RELPAX. 20 mg. 2 tablets
RELPAX. 20 mg. 2 tablets
What RELPAX and what it is used
RELPAX eletriptan contains the active substance . RELPAX to a class of drugs called serotonin agonists . Serotonin is a natural substance in the brain , which supports the constriction of blood vessels.
RELPAKS is used for the treatment of migraine headaches with or without aura in adults. Before the onset of migraine headaches may go through a phase called aura that include visual disturbances , numbness and speech disorders .
2 . What you should know before taking RELPAX
Do not take RELPAX :
If you are allergic to eletriptan or any of the other ingredients of this medicine (listed in Section 6) ;
If you have liver disease or kidney ;
If you have moderate to severe high blood pressure or untreated mild hypertension ;
If you have heart problems [ such as heart attack, angina, heart failure or significantly abnormal heart rhythm (arrhythmia )] ;
If you have impaired circulation (peripheral vascular disease ) ;
If you have ever had a stroke (even slight , that lasted only a few minutes or hours) ;
If you have taken ergotamine or medicines like ergotamine (including methysergide ) within 24 hours before or after taking RELPAKS ;
If you are taking other medicines ending in " triptan " such as sumatriptan, rizatriptan, naratriptan, zolmitriptan , almotriptan and frovatriptan .
Please consult your doctor and do not take RELPAX if these statements apply to you now or have included for you in the past.
Warnings and Precautions
Talk to your doctor or pharmacist before taking RELPAX :
if you have diabetes ;
if you smoke or nicotine replacement therapy ;
if you are a man over 40 years;
if you are a woman and you're in postmenopausal ;
if you or someone in your family has heart disease ;
if you have ever been told that you have an increased risk of heart disease.
Repeated use of drugs for the treatment of migraine
If you are repeatedly applied RELPAX or other medication for migraine treatment within a few days or weeks , it may cause prolonged daily headaches. Tell your doctor if you experience this, as may be necessary to stop treatment for a while.
Other medicines and RELPAX
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.
Taking RELPAX simultaneously with certain medications can cause serious side effects. Do not take RELPAKS if:
have taken ergotamine or medicines like ergotamine (including methysergide ) within 24 hours before or after taking RELPAKS ;
taking other medicines ending in " triptan " such as sumatriptan, rizatriptan, naratriptan, zolmitriptan , almotriptan and frovatriptan ) .
Some medicines may affect the way you act or RELPAKS RELPAKS may decrease the effectiveness of other medicines taken at the same time. This includes :
drugs for the treatment of fungal infections (e.g., ketoconazole and itraconazole ) ;
drugs for the treatment of bacterial infections (e.g., erythromycin , clarithromycin and yozamitsin ) ;
drugs for the treatment of AIDS and HIV (e.g., ritonavir , indinavir and nelfinavir) .
Herbal products containing St. John's wort should not be taken concomitantly with this medicine. If you are already taking St. John's wort , consult your doctor before you stop taking it .
If you are taking certain medicines for depression or other mental illness (called selective inhibitors of serotonin reuptake inhibitors or serotonin reuptake / norepinephrine ) , tell your doctor before starting treatment with eletriptan . These medicines may increase the risk of serotonin syndrome during combined use with anti- migraine. For more information about serotonin syndrome, please see section 4 . "Possible Side Effects . "
RELPAX with food and drink
RELPAX can be taken before or after meals.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
It is advised not to breast-feeding 24 hours after you take this medicine.
Driving and using machines
Tablets RELPAX or migraine itself can make you feel sleepy . RELPAX can also cause dizziness . Therefore, during a migraine attack or after taking this medicine , you should avoid driving or operating machinery.
RELPAKS contains lactose and coloring E110 ( sunset yellow )
Lactose is a type of sugar.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
The coloring agent E110 ( sunset yellow ) may cause allergic reactions.
3 . How to take RELPAX
Always take this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
You can take the medicine at any time after the onset of migraine headaches, but it's best to get it as quickly as possible . Should, however, not use RELPAX only during the headache phase . Do not take this medicine to prevent migraine attacks.
The usual starting dose is one tablet of 40 mg.
You should swallow each tablet whole with water.
If the first tablet does not relieve your migraine should not take a second tablet for the same migraine attack .
If after the first tablet get relief of migraine headaches, but then it appeared again , you can take a second tablet . After taking the first tablet , however , you must wait at least 2 hours before taking a second .
You should not take more than 80 mg eletriptan ( 2 tablets of 40 mg) for 24 hours.
If you find that one 40 mg tablet does not relieve your migraine , talk to your doctor and he / she may decide to increase the dose to two tablets of 40 mg on subsequent attacks.
Children and adolescents under 18 years
RELPAX not recommended in children and adolescents under 18 years.
RELPAX not recommended in patients aged over 65 years.
This medicine can be used by patients with mild or moderate renal impairment . In these patients the recommended starting dose of 20 mg, and the daily dose should not exceed 40 mg. Your doctor will advise you what dose to take .
This medicine may be used by patients with mild or moderate hepatic impairment. Not require dose adjustment in mild or moderate hepatic impairment.
If you take more dose RELPAX
If you accidentally take more than the prescribed dose RELPAX , immediately contact your doctor or go to the nearest emergency room . Always carry a pack of medication prescribed for you , whether there are other tablets. Side effects of overdose RELPAKS include high blood pressure and heart problems.
If you forget to take RELPAX
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten tablet.
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 everybody gets them .
Tell your doctor if you experience any of the following symptoms after taking this medicine :
Sudden shortness of breath , difficulty breathing , swelling of eyelids, face or lips , rash or itching (especially affected the whole body ) , as this may be signs of a hypersensitivity reaction ;
Pain and tightness in the chest , which may be severe and include throat. This may be indicative of problems with the circulation of the heart ( coronary artery disease ) ;
Signs and symptoms of serotonin syndrome, which can include restlessness, hallucinations, loss of coordination , increased heart rate , increased body temperature, fast changes in blood pressure, overactive reflexes.
Other side effects that may occur are:
Common ( may affect up to 1 in 10 people):
Pain , tightness or pressure in the chest , palpitations, rapid pulse ;
Lightheadedness , dizziness, headache, drowsiness, reduced sense of touch or pain ;
Sore throat , throat tightness , dry mouth .
Abdominal pain and stomach , indigestion, nausea ( unpleasant sensation in the stomach or abdomen, feeling sick) ;
Stiffness ( increased muscle tone ) , muscle weakness , back pain , muscle pain ;
General fatigue, heat , chills, fever , sweating, numbness or unusual sensation , redness, pain.
Uncommon ( may affect up to 1 in 100 people):
Difficulty breathing , yawning ;
Swelling of the face or limbs , inflammation or infection of the tongue , skin rash, itching;
Increased sense of touch or pain ( hyperesthesia ), loss of coordination , slowed or reduced movements, tremors, slurred speech ;
Loss of identity ( depersonalization ), depression , strange thoughts , excitability , confusion , changes in mood ( euphoria ) , periods of unresponsiveness ( stupor ) , general feeling of discomfort , illness, or lack of well-being ( anxiety ) , insomnia ;
Loss of appetite and weight loss (anorexia ) , taste disturbances , thirst ;
Joint degeneration ( arthritis ) , pain in bones and joints ;
Increased need to urinate , difficulty urinating , increased amount of urine, diarrhea ;
Altered vision , eye pain , intolerance to light , dry or watery eyes ;
Ear pain , ringing in the ears ( tinnitus) ;
Impaired circulation ( peripheral vascular disorder) .
Rare ( may affect up to 1 in 1,000 people):
Shock , asthma , rash, skin disorder , swollen tongue ;
Infection of the throat or chest, swollen lymph glands ;
Slow heartbeat ;
Emotional lability ( mood swings ) ;
Joint degeneration ( arthritis) , muscle disorder , muscle twitching ;
Constipation, inflamed esophagus , belching ;
Chest pain , severe or prolonged monthly cycle ;
Eye infections ( conjunctivitis) ;
Changes in voice .
Other reported side effects include seizures , high blood pressure , inflammation of the colon, vomiting incident involving the brain and blood vessels , insufficient blood flow to the heart , heart attack, coronary artery spasm ( artery that supplies the heart).
Your doctor may perform regular blood tests to monitor liver enzymes or blood problems indicators.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store RELPAX
Keep out of 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.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does RELPAX :
The active substance (s) (s) is (are ): eletriptan
The other ingredients ( excipients ) are: microcrystalline cellulose , lactose monohydrate, croscarmellose sodium , magnesium stearate , titanium dioxide ( E171 ), hypromellose , glycerol triacetate and colorant E110 ( sunset yellow ) .
RELPAX looks like and contents of pack
RELPAX tablets are orange , round tablets.
RELPAX 20 mg film-coated tablets marked with "REP 20" on one side and "Pfizer" on the other.
RELPAX 40 mg film-coated tablets marked with "REP 40 " on one side and "Pfizer" on the other.
The tablets are sold in packs of 2, 4 or 6 pieces .
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: