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NARATRIPTAN 2.5MG FILM-COATED TABLETS

Active substance(s): NARATRIPTAN HYDROCHLORIDE

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e-mail : artworkcd@gmail.com
Ph : +91-9845156610

Artwork No.

160411/8

Colours Used

Customer

Morningside

Black
Keyline

Description

Naratriptan 2,5mg Leaflet

Market

UK

Language

English

Size

160 x 300 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

2

Date

17-04-12

Software

Illustrator 11

Packaging Development

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Quality Control (QC)

Production

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Naratriptan 2.5 mg film-coated tablets
naratriptan
Read all of this leaflet carefully before you start taking
this medicine
! 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. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
! If any of the side effects get serious (see section 4), or if
you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet
1. What Naratriptan tablets are and what they are used for
2. Before you take Naratriptan tablets
3. How to take Naratriptan tablets
4. Possible side effects
5. How to store Naratriptan tablets
6. Further information
1. WHAT NARATRIPTAN TABLETS ARE AND WHAT
THEY ARE USED FOR
Naratriptan tablets contain naratriptan (as hydrochloride),
which belongs to a group of medicines called triptans (also
known as 5-HT1 receptor agonists).
Naratriptan tablets are used to treat migraine headaches.
Migraine symptoms are likely to be caused by the temporary
swelling of blood vessels in the head.
Naratriptan tablets are believed to work by reducing the size
of these blood vessels. This in turn will help to relieve
headache and other symptoms of a migraine attack, such as
nausea and vomiting or sensitivity to light and sound.

If any of the below applies to you, you might have a higher
risk of a heart disease: Tell your doctor, so that your heart
condition may be evaluated before you are prescribed
Naratriptan tablets if you:
! smoke a lot or you are using nicotine replacement
therapy, especially if you;
, are a man over 40 years of age
, are a post-menopausal woman
Also tell your doctor if:
! If you are allergic to antibiotics known as sulphonamides
! If you are allergic to sulphonamides, you may also be
allergic to Naratriptan tablets.
! If you know you are allergic to some antibiotics but are
not sure if it is a sulphonamide.
! If you are taking a medication for depression that
belongs to the medicinal groups called SSRI (selective
serotonin reuptake inhibitors) or SNRI (serotonin
norepinephrine reuptake inhibitors).
Taking Naratriptan tablets too often can worsen your
headaches.
Tell your doctor if this applies to you. Your doctor may
recommend that you stop taking Naratriptan tablets.
If you experience pain or pressing sensation in your
chest after taking Naratriptan tablets
These effects can be severe, but usually resolve quickly. If
they do not go away quickly or if the symptoms become
serious contact your doctor immediately. For more
information on possible side effects, see section 4.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.

2. BEFORE YOU TAKE NARATRIPTAN TABLETS
Do not take Naratriptan tablets:
! if you are allergic (hypersensitive) to naratriptan or any of
the other ingredients of Naratriptan tablets (for a full list
see section 6).
! if you have heart problems, such as obstruction of blood
vessels (ischemic heart disease) or chest pain (angina)
or have had a heart attack.
! if you have circulatory problems in the legs that cause
cramp-like symptoms when you walk (peripheral blood
circulation problem)
! if you have had a stroke or transient ischemic attack
(TIA)
! if you have high blood pressure. You may be able to take
Naratriptan tablets if your blood pressure is only slightly
elevated and you receive medication for it.
! if you have severe kidney disease or severe liver
disease.
! with other migraine medications, nor with ergotamine
containing drugs or similar drugs, such as methysergide,
or with other triptans or another 5-HT1-receptor agonist.
If any of the above apply to you please tell your doctor and do
not take Naratriptan tablets.
Take special care with Naratriptan tablets
Before taking Naratriptan tablets, your doctor should know
certain things.
In some rare cases patients have developed severe heart
disease after taking Naratriptan tablets, even if they have not
previously had signs of symptoms of heart disease.

Some medicines should not be taken simultaneously with
Naratriptan tablets, and some may cause side effects if taken
together with Naratriptan tablets.
Tell your doctor, if you are taking:
! any triptan, e.g. 5-HT1-receptor agonist, which are used
to treat migraine. Do not take Naratriptan tablets with
these medicines. Do not take these medicines again
until at least 24 hours after taking Naratriptan tablets.
! any medicines for your migraine which contain
ergotamine or similar medicines, such as methysergide.
Do not take Naratriptan tablets with these medicines.
You should stop taking them at least 24 hours before
taking Naratriptan tablets. Do not take them again for at
least 24 hours after taking Naratriptan tablets.
! medications for depression that belong to the SSRI
(Serotonin reuptake Inhibitors) or SNRI (serotonin
norepinephrine reuptake inhibitor) groups. Taking
Naratriptan tablets with these medicines can cause
dizziness, weakness and/or problems with coordination.
Tell your doctor immediately if you experience these
symptoms.
! St John's Wort (hypericum perforatum). Taking herbal
remedies containing St John's Wort together with
Naratriptan tablets may increase the likelihood of
suffering side effects.
Pregnancy and breast-feeding
! if you are pregnant or may be pregnant, consult your
doctor before taking Naratriptan tablets. There is little
information available on the safety of Naratriptan tablets
in pregnant women, although there is no indication that it
would increase the risk of malformations. Your doctor
may recommend that you do not take Naratriptan tablets
during pregnancy.

e-mail : artworkcd@gmail.com
Ph : +91-9845156610

Artwork No.

160411/8

Colours Used

Customer

Morningside

Black
Keyline

Description

Naratriptan 2,5mg Leaflet

Market

UK

Language

English

Size

160 x 300 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

2

Date

17-04-12

Software

Illustrator 11

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

Clearly mark any amendments on one proof and return to Artwork Creative Design.
Your Artwork/Disk has been translated through our Digital Artwork System into a format compatible with that of the litho Printing Process.
Warning! We cannot accept responsibility for any errors in this proof after approval. The artwork received has been significantly adjusted, revised or reset by
us from disk or hard copy. Whilst we take extreme care at all times to ensure accuracy, the final responsibility must be taken by our customer.
If you sign this proof you are signifying full approval of design and text.

!

Do not breast feed for 24 hours after taking Naratriptan
tablets. If any milk is excreted during this time period,
discard the milk and do not give it to your child.

Driving and using machines
Either the symptoms of migraine or the medicines for it may
make you feel tired. If you feel tired, do not drive or operate
machinery.
Important information about some of the ingredients of
Naratriptan tablets
Naratriptan tablets contain a small amount of lactose. If you
are lactose-intolerant or are intolerant to other sugars ask
your doctor if you can take Naratriptan tablets.
3. HOW TO TAKE NARATRIPTAN TABLETS
Only take Naratriptan tablets when the migraine
headache has already started.
Do not take Naratriptan tablets to try to prevent a migraine
attack.
Always take Naratriptan tablets exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
Dosage
The usual dose for adults of 18-65 years of age is a single 2.5
mg tablet of Naratriptan tablets swallowed whole with water.
Naratriptan tablets are not recommended for children under
18 years of age or adults over 65 years of age.
When to take Naratriptan tablets
It is best to take Naratriptan tablets at the first sign of a
migraine attack, although it can be taken at any stage of the
attack.
If your symptoms begin to come back
You may take a second Naratriptan tablet after four hours. Do
not take more than two tablets within 24 hours.
If you have kidney or liver disease, do not take more than one
tablet in any 24-hour period.
If the first tablet is not effective
Do not take another tablet to treat the same attack.
If Naratriptan tablets do not help at all contact your doctor or
pharmacist.

Uncommon side effects
(happens to no more than 1 patient out of 100)
! Feeling of heaviness, pressure, tightness or pain in the
chest or throat or anywhere else in the body. Although
sometimes very strong, these effects usually do not last
for very long.
! If these symptoms persist or become severe (especially
chest pain) immediately contact your doctor. In a very
small portion of people these may be symptoms of a
heart attack.
Other uncommon side effects include:
! Visual disturbances (although these may occur due to
the migraine attack itself),
! changes in heart rhythm or slight elevation of blood
pressure, which may last up to 12 hours after taking
Naratriptan tablets.
Rare side effects
(happens to no more than 1 patient out of 1000)
! Lower left-side abdominal pain and bloody diarrhoea
(ischemic colitis)
Very rare side effects
(happens to no more than 1 patient out of 10000)
! heart problems, including chest pain (angina) and heart
attack.
! poor blood circulation in hands and legs, causing pain
and discomfort.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE NARATRIPTAN TABLETS
Keep out of the reach and sight of children. Do not use
Naratriptan tablets after the expiry date that is stated on the
carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION

If you take more Naratriptan tablets than you should
Do not take more than two Naratriptan tablets in any 24-hour
period.
Taking too many Naratriptan tablets could make you ill. If you
have taken more than two tablets in any 24-hour period
contact your doctor as soon as possible.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Naratriptan tablets can cause side effects,
although not everybody gets them.
Allergic reaction (happens to no more than 1 patient out of
1000): if you experience any of the below side effects
immediately contact your doctor:
! rash, wheeziness of lungs, swelling of eyelids, face or
lips, unconsciousness.
Common side effects
(happens to no more than 1 patient out of 10)
! Nausea or vomiting, although these may occur due to
the migraine attack itself.
! Fatigue, drowsiness or general malaise.
! Dizziness, tingling sensation or hot flashes.

What Naratriptan tablets contain
! The active substance is naratriptan hydrochloride
corresponding to 2.5 mg naratriptan.
! The other ingredients are: core of the tablet:
Microcrystalline Cellulose, Lactose Anhydrous,
Croscarmellose Sodium and Magnesium Stearate; filmcoating of the tablet: Hypromellose, Titanium oxide
(E171), Triacetin, Iron Oxide Yellow (E172), Indigo
Carmine (E132).
What Naratriptan tablets look like and contents of the
pack
The tablet is Green 'D' shaped biconvex coated tablets
debossed with 'U54' on one side and plain on the other side.
They are available in blister packs of 2, 3, 4, 6, 12 or 18
tablets and HDPE containers of 30 tablets and 500 tablets,
although not all pack sizes may be marketed
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road. Leicester,
LE3 0PA, UK.
Manufacturer
Accord Healthcare Limited,
Sage house, 319 Pinner Road,
North Harrow, Middlesex
HA1 4HF, UK.
This leaflet was approved in April 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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