RELPAX 20 мг Фильм-coated таблетки

Содержание инструкции

1. What is Relpax and what is it used for
2. What you need to know before taking Relpax
3. How to take Relpax
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE RELPAX
6. Package Contents and Other Information

RELPAX® 20 mg film-coated tablets
RELPAX® 40 mg film-coated tablets
eletriptan
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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Relpax and what is it 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 promotes the constriction of blood vessels.
Relpax can be used for the treatment of migraine with or without aura in adult patients.
Before the migraine attack, it may go through a phase called “aura” which involves disturbances
of vision, numbness and speech disorders.

2. What you need to 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 a severe liver or kidney disease
If you suffer from 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 abnormal heart rhythm (arrhythmia), sudden, temporary narrowing of
one of the coronary arteries].
If you suffer from circulatory disorders (peripheral vascular disease).
If you have had a stroke (even mild, 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 taking other medicines whose name ends 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 have ever occurred
in your case.

Warnings and precautions
Consult your doctor or pharmacist before taking Relpax if:
you have diabetes
you smoke or are undergoing nicotine replacement therapy
you are male and over 40 years old
you are female and post-menopausal
you or a family member suffer from coronary artery disease
you have been told you are at risk of heart disease, before taking Relpax, talk to
your doctor

Repeated use of medicines for migraine
Repeated use of Relpax or other medicines for the treatment of migraine for several days or
weeks, can cause chronic daily headache. Inform your doctor if this condition occurs, as you may
need to discontinue treatment.

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

Taking Relpax with other medicines can cause serious side 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 taking other medicines whose name ends in “triptan” (e.g. sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan and frovatriptan).

Some medicines can affect the mechanism of action of Relpax or Relpax can
reduce the effectiveness of other medicines taken at the same time, including:

• Medicines used for the treatment of fungal infections (e.g. ketoconazole and itraconazole)
• Medicines used for the treatment of bacterial infections (e.g. erythromycin, clarithromycin and josamycin).
• Medicines used for the treatment of AIDS and HIV (e.g. ritonavir, indinavir and nelfinavir).

St. John's Wort ( Hypericum perforatum) should not be taken at the same time
with this medicine. If you are already taking St. John's Wort ( Hypericum perforatum), consult
your doctor before stopping taking it.
Before taking Relpax, tell your doctor if you are taking certain medicines (commonly
called SSRIs* or SNRIs**) for depression or other mental disorders. These medicines can
increase the risk of developing serotonin syndrome if used together with some
medicines for migraine. See section 4 “Possible Side Effects” for more
information on the symptoms of serotonin syndrome.
*SSRIs – selective serotonin reuptake inhibitors
**SNRIs – serotonin and norepinephrine reuptake inhibitors

RELPAX with food and drink
Relpax can 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, if you suspect or are planning a
pregnancy, ask your doctor for advice before taking this medicine.
It is recommended to avoid breastfeeding for 24 hours after taking this
medicine.

Driving and operating machinery
Relpax or migraine can cause drowsiness. This medicine can also cause
dizziness. It is therefore recommended to avoid driving vehicles or operating machinery during
the migraine attack or after taking the medicine.

Relpax contains lactose and aluminium yellow sunset lacca (E 110)
Lactose is a type of sugar. If you have been told you have an intolerance to some sugars,
contact your doctor before taking this medicine.
Aluminium yellow sunset lacca (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, ask your doctor or pharmacist.

Adults
This medicine can be taken at any time after the start of a migraine attack,
but it is best to take it as soon as possible.

However, take Relpax only during the migraine phase, do not take it to prevent
a migraine attack.

• The usual starting dose is one 40 mg tablet
• The tablet should be swallowed whole with a glass of water
• If the first tablet does not make the migraine go away, do not take a second dose for the same migraine attack.
• If the migraine disappears after the first tablet and then returns, you can take a second dose. However, after taking the first tablet you must wait at least 2 hours before taking the second.
• You should not take more than 80 mg of Relpax in 24 hours (2 tablets x 40mg).
• If you think that a 40 mg tablet does not make the migraine go away, tell 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 can be used in patients with mild to moderate kidney disorders. In
these patients, a starting dose of 20 mg and a total daily dose of
no more than 40 mg are recommended. Your doctor will advise you which dose to take.

Hepatic impairment
This medicine can be used in patients with mild to moderate liver disorders. No
dose adjustment is 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 bring the medicine packaging with you, whether or not any tablets
remain. The undesirable effects resulting from taking too many Relpax
tablets 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
time to take the next one. Do not take a double dose to make up for a forgotten one.
If you have any further questions on 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 will experience them.

Inform your doctor immediatelyif, 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 (especially all over the body) as this may be a symptom of an allergic reaction.
• Chest pain and a feeling of tightness which may be severe and affect the throat. These may be symptoms of heart circulatory problems (cardiac ischemia).
• Signs and symptoms of serotonin syndrome which may include agitation, hallucinations, loss of coordination, increased heartbeat, increased body temperature, sudden changes in blood pressure and overactive reflexes.

Other side effects that may occur:
Common
(may affect up to 1 in 10 people)

• Chest pain or a feeling of tightness or pressure, palpitations, increased heart rate
• Dizziness, feeling of spinning of your body or objects (vertigo), headache, drowsiness, reduced sensitivity to touch and pain
• Sore throat, feeling of tightness in the throat, dry mouth
• Abdominal and stomach pain, indigestion (stomach discomfort), nausea (feeling of discomfort and queasiness 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 of warmth, chills, runny nose, sweating, tingling or abnormal sensations, hot flashes, 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 unreal (depersonalization), depression, altered thoughts, agitation, confusion, mood change (euphoria), periods of unresponsiveness (stupor), general feeling of discomfort, unwellness or lack of wellbeing (malaise), sleep problems (insomnia)
• Loss of appetite and weight (anorexia), altered taste, feeling of thirst
• Joint degeneration (osteoarthritis), bone pain, joint pain
• Increased need to urinate, problems with urination, excessive urination, diarrhea
• Blurred vision, 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
• Throat or chest infection, swollen lymph glands
• Slowed heartbeat
• Emotional instability (mood swings)
• Joint degeneration (arthritis), muscle disorders, muscle contractions
• Constipation, inflammation of the esophagus, belching
• Chest pain, heavy or prolonged menstrual periods
• Eye infections (conjunctivitis)
• Voice alteration

Other side effects reported include fainting, high blood pressure, inflammation of the colon and 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 request regular blood tests to check for any increase in liver enzymes or other blood problems.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 RELPAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) that is stated on the pack. The expiry
date refers to the last day of that month.

BlistersPVC Aclar/Al: This medicine does not require any special storage conditions.

HDPE Bottles: Keep the tablets in the original container. Once opened, keep the
container tightly closed and protected from moisture.
Do not dispose of any medicine in 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 Relpax contains
The active ingredient of Relpax is eletriptan (as eletriptan bromhydrate).
Each film-coated tablet of Relpax 20mg contains 20mg of eletriptan (as eletriptan
bromhydrate).
Each film-coated tablet of Relpax 40mg contains 40mg of eletriptan (as eletriptan
bromhydrate).
The tablets also contain the following excipients: microcrystalline cellulose, lactose
monohydrate, sodium croscarmellose, magnesium stearate, titanium dioxide (E171), hypromellose,
triacetin, sunset yellow FCF aluminium lake (E110).

Description of the appearance of Relpax and contents of the packs
Relpax tablets are orange in colour and round in shape.
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 Aclar/Al PVC blisters in packs of 2, 3, 4, 5, 6, 10, 18, 30 and 100
tablets or in child-resistant HDPE bottles with HDPE/PP closures containing 30 and 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
Manufacturer:
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 Member States of the European Economic Area
under the following denominations:
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

This leaflet was last updated on