Naramig 2.5mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Naratriptan hydrochloride

Tilgængelig fra:

CST Pharma Ltd

ATC-kode:

N02CC02

INN (International Name):

Naratriptan hydrochloride

Dosering:

2.5mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04070401; GTIN: 5055946800974

Indlægsseddel

PATIENT INFORMATION LEAFLET
NARAMIG® 2.5MG TABLETS
(NARATRIPTAN HYDROCHLORIDE)
Your tablets are available using the name Naramig 2.5mg tablets, but
will be referred to as Naramig throughout this leaflet.
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 Naramig is and what it is used for
2. What you need to know before you take Naramig
3. How to take Naramig
4. Possible side effects
5. How to store Naramig
6. Contents of the pack and other information
1. WHAT NARAMIG IS AND WHAT IT IS USED FOR
Naramig contains naratriptan (hydrochloride), which belongs to a
group of medicines called triptans (_also known as 5-HT_
_1_
_ receptor _
_agonists_).
NARAMIG IS USED TO TREAT MIGRAINE.
Migraine symptoms may be caused by the temporary widening of
blood vessels in the head. Naramig is believed to reduce the widening
of these blood vessels. This in turn helps to take away the headache
and relieve other symptoms of a migraine attack, such as feeling or
being sick (nausea or vomiting) and sensitivity to light and sound.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NARAMIG
DO NOT TAKE NARAMIG:

IF YOU ARE ALLERGIC to naratriptan, or any of the other ingredients of
this medicine (listed in section 6)

IF YOU HAVE A HEART PROBLEM such as heart failure or chest pains
(_angina_), or have already had a heart attack

IF YOU HAVE CIRCULATION PROBLEMS IN YOUR LEGS that cause cramp-
like pains when you walk (_peripheral vascular disease_)

IF YOU HAVE HAD A STROKE or a mini-stroke (_also called a transient _
_ischaemic

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Naramig 2.5 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 2.5 mg of naratriptan as naratriptan hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naramig Tablets are indicated for the acute treatment of migraine
attacks with
or without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Naramig tablets should be taken as early as possible after the onset
of a
migraine headache but they are effective if taken at a later stage.
Naramig Tablets are recommended as monotherapy for the acute treatment
of
a migraine attack.
Naramig Tablets should not be used prophylactically.
Posology
Adults (18-65 years of age)
The recommended dose of Naramig Tablets is a single 2.5mg tablet.
The total dose should not exceed two 2.5mg tablets in any 24 hour
period.
If symptoms of migraine should recur, following an initial response, a
second
dose may be taken provided that there is a minimum interval of four
hours
between the two doses.
If a patient does not respond to a first dose of Naramig Tablets a
second dose
should not be taken for the same attack, as it is unlikely to be of
benefit.
However Naramig Tablets may be used for subsequent migraine attacks.
Adolescents (12-17 years of age)
Efficacy of Naramig Tablets at single doses of 0.25, 1.0 and 2.5mg was
not
demonstrated to be greater than placebo in a placebo-controlled study
in
adolescents (12 to 17 years). Therefore, the use of Naramig Tablets in
patients
under 18 years of age is not recommended.
Children (under 12 years of age)
There are no data available on the use of naratriptan in children
under 12 years
of age therefore its use in this age group is not recommended.
Elderly (over 65 years of age)
The safety and effectiveness of naratriptan in individuals over age 65
have not
been evaluated and therefore, its use in this age group can not be
recommended. There is a moderate decreas