Consumer medicine information

1. Why am I using RIZATRIPTAN WAFERS-10 MG?

RIZATRIPTAN WAFERS-10 MG contains the active ingredient rizatriptan benzoate. RIZATRIPTAN WAFERS-10 MG is used to relieve the headache pain and other symptoms of acute migraine attacks.
For more information, see Section 1. Why am I using RIZATRIPTAN WAFERS-10 MG? in the full CMI.

2. What should I know before I use RIZATRIPTAN WAFERS-10 MG?

Do not use if you have ever had an allergic reaction to RIZATRIPTAN WAFERS-10 MG or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use RIZATRIPTAN WAFERS-10 MG? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with RIZATRIPTAN WAFERS-10 MG and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use RIZATRIPTAN WAFERS-10 MG?

• Take RIZATRIPTAN WAFERS-10 MG wafers only when prescribed by your doctor.

• The usual dose to treat a migraine is one 10 mg wafer

• If the first RIZATRIPTAN WAFERS-10 MG Wafer does help your migraine, but it comes back later, you may take another wafer. Take the second wafer at least 2 hours after the first. Do not take more than 30 mg (three 10 mg wafers) in a 24 hour period.

5. What should I know while using RIZATRIPTAN WAFERS-10 MG?

6. Are there any side effects?

The Common side effects are dizziness, sleepiness and tiredness. As with other medicines in the same class as RIZATRIPTAN WAFERS-10 MG, heart attack, angina and stroke have been reported very rarely, and generally occurred in people with risk factors for heart or blood vessel disease.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Rizatriptan benzoate.

2 Qualitative and Quantitative Composition

Rizatriptan benzoate is a white to off-white, crystalline solid. Rizatriptan benzoate is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.
Each lyophilised wafer contains 14.53 mg of rizatriptan benzoate (corresponding to 10 mg rizatriptan).
List of excipients with known effect. Mannitol, aspartame.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

10 mg wafer - White to off-white round wafer with a flat or slightly irregular surface and a modified square on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
No overdoses of Rizatriptan Wafers-10 mg were reported during clinical trials.
Rizatriptan 40 mg (administered as either a single dose or as two doses with a 2-hour inter-dose interval) was generally well tolerated in over 300 patients; dizziness and somnolence were the most common drug-related adverse effects.
In a clinical pharmacology study in which 12 subjects received rizatriptan, at total cumulative doses of 80 mg (given within four hours), two subjects experienced syncope and/or bradycardia. One subject, a female aged 29 years, developed vomiting, bradycardia, and dizziness beginning three hours after receiving a total of 80 mg rizatriptan (administered over two hours). A third degree AV block, responsive to atropine, was observed an hour after the onset of the other symptoms. The second subject, a 25 year old male, experienced transient dizziness, syncope, incontinence, and a 5 second systolic pause (on ECG monitor) immediately after a painful venipuncture. The venipuncture occurred two hours after the subject had received a total of 80 mg rizatriptan (administered over four hours).
In addition, based on the pharmacology of rizatriptan, hypertension or other more serious cardiovascular symptoms could occur after overdosage. Gastrointestinal decontamination (e.g. gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with Rizatriptan Wafers-10 mg. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
The effects of haemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Rizatriptan, with and without metabolic activation, was neither genotoxic, mutagenic, nor clastogenic in all in vitro and in vivo genetic toxicity studies, including: microbial mutagenesis, in vitro chromosome aberration assays, in vitro V-79 mammalian cell mutagenesis assays, an in vitro alkaline elution/rat hepatocyte assay, and an in vivo chromosome aberration assay in mouse bone marrow.
Carcinogenicity. The carcinogenic potential of rizatriptan was evaluated in a 106 week study in rats and a 100 week study in mice at oral doses of up to 125 mg/kg/day. Exposure data were not obtained in those studies, but plasma AUC's of the parent drug were measured in other studies and indicate that exposures to the parent drug at the highest dose level would have been approximately 150 times (mice) and 240 times (rats) average AUC's measured in humans after three 10 mg doses, the maximum recommended daily dose. There was no evidence of an increase in tumour incidence related to rizatriptan in either species.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Rizatriptan benzoate is described chemically as: N,N- dimethyl-5-(1H- 1,2,4-triazol- 1-ylmethyl)-1H -indole-3-ethanamine monobenzoate.
Its empirical formula is C₁₅H₁₉N₅.C₇H₆O₂. The molecular weight of the benzoate salt is 391.47; the molecular weight of the free base is 269.4.
Chemical structure. Its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSRIZBEN.gif CAS number. CAS Number 145202-66-0.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/RIZWAFST.gif