Leaflet: information for the user

Rizatriptán flas pensa10mg buccal dispersible tablets EFG

Readalltheleafletcarefullybeforeyoustarttakingthismedicine,becauseitcontainsimportantinformationforyou.

-Keepthisleaflet,andshowittoanyonewhogivesyouanyadviceontheuseofthismedicine.

-Ifyouhaveanyquestions,askyourdoctororpharmacist.

-Thismedicinehasbeenprescribedforyoualone.Donotgiveittootherseveniftheyhavethesamesymptomsasyou,becauseitmayharmthem.

-Ifyouexperienceanysideeffects,consultyourdoctororpharmacist,eveniftheyarenotlistedinthisleaflet.

Contentsoftheleaflet:

1. WhatisRizatriptán Flas Pensaandwhatisitusedfor

2. WhatyouneedtoknowbeforetakingRizatriptán Flas Pensa

3. HowtotakeRizatriptán Flas Pensa

4. Sideeffects

5. StorageofRizatriptán Flas Pensa

6. Contentsofthepackandadditionalinformation

Rizatriptán Flas Pensabelongstoaclassofmedicationscalledselectiveserotonin5-HT1B/1Dreceptoragonists.

Rizatriptán Flas Pensaisusedtotreatheadachesfrommigraineattacksinadults.

TreatmentwithRizatriptán Flas Pensa:

Reducestheinflamationofthebloodveinsthatrunthroughthebrain.Thisinflamationprovokestheheadacheofamigraineattack

Do not take Rizatriptán Flas Pensa

-if you are allergic to the active ingredient (rizatriptan benzoate) or any of the other components of this medication (listed in section 6).

-if you have moderately severe, severe, or mild high blood pressure that is not controlled with medication.

-if you have or have had any heart problems, including myocardial infarction or chest pain (angina) or have experienced signs related to heart disease.

-if you have severe liver or kidney problems.

-if you have had a stroke or transient ischemic attack (TIA).

-if you have peripheral vascular disease (blockage in your arteries).

-if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (depression medications), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking an MAOI.

-if you are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine for migraine, or methysergide for migraine prevention.

-if you are taking any other medication in the same class, such as sumatriptan, naratriptan, or zolmitriptan for migraine. (See belowUse of Rizatriptán Flas Pensa with other medications).

If you are unsure if any of the above applies to you, consult your doctor or pharmacist before taking Rizatriptán Flas Pensa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptán Flas Pensa

Before taking Rizatriptán Flas Pensa, inform your doctor or pharmacist if:

-you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking or using nicotine substitutes, a family history of heart disease, are a man over 40 years old or a postmenopausal woman.

-you have kidney or liver problems.

-you have a specific problem with the way your heart beats (left branch block).

-you have or have had any allergies.

-your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm.

-you take medicinal plants that contain St. John's Wort.

-you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (angioedema).

-you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

-you have had transient symptoms including chest pain and pressure.

If you take Rizatriptán Flas Pensa frequently, this may cause you to develop chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptán Flas Pensa.

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have a migraine. You should only take Rizatriptán Flas Pensa for a migraine attack.

Rizatriptán Flas Pensa should not be used to treat other headaches that may be caused by more serious underlying conditions.

Inform your doctor that you are using, have used recently, or may need to use any other medication. This includes medicinal plants and those medications you normally take for migraine. This is because Rizatriptán Flas Pensa may affect the way some medications work. Other medications may also affect Rizatriptán Flas Pensa.

Use of Rizatriptán Flas Pensa with other medications

Do not take Rizatriptán Flas Pensa:

-if you are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan.

-if you are taking a monoamine oxidase inhibitor (MAOI), such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if it has been less than two weeks since you stopped taking an MAOI.

-if you are taking ergotamine-type medications, such as ergotamine or dihydroergotamine for migraine.

-if you are taking methysergide for migraine prevention.

The medications mentioned above may increase the risk of adverse effects when taken with Rizatriptán Flas Pensa.

After taking Rizatriptán Flas Pensa, wait at least 6 hours before taking ergotamine-type medications such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medications, wait at least 24 hours before taking Rizatriptán Flas Pensa.

Ask your doctor for instructions on how to take Rizatriptán Flas Pensa and information on the risks

-if you are currently taking propranolol (see section 3How to take Rizatriptán Flas Pensa).

-if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

Taking Rizatriptán Flas Pensa with food and drinks

Rizatriptán Flas Pensa may take longer to take effect if taken after meals. Although it is better to take it on an empty stomach, you can still take it even if you have eaten.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The available data on the safety of rizatriptan when used during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown whether Rizatriptán Flas Pensa is harmful to the fetus when taken by a pregnant woman after the first three months of pregnancy.

If you are breastfeeding, you may postpone breastfeeding for 12 hours after treatment to avoid exposing your baby.

Use in children

Rizatriptán Flas Pensa is not recommended for use in children under 18 years of age.

Use in patients over 65 years of age

There are no completed studies to evaluate the safety and efficacy of Rizatriptán Flas Pensa in patients over 65 years of age.

Driving and operating machinery

After taking Rizatriptán Flas Pensa, you may feel drowsiness or dizziness. If this occurs, do not drive or operate tools or machinery.

Important information about some of the components of Rizatriptán Flas Pensa

This tablet contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Rizatriptan Fast Dissolving Tabletsareusedtotreatmigrainecrises.TakeRizatriptan Fast Dissolving Tabletsassoonaspossibleaftertheonsetofyourmigrainesymptoms.DonotuseRizatriptan Fast Dissolving Tabletstopreventamigraineattack.

Followtheadministrationinstructionsforthismedicationasindicatedbyyourdoctororpharmacist.Incaseofdoubt,consultyourdoctororpharmacistagain.

Therecommendeddoseis10mg.

Ifyouarecurrentlytakingpropranololorhaverenalorhepaticimpairment,useadoseof5mgofRizatriptan Fast Dissolving Tablets.Waitatleast2hoursbetweenthetimeyoutakepropranololandRizatriptan Fast Dissolving Tabletsanddonotexceed2dosesina24hourperiod.

Ifyourmigrainereturnswithin24hours

Insomepatients,migrainesymptomsmayreappearwithin24hours.Ifyourmigrainereturns,youmaytakeanadditionaldoseofRizatriptan Fast Dissolving Tablets.Waitatleast2hoursbetweendoses.

Morethan2hoursafteryourmigrainesymptomsstillpersist

IfyoudonotrespondtotheinitialdoseofRizatriptan Fast Dissolving Tabletsduringamigraineattack,donottakeaseconddoseforthesamemigraineattack.However,itislikelythatRizatriptan Fast Dissolving Tabletswillrespondduringthenextmigraineattack.

Donottakemorethan2tabletsofRizatriptanFastDissolvingTabletsina24hourperiod.Alwayswaitatleast2hoursbetweendoses.

Ifyourconditionworsens,seekmedicalattention.

HowtoAdministerRizatriptan Fast Dissolving Tablets

• Separatethealuminumfoilandcarefullyremovethetablet.Donotpushthetabletthroughthealuminumfoil.
• Placethetabletonthetonguewhereitwilldissolveandswallowwithsaliva.
• Thefast-dissolvingtabletcanbeusedinsituationswhereliquidsarenotavailable,ortoavoidnauseaandvomitingthatmayaccompanytheingestionoftabletswithliquids.

TakingMoreRizatriptan Fast Dissolving Tablets

IfyoutakemoreRizatriptan Fast Dissolving Tabletsthanyoushould,consultyourdoctororpharmacistimmediately,orcalltheToxicologyInformationService,phone915620420,indicatingthemedicationandtheamounttaken.Sendthecontainerandthepackageinserttoahealthcareprofessional.

Thesignsofoverdosemayincludedizziness,drowsiness,vomiting,weakness,andcardiacarrhythmias.

Ifyouhaveanyotherquestionsabouttheuseofthismedication,askyourdoctororpharmacist.

Like all medications, Rizatriptán Flas Pensa can produce adverse effects, although not all people experience them. The following adverse effects may occur with this medication.

In studies in adults, the most common adverse effects that occurred with more frequency were headache and fatigue.

Frequent (may affect up to 1 in 10 people):

-tingling sensation (paresthesia),headache,reduced sensitivity in the skin (hypoesthesia),diminished mental acuity,nausea,

-rapid or irregular heartbeat (palpitation),rapid or irregular heartbeat (tachycardia),

-flushing (redness of the face that lasts for a brief time),headaches,sweating,

-throat tightness,difficulty breathing (dyspnea),

-nausea,mouth dryness,diarrhea,

-heaviness in the limbs,

-abdominal or chest pain,

-skin rash.

Rare (may affect up to 1 in 1,000 people):

-bad taste in the mouth,

-syncope (fainting),a condition called "serotoninergic syndrome" that can cause adverse effects, unstable arterial pressure,high fever,lack of coordination,agitation,and hallucinations,

-facial pain,noises while breathing,

-immediate and potentially severe allergic reaction (anaphylaxis);severe skin peeling (necrotizing epidermal toxic epidermal necrolysis),

-myocardial infarction,spasms of the coronary arteries,stroke.

These occurred generally in patients with a history of cardiovascular disease or risk factors for cardiovascular disease (hypertension, diabetes, smoking, or use of nicotine substitutes, family history of cardiovascular disease or stroke, age over 40, postmenopausal status, and use of a pacemaker with a left ventricular lead).

Frequency not known (the frequency cannot be estimated from available data):

-seizures (convulsions/ spasms),

-contraction of the peripheral blood vessels, including coldness and numbness of the extremities,

-contraction of the blood vessels of the colon (large intestine), which can cause abdominal pain,

-muscular pain,

-arrhythmia (abnormal heart rhythm),bradycardia (slow heart rate),electrocardiogram alterations (a test that records the electrical activity of the heart).

Inform your doctor immediately if you experience any symptoms of an allergic reaction, serotonin syndrome, heart attack, or stroke.

Also, inform your doctor if you experience any symptoms that indicate an allergic reaction (rash or itching) after taking Rizatriptán Flas Pensa.

Seek medical attention if you experience any adverse effects, consult your doctor as soon as possible, or seek emergency medical attention if you experience any symptoms that are severe or that you do not know how to treat.

Keepitoutofthereachandsightofchildren.

Donotusethismedicationaftertheexpirationdatethatappearsonthebox/container/suppliedin"CAD".Theexpirationdateisthelastdayofthemonthindicated.

Donotstoreatatemperatureabove30ºC.

Disposeofthemedicationsbynotthrowingtheminthedrainsortrash.DepositthepackagingandunusedmedicationsattheSIGREcollectionpointofyourpharmacy.Incaseofdoubtaskyourpharmacistordiscardthepackagingandunusedmedicationsthatyoudonotneed.Thiswillhelptoprotecttheenvironment.

Composition of Rizatriptan Flas Pensa

-The active ingredient is rizatriptan. A buccal dispersible tablet contains 10 mg of rizatriptan equivalent to 14.53 mg of rizatriptan benzoate.

− The other components are: lactose monohydrate, microcrystalline cellulose (E460a), calcium silicate, crospovidone, aspartame (E951), peppermint aroma, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

The 10 mg buccal dispersible tablets are white, flat-faced, and round.

Rizatriptan Flas Pensa 10 mg tablets are presented in packs of 2 or 6 tablets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Neuraxpharm Pharmaceutical, S.L.

Avda. de Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:January 2013.

Other sources of information:

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/