দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Diphenhydramine hydrochloride
Chefaro Ireland DAC
R06AA; R06AA02
Diphenhydramine hydrochloride
50 milligram(s)
Tablet
Product not subject to medical prescription
Aminoalkyl ethers; diphenhydramine
Marketed
2017-05-26
PACKAGE LEAFLET: INFORMATION FOR THE USER Nytol One‐A‐Night 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 Nytol One‐A‐Night 50mg Tablets are and what are they used for 2. What you need to know before you take Nytol One‐A‐Night 50mg Tablets 3. How to take Nytol One‐A‐Night 50mg Tablets 4. Possible side effects 5. How to store Nytol One‐A‐Night 50mg Tablets 6. Contents of the pack and other information 1. WHAT NYTOL ONE‐A‐NIGHT 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, Nytol One‐A‐Night 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 NYTOL ONE‐A‐NIGHT 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 সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 03 December 2021 CRN00C94P Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nytol One-A-Night 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg Diphenhydramine Hydrochloride (equivalent to 43.8 mg Diphenhydramine base) Excipients with known effect: 168.75 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A white to off white, 15 mm in length, oblong capsule-shaped tablet, embossed with “N50” logo on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nytol One-A-Night 50 mg 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_ Nytol One-A-Night 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 Nytol One-A-Night 50 mg 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. Nytol One-A-Night 50mg Tablets are also contraindicated in patients with the following conditions: Stenosing peptic ulcer Pyloroduodenal obstruction Phaeochromocytoma Health Products Regulatory Authority 03 December 2021 CRN00C94P Page 2 of 6 Known acquired or congenital QT interval prolongation Kno সম্পূর্ণ নথি পড়ুন