Apap Nbg

Package Leaflet: Information for the Patient

APAP NBG, 500 mg + 50 mg, 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 this package leaflet or as directed by a doctor or pharmacist.

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

Table of Contents of the Package Leaflet

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

1. What is APAP NBG and what is it used for

APAP NBG contains two active substances: paracetamol and caffeine.
Paracetamol has analgesic and antipyretic effects. Caffeine is a substance that has a mildly stimulating effect on the central nervous system.
The addition of caffeine to paracetamol significantly increases its effectiveness in treating tension headaches. Caffeine also accelerates the onset of action of paracetamol.
The indication for use of the medicine is mild or moderate tension headache.
Tension headaches are the most common type of headache. Tension headaches are described as dull, pressing, band-like, and squeezing, radiating from the forehead to the back of the head, often also affecting the back of the neck.
If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking APAP NBG

When not to take APAP NBG

• If you are allergic to paracetamol or caffeine or any of the other ingredients of this medicine (listed in section 6).
• In patients with alcoholism.
• In patients with diagnosed hemolytic anemia or congenital glucose-6-phosphate dehydrogenase deficiency.
• In patients with diagnosed congenital methemoglobin reductase deficiency.
• In severe renal or hepatic impairment.
• In patients with heart rhythm disorders.
• In patients taking monoamine oxidase inhibitors (MAOIs) and for up to 2 weeks after their discontinuation.
• In women during the first trimester of pregnancy and during breastfeeding.
• In children under 12 years of age.

Warnings and precautions

Before starting treatment with APAP NBG, discuss with your doctor or pharmacist if you have any of the following conditions:

• liver function disorders,
• use of drugs that induce liver microsomal enzymes (see "APAP NBG and other medicines"),
• alcohol abuse,
• dehydration,
• possible glutathione deficiency (e.g., in patients with nutritional disorders, fasting, cystic fibrosis, HIV infection, wasting),
• you should immediately inform your doctor if you have severe diseases, including severe kidney or liver disorders, or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are 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 regular 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, feeling of nausea (nausea) and vomiting,
• kidney function disorders,
• asthma,
• hyperthyroidism,
• sleep disorders in the form of insomnia,
• aspirin asthma, hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• gout,
• hypertension, due to the risk of increased blood pressure.

The medicine contains paracetamol.Due to the risk of overdose, do not take with other medicines containing paracetamol.
In case of overdose, consult a doctor immediately, even if you feel well, due to the risk of delayed, severe liver damage.
Do not drink alcohol while taking this medicine (see "APAP NBG with alcohol").
Long-term use of the medicine without medical supervision may be harmful.
Long-term use of high doses may cause interstitial nephritis.

Children and adolescents

Do not use in children under 12 years of age.

APAP NBG and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Do not take this medicine at the same time as other medicines containing paracetamol or caffeine.

Before taking APAP NBG, tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, especially if you are taking:

• oral anticoagulants (preventing blood clots, such as warfarin or acenocoumarol),
• dipyridamole (often used in hospitals during heart function tests),
• rifampicin (an antibacterial medicine, including for the treatment of tuberculosis),
• carbamazepine, phenobarbital, phenytoin, stiripentol, and lamotrigine (used in the treatment of epilepsy),
• St. John's Wort (used in the treatment of mild depression),
• isoniazid (used in the treatment of tuberculosis),
• salicylamide (used in fever and mild pain),
• metoclopramide and domperidone (used during nausea and vomiting),
• cholestyramine (used in the treatment of high cholesterol and reducing fat in the blood),
• propantheline (a medicine used in spastic conditions of the digestive tract),
• fluvoxamine, monoamine oxidase inhibitors (see also "When not to take APAP NBG") and lithium (used in the treatment of anxiety, depression, and other mental states), diazepam (used in the treatment of anxiety or as a sedative),
• sleeping pills,
• zidovudine (used in the treatment of HIV infection),
• probenecid (used in the treatment of gout),
• levothyroxine (used in the treatment of thyroid diseases),
• beta-blockers such as atenolol, metoprolol, oxprenolol, or propranolol (used in the treatment of high blood pressure and heart diseases),
• phenylpropanolamine and ephedrine (vasoconstrictor medicines) or theophylline (used in the treatment of asthma),
• disulfiram (used in the treatment of alcoholism),
• clozapine (used in the treatment of, among other things, schizophrenia),
• methoxsalen (used in the treatment of skin disease, psoriasis),
• pipemidic acid (used in the treatment of infections),
• chloramphenicol, ciprofloxacin, norfloxacin, enoxacin, rifampicin (antibiotics),
• mexiletine (used in arrhythmias),
• oral contraceptives,
• cimetidine (used in gastric ulcer disease),
• verapamil (used in the treatment of heart diseases),
• lithium salts (medicines used in the treatment of mental disorders).

Tell 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 urgently treated (see section 2).

Effect on diagnostic test results
Taking paracetamol may affect the results of blood sugar level measurements using glucose meters that use glucose oxidase and peroxidase.
Paracetamol use may interfere with glucose and uric acid measurements in the blood.
If you have been referred for these tests, tell your doctor or nurse that you are taking a paracetamol-containing medicine.
Caffeine use should be stopped at least 5 days before cardiac muscle imaging.
For 24 hours before the test, avoid consuming coffee, tea, and chocolate.

Using APAP NBG with food, drink, and alcohol

Do not drink alcohol while taking this medicine containing paracetamol due to the increased risk of liver damage.
Limit the amount of caffeine-containing beverages (see "Warnings and precautions" above).
While taking APAP NBG, you should limit your consumption of products containing caffeine. Since caffeine is a natural ingredient in tea, coffee, chocolate, and some carbonated drinks, it is possible to overdose on it. You should consider the caffeine content in your diet and other medical sources and ensure that you do not exceed the permissible dose.
Typical caffeine content in some beverages and foods:

• brewed coffee: 50-100 mg/100 ml*
• instant coffee and tea: 20-73 mg/100 ml*
• carbonated drinks (cola): 9-19 mg/100 ml*
• chocolate: 5-20 mg/100 ml* (*100 ml corresponds to 1 small cup of beverage).

APAP NBG contains sodium

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Do not use APAP NBG during the first trimester of pregnancy.
Your doctor will decide whether you can use this medicine during the second and third trimesters of pregnancy, only if in their opinion the benefit to the mother outweighs the potential risk to the fetus.
During pregnancy, there is a slowing of caffeine metabolism and higher concentrations in serum after taking the same dose of the medicine.
Caffeine passes into breast milk. Do not use APAP NBG during breastfeeding.

Driving and using machines

Taking APAP NBG does not affect or has a minor effect on the ability to drive and use machines.

3. How to take APAP NBG

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose

Adults and adolescents over 12 years of age

Orally 1 or 2 tablets. If necessary, the dose can be administered every 4-6 hours, up to a maximum of 8 tablets in 24 hours.
Without consulting a doctor, do not use the medicine for more than 3 days.

Use in children

Do not use in children under 12 years of age.

Taking a higher dose of APAP NBG than recommended

If you take a dose higher than recommended, consult a doctor immediately, even if you do not experience any side effects, as this may lead to life-threatening paracetamol poisoning and 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 resolve the next day, despite the fact that liver damage is beginning to develop, which will then become apparent with abdominal distension, return of nausea, and jaundice. Paracetamol overdose may cause metabolic acidosis, the symptoms of which include:

• deep, rapid, and difficult breathing,
• feeling of nausea and vomiting,
• loss of appetite.

Acute caffeine poisoning occurs very rarely. It is manifested by abdominal pain, insomnia, frequent urination, dehydration, anxiety, nervousness, restlessness, insomnia, stimulation, muscle tremors, confusion, and fever. More severe poisoning is manifested by rapid heartbeat, heart rhythm disorders, and convulsions.
In any case of taking more than 8 tablets of the medicine in 24 hours or a single dose of paracetamol of 5 g or more, you should induce vomiting if it has been less than an hour since ingestion and immediately consult a doctor. To bind the remaining medicine in the stomach, it is worth administering 60-100 g of activated charcoal orally, preferably mixed with water.

Missing a dose of APAP NBG

If your doctor recommends regular use, 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.
If you experience any of the following symptoms, 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 that may make breathing difficult;
• anaphylactic shock, with symptoms such as altered consciousness, pale skin, low blood pressure, sweating, decreased urine production, rapid breathing;
• severe skin reactions, with symptoms such as acute vesicular rash on the entire body, erythema, erosions that may cover large areas of the body, mouth, and genitals, bursting giant blisters, exfoliation of large skin plates, fever, joint pain.

Frequent (may affect less than 1 in 10 people)

• mild drowsiness.

Uncommon (may affect less than 1 in 100 people)

• dizziness, drowsiness, nervousness.

Rare (may affect less than 1 in 1,000 people)

• bone marrow suppression,
• coagulation disorders,
• allergic reactions: urticaria, erythema, rash (including generalized),
• depression, confusion, hallucinations,
• tremors, headache,
• vision disorders,
• edema,
• nausea, vomiting, diarrhea, abdominal pain, digestive disorders,
• increased liver enzyme activity (transaminases), abnormal liver function,
• itching, sweating,
• malaise, fever,
• overdose and poisoning.

Very rare (may affect less than 1 in 10,000 people)

• anemia (reduced red blood cell count), thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), or neutropenia (reduced neutrophil count), agranulocytosis (almost complete lack of granulocytes),
• hypoglycemia (low blood sugar level),
• bronchospasm in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, respiratory disorders, asthma attack,
• acute liver damage, most often due to overdose, liver failure, liver necrosis, jaundice,
• pigmentary purpura,
• sterile pyuria (cloudy urine).

Frequency not known (cannot be estimated from the available data)

• a serious condition that can cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2),
• insomnia, restlessness, anxiety, irritability,
• palpitations,
• acute or chronic pancreatitis,
• interstitial nephritis after long-term use of high doses.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, consult 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
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store APAP NBG

Keep the medicine out of the sight and reach of children.
Store the medicine at a temperature below 30 °C.
Do not use this medicine after the expiry date stated on the carton and blister pack (month/year). The expiry date refers to the last day of the stated month.
The labeling on the blisters is: EXP - expiry date, Lot - batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What APAP NBG contains

The active substances of the medicine are: paracetamol and caffeine.
One tablet contains 500 mg of paracetamol and 50 mg of caffeine.
The other ingredients are: povidone (K29/32), potato starch, microcrystalline cellulose, sodium carboxymethyl cellulose (Type A), talc, anhydrous colloidal silica, magnesium stearate.

What APAP NBG looks like and contents of the pack

The medicine is in the form of oblong, biconvex, white tablets with a dividing line. The dividing line on the tablet only facilitates its breaking, for easier swallowing, and does not divide it into equal doses.
For oral use, packaged in PVC/PVDC/Aluminum blisters and a carton with a package leaflet.
The medicine is available in packs of:
6, 8, 10, 12, 24 tablets in blisters.
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 on this medicine, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
tel. +48 22 543 60 00

Date of last revision of the package leaflet: