Country: Svíþjóð
Tungumál: sænska
Heimild: Läkemedelsverket (Medical Products Agency)
prometazinhydroklorid
Actavis Group PTC ehf.
R06AD02
promethazine
25 mg
Filmdragerad tablett
prometazinhydroklorid 25 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 2 tabletter; Blister, 4 tabletter; Blister, 8 tabletter; Blister, 12 tabletter; Blister, 16 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 100 tabletter
Godkänd
2016-11-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Prometazin Actavis 25 mg film-coated tablets promethazine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS INPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it in to others. It may harm them, even if their signs of illness are the same as yours. - 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. WHAT IS IN THIS LEAFLET 1. What Prometazin Actavis is and what it is used for 2. What you need to know before you take Prometazin Actavis 3. How to take Prometazin Actavis 4. Possible side effects 5. How to store Prometazin Actavis 6. Content of the pack and other information 1. WHAT PROMETAZIN ACTAVIS IS AND WHAT IT IS USED FOR Prometazin Actavis contains a medicine called promethazine hydrochloride. It belongs to a group of medicines called phenothiazines. It works by blocking the natural substance histamine in your body that causes itching during an allergic reaction. This medicine also has a sedative effect. Prometazin Actavis can be used in the following situations: - short-term treatment of sleep disorders - short-term treatment of anxiety symptoms - to help you feel more relaxed before an operation or a dental procedure - to treat or stop motion sickness (e.g. sea sickness) - to treat itchiness of the skin and allergies - to treat or stop you feeling sick and dizzy 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROMETAZIN ACTAVIS DO NOT TAKE PROMETAZIN ACTAVIS - if you are allergic to promethazine hydrochloride or any of the other ingredients of this medicine (listed in section 6). - if you are taking a medicine for depression belonging to a group of medicines called monoamine oxidase inhibitors (MAOIs). Also, do not take Prometazin Actavis if you have stopped taki Lestu allt skjalið
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Prometazin Actavis 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg of promethazine hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White coloured, oval shaped, 9.8 x 6.2 mm biconvex, film-coated tablets debossed with "C25" on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Short-term treatment of sleep disorders - Symptomatic short-term treatment of anxiety - Premedication in surgical and dental practice - Motion sickness - Allergic reactions of different origins - Pruritus - Nausea and vertigo (morning sickness, Ménière's disease, nausea after radium treatment and anaesthetics) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prometazin Actavis should be used at the lowest effective dose and for the shortest possible treatment period. The recommended dose should not be exceeded (see also section 4.4). SYMPTOMATIC SHORT-TERM TREATMENT OF ANXIETY: _Adults:_ 25-50 mg, 1-3 times a day. SHORT-TERM TREATMENT OF SLEEP DISORDERS: _Adults:_ 25-50 mg 1-2 hours before bedtime. Sometimes this dose can lead to residual morning drowsiness, which disappears after a few days continuous medication, In many cases, a lower dose will give adequate effect. In more severe cases, the dose is increased. _Children 5-12 years-of-age: _ 25 mg 1-2 hours before bedtime. Usually, the hypnotic effect decreases with continuous use. In more severe cases of sleep disorder, intermittent medication may be necessary (a break every third or fourth night). Elderly people can usually take promethazine continuously as a hypnotic. Patients with some form of lesion will rarely tolerate high doses. 2 MOTION SICKNESS: _Adults: _ 25 mg, 1-2 hours before the trip or alternatively the evening before the trip. If needed, two extra doses can be taken within a 24-hour period. ALLERGIC CONDITIONS: _Adults:_ 25-50 mg at night; PREMEDICATION: Lestu allt skjalið