Apap direct max

Package leaflet: Information for the user

Apap Direct Max, 1000 mg, granules in sachets
Paracetamolum
Please read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by
a 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 adverse reactions, including any possible adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, you should contact your doctor.

Leaflet contents:

1. What Apap Direct Max is and what it is 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 pack and other information

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

Paracetamol belongs to the pharmacotherapeutic group of analgesics (pain-relieving medicines), which
also act as antipyretics (fever-reducing medicines) and have weak anti-inflammatory properties.
Apap Direct Max is used to reduce fever and relieve mild to 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 impairment.

Warnings and precautions

Consult your doctor before starting to take Apap Direct Max if you have:

• kidney or liver function disorders,
• alcoholic liver disease without signs of cirrhosis,
• chronic alcoholism,
• glucose-6-phosphate dehydrogenase deficiency,
• haemolytic anaemia,
• Gilbert's syndrome (hereditary non-haemolytic jaundice).

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During treatment with Apap Direct Max, inform your doctor immediately if:

you have serious illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, severe metabolic acidosis (a blood and body fluid disorder) has been reported in patients who took paracetamol regularly for 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.

Long-term or frequent use is not recommended. Patients should be advised not to take other medicines containing paracetamol simultaneously. Taking multiple daily doses at once may cause severe liver damage. In such cases, loss of consciousness does not occur, but immediate medical attention is required.

Prolonged use of the medicine without medical supervision may be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, there is no justification for administering another antipyretic simultaneously unless paracetamol alone is ineffective.

Caution is advised when administering paracetamol to patients with kidney or liver impairment (mild to moderate). In such cases, consult your doctor.

The risk of overdose is higher in individuals with alcohol-related liver damage without signs of cirrhosis. Caution is advised in cases of chronic alcoholism. In such cases, the daily dose should not exceed 2 g.

If high fever or signs of secondary infection occur, or if symptoms persist beyond 3 days, the treatment should be re-evaluated.

Caution is advised when administering paracetamol to dehydrated or chronically malnourished individuals. The total daily dose of paracetamol should not exceed 3 g in adults and children weighing at least 50 kg.

If symptoms worsen or do not subside after 3 days, or if high fever develops, consult your doctor.

If you are alcohol-dependent or have liver damage, do not take paracetamol unless prescribed by a doctor. Do not consume alcohol while taking paracetamol. Paracetamol does not enhance the effects of alcohol.

If you are taking other pain-relieving medicines containing paracetamol, do not take Apap Direct Max without consulting your doctor or pharmacist.

Never take a higher dose than recommended. Higher doses do not provide stronger pain relief but may cause severe liver damage. The first signs of liver damage appear after several days. Therefore, it is very important to contact your doctor immediately if you have taken Apap Direct Max in a dose higher than recommended in this leaflet.

Prolonged or improper use of pain-relieving medicines, or taking them in high doses, may lead to headaches that should not be treated with higher doses of this medicine.

Generally, habitual use of pain-relieving medicines, especially combinations of several analgesic substances, may lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy).

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Sudden discontinuation of pain-relieving medicines after prolonged, high-dose, improper use may cause headaches, weakness, muscle pain, restlessness, and autonomic symptoms. These withdrawal symptoms resolve within a few days. During this time, further use of pain-relieving medicines should be avoided, and they should not be taken again without consulting a doctor.

Do not take Apap Direct Max for long periods or in high doses without consulting a doctor or dentist.

Children

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

Apap Direct Max and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.

Medicines that may interfere with the action of Apap Direct Max:

• probenecid (a medicine used in the treatment of gout);
• medicines that may damage the liver, e.g. phenobarbital (sleeping tablets), phenytoin, carbamazepine, primidone (antiepileptic medicines), and rifampicin (used in the treatment of tuberculosis). Concurrent use of these medicines with paracetamol may cause liver damage;
• metoclopramide and domperidone (used to treat nausea) may accelerate the absorption and onset of action of paracetamol;
• medicines that slow gastric emptying may delay the absorption and onset of action of paracetamol;
• colestyramine (used to reduce elevated serum lipid levels) may reduce the absorption and onset of action of paracetamol. Therefore, colestyramine should not be taken within the first hour after paracetamol administration;
• medicines that reduce blood clotting (oral anticoagulants, especially warfarin). Repeated use of paracetamol for more than one week increases the tendency to bleed. Therefore, long-term use of paracetamol should only be carried out under medical supervision. Occasional use of paracetamol has no significant effect on bleeding tendency.

Concurrent administration of paracetamol and AZT (zidovudine, a medicine used in HIV infections)
increases the tendency for a decrease in white blood cell count (neutropenia), which impairs the
immune system and increases the risk of infections. Therefore, Apap Direct Max may be taken
concurrently with zidovudine only on a doctor's recommendation.

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 require urgent treatment (see section 2).

Effect of paracetamol on laboratory test results
Paracetamol may affect the measurement of uric acid and blood glucose levels.

Apap Direct Max with food, drink and alcohol
Alcohol should not be consumed during treatment with paracetamol.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, you should consult your doctor before using this medicine.

Apap Direct Max may be given to pregnant women if necessary. Use the lowest effective dose that adequately relieves pain or reduces fever, and take the medicine for as short a time as possible.

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If pain is not relieved or fever does not subside, or if you need to increase the frequency of dosing, consult your doctor. Paracetamol should not be used together with other medicinal products.

After oral administration, paracetamol passes into breast milk in small amounts. During breastfeeding, Apap Direct Max may be used at therapeutic doses.

Driving and operating machinery
The use of Apap Direct Max does not affect the ability to drive or operate machinery.

Apap Direct Max contains sorbitol, glucose (component of maltodextrin) and sodium.
The medicine contains 806 mg/sachet of sorbitol. Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in you (or your child), or if hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, has been diagnosed, you should contact your doctor before taking the medicine or giving it to your child.

If intolerance to certain sugars has previously been diagnosed in you, you should contact your doctor before taking the medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. HOW TO USE THE MEDICINE Apap Direct Max

The medicine Apap Direct Max should always be taken exactly as instructed in this
leaflet. In case of doubt, 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, the single dose is 10–15 mg of paracetamol per kilogram
of body weight, up to a maximum daily dose of 60–75 mg/kg body weight.
The appropriate interval between doses depends on symptoms and the maximum total daily dose.
At least a 6-hour interval should be maintained between two doses, meaning the medicine
should be administered no more than 4 times per day.
If symptoms persist for longer than 3 days, consult your doctor.

Body weight (age) | Single dose | Maximum daily dose
--- | --- | ---

40 kg | 1000 mg paracetamol | 3000 mg paracetamol
(children over 12 years of age and adults) | (1 sachet) | (3 sachets of 1000 mg each)

Method and route of administration
Apap Direct Max is for oral use only.
Do not take Apap Direct Max after a meal.
The granulate should be placed directly into the mouth onto the tongue and then swallowed without water.

Special patient groups
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Hepatic or renal impairment
In patients with impaired liver or kidney function, the dose should be reduced or the dosing interval extended.
Consult your doctor.

Chronic alcoholism
Chronic alcohol consumption may lower the toxic threshold of paracetamol. In such patients,
the minimum interval between two doses should be at least 8 hours. Do not exceed 2 g of paracetamol per day.

Elderly patients
Dosage adjustment is not required.

Paracetamol 1000 mg is not intended for use in children under 12 years of age or weighing less than 40 kg,
as this dosage strength is inappropriate for this age group. Other pharmaceutical forms and dosage strengths are available for such patients.

Use of a higher than recommended dose of Apap Direct Max
In case of overdose of Apap Direct Max, contact your doctor or emergency department immediately.
Overdose has very serious consequences and may 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 risk of organ damage.

Missed dose of Apap Direct Max
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 REACTIONS

Like all medicines, Apap Direct Max can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, discontinue treatment immediately and contact your doctor without delay:
Rarely occurring (may affect less than 1 in 1,000 people)

• itching, rash, sweating, purpura, angioedema (swelling of the face, lips, throat, breathing difficulties), urticaria, edema;
• bleeding;
• abdominal pain, diarrhea, nausea, vomiting, liver failure, hepatic necrosis, jaundice;
• acute and chronic pancreatitis (severe abdominal pain, vomiting, bloating, fever, muscle pain, diarrhea, itching).
  Very rarely occurring (may affect less than 1 in 10,000 people)
• severe skin reactions (rash with blisters all over the body or erosions in the mouth, eyes, genital organs and skin, red spots on the body, often with blisters in the center, ruptured blisters, large peeling skin sheets, weakness, fever and joint pain).

Other adverse reactions occurring rarely (may affect less than 1 in 1,000 people)
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• anaemia;
• non-hemolytic anaemia and bone marrow suppression;
• thrombocytopenia (reduced platelet count, nosebleeds, gum bleeding, bruising);
• kidney disorders.

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

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

Paracetamol is a widely used medicine, and reports of adverse reactions are rare and usually associated with overdose.
Nephrotoxic effects are rare; no association with therapeutic doses has been reported, except in cases of long-term use of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE THE MEDICINAL PRODUCT Apap Direct Max

Keep the medicinal product out of sight and reach of children.
Do not use Apap Direct Max after the expiry date stated on the carton
and sachet {marked as EXP}. The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from light and moisture.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Apap Direct Max contains
Each sachet contains:
Active substance: paracetamol 1000 mg;
Other ingredients: sorbitol (E420), talc, basic butyl methacrylate copolymer, light magnesium oxide, sodium carmellose, sucralose (E955), magnesium stearate, hypromellose, stearic acid, sodium lauryl sulfate, titanium dioxide (E171), simethicone, N,2,3-trimethyl-2-(propan-2-yl)butanamide;
Cappuccino flavour (containing maltodextrin, gum arabic, natural and nature-identical flavours, triacetin).

What Apap Direct Max looks like and contents of the pack
Sachets made of PETP/Aluminium/LDPE foil containing a white or almost white granulate.
Apap Direct Max is available in the following pack sizes containing:
2, 6, 12, 24 sachets in a cardboard box.

Marketing Authorisation 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

For further information regarding this medicinal product, please contact:
USP Zdrowie Sp. z o.o.,
ul. Poleczki 35,
02-822 Warsaw,
tel. +48 (22) 543 60 00.
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