Apap for pain and fever

APAP ból i gorączka
500 mg, effervescent tablets
Paracetamolum
Please read the entire leaflet carefully before using 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 advised by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days (for pain) or 3 days (for fever), or if your condition worsens, consult your doctor.

Contents of the leaflet:

1. What APAP ból i gorączka is and what it is used for
2. Important information before taking APAP ból i gorączka
3. How to take APAP ból i gorączka
4. Possible side effects
5. How to store APAP ból i gorączka
6. Contents of the pack and other information

1. What APAP ból i gorączka is and what it is used for

APAP ból i gorączka effervescent tablets contain paracetamol, which is a medicine with mild analgesic and antipyretic properties. These tablets are recommended for the treatment of mild to moderate pain and (or) fever.

2. Important information before using the medicine ból i gorączka

When not to use ból i gorączka

• if the patient has a known allergy to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use ból i gorączka, discuss with your doctor or pharmacist if:

• the patient suffers from liver disease, including conditions caused by excessive alcohol consumption
• the patient has Gilbert's syndrome (a mild form of jaundice)
• the patient suffers from kidney disease
• the patient is dehydrated or chronically undernourished
• the patient is undergoing long-term treatment with high doses of paracetamol
• the patient suffers from asthma with aspirin sensitivity
• the patient is taking other medicines containing paracetamol
• the patient has fever, even after completing paracetamol treatment
• the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency)
• the patient suffers from haemolytic anaemia (an abnormal decrease in red blood cells).

ból i gorączka and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Before using ból i gorączka, inform your doctor if you are taking:

• anticoagulant medicines (blood thinners, e.g. warfarin, other coumarins)
• antiemetic medicines (e.g. metoclopramide, domperidone)
• medicines used to treat patients with high blood cholesterol (cholestyramine)
• probenecid (a medicine used to treat high blood uric acid levels (gout))
• a mild analgesic or antipyretic medicine (aspirin, salicylamide)
• barbiturates and tricyclic antidepressants (medicines used to treat depression)
• medicines used to treat seizures (lamotrigine)
• medicines used to treat tuberculosis (isoniazid)
• flucloxacillin (an antibiotic), due to the serious risk of a disorder affecting blood and body fluids (metabolic acidosis with a high anion gap), which requires urgent treatment and may occur particularly in patients with severe kidney function disorders, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and also in patients taking the maximum daily dose of paracetamol.

Effect of paracetamol on laboratory tests:
Results of tests assessing blood uric acid and blood glucose levels may be altered.

Using ból i gorączka with food, drink and alcohol
Taking ból i gorączka with food does not significantly affect the absorption of the medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using ból i gorączka.
The medicine ból i gorączka may be given to pregnant women if necessary. The lowest effective dose that adequately relieves pain or reduces fever should be used, and the medicine should be taken for as short a duration as possible.
If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, consult your doctor.
Paracetamol passes into breast milk. Paracetamol in therapeutic doses may be used in breastfeeding women.

Driving and operating machinery
Paracetamol has no effect on the ability to drive or operate machinery.

Important information about certain ingredients of ból i gorączka
This medicine contains 100 mg of sorbitol in each tablet.
The medicine contains 418.5 mg of sodium (the main component of cooking salt/table salt) in each tablet. This corresponds to 20.92% of the recommended maximum daily sodium intake for an adult.
The maximum daily dose of the product equals 125.55% of the daily sodium intake recommended by WHO.
The sodium content in the medicine ból i gorączka is considered high. This should be particularly taken into account in individuals on a low-salt diet.

3. How to use ból i gorączka

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for use in adults and adolescents aged 12 years and above.
Children and adolescents:

• Children under 12 years: do not give to children under 12 years of age.
• Adolescents aged 12 to 15 years with body weight between 41 and 50 kg: the single dose is one tablet, administered every 4 to 6 hours if necessary. Do not exceed 4 tablets per day.
• Adolescents aged 16 to 18 years with body weight above 50 kg: dosage as for adults.

Adults:
The usual dose for adults is 1 to 2 tablets of 500 mg, which may be repeated every 4 to 6 hours. The maximum daily dose is 6 tablets (3000 mg).
Recommended maximum daily dose:

• The maximum daily dose of paracetamol should not exceed 3000 mg.
• The maximum single dose of paracetamol is 1000 mg (2 effervescent tablets).

Method of administration:
Effervescent tablets must be dissolved in a glass of water. Wait until completely dissolved, then drink the prepared solution.
ból i gorączka may be taken with food and drink or independently of meals.
If pain persists for more than 5 days or fever lasts longer than 3 days, worsens or other symptoms develop, treatment should be discontinued and medical advice sought.
If symptoms persist or worsen, seek medical advice.
Do not exceed the recommended dose. The cap contains a moisture-absorbing agent, which is not suitable for consumption.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.
Use of a higher than recommended dose of ból i gorączka
In case of accidental ingestion of a significantly higher dose than recommended (overdose), contact a doctor immediately, even if the patient feels well, due to the risk of delayed, severe liver damage.
Missed dose of ból i gorączka
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Remember to maintain at least a 4-hour interval between doses. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rare (may affect less than 1 in 1,000 people):
Allergic reactions, red or purple spots on the skin (purpura), general discomfort (malaise), interactions with other medicines, swelling (abnormal accumulation of fluid under the skin), unusual vision, skin rash or urticaria (dark red rash on the skin), bleeding, abdominal pain, diarrhoea, nausea, vomiting, dizziness, fever, sedation, liver failure, liver necrosis (death of living cells), jaundice, overdose and poisoning, convulsions, headache, depression, disorientation, hallucinations, sweating, itching (pruritus).
Very rare (may affect less than 1 in 10,000 people):
Hepatotoxicity (liver damage caused by chemical substances), disturbances in liver function, hypersensitivity reaction requiring discontinuation of treatment (immediate severe allergic reaction), angioedema (swelling of the face, lips, hands), anaphylactic shock (acute allergic reaction), bronchospasm*, thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), agranulocytosis (reduced number of neutrophils in the blood), haemolytic anaemia (abnormal breakdown of red blood cells), hypoglycaemia (low blood glucose levels), cloudy urine, disturbances in kidney function, including severe kidney failure, interstitial nephritis (kidney disease), haematuria (blood in urine), anuria (inability to pass urine). In very rare cases, serious skin reactions have been reported.
Other adverse reactions of paracetamol, whose frequency cannot be estimated from available data, include: toxic epidermal necrolysis (a life-threatening skin disease), erythema multiforme (allergic reaction or skin infection), Stevens-Johnson syndrome (a serious, life-threatening skin disease), laryngeal oedema, harmful effects on the gastrointestinal tract (gastric ulceration and bleeding), and feelings of restlessness.
*Cases of breathing difficulties, wheezing, cough and shortness of breath have been reported after administration of paracetamol; however, these are likely to occur in patients with asthma who are hypersensitive to aspirin or other NSAIDs such as ibuprofen.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store APAP ból i gorączka

Keep out of the sight and reach of children.
Do not use APAP ból i gorączka after the expiry date stated on the label after EXP.
The expiry date refers to the last day of the stated month.
Store below 30°C. Keep the polypropylene tube tightly closed.
Store in the original packaging to protect from light and moisture.
Do not use this medicine if there are any signs of deterioration, such as brown or black spots on the tablets, tablet swelling, or discoloration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ból i gorączka contains

• The active substance is paracetamol. Each effervescent tablet contains 500 mg of paracetamol.
• Other ingredients are: citric acid, sodium bicarbonate, sorbitol, anhydrous sodium carbonate, povidone K 25, simethicone, sodium saccharin, lemon flavour (containing maltodextrin, gum arabic (E 414), α-tocopherol (E 307)), macrogol 6000.

What ból i gorączka looks like and contents of the pack
ból i gorączka, 500 mg, effervescent tablets are white to off-white, round, flat, with bevelled edges, smooth on both sides.

Tubes (polypropylene):
ból i gorączka, 500 mg, effervescent tablets are packed in polypropylene tubes with a polyethylene cap containing a desiccant and a tamper-evident seal. Each tube contains 8, 10, 20 or 24 tablets.
Pack sizes: 10 (1 x 10), 16 (2 x 8), 20 (1 x 20), 24 (1 x 24), 24 (3 x 8), 30 (3 x 10), 60 (3 x 20) or 100 (5 x 20) tablets in a cardboard box.
WARNING: The cap contains a desiccant. Do not eat it.

Blister packs:
ból i gorączka 500 mg is also packed in aluminium/aluminium foil blisters.
Pack sizes: 4, 8, 10, 16, 20, 24, 30, 32, 60 and 100 effervescent tablets.

ból i gorączka 500 mg is also packed in blisters made of paper/polyethylene/aluminium/surlyn foil.
Pack sizes: 8, 10, 16, 20, 24, 30, 32, 60 and 100 effervescent tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer:
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław
Poland

Manufacturer/Importer
Accord Healthcare Limited
Sage House
319 Pinner Road,
North Harrow, HA1 4HF
Middlesex,
United Kingdom

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

Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50,
95-200 Pabianice,
Poland

Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

This medicinal product is authorised in the European Economic Area under the following names:
Member State: Name of the medicinal product
Finland: Paracetamol Accord 500 mg poretabletti/brustabletter
Ireland: Phizamol 500 mg Effervescent Tablets
Italy: Phizamol 500 mg compresse effervescenti
Poland: ból i gorączka, 500 mg, effervescent tablets
Portugal: Paracetamol Accord
Netherlands: Paracetamol Accord 500 mg bruistabletten
United Kingdom: Paracetamol 500 mg Effervescent Tablets