ELETRIPTAN 20 mg Фильм-Coated Таблетки

Содержание инструкции

1. Eletriptan Mylan 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is Eletriptan Mylan and what it is used for
   2. What you need to know before taking Eletriptan Mylan
   3. How to take Eletriptan Mylan
   4. Possible side effects
   5. How to store Eletriptan Mylan
   6. Contents of the pack and other information

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

Equivalent Medicinal Product
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same
symptoms as you, as it may be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Eletriptan Mylan 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 present 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 start of a migraine attack, a phase called aura may occur, which may
involve visual disturbances, numbness and speech disorders.

2. What you need to know before taking Eletriptan Mylan

Do not take 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 problems 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 (even a milder attack that lasted 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 that ends 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 to you in the past.

Warnings and precautions
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 over 40 years of age
• if you are a post-menopausal woman
• if you or someone in your family suffers from coronary artery disease
• if you have been told that you may have an increased risk of heart disease, talk to your doctor before using Eletriptan Mylan.

Children and adolescents under the age of 18
The use of Eletriptan Mylan in children and adolescents under the age of 18 is not recommended.

Elderly
Eletriptan Mylan is not recommended in patients over 65 years of age.

Frequent use of medicines for migraine
If you repeatedly use eletriptan or other medicines to treat migraine for several days or
weeks, this can cause long-term daily headaches. If this is the case, tell your
doctor as it may be necessary to stop treatment for a period of time.

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

Taking Eletriptan Mylan with certain medicines can 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 that ends in “triptan” (e.g. sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan and frovatriptan).

Taking other medicines with Eletriptan Mylan can affect its action or Eletriptan
Mylan can reduce the effectiveness of other medicines you are taking 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) should not be taken at the same time with
this medicine. If you are already taking St John's Wort, consult your doctor before
stopping St John's Wort.
Tell 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
can increase the risk of developing serotonin syndrome when used in combination with
some migraine medicines. See section 4 Possible side effects for more
information on the symptoms of serotonin syndrome.
*SSRIs - Selective serotonin reuptake inhibitors
**SNRIs - Serotonin and noradrenaline reuptake inhibitors

Eletriptan Mylan with food and drink
Eletriptan Mylan can be taken before or after meals and drinks.

Pregnancy and breastfeeding
Pregnancy
Eletriptan Mylan can be used during pregnancy only if necessary.
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding
It is recommended to avoid breastfeeding for 24 hours after taking this medicine.

Driving and using machines
Eletriptan Mylan or the migraine itself can cause drowsiness. This medicine can also make you
feel dizzy. If this happens, do not drive or use machines during a migraine attack or after taking
this medicine.

Eletriptan Mylancontainslactose and aluminium lake yellow sunset (E 110). 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.
Aluminium lake yellow sunset (E 110) may cause allergic reactions.

3. How to take Eletriptan Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

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

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

Renal impairment
The medicine can be used in patients with mild or moderate kidney problems. In these patients, a starting 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
The medicine can be used in patients with mild or moderate liver problems. No dose adjustment is required in case of mild or moderate hepatic impairment.

If you take more Eletriptan Mylan than you should
If you accidentally take an excessive amount of Eletriptan Mylan, contact your doctor or go to the
nearest hospital emergency room. Always bring the medicine packaging with you, empty or with the
remaining medicines. The undesirable effects of an Eletriptan Mylan overdose 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 time to
take the next dose. Do not take a double dose to make up for a missed dose.
If you have any doubts 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 everybody gets them.

If any of the following serious side effects occur, stop using Eletriptan Mylan and
inform your doctor immediately as urgent medical treatment may be needed:

• Chest pain and a feeling of tightness, which may be severe and spread to the throat. These may be symptoms of heart blood flow problems (ischaemic heart disease). Inthis case, you should inform your doctor immediately as you may needurgent medical attention.This is common and can affect up to 1 in 10 people.
• Allergic reactions: you may notice symptoms such as sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rashes or itching (especially all over the body). If these effects occur or develop suddenly after using eletriptan, tell your doctor immediately. The frequency of allergic reactions to eletriptan is unknown.
• Serotonin syndrome: signs and symptoms of serotonin syndrome can include agitation, hallucinations, loss of coordination, fast heartbeat, increased body temperature, rapid changes in blood pressure and overactive reflexes. If any of these symptoms occur, tell your doctor immediately. The frequency of serotonin syndrome is unknown.

Other side effects that may occur are:
Common side effects
(may affect up to 1 in 10 people)

• chest pain or a feeling of pressure or tightness, palpitations, increased heart rate
• dizziness, feeling lightheaded or giddy, headache, drowsiness, reduced sense of touch or pain
• sore throat, feeling of tightness in the throat, dry mouth
• abdominal pain and stomach discomfort, indigestion, nausea (a feeling of discomfort and sickness in the stomach or abdomen with an urge to vomit)
• stiffness (increased muscle tone), muscle weakness, back pain, muscle pain
• feeling generally weak, feeling of warmth, chills, runny nose, sweating, tingling or abnormal sensations, hot flushes.

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

• difficulty breathing, yawning
• swelling of the face or hands and feet, inflammation or infection of the tongue, skin rashes, itching
• increased sense of touch or pain (hyperaesthesia), loss of coordination, slow or reduced movements, tremor, speech disorders
• feeling detached from yourself (depersonalisation), depression, strange thoughts, feeling agitated, feeling confused, mood swings (euphoria), lack of reaction (stupor), feeling generally unwell, sick or lacking in wellbeing, insomnia
• loss of appetite and weight loss (anorexia), taste disturbances, thirst
• joint degeneration (osteoarthritis), bone pain, joint pain
• increased need to urinate, urination disorders, excessive urine production, diarrhoea
• altered vision, eye pain, light sensitivity, altered tear production
• ear pain, ringing in the ears (tinnitus)
• insufficient circulation (peripheral vascular disorder).

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

• shock, asthma (bronchial disorder), hives, skin disorders, swelling of the tongue
• infection of the throat or chest, swollen lymph glands
• slowed heartbeat
• emotional instability (mood swings)
• joint degeneration (arthritis), muscle disorders, spasms
• constipation, inflamed throat, belching
• breast pain, prolonged or heavy periods
• eye infections (conjunctivitis)
• altered voice
• syncope.

Other side effects reported include fainting, high blood pressure, strokes,
inflammation of the large intestine and vomiting, inadequate heart flow, heart attack, spasms
in the coronary artery and heart muscle.
Your doctor may also request regular blood tests to detect an increase in liver enzymes or
any other blood abnormalities.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eletriptan Mylan contains
The active ingredient is eletriptan.
Each film-coated tablet contains eletriptan bromhydrate equivalent to 20 mg of eletriptan.
Each film-coated tablet contains eletriptan bromhydrate equivalent to 40 mg of eletriptan.

The excipientsare microcrystalline cellulose, anhydrous lactose, sodium croscarmellose, magnesium stearate,
titanium dioxide (E171), talc (E553b), sunset yellow FCF aluminium lake (E110), lecithin (E322),
xanthan gum (E415).

Description of the appearance of Eletriptan Mylan and contents of the pack
20 mg: biconvex, round (6.4 mm) orange-colored tablets marked "M" on one side and
"EL1" on the other.
40 mg: biconvex, round (8.2 mm) orange-colored tablets marked "M" on one side and
"EL2" on the other.
Eletriptan Mylan is packaged in blisters containing 3, 4, 6, 10, 18, 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 Milan

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 Member States of the European Economic Area with the
following denominations
Denmark, Finland, Norway, Sweden: Eletriptan Mylan

France:ELETRIPTAN MYLAN 20 mg, film-coated tablet, ELETRIPTAN MYLAN 40 mg,
film-coated tablet

Italy:Eletriptan Mylan