Rizatriptan 10mg orodispersible 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 10 mg

Pharmaceutical form:

ORODISPERSIBLE TABLET

Composition:

RIZATRIPTAN 10 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2013-03-14

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
RIZATRIPTAN 5 MG ORODISPERSIBLE TABLETS
RIZATRIPTAN 10 MG ORODISPERSIBLE 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)
•
If you have moderately severe or severe high blood pressure, or mild
high blood pressure
that is not controlled by medication
•
If 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
•
If you have severe liver or severe kidney problems
•
If you have had a stroke (cerebrovascular accident CVA) or mini stroke
(transient
ischaemic attack TIA)
•
If you have blockage problems with your arteries (peripheral vascular
disease)
•

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rizatriptan 5 mg orodispersible tablets
Rizatriptan 10 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 7.265 mg of rizatriptan benzoate
equivalent to 5 mg of
rizatriptan.
Each orodispersible tablet contains 14.530 mg of rizatriptan benzoate
equivalent to 10 mg of
rizatriptan.
Excipients with known effect
Each orodispersible tablet contains 1.870 mg of aspartame.
Each orodispersible tablet contains 3.741 mg of aspartame.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
_Rizatriptan 5 mg Orodispersible Tablets: _
White to off-white coloured, circular, biconvex, uncoated tablets
debossed with ‘F24’ on one
side and plain on other side with a peppermint flavor.
_Rizatriptan 10 mg Orodispersible Tablets: _
White to off-white coloured, circular, biconvex, uncoated tablets
debossed with ‘F25’ on one
side and plain on other side with a peppermint flavor.
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.
Rizatriptan orodispersible tablets need not be taken with liquid.
The orodispersible tablet is packaged in an aluminium blister.
Patients should be instructed
not to remove the orodispersible tablet from the blister until just
prior to dosing. The
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orodispersible tablet should then be removed from the aluminium
blister with dry hands and
the placed on the tongue, where it will dissolve and be swallowed with
the saliva.
The orodispersible tablet 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 2 hours;