Apap Noc

Leaflet attached to the packaging: patient information

APAP Noc

Paracetamol + Diphenhydramine hydrochloride

500 mg + 25 mg coated tablets

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

2. Important information before using APAP Noc

3. How to use APAP Noc

4. Possible side effects

5. How to store APAP Noc

6. Contents of the packaging and other information

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

APAP Noc is a pain reliever and antipyretic that combines the action of paracetamol with the sedative and hypnotic action of diphenhydramine. It relieves pain, facilitates falling asleep, and prevents nighttime awakenings caused by pain.

The indication for use is short-term treatment of pain, including: headache, musculoskeletal pain, muscle pain, toothache, menstrual pain, neuralgia, pain associated with colds and flu, causing difficulty falling asleep.

2. Important information before using APAP Noc

When not to use APAP Noc:

• during treatment with MAO inhibitors (drugs used in depression) and within 2 weeks of stopping these medications;
• in children under 12 years of age;

Warnings and precautions

Before starting to use APAP Noc, you should discuss it with your doctor or pharmacist.

• using the medicine by people with liver failure, alcohol abusers, and fasting carries a risk of liver damage;
• use with caution in people with kidney failure, heart rhythm disorders, hypertension, epilepsy, myasthenia gravis, hyperthyroidism, pyloric stenosis, and in the elderly;
• do not drink alcohol while taking the medicine;
• the medicine should be taken only before bedtime.

During the use of APAP Noc, you should immediately inform your doctor if:

• the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when the patient is also 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 used 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.

Children

Use in children under 12 years of age is contraindicated.

APAP Noc and other medicines

You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

APAP Noc should not be used at the same time as other medicines containing paracetamol and diphenhydramine.

In the case of concurrent use of anticoagulant medicines (warfarin and other coumarin derivatives), medicines acting depressively on the central nervous system (such as sleeping pills, sedatives, and opioid painkillers), neuroleptic medicines (used in states of excessive excitement), antidepressant medicines (fluoxetine, paroxetine, tricyclic antidepressants), antiepileptic medicines (phenytoin, carbamazepine, phenobarbital), and rifampicin (an antibiotic used, among other things, in the treatment of tuberculosis) - before taking the medicine, you should consult a doctor.

You should inform your doctor or pharmacist if the patient is 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).

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

APAP Noc with food and drink

Food does not reduce the absorption of the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

The medicine should not be used in pregnant and breastfeeding women.

Driving and using machines

While using the medicine, you should not drive vehicles or operate machinery in motion.

3. How to use APAP Noc

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

In case of doubts, you should consult a doctor or pharmacist.

Adults and adolescents over 12 years of age:

Oral administration. Use only before bedtime.

Adults and adolescents from 16 years of age: 1 or 2 tablets 30 minutes before bedtime. Do not take more than 2 tablets per day.

Adolescents from 12 to 15 years of age: 1 tablet 30 minutes before bedtime. Do not take more than 1 tablet per day.

Do not take a dose larger than recommended.

Long-term use without medical supervision may be harmful. Do not use the medicine for more than 7 days without consulting a doctor.

In case of persistent symptoms, you should contact your doctor.

Administration of the medicine to children under 12 years of age is contraindicated.

Using a higher dose of APAP Noc than recommended

Severe nausea, vomiting, excessive sweating, drowsiness, and general weakness may occur.

These symptoms may resolve the next day, despite the fact that liver damage is beginning to develop, which will later manifest as abdominal distension, return of nausea, and jaundice.

Due to the risk of irreversible liver damage in case of overdose, you should immediately contact a doctor.

Missing a dose of APAP Noc

Do not take a double dose to make up for a missed dose.

Stopping the use of APAP Noc

In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

They include:

• common side effects (more than 1 in 100, but less than 1 in 10 people using the medicine):
• drowsiness, attention disorders, dizziness;
• dryness of the mucous membranes of the mouth, throat, and nose.

uncommon side effects (between 1 in 100 and 1 in 1,000 people using the medicine):

• allergic reactions, such as hives, rash, urticaria (including generalized), edema;
• disorientation, anxiety;
• blurred vision;
• tachycardia, arrhythmia;
• gastrointestinal disorders, nausea, vomiting, diarrhea, abdominal pain, digestive disorders;
• itching, sweating;
• urinary retention.

rare side effects (between 1 in 1,000 and 1 in 10,000 people using the medicine):

• anemia, bone marrow suppression, thrombocytopenia (decreased platelet count), agranulocytosis (very significant decrease or absence of white blood cells), leukopenia (decrease in leukocyte count), neutropenia (decrease in neutrophil count);
• pharyngeal edema, angioedema, anaphylactic shock (dizziness, impaired consciousness, accelerated heart rate, decreased blood pressure), Stevens-Johnson syndrome (vesicular multiforme erythema), toxic epidermal necrolysis;
• dizziness;
• bronchospasm in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs;
• bleeding, acute and chronic pancreatitis;
• acute liver damage, most often due to paracetamol overdose, liver failure, liver necrosis, jaundice;
• petechiae;
• renal papillary necrosis during long-term use; nephropathy, tubulopathy (kidney damage).

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

• a serious disease that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell 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 gather more information on the safety of the medicine.

5. How to store APAP Noc

Store the medicine at a temperature below 30°C.

Keep out of sight and reach of children.

Store the blister in the outer packaging to protect from light.

Do not use the medicine after the expiry date stated on the carton and inner packaging (month/year).

The applied labeling for the blister is: EXP - expiry date; Lot - batch number.

The expiry date means the last day of the given month.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What APAP Noc contains

The active substances of the medicine are:

Paracetamol

500 mg

Diphenhydramine hydrochloride

25 mg

The other ingredients are:

tablet core:pregelatinized starch, povidone, crospovidone, stearic acid, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, cornstarch, brilliant blue, lake (E 133);

coating:Opadry Blue YS-1-10524 (hypromellose, titanium dioxide (E 171), macrogol 400, brilliant blue, lake (E 133), polysorbate 80, carmine (E 132));

coating:colorless coating (hypromellose, macrogol 400, macrogol 8000).

What APAP Noc looks like and what the packaging contains

Blue, elongated, coated tablets with the inscription "APAP N" embossed on one side; intended for oral administration, packaged in blisters or bottles and cartons with a leaflet.

APAP Noc is available in the following packaging:

6, 12, 24 tablets in blisters and 50 tablets in a bottle.

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 about this medicine, you should 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 leaflet: