Paracetamol Hasco

Leaflet attached to the packaging: patient information

PARACETAMOL HASCO

500 mg, oral powder in a sachet

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 as advised by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible 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 a 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 reliever and antipyretic for the symptomatic treatment of mild to moderate pain of various origins (headaches, including migraines, sore throats, toothaches, bone, joint, and muscle pain, painful menstruation) and fever (in the course of colds and flu-like conditions).
If there is no improvement after 3 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Paracetamol Hasco

When not to take 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.

Warnings and precautions

Before taking Paracetamol Hasco, the patient should discuss it with their doctor or pharmacist.
Special caution should be exercised when taking paracetamol in patients:

• with liver failure,
• chronically addicted to alcohol,
• with severe kidney failure,
• with Gilbert's syndrome (familial non-hemolytic jaundice),
• with acute liver inflammation,
• taking other medicines that affect liver function, 1/6
• with a deficiency of glucose-6-phosphate dehydrogenase,
• with hemolytic anemia (anemia caused by excessive breakdown of red blood cells).

If a high fever or symptoms of secondary infection occur, or if symptoms persist for more than 3 days, the patient should consult a doctor.
During treatment with Paracetamol Hasco, the patient should immediately inform their doctor if they experience severe illnesses, including severe kidney or liver 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).
There have been reports of a severe condition called metabolic acidosis (a blood and fluid disorder) 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.
Habitual use of painkillers, especially combinations of several painkillers, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy).
It is not recommended to take this medicine for an extended period or frequently, or to take other medicines containing paracetamol. Taking a multiple of the daily dose at once can cause severe liver damage. In such a case, there is no loss of consciousness, but immediate medical attention is necessary. Prolonged use of the medicine without medical supervision can be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, it is not justified to administer another antipyretic medicine at the same time, unless the use of paracetamol alone is ineffective.
Sudden discontinuation of the medicine after long-term, high-dose, improper use of painkillers may cause headaches, weakness, muscle pain, restlessness, and vegetative symptoms. These withdrawal symptoms subside after a few days. Until then, the patient should avoid taking painkillers again and not take them again without consulting a doctor.
Care should be taken when using paracetamol in patients with kidney or liver failure, as well as in dehydrated or chronically malnourished patients. Due to the risk of overdose, the patient should not take Paracetamol Hasco at the same time as other medicines containing paracetamol, and should not take doses larger than recommended.
Taking doses larger than recommended is associated with very serious liver damage.
The risk of overdose is higher in people with alcoholic liver damage, without cirrhosis. The patient should not take this medicine without consulting a doctor if they have problems with alcohol consumption.
Paracetamol may cause false results in some laboratory tests (e.g., glucose measurement in blood serum).

Children and adolescents

The medicine is not recommended for children under 8 years of age.

Paracetamol Hasco and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Paracetamol Hasco may affect the action of other medicines or other medicines may affect the action of Paracetamol Hasco, for example:
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• probenecid (a medicine used to treat gout),
• metoclopramide and domperidone (medicines used against nausea and vomiting) increase the absorption rate of paracetamol,
• cholestyramine (a medicine that lowers cholesterol levels in the blood) reduces the absorption of paracetamol,
• long-term use of paracetamol in high doses enhances the effect of anticoagulant medicines (from the coumarin derivative group),
• sedatives or antiepileptic drugs (including barbiturates, e.g., phenobarbital, phenytoin, carbamazepine, primidone) enhance the harmful effect of paracetamol on the liver,
• certain antibiotics, e.g., rifampicin, increase the harmful effect of paracetamol on the liver, chloramphenicol - paracetamol increases its toxicity,
• flucloxacillin (an antibiotic), due to a serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2),
• medicines that slow down gastric emptying may delay the absorption and onset of action of paracetamol,
• 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 painkillers, as it enhances their action,
• caffeine enhances the analgesic effect of paracetamol,
• concomitant administration of paracetamol and zidovudine (a medicine used in HIV infections) increases the tendency to decrease the number of white blood cells (neutropenia), which disrupts the immune system and increases the risk of infections. Therefore, Paracetamol Hasco can be taken with zidovudine only on the advice of a doctor. The patient should consult a doctor if they are taking any of the above medicines.

Paracetamol Hasco with alcohol

Alcohol should not be consumed during treatment with paracetamol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Paracetamol Hasco can be used during pregnancy if it is clinically justified. The patient should take the smallest recommended dose that reduces pain and (or) fever, for the shortest time and as infrequently as possible. The patient should consult a doctor if pain and (or) fever do not decrease or if they need to take the medicine more frequently.
Breastfeeding
After oral administration, paracetamol is excreted into breast milk in small amounts. No adverse effects have been reported in breastfed infants. During breastfeeding, therapeutic doses of this medicinal product can be used.

Driving and using machines

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

Paracetamol Hasco contains sorbitol

The medicine contains 1845 mg of sorbitol in each sachet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult a doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Paracetamol Hasco contains aspartame

The medicine contains 25 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Paracetamol Hasco

This medicine should always be taken exactly as described in this patient leaflet, or as advised by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult a doctor, pharmacist, or nurse.
The recommended dose is:
Adults and adolescents over 12 years old (over 40 kg):
1-2 sachets up to 3 times a day. Not more often than every 4 hours and not more than 3 g (6 sachets) of paracetamol per day.
Children aged 8-12 years (26-40 kg):
1 sachet up to 3 times a day. Not more often than every 4 hours and not more than 1.5 g (3 sachets) of paracetamol per day.
The patient should always take the smallest effective dose for the shortest time necessary to relieve symptoms.
The recommended dose should not be exceeded.
Duration of treatment
Without consulting a doctor, the medicine should not be taken for more than 3 days.
Method of administration
Paracetamol Hasco, oral powder in a sachet, is intended for direct oral use, without the need for drinking water. If necessary, the oral powder in a sachet can be taken with water, or dissolved in a glass of hot water, mixed to obtain a uniform suspension with a milky-yellow color, and taken immediately after cooling. The resulting suspension should not be stored.
Special patient groups
In adult patients with a body weight of less than 50 kg, dehydrated or chronically malnourished, and in the following situations, the effective daily dose should not exceed 60 mg/kg body weight per day, but not more than 3 g (6 sachets) of paracetamol per day.
Liver or kidney function disorders
In patients with liver or kidney function disorders, the dose should be reduced or the intervals between doses prolonged.
Kidney failure
In patients with severe kidney failure, the interval between doses should be at least 8 hours.
Chronic alcoholism
Chronic alcohol consumption may lower the toxicity threshold of paracetamol. In these patients, the time interval between two doses should be at least 8 hours. The dose should not exceed 2 g of paracetamol per day.
Elderly patients
No dose adjustment is required in elderly patients.
Children
The medicine is not recommended for children under 8 years of age. Other forms and strengths are available for children under 8 years of age.

Taking a higher dose of Paracetamol Hasco than recommended

Paracetamol overdose can cause liver or kidney failure. If a dose higher than recommended is taken, the patient should immediately consult a doctor, even if they feel well.
There is a risk of poisoning, especially in the elderly, small children, and in cases of liver disease, chronic alcohol abuse, and chronic malnutrition. Overdose can lead to death in these cases. Accidental or intentional overdose of paracetamol may cause symptoms such as nausea, vomiting, loss of appetite, pallor, and abdominal pain within the first 24 hours.

Missing a dose of Paracetamol Hasco

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

4. Possible side effects

Like all medicines, Paracetamol Hasco can cause side effects, although not everybody gets them.
Rare (in less than 1 in 1000 people):
anemia, non-hemolytic anemia, bone marrow suppression, thrombocytopenia (decreased platelet count), edema, acute and chronic pancreatitis, bleeding, abdominal pain, nausea, vomiting, diarrhea, liver failure, liver necrosis, jaundice, itching, rash, sweating, purpura, angioedema (swelling of the face, lips, throat, and difficulty breathing), and nephropathies and tubulopathies (kidney diseases).
Very rare (in less than 1 in 10,000 people):
severe skin reactions (pustular rash all over the body or ulcers in the mouth, eyes, genitals, and skin, red spots on the body, often in the center of blisters, bursting blisters, large flaking skin patches, weakness, fever, and joint pain).
Paracetamol is a widely used medicine, and reports of side effects are rare and usually related to overdose.
Frequency not known (cannot be estimated from the available data):
a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).
Nephrotoxic effects are rare and have not been reported to be related to therapeutic doses, except in cases of long-term use of the medicine.
The medicine, when taken for a longer period or overdosed, may cause liver and kidney damage, as well as methemoglobinemia with symptoms of cyanosis (gray-blue skin discoloration).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 the medicine.

5. How to store Paracetamol Hasco

Store in a temperature below 25°C. Store in the original packaging to protect from moisture and light.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
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. One sachet contains 500 mg of paracetamol.
• The other ingredients (excipients) are: sorbitol (E 420), orange flavor SD 1912 (contains maltodextrin, gum arabic (E 414), natural flavor preparations, flavoring substances, and natural flavoring substances, including citral, d-limonene, and linalool), aspartame (E 951), colloidal silica anhydrous, magnesium stearate, citric acid, sodium citrate anhydrous.

What Paracetamol Hasco looks like and what the packaging contains

Paracetamol Hasco is a white powder with an orange flavor and a sweet taste.
One packaging of the medicine contains 2, 4, 6, 8, 10, 12, or 24 sachets.

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 last update of the leaflet:01/2025
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