Rizatriptan 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rizatriptan benzoate

Available from:

A A H Pharmaceuticals 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: 5025903014898 5025903014904

Patient Information leaflet

The active ingredient in this medicine,
rizatriptan belongs to a group of medicines
called selective serotonin 5-HT
1B/1D
receptor agonists.
Rizatriptan is used to treat the headache
phase of the migraine attack in adults.
DO NOT TAKE RIZATRIPTAN IF YOU:
• are allergic (hypersensitive) to rizatriptan
or any of the other ingredients of
Rizatriptan _(see Section 6 and end of _
_ Section 2)._
• are currently taking monoamine oxidase
(MAO) inhibitors such as moclobemide,
phenelzine, tranylcypromine (used to
treat depression) or linezolid (drug used
to treat bacterial infections), or have
taken MAO inhibitors within the last two
weeks (see section ‘_Other medicines _
_ and Rizatriptan_’)
• have severely impaired liver or kidney
function.
• have had a previous stroke
(cerebrovascular accident or CVA) or
symptoms similar to a stroke which wear
off after a day or two (transient
ischaemic attack or TIA).
• have moderately severe or severe high
blood pressure, or mild high blood pressure
that is NOT controlled by medication.
• have ever suffered from heart disease
(poor blood flow in the arteries of the
heart), heart attack or a particular type of
chest pain known as Prinzmetal’s angina.
• have had problems with the blood supply
to your legs (peripheral vascular disease).
• are taking any other medicine for your
migraine such as ergotamine,
ergotamine-type medicines
(dihidroergotamine, methysergide), or
another medicine in the same class (i.e.
5-HT
1B/1D
receptor agonists, such as
sumatriptan, naratriptan or zolmitriptan)
(_see section ‘Other medicines and _
_ Rizatriptan_’).
TAKE SPECIAL CARE WITH RIZATRIPTAN
Talk to your doctor before taking
Rizatriptan if you have:
• any of the following risk factors for heart
disease:
- high blood pressure or diabetes
- you smoke or are using a nicotine
substitute
- a family history of heart disease
- you are a man over 40 years, or a
post-menopausal woman.
• kidney or liver problems.
• a particular problem with the way your
heart beats (bundle branch bl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rizatriptan 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains 10 mg of rizatriptan (as rizatriptan
benzoate).
Excipients: Aspartame 8 mg.
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
10 mg tablets are white to off white, approximately 9 mm round, flat,
beveled edged
uncoated tablets, engraved with ‘468’ on one side and plain on
other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks, with or
without aura in
adults.
Rizatriptan should not be used prophylactically.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 Rizatriptan, in
particular the
following patient groups:
− patients on propranolol. Administration of rizatriptan should be
separated by at least
two hours from administration of propranolol. (See section 4.5)
− patients with mild or moderate renal insufficiency.
− patients with mild to moderate hepatic insufficiency.
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 s