20 mg and 40 mg film-coated tablets
eletriptan
What Relpax is and what it is used for
Relpax contains the active substance eletriptan. Relpax belongs to a group of medicines called serotonin receptor agonists. Serotonin is a natural substance found in the brain and has an astringent effect on blood vessels.
Relpax is used in adults to treat migraine headaches, with or without aura. Before the migraine attack starts, you may experience an aura phase, which can cause visual disturbances, numbness, and speech disorders.
What you need to know before using Relpax
Do not use Relpax
- if you are allergic to eletriptan or 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 previously had heart problems (eg heart attack, angina, heart failure, markedly abnormal heart rhythm ( arrhythmia ), or temporary, sudden narrowing of any of the heart’s arteries )
- if you have poor blood circulation ( peripheral vascular disease)
- if you have had a stroke before, even if it was a mild attack that lasted only a few minutes or hours
- if you have taken ergotamine or any other type of ergotamine (eg methysergide) within 24 hours before or after taking Relpax
- if you are taking any other medicines that have a substance name ending in ‘triptan’ (eg sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).
Consult your doctor and do not take Relpax if any of the above apply to you now or if you have experienced it before.
Warnings and cautions
Talk to your doctor or pharmacist before taking Relpax:
- if you have diabetes
- if you smoke or use nicotine replacement
- if you are a man and over 40 years
- if you are a woman and have passed menopause
- if you or someone in your family has coronary heart disease
- if you have ever been informed that you are at increased risk of developing heart disease.
Do not use Relpax without first discussing it with your doctor.
Repeated use of anti-migraine drugs
If you repeatedly use Relpax or another medicine to treat migraines for several days or weeks, it may lead to a headache every day for a long time. Tell your doctor if this happens as you may need 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 any other medicines.
Using Relpax with certain other medicines can cause serious side effects. Do not use Relpax if:
- you have taken ergotamine or another ergotamine-type medicine (eg methysergide) within 24 hours before or after taking Relpax
- you are taking some other medicines that have a substance name ending in “triptan” (eg sumatriptan, rizatriptan, naratriptan, zolmitriptan, almotriptan, and frovatriptan).
Some medicines can affect the effect of Relpax, but Relpax itself can also reduce the effect of other medicines if taken at the same time. This applies, for example:
- antifungal agents (eg ketoconazole and itraconazole)
- medicines for bacterial infections (eg erythromycin, clarithromycin, or josamycin)
- medicines for AIDS and HIV (eg ritonavir, indinavir, and nelfinavir).
The herbal medicine St. John’s wort ( Hypericum perforatum ) should not be taken at the same time as Relpax. If you are already taking St. John’s wort, you should consult your doctor before stopping treatment with St. John’s wort.
If you are taking medicines for depression or any other type of mental illness (so-called SSRIs * or SNRIs **), talk to your doctor before starting treatment with eletriptan. These drugs may increase the risk of developing serotonergic syndrome if taken in combination with certain anti-migraine drugs See section 4 “Possible side effects” for more information on the symptoms of the serotonergic syndrome).
* SSRIs – Selective serotonin reuptake inhibitors
** SNRI – Serotonin noradrenaline reuptake inhibitor
Relpax with food and drink
Relpax can be taken with or without food and drink
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Avoid breastfeeding for up to 24 hours after treatment with this medicine.
Driving and using machines
Relaxation or migraine in itself can make you feel drowsy. This medicine may also make you feel dizzy. Therefore, avoid driving or handling machinery during an ongoing migraine attack or after taking the medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Relpax contains lactose, the dye para-orange (E110), and sodium
Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The dye para-orange (E110) can cause allergic reactions.
Relpax 20 mg and 40 mg tablets contain less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Relpax
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Use for adults
Relpax can be taken at any time after a migraine attack has started, but it is best to take the tablet as soon as possible. However, you should only take Relpax during the headache phase. Do not take this medicine to prevent an attack.
- The usual starting dose is a 40 mg tablet.
- Swallow the tablet whole with water.
- If the migraine has not improved after the first tablet, do not take another tablet.
- However, if the migraine headache has improved after the first tablet but then comes back, you can take another tablet, but only two hours after you took the first tablet.
- Do not take more than 80 mg (2 × 40 mg tablets) within 24 hours.- Do not take more than 80 mg (2 × 40 mg tablets) within 24 hours.
- If you notice that 1 tablet of 40 mg is not enough to relieve your migraine, talk to your doctor to possibly increase the dose from one to 2 tablets of 40 mg in the future.
Use for children and adolescents under 18 years
Relpax tablets are not recommended for children and adolescents under 18 years of age.
Use for the elderly
Relpax tablets are not recommended for patients over 65 years of age.
Use in renal impairment
This medicine can be used in patients with mild to moderate kidney problems. For these patients, a starting dose of 20 mg is recommended, and the total dose should not exceed 40 mg per day. Your doctor will tell you which dose to take.
Use in hepatic impairment
This medicine can be used in patients with mild or moderate liver problems. No dose adjustment is required for mild to moderate hepatic impairment.
If you take more Relpax than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice. Always take the medicine pack with you, regardless of whether there are tablets left or not. Side effects that can occur after an overdose of Relpax 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 dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms after taking this medicine:
- Sudden wheezing, difficulty breathing, swelling of the eyelids or lips or face, rash or itching (especially if it spreads throughout the body) may be a sign of a hypersensitivity reaction.
- Feeling of tightness and pain over the chest that can be intense and also felt in the throat, can be a symptom of problems with blood circulation in the heart (ischemic heart disease).
- Signs and symptoms of serotonergic syndrome e.g. restlessness, hallucinations, coordination difficulties, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, and overactive reflexes.
Other side effects that may occur:
Usual
(may affect up to 1 in 10 users):
- pressure or pain or tightness over the chest, palpitations, increased heart rate
- dizziness, dizziness, headache, drowsiness, decreased sensation or pain on touch
- sore throat, feeling of tightness in the throat, dry mouth
- abdominal and abdominal pain, indigestion, nausea with discomfort, and vomiting
- stiffness (increased muscle tone ), muscle weakness, back pain, muscle aches
- general weakness, feeling hot, chills, cold, runny nose, sweating, tingling or abnormal sensation, redness, pain.
Less common
(may affect up to 1 in 100 people):
- breathing difficulties, yawning
- swelling of the face or hands and feet, inflammation or infection of the tongue, rash, itching
- increased sensation on touch or pain ( hyperesthesia ), coordination difficulties, slow movements, tremors, speech disorder
- Thought and personality effects (depersonalization), depression, strange thoughts, feelings of upset, confusion, mood swings ( euphoria ), periods of disinterest (drowsiness), general feeling of discomfort, malaise or illness (malaise), insomnia (insomnia)
- lost appetite and weight loss ( anorexia ), taste change, thirst
- joint wear and tear ( osteoarthritis ), bone pain, joint pain
- increased need for and problems with throwing water (urination), increased amount of urine, diarrhea
- visual disturbances, eye pain, photosensitivity, dry or watery eyes
- earache, tinnitus
- poor circulation ( peripheral vascular disorder).
Rare
(may affect up to 1 in 1,000 people):
- shock, asthma, hives ( urticaria ), skin change, swollen tongue
- infection of the throat or breast, swollen lymph nodes
- slow pulse
- impact on emotional life (mood swings)
- joint wear and tear ( arthritis ), muscle disorder, twitching
- constipation, inflammation of the esophagus, regurgitation
- chest pain, heavy or prolonged menstruation
- eye infection ( conjunctivitis )
- voice changes.
Other side effects reported are fainting, high blood pressure, inflammation of the colon, vomiting, blood vessel-related damage to the brain, insufficient blood flow to the heart, heart attack, and spasms of the arteries of the heart.
Your doctor may also want to take blood tests on you regularly to test for any elevated liver enzyme levels or other disorders in your blood count.
How to store Relpax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or jar after EXP. The expiration date is the last day of the specified month.
Blister pack in PVC / Aclar / aluminum: No special storage instructions.
Can in HDPE plastic: Store the tablets in the original packaging. Close the jar tightly. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substance is eletriptan (as eletriptan hydrobromide).
Each 20 mg Relpax film-coated tablet contains 20 mg eletriptan (as eletriptan hydrobromide)
Each 40 mg Relpax film-coated tablet contains 40 mg eletriptan (as eletriptan hydrobromide)
The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, titanium dioxide (E171), hypromellose, glycerol triacetate, and para-orange FCF (E110) (see section 2 Relpax contains lactose, para-orange (E110) dye ).
What the medicine looks like and the contents of the pack
Relpax is orange round film-coated tablets.
Relpax 20 mg film-coated tablets are labeled “PFIZER” on one side and REP 20 on the other.
Relpax 40 mg film-coated tablets are marked “PFIZER” on one side and REP 40 on the other.
Relpax is delivered in transparent blister packs in PVC / Aclar / aluminum, containing 2, 3, 4, 5, 6, 10, 18, 30, and 100 tablets or in cans in HDPE plastic with a child-resistant lid in HDPE / PP plastic, containing 30 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Marketing Authorisation Holder
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Local representative
Pfizer AB
191 90 Sollentuna
Phone: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35, 89257 Illertissen
Germany
or
Pfizer Italia Srl,
Location Marino del Tronto,
63100 Ascoli Piceno,
Italy