Naratriptan 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Naratriptan hydrochloride

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

N02CC02

INN (International Name):

Naratriptan hydrochloride

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401

Patient Information 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
Naramig tablets contain naratriptan (hydrochloride),
which belongs to a group of medicines called
triptans _(also known as 5-HT_
_1_
_ receptor agonists). _
NARAMIG TABLETS ARE USED TO TREAT MIGRAINE.
Migraine symptoms may be caused by the
temporary widening of blood vessels in the head.
Naramig tablets are 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.
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 attack or TIA) _
•
IF YOU HAVE HIGH BLOOD PRESSURE. You may be
able to take Naramig if your high blood pressure
is mild and is being treated.
•
IF YOU HAVE KIDNEY OR LIVER DISEASE
•
WITH OTHER MIGRAINE MEDICINES, including those
which contain ergotamine, or with s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Naratriptan 2.5mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.78mg of naratriptan hydrochloride
equivalent to
2.5mg naratriptan.
Each film-coated tablet contains 94mg of lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Green coloured, capsule shaped, film coated tablets debossed with
“N” on one side
and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks with or
without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Naratriptan 2.5mg Film-coated Tablets should not be used
prophylactically.
Naratriptan 2.5mg Film-coated Tablets are recommended as monotherapy
for the acute
treatment of a migraine attack.
Posology
Adults (18 to 65 years)
The recommended dose of Naratriptan 2.5mg Film-coated Tablets is
2.5mg. The total dose
should not exceed two 2.5mg tablets in any 24 hour period.
In case of recurrence of the symptoms of migraine 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 the first dose of Naratriptan 2.5mg
Film-coated Tablets, a
second dose should not be taken for the same attack, as it is unlikely
to be of benefit.
However, Naratriptan 2.5mg Film-coated Tablets may be used for
subsequent migraine
attacks.
Special populations
Elderly patients (over 65 years)
The safety and effectiveness of naratriptan in patients over 65 years
have not been evaluated
and therefore, its use in this age group cannot be recommended. There
is a moderate decrease
in clearance with age (see section 5.2).
Patients with renal impairment
Naratriptan should be used with caution in patients with renal
impairment. The maximum
dose in any 24 hour treatment period is a single 2.5mg tablet. The use
of Naratriptan is
contraindicated in patients with severe renal impairme