Paracetamol Hasco

Patient Information Leaflet: Information for the Patient

Paracetamol Hasco

120 mg/5 ml, oral suspension
Paracetamolum
for infants and children

Read this leaflet carefully before taking this medicine, as it contains important information for you.

Important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your 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 pack and other information

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

Paracetamol Hasco, oral suspension is an antipyretic and analgesic medicine intended for use in infants and children. When used in recommended doses, it is well tolerated.
Indications for use are fever and pain of various origins (e.g., after surgical procedures, pain associated with teething, headache of mild or moderate severity) and discomfort accompanying the body's reaction to vaccination (pain, fever, local reaction).
In addition, the medicine is used in infants from 0 to 3 months of age for the symptomatic treatment of fever lasting no longer than 3 days and pain of mild to moderate severity.

2. Important information before taking Paracetamol Hasco

When not to take Paracetamol Hasco

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in patients with severe liver failure or viral hepatitis,
• in patients with severe kidney failure,
• in alcoholic disease.

Warnings and precautions

Before starting to take Paracetamol Hasco, you should discuss it with your doctor or pharmacist.
Do not take with other medicines containing paracetamol due to the risk of overdose. In case of overdose, consult your doctor immediately, even if you feel well.
Do not take for more than 3 days without consulting your doctor.
Do not take doses larger than recommended.
The medicine should be used with caution in patients with liver and kidney failure.
During treatment with this medicine, do not drink alcoholic beverages, and do not take the medicine if you are addicted to alcohol.
There is a particularly high risk of liver damage in people who are fasting.
In patients with asthma, allergic to acetylsalicylic acid, there may be an allergy to paracetamol.
Available study results indicate that the administration of paracetamol may be a risk factor for the development of asthma and allergic diseases in children.
During treatment with Paracetamol Hasco, you should immediately inform your doctor if you have severe illnesses, 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 you are taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a disorder of blood and body fluids), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Paracetamol Hasco and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
The medicine should not be taken with centrally acting analgesics or with alcohol, as it enhances their effect. When taken together: barbiturates, antiepileptic drugs (including glutethimide, phenobarbital, phenytoin, carbamazepine), rifampicin, it increases the harmful effect of paracetamol on the liver. Paracetamol increases the toxicity of chloramphenicol.
Prolonged use of paracetamol in high doses enhances the effect of oral anticoagulant drugs from the coumarin group.
Concomitant use of paracetamol with nonsteroidal anti-inflammatory drugs increases the risk of kidney function disorders.
You should inform your doctor or pharmacist if you 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).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Women who are pregnant or breastfeeding can take this medicine if, in the doctor's opinion, it is necessary.

Driving and using machines

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

Paracetamol Hasco contains sucrose

The medicine contains 3112.4 mg of sucrose in each 5 ml of oral suspension. This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Paracetamol Hasco contains sodium benzoate (E 211)

The medicine contains 6.82 mg of sodium benzoate in each 5 ml of oral suspension. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).

Paracetamol Hasco contains sodium metabisulfite (E 223)

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
Paracetamol Hasco contains less than 1 mmol (23 mg) of sodium per 5 ml of oral suspension, which means the medicine is considered "sodium-free".

3. How to take Paracetamol Hasco

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The medicine is taken orally.
Before use, shake the bottle vigorously to obtain a uniform suspension.
If your doctor does not recommend otherwise, the average single dose of paracetamol is 10 mg to 15 mg per kilogram of body weight.
If necessary, the dose can be repeated, but not more often than every 4-6 hours, up to 4 times a day, i.e., a maximum of 60 mg/kg body weight per day.

The following table shows an example dosage calculation:

Do not take for more than 3 days without consulting your doctor.
Use in children under 2 years of age should be prescribed by a doctor.
A measuring cup or measuring spoon or a plug and oral syringe are attached to the packaging.
Instructions for dosing with an oral syringe:

• after unscrewing the cap, put the syringe on the plug in the neck of the bottle,
• to fill the syringe, shake the bottle vigorously, turn it upside down, and then carefully move the syringe plunger down, drawing in the suspension in the desired amount indicated on the scale,
• turn the bottle back to its original position and carefully remove the syringe from the plug,
• put the tip of the syringe in the child's mouth, and then slowly pressing the plunger, carefully empty the syringe,
• after use, close the bottle and wash and dry the syringe.

There are no special instructions for taking with food.
If you feel that the effect of Paracetamol Hasco is too strong or too weak, you should consult your doctor.

Taking a higher dose of Paracetamol Hasco than recommended

In case of accidental administration or ingestion of a higher dose of the medicine than recommended, you should immediately contact your doctor.
Severe poisoning may occur in children after ingestion of 200 mg of paracetamol/kg body weight.
Accidental or intentional overdose of paracetamol may cause, within a few or several hours, symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite the slow development of severe liver damage, manifested by a feeling of fullness in the upper abdomen, nausea, and jaundice.
Treatment of paracetamol poisoning must be carried out in a hospital, under intensive medical care. If it has not been more than an hour since the ingestion of paracetamol, you should induce vomiting and administer activated charcoal.

Missing a dose of Paracetamol Hasco

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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), white blood cell count (leukopenia, agranulocytosis); nausea, vomiting, diarrhea.
Frequency not known (cannot be estimated from the available data): a serious disease that can cause blood acidification (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).
The medicine taken for a longer period or overdosed may cause liver and kidney damage and methemoglobinemia with symptoms of cyanosis (gray-blue skin discoloration).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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.: 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Hasco

Store in the original package, in a closed container, at a temperature below 25°C. Do not freeze.
The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Hasco contains

• The active substance of the medicine is paracetamol. 5 ml of oral suspension contains 120 mg of paracetamol.
• The other ingredients are: sucrose, xanthan gum (E 415), citric acid monohydrate (E 330), sodium saccharin (E 954), sodium benzoate (E 211), sodium metabisulfite (E 223), strawberry flavor, purified water.

What Paracetamol Hasco looks like and contents of the pack

The medicine is a milky to light yellow oral suspension.
The packaging of the medicine consists of a 60 ml bottle containing 50 g of the medicine, made of colored glass with an HDPE cap and a LDPE plug and a guarantee seal. The bottle is placed in a cardboard box with a patient information leaflet and a measuring cup or measuring spoon or a plug and oral syringe with a capacity of 5 ml, graduated every 0.5 ml or an oral syringe with a capacity of 5 ml, graduated every 0.25 ml made of PE and polystyrene.
or
The packaging of the medicine consists of a 100 ml colored glass bottle containing 115 g of the medicine, closed with an aluminum cap. The bottle is placed in a cardboard box with a patient information leaflet and a measuring cup or measuring spoon.
or
The packaging of the medicine consists of a 125 ml bottle containing 150 g of the medicine, made of colored glass with an aluminum cap or an HDPE cap with a LDPE plug and a guarantee seal. The bottle is placed in a cardboard box with a patient information leaflet and a measuring spoon or a plug and oral syringe with a capacity of 5 ml, graduated every 0.5 ml or an oral syringe with a capacity of 5 ml, graduated every 0.25 ml made of PE and polystyrene.

Marketing authorization holder and manufacturer

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

Medicine information

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

Date of last revision of the leaflet: