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ALMOTRIPTAN 12.5MG TABLETS

Active substance(s): ALMOTRIPTAN

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Package leaflet: Information for the user

Almogran® 12.5mg Tablets
almotriptan (as almotriptan D, L- hydrogen malate)
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.
The name of your medicine is Almogran 12.5mg Tablets but
will be referred to as Almogran throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Almogran is and what it is used for
What you need to know before you take Almogran
How to take Almogran
Possible side effects
How to store Almogran
Contents of the pack and other information

1. What Almogran is and what it is used for
Almogran is an anti-migraine 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
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 anti-bacterial
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’.
It has been suggested that excessive use of an anti-migraine
medicinal product can lead to daily chronic headache.

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 12.5mg 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 12.5mg tablet can be taken but you must leave at
least two hours between your first and second tablet.
The maximum daily dose is two (12.5mg) tablets within 24
hours.
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 12.5mg 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)
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.

Reporting 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 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.

5. How to store Almogran
Keep out of the sight and reach of children
There are no special storage instructions.
Do not use after the expiry date stated on the box and
packaging label after ‘Exp’. The expiry date refers to the last
day of that month.

If your tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Do not dispose of medicines in household rubbish. Any
unused tablets should be returned to a pharmacist who will
dispose of them properly.

6. Contents of the pack and other information
What Almogran contains
Each film-coated tablet contains 12.5mg of the active
substance almotriptan (as D, L-hydrogen malate).
Almogran also contains the following ingredients:
Tablet core: mannitol, microcrystalline cellulose, povidone,
sodium carboxymethyl starch and sodium stearyl fumarate.
Coating material: hypromellose, titanium dioxide (E171),
macrogol 400 and carnauba wax.
Printing ink: hypromellose, propylene glycol, indigo carmine
(E132).

What Almogran looks like and contents of the pack
Almogran are available as white, circular, biconvex
film-coated tablets with a blue A printed on one side for oral
use.
Almogran are available in aluminium blister packs of 6
tablets.

Manufactured by: Industrias Farmaceuticas Almirall S.L,
Ctra Nacional ll, km 593 - 08740 Sant Andreu de la Barca
(Barcelona), Spain.

Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

Almogran 12.5mg Tablets;
PL 18799/1153

POM

Leaflet date: 11.12.2015
Almogran is a registered trademark of Lundbeck Limited

Package leaflet: Information for the user

Almotriptan 12.5mg Tablets
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.
The name of your medicine is Almotriptan 12.5mg Tablets
but will be referred to as Almotriptan throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Almotriptan is and what it is used for
What you need to know before you take Almotriptan
How to take Almotriptan
Possible side effects
How to store Almotriptan
Contents of the pack and other information

1. What Almotriptan is and what it is used for
Almotriptan is an anti-migraine 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. What you need to know before you take
Almotriptan
Do not take Almotriptan
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
Almotriptan:
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
nor adrenaline reuptake inhibitors). Also see ‘Other
medicines and Almotriptan’.
It has been suggested that excessive use of an anti-migraine
medicinal product can lead to daily chronic headache.

Children and Adolescents
Children under the age of 18 should not take Almotriptan.

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
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 nor adrenaline 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. 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 may cause drowsiness. If you are affected, you
should not drive or use any tools or machines.

3. How to take Almotriptan
Almotriptan should only be used to treat an actual migraine
attack and not to prevent migraine attacks or headaches.
Always take Almotriptan 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 12.5mg 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 12.5mg tablet can be taken but you must leave at
least two hours between your first and second tablet.
The maximum daily dose is two (12.5mg) tablets within 24
hours.
Tablet should be swallowed with liquid (e.g. water) and can
be taken with or without food.
You should take Almotriptan 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 12.5mg tablet every 24 hours.

If you take more Almotriptan 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
Try to take Almotriptan 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)
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.

Reporting 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 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.

5. How to store Almotriptan
Keep out of the sight and reach of children
There are no special storage instructions.
Do not use after the expiry date stated on the box and
packaging label after ‘Exp’. The expiry date refers to the last
day of that month.

If your tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Do not dispose of medicines in household rubbish. Any
unused tablets should be returned to a pharmacist who will
dispose of them properly.

6. Contents of the pack and other information
What Almotriptan contains
Each film-coated tablet contains 12.5mg of the active
substance almotriptan (as D, L-hydrogen malate).
Almotriptan also contains the following ingredients:
Tablet core: mannitol, microcrystalline cellulose, povidone,
sodium carboxymethyl starch and sodium stearyl fumarate.
Coating material: hypromellose, titanium dioxide (E171),
macrogol 400 and carnauba wax.
Printing ink: hypromellose, propylene glycol, indigo carmine
(E132).

What Almotriptan looks like and contents of the
pack
Almotriptan are available as white, circular, biconvex
film-coated tablets with a blue A printed on one side for oral
use.
Almotriptan are available in aluminium blister packs of 6
tablets.

Manufactured by: Industrias Farmaceuticas Almirall S.L,
Ctra Nacional ll, km 593 - 08740 Sant Andreu de la Barca
(Barcelona), Spain.

Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Almotriptan 12.5mg Tablets;
PL : 18799/1153
Leaflet date: 11.12.2015

POM

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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