Zolmitriptan 2.5 mg Orodispersible Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zolmitriptan

Available from:

Actavis Group PTC ehf

ATC code:

N02CC; N02CC03

INN (International Name):

Zolmitriptan

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective serotonin (5HT1) agonists; zolmitriptan

Authorization status:

Marketed

Authorization date:

2009-08-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOLMITRIPTAN 2.5 MG ORODISPERSIBLE TABLETS
zolmitriptan
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 and 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. It will
not stop you from getting an
attack.
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 high blood pressure
-
if you have ever had heart problems, including a heart attack, angina
(chest pain caused by
exercise or effort), Prinzmetal’s angina (chest pain which happens
at rest) or have experienced
heart related symptoms such as shortness of breath or pressure over
the chest
-
if you have circulatory problems (restricted b

Summary of Product characteristics

Health Products Regulatory Authority
28 May 2019
CRN008YP3
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zolmitriptan 2.5 mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 2.5 mg zolmitriptan.
Excipient with known effect:
Each orodispersible tablet contains 4 mg aspartame.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
Zolmitriptan 2.5 mg orodispersible tablets are white and round flat
tablets with the diameter 7.5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of migraine headache with or without aura.
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.
The total daily intake should not exceed 10 mg. Not more than 2 doses
of zolmitriptan should be taken in any 24-hour period.
Zolmitriptan is not indicated for prophylaxis of migraine.
_Paediatric population _
Children_ (below 12 years of age)_
Safety and efficacy of zolmitriptan tablets in paediatric patients
have not been evaluated. Use of zolmitriptan in children is
therefore not recommended.
Adolescents_ (12 - 17 years of age)_
The efficacy of zolmitriptan tablets was not demonstrated in a placebo
controlled clinical trial for patients aged 12 to 17 years.
Use of zolmitriptan in adolescents is therefore not recommended.
_Use i