Apap night

Package leaflet: Information for the patient

APAP Noc
Paracetamolum + Diphenhydramini hydrochloridum
500 mg + 25 mg
Film-coated tablets
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if you feel worse, contact your doctor.

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

1. What APAP Noc is and what it is used for
APAP Noc is an analgesic and antipyretic medicine combining the action of paracetamol with the calming and sleep-inducing effect 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, bone and joint pain, muscle pain, toothache, menstrual pain, neuralgia, and pain associated with colds and flu, when such pain causes difficulty in falling asleep.

2. Important information before taking APAP Noc

When not to take APAP Noc:

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have any of the following conditions: severe liver or kidney failure, viral hepatitis, glaucoma, benign prostatic hyperplasia, porphyria, or acute exacerbation of bronchial asthma;
• during treatment with MAO inhibitors (medicines used for depression) and within 2 weeks after stopping these medicines;
• in children under 12 years of age;
• in pregnant and breastfeeding women.

Warnings and precautions
Before starting treatment with APAP Noc, consult your doctor or pharmacist.

• Use of this medicine in patients with liver dysfunction, chronic alcohol abuse, or malnutrition may increase the risk of liver damage;
• use with caution in patients with kidney dysfunction, cardiac arrhythmias, hypertension, epilepsy, myasthenia gravis, hyperthyroidism, pyloric stenosis, and in elderly patients;
• alcohol must not be consumed during treatment;
• this medicine should be taken only before bedtime.

During treatment with APAP Noc, inform your doctor immediately if:

• you have severe medical conditions, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In such cases, patients using paracetamol regularly over a prolonged period or taking paracetamol together with flucloxacillin have been reported to develop a serious condition called metabolic acidosis (an imbalance in blood and body fluids). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children
Use in children under 12 years of age is contraindicated.

APAP Noc and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take APAP Noc together with other medicines containing paracetamol or diphenhydramine.
Before taking APAP Noc, consult your doctor if you are also taking anticoagulants (such as warfarin or other coumarin derivatives), central nervous system depressants (such as hypnotics, sedatives, or opioid analgesics), neuroleptics (used in states of excessive agitation), antidepressants (fluoxetine, paroxetine, tricyclic antidepressants), antiepileptic drugs (phenytoin, carbamazepine, phenobarbital), or rifampicin (an antibiotic used, among others, in the treatment of tuberculosis).
Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

This medicine contains less than 1 mmol (23 mg) of sodium per single dose (1–2 tablets), meaning it is considered "sodium-free".

APAP Noc with food and drink
Food does not reduce the absorption of the medicine.

Pregnancy, breastfeeding, and effects on fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
This medicine must not be used in pregnant or breastfeeding women.

Driving and operating machinery
Do not drive or operate machinery during treatment with this medicine.

3. How to use APAP Noc

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years of age:
Oral administration. Use only before bedtime.
Adults and adolescents aged 16 years and older: 1 or 2 tablets 30 minutes before bedtime.
Do not exceed 2 tablets per day.
Adolescents aged 12–15 years: 1 tablet 30 minutes before bedtime. Do not exceed 1 tablet per day.
Do not take more than the recommended dose.
Prolonged use without medical supervision may be harmful. Do not use this medicine for longer than 7 days without consulting a doctor.
If symptoms persist, consult a doctor.
Use of this medicine in children under 12 years of age is contraindicated.
Overdose of APAP Noc
Symptoms may include severe nausea, vomiting, excessive sweating, drowsiness, and general weakness.
These symptoms may resolve the next day, even though liver damage may have started to develop, later presenting as upper abdominal discomfort, recurrence of nausea, and jaundice.
Due to the risk of irreversible liver damage in case of overdose, seek immediate medical attention.
Missed dose of APAP Noc
Do not take a double dose to make up for a missed dose.
Stopping treatment with APAP Noc
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, APAP Noc may cause adverse effects, although not everyone experiences them.
These include:

Common adverse effects (occurring in more than 1 in 100 but less than 1 in 10 people using the medicine):

• drowsiness, attention disturbances, dizziness;
• dryness of the mucous membranes of the mouth, throat, and nose.

Uncommon adverse effects (occurring in 1 to 10 in 10,000 patients using the medicine):

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

Rare adverse effects (occurring in less than 1 in 10,000 patients using the medicine):

• anemia, bone marrow suppression, thrombocytopenia (reduced platelet count), agranulocytosis (severe reduction or absence of white blood cells), leukopenia (reduced number of leukocytes), neutropenia (reduced number of neutrophils);
• laryngeal edema, angioedema, anaphylactic shock (dizziness, disturbances of consciousness, increased heart rate, drop in blood pressure), Stevens-Johnson syndrome (erythema multiforme with blistering), toxic epidermal necrolysis;
• dizziness;
• bronchospasm in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs;
• hemorrhage, acute and chronic pancreatitis;
• acute liver injury, most frequently occurring as a result of paracetamol overdose, liver failure, liver necrosis, jaundice;
• pigmented purpura;
• necrosis of renal papillae during prolonged use; nephropathies, tubulopathies (kidney damage).

Adverse effects with unknown frequency (cannot be estimated based on available data):

• serious condition which may lead to blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl/
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide 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 the 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 immediate packaging (month/year).
Blister labelling: EXP – expiry date; Lot – batch number.
The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What Apap Noc contains
The active substances are:
Paracetamol 500 mg
Diphenhydramine hydrochloride 25 mg
The other ingredients are:
tablet core: pregelatinized starch, povidone, crospovidone, stearic acid, microcrystalline cellulose, sodium carboxymethylstarch, magnesium stearate, corn starch, brilliant blue, lac (E 133);
coating: Opadry Blue YS-1-10524 (hypromellose, titanium dioxide (E 171), polyethylene glycol 400, brilliant blue, lac (E 133), polysorbate 80, carmine (E 132));
coating: colourless coating (hypromellose, polyethylene glycol 400, polyethylene glycol 8000).

What Apap Noc looks like and contents of the pack
Blue, film-coated, elongated tablets with the imprint "APAP N" embossed on one side; intended for oral administration by swallowing, packed in blisters and placed in a cardboard box with a leaflet.

Pack sizes available:
6, 12, 24 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
US Pharmacia Sp. z o.o.
Ziębicka 40
50-507 Wrocław
For further information about this medicinal product, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
Tel.: +48 (22) 543 60 00