Apap Direct Max

Leaflet attached to the packaging: information for the user

Apap Direct Max, 1000 mg, granules in sachets

Paracetamol

You should carefully read the contents of the leaflet 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 directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

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

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

2. IMPORTANT INFORMATION BEFORE TAKING Apap Direct Max

When not to take Apap Direct Max

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

Warnings and precautions

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

• alcoholic liver disease without cirrhosis, chronic alcoholism,
• glucose-6-phosphate dehydrogenase deficiency,
• hemolytic anemia,
• Gilbert's syndrome (hereditary non-hemolytic jaundice).

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While taking Apap Direct Max, you should immediately inform your doctor if: you have severe illnesses, including severe kidney or liver dysfunction, 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 develop a severe condition 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.
Long-term or frequent use is not recommended. You should inform the patient not to take other medications containing paracetamol at the same time. Taking a multiple of the daily dose at one time may 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 medication at the same time, unless the use of paracetamol alone is ineffective.
Cautious use is recommended in patients with kidney or liver failure (mild to moderate). In such cases, you should consult your doctor.
The risk of overdose is higher in people with post-alcoholic liver damage without cirrhosis. Caution should be exercised in cases of chronic alcoholism. In such cases, the daily dose should not exceed 2 g.
In the event of high fever or symptoms of secondary infection, or if symptoms persist for more than 3 days, the treatment should be re-evaluated.
Cautious use is recommended in patients who are dehydrated or malnourished. 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 a high fever occurs, you should consult your doctor.
If the patient is addicted to alcohol or has liver damage, paracetamol should not be used unless prescribed by a doctor. During paracetamol use, alcohol should not be consumed. Paracetamol does not enhance the effects of alcohol.
If the patient is taking other pain-relieving medications containing paracetamol, they should not take Apap Direct Max without consulting a doctor or pharmacist.
Never take a dose larger than recommended. Larger doses do not have a stronger pain-relieving 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 Max in a dose larger than recommended in this leaflet.
As a result of long-term or improper use of pain-relieving medications, or taking them in large doses, headaches may occur, which should not be treated with higher doses of this medication.
Generally, habitual use of pain-relieving medications, especially combinations of several pain-relieving substances, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy).
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Sudden discontinuation of the medication after long-term, high-dose, improper use of pain-relieving medications may cause headaches, weakness, muscle pain, restlessness, and vegetative symptoms. These withdrawal symptoms subside after a few days. Until then, you should avoid further use of pain-relieving medications and not take them again without consulting a doctor.
Apap Direct Max should not be taken for long periods or in large doses without consulting a doctor or dentist.

Children

The product is not recommended for children under 12 years of age.

Apap Direct Max and other medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, including those that are available without a prescription.
Medications that may interfere with the action of Apap Direct Max:

• probenecid (a medication used to treat gout);
• medications that can potentially damage the liver, such as phenobarbital (sleeping pills), phenytoin, carbamazepine, primidone (antiepileptic medications), and rifampicin (used to treat tuberculosis). Concurrent use of these medications and paracetamol may cause liver damage;
• metoclopramide and domperidone (used to treat nausea) may accelerate the absorption and onset of action of paracetamol;
• medications 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, cholestyramine should not be taken within the first hour after paracetamol administration;
• medications that reduce blood clotting (oral anticoagulants, especially warfarin). Repeated use 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 use of paracetamol does not have a significant effect on the tendency to bleed.

Concomitant administration of paracetamol and AZT (zidovudine, a medication used in 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 Max can be taken concomitantly with zidovudine only on the advice of a doctor.
You should inform 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 test results

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

Apap Direct Max with food, drink, and alcohol

Alcohol should not be consumed during paracetamol treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medication.
Apap Direct Max can be administered to pregnant women if necessary. The lowest effective dose should be used to relieve pain or reduce fever, and the medication should be taken for as short a time as possible.
If the pain is not relieved or the fever does not decrease, or if it becomes necessary to increase the frequency of medication use, you should consult your doctor. Paracetamol should not be used with other medicinal products.
After oral administration, paracetamol passes into breast milk in small amounts. During breastfeeding, it is allowed to use Apap Direct Max in therapeutic doses.

Driving and using machines

Taking Apap Direct Max does not affect the ability to drive and use machines.
Apap Direct Max contains sorbitol, glucose (a component of maltodextrin), and sodium.
The medication contains 806 mg/sachet of sorbitol. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, you should contact your doctor before taking the medication 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 medication.
The medication contains less than 1 mmol (23 mg) of sodium per sachet, which means the medication is considered "sodium-free".

3. HOW TO TAKE Apap Direct Max

Apap Direct Max should always be taken exactly as directed in this leaflet. In case of doubt, you should consult your doctor or pharmacist.
The dose is determined based on the information provided in the table below. The dose of Apap Direct Max 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 maintain at least a 6-hour interval between two doses, which means taking the medication a maximum of 4 times a day.
If symptoms persist for more than 3 days, you should consult your doctor.
Body weight (age)
Single dose
Maximum daily dose
> 40 kg
(children over 12 years old and adults)
1000 mg of paracetamol
3000 mg of paracetamol
(3 sachets of 1000 mg each)
(1 sachet)

Method and route of administration

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

Special patient groups

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Liver or kidney dysfunction
In patients with liver or kidney dysfunction, the dose should be reduced or the interval between doses prolonged. You should consult your 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.
Paracetamol 1000 mg is not intended for use in children under 12 years of age and with a body weight below 40 kg, as this dose strength is not suitable for this age group. For such patients, other pharmaceutical forms and dose strengths are available.

Use of a higher than recommended dose of Apap Direct Max

In case of overdose of Apap Direct Max, you should contact your 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.

Missing a dose of Apap Direct Max

You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of the medication, you should consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medications, Apap Direct Max can cause side effects, although not everybody gets them.
If you experience the following symptoms, you should stop treatment and contact your 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)
• 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)
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• anemia;
• non-hemolytic anemia and bone marrow suppression;
• thrombocytopenia (decreased platelet count, nosebleeds and gum bleeding, bruising);
• kidney disease.

Frequency of occurrence: "frequency not known" (cannot be estimated from available data)

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

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

Reporting side effects

If you experience any side effects, including those not listed in this 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 medication.

5. HOW TO STORE Apap Direct Max

The medication should be stored out of sight and reach of children.
Apap Direct Max should not be used after the expiration date stated on the carton and sachet (marked as EXP). The expiration date refers to the last day of the given month.
The medication should be stored in its original packaging to protect it from light and moisture.
Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Apap Direct Max contains

1 sachet contains:
active substance: paracetamol 1000 mg;
other ingredients: sorbitol (E420), talc, butyl methacrylate copolymer, light magnesium oxide, sodium carmellose, sucralose (E955), magnesium stearate, hypromellose, stearic acid,
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sodium lauryl sulfate, titanium dioxide (E171), simethicone, N,2,3-trimethyl-2-(propan-2-yl)butanamide;
cappuccino flavor (contains maltodextrin, gum arabic, natural and identical to natural flavors, triacetin).

What Apap Direct Max looks like and what the packaging contains

Sachets made of PETP/Aluminum/LDPE foil with white or almost white granules.
Apap Direct Max 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 medication, you should contact:
USP Zdrowie Sp. z o.o.,
ul. Poleczki 35,
02-822 Warsaw,
phone: +48 (22) 543 60 00.

Date of last update of the leaflet: May 2025

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