ELETRIPTAN 20 mg Фильм-Coated Таблетки

Содержание инструкции

1. ELETRIPTAN DOC GENERICI 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is ELETRIPTAN DOC GENERICI and what it is used for
   2. What you need to know before taking ELETRIPTAN DOC GENERICI
   3. How to take ELETRIPTAN DOC GENERICI
   4. Possible side effects
   5. How to store ELETRIPTAN DOC GENERICI
   6. Package contents and other information

ELETRIPTAN DOC GENERICI 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ELETRIPTAN DOC GENERICI and what it is used for

ELETRIPTAN DOC GENERICI contains the active ingredient eletriptan. ELETRIPTAN DOC
GENERICI belongs to the class of medicines called serotonin receptor agonists. Serotonin is a natural
substance found in the brain that promotes the constriction of blood vessels.
ELETRIPTAN DOC GENERICI can be used for the treatment of migraine with or without aura
in adult patients. Before the migraine attack, a phase called aura may occur, which can
evolve into visual disturbances, numbness and speech disorders.

2. What you need to know before taking ELETRIPTAN DOC GENERICI

Do not take ELETRIPTAN DOC GENERICI:

• If you are allergic (hypersensitive) 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 or have had heart problems [e.g. heart attack, angina, heart failure or significantly abnormal heart rhythm (arrhythmia), temporary and sudden narrowing of one of the coronary arteries].
• If you have poor circulation (peripheral vascular disease).
• If you have or have had a stroke (even mild that lasted a few minutes or hours).
• If you have taken ergotamine or medicines similar to ergotamine (including metisergide) within 24 hours before or after taking ELETRIPTAN DOC GENERICI.
• If you are taking other medicines whose name ends in “triptan” (for example sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan and frovatriptan).

Consult your doctor and do not take ELETRIPTAN DOC GENERICI if these cases apply to you now or
have applied to you at any time in the past.

Warnings and precautions
Talk to your doctor or pharmacist before taking ELETRIPTAN DOC GENERICI.

• If you have diabetes.
• If you smoke or use nicotine replacement therapy.
• If you are a man and are over 40 years old.
• If you are a woman and are post-menopausal.
• If you or a family member suffers from coronary artery disease.
• If you or someone in your family may have an increased risk of heart disease, talk to your doctor before using ELETRIPTAN DOC GENERICI.

If you repeatedly use ELETRIPTAN DOC GENERICI or any medicine for the treatment
of migraine for several days or weeks, this can cause daily headaches of long
duration. Tell your doctor if this happens as you may need to stop treatment
for a while.

Other medicines and ELETRIPTAN DOC GENERICI
Tell your doctor or pharmacist if you are taking, have recently taken or might take>
any other medicines.
Taking ELETRIPTAN DOC GENERICI with certain medicines can cause serious side
effects. Do not use ELETRIPTAN DOC GENERICI if:

• you have taken ergotamine or other medicines like ergotamine (including metisergide) within 24 hours before or after taking ELETRIPTAN DOC GENERICI.
• you are taking other medicines whose name ends in “triptan” (for example sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan and frovatriptan).

Some medicines can affect the way ELETRIPTAN DOC GENERICI works or the
same ELETRIPTAN DOC GENERICI can 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).

The herbal preparation St John's Wort (Hypericum perforatum) should not be taken
at the same time. If you are already taking St John's Wort, consult your doctor before
stopping taking it.
Tell your doctor before starting treatment with eletriptan, if you are taking certain medicines
(commonly called 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
medicines for migraine. See section 4 “Possible side effects” for more
information on the symptoms of serotonin syndrome.
SSRIs* - selective serotonin reuptake inhibitors
SNRIs** - serotonin norepinephrine reuptake inhibitors

ELETRIPTAN DOC GENERICI with food and drink
ELETRIPTAN DOC GENERICI can be used before or after consuming food or drink.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, suspect or are planning a
pregnancy, or if you are breastfeeding with breast milk, ask
your doctor or pharmacist before taking this medicine.
It is recommended to avoid breastfeeding for 24 hours after taking this medicine.

Driving and operating machinery
ELETRIPTAN DOC GENERICI or the migraine itself can make you drowsy. This medicine
can also make you feel dizzy. Therefore, avoid driving or using machinery during a migraine attack or after taking the medicine.

ELETRIPTAN DOC GENERICI contains lactose monohydrate and aluminium yellow sunset lacquer

• Lactose monohydrate: if your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• Aluminium yellow sunset lacquer (E110): this ingredient can cause allergic reactions.

3. How to take ELETRIPTAN DOC GENERICI

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.

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

• The usual starting dose is one 40 mg tablet.
• Swallow the tablet whole with a sip of water.
• If the first tablet does not relieve your migraine, do not take a second tablet for the same attack.
• If your migraine improves after the first tablet and 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.
• You must not take more than 80 mg (2 tablets x 40 mg) within 24 hours.
• If you realize that a 40 mg tablet dose does not relieve your migraines, tell your doctor - he or she may decide to increase the dose to two 40 mg tablets for future attacks.

Use in children and adolescents under 18 years
ELETRIPTAN DOC GENERICI tablets are not recommended in children and
adolescents under 18 years of age.

Elderly
ELETRIPTAN DOC GENERICI tablets are not recommended for patients over
65 years of age.

Renal impairment
This 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 the dose to take.

Hepatic impairment
This medicine can be used in patients with mild or moderate liver problems. No dose adjustments are necessary in patients with
mild or moderate hepatic impairment.

If you take more ELETRIPTAN DOC GENERICI than you should
If you accidentally take too much ELETRIPTAN DOC GENERICI, contact your
doctor immediately or go to the nearest hospital emergency room. Always bring with you the labeled
package of the medicine, regardless of how much medicine is left.
Undesirable effects due to taking too much ELETRIPTAN DOC GENERICI include
high blood pressure and heart problems.

If you forget to take ELETRIPTAN DOC GENERICI
If you forget to take a dose, take it as soon as you remember unless it is time for the next
dose. Do not take a double dose to make up for a missed dose.
If you have any questions about using 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.
Tell your doctor immediately if you experience any of the following symptoms after taking
this medicine:

• Sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if it affects the whole body) as it may be a sign of a hypersensitivity reaction.
• Chest pain or tightness, which may be severe and spread to the throat. These may be symptoms of blood circulation problems (ischemic heart disease).
• Signs and symptoms of serotonin syndrome which can include restlessness, hallucinations, loss of coordination, fast heartbeat, increased body temperature, rapid changes in blood pressure and overactive reflexes.

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

• Chest pain or tightness or pressure, palpitations, increased heart rate.
• Dizziness, spinning sensation (vertigo), headache, drowsiness, reduced sense of touch or pain.
• Sore throat, throat tightness, dry mouth.
• Abdominal and stomach pain, indigestion (stomach discomfort), nausea (feeling sick or discomfort in the stomach or abdomen with an urge to vomit).
• Stiffness (increased muscle tone), muscle weakness, back pain, muscle pain.
• General feeling of weakness, feeling warm, chills, runny nose, sweating, tingling or abnormal sensation, flushing, pain.

Not common
(may affect up to 1 in 100 people)

• Difficulty breathing, yawning.
• Swelling of the face or hands or feet, inflammation or infection of the tongue, skin rash, itching.
• Increased sense of touch or pain (hyperesthesia), loss of coordination, slow or reduced movements, tremor, slurred speech.
• Feeling unreal (depersonalization), depression, having strange thoughts, feeling agitated, feeling confused, mood swings (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, unwellness or malaise, difficulty sleeping (insomnia).
• Loss of appetite and weight loss (anorexia), taste disturbances, thirst.
• Joint degeneration (osteoarthritis), bone pain, joint pain.
• Increased need to urinate, problems with urination, passing excessive amounts of urine, diarrhea.
• Abnormal vision, eye pain, light sensitivity, dry or watery eyes.
• Earache, ringing in the ears (tinnitus).
• Poor circulation (peripheral vasculopathy).

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

• Shock, asthma, hives, skin disorders, swollen tongue.
• Infection of the throat or chest, swollen lymph glands.
• Slow heartbeat.
• Emotional lability (mood swings).
• Joint degeneration (arthritis), muscle disorders, contractions.
• Constipation, inflamed bowel, belching.
• Breast pain, heavy or prolonged menstrual periods.
• Eye infection (conjunctivitis).
• Changes in voice.

Other side effects reported include fainting, high blood pressure, inflammation
of the large intestine, vomiting, events related to the brain and blood vessels, inadequate blood supply
to the heart, heart attack, spasm of the arteries or heart muscle.
Your doctor may also take regular blood samples to check for elevated liver enzymes
or any blood problems. If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

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 DOC GENERICI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package or blister 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 in 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 DOC GENERICI contains

• The active ingredient is eletriptan (as bromhydrate). Each film-coated tablet contains 20.00 of eletriptan (as eletriptan bromhydrate).
• The active ingredient is eletriptan (as bromhydrate). Each film-coated tablet contains 40.00 mg of eletriptan (as eletriptan bromhydrate).

The other excipients are microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium
stearate, Opadry II orange 85F230075 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, PEG
3350 (E1521), talc, sunset yellow FCF aluminum lake (E110) (see end of section 2

ELETRIPTAN DOC GENERICI contains lactose monohydrate and sunset yellow aluminum lake
for further information )

Description of the appearance of ELETRIPTAN DOC GENERICI and package contents
The tablets of Eletriptan DOC GENERICI are orange, biconvex, round, film-coated.
The tablets are supplied in blister packs of 2, 3 or 6 tablets. Not all pack sizes may be marketed.
The tablets are supplied in blister packs of 2, 3, 6 or 10 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
DOC Generici Srl – via Turati 40 – 20121 Milan

Manufacturer responsible for batch release
LABORATOIRES BTT
Z.I. de Krafft
67151 ERSTEIN
FRANCE

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France: ELETRIPTAN REF 20 mg- 40 mg, film-coated tablet
Italy: ELETRIPTAN DOC GENERICI

Other sources of information