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ALMOTRIPTAN 12.5 MG FILM-COATED TABLETS

Active substance(s): ALMOTRIPTAN / ALMOTRIPTAN MALATE

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Almotriptan
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 Almotriptan 12.5 mg Film-coated
tablets is and what it is used for
2. What you need to know before you take
Almotriptan 12.5 mg Film-coated tablets
3. How to take Almotriptan 12.5 mg Film-coated
tablets
4. Possible side effects
5. How to store Almotriptan 12.5 mg
Film-coated tablets
6. Contents of the pack and other information

1. What Almotriptan 12.5 mg Film-coated
tablets is and what it is used for
Almotriptan 12.5 mg Film-coated tablets is an
antimigraine agent which belongs to a class of
compounds known as selective serotonin
receptor agonists. Almotriptan 12.5 mg
Film-coated tablets is believed to reduce the
inflammatory response associated with
migraines by binding to the serotonin receptors
in the brain (cranial) blood vessels and causing
them to narrow.
Almotriptan 12.5 mg Film-coated tablets is used
to relieve headaches associated with migraine
attacks with or without aura.

2. What you need to know before you
take Almotriptan 12.5 mg Film-coated
tablets
Do not take Almotriptan 12.5 mg Film-coated
tablets
• if you are allergic to almotriptan or any of the
ingredients of this medicine (listed in
section 6)
• if you have or have ever suffered from
diseases that restrict the blood supply to the
heart such as:
- heart attack
- chest pain or discomfort that normally
occurs with activity or stress
- heart problems without pain
- chest pain that occurs when you are resting
- severe hypertension (severe high blood
pressure)
- uncontrolled mild or moderate high blood
pressure.
• if you have had a stroke or experienced a
reduction in the blood flow to the brain
• if you have had obstruction of the large
arteries in the arms or legs (peripheral
vascular disease)
• if you are taking other medicines used to treat
migraines including ergotamine,
dihydroergotamine and methysergide or
other serotonin agonists (e.g. sumatriptan)
• if you suffer from severe liver disease
Warnings and precautions:
Talk to your doctor or pharmacist before taking
Almotriptan 12.5 mg Film-coated tablets:
• If your type of migraine has not been
diagnosed
• if you are allergic (hypersensitive) to
antibacterial medicines mainly used for
treatment of urinary tract infections
(sulphonamides)
• if your headache symptoms are different from
your usual attacks i.e. you have a noise in your
ears or vertigo, you have short lived paralysis
of one side of the body or paralysis of the
muscles that control eye movement or if you
have any new symptoms.
• if you are at risk of heart disease, this includes
uncontrolled high blood pressure, high
cholesterol, obesity, diabetes, smoking, clear
family history of heart disease,
postmenopausal females or males over the
age of 40
• if you have mild to moderate liver disease
• if you suffer from severe kidney disease
• if you are over 65 years of age (as you are
more likely to experience blood pressure
increases)
• you are taking anti-depressants SSRIs (selective
serotonin reuptake inhibitors) or SNRIs
(serotonin noradrenaline reuptake inhibitors).
Also see Other medicines and Almotriptan
12.5 mg Film-coated tablets below

It has been suggested that excessive use of an
anti-migraine medicinal product can lead to
daily chronic headache.

If you take more Almotriptan 12.5 mg
Film-coated tablets than you should
If you accidentally take too many tablets, or if
someone else or a child takes this medicine, talk
to a doctor or pharmacist immediately.

Children and adolescents
Children under the age of 18 should not take
Almotriptan 12.5 mg Film-coated tablets.

If you forget to take Almotriptan 12.5 mg
Film-coated tablets
Try to take Almotriptan 12.5 mg Film-coated
tablets as you have been prescribed. Do not take
a double dose to make up for a forgotten tablet.

Elderly (over 65 years of age)
If you are over 65 years of age you should speak
to your doctor before using this medicinal
product.

4. Possible side effects

Other medicines and Almotriptan 12.5 mg
Film-coated tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Please tell your doctor:
• if you are taking medicines used to treat
depression such as monoamine oxidase
inhibitors (e.g.moclobemide), selective
serotonin reuptake inhibitors (e.g. fluoxetine)
or serotonin noradrenaline reuptake
inhibitors (e.g. venlafaxine) as these may
cause serotonin syndrome, a potentially
life-threatening drug reaction. The symptoms
of serotonin syndrome include; confusion,
restlessness, fever, sweating, uncoordinated
movements of the limbs or eyes,
uncontrollable muscle twitches or diarrhoea
• if you are taking herbal St John’s Wort
(Hypericum perforatum) as this may increase
the likelihood of side effects.
Almotriptan should not be taken at the same
time as ergotamine-containing medicines,
which are also used to treat migraine. However,
the medicines may be taken after one another:
provided a suitable amount of time is left
between taking each medicine
• following use of almotriptan, it is advised to
wait at least 6 hours before taking
ergotamine.
• following use of ergotamine, it is advised to
wait at least 24 hours before taking
almotriptan.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Only very limited data is available for
almotriptan in pregnant patients. Almotriptan
12.5 mg Film-coated tablets should only be used
during pregnancy if instructed by your doctor
and only after they have carefully considered
the benefits and risks.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Like all medicines, Almotriptan 12.5 mg
Film-coated tablets can cause side effects,
although not everybody gets them.
Common: (may affect up to 1 in 10 people)
• dizziness
• sleepiness (somnolence)
• nausea
• vomiting
• tiredness
Uncommon: (may affect up to 1 in 100 people)
• sensation of tingling, pricking or numbness of
the skin (paraesthesia)
• headache
• ringing, roaring or clicking noise in the ears
(tinnitus)
• heart pounding (palpitations)
• tightening of the throat
• diarrhoea
• discomfort when digesting food (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling weak (asthenia)
Very rare: ( may affect up to 1 in 10,000 people)
• spasm of the heart blood vessels (coronary
vasospasm)
• heart attack (myocardial infarction)
• increased heart rate (tachycardia)
Not known: (frequency cannot be estimated
from the available data)
• convulsion (seizure)
• allergic reactions (hypersensitivity reactions),
including mouth, throat and hand oedema
(angioedema)
• severe allergic reactions (anaphylactic
reactions)
• visual impairment, vision blurred (visual
disorders may occur also during the migraine
attack itself)
• Intestinal vasospasm, which may result in
intestinal damage (intestinal ischemia). You
may experience abdominal pain and bloody
diarrhoea.

Driving and using machines
Almotriptan 12.5 mg Film-coated tablets may
cause drowsiness. If you are affected, you should
not drive or use any tools or machines.

During treatment with Almotriptan 12.5 mg
Film-coated tablets, tell your doctor straight
away:
• if you have chest pain, tightness in your chest
or throat, or any other symptoms that
resembles a heart attack. Please tell your
doctor straight away and do not take any
more Almotriptan 12.5 mg Film-coated
tablets.

3. How to take Almotriptan 12.5 mg
Film-coated tablets.

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes or if you
notice any side effects not listed in this leaflet.

Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

You can also report side effects directly via the
UK Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard.

Almotriptan 12.5 mg Film-coated tablets should
only be used to treat an actual migraine attack
and not to prevent migraine attacks or
headaches.

By reporting side effects you can help provide
more information on the safety of this medicine.

Caution should be taken when using this
medicine whilst breast-feeding. You should
avoid breast-feeding for 24 hours after taking
this medicine.

Adults (18-65 years old)
The usual dose is one 12.5 mg tablet which
should be taken as early as possible after the
onset of the migraine attack. If your migraine
attack does not subside, do not take more than
one tablet for the same attack.
If you experience a second migraine attack
within 24 hours, a second 12.5 mg tablet can be
taken but you must leave at least two hours
between your first and second tablet.
The maximum daily dose is two (12.5 mg)
tablets within 24 hours.
Tablet(s) should be swallowed with liquid (e.g.
water) and can be taken with or without food.

6. Contents of the pack and other
information
What Almotriptan 12.5 mg Film-coated
tablets contains
The active substance is Almotriptan.
Each film-coated tablet contains 12.5mg
Almotriptan as Almotriptan malate.
The other ingredients are:
Tablet core: Mannitol (E421), microcrystalline
cellulose, povidone, sodium starch glycolate
Type A, sodium stearyl fumarate
Coating material: Hypromellose (E464),
titanium dioxide (E171), Macrogol 400, carnauba
wax
What Almotriptan 12.5 mg Film-coated
tablets looks like and contents of the pack
Almotriptan 12.5 mg Film-coated tablets is
available as a white to off white coloured, round,
biconvex film-coated tablet.
Almotriptan 12.5 mg Film-coated tablets are
available in blister packs containing 2, 3, 4, 6, 9,
12 and 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chanelle Medical
Loughrea
Co.Galway
Ireland
The distributor is
Creo Pharma Ltd
Felsted Business Centre
Felsted
Essex CM6 3LY
UK
Manufacturer
Chanelle Medical
Loughrea
Co. Galway
Ireland
JSC Grindeks
53 Krustpils Street
Riga, LV-1057
Latvia.
This leaflet was last revised in 09/2015

5. How to store Almotriptan 12.5 mg
Film-coated tablets.
Keep this medicine out of the sight and reach
of children.
Do not use Almotriptan 12.5 mg Film-coated
tablets after the expiry date which is stated on
the blister and carton after “EXP”. The expiry date
refers to the last day of that month.
This medicinal product does not require any
special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.

You should take Almotriptan 12.5 mg
Film-coated tablets as soon as possible after the
onset of the migraine, although it is still effective
if taken at a later stage.

KR/Drugs/KTK/25/460/2001
CRE-ALM-PIL-183_03
20/10/2015

Severe kidney disease
If you have severe kidney disease do not take
more than one 12.5 mg tablet every 24 hours.

PET002725-UK

LB9469

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Package leaflet: Information for the patient

Almotriptan 12.5 mg Film-coated tablets

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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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