In this leaflet:

1. What Amignul 12.5 mg film-coated tablets is and what is it used for
2. Before you take Amignul 12.5 mg film-coated tablets
3. How to take Amignul 12.5 mg film-coated tablets
4. Possible side effects
5. How to store Amignul 12.5 mg film-coated tablets

Amignul 12.5 mg film-coated tablets
Almotriptan

Each tablet of Amignul contains 2.5 mg of the active substance almotriptan in the form of almotriptan D,L-malate acid.

The other ingredients (excipients) are:
Core of the tablet: mannitol, microcrystalline cellulose, povidone, sodium carboxymethyl starch and stearyl fumarate and sodium.
Coating material: hypromellose, titanium dioxide (E-171), macrogol 400 and carnauba wax.
Printing ink: hypromellose, propylene glycol and indigo carmine (E-132).

Marketing Authorisation Holder:
Almirall Prodesfarma S.A.
General Mitre, 151 08022 - Barcelona (Spain)

Manufacturer:
Industrias Farmacéuticas Almirall Prodesfarma S.L. Ctra. Nacional II, Km. 593 08740 Sant Andreu de la Barca - Barcelona (Spain)

1. WHAT Amignul 12.5 mg film-coated tablets IS AND WHAT IT IS USED FOR
Amignul is an anti-migraine drug belonging to a class of compounds known as the selective type 1B/1D serotonin receptor agonists.

Amignul is used to alleviate migraine attack-associated headache.

Amignul should only be used to treat an existing migraine attack, but not for prevention.

Amignul is available in round film-coated tablets for oral use with a blue letter A printed on one side in packs of 4 and 6 tablets.

2. BEFORE YOU TAKE Amignul 12.5 mg film-coated tablets

Do not take Amignul if
- You are allergic to almotriptan or any of the other ingredients of Amignul.
- You have a diagnosed cardiovascular disease (for example, myocardial infarct, angina pectoris, asymptomatic ischemic disease, Prinzmetal's angina), serious hypertension or uncontrolled hypertension.
- You have suffered a stroke, a transient ischemic attack or if you have a peripheral vascular disease.
- You have taken other medicines for migraine, including another selective serotonin agonist or any other medicine for migraine containing ergotamine, dihydroergotamine or methysergide before the administration of Amignul.
- You have serious liver impairment.
- You are aged under 18 years.

Take special care with Amignul if
- Your doctor has not yet established a clear diagnosis of migraine, or if your headache is different from your usual migraine attacks.
- You present risk factors for heart disease (high blood pressure, high cholesterol level, obesity, diabetes, you are a smoker, you are in the postmenopausal stage or are a male over 40).
- You are allergic to the sulphamides.
- You have a hepatic or renal disease.
- You are taking Amignul before or after other medicinal products for migraine containing ergotamine.
- Following administration of the drug, your blood pressure increases, you have chest pain, tightness of chest or throat or any other symptom that might be related to a heart attack. In this case do not take any further doses of Amignul until you have seen your doctor.
- You are over 65.

See your doctor even if any of the above situations happened in the past.

Pregnancy
The safety of Amignul for use in pregnancy has not been established, so the administration of almotriptan should only be considered if the expected benefit to the mother outweighs any possible risk to the foetus.
Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding
There are no data regarding excretion of Amignul in human milk. Caution should therefore be exercised when prescribing during breast-feeding. Infant exposure may be minimised by avoiding breast-feeding for 24 hours after treatment.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Migraine or treatment with Amignul may cause somnolence in some patients. Dizziness has been reported in some patients treated with Amignul. If you feel dizzy, do not drive or handle machinery.

Use of other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not prescribed (see no. 2).

3. HOW TO TAKE Amignul 12.5 mg film-coated tablets
Adults may begin with one tablet of Amignul (12.5 mg of almotriptan) taken orally following the onset of migraine-associated headache. A second tablet may be taken if the headache reappears in the same day. A minimum of 2 hours should elapse between the two doses. The maximum recommended dose is two tablets a day.

If you have a serious renal disease do not take more than one tablet a day.

Amignul can be taken with liquids (for example, water). You can take Amignul with or without food.
Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine.
If you have the impression that the effect of Amignul is too strong or too weak, talk to your doctor or pharmacist.

If you take more Amignul than you should
If you accidentally take too many tablets of Amignul, see your doctor or pharmacist immediately.
In case of overdose or accidental intake, call the Toxicological Information Service. Phone number 915 620 420.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Amignul can have side effects. These side effects may include dizziness, somnolence, nausea, vomiting and fatigue. Some people may suffer from paraesthesia, diarrhoea, chest pains, dyspepsia, dry mouth, throat tightness, myalgia, asthenia, palpitations, joint pain and buzzing in the ears.
Do not take preparations containing St. John's Wort (Hypericum perforatum) at the same time as this medicine, since the possibility of the appearance of side effects may increase.
Like other medicines of this class, some exceptional cases of tachycardia (increased heart rhythm), coronary vasospasm and myocardial infarction (heart attack) have been reported.
Excessive use of an anti-migraine medicine can lead to chronic headache requiring a therapeutic window.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. HOW TO STORE Amignul 12.5 mg film-coated tablets
Keep out of the reach and sight of children.
No special storage conditions are required.

Expiry
This medicine should not be used after the expiry date indicated on the container.

This leaflet was approved in August 2006.

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