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ALMOGRAN 12.5MG TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALMOGRAN® 12.5MG TABLETS
(almotriptan D,L-hydrogen malate)
This product will be referred to as Almogran throughout
this leaflet.
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 leafet
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

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.
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 12.5 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.

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 tablets.

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

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: Yellow
Card Scheme, Website: www.mhra.gov.uk/yellowcard

Tablet should be swallowed with liquid (e.g. water) and can be
taken with or without food.

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

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.

5.

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)

How to store Almogran

 This medicinal product does not require any special storage
conditions.
 Keep out of the sight and reach of children.
 Do not use Almogran after the expiry date which is stated
on the carton after “EXP”. The expiry date refers to the last
day of that month.
 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.

Contents of the pack and other information

What Almogran contains
 Each film-coated tablet contains 12.5mg of the active
ingredient almotriptan (as almotriptan D,L-hydrogen
malate).
 The other ingredients are: mannitol, microcrystalline
cellulose, povidone, sodium starch glycollate, sodium
stearyl fumarate, hypromellose, titanium dioxide (E171),
macrogol 400 and carnauba wax.
What Almogran looks like and contents of the pack
Almogran is available as white, circular, biconvex, film-coated
tablets with an engraved ‘A’ engraved on one side and plain on
the other.
Almogran is available in blister packs containing 3, 6, 9 or 12
tablets.
Manufacturer
Industrias Farmaceuticas Almirall SL, Ctra Nacional II, KM 593
08740 Sant Andreu de la Barca, Spain.
Procured from within the EU. Repackaged by the Parallel
Import Product Licence holder: G Pharma Ltd, Dakota Avenue,
Salford M50 2PU.
PL 16369/0896

POM

Almogran 12.5mg Tablets
14/12/2016
Almogran® is a trade mark of Almirall Prodesfarma SL.

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALMOGRAN® 12.5MG TABLETS
(almotriptan D,L-hydrogen malate)
This product will be referred to as Almogran throughout
this leaflet.
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 leafet
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

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.
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 12.5 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.

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 tablets.

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

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: Yellow
Card Scheme, Website: www.mhra.gov.uk/yellowcard

Tablet should be swallowed with liquid (e.g. water) and can be
taken with or without food.

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

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.

5.

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)

How to store Almogran

 This medicinal product does not require any special storage
conditions.
 Keep out of the sight and reach of children.
 Do not use Almogran after the expiry date which is stated
on the carton after “EXP”. The expiry date refers to the last
day of that month.
 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.

Contents of the pack and other information

What Almogran contains
 Each film-coated tablet contains 12.5mg of the active
ingredient almotriptan (as almotriptan D,L-hydrogen
malate).
 The other ingredients are: mannitol, microcrystalline
cellulose, povidone, sodium starch glycollate, sodium
stearyl fumarate, hypromellose, titanium dioxide (E171),
macrogol 400 and carnauba wax.
What Almogran looks like and contents of the pack
Almogran is available as white, circular, biconvex, film-coated
tablets with an engraved ‘A’ engraved on one side and plain on
the other.
Almogran is available in blister packs containing 3, 6, 9 or 12
tablets.
Manufacturer
Industrias Farmaceuticas Almirall SL, Ctra Nacional II, KM 593
08740 Sant Andreu de la Barca, Spain.
Procured from within the EU. Repackaged by the Parallel
Import Product Licence holder: G Pharma Ltd, Dakota Avenue,
Salford M50 2PU.
PL 16369/0896

POM

Almogran 12.5mg Tablets
14/12/2016
Almogran® is a trade mark of Almirall Prodesfarma SL.

Expand Transcript

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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