RIZALT RPD 10 MG WAFERS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RIZATRIPTAN AS BENZOATE

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

N02CC04

Pharmaceutical form:

TABLETS SOLUBLE IN MOUTH

Composition:

RIZATRIPTAN AS BENZOATE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

RIZATRIPTAN

Therapeutic area:

RIZATRIPTAN

Therapeutic indications:

Rizalt is indicated for the acute treatment of migraine attacks with or without aura in adults.

Authorization date:

2023-09-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986
This medicine is marketed upon physician's prescription only
RIZALT
®
10 MG
TABLETS
RIZALT
® RPD
®
10 MG
WAFERS
EACH TABLET CONTAINS:
Rizatriptan 10 mg (as benzoate)
EACH WAFER CONTAINS:
Rizatriptan 10 mg (as benzoate)
For a list of inactive ingredients refer to section 6. See also
section 2.7 “Important information about some
of the ingredients of RIZALT 10 MG TABLETS and RIZALT RPD 10 MG
WAFERS”.
Unless otherwise stated, the information in this Patient Information
Leaflet applies to both RIZALT 10 MG
TABLETS and RIZALT RPD 10 MG WAFERS.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
•
This leaflet contains concise information about RIZALT 10 MG TABLETS
and RIZALT RPD 10 MG WAFERS.
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems
to you that their ailment is similar.
•
This medicine is intended for adults above 18 years of age.
1.
WHAT RIZALT IS AND WHAT IT IS INTENDED FOR?
RIZALT is used for the acute treatment of migraine attacks in adults,
with or without aura.
RIZALT is not to be used to prevent migraine attacks.
RIZALT is not for the treatment of hemiplegic or basilar migraines.
It is not known if RIZALT is safe and effective for the treatment of
cluster headaches.
THERAPEUTIC GROUP: RIZALT belongs to a class of medicines called
selective 5-HT
1B/1D
receptor
agonists or Triptans.
2.
BEFORE USING RIZALT
2.1 DO NOT USE RIZALT IF:
−
you are allergic (hypersensitive) to rizatriptan benzoate or any of
the other ingredients of RIZALT
(for the list of inactive ingredients see section 6).
−
you have or have had heart problems.
−
you have or have had a stroke or a transient ischemic attack (TIA).
−
you have or have had blood vessel problems including ischemic bowel
disease.
−
you have uncontrolled high blood pressure.
−
you are concurrently taking antidepressa

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
RIZALT
®
10 mg Tablets
RIZALT RPD
®
10 mg Wafers
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RIZALT 10 MG TABLETS
Each tablet contains 14.53 mg of rizatriptan benzoate (corresponding
to 10 mg of the rizatriptan).
Excipient(s) with known effect
Lactose monohydrate 60.5 mg in the 10 mg tablet.
RIZALT RPD 10 MG WAFERS
Each tablet contains 14.53 mg of rizatriptan benzoate (corresponding
to 10 mg of the rizatriptan).
For the full list of excipients, see section
2
1 .
3. PHARMACEUTICAL FORM
RIZALT 10 MG TABLETS
Tablet
10 mg tablets are pale pink, capsule-shaped, convex tablets, coded 267
on one side and plain on the
other.
RIZALT RPD 10 MG WAFERS
Wafer
10 mg wafers are white to off-white, round with a flat or slightly
irregular surface and a modified square on
one side and plain on the other side, with a peppermint flavour.
4.
THERAPEUTIC INDICATIONS
RIZALT
®
Tablets and RIZALT RPD
®
10 mg Wafers (orally disintegrating tablets) are indicated for the
acute treatment of migraine with or without aura in adults.
Limitations of Use
•
RIZALT should only be used where a clear diagnosis of migraine has
been established. If a patient
has no response for the first migraine attack treated with RIZALT, the
diagnosis of migraine should be
reconsidered before RIZALT is administered to treat any subsequent
attacks.
•
RIZALT
is
not
indicated
for
use
in
the
management
of
hemiplegic
or
basilar
migraine
[_see_
_Contraindications_ (6)].
•
RIZALT is not indicated for the prevention of migraine attacks.
•
Safety and effectiveness of RIZALT have not been established for
cluster headache.
5
DOSAGE AND ADMINISTRATION
5.1
DOSING INFORMATION IN ADULTS
The recommended starting dose of RIZALT is 10 mg for the acute
treatment of migraines in adults.
_Redosing _
Although the effectiveness of a second dose or subsequent doses has
not been established in
placebo-controlled trials, if the migraine headache returns, a second
dose may be administered 2
hours after the first dose. The maximum daily dose should