Apap bul i goromhka

PATIENT INFORMATION LEAFLET: USER INFORMATION

APAP PAIN AND FEVER

500 mg, effervescent tablets

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 information leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days (pain) or 3 days (fever) there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet:

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

1. What APAP pain and fever is and what it is used for

APAP pain and fever effervescent tablets contain paracetamol, which is a mild analgesic and antipyretic. The use of these tablets is recommended for the treatment of mild or moderate pain and/or fever.

2. Important information before taking APAP pain and fever

When not to take APAP pain and fever

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking APAP pain and fever, discuss it with your doctor or pharmacist if:

• you have liver disease, including disorders due to excessive alcohol consumption
• you have Gilbert's syndrome (a mild form of jaundice)
• you have kidney disease
• you are dehydrated or chronically malnourished
• you are undergoing long-term treatment with high doses of paracetamol
• you have asthma with aspirin sensitivity
• you are taking other medicines containing paracetamol
• you have a fever, even after finishing paracetamol treatment
• you have a deficiency of glucose-6-phosphate dehydrogenase (an enzyme deficiency)
• you have hemolytic anemia (abnormal breakdown of red blood cells).

APAP pain and fever and other medicines
Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Before taking APAP pain and fever, inform your doctor about taking:

• medicines that prevent blood clotting (anticoagulants, e.g., warfarin, other coumarins)
• anti-emetic medicines (e.g., metoclopramide, domperidone)
• medicines used to treat high cholesterol (cholestyramine)
• probenecid (a medicine used to treat high uric acid levels in the blood, gout)
• a mild analgesic or antipyretic (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 risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney dysfunction, 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.

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

Taking APAP pain and fever with food, drink, and alcohol

Taking APAP pain and fever with food has no significant effect on the absorption of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, and also if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking APAP pain and fever.
APAP pain and fever can be given to pregnant women if necessary. The lowest effective dose should be used for the shortest possible time.
If the pain is not relieved or the fever does not subside, or if it becomes necessary to increase the frequency of taking the medicine, consult a doctor.
Paracetamol passes into breast milk. Paracetamol can be used in therapeutic doses in breastfeeding women.

Driving and using machines

Paracetamol has no effect on the ability to drive and use machines.

Important information about some ingredients of APAP pain and fever

This medicine contains 100 mg of sorbitol in each tablet.
The medicine contains 418.5 mg of sodium (a major cooking ingredient/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 is equal to 125.55% of the maximum daily sodium dose recommended by the WHO.
The sodium content in APAP pain and fever is considered high. This should be taken into account especially in people using a low-salt diet.

3. How to take APAP pain and fever

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

• Children under 12 years: do not give to children under 12 years.
• Adolescents from 12 to 15 years with a body weight from 41 to 50 kg: a single dose is one tablet, given every 4-6 hours if necessary. Do not exceed 4 tablets per day.
• Adolescents from 16 to 18 years with a body weight over 50 kg: dosing is the same as for adults.

Adults:
The usual dose for adults is 1 to 2 tablets of 500 mg, the dose can 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 should be dissolved in a glass of water, wait until they are completely dissolved, then drink the prepared solution.
APAP pain and fever can be taken with food and drink or independently of meals.
If the pain persists for more than 5 days or the fever lasts for more than 3 days, worsens, or other symptoms appear, stop the treatment and consult a doctor.
If symptoms persist or worsen, seek medical advice.
Do not exceed the recommended dose. The cap contains a desiccant, which is not suitable for consumption.
In case of any doubts related to the use of the medicine, consult a doctor or pharmacist.

Taking a higher dose of APAP pain and fever than recommended

In case of accidental ingestion of a significantly higher dose than recommended (overdose), immediately contact a doctor, even if you feel well, due to the possibility of delayed, severe liver damage.

Missing a dose of APAP pain and fever

If you miss a dose, take it as soon as you remember, unless it is close to the time for the next dose. Remember to maintain at least 4-hour intervals between doses. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Allergic reactions, red or purple spots on the skin (purpura), general feeling of discomfort (malaise), interactions with other medicines, swelling (abnormal accumulation of fluid under the skin), abnormal vision, skin rash or hives (dark red rash on the skin), bleeding, abdominal pain, diarrhea, nausea, vomiting, dizziness, fever, sedation, liver failure, liver necrosis (death of living cells), jaundice, overdose, and poisoning, seizures, headache, depression, disorientation, hallucinations, sweating, itching.

Very rare (may affect up to 1 in 10,000 people):

Hepatotoxicity (liver damage caused by chemicals), liver function disorders, hypersensitivity reaction requiring treatment discontinuation (severe allergic reaction), angioedema (swelling of the face, lips, hands, anaphylactic shock (acute allergic reaction), thrombocytopenia (low platelet count), leukopenia (low white blood cell count), agranulocytosis (low neutrophil count in the blood), hemolytic anemia (abnormal breakdown of red blood cells), hypoglycemia (low blood sugar), cloudy urine, kidney function disorders, including severe kidney failure, interstitial nephritis (kidney disease), hematuria (blood in the urine), anuria (inability to urinate). In very rare cases, serious skin reactions have been reported.
Other side effects of paracetamol, whose frequency cannot be estimated from the 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 edema, adverse effects on the gastrointestinal tract (stomach ulcers and bleeding), and a feeling of restlessness.
*Cases of breathing difficulties, wheezing, coughing, and shortness of breath have been reported after taking paracetamol, but they are likely to occur in people with asthma who are sensitive to aspirin or other NSAIDs, such as ibuprofen.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, consult a doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
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 pain and fever

Store out of sight and reach of children.
Do not use APAP pain and fever after the expiry date stated on the label after EXP.
The expiry date refers to the last day of that month.
Store below 30°C. Store the polypropylene tube tightly closed. Store in the original package to protect from light and moisture.
Do not use this medicine if you notice any signs of deterioration, such as brown or black spots on the tablets, swelling, or discoloration of the tablets.
Medicines should 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 APAP pain and fever 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 flavor (contains maltodextrin, gum arabic (E 414), α-tocopherol (E 307)), macrogol 6000.

What APAP pain and fever looks like and what the pack contains

APAP pain and fever, 500 mg, effervescent tablets are white to off-white, round, flat, with beveled edges, smooth on both sides.
Polypropylene tubes:
APAP pain and fever, 500 mg, effervescent tablets are packaged in polypropylene tubes with a polyethylene cap containing a desiccant with a tamper-evident seal. Each tube contains 8, 10, 20, or 24 tablets.
Package size: 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:
APAP pain and fever 500 mg is also packaged in blister packs of aluminum/aluminum foil.
Package size: 4, 8, 10, 16, 20, 24, 30, 32, 60, and 100 effervescent tablets.
APAP pain and fever 500 mg is also packaged in blister packs of paper/polyethylene/aluminum/Surlyn.
Package size: 8, 10, 16, 20, 24, 30, 32, 60, and 100 effervescent tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer:

Marketing authorization holder

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

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
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 authorized in the Member States of the European Economic Area under the following names:

Member State: Name of the medicinal product

Finland
: Paracetamol Accord 500 mg effervescent tablets
Ireland
: Phizamol 500 mg Effervescent Tablets
Italy
: Phizamol 500 mg effervescent tablets
Poland
:
APAP pain and fever, 500 mg, effervescent tablets
Portugal
: Paracetamol Accord
Netherlands
: Paracetamol Accord 500 mg effervescent tablets
United Kingdom
: Paracetamol 500 mg Effervescent Tablets

Date of revision of the leaflet: May 2022