Land: Schweden
Sprache: Schwedisch
Quelle: Läkemedelsverket (Medical Products Agency)
melatonin
EQL Pharma AB
N05CH01
melatonin
0,5 mg
Tablett
melatonin 0,5 mg Aktiv substans
Receptbelagt
Förpacknings: Burk, 30 tabletter; Burk, 26 tabletter; Burk, 100 tabletter
Godkänd
2021-02-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MELLOZZAN 0.5 MG TABLETS MELLOZZAN 1 MG TABLETS MELLOZZAN 2 MG TABLETS MELLOZZAN 3 MG TABLETS MELLOZZAN 4 MG TABLETS MELLOZZAN 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 Mellozzan is and what it is used for 2. What you need to know before you take Mellozzan 3. How to take Mellozzan 4. Possible side effects 5. How to store Mellozzan 6. Contents of the pack and other information 1. WHAT MELLOZZAN IS AND WHAT IT IS USED FOR The active substance of Mellozzan, melatonin, belongs to a group of natural hormones produced by the body. The hormone helps regulate the body’s day and night rhythm. Mellozzan 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 (attention-deficit hyperactivity disorder), where other healthy sleeping routines have not worked well enough. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELLOZZAN DO NOT TAKE MELLOZZAN - 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- or pharmacist before taking Mellozzan: - if you have diabetes or impaired glucose tolerance, as this medicine may increase the level of glucose in your blood (see section 3); - if you have liver or kidney problems; - if you have an autoimmune disease (where th Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mellozzan 0.5 mg tablets Mellozzan 1 mg tablets Mellozzan 2 mg tablets Mellozzan 3 mg tablets Mellozzan 4 mg tablets Mellozzan 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg, 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 to yellowish, round biconvex tablet. Mellozzan 0.5 mg: marked “0” on one side, tablet size, 7.5 mm diameter Mellozzan 1 mg: marked “1” on one side, tablet size, 9.5 mm diameter Mellozzan 2 mg: marked “2” on one side, tablet size, 7.0 mm diameter Mellozzan 3 mg: marked “3” on one side, tablet size, 8.0 mm diameter Mellozzan 4 mg: marked “4” on one side, tablet size, 9.0 mm diameter Mellozzan 5 mg: marked “5” on one side, tablet size, 10.0 mm diameter 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mellozzan is indicated for: - Short-term treatment of jet lag in adults - 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 0.5-5 mg for a maximum of 5 days. The maximum daily dose is 5 mg once daily. The dose that adequately alleviates symptoms should be taken for the shortest period. The dose should be taken before bedtime at the destination for journeys of 5 time zones or longer, especially when traveling in an easterly direction. As incorrectly timed intake of melatonin may result in no effect or an adverse effect on resynchronization of jet lag, Mellozzan tablets should not be taken before 20:00 or after 04:00 at the destination time. _Paediatric population_ The safety and efficacy of melatonin in children and adolescents less than 18 years in jet lag has not been established. _Insomnia in children and adolescents aged 6-17 years with ADHD_ Treatment should be initiated by physicians experienced in ADHD and/or Lesen Sie das vollständige Dokument