Maxalt 5mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Rizatriptan benzoate

Disponible depuis:

CST Pharma Ltd

Code ATC:

N02CC04

DCI (Dénomination commune internationale):

Rizatriptan benzoate

Dosage:

5mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04070401; GTIN: 5055946807171 5055946807188

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
MAXALT
® 5MG TABLETS
(RIZATRIPTAN)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
The name of your medicine is Maxalt 5mg tablets, and will be referred
to as Maxalt throughout this leaflet. Maxalt Tablets are also
available in
10mg strengths.
•
Keep this leaflet. You may need to read it again.
•
If you have 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 Maxalt is and what it is used for
2) What you need to know before you take Maxalt
3) How to take Maxalt
4) Possible side effects
5) How to store Maxalt
6) Contents of the pack and other information
1) WHAT MAXALT IS AND WHAT IT IS USED FOR
Maxalt belongs to a class of medicines called selective serotonin
5-HT
1B/1D
receptor agonists.
Maxalt is used to treat the headache phase of the migraine attack in
adults.
Treatment with Maxalt:
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
DO NOT TAKE MAXALT IF:
•
you are allergic 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
(transient ischaemic attack TIA)
•
you have blockage problems with your arteri

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MAXALT
®
5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding
to 5 mg
of the rizatriptan).
Excipients with known effect: lactose monohydrate 30.25 mg in the 5 mg
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
5 mg tablets are pale pink, capsule-shaped, coded MSD on one side and
266
on the other.
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 should not be used prophylactically.
The oral tablets should be swallowed whole with liquid.
_ _
_Effect of Food_: The absorption of rizatriptan is delayed by
approximately 1
hour when administered together with food. Therefore, onset of effect
may be
delayed
when
rizatriptan
is
administered
in
the
fed
state
(see
also
Pharmacokinetic properties, Absorption).
MAXALT is also available as an alternative oral lyophilisate.
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 patient does not respond to the
first
dose, a second dose should not be taken for the same attack_. _
Clinical studies have shown that patients who do not respond to
treatment of
an attack are still likely to respond to treatment for subsequent
attacks.
Some
patients
should
receive
the
lower
(5
mg)
dose
of
MAXALT,
in
particular the following patient groups:
−
pa