Maxalt Melt 10mg oral lyophilisates

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Rizatriptan benzoate

Предлага се от:

Sigma Pharmaceuticals Plc

АТС код:

N02CC04

INN (Международно Name):

Rizatriptan benzoate

дозиране:

10mg

Лекарствена форма:

Oral lyophilisate

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04070401

Листовка

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

Данни за продукта

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