País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diphenhydramine hydrochloride
DE Pharmaceuticals
R06AA02
Diphenhydramine hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100
PACKAGE LEAFLET: INFORMATION FOR THE USER Diphenhydramine 50mg Tablets Diphenhydramine Hydrochloride READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take 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 after 7 days. WHAT IS IN THIS LEAFLET 1. What Diphenhydramine 50mg Tablets are and what are they used for 2. What you need to know before you take Diphenhydramine 50mg Tablets 3. How to take Diphenhydramine 50mg Tablets 4. Possible side effects 5. How to store Diphenhydramine 50mg Tablets 6. Contents of the pack and other information 1. WHAT DIPHENHYDRAMINE 50MG TABLETS ARE AND WHAT ARE THEY USED FOR THESE TABLETS ARE USED TO RELIEVE TEMPORARY SLEEPING DIFFICULTIES. The active ingredient is diphenhydramine hydrochloride, an antihistamine that causes sleepiness or drowsiness. Temporary difficulties in getting a good night's sleep can be caused by various problems such as stress, jet lag or personal problems such as bereavement. In sleep problems of this type, Diphenhydramine 50mg tablets have been shown to help people to fall asleep faster and to have a longer and deeper sleep. You must talk to a doctor after 7 days if you do not feel better, or if you feel worse. You should not drive or operate machinery for at least 8 hours after taking the tablet. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIPHENHYDRAMINE 50MG TABLETS DO NOT TAKE THESE TABLETS: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to diphenhydramine hydrochloride or to any of the other ingredients (listed in Section 6) • if you have an OBSTRUCTION IN YOUR STOMACH OR GUT (for example, because of Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diphenhydramine 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg Diphenhydramine Hydrochloride (equivalent to 43.8mg Diphenhydramine base) Excipients with known effect:168.75mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A white to off white, 15mm in length, oblong capsule-shaped tablet, embossed with “N50” logo on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diphenhydramine 50mg Tablets are indicated as a symptomatic aid to the relief of temporary sleep disturbance in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ One tablet to be taken 20 minutes before going to bed, or as directed by a physician. Do not exceed the maximum dose of one tablet in 24 hours. _Elderly_ The product should only be given to the elderly if the benefits for the patient outweigh the potential risks (see section 4.4). _ _ _Renal and Hepatic Impairment_ In patients with moderate to severe renal or hepatic impairment, a lower dose might be required (see section 4.4). _Paediatric population_ Diphenhydramine 50mg Tablets should not be used in children under 18 years. Method of administration Oral administration only. Do not exceed the stated dose or frequency of dosing. The product should not be taken for more than 7 days without consulting a doctor. 4.3 CONTRAINDICATIONS Diphenhydramine 50mg Tablets are contraindicated in patients who are hypersensitive to the active substance (diphenhydramine hydrochloride) or to any of the excipients listed in section 6.1. Diphenhydramine 50mg Tablets are also contraindicated in patients with the following conditions: • Stenosing peptic ulcer • Pyloroduodenal obstruction • Phaeochromocytoma • Known acquired or congenital QT interval prolongation • Known risk factors for QT interval prolongation including a known cardiovascular disease, significant electrolytes imbalance (hypokalaemia, hypomagnesaemia), family history of Llegiu el document complet