Apap Direct

Package Leaflet: Information for the User

Apap Direct, 500 mg, Granules in Sachets

Paracetamol

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Package Leaflet:

• 1. What is Apap Direct and what is it used for
• 2. Important information before taking Apap Direct
• 3. How to take Apap Direct
• 4. Possible side effects
• 5. How to store Apap Direct
• 6. Contents of the package and other information

1. WHAT IS Apap Direct AND WHAT IS IT USED FOR

Paracetamol belongs to the pharmacotherapeutic group of analgesics (pain relievers) that also act as antipyretics (fever reducers) and weak anti-inflammatory drugs. Apap Direct is used to reduce fever and relieve mild or moderate pain.

2. IMPORTANT INFORMATION BEFORE TAKING Apap Direct

When not to take Apap Direct

- if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Apap Direct, - if you have severe liver failure.

Warnings and precautions

You should consult a doctor before starting to take Apap Direct if you have: - kidney or liver function disorders, - alcoholic liver disease without signs of cirrhosis, chronic alcoholism, - glucose-6-phosphate dehydrogenase deficiency, - hemolytic anemia, - Gilbert's syndrome (hereditary non-hemolytic jaundice).

• chronic alcoholism,
• glucose-6-phosphate dehydrogenase deficiency,
• hemolytic anemia,
• Gilbert's syndrome (hereditary non-hemolytic jaundice).

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During treatment with Apap Direct, you should immediately inform your doctor if: you have severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins are in the blood, leading to organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to have a severe disease called metabolic acidosis (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.
Long-term or frequent use is not recommended. You should inform the patient not to take other painkillers containing paracetamol at the same time. Taking multiple daily doses in one dose can cause severe liver damage.
In such a case, there is no loss of consciousness, but immediate medical attention is necessary. Prolonged use of the medicine without medical supervision can be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, it is not justified to administer another antipyretic drug at the same time, unless the use of paracetamol alone is ineffective.
Care should be taken when administering paracetamol to patients with kidney or liver failure (mild to moderate). In such cases, you should consult a doctor.
The risk of overdose is higher in people with post-alcoholic liver damage without signs of cirrhosis. Care should be taken in cases of chronic alcoholism.
In such cases, the daily dose should not exceed 2 g.
In case of high fever or symptoms of secondary infection or if symptoms persist for more than 3 days, the treatment should be re-evaluated.
Care should be taken when administering paracetamol to dehydrated or chronically malnourished individuals. The total dose of paracetamol should not exceed 3 g per day in adults and children with a body weight of at least 50 kg.
If symptoms worsen or do not improve after 3 days, or if high fever occurs, you should consult a doctor.
If the patient is addicted to alcohol or has liver damage, paracetamol should not be taken unless prescribed by a doctor. During treatment with paracetamol, you should not consume alcohol. Paracetamol does not enhance the effects of alcohol.
If the patient is taking other painkillers containing paracetamol at the same time, they should not take Apap Direct without consulting a doctor or pharmacist.
Never take Apap Direct in a dose larger than recommended. Larger doses do not have a stronger analgesic effect, but may cause severe liver damage.
The first symptoms of liver damage appear after several days. Therefore, it is very important to contact a doctor immediately in case of taking Apap Direct in a dose larger than recommended in this package leaflet.
As a result of long-term or improper use of painkillers, or taking them in large doses, headaches may occur, which should not be treated with higher doses of this medicine.
Generally, habitual use of painkillers, especially combinations of several painkillers, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy).
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Sudden discontinuation of the medicine after long-term, high-dose, improper use of painkillers may cause headaches, weakness, muscle pain, restlessness, and vegetative symptoms. These withdrawal symptoms disappear after a few days. Until then, you should avoid taking painkillers again and not take them without consulting a doctor.
Do not take Apap Direct for long periods or in large doses without consulting a doctor or dentist.

Children

The product is not recommended for children under 8 years of age.

Apap Direct and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.
Medicines that may interfere with the action of Apap Direct:

• probenecid (a medicine used to treat gout);
• medicines that can potentially damage the liver, such as phenobarbital (sleeping pills), phenytoin; carbamazepine, primidone (antiepileptic drugs) and rifampicin (used to treat tuberculosis). Taking these medicines and paracetamol at the same time may cause liver damage;
• metoclopramide and domperidone (used to treat nausea) may accelerate the absorption and onset of action of paracetamol;
• medicines that slow down gastric emptying may delay the absorption and onset of action of paracetamol;
• cholestyramine (used to reduce increased lipid levels in serum) may reduce the absorption and onset of action of paracetamol. Therefore, you should not take cholestyramine within the first hour after taking paracetamol;
• medicines that reduce blood clotting (oral anticoagulants, especially warfarin). Repeated intake of paracetamol for more than a week increases the tendency to bleed. Therefore, long-term use of paracetamol should only be done under medical supervision. Occasional intake of paracetamol does not have a significant effect on the tendency to bleed.

Concomitant administration of paracetamol and AZT (zidovudine, a medicine used to treat HIV infections) increases the tendency to decrease the number of white blood cells (neutropenia), which disrupts the immune system and increases the risk of infections. Therefore, Apap Direct can be taken with zidovudine only on the advice of a doctor.
Tell 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).

Effect of paracetamol on laboratory tests

Paracetamol may affect the determination of uric acid and blood sugar levels.

Apap Direct with food, drink, and alcohol

You should not consume alcohol during treatment with paracetamol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
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Apap Direct can be given to pregnant women if necessary. You should use the lowest effective dose that relieves pain or reduces fever and take the medicine for as short a time as possible.
If the pain is not relieved or the fever does not subside or if it is necessary to increase the frequency of taking the medicine, you should consult a doctor. Paracetamol should not be taken with other medicinal products.
After oral administration, paracetamol passes into breast milk in small amounts.
During breastfeeding, it is allowed to use Apap Direct in therapeutic doses.

Driving and using machines

Taking Apap Direct does not affect the ability to drive and use machines.
Apap Direct contains sorbitol, sucrose, glucose(a component of maltodextrin)and sodium.
The medicine contains 801 mg/sachet of sorbitol. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or previously diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, you should contact your doctor before taking the medicine or giving it to your child.
If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".

3. HOW TO TAKE Apap Direct

Apap Direct should always be taken exactly as directed in this package leaflet.
In case of doubt, consult a doctor or pharmacist.
The dose is determined based on the information provided in the table below. The dose of the medicine depends on age and body weight, usually a single dose is 10-15 mg of paracetamol per kilogram of body weight, up to a total daily dose of 60-75 mg/kg of body weight.
The appropriate interval between doses depends on the symptoms and the maximum total daily dose.
You should keep at least a 6-hour interval between two doses, which means taking the medicine a maximum of 4 times a day.
If symptoms persist for more than 3 days, you should consult a doctor.
Body weight (age)
Single dose
Maximum daily dose
26 kg - 40 kg
500 mg of paracetamol
(1 sachet)
1500 mg of paracetamol
(3 sachets)
(8-12 years)
> 40 kg
500-1000 mg of paracetamol
(1-2 sachets)
3000 mg of paracetamol
(6 sachets of 500 mg)
(children over 12 years and adults)
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Method and route of administration

Apap Direct is administered orally only.
You should not take Apap Direct after a meal.
The granules should be taken directly into the mouth on the tongue and then swallowed without drinking water.

Special patient groups

Impaired liver or kidney function
In patients with impaired liver or kidney function, the dose should be reduced or the interval between doses prolonged. You should consult a doctor.
Chronic alcoholism
Chronic alcohol consumption may lower the toxicity threshold of paracetamol. In such patients, the minimum interval between two doses should be at least 8 hours.
You should not take more than 2 g of paracetamol per day.
Elderly patients
No dose adjustment is required.
Children and adolescents with low body weight
Paracetamol 500 mg is not intended for use in children under 8 years of age and with a body weight below 26 kg, as the dose strength is not suitable for this age group.
For such patients, other pharmaceutical forms and dose strengths are available.

Overdose of Apap Direct

In case of overdose of Apap Direct, you should contact a doctor or emergency department. Overdose has very serious consequences and can even lead to death.
Immediate treatment is necessary, even if the patient feels well, due to the risk of delayed severe liver damage. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage.

Missed dose of Apap Direct

You should not take a double dose to make up for a missed dose.
In case of any further doubts regarding the use of the medicine, you should consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Apap Direct can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should stop treatment and contact a doctor immediately: rare (may affect up to 1 in 1,000 people)

• itching, rash, sweating, petechiae, angioedema (swelling of the face, lips, throat, difficulty breathing), urticaria, edema;
• bleeding;
• abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice;
• acute and chronic pancreatitis (severe abdominal pain, vomiting, bloating, fever, muscle pain, diarrhea, itching); very rare (may affect up to 1 in 10,000 people)

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• severe skin reactions (rash with blisters all over the body or ulcers in the mouth, eyes, genitals, and skin, red spots on the body, often in the center of blisters, bursting blisters, large peeling skin patches, weakness, fever, and joint pain).

Other side effects that occur rarely (may affect up to 1 in 1,000 people)

• anemia;
• non-hemolytic anemia and bone marrow suppression;
• thrombocytopenia (decreased platelet count, bleeding from the nose and gums, bruising);
• kidney disease.

Frequency not known (cannot be estimated from the available data)

• a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Paracetamol is a widely used medicine, and reports of side effects are rare and usually related to overdose.
Nephrotoxic effects are rare, not reported to be related to therapeutic doses, except in cases of long-term use of the medicine.

Reporting side effects

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

5. HOW TO STORE Apap Direct

Do not store above 30°C. Store in the original packaging to protect from light and moisture.
Medicines should be kept out of the sight and reach of children.
Do not use Apap Direct after the expiry date stated on the carton and sachet (marked as EXP). The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Apap Direct contains

1 sachet contains the active substance paracetamol 500 mg.
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The other ingredients are: sorbitol (E 420), talc, butyl methacrylate copolymer, light magnesium oxide, sodium carmellose, sucralose (E 955), magnesium stearate, hypromellose, stearic acid, sodium lauryl sulfate, titanium dioxide (E 171), N,2,3-trimethyl-2-(propan-2-yl)butanamide, simethicone;
strawberry flavor (contains maltodextrin, gum arabic, natural and identical to natural flavors, propylene glycol, triacetin, 3-hydroxy-2-methyl-4H-pyran-4-one);
vanilla flavor (contains maltodextrin, natural and identical to natural flavors, propylene glycol, sucrose).

What Apap Direct looks like and contents of the package

Sachets made of PETP/Aluminum/LDPE film with white or almost white granules.
Apap Direct is available in the following packages containing: 2, 6, 12, 24 sachets in a cardboard box.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Losan Pharma GmbH
Otto-Hahn-Str. 13,
79395 Neuenburg,
Germany
To obtain more detailed information about this medicine, you should contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00.

Date of last revision of the package leaflet: May 2025

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