Apap caps

Leaflet attached to the packaging: information for the user

APAP caps, 500 mg, soft capsules
Paracetamol

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
This medicine is available without a prescription. However, caution should be exercised when taking it. This approach will ensure the best treatment results.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is APAP caps and what is it used for
• 2. Important information before taking APAP caps
• 3. How to take APAP caps
• 4. Possible side effects
• 5. How to store APAP caps
• 6. Package contents and other information

1. What is APAP caps and what is it used for

APAP caps contains the active substance paracetamol, which belongs to a group of medicines called analgesics (pain relievers).
APAP caps is used to treat mild to moderate pain and/or fever.
APAP caps can be used in adults, adolescents, and children, but it is not intended for use in children under 9 years of age.

2. Important information before taking APAP caps

When not to take APAP caps:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take APAP caps, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver or kidney function disorders
• if the patient has moderate to severe kidney failure (insufficient kidney function)
• if the patient has mild to severe liver failure (insufficient liver function)
• if the patient has Gilbert's syndrome

1/6

• if the patient has a deficiency of 6-phosphodehydrogenase
• if the patient has hemolytic anemia
• if the patient is dehydrated
• if the patient is chronically malnourished
• if the patient has asthma and is allergic to aspirin (acetylsalicylic acid)
• if the patient drinks large amounts of alcohol daily; in this case, there is a greater risk of harmful effects on the liver
• if the symptoms of the disease persist for more than 3 days or recur, the patient should contact their doctor
• if the patient is already taking other painkillers containing paracetamol, they should not take APAP caps.

It is not recommended to take this medicine for a long time or frequently.
The patient should consult their doctor if any of the above warnings apply or have applied in the past.

APAP caps and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take, including those prescribed by a doctor.
Various medicines, taken at the same time, can interact with each other.
Before taking paracetamol, the patient should consult their doctor or pharmacist. They should also consult their doctor or pharmacist when taking the following medicines:

• barbiturates (sedatives or anesthetics)
• certain antidepressants
• probenecid (used to treat jaundice)
• chloramphenicol (antibiotic)
• metoclopramide or domperidone (anti-emetic medicines)
• cholestyramine (a medicine with anticholinergic effects)
• warfarin and other coumarin derivatives (with anticoagulant effects)
• zidovudine (a medicine used to treat AIDS)
• salicylamide (a pain reliever)
• isoniazid (a medicine used to treat tuberculosis)
• lamotrigine (an antiepileptic medicine)
• flucloxacillin (an antibiotic), due to the high risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney function disorders, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

Paracetamol may affect the results of various laboratory tests.

APAP caps with food, drink, and alcohol

In patients with chronic alcohol disease, the dose should not exceed 2 g (4 capsules) per day. Long-term use of paracetamol and concurrent alcohol consumption may cause liver damage due to paracetamol overdose.
Alcohol should not be consumed during the use of APAP caps.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
APAP caps can be used during pregnancy if necessary. The patient should use the smallest effective dose to relieve pain or reduce fever and take the medicine for as short a time as possible. If the pain is not relieved or the fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, the patient should consult their doctor.
Breastfeeding
Although paracetamol passes into breast milk in small amounts, it does not affect breastfed babies. Paracetamol can be used for a short time in breastfeeding women at recommended doses.

Driving and using machines

Based on current observations, paracetamol has no effect on the ability to drive vehicles and operate machines.

Soy warning

APAP caps contains soy lecithin. If the patient is allergic to peanuts or soy, they should not take this medicine.

APAP caps contains sorbitol:

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take APAP caps

This medicine should always be taken exactly as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Method of use:
The capsule should be swallowed with a large amount of water (half a glass).

Recommended dose:

Adults and adolescents over 15 years old (body weight >55 kg):
1 or 2 capsules (500 mg - 1 g) at a time, a maximum of 6 capsules (3 g) per day.
Children and adolescents under 15 years old:
Children aged 9 to 12 years (30 - 40 kg): 1 capsule (500 mg) at a time, 3 - 4 times a day.
Children aged 12 to 15 years (40 - 55 kg): 1 capsule (500 mg) at a time, 4 - 6 times a day.
A lower frequency of administration is intended for younger children in the same age group.
In children under 12 years old, the dose should not exceed 60 mg/kg body weight per day.

• APAP caps should not be used in children under 9 years old.
• There should be at least 4-hour intervals between administrations of consecutive doses.
• APAP caps should not be taken at the same time as other medicines containing paracetamol.
• The recommended doses should not be exceeded.
• If the symptoms of fever and/or pain recur, the use of the medicine may be repeated according to the recommended dosing schedule.
• If the pain persists for more than 5 days or the fever for more than 3 days, or if these symptoms worsen or other symptoms occur, the use of the medicine should be stopped and the doctor consulted.

3/6
The effective daily dose should not exceed 60 mg/kg body weight per day (more than 2 g/day) in the following cases:

• in adults with a body weight of less than 50 kg
• in mild to moderate liver failure, Gilbert's syndrome (familial non-hemolytic jaundice)
• in dehydration
• in chronic malnutrition.

This medicine should always be taken exactly as directed by a doctor or pharmacist.
In case of feeling that the effect of the medicine is too strong or too weak, the patient should consult their doctor or pharmacist.

Taking a higher dose of APAP caps than recommended

If the patient has taken a higher dose than recommended, they should immediately consult their doctor or pharmacist. Taking a higher dose than recommended may cause nausea, vomiting, loss of appetite. Taking several times the maximum daily dose at once may cause very severe liver damage. Usually, there is no loss of consciousness.
However, the patient should seek medical help immediately.
If the patient does not receive appropriate help in time, liver damage may be irreversible.

Missing a dose of APAP caps

A double dose should not be taken to make up for a missed dose.

Stopping the use of APAP caps

Stopping the use of the medicine does not cause any special symptoms.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, APAP caps can cause side effects, although not everybody gets them.
The following side effects may occur:
Rarely (occurring in 1 to 10 patients out of 10,000)

• various blood test abnormalities, including agranulocytosis, thrombocytopenia, thrombocytopenic purpura, leukopenia, and hemolytic anemia
• allergies (excluding angioedema)
• liver function disorders, liver failure, liver cell necrosis, and jaundice
• itching, rash, sweating, purpura, urticaria
• overdose and poisoning
• depression, confusion, hallucinations
• tremors, headache
• blurred vision
• edema
• bleeding, abdominal pain, diarrhea, nausea, vomiting
• dizziness, fever, drowsiness.

Very rarely (occurring less frequently than in 1 out of 10,000 patients)

• pancytopenia (reduced blood cell count)
• hypersensitivity reactions, which should be discontinued, including angioedema, breathing difficulties, sweating, nausea, decreased blood pressure, shock, and anaphylaxis 4/6
• feeling of chest tightness due to bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs, a group of pain relievers with anti-inflammatory and antipyretic effects)
• liver poisoning
• rash (skin eruptions)
• hypoglycemia (low blood sugar levels)
• dark urine color (sterile pyuria) and kidney function disorders
• severe skin reactions.

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

• acute generalized exanthematous pustulosis, toxic epidermal necrolysis, drug-induced dermatoses, Stevens-Johnson syndrome.

After long-term use of 3 to 4 grams of paracetamol per day, liver damage may occur.
Liver damage may also occur after a single dose of paracetamol in an amount of 6 g.
If other side effects occur that are not listed in this leaflet, or if the patient considers them serious, they should inform their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C, 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 will help gather more information on the safety of the medicine.

5. How to store APAP caps

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What APAP caps contains

The active substance of the medicine is paracetamol. Each soft capsule contains 500 mg of paracetamol.
The other ingredients are:
Capsule contents: macrogol 400, macrogol 600, purified water, propylene glycol, povidone,
colloidal anhydrous silica.
Capsule shell: gelatin, liquid sorbitol, partially dehydrated, purified water, glycerol,
titanium dioxide (E171).
5/6
Contains trace amounts of isopropyl alcohol, saturated fatty acid triglycerides of medium chain length, soy lecithin.

What APAP caps looks like and what the package contains

White, elongated, soft gelatin capsule (size 11).
White PVC/PVDC-Aluminum blisters in a cardboard box.
Packages of 4, 6, 10, 20, 30, 50, 90, 100, 250, or 500 capsules in blisters or single-dose blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

Apotex Nederland B.V.
Archimedesweg 2
2333 CN Leiden
Netherlands
Generis Farmaceutica S.A.,
Rua Joao de Deus, no 19, Venda Nova,
2700-487 Amadora,
Portugal
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
To obtain more detailed information, the patient should contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of last revision of the leaflet: November 2022

6/6