Country: Sweden
Language: Swedish
Source: Läkemedelsverket (Medical Products Agency)
melatonin
AGB-Pharma AB
N05CH01
melatonin
2 mg
Tablett
melatonin 2 mg Aktiv substans
Receptbelagt
Förpacknings: Burk, 30 tabletter (barnskyddande); Burk, 30 tabletter; Burk, 100 tabletter (barnskyddande); Burk, 100 tabletter
Godkänd
2019-12-11
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MELATONIN AGB 1 MG TABLETS MELATONIN AGB 2 MG TABLETS MELATONIN AGB 3 MG TABLETS MELATONIN AGB 4 MG TABLETS MELATONIN AGB 5 MG TABLETS melatonin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Melatonin AGB is and what it is used for 2. What you need to know before you take Melatonin AGB 3. How to take Melatonin AGB 4. Possible side effects 5. How to store Melatonin AGB 6. Contents of the pack and other information 1. WHAT MELATONIN AGB IS AND WHAT IT IS USED FOR The active substance of Melatonin AGB, melatonin, belongs to a group of natural hormones produced by the body. The hormone helps regulate the body’s day- and night rhythm. Melatonin AGB is used for: - short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by the time difference when traveling across several time zones. - Insomnia in children and adolescents (6 to 17 years old) with ADHD, where other healthy sleeping routines has not worked well enough. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELATONIN AGB DO NOT TAKE MELATONIN AGB: - if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Melatonin AGB if you have: - diabetes or impaired glucose tolerance, as this medicine may increase the level of glucose in your blood - liver or kidney problems - an autoimmune disease (where the body is ‘attacked’ by its own immune Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Melatonin AGB 1 mg tablets Melatonin AGB 2 mg tablets Melatonin AGB 3 mg tablets Melatonin AGB 4 mg tablets Melatonin AGB 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains 1 mg, 2 mg, 3 mg, 4 mg or 5 mg melatonin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. All strengths: White, round, biconvex tablets, diameter 9.5 mm. Melatonin AGB 1 mg: marked 1 Melatonin AGB 2 mg: marked 2 Melatonin AGB 3 mg: marked 3 Melatonin AGB 4 mg: marked 4 Melatonin AGB 5 mg: marked 5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Melatonin AGB is indicated for: Short term treatment of jet lag in adults (see section 5.1). Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with jet lag_ The recommended dose is 1-5 mg for a maximum of 5 days. The dose should be taken at the time of destination bedtime for journeys of 5 time zones or longer, especially when traveling in an easterly direction. Due to the potential for incorrectly timed intake of melatonin to have no effect, or an adverse effect, on re-synchronisation following jet lag, Melatonin AGB tablets should not be taken before 20:00 hr or after 04:00 hr at destination. 2 As alcohol can impair sleep and potentially worsen certain symptoms of jet lag (e.g. headache, morning fatigue, concentration) it is recommended that alcohol is not consumed when taking Melatonin AGB tablets. A maximum of 16 treatment cycles may occur per year. _Insomnia in children and adolescents with ADHD_ Treatment should be initiated by physicians experienced in ADHD and/or paediatric sleep medicine. Recommended starting dose of Melatonin AGB tablet: 1-2 mg 30-60 minutes before bedtime. The dose of melatonin can be increased by 1 mg every week until effect up to a maximum 5 mg per day, independent of age. The lowest effective dose should be sough Read the complete document