Patient Information Leaflet

RELPAX® 20 mg film-coated tablets
RELPAX® 40 mg film-coated tablets
eletriptan
Please 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 other people, even if their symptoms are the same as yours, as it may be harmful to them.
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:

What RELPAX is and what it is used for
What you need to know before taking RELPAX
How to take RELPAX
Possible side effects
How to store RELPAX
Contents of the pack and other information

1. What RELPAX is and what it is used for

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

2. What you should know before taking Relpax

Do not take RELPAX
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 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 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 Relpax.
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 Relpax if any of the above conditions apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Relpax 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 have coronary heart disease
you have been told you are at risk of heart disease, talk to your doctor before taking Relpax

Repeated use of migraine medicines
Frequent or prolonged use of Relpax or other migraine treatments over several days or
weeks may lead to chronic daily headache. Inform your doctor if this occurs, as you may
need to discontinue treatment.

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

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

Some medicines may affect how Relpax works, or Relpax may reduce the effectiveness of other
medicines taken concurrently, 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 ( Hypericum perforatum ), consult your
doctor before stopping it.

Before taking Relpax, 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

Relpax with food and drink
Relpax 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 or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Breastfeeding is recommended to be avoided for 24 hours following administration of this
medicine.

Driving and using machines
Relpax 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.

Relpax contains lactose and the colouring agent sunset yellow aluminium lake (E 110)
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 (E 110) may cause allergic reactions.

3. How to take Relpax

Always take this medicine exactly as your doctor has told you. 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 to take it as early as possible.
However, take Relpax 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 your migraine, do not take a second dose for the same migraine attack.
If the migraine disappears after the first tablet but returns later, you may take a second dose. However, you must wait at least 2 hours after taking the first tablet before taking the second.
Do not take more than 80 mg of Relpax within 24 hours (2 tablets x 40 mg).
If you feel that one 40 mg tablet does not 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
Relpax tablets are not recommended for children and adolescents under 18 years of age.
Elderly
Relpax 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, with a maximum total daily dose of 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. Dose adjustment is not required for mild to moderate hepatic impairment.
If you take more Relpax than you should:
If you accidentally take too many Relpax 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 Relpax tablets may include high blood pressure and heart problems.
If you forget to take Relpax:
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 a missed dose.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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, rash or itching (particularly affecting the whole body), as these may be symptoms of an allergic 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 adverse effects that may occur:
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 (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, confused 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, 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 edema
Infection of the throat or chest, swelling of the lymph glands
Slowed heart rate
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 infections (conjunctivitis)
Voice changes

Other reported adverse effects include fainting, hypertension, inflammation of the colon, and vomiting, cerebrovascular events, insufficient blood flow to the heart, heart attack, spasms of arteries or of the heart muscle.
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 adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RELPAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the pack. The expiry date refers to the last day of that month.
PVC Aclar/Al blisters: This medicine does not require any special storage conditions.
HDPE bottles: Store the tablets in the original container. After opening, keep the container tightly closed and protected from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Relpax contains
The active substance in Relpax is eletriptan (as eletriptan hydrobromide).
Each Relpax 20mg film-coated tablet contains 20mg of eletriptan (as eletriptan hydrobromide).
Each Relpax 40mg film-coated tablet contains 40mg of eletriptan (as eletriptan hydrobromide).
The tablets also contain the following excipients: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, titanium dioxide (E171), hypromellose, glycerol triacetate, sunset yellow FCF aluminium lake (E110).

Description of the appearance of Relpax and contents of the pack
Relpax tablets are orange-colored and round.
Relpax 20mg film-coated tablets are marked “PFIZER” on one side and “REP 20” on the other.
Relpax 40mg film-coated tablets are marked “PFIZER” on one side and “REP 40” on the other.
Relpax is available in opaque PVC Aclar/Al blisters in pack sizes of 2, 3, 4, 5, 6, 10, 18, 30 and 100 tablets, or in HDPE bottles with HDPE/PP child-resistant caps containing 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Established Medicine Italy S.r.l. – via Isonzo, 71 – 04100 Latina, Italy

Manufacturers:
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 authorised in the European Economic Area Member States under the following names:
Relert 20 mg and 40 mg film-coated tablets: Belgium, Finland, France, Luxembourg, Portugal, Spain, United Kingdom
Relpax 20 mg and 40 mg film-coated tablets: Austria, Denmark, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Spain, Sweden, Netherlands, United Kingdom

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