Eletriptan EG

Patient Information Leaflet: Information for the User

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

Generic medicine
Please read all of 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 give it 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 EG is and what it is used for
2. What you need to know before taking Eletriptan EG
3. How to take Eletriptan EG
4. Possible side effects
5. How to store Eletriptan EG
6. Contents of the pack and other information

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

This medicinal product contains the active substance eletriptan. Eletriptan 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 can be used in adults for the treatment of migraine with or without aura. Prior to a migraine attack, you may experience a phase called "aura", which involves visual disturbances, numbness, and speech difficulties.

2. What you need to know before taking Eletriptan EG

Do not take Eletriptan EG

• If you are allergic to eletriptan or to any of the excipients 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 ever had heart problems (e.g. heart attack, angina, heart failure or significant irregular heartbeat (arrhythmia), sudden temporary narrowing of one of the coronary arteries).
• 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 EG.

Do not take Eletriptan EG if you are taking other medicines whose names end in "triptan" (e.g. sumatriptan, rizatriptan, naratriptan,
zolmitriptan, almotriptan and frovatriptan).
Contact your doctor and do not take Eletriptan EG if any of the conditions listed above apply to you or have applied in the past.
Warnings and precautions
Talk to your doctor or pharmacist before taking Eletriptan EG if:

• you have diabetes;
• you smoke or are on 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 you are at risk of heart disease, discuss this with your doctor before taking Eletriptan EG.

Children and adolescents
The administration of Eletriptan EG to children and adolescents under 18 years of age is not recommended.
Repeated use of migraine medicines
Repeated use of Eletriptan EG or other medicines for the treatment of migraine over several days or
weeks may cause chronic daily headache. Inform your doctor if this occurs,
as you may need to discontinue treatment.
Other medicines and Eletriptan EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Taking Eletriptan EG with other medicines may cause serious adverse effects. Do not use
Eletriptan EG if:

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

Some medicines may affect how Eletriptan EG works, or Eletriptan EG may
reduce the effectiveness of other medicines taken at the same time, including:

• 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 concomitantly with this
medicine. If you are already taking St John's Wort, consult your doctor before stopping it.
Before taking Eletriptan EG, inform your doctor if you are taking certain medicines (commonly
known as SSRIs (serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors)) for depression or other mental disorders.
These medicines may increase the risk of developing serotonin syndrome when used together with
some migraine medicines. See section 4 - Possible Side Effects - for more
information about the symptoms of serotonin syndrome.
Eletriptan EG with food and drink
Eletriptan EG may be taken before or after food and drink.
Pregnancy, breast-feeding and fertility
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 breast-feeding,
please consult your doctor before taking this medicine.
Breast-feeding is recommended to be avoided for 24 hours after taking this medicine.
Driving and using machines
Eletriptan EG or migraine itself may cause drowsiness. This medicine may also cause
dizziness. Therefore, you are advised to avoid driving or operating machinery during a
migraine attack or after taking this medicine.
Eletriptan EG contains lactose, sunset yellow colour (E110) and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
Sunset Yellow aluminium lake (E110) may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Eletriptan EG

Take this medicine exactly as instructed by your doctor. If you have any doubts, 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 taken as early as possible. However, take Eletriptan EG 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 the migraine improves after the first tablet but then returns, you may take a second dose. However, after taking the first tablet, you must wait at least 2 hours before taking the second dose.
• Do not take more than 80 mg within 24 hours (2 tablets x 40 mg).
• If you feel that a 40 mg tablet does not adequately relieve your migraine, inform your doctor, who may decide to increase the dose to two 40 mg tablets for future episodes.

Elderly
Eletriptan EG 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. In these patients, an initial dose of 20 mg is recommended, and the total daily dose should not exceed 40 mg. Your doctor will prescribe the appropriate dose for you.
Hepatic impairment
This medicine may be used in patients with mild to moderate hepatic impairment. Dose adjustment is not necessary in patients with mild or moderate hepatic impairment.
If you take more Eletriptan EG than you should
If you accidentally take too many Eletriptan tablets, contact your doctor immediately or go to the nearest emergency room. Always bring the medicine package with you, whether or not any tablets remain. Adverse effects from taking too many Eletriptan tablets may include high blood pressure and heart problems.
If you forget to take Eletriptan EG
If you forget to take a dose, 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 a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
Contact your doctor immediately if any of the symptoms listed below occur after taking this medicine.

• Sudden breathlessness, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (particularly affecting the whole body), as these may be symptoms of a hypersensitivity reaction.
• Chest pain and tightness, which may be intense and affect the throat. These may be symptoms of cardiac circulatory problems (cardiac ischemia).
• Signs and symptoms of serotonin syndrome, which may include restlessness, 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 oneself or surrounding objects (vertigo), headache, drowsiness, reduced sensitivity to touch and pain.
• Sore throat, tightness in the throat, dry mouth.
• Abdominal or stomach pain, indigestion (stomach discomfort), nausea (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 warmth, 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, disorganized speech.
• Feeling detached from oneself (depersonalization), depression, altered thoughts, agitation, confusion, mood changes (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness or malaise, lack of sleep (insomnia).
• Loss of appetite and weight (anorexia), altered sense of 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, urticaria, skin disorders, tongue edema.
• Infection of the throat or chest, swollen lymph glands.
• Slowed heartbeat.
• Emotional instability (mood changes).
• Degeneration of joints (arthritis), muscular disorders, muscle contractions.
• Constipation, inflammation of the esophagus, belching.
• Chest pain, heavy or prolonged menstrual periods.
• Eye infection (conjunctivitis).
• Voice changes.

Other reported side effects include fainting, hypertension, inflammation of the colon, vomiting, cerebrovascular and vascular events, inadequate blood supply to the heart, heart attack, spasm of the heart muscle/arterial spasm.
Your doctor may ask you to have regular blood tests to monitor for possible increases in liver enzymes or other blood-related 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eletriptan EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and bottle after the word 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 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 EG contains
The active substance is eletriptan (as eletriptan hydrobromide).
Each film-coated tablet of Eletriptan EG 20 mg contains 20 mg of eletriptan (as eletriptan hydrobromide).
Each film-coated tablet of Eletriptan EG 40 mg contains 40 mg of eletriptan (as eletriptan hydrobromide).
The other components (excipients) are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc, sunset yellow FCF
aluminium lake (E110, colouring agent).

Description of the appearance of Eletriptan EG and package contents
Eletriptan EG tablets are orange-coloured, film-coated, convex and round.
Eletriptan EG 20 mg film-coated tablets are smooth on one side and marked with "20" on the other side.
Eletriptan EG 40 mg film-coated tablets are smooth on one side and marked with "40" on the other side.

Eletriptan EG 20 mg film-coated tablets
Opaque PVC/PCTFE/Aluminium blister packs containing 1, 2, 3, 4, 6, 10 and 18 tablets.

Eletriptan EG 40 mg film-coated tablets
Opaque PVC/PCTFE/Aluminium blister packs containing 1, 2, 3, 4, 6, 10, 18 and 20 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturer
Chanelle Medical Unlimited Company, Dublin Road, Loughrea, County Galway, Ireland