Naratriptan 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Naratriptan hydrochloride

Available from:

DE Pharmaceuticals

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

If any of the points in the list applies to you, it could mean you
have a
greater risk of developing heart disease – so:
TELL YOUR DOCTOR SO THAT YOUR HEART FUNCTION CAN BE CHECKED before
Naramig is prescribed for you.
IF YOU ARE ALLERGIC TO ANTIBIOTICS CALLED SULPHONAMIDES
If so, you may also be allergic to Naramig. If you know you are
allergic to an
antibiotic but you are not sure whether it is a sulphonamide:
TELL YOUR DOCTOR OR PHARMACIST BEFORE TAKING NARAMIG.
IF YOU TAKE NARAMIG FREQUENTLY
Taking Naramig too often may make your headaches worse.
TELL YOUR DOCTOR IF THIS APPLIES TO YOU. He or she may recommend you
stop taking Naramig.
IF YOU FEEL PAIN OR TIGHTNESS IN YOUR CHEST AFTER YOU TAKE NARAMIG
These effects may be intense but they usually pass quickly. If they
don’t
pass quickly, or they become severe:
GET MEDICAL HELP IMMEDIATELY. Section 4 of this leaflet has more
information about these possible side effects.
NOT FOR OLDER PEOPLE OR CHILDREN UNDER 18
Naramig is not recommended for people aged over 65 or for children
under
the age of 18.
OTHER MEDICINES AND NARAMIG
TELL YOUR DOCTOR IF YOU’RE TAKING, HAVE RECENTLY TAKEN OR MIGHT TAKE
ANY
OTHER MEDICINES.
Some medicines must not be taken with Naramig and others may cause
adverse effects if they’re taken with Naramig. YOU MUST TELL YOUR
DOCTOR IF
YOU ARE TAKING:
*
any medicines for your MIGRAINE which contain any TRIPTAN/5-HT
1
AGONIST
(such as sumatriptan or zolmitriptan). Don’t take Naramig at the
same time
as these medicines. Stop taking these medicines at least 24 hours
before
taking Naramig.
*
ERGOTAMINE also used to treat MIGRAINE or similar medicines such as
methysergide. Don’t take Naramig at the same time as these
medicines.
Stop taking these medicines at least 24 hours before taking Naramig.
*
any ANTIDEPRESSANTS classed as selective serotonin reuptake inhibitors
(SSRIs), such as citalopram, fluoxetine or paroxetine, or serotonin
noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine. If you
are
not sure, talk to your doctor

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