film-coated tablets 
eletriptan

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Eletriptan Mylan is and what it is used for 
2. What you need to know before you use Eletriptan Mylan 
3. How to use Eletriptan Mylan 
4. Possible side effects 
5. How to store Eletriptan Mylan 6. Contents of the pack 
and other information 

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 found in the brain and has an astringent effect on blood vessels.

Eletriptan Mylan is used in adults to treat migraine headaches, with or without aura. Before the migraine attack starts, you may experience a phase called an aura, which can cause visual disturbances, numbness, and speech disorders.

Eletriptan contained in Eletriptan Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Eletriptan Mylan

Do not use Eletriptan Mylan

  • if you are allergic to eletriptan or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe liver or kidney disease.
  • if you have moderate to severe high blood pressure or untreated mild high blood pressure.
  • if you have a history of heart problems (eg heart attack, angina, heart failure, or markedly abnormal heart rhythm ( arrhythmia, temporary and sudden narrowing of the coronary arteries).
  • if you have poor blood circulation ( peripheral vascular disease).
  • If you have previously had a stroke ( stroke ), although there was a slight stroke, which only lasted a few minutes or hours.
  • if you have taken ergotamine or any other type of ergotamine (eg methysergide) within 24 hours before or after taking Eletriptan Mylan.
  • if you are taking any other medicines that have a substance name ending in ‘triptan’ (eg sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

Consult your doctor and do not take Eletriptan Mylan if any of the above apply to you now or if you have experienced it before.

Warnings and cautions

Talk to your doctor or pharmacist before taking Eletriptan Mylan:

  • if you have diabetes
  • if you smoke or use nicotine replacement therapy
  • if you are a man and over 40 years
  • if you are a woman and have passed menopause
  • if you or someone in your family has coronary heart disease
  • if you have ever been informed that you are at increased risk of getting heart disease, do not use Eletriptan Mylan without first discussing it with your doctor.

Children and young people

Eletriptan is not recommended for use in children and adolescents below 18 years.

Older

Eletriptan is not recommended for patients over 65 years of age.

Repeated use of anti-migraine drugs

If you repeatedly use eletriptan or another medicine to treat migraines for several days or weeks, it may lead to a headache every day for a long time. Tell your doctor if this happens because you may need to stop treatment for a while.

Other medicines and Eletriptan Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The use of Eletriptan Mylan with certain other medicines can cause serious side effects. Do not use Eletriptan Mylan if:

  • you have taken ergotamine or another ergotamine-type medicine (eg methysergide) within 24 hours before or after taking Eletriptan Mylan.
  • you are taking some other medicines that have a substance name ending in ‘triptan’ (eg sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).

Some medicines can affect the effect of Eletriptan Mylan, but Eletriptan Mylan itself can also reduce the effect of other medicines if taken at the same time. This applies, for example:

  • antifungal agents (eg ketoconazole and itraconazole)
  • medicines for bacterial infections (eg erythromycin, clarithromycin, or josamycin)
  • medicines for AIDS and HIV (eg ritonavir, indinavir, and nelfinavir).

The herbal medicine St. John’s wort ( Hypericum perforatum ) should not be taken at the same time as Eletriptan Mylan. If you are already taking St. John’s wort, you should consult your doctor before stopping treatment with St. John’s wort.

If you are taking medicines for depression or any other type of mental illness (so-called SSRIs * or SNRIs **), talk to your doctor before starting treatment with eletriptan. These drugs may increase the risk of developing serotonergic syndrome if taken in combination with certain anti-migraine drugs. See section 4 “Possible side effects” for more information on the symptoms of a serotonergic syndrome).

* SSRIs – Selective serotonin reuptake inhibitors which are medicines normally taken for depression, e.g. citalopram, fluoxetine.

** SNRI – Serotonin noradrenaline reuptake inhibitors which are drugs normally taken in depression, e.g. venlafaxine or duloxetine (which can also be taken for urinary problems).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy t

Eletriptan Mylan may be recommended by your doctor during pregnancy, but only if necessary.

Breast-feeding

It is recommended to avoid breast-feeding for up to 24 hours after treatment with this medicine, as the medicine is excreted in human milk.

Driving and using machines

Eletriptan or migraine in itself can make you feel sleepy. This medicine may also cause dizziness. Therefore, avoid driving a motor vehicle or handling machinery during an ongoing migraine attack or after taking the medicine.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Eletriptan Mylan contains lactose and the dye para-orange (E110).

Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The color para-orange (E110) can cause allergic reactions.

3. How to use Eletriptan Mylan

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Adults

Eletriptan Mylan can be taken at any time after the onset of a migraine attack, but it is best to take the tablet as soon as possible. However, you should only take  Eletriptan Mylan during the headache phase of migraine one.  Do not take this medicine to prevent a migraine attack.

  • The recommended starting dose is a 40 mg tablet.
  • Swallow the tablet whole with water, before or after a meal
  • If the migraine has not improved after the first tablet, do not take another tablet.
  • If, on the other hand, the migraine headache has improved after the first tablet but then comes back, you can take another tablet, but not earlier than two hours after you took the first tablet.
  • Do not take more than 80 mg (4 x 20 mg or 2 × 40 mg tablets) within 24 hours.
  • If you notice that 1 tablet of 40 mg is not enough to relieve your migraine, talk to your doctor. Your doctor may increase the dose to one to 2 40 mg tablets in the future.

Impaired renal function

This medicine can be used in patients with mild or moderate kidney problems. For these patients, a starting dose of 20 mg is recommended, and the total dose should not exceed 40 mg per day. 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 for mild to moderate hepatic impairment.

If you use more Eletriptan Mylan then you should  

If you have taken too much Eletriptan Mylan, or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Always take the medicine pack with you, regardless of whether there are tablets left or not. Side effects that can occur after an overdose of eletriptan include high blood pressure and heart problems.

If you forget to use Eletriptan Mylan

You should only take this medicine during the migraine headache phase. If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop using Eletriptan Mylan if you experience any of the following serious side effects and tell your doctor immediately or go to the nearest emergency room as you may need urgent medical attention:

  • Chest pain and feeling of tightness that can be intense and also felt in the throat. You may also get cold sweats, shortness of breath, or pain that spreads to the jaw and arms. This can be a symptom of problems with the blood circulation in the heart (ischemic heart disease), heart muscle/artery spasm, or a heart attack.
  • Feeling of weakness, especially along one side of the body, difficulty speaking, or difficulty lifting both arms above the head. This can be a symptom of a stroke (a blockage of blood flow to the brain or leakage of blood from the blood vessels in the brain).
  • Allergic reactions: You may notice symptoms such as sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially if it spreads throughout the body).
  • Serotonergic syndrome: Signs and symptoms of serotonergic syndrome e.g. restlessness, hallucinations (seeing, feeling, and hearing things that do not exist), coordination difficulties, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, and overactive reflexes.
  • Insufficient blood flow to the intestines – you may notice bloody diarrhea, abdominal pain, or vomiting.

Other side effects that may occur:

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

  • Feeling of pain or tightness or feeling of pressure over the chest, palpitations, increased heart rate
  • Dizziness, vertigo, headache, drowsiness, decreased sensation of touch or pain
  • Sore throat, feeling of tightness in the throat, dry mouth
  • Abdominal and abdominal pain, indigestion (upset stomach), nausea (feeling of discomfort in the stomach or abdomen witha feeling of wanting to vomit)
  • Stiffness (increased muscle tone ), muscle weakness, back pain, muscle aches, general pain
  • A general feeling of weakness, feeling of heat, chills, runny nose, sweating, tingling or abnormal feeling, redness

Less common side effects are (may affect up to 1 in 100 anvädare)

  • Breathing difficulties, yawning
  • Swelling of the face or hands and feet, inflammation or infection of the tongue, rash, itching
  • Increased feeling of touch or pain ( hyperesthesia ), coordination difficulties, slow movements or reduced mobility, tremors, speech disorders
  • Thoughts and personality effects (depersonalization), depression, strange thoughts, feeling upset, confusion, mood swings ( euphoria ), periods of disinterest (hibernation), a general feeling of discomfort, malaise or illness (malaise), insomnia (insomnia)
  • Loss of appetite and weight loss ( anorexia ), taste change, thirst
  • Joint wear and tear ( osteoarthritis ), skeletal pain, joint pain
  • Increased need to urinate (urinate), problems with urination, increased urine output, diarrhea
  • Visual disturbance, eye pain, photosensitivity, dry or watery eyes
  • Ear pain, tingling ( tinnitus )
  • Poor circulation ( peripheral vascular disorder)

Rare  side effects are (may affect up to 1 in 1000 users)

  • Shock  asthma (lung disease), hives ( urticaria ), skin change, swollen tongue
  • Infection of the throat or breast, swollen lymph nodes
  • Slow pulse
  • Impact on emotional life (mood swings)
  • Arthritis ( arthritis ), muscle disorder, twitching
  • Constipation, inflammation of the esophagus, belching
  • Chest pain, heavy or prolonged menstruation
  • Eye infection ( conjunctivitis )
  • Voice changes
  • Fainting ( syncope )

Other side effects reported are high blood pressure.

Your doctor may also want to take blood tests on you regularly to test for any elevated liver enzyme levels, levels of a substance called bilirubin, or other blood disorders.

5. How to store Eletriptan Mylan

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is eletriptan. Each film-coated tablet contains eletriptan hydrobromide equivalent to 20 mg eletriptan. 
    Each film-coated tablet contains eletriptan hydrobromide equivalent to 40 mg eletriptan.

  • The other ingredients are microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate, titanium dioxide (E171), talc (E553b), para-orange aluminum lacquer (E110), soy lecithin (E322), xanthan gum (E415).

What the medicine looks like and the contents of the pack

20 mg: Round (6.4 mm), biconvex orange tablets marked with “M” on one side of the tablet and “EL1” on the other side.

40 mg: Round (8.2 mm), biconvex orange tablets marked with “M” on one side of the tablet, and “EL2” on the other side.

Eletriptan Mylan is available in blister packs containing 3, 4, 6, 6 x 1, 10, 10 x 1 (40 mg tablets only), 18 and 20 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Mylan AB, Box 23033, 104 35 Stockholm

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Hungary Kft, Mylan utca 1., Komárom, 2900, Hungary

Muhammad Nadeem

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