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ALMOGRAN 12.5MG FILM-COATED TABLETS

Active substance(s): ALMOTRIPTAN D L-HYDROGEN MALATE

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Package leaflet: Information for the user

Almogran 12.5 mg Film-Coated Tablets
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,
pharmacist or nurse.
• 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.: See section 4.
What is in this leaflet
1. What Almogran is and what it is used for
2. What you need to know before you take Almogran
3. How to take Almogran
4. Possible side effects
5. How to store Almogran
6. Contents of the pack and other information
1. What Almogran is and what it is used for
Almogran is an antimigraine agent which belongs to a class
of compounds known as selective serotonin receptor
agonists. Almogran 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.
Almogran is used to relieve headaches associated with
migraine attacks with or without aura.
2. What you need to know before you take Almogran

80009663

Do not take Almogran
— 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, pharmacist or nurse before taking
Almogran:
• 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)
• If you are taking anti-depressants SSRIs (selective
serotonin reuptake inhibitors) or SNRIs (serotonin
noradrenaline reuptake inhibitors). Also see Other
medicines and Almogran, below.

attack. If your migraine attack does not subside, do not
take more than one tablet for the same attack.

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

The maximum daily dose is two (12.5 mg) tablets within
24 hours.

Children and Adolescents
Children under the age of 18 should not take Almogran.
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.
Other medicines and Almogran
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 breast-feeding, 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. Almogran should only be used during
pregnancy if instructed by your doctor and only after they
have carefully considered the benefits and risks.
Caution should be taken when using this medicine
whilst breast-feeding. You should avoid breast-feeding
for 24 hours after taking this medicine.
Driving and using machines
Almogran may cause drowsiness. If you are affected, you
should not drive or use any tools or machines.
3. How to take Almogran
Almogran should only be used to treat an actual migraine
attack and not to prevent migraine attacks or headaches.
Always take Almogran exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
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

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.

Tablet should be swallowed with liquid (e.g. water) and
can be taken with or without food.
You should take Almogran as soon as possible after the
onset of the migraine, although it is still effective if taken at
a later stage.
Severe kidney disease
If you have severe kidney disease do not take more than
one 12.5 mg tablet every 24 hours.
If you take more Almogran 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.
If you forget to take Almogran
Try to take Almogran as you have been prescribed. Do not
take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Common side effects (1 to 10 users in 100):
• dizziness
• sleepiness (somnolence)
• nausea
• vomiting
• tiredness
Uncommon side effects (1 to 10 users in 1,000):
• 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 side effects (less than 1 user in 10,000):
• spasm of the heart blood vessels (coronary vasospasm)
• heart attack (myocardial infarction)
• increased heart rate (tachycardia)
Frequency unknown (frequency cannot be estimated
from the available data):
• allergic reactions (hypersensitivity reactions), including
mouth, throat or hand oedema (angioedema)
• severe allergic reactions (anaphylactic reactions)
• convulsion (seizure)
• visual impairment, vision blurred (visual disorders may
also occur during a migraine attack itself)

Name Description:

PROOF :

1

PIL Almogran 12,5mg 3 tab GB_IE 80009663
Regulatory text number:

N/A
Name:

Item number:

80009663
Date:

Version number:

17/06/2015

01

Printing Colours

In Line Control Code
P BLACK

Non Printing Colours
DIE CUT

Material size:

260 x 320 mm
Fonts: Frutiger LT Com Bold, Frutiger LT Com Light, Frutiger LT Com Light Italic.

During treatment with Almogran, 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 Almogran tablets.

This medicinal product is authorised in the Member
States of the EEA under the following names:
Belgium

Almogran 12,5 mg
filmomhulde tabletten

Denmark

Almogran 12,5 mg
filmovertrukne tabletter

Germany

Almogran 12,5 mg
Filmtablette

United Kingdom
Yellow Card Scheme, Website:
www.mhra.gov.yuk/yellowcard

Greece

Almogran 12,5 mg

Ireland
Pharmacovigilance Section, Irish Medicines Board, Kevin
O'Malley House, Earlsfort Centre, Earlsfort Terrace, IRL Dublin 2, Tel: +353 1 67634971, Fax +353 1 6762517,
Website: www.imb.ie,
email: imbpharmacovigilance@imb.ie

Finland

Almogran 12,5 mg
tabletti, kalvopäällysteinen

France

Almogran 12,5 mg
comprimé pelliculé

Iceland

Almogran 12,5 mg
filmuhúðaðar töflur

Ireland

Almogran 12.5 mg
Film-coated tablet

Italy

Almogran 12,5 mg
compresse rivestite con film

Luxembourg

Almogran 12,5 mg
comprimés pelliculés

Netherlands

Almogran 12,5 mg
omhulde tablet

Norway

Almogran 12,5 mg
filmdrasjert tablett

Portugal

Almogran 12,5 mg
comprimidos revestidos
por película

Sweden

Almogran 12,5 mg
filmdragerad tablett

Spain

Almogran 12,5 mg
comprimidos recubiertos
con película

United Kingdom

Almogran 12.5 mg
Film-coated tablet

Reporting of side effects
If you get any side effects talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via:

By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Almogran
Keep this medicine out of the sight and reach of
children
Do not use Almogran 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 to
protect the environment.
6. Contents of the pack and other information
What Almogran contains
The active substance is almotriptan 12.5 mg (as
almotriptan D,L-hydrogen malate).
The other ingredients are:
Tablet core: Mannitol (E-421), microcrystalline cellulose,
povidone, sodium starch glycolate, sodium stearyl fumarate
Coating material: Hypromellose, titanium dioxide (E-171),
Macrogol 400, carnauba wax.
What Almogran looks like and contents of the pack
Almogran is available as a white, circular, biconvex
film-coated tablet with an A engraved on one side.

This leaflet was last approved in June 2015

Almogran is available in blister packs containing 2, 3, 4, 6,
7, 9, 12, 14 or 18 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almirall, S.A.
General Mitre 151,
08022 Barcelona, Spain
Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca - Barcelona, Spain

Name Description:

PROOF :

1

PIL Almogran 12,5mg 3 tab GB_IE 80009663
Regulatory text number:

N/A
Name:

Item number:

80009663
Date:

Version number:

17/06/2015

01

Printing Colours

In Line Control Code
P BLACK

Non Printing Colours
DIE CUT

Material size:

260 x 320 mm
Fonts: Frutiger LT Com Bold, Frutiger LT Com Light, Frutiger LT Com Light Italic.

Expand view ⇕

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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