Paracetamol hasco orange flavor

Package leaflet: Information for the user

Paracetamol Hasco orange flavour
120 mg/5 ml, oral suspension
Paracetamolum
for infants and children
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Contents of the leaflet

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

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

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

Indications
Fever and pain of various origins (e.g. following surgical procedures, teething pain, mild to moderate headache), as well as symptoms associated with the body's reaction to vaccination (pain, fever, local reaction).

This medicine is indicated for symptomatic treatment of fever lasting no more than 3 days and mild to moderate pain in infants from 0 to 3 months of age.
If there is no improvement after 3 days or if the patient feels worse, medical advice should be sought.
Do not use for longer than 3 days without consulting a doctor.
Use in children under 2 years of age should be under medical supervision.

2. Important information before using Paracetamol Hasco o smaku pomarańczowym

When not to use Paracetamol Hasco o smaku pomarańczowym

• 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 impairment or viral hepatitis,

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• in patients with severe renal impairment,
• in alcoholic liver disease.

Warnings and precautions
Before starting to use Paracetamol Hasco o smaku pomarańczowym, discuss this with your doctor or pharmacist.
Do not use with other medicines containing paracetamol due to the risk of overdose.
Do not take higher doses than recommended.
In case of overdose, seek immediate medical advice, even if the patient feels well. A single intake of multiple daily doses of paracetamol may lead to severe liver damage; in such cases, loss of consciousness does not occur. However, immediate medical advice must be sought.
Without a doctor's recommendation, do not use for longer than 3 days.
Paracetamol should be used with caution in patients with hepatic or renal impairment. Particular risk of liver damage exists in malnourished individuals. Caution should be exercised when using paracetamol in patients with reduced glutathione levels (e.g. in sepsis).
Paracetamol use may increase the risk of metabolic acidosis. Caution is advised when administering paracetamol to patients with glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency.
During treatment with Paracetamol Hasco o smaku pomarańczowym, immediately inform the doctor if the patient has serious conditions, 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, severe illness called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients who used paracetamol regularly over a prolonged period or who took paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
In patients with asthma who are allergic to salicylates (e.g. acetylsalicylic acid), allergy to paracetamol may occur.
Available research data suggest that administration of paracetamol may be a risk factor for the development of asthma and allergic diseases in children.

Paracetamol Hasco o smaku pomarańczowym and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This medicine should not be taken together with centrally acting analgesics or alcohol, as it enhances their effects. When used concomitantly with barbiturates, antiepileptic drugs (e.g. glutethimide, phenobarbital, phenytoin, carbamazepine), or rifampicin, the harmful effects of paracetamol on the liver are enhanced. Paracetamol increases the toxicity of chloramphenicol.
Long-term use of high-dose paracetamol intensifies the effect of oral anticoagulants of the coumarin group.
Concomitant use of paracetamol with non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of kidney function disorders.
Paracetamol used simultaneously with monoamine oxidase inhibitors (MAO inhibitors) may cause agitation and high fever.
The absorption of paracetamol is accelerated by drugs that speed up gastric emptying (e.g. metoclopramide, domperidone) and delayed by drugs that slow gastric emptying (e.g. cholestyramine).
Concurrent use of paracetamol with zidovudine may cause neutropenia.
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Salicylamide prolongs the elimination time of paracetamol.
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 must be urgently treated (see section 2).
Paracetamol use may lead to false results in certain laboratory tests (e.g. blood glucose measurement).

Use of Paracetamol Hasco o smaku pomarańczowym with alcohol
This medicine is intended for children.

Pregnancy and breastfeeding
This medicine is intended for children.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Women who are pregnant or breastfeeding may use this medicine when, in the opinion of the doctor, it is necessary.

Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.

Paracetamol Hasco o smaku pomarańczowym 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 certain sugars, the patient should contact the doctor before taking the medicine.

Paracetamol Hasco o smaku pomarańczowym 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 life).

Paracetamol Hasco o smaku pomarańczowym contains sodium metabisulfite
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Paracetamol Hasco o smaku pomarańczowym 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; therefore, the medicine is considered "sodium-free".
Sodium originates from excipients (sodium saccharinate, sodium metabisulfite, and sodium benzoate – see section 6).

3. How to use Paracetamol Hasco o smaku pomarańczowym

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
Shake well before use to obtain a uniform suspension.
Recommended dose:
Unless otherwise advised by a doctor, the usual single dose of paracetamol is 0.4 to 0.6 mL per kilogram of body weight.
If necessary, the dose may be repeated no more frequently than every 4 to 6 hours, up to 4 times daily, i.e. a maximum of 2.4 mL per kilogram of body weight per day.
Do not use for longer than 3 days without consulting a doctor.
Use in children under 2 years of age should be prescribed by a doctor.
The table below provides an example of a dosage calculation scheme:

Instructions for dosing using the oral syringe (with the stopper placed in the bottle neck)
supplied with the package:

• before first use, the syringe must be washed thoroughly in warm (not boiling) water with a detergent,
• after unscrewing the cap, place the syringe onto the stopper inserted into the bottle neck,
• to fill the syringe, shake the bottle vigorously, turn it upside down, then carefully push the syringe plunger downward to draw the suspension in the desired amount indicated on the scale,
• return the bottle to its upright position and carefully remove the syringe from the stopper (see figure),

• place the tip of the syringe into the child's mouth, then slowly press the plunger to carefully empty the syringe contents (the child should be held in an upright or sitting position),
• after use, close the bottle and wash the syringe in warm (not boiling) water with a detergent, then dry it thoroughly.

No special recommendations regarding administration with food.
If the effect of Paracetamol Hasco o smaku pomarańczowym seems too strong
or too weak, consult a doctor.
Use of a higher than recommended dose of Paracetamol Hasco o smaku pomarańczowym
If an overdose is taken, seek immediate advice from a doctor or pharmacist,
even if the patient feels well.
Severe poisoning may occur in children after ingesting 200 mg of paracetamol/kg body weight.
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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. These symptoms may subside 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 hospital under intensive medical care. If less than one hour has passed since paracetamol ingestion, induce vomiting and administer activated charcoal.
Missed dose of Paracetamol Hasco o smaku pomarańczowym
Paracetamol Hasco o smaku pomarańczowym is used on demand when symptoms occur. It should be taken according to the recommendations given in section 3.
However, if the doctor recommends regular administration of the medicine, do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare (occurring in 1 to 10 patients per 10,000):
skin allergic reactions: urticaria, erythema, dermatitis.
Very rare (occurring in less than 1 patient per 10,000):
reduced platelet count (thrombocytopenia)
reduced white blood cell count (leukopenia, agranulocytosis)
nausea, vomiting, diarrhoea
liver function disorders.
Frequency unknown (cannot be estimated from available data):
a serious condition that may cause acidification of the blood (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).
There have been reports of very rare cases of severe skin reactions (acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of the medicine can be collected.
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5. How to store Paracetamol Hasco orange-flavoured

Keep in the tightly closed, original packaging at a temperature below 25°C. Do not freeze.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Period of use after first opening: 12 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Hasco o smaku pomarańczowym contains

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

What Paracetamol Hasco o smaku pomarańczowym looks like and contents of the pack
Milk-coloured to pale yellow oral suspension, with an orange odour and sweet, orange taste.
A 125 ml amber glass bottle closed with a polyethylene cap with a plug and a tamper-evident ring. The bottle is placed in a cardboard box together with the patient leaflet and an oral syringe (5 ml, graduated every 0.25 ml or 0.5 ml).
The pack contains 150 g of oral suspension.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]
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