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ALMOTRIPTAN GALENICUM 12.5 MG FILM-COATED TABLETS

Active substance(s): ALMOTRIPTAN

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CONFORME
LABORATORIO:

Anverso:
170 mm
85 mm
8 mm

150 mm

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

1.

What Almotriptan tablets is and what it is
used for

Almotriptan is an antimigraine agent which belongs to a
class of compounds known as selective serotonin
receptor agonists. Almotriptan 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 is
used to relieve headaches associated with migraine
attacks with or without aura.

2.

8 mm

What you need to know before you take
Almotriptan tablets

Do not take Almotriptan tablets:
- if you are allergic to almotriptan tablets 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
Almotriptan 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

Children and Adolescents
Children under the age of 18 should not take Almotriptan
tablets.
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 Almotriptan 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 monoamino oxidase inhibitors (e.g.
moclobemide), selective serotonin reuptake inhibitors
(e.g. fluoxetine) or serotonine 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 tablets in
pregnant patients. Almotriptan 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
Almotriptan tablets may cause drowsiness. If you are
affected, you should not drive or use any tools or
machines.

3.

How to take Almotriptan tablets

Almotriptan tablets should only be used to treat an actual
migraine attack and not to prevent migraine attacks or
headaches.
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Adults (18-65 years old)
The recommended 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.

I/C01-01.Rev.1

SENTIDO DE LA FIBRA

Almotripan 12.5mg
film-coated tablets

300 mm

Package leaflet: Information for the user

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

CONFORME
LABORATORIO:

Reverso:

If you take more Almotriptan 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.
If you forget to take Almotriptan tablets
Try to take Almotriptan tablets 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
medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Common side effects ( may affect up to 1 in 10 people)
• dizziness
• sleepiness (somnolence)
• nausea
• vomiting
• tiredness

5.

How to store Almotriptan tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.

6.

Contents of the pack and other
information

What Almotriptan tablets contains
The active substance is almotriptan 12.5 mg (as
almotriptan D,L-hydrogen malate).
The other ingredients are:
Tablet core: Mannitol, microcrystalline cellulose,
povidone, sodium starch glycolate (type A), sodium
stearyl fumarate.
Coating material: Hypromellose, titanium dioxide (E-171),
Macrogol 400.
What Almotriptan tablets looks like and contents of
the pack
Almotripan tablets is available as a white, circular,
biconvex film-coated tablet, plain.
Almotripan tablets is available in blister packs containing
3, 4, 6, 9 or 12 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer

8 mm

Uncommon side effects ( 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 side effects (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)

Marketing Authorisation Holder
Galenicum Health S.L.
Avda. Diagonal 123, planta 11
08005 – Barcelona (Spain).
Manufacturer
SAG Manufacturing S.L.U.
Crta. N-I, Km 36,
San Agustín de Guadalix,
28750, Madrid, España
Distributed by :
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
This leaflet was last revised in 09/2015

Frequency unknown (frequency cannot be estimated
from the available data)
• allergic reactions (hypersensitivity reactions), including
mouth, throat or hand edema (angioedema)
• Severe allergic reactions (anaphylactic reactions)
• convulsion (seizure)
• visual impairment, vision blurred (visual disorders may
also occur during a migraine attack itself)
During treatment with Almotriptan, 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 tablets.
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.

8 mm
85
170 mm
I/C01-01.Rev.1

SENTIDO DE LA FIBRA

150 mm

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

You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

300 mm

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

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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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