GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Zolmitriptan Tablets 2.5mg
B. Zolmitriptan Tablets 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Zolmitriptan Tablets 2.5mg
Each Film-coated tablet contains:
Zolmitriptan USP ………………2.5mg
Excipients……………………………. q.s.
*Also contains Lactose.

B) Zolmitriptan Tablets 5mg
Each Film-coated tablet contains:
Zolmitriptan USP ………………5mg
Excipients……………………………. q.s.
*Also contains Lactose.


THERAPEUTIC INDICATIONS:

Zolmitriptan belongs to a class of medicines called Selective serotonin 5-HT1B/ 1D receptor agonists knowns as a “triptans” for short.
Triptans are very effective in stopping a migraine from reaching its full intensity. When taken at the onset of a migraine, Zolmitriptan can effectively stop a migraine from developing and thus prevent any disruption to the patient’s life beyond that point. Usually, a single dose of Zolmitriptan is enough stop a migraine.

CAUTION & WARNING:

CAUTION: Do not take more than 2 doses of Zolmitriptan in a 24-hour period. Always wait at least 2 hours between doses. If your condition worsens, seek medical attention.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
* Zolmitriptan is enough stop a migraine.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
WARNING: If you take more tablets than you should or someone accidentally swallows some, contact your doctor or go to the nearest hospital straight.
Common side-effects: Feeling sleepy, dizzy or warm.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Preserve in a tight container.
Keep in a cool & dry place, Protect from light & moisture.
Dosage:
Usual dose for migraine: One tablet to be taken at the onset (beginning) of a Migraine. Do not use to prevent migraine.
The usual starting dose id 2.5mg of Zolmitriptan.
If a 2.5mg dose did not give you enough help with your migraine then the dose can be increased to 5mg.
The maximum daily dose is 10mg Zolmitriptan.
Attach dispensing label as per end country.

Zolmitriptan Tablets 5mg Technical Specification:

Product Name:Zolmitriptan Tablets 5mg
Brand Name:Generic
Strength:2.5mg, 5mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:3s, 6s, 10s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Selective serotonin 5-HT1B/ 1D receptor agonists
Indication: Zolmitriptan belongs to a class of medicines called Selective serotonin 5-HT1B/ 1D receptor agonists knowns as a “triptans” for short.
Triptans are very effective in stopping a migraine from reaching its full intensity. When taken at the onset of a migraine, Zolmitriptan can effectively stop a migraine from developing and thus prevent any disruption to the patient’s life beyond that point. Usually, a single dose of Zolmitriptan is enough stop a migraine.
Storage:Preserve in a tight container. Keep in a cool & dry place, Protect from light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Zolmitriptan Tablets 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Zolmitriptan Tablets 5mg
    Each Film-coated tablet contains:
    Zolmitriptan USP ………………5mg
    Excipients……………………………. q.s.
    *Also contains Lactose.

THERAPEUTIC INDICATIONS:

Zolmitriptan belongs to a class of medicines called Selective serotonin 5-HT1B/ 1D receptor agonists knowns as a “triptans” for short.

Triptans are very effective in stopping a migraine from reaching its full intensity. When taken at the onset of a migraine, Zolmitriptan can effectively stop a migraine from developing and thus prevent any disruption to the patient’s life beyond that point. Usually, a single dose of Zolmitriptan is enough stop a migraine.

CAUTION & WARNING:

CAUTION: Do not take more than 2 doses of Zolmitriptan in a 24-hour period. Always wait at least 2 hours between doses. If your condition worsens, seek medical attention.

SWALLOW WHOLE DO NOT CHEW OR CRUSH

* Zolmitriptan is enough stop a migraine.

Read enclosed leaflet before use.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

WARNING: If you take more tablets than you should or someone accidentally swallows some, contact your doctor or go to the nearest hospital straight.

Common side-effects: Feeling sleepy, dizzy or warm.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Preserve in a tight container. Keep in a cool & dry place, Protect from light & moisture.

Dosage:
Usual dose for migraine: One tablet to be taken at the onset (beginning) of a Migraine. Do not use to prevent migraine.

The usual starting dose id 2.5mg of Zolmitriptan.
If a 2.5mg dose did not give you enough help with your migraine then the dose can be increased to 5mg.

The maximum daily dose is 10mg Zolmitriptan.

Attach dispensing label as per end country.