Almogran 12.5 mg Film-coated tablet

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

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 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 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.

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.

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 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.

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 (see below):

United Kingdom

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

Ireland

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

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.

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

Manufacturer

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

Greece Almogran 12.5 mg Επικαλυμμένα με λεπτό υμένιο δισκία

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