APAP Night x 50 tablets

• A drug used for pain of various origins with accompanying insomnia, including: headaches, bone and joint pain, muscle pain, toothache, menstrual pain, neuralgia, pain associated with colds and flu. Difficulty falling asleep caused by pain.

Composition
1 film-coated tablet contains 500 mg of paracetamol and 25 mg of diphenhydramine hydrochloride.

Action
The preparation combines the analgesic and antipyretic effects of paracetamol and the hypnotic and sedative effects of diphenhydramine. The mechanism of action of paracetamol is the inhibition of arachidonic acid cyclooxygenase activity. This prevents the formation of prostaglandins in the CNS, which results in an increased pain threshold. Reducing the concentration of prostaglandins in the hypothalamus causes an antipyretic effect. It is quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in the blood is reached after 1 hour, T _0.5 is 2-4 hours. The duration of the analgesic effect is determined to be 4-6 hours, and the antipyretic effect is 6-8 hours. Metabolism occurs in the liver, and excretion through the kidneys. Diphenhydramine is a non-selective antagonist of H ₁ receptors (1st generation). It inhibits watery discharge from the nasal mucosa, itching, sneezing and tearing of the eyes. It easily crosses the blood-brain barrier and affects serotonin and H1 receptors _in the CNS, facilitating sleep. It is quickly and almost completely absorbed from the gastrointestinal tract. It reaches maximum concentration in the blood after 1-2 h, T _0.5 is 4-8 h. The effect lasts for 4-6 h. It is 50% metabolized in the liver.

Indications
Pain of various origins with accompanying insomnia including: headache, bone and joint pain, muscle pain, toothache, menstrual pain, neuralgia, pain associated with colds and flu. Difficulty falling asleep due to pain.

Contraindications
Hypersensitivity to the ingredients of the preparation. Severe hepatic or renal failure. Viral hepatitis. Use of MAO inhibitors and the period of up to 2 weeks after their discontinuation. Children under 13 years of age.

Precautions
The use of the preparation by people with liver failure, alcohol abusers and starving poses a risk of liver damage. Use with caution in people with renal failure, bronchial asthma, cardiac arrhythmias, hypertension, epilepsy, prostatic hyperplasia, hyperthyroidism, glaucoma, pyloric stenosis and in the elderly.

Pregnancy and breastfeeding
The preparation should not be used during pregnancy or breastfeeding.

Interactions
Do not use with other drugs containing paracetamol. The effects of anticoagulants (warfarin, coumarin derivatives), drugs that depress the CNS (hypnotics, anxiolytics, opioid analgesics) may be intensified. The preparation may intensify the effects and increase the toxicity of neuroleptics (haloperidol and other butyrophenone derivatives), antidepressants (fluoxetine, paroxetine, tricyclic antidepressants), anticonvulsants (phenytoin, carbamazepine, phenobarbital), rifampicin.

Dosage
Orally. Adults and children over 13 years of age: 1-2 tablets 30 min. before bedtime.

Comments
During the use of the preparation, do not drive or operate machinery. Do not drink alcohol during treatment.