Eletriptan Teva

Patient Information Leaflet: Information for the User

Eletriptan Teva 40 mg film-coated tablets

Generic Medicine
Please read all of this leaflet carefully before you take this medicine because 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 other people, 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, talk to 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 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

1. What Eletriptan Teva is 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
promotes the narrowing of blood vessels.
Eletriptan Teva can be used for the treatment of migraine, with or without aura, in adult patients.
Before the migraine attack, you may experience a phase called "aura" which involves visual disturbances,
numbness, and speech disturbances.

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 have moderate to severe hypertension or untreated mild hypertension.
• If you currently have or have previously had heart problems [e.g. heart attack, angina, heart failure, significant abnormal heart rhythm (arrhythmia), or sudden temporary narrowing of a coronary artery].
• If you have circulatory problems (peripheral vascular disease).
• If you have had a stroke (even a mild one lasting only a few minutes or hours).
• If you have taken ergotamine or ergotamine derivatives (including methysergide) within 24 hours before or after taking Eletriptan Teva.

Do not take Eletriptan Teva if you are taking other medicines whose names end in "triptan" (e.g. sumatriptan, rizatriptan, naratriptan,
zolmitriptan, almotriptan and frovatriptan).
Consult your doctor and do not take Eletriptan Teva if any of the above conditions apply to you or have applied in the past.

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

• You have diabetes.
• You smoke or are using nicotine replacement therapy.
• You are male and over 40 years of age.
• You are female and post-menopausal.
• You or a family member has coronary heart disease.
• You have been told that you are at risk of heart disease, discuss this with your doctor before taking Eletriptan Teva.

Repeated use of migraine medicines
Repeated use over several days or weeks of Eletriptan Teva or other migraine treatments may cause chronic daily headache. Inform your doctor if this occurs, as you may need to stop treatment.

Other medicines and Eletriptan Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Eletriptan Teva with other medicines may cause serious side effects.
Do not use Eletriptan Teva if:

• You have taken ergotamine or ergotamine derivatives (including methysergide) within 24 hours before or after taking Eletriptan Teva.
• You are taking other medicines whose names end in "triptan" (e.g. sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan or frovatriptan).

Some medicines may affect how Eletriptan Teva works, or Eletriptan Teva 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 together with this medicine. If you are already taking St. John’s Wort ( Hypericum perforatum ), consult your doctor before stopping it.
Before taking Eletriptan Teva, inform your doctor if you are taking certain medicines (commonly known as SSRIs* or SNRIs**) for depression or other mental disorders.
These medicines may increase the risk of developing serotonin syndrome when used together with certain migraine medicines. See section 4 “Possible side effects” for more information about the symptoms of serotonin syndrome.
*SSRI – selective serotonin reuptake inhibitors
**SNRI – serotonin and noradrenaline reuptake inhibitors

Eletriptan Teva with food and drink
Eletriptan Teva may 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, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Breastfeeding is not recommended for 24 hours after taking this medicine.

Driving and using machines
Eletriptan Teva or migraine itself may cause drowsiness. This medicine may also cause dizziness. Therefore, you are advised not to drive or operate machinery during a migraine attack or after taking this medicine.

Eletriptan Teva contains Lactose and the colouring agent Sunset Yellow Aluminium Lake (E110).
Lactose is a type of sugar. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
The colouring agent Sunset Yellow Aluminium Lake (E110) may cause allergic reactions.

3. How to take Eletriptan Teva

Take this medicine exactly as your doctor 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 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 to prevent a migraine attack.

• The usual initial dose is one 40 mg tablet
• Swallow the tablet whole with a glass of water
• If the first tablet does not relieve the migraine, do not take a second dose for the same migraine attack
• If after taking the first tablet the migraine goes away but then returns, you may take a second dose. However, you must wait at least 2 hours after taking the first tablet before taking the second tablet.
• You must not take more than 80 mg of Eletriptan Teva in 24 hours (2 tablets x 40 mg)
• If you feel that one 40 mg tablet is not sufficient to relieve your migraine, inform 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 may be used in patients with mild to moderate renal impairment. For these patients, an initial dose of 20 mg is recommended, with a maximum total daily dose of no more than 40 mg. Your doctor will advise you on the appropriate dose.

Hepatic impairment
This medicine may 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 have accidentally taken too many Eletriptan Teva tablets, contact your doctor immediately or go to the nearest emergency room. Always take the medicine packaging with you, whether or not any tablets are left. Side effects from taking too many Eletriptan Teva tablets may 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 almost time for your next dose. Do not take a double dose to make up for the forgotten 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 everyone gets them.
Contact your doctor immediately if, 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 (particularly widespread over the body), as these may be symptoms of a hypersensitivity reaction.
• Chest pain and tightness, which may be severe and affect the throat. These may be symptoms of cardiac circulatory problems (cardiac ischemia).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, increased heart rate, elevated body temperature, sudden changes in blood pressure, and hyperactive reflexes.

Other possible side effects:

Common
(may affect up to 1 in 10 people)

• Chest pain or tightness or pressure, palpitations, increased heart rate
• Dizziness, sensation of spinning of your body or surroundings (vertigo), headache, drowsiness, reduced sensitivity to touch and pain
• Sore throat, tightness in the throat, dry mouth
• Abdominal and stomach pain, indigestion (stomach discomfort), nausea (a 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 heat, chills, runny nose, sweating, tingling or unusual 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, slurred speech
• Feeling detached from oneself (depersonalization), depression, altered thoughts, agitation, confusion, mood changes (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness or lack of well-being (malaise), lack of sleep (insomnia)
• Loss of appetite and weight (anorexia), altered taste, feeling of thirst
• Degeneration of joints (osteoarthritis), bone pain, joint pain
• Increased need to urinate, urinary problems, excessive urination, diarrhea
• Vision disturbances, 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, tongue swelling
• Throat or chest infection, swollen lymph glands
• Slowed heart rate
• Emotional instability (mood changes)
• Degeneration of joints (arthritis), muscle disorders, muscle contractions
• Constipation, inflammation of the esophagus, belching
• Chest pain, heavy or prolonged menstrual periods
• Eye infections (conjunctivitis)
• Voice changes

Other reported side effects include fainting, hypertension, 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 to have regular blood tests to monitor for possible increases in liver enzymes or other blood problems.
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 Teva

Keep this medicine out of the sight and reach of children.
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.
PVC/Aclar white blister sealed with aluminium foil: This medicine does not require any special storage conditions.
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 Teva contains
The active substance is eletriptan (as eletriptan hydrobromide).
Each film-coated tablet of Eletriptan Teva 40 mg contains 40 mg of eletriptan (as eletriptan hydrobromide).
The other components 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 package contents
Eletriptan Teva 40 mg film-coated tablets are orange, round, biconvex, film-coated tablets with a diameter of 8.2 mm, marked with "40" on one side.
Eletriptan Teva 40 mg is available in opaque PVC/PCTFE/Aluminium blisters containing 3, 6 or 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

This patient information leaflet was last revised in the month of