ALMOTRIPTAN TEVA ITALIA

Package leaflet: Information for the user

Almotriptan Teva Italia 12.5 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Almotriptan Teva Italia is and what it is used for

Almotriptan Teva Italia is an antimigraine agent belonging to a class of medicines
known as selective serotonin receptor agonists. Almotriptan
Teva Italia is believed to reduce the inflammatory response associated with migraine by binding to
serotonin receptors in the blood vessels of the brain (cranial vessels), causing them to constrict.
Almotriptan Teva Italia is used to relieve headache associated with migraine attacks
with or without aura.

2. What you need to know before taking Almotriptan Teva Italia

Do not take Almotriptan Teva Italia:

• if you are allergic to Almotriptan Teva Italia or to any of the ingredients of this medicine (listed in section 6).
• if you have or have had diseases that restrict blood flow to the heart, such as:
  • heart attack
  • chest pain or discomfort that usually occurs during physical activity or stress
  • heart problems without chest pain
  • chest pain occurring at rest
  • severe hypertension (severe increase in blood pressure)
  • mild or moderate increase in blood pressure that is not controlled
• if you have had a stroke or reduced blood flow to the brain
• if you have had blockage 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 have severe liver disease.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Almotriptan Teva Italia:

• if your type of migraine has not been diagnosed
• if you are allergic (hypersensitive) to antibacterial medicines mainly used to treat urinary tract infections (sulfonamides)
• if your headache symptoms are different from your usual attacks, for example, if you experience ringing in the ears or dizziness, if you have temporary paralysis on one side of the body or paralysis of the muscles controlling eye movement, or if new symptoms appear
• if you are at risk of heart disease, which includes uncontrolled high blood pressure, high cholesterol, obesity, diabetes, smoking, a clear family history of heart disease, if you are a postmenopausal woman, or if you are a man over 40 years of age.
• if you have mild or moderate liver disease
• if you have severe kidney disease
• if you are over 65 years of age (because increases in blood pressure are more likely)
• if you are taking SSRI (selective serotonin reuptake inhibitors) or SNRI (serotonin-noradrenaline reuptake inhibitors) antidepressants. See also the section below “Other medicines and Almotriptan Teva Italia.”

It has been suggested that excessive use of anti-migraine medicines may lead to chronic daily headache.
Children and adolescents
Children under 18 years of age must not take Almotriptan Teva Italia.
Elderly (over 65 years)
If you are over 65 years of age, contact your doctor before using this medicine.
Other medicines and Almotriptan Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform 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. Symptoms of serotonin syndrome include: confusion, restlessness, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle spasms, or diarrhea
• if you are taking herbal preparations containing St. John’s wort (Hypericum perforatum), as this may increase the likelihood of side effects.

Almotriptan must not be taken at the same time as medicines containing ergotamine, which are also used to treat migraine. However, these medicines may be taken one after the other, provided an adequate interval is left between doses:

• after taking almotriptan, wait at least 6 hours before taking ergotamine
• after taking ergotamine, wait at least 24 hours before taking almotriptan.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Only limited data are available on the use of Almotriptan Teva Italia in pregnant women. During pregnancy, almotriptan should be used only if prescribed by a doctor and only after careful evaluation of the benefits and risks.
Caution is advised when using this medicine during breastfeeding.
Breastfeeding should be avoided for 24 hours after taking the medicine.
Driving and using machines
Almotriptan Teva Italia may cause drowsiness. If you experience this symptom, do not drive vehicles or operate tools or machinery.

3. How to take Almotriptan Teva Italia

Almotriptan Teva Italia should be used only to treat an acute migraine attack and not to prevent migraine attacks or headaches.
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults (18-65 years)
The recommended dose is one 12.5 mg tablet, to be taken as early as possible after the onset of a migraine attack. If the migraine does not improve, do not take more than one tablet for the same attack.

If a second migraine attack occurs within 24 hours after the first, a second 12.5 mg tablet may be taken, but you must wait at least two hours between the first and second tablet.

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

Swallow the tablets with liquid (e.g. water). They may be taken with or without food.

Take Almotriptan Teva Italia as soon as possible after the onset of migraine, although the medicine is effective even if taken at a later stage.

Severe renal impairment
If you have severe kidney disease, do not take more than one 12.5 mg tablet within 24 hours.

If you take more Almotriptan Teva Italia than you should
If you accidentally take too many tablets, or if someone else or a child takes your medicine, contact your doctor or pharmacist immediately.

If you forget to take Almotriptan Teva Italia
Try to take Almotriptan Teva Italia as prescribed. Do not take a double dose to make up for a missed tablet.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• dizziness
• insomnia (drowsiness)
• nausea
• vomiting
• fatigue

Uncommon side effects (may affect up to 1 in 100 people):

• tingling, prickling or numbness of the skin (paraesthesia)
• headache
• ringing, roaring or clicking noises in the ears (tinnitus)
• rapid heartbeat (palpitations)
• throat tightness
• diarrhoea
• digestive difficulties (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• weakness (asthenia)

Very rare side effects (may affect up to 1 in 10,000 people)

• spasm of the heart blood vessels (coronary vasospasm)
• heart attack (myocardial infarction)
• increased heart rate (tachycardia)

Frequency not known (frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity reactions), including swelling of the mouth, throat or hand (angioedema)
• severe allergic reactions (anaphylactic reactions)
• seizures (epileptic attacks)
• visual disturbances, blurred vision (visual disturbances may also occur during a migraine attack)
• intestinal vasospasm, which may cause intestinal damage (intestinal ischaemia). Abdominal pain and bloody diarrhoea may occur.

During treatment with Almotriptan, inform your doctor immediately:

• if you have chest pain, a feeling of pressure in the chest or throat, or any other symptom that could suggest a heart attack. Inform your doctor immediately and do not take any more Almotriptan tablets.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

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

5. How to store Almotriptan Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Almotriptan Teva Italia contains
The active substance is almotriptan 12.5 mg (as almotriptan D,L-hydrogen malate).
The other components are:
Tablet core: mannitol, microcrystalline cellulose, povidone, sodium starch
glycolate (type A), sodium stearyl fumarate.
Coating: hypromellose, titanium dioxide (E-171), macrogol 400.
Description of the appearance of Almotriptan Teva Italia and pack contents
Almotriptan Teva Italia is available as white, round, biconvex, smooth film-coated tablets.
Almotriptan Teva Italia is available in blister packs containing 3, 4, 6, 9 or 12 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l., Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturers
SAG Manufacturing, S.L.U.
Ctra N-I, Km 36, San Agustin de Guadalix
28750 Madrid
Spain
Galenicum Health, S.L.
Avda Cornella 144, 7°-1 Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain
STE Pharma System, S.L.
Avda. Universitat Autónoma, 13,
Parc Tecnológic del Vallés,
Cerdanyola del Vallés,
08290 Barcelona
Spain
INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/laguna 66-68-70, Pol. Industrial Urtinsa II,
Alcorcón, 28923 Madrid
Spain
This medicinal product is authorized in the European Economic Area countries
under the following names: