Paracetamol Hasco

Package Leaflet: Information for the Patient

PARACETAMOL HASCO, 80 mg, suppositories

PARACETAMOL HASCO, 125 mg, suppositories

PARACETAMOL HASCO, 250 mg, suppositories

PARACETAMOL HASCO, 500 mg, suppositories

Paracetamol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• 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, tell a doctor, pharmacist, or nurse. See section 4.
• If after 5 days in adults or 3 days in children (see "Warnings and precautions") there is no improvement or the patient feels worse, consult a doctor.

Table of Contents of the Leaflet

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

Paracetamol Hasco is a medicine with analgesic and antipyretic effects. The duration of analgesic effect is 4-6 hours. The antipyretic effect lasts 6-8 hours. Indications for use are pains of various origins and febrile conditions.

2. Important information before using Paracetamol Hasco

When not to use Paracetamol Hasco:

• if the patient is hypersensitive to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in case of severe liver failure or viral hepatitis,
• in case of alcoholism,
• in case of severe kidney failure,
• in case of rectal bleeding.

Warnings and precautions

Before starting to use Paracetamol Hasco, discuss it with a doctor, pharmacist, or nurse.
Do not use without a doctor's recommendation:

• as an analgesic for more than 5 days in adults and 3 days in children,
• for sore throat for more than 2 days,
• for recurring or high fever for more than 3 days. Do not exceed the recommended dose.

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It is not recommended to use suppositories in patients with diarrhea.
Use with caution in patients with liver or kidney failure.
There is a special risk of liver damage in fasting individuals. In patients with asthma, hypersensitive to salicylic acid, there may be an allergy to paracetamol.
During the use of Paracetamol Hasco, immediately inform a doctor if the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when 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 used 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 with other medicines

Tell a 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.
Concomitant use of paracetamol and medicines that increase liver metabolism, such as certain sedatives or antiepileptics (e.g., phenobarbital, phenytoin, carbamazepine) or rifampicin, as well as concomitant alcohol consumption, may lead to liver damage.
Regular daily intake of paracetamol may enhance the anticoagulant effect of warfarin or other coumarin derivatives, causing a risk of bleeding.
Paracetamol increases the concentration of acetylsalicylic acid and chloramphenicol in serum.
Concomitant administration of paracetamol and nonsteroidal anti-inflammatory drugs increases the risk of kidney function disorders.
Tell a 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 Hasco with alcohol

Do not consume alcoholic beverages during the use of paracetamol. Do not use the medicine in individuals addicted to alcohol.

Pregnancy and breastfeeding

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 using this medicine.
Paracetamol passes through the placenta and into breast milk. During pregnancy and breastfeeding, use only if necessary, when in the doctor's opinion the benefit to the mother outweighs the potential risk to the fetus.

Driving and using machines

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

3. How to use Paracetamol Hasco

This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse.
In case of doubt, consult a doctor, pharmacist, or nurse.
Paracetamol Hasco suppositories are used rectally.
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In adults, a single dose of 500 mg of paracetamol is used. The maximum daily dose of paracetamol for adults in the case of short-term treatment is 4.0 g, and for long-term treatment, it is 2.6 g. Without a doctor's recommendation, do not use for more than 5 days.
In children, the dose is determined based on the child's weight (on average, a single dose of 10 to 15 mg/kg body weight) or according to the following age-related table.
If necessary, the dose can be repeated every 4 hours, but no more than 4 times a day.
In children, do not use the medicine for more than 3 days without consulting a doctor.
The use of the medicine in children under 2 years of age should be recommended by a doctor.

Using a higher dose of Paracetamol Hasco than recommended

In case of taking a higher dose of the medicine than recommended, immediately consult a doctor or pharmacist.
Severe poisoning may occur in adults after taking 10-15 g of paracetamol. Severe liver damage occurs, developing slowly and usually manifesting from the second day after taking the medicine in toxic doses. Treatment of poisoning up to 24 hours after overdose involves intravenous administration of N-acetylcysteine in a 200 ml 5% glucose solution.

Missing a dose of Paracetamol Hasco

Do not use a double dose to make up for a missed dose.
In case of any further doubts related to 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.
At therapeutic doses, paracetamol is relatively non-toxic.
Rarely(occurring in 1 to 10 patients out of 10,000): angioedema, pseudoanaphylactic reactions (including: blood pressure drop, bronchospasm, urticaria), laryngeal edema.
Very rarely(occurring in less than 1 patient out of 10,000): agranulocytosis, thrombocytopenia, anemia, renal colic, kidney failure, kidney function disorders, pyelonephritis, hypersensitivity, hepatitis.
Frequency not known(cannot be estimated from the available data): a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell a doctor, pharmacist, or nurse. 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:
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Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Paracetamol Hasco

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C.
Store in the outer packaging to protect from light.
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 containers. Ask a pharmacist how to dispose of medicines that are no longer needed. 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. One suppository contains 80 mg, 125 mg, 250 mg, or 500 mg of paracetamol.
• The other ingredient (excipient) is: solid fat (Witepsol S58).

What Paracetamol Hasco looks like and what the pack contains

Paracetamol Hasco is a white, torpedo-shaped suppository.
One pack contains 10 suppositories.

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:

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