Rizatriptan 10mg orodispersible tablets sugar free

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:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401

Summary of Product characteristics

OBJECT 1
RIZATRIPTAN 10 MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 06-Jan-2014 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Rizatriptan 10 mg orodispersible tablets
2. Qualitative and quantitative composition
Each orodispersible tablet contains 14.530 mg of rizatriptan benzoate
equivalent to 10 mg of rizatriptan.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Orodispersible tablet.
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 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.
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