Paracetamol hasco

Package leaflet: Information for the patient

PARACETAMOL HASCO
500 mg, coated tablets
Paracetamolum
Please read carefully the entire leaflet 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 advised by the
doctor, pharmacist, or nurse.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any 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.

Table of contents

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

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

Paracetamol Hasco is an analgesic and antipyretic medicine used for the following indications:

• headaches,
• sore throat,
• migraines,
• toothaches,
• bone, joint, and muscular pain,
• painful menstruation (due to its analgesic effect),
• colds and flu-like conditions (due to its antipyretic effect).

2. Important information before using Paracetamol Hasco

When not to use Paracetamol Hasco

• 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 liver failure or viral hepatitis,
• severe renal failure,
• alcoholic liver disease.

Warnings and precautions
Before starting to use Paracetamol Hasco, consult a doctor, pharmacist, or nurse if the patient:

• has liver impairment,
• has kidney impairment,
• has reduced glucose-6-phosphate dehydrogenase activity,
• has reduced methemoglobin reductase activity,
• suffers from asthma with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, as bronchospasm has been observed in less than 5% of patients after administration of paracetamol.

Due to the risk of overdose, do not take Paracetamol Hasco simultaneously with other medicines containing paracetamol, and do not exceed the recommended doses.
Because of the increased risk of liver damage, Paracetamol Hasco should not be used in chronically undernourished individuals.
During treatment with Paracetamol Hasco, immediately inform a doctor if the patient develops severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (an imbalance in blood and body fluids) when taking paracetamol regularly over a prolonged period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Paracetamol use may lead to false results in certain laboratory tests (e.g., blood plasma glucose measurement).

Children
The use of Paracetamol Hasco in the form of coated tablets is not recommended in children under 6 years of age. In such cases, Paracetamol Hasco oral suspension intended for children from 3 months of age should be used.

Paracetamol Hasco and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
Paracetamol Hasco may affect the action of other medicines, or other medicines may affect the action of Paracetamol Hasco, for example:

• metoclopramide and domperidone (medicines used for nausea and vomiting) increase the rate of paracetamol absorption,
• cholestyramine (a medicine that lowers blood cholesterol levels) slows down paracetamol absorption,
• long-term use of high-dose paracetamol intensifies the effect of anticoagulant medicines (coumarin derivatives),
• sedatives or antiepileptic medicines (including glutethimide, barbiturates such as phenobarbital, phenytoins, carbamazepines) increase the harmful effects of paracetamol on the liver,
• certain antibiotics, e.g., rifampicin, increase the harmful effects of paracetamol on the liver; chloramphenicol – paracetamol increases its toxicity,
• simultaneous use of antidepressants (so-called MAO inhibitors) with paracetamol may cause agitation and high fever,
• simultaneous use of paracetamol with non-steroidal anti-inflammatory drugs (including ibuprofen, acetylsalicylic acid) increases the risk of kidney function disorders,
• paracetamol should not be used simultaneously with centrally acting analgesics, as it intensifies their effect,
• caffeine enhances the analgesic effect of paracetamol. Consult a doctor if taking any of the above-mentioned medicines.

Inform your 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 require urgent treatment (see section 2).

Use of Paracetamol Hasco with alcohol
Due to the increased risk of liver damage, alcoholic beverages should not be consumed during treatment with Paracetamol Hasco, and Paracetamol Hasco should not be used in individuals who regularly consume alcohol. Paracetamol intensifies the effects of alcohol.

Pregnancy and breastfeeding
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 Hasco may be used during pregnancy if clinically justified. The lowest effective dose that reduces pain and/or fever should be used for the shortest possible duration and as infrequently as possible. Consult a doctor if pain and/or fever do not subside or if more frequent dosing is needed.

During breastfeeding, use only when necessary and when, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the infant.

Driving and operating machinery
Paracetamol has no effect or negligible effect on the ability to drive vehicles and operate machinery.

3. How to use Paracetamol Hasco
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, consult a doctor, pharmacist, or nurse.
Paracetamol Hasco is taken orally.

Recommended dose:
Adults and adolescents over 12 years of age
2 tablets, if necessary up to 4 times daily.
Do not take the medicine more frequently than every 4 hours. Do not exceed the maximum daily dose of 8 tablets.

Children aged 6–12 years
½ to 1 tablet, if necessary up to 4 times daily.
Do not take the medicine more frequently than every 4 hours. Do not exceed the maximum daily dose of 4 tablets.

Without consulting a doctor, this medicine should not be used regularly for longer than 3 days.

Use of a higher than recommended dose of Paracetamol Hasco
Overdose of paracetamol may cause liver or kidney failure. In case of ingestion of a dose higher than recommended, seek immediate medical advice, even if the patient feels well.
Accidental or intentional overdose of paracetamol may cause symptoms within a few to several hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. In any case of ingestion of 5 g or more of paracetamol, if the patient is conscious and less than one hour has passed since ingestion, induce vomiting and administer activated charcoal (60 to 100 g mixed with water), and contact a doctor immediately.

If a dose of Paracetamol Hasco is missed
Do not take a double dose to make up for a missed dose.
In case of any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Rare (in less than 1 in 1,000 people):

• allergic skin reactions: urticaria, erythema, dermatitis.

Very rare (in less than 1 in 10,000 people):

• reduction in platelet count (thrombocytopenia), reduction in white blood cell count (leukopenia, agranulocytosis), nausea, vomiting, diarrhoea.

Frequency unknown (cannot be estimated from available data):

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

Prolonged or overdosed use of the medicine may cause liver and kidney damage, as well as methemoglobinemia with symptoms of cyanosis (bluish discoloration of the skin).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49-21-301, Fax: +48 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 Hasco

Store below 25°C, in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "Tw."
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 in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Hasco contains

• The active substance is paracetamol. One coated tablet contains 500 mg of paracetamol.
• The other ingredients (excipients) are: pregelatinized corn starch, povidone K-30, potassium sorbate, magnesium stearate, and tablet coating (Opadry II 57U18539 White): hypromellose, titanium dioxide (E 171), polydextrose, talc, maltodextrin, medium-chain triglycerides.

What Paracetamol Hasco looks like and contents of the pack
Paracetamol Hasco is a white, oval, biconvex, smooth coated tablet.
One pack contains 2, 4, 6, 15 or 30 coated tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product information
tel.: (22) 742 00 22
e-mail: [email protected]