Almotriptan 12.5 mg Film Coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

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

• 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.

Talk to your doctor or pharmacist before taking Almotriptan if:

• your type of migraine has not been diagnosed
• you are allergic (hypersensitive) to antibacterial medicines mainly used for treatment of urinary tract infections (sulphonamides)
• 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.
• 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
• you have mild to moderate liver disease
• you suffer from severe kidney disease
• you are over 65 years of age (as you are more likely to experience blood pressure increases)
• you are taking anti-depressants SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin noradrenaline reuptake inhibitors). Also see the section “Other medicines and Almotriptan” below.

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

Children under the age of 18 should not take Almotriptan.

If you are over 65 years of age you should speak to your doctor before using this medicinal product.

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.

If you are pregnant or breastfeeding, 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.

Almotriptan may cause drowsiness. If you are affected, you should not drive or use any tools or machines.

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’.

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(s) 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.

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

If you accidentally take too many tablets, or if someone else or a child takes this medicine, talk to a doctor or pharmacist immediately.

Try to take Almotriptan as you have been prescribed. Do not take a double dose to make up for a forgotten tablet.

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is almotriptan.
  Each film-coated tablet contains 12.5mg almotriptan as almotriptan malate.
• The other ingredients are:
  Tablet core: Mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate Type A, sodium stearyl fumarate.
  Coating material: Hypromellose (E464), titanium dioxide (E171), Macrogol 400, carnauba wax.

Almotriptan 12.5 mg Film-coated tablets:

White to off white coloured, round, biconvex film-coated tablets.

The film-coated tablets are available in blister packs containing 2, 3,4,6, 9, 12 and 14 tablets.

Not all pack sizes may be marketed.

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