APAP 325 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. APAP 325 mg
3. 325 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is APAP 325 mg and what is it used for
5. Important information before taking APAP 325 mg
   1. When not to take APAP 325 mg
   2. Warnings and precautions
   3. Before starting APAP 325 mg, discuss with your doctor or pharmacist if you have:
   4. APAP 325 mg contains sodium
   5. Children and adolescents
   6. APAP 325 mg and other medicines
   7. APAP 325 mg with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
6. How to take APAP 325 mg
   1. Usual dose of the medicine
   2. Taking a higher dose of the medicine than recommended
   3. Missing a dose of APAP 325 mg
7. Possible side effects
   1. If the following symptoms occur, do not continue taking the medicine and consult a doctor immediately. These are life-threatening conditions. They occur very rarely.
   2. Uncommon side effects (occurring in 1 to 10 out of 10,000 patients taking the medicine):
   3. Rare side effects (occurring in less than 1 out of 10,000 patients taking the medicine):
   4. Side effects with unknown frequency (cannot be estimated from available data):
   5. Reporting side effects
8. How to store APAP 325 mg
9. Contents of the packaging and other information
   1. What APAP 325 mg contains
   2. What APAP 325 mg looks like and what the packaging contains
   3. Available packaging
   4. Marketing authorization holder and manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

APAP 325 mg

325 mg, coated 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 this patient leaflet or as advised 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 this leaflet, they should inform their doctor or pharmacist. See section 4.
• If pain persists for more than 5 days, or fever for more than 3 days, consult a doctor.

Table of contents of the leaflet

• 1. What is APAP 325 mg and what is it used for
• 2. Important information before taking APAP 325 mg
• 3. How to take APAP 325 mg
• 4. Possible side effects
• 5. How to store APAP 325 mg
• 6. Contents of the packaging and other information

1. What is APAP 325 mg and what is it used for

APAP 325 mg is a pain reliever and antipyretic. It contains paracetamol as the active substance. The medicine has a pain-relieving effect in mild or moderate pain: headaches, migraines, neuralgia, toothaches, throat pain, back pain, muscle pain, and menstrual pain. It alleviates symptoms of colds and flu, such as fever, chills, headaches, throat pain, muscle pain, and bone and joint pain.

2. Important information before taking APAP 325 mg

When not to take APAP 325 mg

If the patient:

• has previously been diagnosed with an allergy to paracetamol or any component of the medicine;
• has severe liver failure;
• has severe kidney failure;

Warnings and precautions

The medicine contains paracetamol. To avoid overdose, ensure that none of the other medicines taken at the same time contain paracetamol. Do not take other medicines containing paracetamol at the same time.
Long-term or frequent use of the medicine is not recommended.
If a higher dose than recommended is taken, consult a doctor immediately, even if no side effects have occurred, as it may lead to life-threatening liver damage.

Before starting APAP 325 mg, discuss with your doctor or pharmacist if you have:

• liver failure,
• chronic alcoholism,
• kidney failure,
• Gilbert's syndrome (familial non-hemolytic jaundice),
• acute liver inflammation,
• glucose-6-phosphate dehydrogenase deficiency or hemolytic anemia,
• methemoglobin reductase deficiency,
• asthma or hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, as less than 5% of people have been observed to experience bronchospasm after taking paracetamol,
• the patient is taking other medicines that affect liver function.

During treatment with APAP 325 mg, inform your doctor immediately if:

• Severe diseases occur, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if 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) when taking paracetamol in standard doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Long-term, high-dose, improper use of painkillers may lead to headaches. In such cases, do not increase the dose of the painkiller; instead, stop treatment and consult a doctor.
Habitual use of painkillers, especially combinations of several pain-relieving substances, may lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy).
Long-term or frequent use of the medicine is not recommended. Do not take other medicines containing paracetamol at the same time. Taking multiple daily doses at once may cause severe liver damage. In such cases, there is no loss of consciousness, but immediate medical attention is necessary. Prolonged use of the medicine without medical supervision may be harmful.
Sudden withdrawal of the medicine after long-term, high-dose, improper use of painkillers may cause headaches, weakness, muscle pain, restlessness, and vegetative symptoms (such as sweating, palpitations, hand tremors). These withdrawal symptoms will subside after a few days. Do not increase the dose of paracetamol during this time, and avoid further use of painkillers; do not take them again without consulting a doctor.

APAP 325 mg contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per single dose (2 tablets), which means the medicine is considered "sodium-free".

Children and adolescents

APAP 325 mg is not recommended for children under 6 years of age.
In children treated with paracetamol at a daily dose of 60 mg/kg, it is not justified to administer another antipyretic medicine at the same time, unless the use of paracetamol alone is ineffective.

APAP 325 mg and other medicines

Do not take APAP 325 mg with other medicines containing paracetamol.
Medicines that can be taken with APAP 325 mg only after consulting a doctor:

• zidovudine (an antiviral medicine used in HIV infection);
• oral anticoagulants (warfarin, other coumarin derivatives);
• rifampicin and isoniazid (medicines used in the treatment of tuberculosis);
• medicines that increase liver metabolism, including antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine), sedative and hypnotic drugs (e.g., barbiturates);
• non-steroidal anti-inflammatory drugs (NSAIDs) - the risk of kidney function disorders increases;
• metoclopramide or domperidone (medicines used in the treatment of nausea and vomiting);
• propanteline (a medicine used in the treatment of spastic conditions of the digestive tract);
• cholestyramine (a medicine used to lower blood cholesterol levels);
• lamotrigine (an antiepileptic medicine) - its effectiveness may decrease;
• monoamine oxidase inhibitors (MAOIs) (medicines used in the treatment of depression) - excitement and high fever may develop;
• chloramphenicol (an antibiotic) - it may enhance the toxic effects of chloramphenicol, such as vomiting, hypotension, hypothermia;
• probenecid (a medicine that increases uric acid excretion, used in gout) - the dose of paracetamol should be reduced;
• salicylamide;
• caffeine.

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 must be treated urgently (see section 2).

Effect on diagnostic test results
Taking paracetamol may affect the results of uric acid tests using phosphotungstic acid and blood sugar levels using glucose meters that use glucose oxidase and peroxidase.

APAP 325 mg with food, drink, and alcohol

Taking the medicine with food may delay the onset of its action.
When taking paracetamol, do not consume alcohol due to the increased risk of toxic liver damage. Particular risk of liver damage exists in malnourished individuals, regular alcohol drinkers, and patients with alcoholic liver disease without cirrhosis.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
If necessary, APAP 325 mg can be given to pregnant women.
Use the smallest effective dose to relieve pain or reduce fever and take the medicine for as short a time as possible.
If pain is not relieved or fever does not subside, or if it is necessary to increase the frequency of taking the medicine, consult a doctor.
During pregnancy, do not take paracetamol in combination with other medicines, as the safety of the medicine in such cases has not been established.
After oral administration, paracetamol is excreted into human milk in small amounts. No adverse effect on breastfed infants has been reported.
During breastfeeding, therapeutic doses of this medicine can be taken.

Driving and using machines

Taking the medicine does not affect the ability to drive and use machines.

3. How to take APAP 325 mg

This medicine should always be taken exactly as described in this patient leaflet.
In case of doubt, consult a doctor or pharmacist.
The medicine is taken orally. The tablets should be swallowed without chewing, with a sufficient amount of liquid. Taking the medicine with food may delay the onset of its action.

Usual dose of the medicine

Adults and adolescents over 12 years of age
2 tablets (corresponding to 650 mg of paracetamol), which can be repeated if necessary, but not more often than every 4-6 hours. A maximum of 10 tablets (i.e., 3250 mg of paracetamol) per day.
Children aged 6-11 years
1 tablet (i.e., 325 mg of paracetamol), which can be repeated if necessary, but not more often than every 4-6 hours. Do not take more than 5 tablets (i.e., 1625 mg of paracetamol) per day.
Children under 6 years of age
APAP 325 mg coated tablets are not recommended for children under 6 years of age.
Consult a doctor if pain persists for more than 5 days, or fever for more than 3 days.
Patients with liver function disorders
In patients with liver function disorders or Gilbert's syndrome, the doctor will reduce the dose or prolong the intervals between doses.
Patients with kidney function disorders
In patients with kidney function disorders, the doctor will reduce the dose or prolong the intervals between doses. In patients with severe kidney failure (creatinine clearance <10 ml min), the interval between doses must be at least 8 hours.
Patients with chronic alcoholism
Chronic alcohol consumption may lower the toxicity threshold of paracetamol. In these patients, subsequent doses can be taken not more often than every 8 hours. Do not take more than 2 g of paracetamol per day.
Older adults
In older adults, no dose modification is necessary due to age.

Taking a higher dose of the medicine than recommended

In case of taking a higher dose than recommended, consult a doctor immediately, even if no side effects have occurred, as it may lead to life-threatening liver damage. Within a few to several hours after taking the medicine, the following may occur: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite the fact that liver damage has begun, which will then become apparent with abdominal distension, return of nausea, and jaundice.
In every case of taking paracetamol in a single dose of 5 g or more, induce vomiting if it has been less than an hour since ingestion and consult a doctor immediately. To bind the remaining medicine in the stomach, give 60-100 g of activated charcoal orally, preferably mixed with water.

Missing a dose of APAP 325 mg

APAP 325 mg is taken as needed. It should be taken following the instructions given in section 3.

4. Possible side effects

Like all medicines, APAP 325 mg can cause side effects, although not everybody gets them.

If the following symptoms occur, do not continue taking the medicine and consult a doctor immediately. These are life-threatening conditions. They occur very rarely.

• Angioedema, with symptoms such as facial or throat swelling, which may make breathing difficult.
• Anaphylactic shock, with symptoms such as impaired consciousness, pale skin, low blood pressure, sweating, decreased urine production, rapid breathing.
• Severe skin reactions with a sudden onset, with symptoms such as acute pustular rash all over the body, redness, blistering, and erosions that can cover large areas of the skin, mouth, and genitals, fever, joint pain.

Uncommon side effects (occurring in 1 to 10 out of 10,000 patients taking the medicine):

• bone marrow suppression, coagulation disorders;
• hypersensitivity reactions: hives, redness, rash (including generalized);
• depression, confusion, hallucinations;
• tremors, headaches;
• vision disorders;
• edema;
• nausea, vomiting, diarrhea, abdominal pain, digestive disorders;
• increased liver enzyme activity (transaminases), abnormal liver function;
• itching, sweating;
• dizziness, malaise, fever, excessive sedation;
• overdose and poisoning.

Rare side effects (occurring in less than 1 out of 10,000 patients taking the medicine):

• decreased red blood cell count, decreased platelet count, decreased white blood cell count - leukocytes or neutrophils, complete absence of a type of white blood cell - granulocytes;
• hypoglycemia (excessive decrease in blood sugar levels);
• bronchospasm in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, respiratory disorders, asthma attacks;
• bleeding (in the digestive tract);
• acute liver damage, most often due to overdose, liver failure, liver necrosis, jaundice;
• pigmentary purpura;
• severe skin reactions;
• sterile pyuria (cloudy urine).

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

• metabolic acidosis (a disorder of the body's acid-base balance); a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
• acute and chronic pancreatitis;
• interstitial nephritis after long-term use of high doses;

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 gather more information on the safety of the medicine.

5. How to store APAP 325 mg

Product packaged in a blister:
No special storage temperature recommendations for the medicinal product.
Store the blister in the outer packaging to protect it from light.
Product packaged in a bottle:
No special storage recommendations for the medicinal product.
Store in a place out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and inner packaging (month/year).
The expiry date refers to the last day of the stated month. The labeling used for the blister is:
EXP - expiry date, Lot - batch number.

6. Contents of the packaging and other information

What APAP 325 mg contains

• The active substance of the medicine is paracetamol. One coated tablet contains 325 mg of paracetamol.
• Excipients: Core: cornstarch, croscarmellose sodium, povidone, stearic acid. Coating: hypromellose, macrogol 400, macrogol 8000.

What APAP 325 mg looks like and what the packaging contains

A white, elongated tablet with a transparent coating.

Available packaging

PVC/Aluminum blisters in a cardboard box: 2 coated tablets (1 blister of 2), 6 coated tablets (1 blister of 6), 12 coated tablets (1 blister of 12), 24 coated tablets (2 blisters of 12); HDPE bottle with an HDPE cap in a cardboard box: 50 coated tablets (1 bottle of 50).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet:

Monika
Monicz-
Madej