Paracetamol hasco

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.
• If there is no improvement after 3 days or the patient feels worse, consult a doctor.

Leaflet contents:

1. What Paracetamol Hasco is and what it is used for
2. Important information before using Paracetamol Hasco
3. How to use Paracetamol Hasco
4. Possible side effects
5. How to store Paracetamol Hasco
6. Contents of the pack and other information

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

Paracetamol Hasco oral suspension is an antipyretic and analgesic medicine intended for use in infants and children. When used at recommended doses, it is well tolerated.
The medicine is indicated for 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).
Additionally, the medicine is used in infants aged 0 to 3 months for symptomatic treatment of fever lasting no longer than 3 days and for mild to moderate pain.

2. Important information before using Paracetamol Hasco

When not to use Paracetamol Hasco

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

Warnings and precautions
Before starting treatment with Paracetamol Hasco, consult your doctor or pharmacist.
Do not use together with other medicines containing paracetamol due to the risk of overdose. In case of overdose, consult a doctor immediately, even if the patient feels well.
Do not use for longer than 3 days without medical advice.
Do not exceed the recommended doses.
Use with caution in patients with impaired liver or kidney function.
Alcoholic beverages should not be consumed during treatment; do not use this medicine in patients with alcohol dependence.
The risk of liver damage is particularly high in fasting patients.
In patients with asthma who are allergic to acetylsalicylic acid, hypersensitivity 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.
During treatment with Paracetamol Hasco, inform your doctor immediately if the patient develops serious conditions, including severe kidney disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, severe metabolic acidosis (a disorder of blood and body fluid balance) has been reported in patients receiving paracetamol regularly over a prolonged period or taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Paracetamol Hasco and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take this medicine together with centrally acting analgesics or alcohol, as it may enhance their effects. When used concomitantly with barbiturates, antiepileptic drugs (e.g. glutethimide, phenobarbital, phenytoin, carbamazepine), or rifampicin, the hepatotoxic effect of paracetamol may be increased. Paracetamol increases the toxicity of chloramphenicol.
Long-term use of high-dose paracetamol may enhance the effect of oral anticoagulants of the coumarin group.
Concomitant use of paracetamol with nonsteroidal anti-inflammatory drugs increases the risk of kidney function impairment.
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 require urgent treatment (see section 2).

Pregnancy, breastfeeding and fertility
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.
Pregnant or breastfeeding women may use this medicine when, in the opinion of a doctor, it is necessary.

Driving and operating machinery
Paracetamol Hasco has no effect or negligible effect on the ability to drive or operate machinery.

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 a patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this 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, meaning the medicine is considered "sodium-free".

3. How to use Paracetamol Hasco

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 your doctor or pharmacist.
This medicine is for oral use.
Shake the bottle vigorously before use to obtain a uniform suspension.
Unless otherwise directed by a doctor, the usual single dose of paracetamol is 10 mg to 15 mg 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 60 mg/kg body weight/day.
The table below provides an example of the dosing regimen:

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 package contains a measuring spoon or oral syringe or cap and oral syringe.
Dosage instructions using the oral syringe:

• firmly press the cap into the neck of the bottle using the syringe,
• to fill the syringe, shake the bottle vigorously, turn it upside down, then carefully pull the plunger down, drawing the suspension into the syringe to the desired volume indicated on the scale,
• return the bottle to its upright position and carefully remove the syringe from the cap,
• place the tip of the syringe into the child's mouth, then slowly press the plunger to carefully empty the syringe contents,
• after use, close the bottle, leaving the cap in the neck of the bottle, and wash and dry the syringe.

No special recommendations regarding administration with food.
If you feel that the effect of Paracetamol Hasco is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Paracetamol Hasco
In case of accidental administration or ingestion of a higher than recommended dose, contact a doctor immediately.
Severe poisoning may occur in children after ingestion of 200 mg of paracetamol/kg body weight.
Accidental or intentional paracetamol overdose may cause symptoms within several to several dozen hours, such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite slowly developing 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 less than one hour has passed since paracetamol ingestion, 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 regarding 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 (in less than 1 in 1,000 people): skin allergic reactions: urticaria, erythema, dermatitis.
Very rare (in less than 1 in 10,000 people): decreased number of blood platelets (thrombocytopenia), white blood cells (leukopenia, agranulocytosis); nausea, vomiting, diarrhoea.
Frequency not known (cannot be estimated from available data): serious condition which 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).

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 181C, 02-222 Warsaw
Phone: +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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Paracetamol Hasco

Store in a tightly closed, original container at a temperature below 25°C. Do not freeze.
Keep the 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 specified month.
Medicines must 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. Package contents and other information

What Paracetamol Hasco contains

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

What Paracetamol Hasco looks like and contents of the pack
The medicine is an oral suspension of milky to light yellow colour.
The medicine pack consists of a 60 ml amber glass bottle containing 50 g of the medicine, closed with an HDPE cap with an LDPE plug and a tamper-evident seal. The bottle is placed in a cardboard box together with the patient leaflet and a measuring device (measuring cup) or a measuring spoon or a cap and an 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 medicine pack consists of a 100 ml amber glass bottle containing 115 g of the medicine, closed with an aluminium cap. The bottle is placed in a cardboard box together with the patient leaflet and a measuring device or a measuring spoon.
or
The medicine pack consists of a 125 ml amber glass bottle containing 150 g of the medicine, closed with an aluminium cap or an HDPE cap with an LDPE plug and a tamper-evident seal. The bottle is placed in a cardboard box together with the patient leaflet and a measuring spoon or a cap and an 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 Authorisation 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: [email protected]

Package leaflet: information for the patient

Paracetamol Hasco
120 mg/5 ml, oral suspension
Paracetamolum
for infants and children
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, contact your doctor.

Leaflet contents:

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

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

2. Important information before taking Paracetamol Hasco

When not to use Paracetamol Hasco

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

Warnings and precautions
Before starting treatment with Paracetamol Hasco, consult your doctor or pharmacist.
Do not use together with other medicines containing paracetamol due to the risk of overdose. In case of overdose, consult a doctor immediately, even if the patient feels well.
Do not use for longer than 3 days without medical advice.
Do not exceed the recommended doses.
The medicine should be used with caution in patients with liver or kidney impairment.
Do not consume alcoholic beverages while taking this medicine. Do not use the medicine in patients with alcohol dependence.
The risk of liver damage is particularly high in fasting patients.
In patients with asthma who are allergic to acetylsalicylic acid, hypersensitivity to paracetamol may occur.
Available research data suggest that administering paracetamol may be a risk factor for developing asthma and allergic diseases in children.
During treatment with Paracetamol Hasco, immediately inform your doctor if the patient has severe medical conditions, 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 the patient is also taking flucloxacillin (an antibiotic). In these situations, severe metabolic acidosis (a blood and body fluid imbalance) has been reported in patients taking paracetamol regularly over a long period or taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Paracetamol Hasco 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.
Do not take this medicine with centrally acting analgesics or alcohol, as it may enhance their effects. When used concomitantly with barbiturates, antiepileptic drugs (e.g. glutethimide, phenobarbital, phenytoin, carbamazepine), or rifampicin, the hepatotoxic effect of paracetamol is 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 increases the risk of kidney function disorders.
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 require urgent treatment (see section 2).
Pregnancy, breastfeeding and fertility
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 if, in the opinion of the doctor, it is necessary.
Driving and operating machinery
Paracetamol Hasco has no effect or negligible effect on the ability to drive and operate machinery.
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 the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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 in 5 ml of oral suspension, meaning the medicine is considered "sodium-free".

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 or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally.
Shake the bottle vigorously before use to obtain a uniform suspension.
Unless otherwise advised by a doctor, the usual single dose of paracetamol is 10 mg to 15 mg per kilogram of body weight.
If necessary, the dose may be repeated no more frequently than every 4–6 hours, up to 4 times daily, i.e. a maximum of 60 mg/kg body weight/day.
The table below provides an example dosing schedule:

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.
A measuring cup, measuring spoon, cap, or oral syringe is included in the package.
Dosing instructions using the oral syringe:

• after unscrewing the cap, attach the oral syringe onto the cap located in the neck of the bottle,
• to fill the syringe, shake the bottle vigorously, turn it upside down, then carefully pull the plunger down, drawing the suspension into the syringe to the desired volume indicated on the scale,
• return the bottle to its original upright position and carefully remove the syringe from the cap,
• place the tip of the syringe into the child's mouth, then slowly depress the plunger to carefully empty the syringe's contents,
• after use, close the bottle, wash the syringe, and dry it.

No special recommendations regarding administration with food.
If you feel that the effect of Paracetamol Hasco is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Paracetamol Hasco
If a higher than recommended dose of Paracetamol Hasco is accidentally administered or ingested, contact a doctor immediately.
Severe poisoning may occur in children after ingestion of 200 mg of paracetamol/kg body weight.
Accidental or intentional overdose of paracetamol may cause symptoms within several to several dozen hours, such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite slowly developing severe liver damage, manifesting as 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 less than one hour has passed since paracetamol ingestion, induce vomiting and administer activated charcoal.
Missed dose of Paracetamol Hasco
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Rarely (in less than 1 in 1,000 people): allergic skin reactions: urticaria, erythema, 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 unknown (cannot be estimated from available data): serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).
Prolonged use or overdose of paracetamol may cause liver and kidney damage, as well as methemoglobinemia with symptoms of cyanosis (bluish discoloration of the skin).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side 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 181C, 02-222 Warsaw
Phone: 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 helps provide more information on the safety of this medicine.

5. How to store Paracetamol Hasco

Store in the original closed container at a temperature below 25°C. Do not freeze.
Keep the 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 specified month.
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 pack and other information

What Paracetamol Hasco contains

• The active substance is paracetamol. 5 ml of oral suspension contains 120 mg of paracetamol.
• 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 an oral suspension, milky to light yellow in color.
The pack consists of a 60 ml amber glass bottle containing 50 g of medicine, closed with an HDPE cap with an LDPE plug and tamper-evident seal. The bottle is placed in a cardboard box together with the patient leaflet and a measuring cup or measuring spoon or cap 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 pack consists of a 100 ml amber glass bottle containing 115 g of medicine, closed with an aluminum cap. The bottle is placed in a cardboard box together with the patient leaflet and a measuring cup or measuring spoon.
or
The pack consists of a 125 ml amber glass bottle containing 150 g of medicine, closed with an aluminum cap or an HDPE cap with an LDPE plug and tamper-evident seal. The bottle is placed in a cardboard box together with the patient leaflet and a measuring spoon or cap 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

Product Information
Phone: (22) 742 00 22
e-mail: [email protected]