Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Promethazine hydrochloride
Sanofi Consumer Healthcare
R06AD02
Promethazine hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100
PACKAGE LEAFLET: INFORMATION FOR THE USER PHENERGAN NIGHT TIME 25MG FILM-COATED TABLETS promethazine hydrochloride Is this leaflet hard to see or read? Phone 0845 372 7101 for help READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Always take this medicine exactly as described in the 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 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 Phenergan Night Time is and what it is used for 2. What you need to know before you take Phenergan Night Time 3. How to take Phenergan Night Time 4. Possible side effects 5. How to store Phenergan Night Time 6. Contents of the pack and other information 1. WHAT PHENERGAN NIGHT TIME IS AND WHAT IT IS USED FOR Phenergan Night Time contains a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed. WHAT PHENERGAN NIGHT TIME IS USED FOR Phenergan Night Time is used to treat the following conditions: • For short term use: to treat adults with difficulty sleeping (insomnia) • For short term use: as a sedative for children aged 16 years and above 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENERGAN NIGHT TIME DO NOT TAKE THIS MEDICINE IF: The person taking the medicine is under 16 years of age You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Phenergan Night Time (listed in section 6 below) The signs of an allergic reaction include: a rash, swallowing or breathing p Przeczytaj cały dokument
OBJECT 1 PHENERGAN NIGHT TIME 25 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 14-Sep-2017 | SANOFI 1. Name of the medicinal product Phenergan Night Time 25 mg Film-coated Tablets. 2. Qualitative and quantitative composition Each film-coated tablet contains 25 mg of the active substance promethazine hydrochloride. Also contains 173.52 mg of lactose monohydrate. For the full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated tablets (tablets) Pale blue film coated tablets marked PN 25 on one side. 4. Clinical particulars 4.1 Therapeutic indications For short term use in the treatment of insomnia in adults and as a sedative in children over 16 years of age. 4.2 Posology and method of administration Method of administration: For oral use. Adults (including the elderly) and children over 16 years of age 25mg or 50mg as a single night time dose. Paediatric population: Not to be used in children under 16 years of age. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Phenergan Night Time should not be used in patients in coma or suffering from CNS depression of any cause. Phenergan Night Time should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously. 4.4 Special warnings and precautions for use Phenergan Night Time may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis. Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy or hepatic and renal insufficiency. Caution should be exercised in patients with bladder neck or pyloro-duodenal obstruction. The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye's Syndrome. Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracr Przeczytaj cały dokument