Stopadol Night 30 tablets

Stopadol Night 30 tablets

Composition:

Each tablet contains:
Paracetamol — 500 mg;
Diphenhydramine hydrochloride — 25 mg.
Excipients: corn starch, polyvinylpyrrolidone, microcrystalline cellulose, cetylstearyl alcohol, magnesium stearate, colloidal silicon dioxide, ethanol, Opadry Blue.

Product Description:

Stopadol Night is a combination of paracetamol and diphenhydramine.
Paracetamol provides analgesic and antipyretic effects through inhibition of prostaglandin synthesis in the CNS.
Diphenhydramine is an H1 antihistamine with sedative, anticholinergic, and local anesthetic properties, helping relieve pain and promote sleep.

Indications for Use:

Short‑term treatment of pain interfering with sleep, including rheumatic pain, muscle pain, backache, toothache, migraine, headache, and menstrual pain.

Method of Administration and Dosage:

• Oral use only.
• Adults (including elderly) and children ≥16 years: 2 tablets 20 minutes before bedtime.
• Maximum daily dose: 2 tablets (1000 mg paracetamol, 50 mg diphenhydramine).
• Other paracetamol products may be used during the day, but total dose must not exceed 6 tablets in 24 hours.
• Do not repeat more frequently than every 4 hours.
• Not recommended for children under 16 years unless medically indicated.
• Do not use for more than 7 consecutive nights without medical advice.
• Tablets must be swallowed whole with water.

Contraindications:

Hypersensitivity to paracetamol, diphenhydramine, or excipients.
Porphyria.

Precautions:

• Contains paracetamol: avoid concurrent use of other paracetamol products.
• Risk of overdose is higher in patients with alcoholic liver disease.
• Avoid alcohol and other sedatives.
• Use with caution in hepatic or renal impairment, epilepsy, myasthenia, narrow‑angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis, COPD.
• Contraindicated with MAO inhibitors or within 2 weeks of discontinuation.
• Possible drug interactions:
  Paracetamol absorption increased by metoclopramide/domperidone, reduced by cholestyramine.
  Warfarin/coumarins: prolonged use may enhance anticoagulant effect.
  Diphenhydramine potentiates CNS depressants and alcohol.
  Diphenhydramine may interact with CYP2D6 substrates (e.g., metoprolol, venlafaxine).
• Elderly patients are more prone to confusion and paradoxical excitation.
• Do not exceed recommended dose or duration.

Adverse Reactions / Side Effects:

• Blood and lymphatic system: thrombocytopenia, agranulocytosis (rare).
• Immune system: anaphylaxis, hypersensitivity skin reactions (rash, urticaria, angioedema).
• Very rare: severe skin reactions.
• Respiratory system: bronchospasm.
• Hepatic: impaired liver function.
• Common: fatigue, sedation, drowsiness, dry mouth, dizziness, impaired attention.
• Nervous system: confusion, paradoxical excitation (especially in elderly); rare — seizures, headache, paresthesia.
• Eyes: blurred vision.
• Cardiovascular: tachycardia, palpitations.
• Gastrointestinal: nausea, vomiting.
• Urinary system: difficulty urinating, urinary retention.

Pregnancy and Lactation:

• Pregnancy: use only if benefit outweighs risk.
  Minimal effective dose and shortest duration recommended.
  Paracetamol: epidemiological data show no adverse effects at recommended doses, but medical advice required.
  Diphenhydramine: insufficient data; potential risk unknown.
  Sedating antihistamines may cause neonatal reactions if used in the third trimester.
• Lactation: not recommended without medical advice.
  Paracetamol is considered safe; diphenhydramine data are insufficient.

Storage Conditions:

Store at temperatures not exceeding 30 °C, in a dry place, protected from light.

Packaging:

Carton box containing 3 blisters of 10 film‑coated tablets and a leaflet.