Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rizatriptan benzoate
Mawdsley-Brooks & Company Ltd
N02CC04
Rizatriptan benzoate
10mg
Oral lyophilisate
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401
PATIENT INFORMATION LEAFLET MAXALT ® MELT 10 MG ORAL LYOPHILISATE (RIZATRIPTAN BENZOATE) 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 further questions, ask your doctor or pharmacist. The name of this medicine is Maxalt Melt 10 mg Oral Lyophilisate but it will be referred to as Maxalt Melt or Maxalt throughout the remainder of this leaflet. 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 Maxalt Melt is and what it is used for 2) What you need to know before you take Maxalt Melt 3) How to take Maxalt Melt 4) Possible side effects 5) How to store Maxalt Melt 6) Contents of the pack and other information 1) WHAT MAXALT MELT IS AND WHAT IT IS USED FOR Maxalt Melt belongs to a class of medicines called selective serotonin 5-HT 1B/1D receptor agonists. Maxalt Melt is used to treat the headache phase of the migraine attack in adults. Treatment with Maxalt Melt: Reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack. 2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAXALT MELT DO NOT TAKE MAXALT MELT IF: you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6) you have moderately severe or severe high blood pressure or mild high blood pressure that is not controlled by medication you have or have ever had heart problems including heart attack or pain on the chest (angina) or you have experienced heart disease related signs you have severe liver or severe kidney problems you have had a stroke (cerebrovascular accident CVA) or mini stroke (tr Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MAXALT® MELT 10 mg oral lyophilisates 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each oral lyophilisate contains 14.53 mg of rizatriptan benzoate (corresponding to 10 mg of the rizatriptan). Excipients with known effect: aspartame (E951) 3.75 mg in the 10mg oral lyophilisate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral lyophilisate 10 mg oral lyophilisates are white to off-white, round with a modified square on one side, with a peppermint flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute treatment of the headache phase of migraine attacks with or without aura in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration MAXALT MELT oral lyophilisates should not be used prophylactically. MAXALT MELT oral lyophilisates need not be taken with liquid. The oral lyophilisate is packaged in a blister within an outer aluminium sachet. Patients should be instructed not to remove the blister from the outer sachet until just prior to dosing. The blister pack should then be peeled open with dry hands and the oral lyophilisate placed on the tongue, where it will dissolve and be swallowed with the saliva. MAXALT MELT is also available as a tablet formulation. The oral lyophilisate can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids. Posology Adults 18 years of age and older The recommended dose is 10 mg. _Redosing:_ Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period. • _for headache recurrence within 24 hours:_ If headache returns after relief of the initial attack, one further dose may be taken. The above dosing limits should be observed. • _after non-response:_ The effectiveness of a second dose for treatment of the same attack, when an initial dose is ineffective, has not been examined in controlled trials. Therefore, if a patien Прочетете целия документ