Страна: Швеция
Язык: шведский
Источник: Läkemedelsverket (Medical Products Agency)
melatonin
Evolan Pharma AB
N05CH01
melatonin
1 mg/ml
Oral lösning
propylenglykol Hjälpämne; melatonin 1 mg Aktiv substans; bensylalkohol Hjälpämne
Receptbelagt
Förpacknings: Flaska, 150 ml; Flaska, 100 ml; Flaska, 200 ml
Godkänd
2022-07-01
PACKAGE LEAFLET: INFORMATION FOR THE USER MELATONIN EVOLAN 1 MG/ ML ORAL SOLUTION 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Melatonin Evolan is and what it is used for 2. What you need to know before you take Melatonin Evolan 3. How to take Melatonin Evolan 4. Possible side effects 5. How to store Melatonin Evolan 6. Contents of the pack and other information 1. WHAT MELATONIN EVOLAN IS AND WHAT IT IS USED FOR Melatonin Evolan contains the active substance melatonin, which belongs to a group of natural hormones produced by the body. Melatonin helps regulate the body’s day and night rhythm. Melatonin Evolan can be used for: - short-term treatment of jet lag in adults. Jet lag is characterized by sleep disturbances, daytime fatigue, exhaustion, mild cognitive symptoms, irritability and gastrointestinal disturbances after a flight. - insomnia in children and adolescents aged 6-17 years with ADHD where other sleep-supporting measures has not worked well enough. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MELATONIN EVOLAN DO NOT TAKE MELATONIN EVOLAN - 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 Melatonin Evolan, if you have: - epilepsy, as melatonin might increase or decrease the frequency of seizures. - an autoimmune disease (where the body is ‘attacked’ by its own immune system). - diabetes or impaired glucose tolerance, as this medicine m Прочитать полный документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Melatonin Evolan 1 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml oral solution contains 1 mg melatonin. Excipients with known effect: Benzyl alcohol 6 mg/ml Propylene glycol 52 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear, pale yellow to yellow coloured solution with strawberry taste. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 1-5 mg (1-5 ml) and should be taken at bedtime, for 4-7 days. The dose may be increased up to 5 mg (5 ml) if symptoms are not sufficiently relieved at lower doses. The first dose should be taken on arrival at the destination, at the usual bedtime. 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 Evolan should not be taken before 20:00 or after 04:00 at destination. A maximum of 16 treatment cycles of jet lag with Melatonin Evolan may occur per year. _Insomnia in children and adolescents with ADHD _ The treatment must be initiated by physicians with experience in ADHD and/or the treatment of sleep disorders in children. The standard dose is 1-2 mg (equivalent to 1-2 ml) 30 to 60 minutes before bedtime. The dose of melatonin can be increased by 1 mg (1 ml) per week until an effect is achieved to a maximum of 5 mg (5 ml) daily, regardless of age. The lowest effective dose should be sought. Limited data are available for up to 3 years of treatment. After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant 2 treatment effect is seen. The patient should be monitored at regular intervals (at least ev Прочитать полный документ