Eletriptan Viatri

Package leaflet: Information for the user

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

Generic medicine
Please read this leaflet carefully before you start 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Eletriptan Viatris contains the active substance eletriptan. Eletriptan Viatris belongs to a class of
medicines called serotonin receptor agonists. Serotonin is a natural substance found in the
brain that causes blood vessels to narrow.
Eletriptan Viatris can be used for the treatment of migraine with or without aura in adults. Before
the onset of a 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 Viatris

Do not take Eletriptan Viatris:
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 suffer from or have ever suffered from heart problems [e.g. heart attack, angina, heart failure or
significant abnormalities in heart rhythm (arrhythmia), sudden temporary narrowing of one of the
coronary arteries].
If you suffer from circulatory deficiency (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 Viatris.
If you are currently 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 Viatris if any of the above conditions apply to you or have occurred in the past.

Warnings and precautions
Talk to your doctor or pharmacist before taking Eletriptan Viatris if:
you have diabetes.
you smoke or are undergoing nicotine replacement therapy.
you are male and over 40 years of age.
you are female and post-menopausal.
you or a family member suffer from coronary artery disease.
you have been told that you may have an increased risk of heart disease, talk to your doctor before using Eletriptan Viatris.

Repeated use of migraine medicines
Repeated use of Eletriptan Viatris 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 stop treatment.

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

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

Some medicines may affect how Eletriptan Viatris works, or Eletriptan Viatris 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, consult your doctor before stopping the preparation.
Inform your doctor before starting treatment with eletriptan if you are taking certain medicines (commonly called SSRIs* or SNRIs**) for depression or other mental disorders. These medicines may increase the risk of developing serotonin syndrome when used in combination 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 norepinephrine reuptake inhibitors

Eletriptan Viatris with food and drink
Eletriptan Viatris 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 recommended to be avoided for 24 hours after taking this medicine.

Driving and using machines
Eletriptan Viatris or migraine itself may cause drowsiness. This medicine may also cause dizziness. Therefore, it is recommended to avoid driving vehicles or operating machinery during a migraine attack or after taking this medicine.

Eletriptan Viatris contains lactose and the colouring agent sunset yellow aluminium lake (E 110)
Lactose is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
The colouring agent sunset yellow aluminium lake (E 110) may cause allergic reactions.

3. How to take Eletriptan Viatris

Take this medicine exactly as your doctor has told you. If you are not sure, 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 early as possible. However, take Eletriptan Viatris only during the migraine phase; do not take it to prevent a migraine attack.

• The usual initial dose is one 40 mg tablet.
• Swallow each tablet whole with a glass of water.
• If the first tablet does not relieve the migraine, do not take a second tablet for the same migraine attack.
• If after taking the first tablet the migraine goes away 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.
• Do not take more than 80 mg (2 x 40 mg) within 24 hours.
• If you feel that the dose of one 40 mg tablet does not relieve your migraine, inform your doctor – he/she 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 Viatris tablets are not recommended for children and adolescents under 18 years of age.
Elderly
Eletriptan Viatris 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 problems. In these patients, an initial dose of 20 mg is recommended, and the total daily dose should not exceed 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 problems. Dose adjustment is not required for mild to moderate hepatic impairment.
If you take more Eletriptan Viatris than you should
If you accidentally take too much Eletriptan Viatris, contact your doctor immediately or go to the nearest emergency room. Always bring the medicine package with you, whether or not there are tablets left. Adverse effects from taking too much Eletriptan Viatris include high blood pressure and heart problems.
If you forget to take Eletriptan Viatris
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a 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 everybody gets them.
Contact 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 (particularly affecting the whole body), as these may be signs 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 overactive 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 the 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 (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 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 wellbeing (malaise), lack of sleep (insomnia)
• Loss of appetite and weight (anorexia), altered taste, thirst
• Degeneration of joints (osteoarthritis), bone pain, joint pain
• Increased need to urinate, urinary problems, excessive urination, diarrhoea
• Vision disturbances, eye pain, light sensitivity, dry or watery eyes
• Ear pain, ringing in the ears (tinnitus)
• Decreased circulation (peripheral circulation 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 oesophagus, belching
• Chest pain, heavy or prolonged menstrual periods
• Eye infections (conjunctivitis)
• Voice changes

Other reported side effects include fainting, high blood pressure, inflammation of the colon, vomiting, brain and blood vessel events, insufficient blood flow to the heart, heart attack, spasms of the arteries or heart muscle.
Your doctor may also 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 Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
PVC/Aclar/Aluminium blisters: This medicine requires no 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 Viatris contains
The active substance is eletriptan (as eletriptan hydrobromide).
Each 20 mg film-coated tablet of Eletriptan Viatris contains 20 mg of eletriptan (as eletriptan hydrobromide).
Each 40 mg film-coated tablet of Eletriptan Viatris contains 40 mg of eletriptan (as eletriptan hydrobromide).
The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, titanium dioxide (E171), hypromellose, glycerol triacetate, and sunset yellow FCF aluminium lake (E110).

Description of the appearance of Eletriptan Viatris and contents of the pack
Eletriptan Viatris film-coated tablets are orange-colored and round.
Eletriptan Viatris 20 mg film-coated tablets are marked with “Pfizer” on one side and “REP 20” on the other side.
Eletriptan Viatris 40 mg film-coated tablets are marked with “Pfizer” on one side and “REP 40” on the other side.
Eletriptan Viatris is available in opaque PVC/Aclar/aluminum blisters in pack sizes of 2, 3, 4, 5, 6, 10, 18, 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano, Italy

Responsible producer for batch release
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35,
89257 Illertissen, Germany
or
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno, Italy

This medicinal product is authorized in the European Economic Area countries under the following names: