ELETRIPTAN DOC GENERICI

Patient Information Leaflet

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

Generic medicine
Please read all of this leaflet carefully before taking 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you should know before taking ELETRIPTAN DOC GENERICS

Do not take ELETRIPTAN DOC GENERICS:

• 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 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 had or have a stroke (even a mild one lasting only a few minutes or hours).
• If you have taken ergotamine or medicines similar to ergotamine (including methysergide) within 24 hours before or after taking ELETRIPTAN DOC GENERICS.
• 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 DOC GENERICS if any of these conditions apply to you now or have ever applied to you in the past.

Warnings and precautions

Talk to your doctor or pharmacist before taking ELETRIPTAN DOC GENERICS if:

• You have diabetes.
• You smoke or use nicotine replacement therapy.
• You are a man over 40 years of age.
• You are a woman in post-menopause.
• You or a family member has coronary heart disease.
• You or someone in your family may have an increased risk of heart disease; discuss this with your doctor before using ELETRIPTAN DOC GENERICS.

If you repeatedly use ELETRIPTAN DOC GENERICS or any medicine for the treatment of migraine over several days or weeks, this may cause long-lasting daily headaches. Inform your doctor if this happens, as you may need to stop treatment for a period of time.

Other medicines and ELETRIPTAN DOC GENERICS

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

Taking ELETRIPTAN DOC GENERICS with certain medicines may cause serious adverse effects. Do not use ELETRIPTAN DOC GENERICS if:

• You have taken ergotamine or medicines similar to ergotamine (including methysergide) within 24 hours before or after taking ELETRIPTAN DOC GENERICS.
• 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 DOC GENERICS works, or ELETRIPTAN DOC GENERICS 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 josamicin).
• Medicines used to treat AIDS and HIV (e.g. ritonavir, indinavir, and nelfinavir).

Do not take the herbal preparation St. John’s wort (Hypericum perforatum) at the same time. If you are already taking St. John’s wort, consult your doctor before stopping it.

Inform your doctor before starting eletriptan treatment if you are taking certain medicines (commonly known as SSRIs* or SNRIs**) for depression and 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.

SSRIs* – selective serotonin reuptake inhibitors
SNRIs** – serotonin-norepinephrine reuptake inhibitors

ELETRIPTAN DOC GENERICS with food and drink

ELETRIPTAN DOC GENERICS may be taken before or after food or 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 or pharmacist before taking this medicine.

Breastfeeding should be avoided for 24 hours after taking this medicine.

Driving and using machines

ELETRIPTAN DOC GENERICS or migraine itself may cause drowsiness. This medicine may also cause dizziness. Therefore, avoid driving or operating machinery during a migraine attack or after taking this medicine.

ELETRIPTAN DOC GENERICS contains lactose monohydrate and sunset yellow aluminium lake

• Lactose monohydrate: If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
• Sunset yellow aluminium lake (E110): This ingredient may cause allergic reactions.

3. How to take ELETRIPTAN DOC GENERICI

Always 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 migraine headache, but it is
best to take it as soon as possible. However, you must take ELETRIPTAN DOC GENERICI
only during the headache phase of the migraine.
You must not take this medicine 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 your migraine, do not take a second tablet for the same attack.
• If after taking the first tablet your migraine improves but then returns, you may take a second tablet. 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 (2 tablets x 40 mg) within 24 hours.
• If you find that a single 40 mg tablet does not relieve your migraines, inform 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 of age
ELETRIPTAN DOC GENERICI tablets are not recommended for 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 may be used in patients with mild or moderate kidney problems. In these patients, an initial dose of 20 mg is recommended, and the total daily dose must not exceed 40 mg. Your doctor will advise you on the appropriate dose.
Hepatic impairment
This medicine may be used in patients with mild or moderate liver problems. Dose adjustments are not 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 department. Always bring the labelled medicine package with you, regardless of how much medicine is left.
Adverse effects due to overdose of 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 almost time for your next dose. Do not take a double dose to make up for the forgotten dose.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine:

• Sudden breathlessness, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if affecting the whole body), as these may be signs of a hypersensitivity reaction.
• Pain or tightness in the chest, which may be severe and involve the throat. These may be symptoms of problems with blood circulation (ischaemic heart disease).
• Signs and symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, and overactive reflexes.

Other possible side effects include:
Common:
(may affect up to 1 in 10 people)

• Chest pain, tightness or pressure, palpitations, increased heart rate.
• Dizziness, sensation of spinning (vertigo), headache, drowsiness, reduced sense of touch or pain.
• Sore throat, throat tightness, dry mouth.
• Abdominal and stomach pain, indigestion (stomach discomfort), nausea (a feeling of discomfort or 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, feeling hot, chills, runny nose, sweating, tingling or abnormal sensations, flushing, 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, slow or reduced movements, tremor, slurred speech.
• Feeling detached from oneself (depersonalization), depression, having strange thoughts, feeling restless, feeling confused, mood swings (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, illness or lack of wellbeing (malaise), lack of sleep (insomnia).
• Loss of appetite and weight loss (anorexia), taste disturbances, thirst.
• Degeneration of joints (osteoarthritis), bone pain, joint pain.
• Increased need to urinate, problems urinating, passing excessive amounts of urine, diarrhoea.
• Abnormal vision, eye pain, light sensitivity, dry or watery eyes.
• Earache, ringing in the ears (tinnitus).
• Poor circulation (peripheral vascular disease).

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

• Shock, asthma, hives (urticaria), skin disorders, swollen tongue.
• Throat or chest infection, swollen lymph glands.
• Slow heart rate.
• Emotional lability (mood swings).
• Joint degeneration (arthritis), muscle disorders, spasms.
• Constipation, inflamed colon, belching.
• Breast pain, heavy or prolonged menstrual periods.
• Eye infection (conjunctivitis).
• Changes in voice.

Other reported side effects include fainting, high blood pressure, inflammation of the large intestine, vomiting, brain and blood vessel events, inadequate blood supply to the heart, heart attack, spasms of the arteries or heart muscle.
Your doctor may also regularly take blood samples to check for elevated liver enzymes or any blood-related problems. If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you get 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 DOC GENERICS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 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. Contents of the Pack and Other Information

What ELETRIPTAN DOC GENERICI Contains

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

The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, Opadry II orange 85F230075 (partially hydrolysed polyvinyl alcohol, titanium dioxide, PEG 3350 (E1521), talc, sunset yellow aluminium lake (E110) (see end of section 2 ELETRIPTAN DOC GENERICI contains lactose monohydrate and sunset yellow aluminium lake for further information).

Description of the Appearance of ELETRIPTAN DOC GENERICI and the Contents of the Pack
Eletriptan DOC GENERICI tablets are orange, biconvex, round, film-coated tablets.
The tablets are supplied in blister packs containing 2, 3, or 6 tablets. Not all pack sizes may be marketed.
The tablets are supplied in blister packs containing 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, Italy

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

This medicinal product is authorised in the European Economic Area member states under the following names:
France: ELETRIPTAN REF 20 mg - 40 mg, film-coated tablet
Italy: ELETRIPTAN DOC GENERICI

Other Sources of Information