Paracetamol promedo

Package leaflet: Information for the user

Paracetamol Promedo
500 mg, tablets
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Paracetamol Promedo is and what it is used for

Paracetamol Promedo is a medicine with analgesic and antipyretic properties.
Paracetamol Promedo is indicated for symptomatic treatment of mild to moderate pain of various origins (headaches, including tension-type headaches, sore throat, toothache, bone, joint and muscle pain, painful menstruation) and fever, for example, associated with the common cold.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Important information before using Paracetamol Promedo

When not to use Paracetamol Promedo:

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in case of alcohol-related disease,
• in case of severe liver or kidney failure,
• viral hepatitis,
• in children under 12 years of age.

Warnings and precautions
The medicine contains paracetamol.
Do not take a higher dose than recommended. Overdosing on paracetamol may lead to
severe liver damage.
This medicine should not be used simultaneously with other medicines containing paracetamol, such as
painkillers, antipyretics, or medicines used to treat symptoms of flu and colds.
Read the leaflet carefully before using the medicine and follow the instructions contained therein.
Consult a doctor before using the medicine if:

• liver or kidney failure,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• underweight or malnourished patients suffering from anorexia (malnutrition),
• patients who regularly consume alcohol (it may be necessary to completely stop taking this product or reduce the dose),
• severe infection (sepsis), which may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include, among others:
• deep, rapid, and labored breathing,
• nausea, vomiting, and loss of appetite,
• general feeling of being unwell. Contact a doctor immediately if the patient develops the above symptoms simultaneously. Consult a doctor if the patient suffers from chronic headaches.

Do not drink alcohol while taking this medicine due to an increased risk of liver damage. The risk of liver damage is particularly high in malnourished patients and those who regularly consume alcohol. Existing liver disease increases the risk of liver damage associated with the use of paracetamol.
During treatment with Paracetamol Promedo, inform the doctor immediately if:

• the patient has severe diseases, including severe kidney function disorders or 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). In these situations, severe illness called metabolic acidosis (abnormality in blood and body fluids) has been reported in patients who used paracetamol at regular doses for a prolonged period or who took paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

If symptoms persist for more than 3 days, consult a doctor.
Do not take a higher dose than recommended.
Keep the medicine out of sight and reach of children.
Children
Use in children under 12 years of age is contraindicated.
Paracetamol Promedo and other medicines
Inform the doctor about all medicines recently taken, even those available without a prescription.
Do not take other medicines containing paracetamol simultaneously. Taking Paracetamol Promedo together with other medicines containing paracetamol may lead to overdose and liver failure.
Inform the doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2).

Consult a doctor if taking the following medicines:
metoclopramide, domperidone (used against nausea and vomiting), cholestyramine (used to reduce high blood cholesterol levels), anticoagulants such as warfarin if long-term pain relief is needed, sedatives, antiepileptics, antituberculosis drugs, MAO inhibitors (medicines used for depression), non-steroidal anti-inflammatory drugs (including acetylsalicylic acid).
Paracetamol use may lead to false results in certain laboratory tests (e.g., blood glucose measurement).
Paracetamol taken together with MAO inhibitors may cause a state of excitation and high temperature.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Paracetamol Promedo may be used during pregnancy if clinically justified.
Take the lowest recommended dose that reduces pain and (or) fever, for the shortest possible duration, as infrequently as possible.
Consult a doctor if pain and (or) fever do not subside or if it becomes necessary to increase the frequency of taking the medicine. As with other medicines, this medicine should be used during pregnancy only if absolutely necessary.
Paracetamol passes into breast milk in clinically insignificant amounts. As with other medicines, this medicine should be used during breastfeeding only if absolutely necessary.
Driving and operating machinery
Paracetamol Promedo has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.

3. How to take Paracetamol Promedo

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
For oral use only. Swallow the tablets whole with an adequate amount of water. Use the lowest effective dose for the shortest possible duration.
Do not exceed the maximum daily dose.

Recommended dose
The paracetamol dose is determined based on body weight and age. The usual single dose is 10 mg to 15 mg/kg body weight. The maximum daily dose is 60 mg/kg body weight.

Adults, including elderly individuals and adolescents over 12 years of age (body weight
above 50 kg):
The recommended single dose is 1 to 2 tablets.
If necessary, the dose may be repeated no more frequently than every 4 hours, up to 4 times daily.
The maximum daily dose of paracetamol is 4000 mg (8 tablets).

Adults, including elderly individuals and adolescents over 12 years of age (body weight
40–50 kg):
The recommended single dose is 1 tablet.
If necessary, the dose may be repeated no more frequently than every 4 hours, up to 6 times daily.
The maximum daily dose of paracetamol is 3000 mg (6 tablets).
Do not use the medicine for longer than 3 days without consulting a doctor.
If you feel the medicine's effect is too strong or too weak, consult your doctor.

Taking a higher than recommended dose of Paracetamol Promedo
In any case of ingestion of a dose higher than recommended, the patient should contact a doctor immediately, even if no symptoms are present, as this may lead to life-threatening liver damage.
In every case of single ingestion of 5 g or more of paracetamol, the patient must be taken to hospital.
Paracetamol overdose may cause symptoms within several to several dozen hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite the onset of liver damage, which subsequently becomes apparent as upper abdominal discomfort, recurrence of nausea, and jaundice.

Missing a dose of Paracetamol Promedo
Do not take a double dose to make up for a missed dose.

Stopping treatment with Paracetamol Promedo
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rare adverse reactions (occurring in less than 1 in 10,000 people):

• thrombocytopenia (reduced number of blood platelets)
• bronchospasm in patients hypersensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs
• acute liver injury, most commonly occurring as a result of overdose
• severe skin reactions presenting as acute generalized vesiculobullous rash or erosions and ulcers
• anaphylactic reactions

Rare adverse reactions (occurring in less than 1 in 1,000 people):

• skin hypersensitivity reactions, including rash and angioedema.

Frequency unknown (cannot be estimated from available data):

• serious condition which may cause acidification of the blood (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, inform your doctor or pharmacist.
This includes any possible adverse reactions not listed in this leaflet. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel: (22) 49 21 301
Fax: (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Paracetamol Promedo

Keep this medicine out of the sight and reach of children.
No special storage conditions apply.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Paracetamol Promedo contains

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: pregelatinized maize starch, magnesium stearate (E572).

What Paracetamol Promedo looks like and contents of the pack
Paracetamol Promedo is a white or almost white capsule-shaped tablet, smooth on one side and with a breakline on the other side.
The breakline on the tablet is not intended for breaking the tablet.
The tablets are packed in PVC/Aluminium blisters in a cardboard box.
The pack contains 10, 12, 20, 24, 30, 36, 48, 50 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany
Manufacturer and importer
Medezin Sp. z o.o.
Ks. Kazimierza Janika 14
95-050 Konstantynów Łódzki
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
Germany
[email protected]
+48 22 329 65 00