Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diphenhydramine hydrochloride
Crescent Pharma Ltd
R06AA02
Diphenhydramine hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5017123096259
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET: 1. What this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR This medicine contains the active substance diphenhydramine hydrochloride which is an antihistamine with sedative properties which induces drowsiness or sedation. It works by reducing the time needed to fall asleep and increases the depth and quality of sleep. This medicine is used to aid relief of temporary sleep disturbance (difficulties sleeping) in adults and children over 16 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE DO NOT TAKE THIS MEDICINE: • if you are allergic to diphenhydramine hydrochloride or any of the other ingredients of this medicine (listed in section 6) • if you have a peptic ulcer • if you have a blockage between your stomach and small intestine. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking this medicine: • if you suffer from myasthenia gravis (abnormal muscle function) • if you suffer from seizures or have epilepsy • if you have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD) • if you have narrow angle glaucoma • if you have enlarged prostate • if you have difficulty urinating • if you have moderate to severe liver or kidne Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diphenhydramine Hydrochloride Tablets 25 mg Tesco Sleep Aid 25 mg Tablets Lunox Sleep Aid 25 mg Tablets Llodys Pharmacy Sleep Aid 25mg Tablets Careway Sleep Aid 25mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Diphenhydramine hydrochloride 25 mg For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet. White, circular, normal convex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An aid to the relief of temporary sleep disturbance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Dosage instructions: Two tablets to be taken 20 minutes before going to bed, or as directed by a physician. Do not exceed the stated dose or frequency of dosing. Children: Do not use in children under 16 years. This medicinal product should not be used continuously for longer than 2 weeks without consulting a doctor. 4.3 CONTRAINDICATIONS Hypersensitivity to diphenhydramine hydrochloride or to any of the excipients. Contraindicated for use in patients with the following conditions: stenosing peptic ulcer, pyloroduodenal obstruction. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Diphenhydramine should be used with caution in patients with myasthenia gravis, epilepsy or seizure disorders, prostatic hypertrophy, urinary retention, narrow-angle glaucoma, asthma, bronchitis and chronic obstructive pulmonary disease (COPD), moderate to severe hepatic impairment and moderate to severe renal impairment. Tolerance may develop with continuous use. Seek medical advice if sleeplessness persists, as insomnia may be a symptom of a serious underlying medical illness. This medicinal product should not be used continuously for longer than 2 weeks without consulting a doctor. May increase the effects of alcohol, therefore alcohol should be avoided. Avoid use of other antihistamine-containing preparations, including topical antihistamines and cough and cold medicines. Use with caution in the elderly, who are more likely to experience side-effects. Avo Lugege kogu dokumenti