-6 hours between doses.
The maximum daily dose is 6 tablets.

Children 6-12 years old (or with a body weight over 21 kg)

The recommended dose is ½ - 1 tablet several times a day, with an interval of at least 4-6 hours between doses.
Maximum single and daily doses depending on body weight are given in the table below.

Use in children under 6 years old or weighing less than 21 kg

Due to the content of the active substance, Paracetamol Dr.Max is not recommended for children under 6 years old or with a body weight below 21 kg.

Patient with kidney or liver disorders

If the patient has kidney or liver disorders, they should consult their doctor before starting treatment. The doctor will determine the dose. The patient should not take this medicine if they have severe liver function disorders.

Without a doctor's recommendation, Paracetamol Dr.Max should not be taken for more than 7 days in adults and 3 days in children. If after 3 days the patient does not feel better or feels worse, they should consult their doctor.
In the case of long-term treatment (several weeks), regular visits to the doctor are necessary.

Taking a higher dose of Paracetamol Dr.Max than recommended

In all cases of overdose or suspected overdose, which may be manifested by nausea, vomiting, and paleness, or if a child accidentally swallows the medicine, the patient should immediately contact their doctor or the nearest hospital, even if no symptoms of overdose occur. The patient should take the packaging and patient leaflet with them and show them to the doctor.
Paracetamol overdose can cause liver failure leading to the need for a liver transplant or death.

Missing a dose of Paracetamol Dr.Max

If the patient misses a dose of Paracetamol Dr.Max, they should take the next dose as soon as they remember, and then follow the intervals between doses given in section 3. The patient should not exceed the maximum daily dose. The patient should not take a double dose to make up for a missed dose.
If the patient has further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Dr.Max can cause side effects, although not everybody gets them.
If the medicine is taken in the recommended doses, it is usually well-tolerated.

The patient should stop taking this medicine and immediately inform their doctor if they experience any of the following problems:

• allergic reactions, which can be serious, including skin rash, itching, sometimes swelling of the lips or face or breathing difficulties;
• skin rash or peeling or ulcers in the mouth;
• breathing problems; these side effects are more likely if the patient has had breathing problems after taking other pain and fever medicines (such as ibuprofen or acetylsalicylic acid) before;
• unusual bruising or bleeding.

Rarely(may affect up to 1 in 1,000 patients):

• allergic reactions, skin hypersensitivity reactions
• increased levels of liver enzymes

Very rarely(may affect up to 1 in 10,000 patients):

• severe allergic reaction (anaphylaxis)
• bronchospasm
• blood disorders
• very rare cases of severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis) have been reported.

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

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

If the patient experiences any of the above or other unusual reactions, they should stop taking this medicine or giving it to their child and talk to their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Paracetamol Dr.Max

Keep out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Dr.Max contains

• The active substance of the medicine is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: maize starch, povidone (K-25), sodium croscarmellose, microcrystalline cellulose (PH102), colloidal anhydrous silica, magnesium stearate.

What Paracetamol Dr.Max looks like and what the pack contains

Paracetamol Dr.Max is almost white, elongated tablets with a dividing line on both sides, 16 mm long. The tablet can be divided into equal doses.
Blister pack of transparent PVC/PVDC/Aluminum in a cardboard box.
Pack sizes: 10, 20, 30, and 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
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia

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

Slovakia:
Paracetamol Dr.Max 500 mg
Czech Republic:
Paracetamol Dr.Max
Italy:
Paracetamol Dr.Max
Poland:
Paracetamol Dr.Max
Romania:
Paracetamol Dr.Max 500 mg tablets

Date of last revision of the leaflet: 03/2025