Paracetamol Hasco o smaku pomaranihovim

Leaflet attached to the packaging: patient information

Orange-flavored Paracetamol Hasco

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

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 or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Paracetamol Hasco orange-flavored and what is it used for
• 2. Important information before taking Paracetamol Hasco orange-flavored
• 3. How to take Paracetamol Hasco orange-flavored
• 4. Possible side effects
• 5. How to store Paracetamol Hasco orange-flavored
• 6. Package contents and other information

1. What is Paracetamol Hasco orange-flavored and what is it used for

Paracetamol Hasco orange-flavored oral suspension is an antipyretic and analgesic medicine intended for use in infants and children.
When taken in recommended doses, it is well tolerated.

Indications for use

Fever and pain of various origins (e.g., after surgical procedures, pain associated with teething, mild to moderate headaches) and symptoms accompanying the body's reaction to vaccination (pain, fever, local reaction).
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.
If there is no improvement after 3 days or if the patient feels worse, they should consult a doctor.
Without consulting a doctor, do not use for more than 3 days.
Use in children under 2 years of age should be prescribed by a doctor.

2. Important information before taking Paracetamol Hasco orange-flavored

When not to take Paracetamol Hasco orange-flavored

• if the patient is 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,

1/6

• in patients with severe kidney failure,
• in alcoholism.

Warnings and precautions

Before starting to take Paracetamol Hasco orange-flavored, discuss it with your doctor or pharmacist.
Do not take with other medicines containing paracetamol due to the risk of overdose.
Do not take higher doses than recommended.
In case of overdose, consult a doctor immediately, even if the patient feels well. Taking a multiple daily dose of paracetamol at once can lead to severe liver damage; in such cases, there is no loss of consciousness. However, medical advice should be sought immediately.
Without a doctor's recommendation, do not use for more than 3 days.
The medicine should be used with caution in patients with liver and kidney failure. Particular risk of liver damage occurs in malnourished individuals. Caution should be exercised when using in patients with reduced glutathione levels (such as sepsis).
Paracetamol may increase the risk of metabolic acidosis. Caution should be exercised when using paracetamol in patients with glucose-6-phosphate dehydrogenase deficiency and methemoglobin reductase deficiency.
During treatment with Paracetamol Hasco orange-flavored, the doctor should be informed immediately if the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is 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 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.
In patients with asthma, allergic to salicylates (e.g., acetylsalicylic acid), an allergy to paracetamol may occur.
Available study results indicate that paracetamol administration may be a risk factor for the development of asthma and allergic diseases in children.

Paracetamol Hasco orange-flavored and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
The medicine should not be taken with centrally acting analgesics or with alcohol, as it enhances their effect. In the case of concomitant use: barbiturates, antiepileptic drugs (including glutethimide, phenobarbital, phenytoin, carbamazepine), rifampicin, the harmful effect of paracetamol on the liver is increased. Paracetamol increases the toxicity of chloramphenicol.
Prolonged use of paracetamol in high doses enhances the effect of oral anticoagulant medicines from the coumarin group.
Concomitant use of paracetamol with non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of kidney function disorders.
Paracetamol used concomitantly with MAO inhibitors may cause excitement and high temperature.
The absorption of paracetamol is accelerated by drugs that accelerate gastric emptying (e.g., metoclopramide, domperidone) and delayed by drugs that delay gastric emptying (e.g., cholestyramine).
Using paracetamol in combination with zidovudine may cause neutropenia.
2/6
Salcylamide prolongs the elimination time of paracetamol.
Tell 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 must be treated urgently (see section 2).
Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).

Using Paracetamol Hasco orange-flavored with alcohol

This medicine is intended for children.

Pregnancy and breastfeeding

This medicine is intended for children.
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Pregnant or breastfeeding women may use this medicine if, in the doctor's opinion, it is necessary.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Paracetamol Hasco orange-flavored contains 3.1 g of sucrose in 5 ml of suspension

This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Paracetamol Hasco orange-flavored contains 6.82 mg of sodium benzoate in 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 age).

Paracetamol Hasco orange-flavored contains sodium metabisulfite

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Paracetamol Hasco orange-flavored contains 0.151 mmol (i.e., 3.47 mg) of sodium in

5 ml of oral suspension,which corresponds to less than 1 mmol (23 mg) of sodium in 5 ml of oral suspension, i.e., the medicine is considered "sodium-free".
Sodium comes from excipients (sodium saccharin, sodium metabisulfite, and sodium benzoate - see section 6).

3. How to take Paracetamol Hasco orange-flavored

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The medicine is taken orally.
Before use, shake the bottle vigorously to obtain a uniform suspension.

Recommended dose:

Unless the doctor recommends 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/day.
Without consulting a doctor, do not use for more than 3 days.
Use in children under 2 years of age should be prescribed by a doctor.

The following table shows an example dosage calculation:

Instructions for dosing using the oral syringe (with a plug in the bottle neck) included in the packaging:

• before the first use of the syringe, it must be washed in warm (not boiling) water with a detergent,
• after unscrewing the cap, put the syringe on the plug in the bottle neck,
• 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 (see picture),

• put the syringe tip in the child's mouth and, slowly pressing the plunger, carefully empty the syringe (the child should be held in a vertical or sitting position),
• after use, close the bottle and wash the syringe in warm (not boiling) water with a detergent and dry it.

There are no special recommendations for use with food.
If you feel that the effect of Paracetamol Hasco orange-flavored is too strong or too weak, consult a doctor .

Taking a higher dose of Paracetamol Hasco orange-flavored than recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately, even if the patient feels well.
Severe poisoning can occur in children after taking 200 mg of paracetamol/kg body weight.
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. These symptoms may resolve the next day, despite the gradual 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 been less than an hour since taking paracetamol, vomiting should be induced and activated charcoal administered.

Missing a dose of Paracetamol Hasco orange-flavored

Paracetamol Hasco orange-flavored is taken as needed when symptoms occur. It should be taken according to the recommendations given in section 3.
However, if a doctor recommends regular intake of the medicine, do not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely(in 1 to 10 patients out of 10,000):
skin allergic reactions: hives, rash, skin inflammation.
Very rarely(in less than 1 patient out of 10,000):
decreased platelet count (thrombocytopenia)
decreased white blood cell count (leukopenia, agranulocytosis)
nausea, vomiting, diarrhea
liver function disorders.
Frequency not known(cannot be estimated from the available data):
a serious disease that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
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).
There are reports of very rare cases of severe skin reactions (acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, they should be reported to a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181 C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.
5/6

5. How to store Paracetamol Hasco orange-flavored

Store in a closed, original package at a temperature below 25°C. Do not freeze.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the package. The expiration date refers to the last day of the specified month.
Shelf life after first opening: 12 months.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Paracetamol Hasco orange-flavored contains

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

What Paracetamol Hasco orange-flavored looks like and what the package contains

A milky to light yellow suspension with an orange smell and sweet, orange taste.
A 125 ml brown glass bottle, closed with a polyethylene cap and a guarantee ring. The bottle is placed in a cardboard box with a patient leaflet and an oral syringe (5 ml scaled every 0.25 ml or 0.5 ml).
The package contains 150 g of oral suspension.

Marketing authorization holder and manufacturer

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

Medicine information

phone: 22 742 00 22
e-mail: [email protected]

Date of last update of the leaflet:

6/6