Rizatriptan 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rizatriptan benzoate

Available from:

Lupin Healthcare (UK) Ltd

ATC code:

N02CC04

INN (International Name):

Rizatriptan benzoate

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401; GTIN: 5060346430010 5060346430027

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 TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT
YOU NEED TO KNOW BEFORE YOU TAKE RIZATRIPTAN
TABLETS
3. HOW TO TAKE RIZATRIPTAN TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE RIZATRIPTAN TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT RIZATRIPTAN TABLETS ARE AND WHAT THEY ARE USED
FOR
Rizatriptan belongs
to a class
of
medicines
called serotonin
5-HT
1B/1D
receptor agonists. Rizatriptan Tablets is used to treat the
headache phase of the migraine attack in adults.
Treatment with Rizatriptan Tablets:
Reduces swelling of blood vessels surrounding the brain.
This
swelling results in the headache pain of a migraine attack.
Rizatriptan Tablets can be used to treat
migraine attacks which
may or may not be associated with visual disturbances (an aura).
They are not used to prevent migraine attacks.
Please tell your doctor or pharmacist about your symptoms. Your
doctor will decide if you suffer from migraines. You should take
Rizatriptan Tablets
ONLY FOR A MIGRAINE
attack.
This medicine
should not
be used to treat
headaches that
might
be caused by
other, more serious conditions.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZATRIPTAN
TABLETS
DO NOT TAKE RIZATRIPTAN TABLETS
-
you are allergic to rizatriptan or any of the other ingredients of
this medicine (listed in section 6)
-
you have moderately severe or severe high blood pre

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rizatriptan
10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg
One tablet contains 14.53 mg rizatriptan benzoate, equivalent to 10 mg
rizatriptan.
Excipients: lactose 118.74 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
10mg Tablet
Light pink to pink coloured, capsule shaped, biconvex, un-coated
tablet with “R” on
one side and “10” on the other side
Length – 11.90 ± 0.20 mm
Width – 4.70 ± 0.20 mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks with or
without
aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_General_
Rizatriptan should not be used prophylactically.
The 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).
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.
Doses should be separated by at least two hours; no more than two
doses
should be taken in any 24-hour period.
Patients older than 65 years
The safety and effective