Rizatriptan 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RIZATRIPTAN

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

N02CC04

INN (International Name):

RIZATRIPTAN 5 mg

Pharmaceutical form:

TABLET

Composition:

RIZATRIPTAN 5 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2014-04-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIZATRIPTAN 5 MG TABLETS
RIZATRIPTAN 10 MG TABLETS
rizatriptan
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 Rizatriptan is and what it is used for
2.
What you need to know before you take Rizatriptan
3.
How to take Rizatriptan
4.
Possible side effects
5.
How to store Rizatriptan
6.
Contents of the pack and other information
1.
WHAT RIZATRIPTAN IS AND WHAT IT IS USED FOR
Rizatriptan belongs to a class of medicines called selective serotonin
5-HT1B/1D receptor agonists.
Rizatriptan is used to treat the headache phase of the migraine attack
in adults.
Treatment with Rizatriptan:
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 RIZATRIPTAN
DO NOT TAKE RIZATRIPTAN:

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 arteries (peripheral vascular
disease)

you are taking monoamine oxidase (MAO) inhibitors such

Summary of Product characteristics

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rizatriptan 5 mg tablets
Rizatriptan 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.265 mg of rizatriptan benzoate equivalent to 5
mg of rizatriptan.
Each tablet contains 14.530 mg of rizatriptan benzoate equivalent to
10 mg of rizatriptan.
Excipients with known effect:
Each tablet contains 30.25 mg of lactose monohydrate.
Each tablet contains 60.50 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
_Rizatriptan 5 mg tablets: _
Pale pink coloured, circular, flat, beveled edge uncoated tablets
debossed with ‘X’ on one side and
‘13’ on other side. The tablets may be mottled.
_Rizatriptan 10 mgt tablets: _
Pale pink coloured, circular, flat, beveled edge uncoated tablets
debossed with ‘X’ on one side and
‘14’ on other side. The tablets may be mottled.
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
_General_
Rizatriptan 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.).
Rizatriptan is also available as an alternative orodispersible
tablets.
Page 2 of 11
Adults 18 years of age and older
The recommended dose is 10 mg.
_ _
_Redosing:_ Doses should be separated by at least 2 hours; no more
than 2 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,