Package Leaflet: Information for the User

Eletriptan Mylan 20 mg film-coated tablets, 40 mg film-coated tablets

Generic Medicine
Please 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 or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, 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, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Eletriptan Mylan is and what it is used for
What you need to know before taking Eletriptan Mylan
How to take Eletriptan Mylan
Possible side effects
How to store Eletriptan Mylan
Contents of the pack and other information

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

Eletriptan Mylan contains the active substance eletriptan. Eletriptan belongs to a group of medicines called "serotonin receptor agonists". Serotonin is a natural substance in the brain that helps to narrow blood vessels.
Eletriptan Mylan can be used to treat the headache phase of migraine, with or without aura, in adults. Before the onset of a migraine attack, a phase called aura may occur, which can involve visual disturbances, numbness, and speech disturbances.

2. What you need to know before taking Eletriptan Mylan

Do not take Eletriptan Mylan:
if you are allergic to eletriptan or to any of the other ingredients of this medicine (listed in
section 6)
if you have severe liver or severe kidney problems
if you have moderately severe or severe high blood pressure, or mild hypertension that is not
controlled with medication
if you have or have ever had heart problems (e.g. heart attack, angina, heart failure or
significantly irregular heartbeat (arrhythmia))
if you suffer from reduced blood flow (peripheral vascular disease)
if you have ever had a stroke (including a milder attack lasting only a few minutes or hours)
if you have taken ergotamine or ergotamine-like medicines (including methysergide) within 24 hours before or after taking Eletriptan Mylan
if you are taking any medicine ending in “triptan” (e.g. sumatriptan, rizatriptan,
naratriptan, zolmitriptan, almotriptan, and frovatriptan).
Consult your doctor and do not take Eletriptan Mylan if any of these conditions apply to you or have ever applied in the past.

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

you have diabetes
you smoke or use nicotine replacement therapy
you are a man over 40 years of age
you are a post-menopausal woman
you or someone in your family has coronary artery disease
you have ever been told that you may have an increased risk of heart disease, talk to your doctor before using Eletriptan Mylan.

Children and adolescents under 18 years of age
The use of Eletriptan Mylan in children and adolescents under 18 years of age is not recommended.
Elderly
Eletriptan Mylan is not recommended in patients over 65 years of age.
Repeated use of migraine medicines
If you repeatedly use eletriptan or other medicines for migraine treatment for several days or
weeks, this may cause long-term daily headaches. If this applies to you, inform your doctor, as it may be necessary to stop treatment for a period of time.
Other medicines and Eletriptan Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Taking Eletriptan Mylan together with certain medicines may cause serious side effects. Do not
take Eletriptan Mylan if:

you have taken ergotamine or ergotamine-like medicines (including methysergide) within 24 hours before or after taking Eletriptan Mylan
you are taking any medicine ending in “triptan” (e.g. sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

Taking other medicines together with Eletriptan Mylan may affect its action, or Eletriptan Mylan may reduce the effectiveness of other medicines taken at the same time. These include:

Medicines used to treat fungal infections (e.g. ketoconazole and itraconazole)
Medicines used to treat bacterial infections (e.g. erythromycin, clarithromycin, and josamycin)
Medicines used to treat AIDS and HIV (e.g. ritonavir, indinavir, and nelfinavir).

St John’s wort ( Hypericum perforatum ) must not be taken at the same time as this medicine. If you are already taking St John’s wort, consult your doctor before stopping it.
Inform your doctor before starting treatment with eletriptan if you are taking certain medicines (commonly known as SSRIs* or SNRIs**) for depression and other mental disorders. These medicines may increase the risk of developing serotonin syndrome when used in combination with certain migraine medicines. See section 4 Possible side effects for further information on symptoms of serotonin syndrome.
*SSRI – Selective Serotonin Reuptake Inhibitors
**SNRI – Serotonin and Noradrenaline Reuptake Inhibitors
Eletriptan Mylan with food and drink
Eletriptan Mylan may be taken before or after meals and drinks.
Pregnancy and breastfeeding
Pregnancy
Eletriptan Mylan may be administered during pregnancy only if necessary.
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
Breastfeeding is recommended to be avoided for 24 hours after taking this medicine.
Driving and using machines
Eletriptan Mylan or the migraine itself may cause drowsiness. This medicine may also cause dizziness. In such cases, you must not drive or operate machinery during a migraine attack or after taking this medicine.
Eletriptan Mylan contains lactose and the colouring agent sunset yellow aluminium lake (E 110). Lactose is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
The colouring agent sunset yellow aluminium lake (E 110) may cause allergic reactions.

3. How to take Eletriptan Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Adults
This medicine can be taken at any time after the onset of migraine headache, but it is best taken as early as possible. However, you must take Eletriptan Mylan only during the headache phase of migraine. Do not take this medicine to prevent a migraine attack.

The recommended initial dose is one 40 mg tablet.
Swallow each tablet whole with a glass of water.
If the first tablet is not effective, do not take a second tablet for the same attack.
If after taking the first tablet the migraine goes away but then returns, you may take a second tablet. However, you must wait at least 2 hours after taking the first tablet before taking the second tablet.
It is recommended not to exceed 80 mg (2 tablets of 40 mg) within 24 hours.
If you notice that a dose of one 40 mg tablet does not relieve your migraine, inform your doctor, who may decide to increase the dose to two 40 mg tablets for future attacks.

Renal impairment
This medicine can be used in patients with mild or moderate kidney problems. In these patients, an initial dose of 20 mg is recommended, and the total daily dose should not exceed 40 mg. Your doctor will tell you which dose to take.
Hepatic impairment
This medicine can be used in patients with mild or moderate liver problems. No dose adjustment is required in cases of mild or moderate hepatic impairment.
If you take more Eletriptan Mylan than you should
If you accidentally take too much Eletriptan Mylan, contact your doctor or go to the nearest hospital emergency department. Always bring the medicine pack, empty or containing any remaining tablets. Adverse effects from overdose of Eletriptan Mylan include high blood pressure and heart problems.
If you forget to take Eletriptan Mylan
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the following serious side effects occur, stop taking Eletriptan Mylan and
contact your doctor immediately, as you may need urgent medical treatment:

Chest pain and tightness, which may be severe and affect the throat. These may be symptoms of heart circulation problems (ischaemic heart disease). In this case, you must contact your doctor immediately, as you may require urgent medical care. This is common and may affect up to 1 in 10 people.
Allergic reactions: you may experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially affecting the whole body). If you experience these effects or if they occur suddenly after taking eletriptan, contact your doctor immediately. The frequency of allergic reactions to eletriptan is unknown.
Serotonin syndrome: signs and symptoms of serotonin syndrome may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, and hyperactive reflexes. If any of these symptoms occur, contact your doctor immediately. The frequency of serotonin syndrome is unknown.

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

Chest pain or tightness or pressure, palpitations, increased heart rate
Dizziness, spinning sensation or lightheadedness, headache, drowsiness, reduced sense of touch or pain
Sore throat, tightness in the throat, dry mouth
Abdominal pain and stomach ache, indigestion (dyspepsia), nausea (feeling of discomfort and uneasiness in the stomach or abdomen with an urge to vomit)
Stiffness (increased muscle tone), muscle weakness, back pain, muscle pain
General feeling of weakness, sensation of warmth, chills, runny nose, sweating, tingling or unusual sensations, hot flushes.

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

Breathing difficulties, yawning
Swelling of the face or hands and feet, inflammation or infection of the tongue, skin rashes, itching
Increased sense of touch or pain (hyperesthesia), loss of coordination, slow or reduced movements, tremor, speech disorders
Feeling detached from oneself (depersonalization), depression, strange thoughts, feeling restless, confusion, mood swings (euphoria), lack of response (stupor), general feeling of discomfort, illness or malaise, insomnia
Loss of appetite and weight loss (anorexia), taste disturbances, thirst
Joint degeneration (arthrosis), bone pain, joint pain
Increased need to urinate, urinary disorders, excessive urine production, diarrhoea
Vision disturbances, eye pain, light sensitivity, changes in tear production
Ear pain, ringing in the ears (tinnitus)
Poor circulation (peripheral vascular disorder).

Rare side effects
(may affect up to 1 in 1,000 people)

Shock, asthma (bronchial disorder), urticaria, skin disorders, swelling of the tongue
Throat or chest infection, swollen lymph glands
Slowed heartbeat
Emotional instability (mood swings)
Joint degeneration (arthritis), muscle disorders, spasms
Constipation, inflamed throat, belching
Breast pain, prolonged or heavy menstrual periods
Eye infections (conjunctivitis)
Voice changes
Syncope.

Other reported side effects include fainting, high blood pressure, stroke, inflammation of the large intestine, and vomiting, inadequate cardiac output, heart attack, spasms in the coronary artery and heart muscle.
Your doctor may also request regular blood tests to detect increases in liver enzymes or any other blood abnormalities.
Reporting of side effects
If you experience any side effect, 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 Eletriptan Mylan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Eletriptan Mylan contains
The active substance is eletriptan.
Each film-coated tablet contains eletriptan hydrobromide equivalent to 20 mg of eletriptan.
Each film-coated tablet contains eletriptan hydrobromide equivalent to 40 mg of eletriptan.
The excipients are microcrystalline cellulose, anhydrous lactose, sodium croscarmellose, magnesium stearate,
titanium dioxide (E171), talc (E553b), sunset yellow FCF aluminium lake (E110), lecithin (E110),
xanthan gum (E415).
Description of the appearance of Eletriptan Mylan and pack sizes
20 mg: biconvex, round (6.4 mm), orange tablets marked "M" on one side and "EL1" on the other.
40 mg: biconvex, round (8.2 mm), orange tablets marked "M" on one side and "EL2" on the other.
Eletriptan Mylan is packed in blisters containing 3, 4, 6, 10, 18, or 20 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturers
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft.
Mylan utca 1., Komarom, 2900, Hungary
This medicinal product is authorised in the European Economic Area countries under the following names
Denmark, Finland, Norway, Sweden: Eletriptan Mylan
France: ELETRIPTAN MYLAN 20 mg, comprimé pelliculé, ELETRIPTAN MYLAN 40 mg, comprimé pelliculé
Italy: Eletriptan Mylan