Paracetamol Hasco

Leaflet attached to the packaging: patient information

PARACETAMOL HASCO

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 according to the
recommendations of a doctor, pharmacist, or nurse.

• This leaflet should be kept, so that it can be read again if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 Hasco and what is it 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 packaging and other information

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

Paracetamol Hasco is a pain-relieving and antipyretic medicine used for the following indications:

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

2. Important information before taking Paracetamol Hasco

When not to take Paracetamol Hasco

• if the patient is allergic to paracetamol or any other component of this medicine (listed in section 6),
• if the patient has:
• severe liver failure or viral hepatitis,
• severe kidney failure,
• alcoholic liver disease.

Warnings and precautions

Before starting to take Paracetamol Hasco, the patient should discuss it with their doctor, pharmacist, or
nurse if they:

• have liver failure,
• have kidney failure,
• have reduced activity of glucose-6-phosphate dehydrogenase,
• have reduced activity of methemoglobin reductase,
• have 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 taking paracetamol.

Due to the risk of overdose, Paracetamol Hasco should not be taken at the same time as other medicines containing paracetamol, and doses higher than recommended should not be taken.
Due to the increased risk of liver damage, this medicine should not be taken by people who are malnourished for a long time.
During treatment with Paracetamol Hasco, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder) when taking 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, nausea, and vomiting.
Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).

Children

Paracetamol Hasco in the form of coated tablets is not recommended for children under 6 years of age. In this case, Paracetamol Hasco in the form of an oral suspension intended for children from 3 months of age should be used.

Paracetamol Hasco and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
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 against nausea and vomiting) increase the absorption rate of paracetamol,
• cholestyramine (a medicine that lowers blood cholesterol levels) slows down the absorption of paracetamol,
• long-term use of paracetamol in high doses enhances the effect of anticoagulant medicines (from the coumarin derivative group),
• sedative or antiepileptic medicines (e.g., glutethimide, barbiturates, and e.g., phenobarbital, phenytoin, carbamazepine) enhance the harmful effects of paracetamol on the liver,
• certain antibiotics, e.g., rifampicin, increase the harmful effect of paracetamol on the liver; chloramphenicol - paracetamol increases its toxicity,
• concomitant use of antidepressant medicines (from the MAO inhibitor group) with paracetamol may cause a state of excitement and high temperature,
• concomitant use of paracetamol with non-steroidal anti-inflammatory medicines (e.g., ibuprofen, acetylsalicylic acid) increases the risk of kidney function disorders,
• paracetamol should not be taken at the same time as centrally acting pain-relieving medicines, as it enhances their effect,
• caffeine enhances the pain-relieving effect of paracetamol. The patient should consult their doctor if they are taking any of the above-mentioned medicines.

The patient should inform their doctor or pharmacist if they are 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).

Taking Paracetamol Hasco with alcohol

Due to the increased risk of liver damage, the patient should not consume alcoholic beverages during treatment with Paracetamol Hasco, and this medicine should not be taken by people who regularly drink alcohol. Paracetamol enhances the effect of alcohol.

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.
Paracetamol Hasco can be used during pregnancy if it is clinically justified. The patient should take the smallest possible recommended dose that reduces pain and (or) fever, for the shortest possible time and as infrequently as possible. The patient should consult their doctor if pain and (or) fever do not decrease or if they need to take the medicine more frequently.
During breastfeeding, this medicine should be used only if necessary, when the benefit to the mother outweighs the potential risk to the child.

Driving and using machines

Paracetamol has no effect or a negligible effect on the ability to drive and use machines.

3. How to take Paracetamol Hasco

This medicine should always be taken exactly as described in this patient leaflet, or according to the
recommendations of a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
Paracetamol Hasco is taken orally.
The recommended dose is:
Adults and adolescents over 12 years old
2 tablets, if necessary up to 4 times a day.
The medicine should not be taken more often than every 4 hours. The maximum dose should not be exceeded - up to 8 tablets per day.
Children aged 6-12 years
½ - 1 tablet, if necessary up to 4 times a day.
The medicine should not be taken more often than every 4 hours. The maximum dose should not be exceeded - up to 4 tablets per day.
Without consulting a doctor, the medicine should not be taken regularly for more than 3 days.

Taking a higher dose of Paracetamol Hasco than recommended

Overdosing on paracetamol can cause liver or kidney failure. If a dose higher than recommended is taken, the patient should immediately seek medical advice, even if they feel well.
Accidental or intentional overdose of paracetamol may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. In every case of taking paracetamol in a dose of 5 g or higher, if the patient is conscious and it has not been more than an hour since taking the paracetamol, vomiting should be induced and activated charcoal (60-100 g mixed with water) should be administered, and the patient should contact their doctor.

If a dose of Paracetamol Hasco is missed

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Paracetamol Hasco can cause side effects, although not everybody gets them.
Rarely (in less than 1 in 1000 people):

• skin allergic reactions: hives, rash, skin inflammation.

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

• decreased platelet count (thrombocytopenia), decreased white blood cell count (leukopenia, agranulocytosis), nausea, vomiting, diarrhea.

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

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

Long-term use of this medicine or overdose may cause liver and kidney damage, as well as methemoglobinemia with symptoms of cyanosis (gray-blue skin discoloration).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309
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 this medicine.

5. How to store Paracetamol Hasco

Store in a temperature below 25°C, in the original packaging.
The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
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 packaging and other information

What Paracetamol Hasco contains

• The active substance of the medicine is paracetamol. 1 coated tablet contains 500 mg of paracetamol.
• Other ingredients (excipients) are: maize starch, povidone K-30, potassium sorbate, magnesium stearate, and the tablet coating (Opadry II 57U18539 White): hypromellose, titanium dioxide (E 171), polydextrose, talc, maltodextrin, triglycerides of saturated fatty acids of medium chain length.

What Paracetamol Hasco looks like and what the packaging contains

Paracetamol Hasco is a white, oval, biconvex, and smooth coated tablet.
One packaging of the medicine contains 2, 4, 6, 15, or 30 coated tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: