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ALMOGRAN 12.5 MG FILM-COATED TABLETS

Active substance(s): ALMOTRIPTAN

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Almogran® 12.5 mg
film-coated tablets

2661
27.02.15[3]

(almotriptan D,L-hydrogen malate)
PATIENT INFORMATION 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.
Your medicine is called Almogran 12.5 mg film-coated tablets but will be
referred to as Almogran throughout the following leaflet.
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
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.
The maximum daily dose is two (12.5 mg) 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 12.5 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.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Industrias Farmaceuticas Almirall S.L., Ctra Nacional II,
KM 593, 08740 Sant Andreu de la Barca, Barcelona, Spain.

Common side effects (1 to 10 users in 100):
- dizziness
- sleepiness (somnolence)
- nausea
- vomiting
- tiredness

Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.

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)

Leaflet revision and issue date (Ref) 27.02.15[3]

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
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. 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 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.
- If your tablets becomes discoloured or shown any other signs of
deterioration, please contact your doctor or pharmacist before taking
your medication.
- Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Almogran contains
Each film-coated tablet contains 12.5 mg of the active substance
almotriptan as D, L-hydrogen malate.
The other ingredients are:
Tablet core: mannitol (E 421), microcrystalline cellulose, povidone, sodium
starch glycolate and sodium stearyl fumarate.
Coating material: hypromellose, titanium dioxide (E 171), macrogol 400,
and carnauba wax.
Printing ink: hypromellose, propylene glycol, indigo carmine.
What Almogran looks like and contents of the pack
Almogran is available as white, circular, biconvex, film-coated tablet with a
blue A printed on one side.
Available in blister packs of 3, 6 and 9 tablets.

POM

PL No: 20636/2661

Almogran is a trademark of Almirall S.A.

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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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