Zolmitriptan 2.5mg orodispersible tablets sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zolmitriptan

Available from:

Viatris UK Healthcare Ltd

ATC code:

N02CC03

INN (International Name):

Zolmitriptan

Dosage:

2.5mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401; GTIN: 5016695004556

Patient Information leaflet

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOLMITRIPTAN 2.5
MG
ORODISPERSIBLE TABLETS
ZOLMITRIPTAN 5 MG ORODISPERSIBLE TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zolmitriptan is and what it is used for
2.
What you need to know before you take Zolmitriptan
3.
How to take Zolmitriptan
4.
Possible side effects
5.
How to store Zolmitriptan
6.
Contents of the pack and other information
1.
WHAT ZOLMITRIPTAN IS AND WHAT IT IS USED FOR
Zolmitriptan contains zolmitriptan, which belongs to a group of
medicines called triptans.
ZOLMITRIPTAN IS USED TO TREAT MIGRAINE HEADACHE.

Migraine symptoms may be caused by the widening of blood vessels in
the head. Zolmitriptan
is thought to reduce the widening of these blood vessels. This helps
to take away the headache
and other symptoms of a migraine attack, such as feeling or being sick
(nausea or vomiting)
and being sensitive to light and sound.

Zolmitriptan works only when a migraine attack has started. You should
not take Zolmitriptan
to prevent migraines occuring.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOLMITRIPTAN
DO NOT TAKE ZOLMITRIPTAN:
-
if you are allergic to zolmitriptan or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have moderately high or very high blood pressure or mild
uncontrolled high blood
pressure.
-
if you have or have had heart disease, a heart attack, or symptoms or
signs of coronary heart
disease, or angina (chest pain as a result of lack of oxygen in the
heart muscle).
-

Summary of Product characteristics

OBJECT 1
ZOLMITRIPTAN 5 MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 06-Sep-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Zolmitriptan 2.5 mg Orodispersible tablets
Zolmitriptan 5 mg Orodispersible tablets
2. Qualitative and quantitative composition
Each orodispersible tablet contains 2.5 mg zolmitriptan
Each orodispersible tablet contains 5 mg zolmitriptan.
Excipient with known effect:
Each orodispersible tablet contains 5 mg aspartame.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Orodispersible Tablet
White to off-white, round, flat faced bevelled edged orodispersible
tablet of 6.5 mm diameter debossed
with “M” on one side and “ZT1” on the other side.
White to off-white, round, flat faced bevelled edged tablet of 6.5 mm
diameter debossed with “M” on one
side and “ZT3” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Acute treatment of migraine headache with or without aura.
Zolmitriptan is not indicated for prophylaxis of migraine.
4.2 Posology and method of administration
Posology
The recommended dose of Zolmitriptan to treat a migraine attack is 2.5
mg. It is advisable that
zolmitriptan is taken as early as possible after the onset of migraine
headache but it is also effective if
taken at a later stage.
If symptoms of migraine should recur within 24 hours following an
initial response, a second dose may
be taken. If a second dose is required, it should not be taken within
2 hours of the initial dose. If a patient
does not respond to the first dose, it is unlikely that a second dose
will be of benefit in the same attack.
If a patient does not achieve satisfactory relief with 2.5 mg doses,
for subsequent attacks 5 mg doses of
zolmitriptan could be considered. Caution is advised due to an
increased incidence of side effects. A
controlled clinical study failed to demonstrate superiority of the 5
mg dose over the 2.5 mg dose.
Nevertheless a 5 mg dose may be of benefit in some patients.
The total daily intake s