APAP 500 mg/300 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. APAP pain and fever C plus
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is APAP pain and fever C plus and what is it used for
4. Important information before taking APAP pain and fever C plus
5. How to take APAP pain and fever C plus
6. Possible side effects
7. How to store APAP pain and fever C plus
8. Package contents and other information
9. What is APAP pain and fever C plus and what is it used for
10. Important information before taking APAP pain and fever C plus
    1. When not to take APAP pain and fever C plus:
    2. Warnings and precautions
    3. When to exercise special caution when taking APAP pain and fever C plus:
    4. Children
    5. APAP pain and fever C plus and other medicines
    6. APAP pain and fever C plus with food, drink, or alcohol
    7. Pregnancy, breastfeeding, and fertility
    8. Driving and using machines
    9. The medicine contains excipients with known effects:
11. How to take APAP pain and fever C plus
    1. Use in children and adolescents
    2. Adults and adolescents over 12 years of age
    3. Taking a higher dose of APAP pain and fever C plus than recommended
    4. Missing a dose of APAP pain and fever C plus
    5. Stopping treatment with APAP pain and fever C plus
12. Possible side effects
    1. Reporting side effects
13. How to store APAP pain and fever C plus
14. Package contents and other information
    1. What APAP pain and fever C plus contains
    2. What APAP pain and fever C plus looks like and what the package contains
    3. APAP pain and fever C plus is available in:
    4. Marketing authorization holder and importer:
    5. Manufacturer:
    6. Date of the last update of the leaflet:

Leaflet attached to the packaging: patient information

APAP pain and fever C plus

500 mg + 300 mg, effervescent tablets
Paracetamol + Ascorbic acid

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.

• Keep this leaflet, you may need to read it again.
• 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 inform their doctor or pharmacist. See section 4.
• If after 5 days of pain treatment or 3 days of fever treatment there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

2. Important information before taking APAP pain and fever C plus

3. How to take APAP pain and fever C plus

4. Possible side effects

5. How to store APAP pain and fever C plus

6. Package contents and other information

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

APAP pain and fever C plus contains paracetamol and vitamin C. Paracetamol acts as a pain reliever and antipyretic. Ascorbic acid (vitamin C) supplements vitamin C deficiency, supporting the body's immunity during viral infections.
APAP pain and fever C plus is indicated for short-term treatment of pain and/or fever.
If after 5 days of pain treatment or 3 days of fever treatment there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking APAP pain and fever C plus

When not to take APAP pain and fever C plus:

• if the patient is allergic to any active substance or any of the other ingredients of this medicine (listed in section 6);
• if the following diseases occur:
• congenital glucose-6-phosphate dehydrogenase deficiency,
• severe liver or kidney failure,
• viral hepatitis,
• uric acid kidney stones,
• alcoholic disease,
• phenylketonuria (due to the presence of aspartame);
• during treatment with zidovudine or MAO inhibitors (used in HIV therapy and depression) and within 2 weeks of stopping these medications;
• in pregnant or breastfeeding women;
• in children under 12 years of age.

Warnings and precautions

Before starting APAP pain and fever C plus, the patient should discuss it with their doctor or pharmacist.
During treatment with APAP pain and fever C plus, the patient should immediately inform their doctor if:
they have severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition,
they have chronic alcoholism or are taking flucloxacillin (an antibiotic).
In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin.
Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

When to exercise special caution when taking APAP pain and fever C plus:

• if the patient abuses alcohol and starves, as this creates a risk of liver damage;
• if the patient has liver or kidney failure, asthma, hemochromatosis (a disorder of iron absorption) or is on a low-sodium diet.

Children

Use in children under 12 years of age is contraindicated.

APAP pain and fever C plus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The medicine should not be taken at the same time as other medicines:

• containing paracetamol (an active substance found in many medicines used for colds and flu) and vitamin C,
• medicines that accelerate or delay stomach emptying (e.g., metoclopramide or propanteline),
• MAO inhibitors (medicines used, among others, in depression) (see When not to take APAP pain and fever C plus).

The patient should consult their doctor or pharmacist before taking APAP pain and fever C plus with:

• anticoagulant medicines (warfarin, coumarin),
• zidovudine (a medicine used in HIV infection, concomitant use is contraindicated),
• rifampicin, isonicotinic acid hydrazide (medicines used in tuberculosis treatment),
• antiepileptic medicines, e.g., phenytoin, carbamazepine,
• sedative and hypnotic medicines, e.g., phenobarbital,
• medicines containing aluminum (used to alleviate heartburn), iron (used to prevent and treat anemia),
• chloramphenicol (an antibiotic),
• chlorzoxazone (a muscle relaxant),

The patient should inform their doctor or pharmacist if they 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).

Taking the medicine may cause false results in some laboratory tests (e.g., glucose, creatinine).

APAP pain and fever C plus with food, drink, or alcohol

Taking the medicine with food may reduce the absorption of the medicine.
During treatment with APAP pain and fever C plus, the patient should not drink alcohol due to the increased risk of liver damage. Special risk of liver damage exists in starved individuals and those who regularly consume alcohol.

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.

Driving and using machines

APAP pain and fever C plus does not affect the ability to drive and use machines.

The medicine contains excipients with known effects:

Aspartame (E 951)
The medicine contains 15 mg of aspartame in each effervescent tablet. Aspartame is a source of phenylalanine.
It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
Sodium
The medicine contains 375 mg of sodium (the main component of common salt) in 1 effervescent tablet.
This corresponds to 18.75% of the maximum recommended daily intake of sodium in the diet for adults.
Glucose and sucrose
The medicine contains glucose (a component of maltodextrin with flavors) and sucrose (from flavor).
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take APAP pain and fever C plus

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Use in children and adolescents

Use in children under 12 years of age is contraindicated.

Adults and adolescents over 12 years of age

Take 1 tablet at a time. Take every 4-6 hours.
Do not take more than 3 tablets per day.
Before taking the tablet, dissolve it in 1/2 glass of water.

Taking a higher dose of APAP pain and fever C plus than recommended

In case of taking a higher dose of the medicine than recommended, the patient should stop taking the medicine and immediately contact their doctor or the nearest hospital emergency department.
The patient should take the leaflet and the medicine packaging with them.
Procedure after overdose:

• if the patient is conscious and it has been less than 1 hour since the overdose, they should induce vomiting,
• it is worth administering 60-100 g of activated carbon orally, preferably mixed with water. Antidote: up to 24 hours after overdose N-acetylcysteine, methionine.

Overdosed paracetamol may cause severe liver damage, especially in individuals who have previously starved or abused alcohol.
Symptoms may include: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the next day, despite the fact that liver damage is developing, which will then become apparent with abdominal distension, return of nausea, and jaundice.

Missing a dose of APAP pain and fever C plus

APAP pain and fever C plus is used for short-term, occasional treatment of pain and/or fever symptoms.
If a dose of the medicine is missed and the symptoms persist, the patient should take the next dose of the medicine. They should not take a double dose to make up for the missed dose.

Stopping treatment with APAP pain and fever C plus

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, APAP pain and fever C plus can cause side effects, although not everybody gets them. These include:
Uncommon side effects(in 1 to 10 out of 1,000 patients taking the medicine):

• skin and subcutaneous tissue disorders: flushing, urticarial skin reactions, and skin redness.

Rare side effects(in 1 to 10 out of 10,000 patients taking the medicine):
immune system disorders: allergic reactions, such as Quincke's edema, dyspnea, bronchospasm, sweating, nausea, decreased blood pressure to shock symptoms;
gastrointestinal disorders: nausea, vomiting.
Very rare side effects(less than 1 in 10,000 patients taking the medicine):
severe skin reactions characterized by acute generalized pustular rash on the entire body or blisters and erosions on the skin, mouth, eyes, and genital organs, with fever and joint pain or bursting large blisters, extensive erosions on the skin, exfoliation of large skin plates, and fever,
blood and lymphatic system disorders: thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), agranulocytosis (absence of granulocytes in the blood), granulocytopenia (decreased granulocyte count), neutropenia (decreased neutrophil count), hemolytic anemia (rapid breakdown of red blood cells);
hepatic and biliary disorders: liver damage;
renal and urinary disorders: renal colic, renal papillary necrosis, acute renal failure, uric acid kidney stones.
Side effects with unknown frequency(cannot be estimated from available data):
a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 (22) 492 13 01,
fax: +48 (22) 492 13 09
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 pain and fever C plus

Store the medicine at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date stated on the packaging means the last day of the given month.
The labeling on the immediate packaging includes: EXP - expiry date, Lot - batch number.
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 pain and fever C plus contains

The active substances of the medicine are: one tablet contains 500 mg of paracetamol and 300 mg of ascorbic acid (vitamin C).
The other ingredients are: citric acid, sodium bicarbonate, anhydrous sodium carbonate, povidone, Macrogol 6000, lemon flavor 135460 (including citral, corn starch maltodextrin, sucrose), sodium saccharin, aspartame (E 951), lemon-lime flavor 135459 (including citral, geraniol, linalol, corn starch maltodextrin, butylhydroxyanisole (E 320)), magnesium stearate, sodium riboflavin phosphate.

What APAP pain and fever C plus looks like and what the package contains

A tube with a screw cap containing a desiccant, packaged in a cardboard box.
A soft blister pack packaged in a cardboard box.

APAP pain and fever C plus is available in:

Soft blisters in a cardboard box with a leaflet:
2 pieces (1 soft blister pack of 2 pieces)
6 pieces (3 soft blister packs of 2 pieces)
10 pieces (5 soft blister packs of 2 pieces)
20 pieces (10 soft blister packs of 2 pieces)
Containers in a cardboard box with a leaflet:
10 pieces (1 container of 10 pieces)
20 pieces (2 containers of 10 pieces)
Not all pack sizes may be marketed.

Marketing authorization holder and importer:

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

Manufacturer:

Wörwag Pharma Operations Sp. z o.o.
General Mariana Langiewicza Street 58
95-050 Konstantynów Łódzki
To obtain more detailed information about this medicine, the patient should contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of the last update of the leaflet: