Rizatriptan 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rizatriptan benzoate

Available from:

Milpharm 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: 8901175023837 8901175023844

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIZATRIPTAN 5 MG TABLETS
RIZATRIPTAN 10 MG TABLETS
rizatriptan
P15XXXXX
Black
have migraine. You should take
Rizatriptan only for a migraine
attack. Rizatriptan should not
be used to treat headaches that
might be caused by other, more
serious conditions.
Please tell your doctor if you
are taking or have recently
taken or plan to take, any other
medicines including medicines
obtained without a prescription.
This includes herbal medicines
and those you normally take
for a migraine. This is because
Rizatriptan can affect the way
some medicines work. Also other
medicines can affect Rizatriptan.
OTHER MEDICINES AND
RIZATRIPTAN
Tell your doctor or pharmacist
if you are taking, have recently
taken or might take any other
medicines.
Do not take Rizatriptan:
•
if you are already taking a
5HT1B/1D agonist (sometimes
referred to as ‘triptans’), such
as sumatriptan, naratriptan or
zolmitriptan.
•
if you are taking a monoamine
oxidase (MAO) inhibitor such
as moclobemide, phenelzine,
tranylcypromine, linezolid,
or pargyline or if it has been
less than two weeks since
you stopped taking an MAO
inhibitor.
•
if you use ergotamine-
type medications such as
ergotamine or dihydro-
ergotamine to treat your
migraine
•
if you use methysergide to
prevent a migraine attack.
The above listed medicines
when taken with Rizatriptan may
increase the risk of side effects.
You should wait at least 6 hours
after taking Rizatriptan before you
take ergotamine-type medications
such as ergotamine or dihydro-
ergotamine or methysergide.
You should wait at least 24
hours after taking ergotamine-
type medications before taking
Rizatriptan.
Ask your doctor for instructions
and the risks about taking
Rizatriptan
•
if you are taking propranolol
(see section 3: How to take
Rizatriptan)
•
if you are taking SSRIs such
as sertraline, escitalopram
oxalate, and fluoxetine or
SNRIs such as venlafaxine,
and duloxetine for depression.
RIZATRIPTAN WITH FOOD, DRINK AND
ALCOHOL
Rizatriptan can take longer to
w

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rizatriptan 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 14.530 mg of rizatriptan benzoate equivalent to
10 mg of
rizatriptan.
Excipients with known effect:
Each tablet contains 60.50 mg of lactose monohydrate.
For
the
full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Pale pink coloured, circular, flat, bevelled 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.
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, 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 Rizatri