Apap Extra

Package Leaflet: Information for the Patient

Apap Extra

500 mg + 65 mg

coated tablets
Paracetamol + Caffeine

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 the package leaflet for the patient or as directed by a doctor or pharmacist.

• 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 possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Apap Extra and what is it used for

Apap Extra is a pain reliever and antipyretic. It contains paracetamol and caffeine as active substances. Caffeine enhances the analgesic effect of paracetamol. Additionally, caffeine has a mildly stimulating effect on the central nervous system.
Apap Extra is used for temporary relief of pain.
The indications for use are pains of various etiologies: headaches, including migraines, muscle pains, toothaches, neuralgia, menstrual pains, musculoskeletal pains, post-operative and post-traumatic pains. The medicine relieves symptoms of colds and flu, such as fever, sore throat, muscle and musculoskeletal pains.

2. Important information before taking Apap Extra

When not to take Apap Extra:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the following conditions occur: hemolytic anemia, congenital glucose-6-phosphate dehydrogenase deficiency and methemoglobin reductase deficiency, alcoholism, severe liver or kidney failure, heart rhythm disorders;
• during treatment with MAO inhibitors and for up to 2 weeks after stopping these medicines.
• Do not use in the first trimester of pregnancy and during breastfeeding.
• Do not use in children under 12 years of age.

Warnings and precautions:

Before starting to take Apap Extra, discuss it with your doctor or pharmacist.

• The medicine contains paracetamol. Due to the risk of overdose, check if other medicines being taken contain paracetamol.
• Taking the medicine by people with liver failure, alcohol abusers, and fasting individuals poses a risk of liver damage.
• Use with caution in people with kidney failure, asthma, hyperthyroidism, sleep disorders such as insomnia.
• Do not drink alcohol while taking the medicine due to the increased risk of liver damage.
• There is a particular risk of liver damage in fasting individuals and those who regularly drink alcohol.

During the use of Apap Extra, immediately inform your doctor if:

• the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present 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 condition called metabolic acidosis (a blood and body fluid disorder), which must be treated promptly (see section 2).

Children:

Use in children under 12 years of age is contraindicated (see When not to take Apap Extra).

Apap Extra and other medicines:

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
Do not take the medicine simultaneously with other medicines containing paracetamol and caffeine.
In the case of concomitant use of oral antidiabetic medicines, anticoagulants (warfarin, coumarin), rifampicin (a medicine used to treat tuberculosis), antiepileptic medicines, sedatives and hypnotics, MAO inhibitors (medicines used, among others, in depression), zidovudine (an antiviral medicine used in HIV infection), sympathomimetic medicines (i.e., decongestants, appetite suppressants, and psychostimulants similar to amphetamine), nonsteroidal anti-inflammatory medicines, thyroid hormones, oral contraceptives, cimetidine (a medicine used mainly for stomach and duodenal ulcers), chloramphenicol (an antibiotic), quinolones (bactericidal medicines), and verapamil (a medicine used for heart diseases) - consult a doctor before taking the medicine.

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated promptly (see section 2).

Using Apap Extra with food and drink:

Food does not reduce the absorption of the medicine.

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 a doctor or pharmacist before taking this medicine.
Do not use in the first trimester of pregnancy. In the second and third trimesters, consult a doctor before taking the medicine.
Do not use during breastfeeding.

Driving and using machines:

It does not affect the ability to drive and use machines.

3. How to take Apap Extra

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults and adolescents over 12 years of age:

1 or 2 tablets every 4 to 6 hours, a maximum of 8 tablets per day.
Do not take the medicine for more than 3 days without a doctor's recommendation.
Do not give to children under 12 years of age.
Method of administration: orally.

Taking a higher dose of Apap Extra than recommended:

May cause severe nausea, vomiting, excessive sweating, drowsiness or insomnia, general weakness, abdominal pain, increased diuresis, dehydration, and fever. More severe poisoning is characterized by cardiac arrhythmia and tonic-clonic seizures.
If a higher dose of the medicine than recommended is taken, consult a doctor or pharmacist immediately.

Missing a dose of Apap Extra:

The medicine is used for temporary relief of symptoms.
Do not take a double dose to make up for a missed dose.

Stopping the use of Apap Extra:

In case of further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Apap Extra can cause side effects, although not everybody gets them.

If the following symptoms occur, do not take the medicine and contact a doctor immediately. These are life-threatening conditions.

• rare - allergic skin reactions, such as hives, rash
• very rare - severe skin reactions: rash with blisters all over the body or ulcers in the mouth, eyes, genitals, and skin, or bursting large blisters, peeling off large skin flakes, accompanied by weakness, fever, and joint pain

Uncommon side effects (may affect up to 1 in 100 people):

• nausea, vomiting, abdominal pain

Rare side effects (may affect up to 1 in 1,000 people):

• thrombocytopenia characterized by bruising and a tendency to bruise, agranulocytosis (a lack of one type of white blood cell characterized by susceptibility to infections)
• dizziness
• renal papillary necrosis during long-term use; renal colic

Side effects with unknown frequency (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)

If a medicine containing caffeine is taken in the recommended dose in combination with caffeine contained in food, it is possible to exacerbate side effects related to the increased total dose of caffeine, such as:

Side effects with unknown frequency (cannot be estimated from the available data):

• arrhythmia
• insomnia, attention disorders, muscle tremors, irritability, dizziness

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, 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
Aleje 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Apap Extra

Store at a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack (month/year).
The applied labeling for the blister is: EXP - expiry date, Lot - batch number.

6. Package contents and other information

What Apap Extra contains

The active substances of the medicine are:
paracetamol 500 mg
caffeine 65 mg
The other ingredients are:
povidone, corn starch, methylcellulose, talc, calcium stearate;
the composition of the tablet coating includes: hypromellose 5, hypromellose 15, macrogol 3350.

What Apap Extra looks like and what the pack contains

White, oblong, coated tablets.
Packaged in blisters or a bottle and a cardboard box with a leaflet.

The medicine is available in packs of:

2, 4, 6, 8, 10, 12, 24 tablets in blisters and 50, 60 tablets in a bottle.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
To obtain more detailed information about this medicine, contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
tel.: +48 (22) 543 60 00.

Date of the last revision of the leaflet: