Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lisdexamfetamine dimesylate
Takeda UK Ltd
N06BA12
Lisdexamfetamine dimesylate
30mg
Oral capsule
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04040000; GTIN: 5022690008895
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ELVANSE ADULT 30 MG CAPSULES, HARD ELVANSE ADULT 50 MG CAPSULES, HARD ELVANSE ADULT 70 MG CAPSULES, HARD Lisdexamfetamine dimesylate This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. THIS MEDICINE IS USED TO TREAT ADHD: The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’. The medicine helps with your brain activity. It can help improve your attention, help you concentrate, and make you less impulsive. You need to have other treatments for ADHD (such as counselling and behavioural therapy) as well as this medicine. Read Section 1 for more information. BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF YOU: have heart, circulation, or mental health problems - you may not be able to take this medicine. are taking any other medicines - this is because Elvanse Adult can affect how other medicines work. Read Section 2 for more information. WHILE TAKING THIS MEDICINE: See your doctor regularly. This is because your doctor will want to check how the medicine is working. Do not stop taking the medicine without first talking to your doctor. If you take your medicine for more than a year, your doctor may stop your medicine to see if it is still needed. The most common side effects in adults are decreased appetite, being unable to sleep, dry mouth or headache. Read Sections 3 and 4 for more information. TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE FOLLOWING HAPPEN: Your mood or how you feel changes. You feel any problems with your heart. Read Section 4 for more information. THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER IMPORTANT INFORMATION TO HELP YOU U Pročitajte cijeli dokument
OBJECT 1 ELVANSE ADULT 30MG CAPSULES, HARD Summary of Product Characteristics Updated 03-Nov-2017 | Shire Pharmaceuticals Limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Elvanse Adult 30 mg capsules, hard. Elvanse Adult 50 mg capsules, hard. Elvanse Adult 70 mg capsules, hard. 2. Qualitative and quantitative composition 30 mg Capsules: Each capsule contains 30 mg lisdexamfetamine dimesylate, equivalent to 8.9 mg of dexamfetamine. 50 mg Capsules: Each capsule contains 50 mg lisdexamfetamine dimesylate, equivalent to 14.8 mg of dexamfetamine. 70 mg Capsules: Each capsule contains 70 mg lisdexamfetamine dimesylate, equivalent to 20.8 mg of dexamfetamine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsule, hard. Elvanse Adult 30 mg capsule: white opaque body and pink opaque cap, printed 'S489' and '30 mg' in black ink. Elvanse Adult 50 mg capsule: white opaque body and blue opaque cap, printed 'S489' and '50 mg' in black ink. Elvanse Adult 70 mg capsule: blue opaque body and pink opaque cap, printed 'S489' and '70 mg' in black ink. Each capsule measures approximately 16 mm long and 6 mm wide. 4. Clinical particulars 4.1 Therapeutic indications Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults. Elvanse Adult is not indicated in all adult patients and the decision to use the medicinal product must take into consideration the profile of the patient, including a thorough assessment of the severity and chronicity of the patient's symptoms, the potential for abuse, misuse or diversion and clinical response to any previous pharmacotherapies for the treatment of ADHD. Treatment must be under the supervision of a specialist in behavioural disorders. Diagnosis should be Pročitajte cijeli dokument