Almotriptan Mylan

PATIENT LEAFLET: INFORMATION FOR THE USER

Almotriptan Mylan 12.5 mg film-coated tablets

Almotriptan
Equivalent medicine
Please read all of 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Almotriptan Mylan is and what it is used for

Almotriptan Mylan contains almotriptan, which is an antimigraine agent belonging to a
class of compounds known as selective serotonin receptor agonists (also known as “triptans”).
Almotriptan is thought to reduce the inflammatory response associated with migraine by binding to serotonin receptors in the blood vessels of the brain (cranial vessels) and causing them to constrict.
Almotriptan Mylan is used to treat headache associated with migraine attacks with or without aura.

2. What you need to know before taking Almotriptan Mylan

Do not take Almotriptan Mylan

• if you are allergic to almotriptan or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have ever had conditions that reduce blood flow to the heart, such as: heart attack, or chest pain or discomfort occurring typically during physical activity or stress (angina), or heart problems without chest pain or chest pain at rest (Prinzmetal's angina), or severe hypertension (severe increase in blood pressure), or uncontrolled mild to moderate increase in blood pressure.
• if you have had a stroke, a mini-stroke (also known as TIA), or an event involving 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 migraine, including ergotamine, dihydroergotamine, and methysergide, or other serotonin agonists (e.g., sumatriptan). See "Other medicines and Almotriptan Mylan" for further information.
• if you have severe hepatic impairment.

Warnings and precautions
Talk to your doctor or pharmacist before taking Almotriptan Mylan if:

• your type of migraine has not been diagnosed.
• you are allergic to sulfonamides used mainly to treat urinary tract infections and as diuretics (diuretics).
• your headache symptoms are different from your usual attacks, for example, if you experience ringing in the ears or dizziness, temporary paralysis on one side of the body or in the muscles controlling eye movements, or if new symptoms appear.
• you have risk factors for heart disease, such as uncontrolled hypertension, hypercholesterolemia, obesity, diabetes, smoking, a strong family history of cardiovascular disease, post-menopausal women, or men over 40 years of age.
• you have mild to moderate liver disease.
• you have severe renal impairment.
• you are over 65 years of age (you are more likely to develop increased blood pressure).
• you are taking antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). See also "Other medicines and Almotriptan Mylan" below.

During treatment
It is believed that excessive use of migraine medication may lead to chronic daily headache.
Children and adolescents
Children under 18 years of age must not take Almotriptan Mylan.
Elderly (over 65 years)
If you are over 65 years of age, you should speak with your doctor before using this medicine.
Other medicines and Almotriptan Mylan
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-norepinephrine reuptake inhibitors (e.g., venlafaxine), as these may cause serotonin syndrome, a potentially life-threatening drug reaction. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle spasms, or diarrhea.
• if you are taking herbal products containing St. John's Wort (Hypericum perforatum), as this may increase the likelihood of side effects.
• Almotriptan Mylan 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 sequentially, provided there is an adequate time interval between doses.

After taking Almotriptan Mylan, it is recommended to wait at least 6 hours before taking ergotamine (a medicine used to treat migraine attacks).
After taking ergotamine, it is recommended to wait at least 24 hours before taking Almotriptan Mylan.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Only very limited data are available regarding the use of almotriptan during pregnancy.
Pregnancy: Almotriptan Mylan should be used during pregnancy only if clearly indicated by your doctor and only after careful assessment of risks and benefits.
Breastfeeding: Caution is recommended when taking this medicine during breastfeeding. If you are breastfeeding, you should wait 24 hours after taking the medicine before resuming breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Almotriptan Mylan may cause drowsiness. If you experience these symptoms, you must not drive or operate tools or machinery.

3. How to take Almotriptan Mylan

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. Almotriptan Mylan should only be used for the treatment of an ongoing migraine attack and not to prevent migraine attacks or headaches.
The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water) and may be taken with or without food.

Adults (18-65 years of age)

• The recommended dose is one 12.5 mg tablet, taken as soon as possible after the onset of a migraine attack.
• If your migraine attack does not subside, do not take more than one tablet for the same attack.
• If a second migraine attack occurs within 24 hours, you may take a second 12.5 mg tablet, but you must wait at least two hours between the first and second tablet.
• The maximum daily dose is two tablets (12.5 mg) within 24 hours.
• Take Almotriptan Mylan as soon as possible after the onset of migraine, although it remains effective even if taken later.

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

If you take more Almotriptan Mylan than you should
If you accidentally take too many tablets, or if someone else or a child takes this medicine, seek immediate advice from your doctor or pharmacist.

If you forget to take Almotriptan Mylan
Try to take Almotriptan Mylan as prescribed. Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Almotriptan Mylan and contact your doctor immediately or go to the nearest hospital if you experience any of the following side effects:
Very rare (may affect up to 1 in 10,000 people):

• Chest pain, chest tightness, which may affect the jaw, neck and arms, feeling of discomfort, malaise, with sensation of squeezing and irregular heartbeat. These may be signs of a heart attack or reduced blood flow to the heart muscle.

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

• Severe sudden allergic reaction such as rash, itching, swelling of the face, lips, tongue or other parts of the body, feeling of tightness in the chest, wheezing
• Seizures (convulsive fits)
• Reduced blood flow to the intestine which may damage the intestine (intestinal ischemia). This may cause abdominal pain and bloody diarrhoea.

During treatment with Almotriptan Mylan, inform your doctor immediately if:

• This medicine may cause short-term chest pain or tightness in the chest and throat, which may be intense. If these effects last for a long time, or if you notice them when you are not taking this medicine, inform your doctor immediately and do not take any more Almotriptan Mylan tablets. These effects may be signs of problems with blood flow to the heart.

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

• dizziness
• drowsiness
• feeling unwell (nausea)
• malaise (vomiting)
• fatigue

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

• sensation of tingling, pricking or numbness of the skin (paraesthesia)
• headache
• noise, sound or ringing in the ears (tinnitus)
• fast or pounding heartbeat (palpitations)
• diarrhoea
• indigestion (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• bone pain
• feeling of weakness (asthenia)

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

• increased heart rate (tachycardia)

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

• visual disturbances, blurred vision (visual disturbances may also occur during a migraine attack itself)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Mylan

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 on the 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Almotriptan Mylan contains

• The active substance is almotriptan malate. Each film-coated tablet contains almotriptan malate equivalent to 12.5 mg of almotriptan.
• The other components are:
  Tablet core: mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate.
  Coating: hypromellose, titanium dioxide (E171), macrogol.

Description of the appearance of Almotriptan Mylan and contents of the pack
Almotriptan Mylan tablets are film-coated tablets, white to almost white in colour, round, biconvex, with "M" engraved on one side and "AL2" on the other side.
Almotriptan Mylan tablets are packed in blisters of 3, 4, 6, 9, and 12 tablets.
Almotriptan Mylan tablets are also packed in perforated blister packs of 4 and 6 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Mylan SpA
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer responsible for batch release:
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Generics [UK] Ltd
Station Close, Potters Bar, Hertfordshire, EN6 1TL
United Kingdom
Mylan Hungary Kft.
Mylan utca 1, Komárom, 2900
Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Spain – Almotriptán MYLAN 12.5 mg comprimidos recubiertos con película EFG
France – ALMOTRIPTAN MYLAN 12.5 mg, comprimé pelliculé
Italy – Almotriptan Mylan