ELETRIPTAN 40 mg Tabletki Powlekane

Treść ulotki

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

Eletriptan Teva 40 mg film-coated tablets

Equivalent Medicinal Product

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

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

Eletriptan Teva contains the active substance eletriptan. Eletriptan Teva belongs to a class of
medicines called serotonin receptor agonists. Serotonin is a natural substance found in the
brain that helps to narrow blood vessels.
Eletriptan Teva can be used for the treatment of migraine, with or without aura, in adult patients.
Before the migraine attack, it may go through a phase called “aura” which involves visual disturbances,
numbness and speech disorders.

2. What you need to know before taking Eletriptan Teva

Do not take Eletriptan Teva

• If you are allergic (hypersensitive) to eletriptan or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver or kidney disease.
• If you suffer from moderate to severe hypertension or untreated mild hypertension.
• If you suffer from or have suffered from heart problems [e.g. heart attack, angina, heart failure or significant abnormality of the heart rhythm (arrhythmia), temporary and sudden narrowing of a coronary artery].
• If you suffer from circulatory deficiency (peripheral vascular disease).
• If you have had a stroke (even mild, lasting only a few minutes or hours).
• If you have taken ergotamine or ergotamine derivatives (including metisergide) within 24 hours before or after taking Eletriptan Teva.

If you are taking other medicines whose name ends in “triptan” (e.g. sumatriptan, rizatriptan, naratriptan,
zolmitriptan, almotriptan and frovatriptan).
Consult your doctor and do not take Eletriptan Teva if the conditions listed above apply to you or
have applied to you in the past.

Warnings and precautions
Talk to your doctor or pharmacist before taking Eletriptan Teva.

• If you have diabetes
• If you smoke or are undergoing nicotine replacement therapy
• If you are male and over 40 years old
• If you are female and postmenopausal
• If you, or a family member, suffer from coronary artery disease
• If you have been told that you are at risk of heart disease, talk to your doctor before taking Eletriptan Teva.

Repeated use of medicines for migraine
Repeated use for several days or weeks of Eletriptan Teva or other medicines for the treatment
of migraine can cause chronic daily headache. Tell your doctor if this condition occurs, as you may need to stop treatment.

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

Taking Eletriptan Teva with other medicines can cause serious side effects.
Do not use Eletriptan Teva if:

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

Some medicines can affect how Eletriptan Teva works, or Eletriptan Teva can
reduce the effectiveness of other medicines taken at the same time. These include:

• Medicines used for the treatment of fungal infections (e.g. ketoconazole and itraconazole).
• Medicines used for the treatment of bacterial infections (e.g. erythromycin, clarithromycin and josamycin).
• Medicines used for the treatment of AIDS and HIV (e.g. ritonavir, indinavir and nelfinavir).

St. John's Wort ( Hypericum perforatum) should not be taken at the same time as this
medicine. If you are already taking St. John's Wort ( Hypericum perforatum), consult your doctor before
stopping taking it.
Before taking Eletriptan Teva, tell your doctor if you are taking any medicines (commonly
called SSRIs* or SNRIs**) for depression or other mental disorders.
These medicines can increase the risk of developing serotonin syndrome if used
together 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 and norepinephrine reuptake inhibitors

Eletriptan Teva with food and drink
Eletriptan Teva can be taken before or after food and drink.

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

Driving and operating machinery
Eletriptan Teva or migraine can cause drowsiness. This medicine can also
cause dizziness. It is therefore recommended to avoid driving vehicles or operating machinery during
a migraine attack or after taking the medicine.

Eletriptan Teva contains Lactose and aluminium lake yellow sunset (E110).
Lactose is a type of sugar. If you have been told that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
The colourant aluminium lake yellow sunset (E 110) may cause allergic reactions.

3. How to take Eletriptan Teva

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

Adults
This medicine can be taken at any time after the start of a migraine attack, but it is
best to take it as soon as possible. However, take Eletriptan Teva only during the
migraine phase. Do not take it toprevent a migraine attack.

• The usual starting dose is one 40 mg tablet
• The tablet should be swallowed whole with a glass of water
• If the first tablet does not reduce the migraine, do not take a second dose for the same migraine attack
• If the migraine disappears after the first tablet and then returns, you can take a second dose. However, after taking the first tablet, you must wait at least 2 hours before taking the second tablet.
• You should not take more than 80 mg of Eletriptan Teva in 24 hours (2 tablets x 40mg)
• If you think that a 40 mg tablet is not enough to eliminate the migraine, tell your doctor, who may decide to increase the dose to two 40 mg tablets for future episodes.

Use in children and adolescents under 18 years of age
Eletriptan Teva tablets are not recommended for children and adolescents under
18 years of age.

Elderly
Eletriptan Teva tablets are not recommended for patients over 65 years of
age.

Renal impairment
This medicine can be used in patients with mild to moderate renal impairment. For these
patients, a starting dose of 20 mg and a total daily dose of no more than 40
mg is recommended. Your doctor will advise you which dose to take.

Hepatic impairment
This medicine can be used in patients with mild to moderate hepatic impairment. No dose adjustment is required
for mild to moderate hepatic impairment.

If you take more Eletriptan Teva than you should:
If you accidentally take too many Eletriptan Teva tablets, contact your doctor immediately or go to the
nearest emergency room. Always bring the medicine packaging with you, whether there are any
tablets remaining or not. Undesirable effects resulting from taking too many Eletriptan
Teva tablets include high blood pressure and heart problems.

If you forget to take Eletriptan Teva
If you forget to take a tablet, take it as soon as you remember unless it is time to
take the next one. Do not take a double dose to make up for a missed dose.
If you have any further 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 everybody gets them.

Tell your doctor immediatelyif, after taking this medicine, you experience any of the
symptoms listed below.

• Sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially all over the body) as this may be a symptom of a hypersensitivity reaction.
• Chest pain and a feeling of tightness which may be severe and spread to the throat. These may be symptoms of heart circulation problems (cardiac ischemia).
• Signs and symptoms of serotonin syndrome which may include agitation, hallucinations, loss of coordination, increased heart rate, increased body temperature, sudden changes in blood pressure and overactive reflexes.

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

• Chest pain or a feeling of tightness or pressure, palpitations, increased heart rate
• Dizziness, feeling of spinning around or objects spinning (vertigo), headache, drowsiness, reduced sensitivity to touch and pain
• Sore throat, feeling of tightness in the throat, dry mouth
• Abdominal and stomach pain, indigestion (stomach discomfort), nausea (feeling sick and unwell 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 hot, chills, runny nose, sweating, tingling or abnormal sensations, hot flushes, pain.

Uncommon
(may affect up to 1 in 100 people)

• Difficulty breathing, yawning
• Swelling of the face, hands or feet, inflammation or infection of the tongue, skin rash, itching
• Increased sensitivity to touch or pain (hyperesthesia), loss of coordination, reduced or slow movements, tremor, confused speech
• Feeling unreal (depersonalization), depression, altered thoughts, agitation, confusion, mood changes (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, unwellness or lack of wellbeing (malaise), difficulty sleeping (insomnia)
• Loss of appetite and weight (anorexia), altered taste, feeling thirsty
• Degeneration of the joints (osteoarthritis), bone pain, joint pain
• Increased need to urinate, problems with urination, excessive urination, diarrhea
• Blurred vision, eye pain, light sensitivity, dry or watery eyes
• Ear pain, ringing in the ears (tinnitus)
• Decreased circulation (peripheral circulatory disorders)

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

• Shock, asthma, hives, skin disorders, swelling of the tongue
• Infection of the throat or chest, swollen lymph glands
• Slowed heartbeat
• Emotional instability (mood swings)
• Degeneration of the joints (arthritis), muscle disorders, muscle contractions
• Constipation, inflammation of the esophagus, belching
• Chest pain, heavy or prolonged menstrual periods
• Eye infections (conjunctivitis)
• Change in voice

Other side effects reported include fainting, high blood pressure, inflammation of the colon, vomiting,
events related to the brain and blood vessels, insufficient blood supply to the heart, heart attack, spasms of the arteries or heart muscle.
Your doctor may ask you for regular blood tests to check for any increase in liver enzymes or other blood problems.

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 Teva

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 pack after EXP. The expiry
date refers to the last day of that month.

PVC/Aclar white sealed blister with aluminium foil: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. Contents of the pack and other information

What Eletriptan Teva contains
The active substance is eletriptan (as eletriptan bromide)
Each film-coated tablet of Eletriptan Teva 40 mg contains 40 mg of eletriptan (as
eletriptan bromide).
The other ingredients are:
Tablet core:
Microcrystalline Cellulose
Lactose monohydrate
Sodium croscarmellose
Magnesium stearate
Film coating:
Lactose monohydrate
Hypromellose
Titanium dioxide (E171)
Triacetin
Sunset Yellow FCF aluminium lake (E110)

Description of the appearance of Eletriptan Teva and contents of the pack
Eletriptan Teva 40 mg film-coated tablets are orange, round and biconvex
film-coated tablets with a diameter of 8.2 mm imprinted with “40” on one side.
Eletriptan Teva 40 mg is available in opaque PVC/PCTFE/Aluminium blisters in packs of 3, 6 and 18
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Via Messina 38
20154 Milan (Italy)

Manufacturer
RAFARM S.A.
Thesi Pousi – Xatzi
Agiou Louka
19002, Paiania Attiki - Greece