Rizatriptan Orifarm

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Package leaflet: Information for the patient

[Product name] 10 mg tablet

rizatriptan

Readallofthisleafletcarefullybeforeyoustarttakingthismedicine because it contains important information for you.

- Keepthisleaflet.Youmayneedtoreaditagain.

- Ifyouhaveanyfurtherquestions,askyourdoctor,pharmacist or nurse.

- Thismedicinehasbeenprescribedforyou only.Donotpassitontoothers.Itmayharmthem,eveniftheir signs of illnessarethesameasyours.

- If you get anysideeffects, talk to your doctor, pharmacist or nurse. This includes any possibleanysideeffectsnotlistedinthisleaflet. See section 4.

What is inthisleaflet:

1. What[Productname]isandwhatitisusedfor

2. What you need to know beforeyoutake[Productname]

3. Howtotake[Productname]

4. Possiblesideeffects

5. Howtostore[Productname]

6. Contents of the pack and otherinformation

What [Product name] is and what it is used for

[Product name] belongs to a class of medicines called selective serotonin 5-HT_1B/1D receptor agonists.

[Product name] is used to treat the headache phase of the migraine attack in adults.

Treatmentwith[Productname]reducesswellingofbloodvesselssurroundingthebrain.Thisswelling resultsintheheadachepainofamigraineattack.

2. What you need to know before you take [Product name]

Donottake[Productname]:

• if youareallergictorizatriptanbenzoateoranyoftheotheringredientsofthis medicine (listed in section 6).

• if youhavemoderatelysevereorseverehighbloodpressure,ormildhighbloodpressurethatisnot controlledbymedication.

• if youhaveorhaveeverhadheartproblemsincludingheartattackorpainonthechest(angina)oryou haveexperiencedheartdiseaserelatedsigns.

• if youhavesevereliverorseverekidneyproblems.

• if youhavehadastroke(cerebrovascularaccidentCVA)orministroke(transientischaemicattackTIA).

• if youhaveblockageproblemswithyourarteries(peripheralvasculardisease).

• if youaretakingmonoamineoxidase(MAO)inhibitorssuchasmoclobemide,phenelzine, tranylcypromine,orpargyline(drugsagainstdepression),orlinezolid(anantibiotic),orifithasbeen lessthantwoweekssinceyoustoppedtakingMAOinhibitors.

• if youarenowtakingergotamine-typemedications,suchasergotamineordihydro-ergotaminetotreat yourmigraineormethysergidetopreventamigraineattack.

• if youaretakinganyotherdruginthesameclass,suchassumatriptan,naratriptanorzolmitriptanto treatyourmigraine.(See“Takingwithothermedicines”below).

Ifyouarenotsureifanyoftheaboveapplytoyou,talktoyourdoctororpharmacistbeforetaking[Product name].

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking [Product name]

• if youhaveanyofthefollowingriskfactorsforheartdisease:highbloodpressure,diabetes,yousmoke oryouareusingnicotinesubstitution,yourfamilyhasahistoryofheartdisease,youareamanover 40yearsofage,oryouareapost-menopausalwoman.

• if youhavekidneyorliverproblems.

• if youhaveaparticularproblemwiththewayyourheartbeats(bundlebranchblock).

• if you have or have had any allergies.

• if yourheadacheisassociatedwithdizziness,difficultyinwalking,lackofco-ordinationorweaknessin thelegandarm

• if youuseherbalpreparationcontainingSt.John'swort.

• if youhavehadallergicreactionlikeswellingoftheface,lips,tongueand/orthroatwhichmaycause difficultybreathingand/orswallowing(angioedema).

• if youaretakingselectiveserotoninreuptakeinhibitors(SSRIs)suchassertraline,escitalopramoxalate, andfluoxetineorserotoninnorepinephrinereuptakeinhibitors(SNRIs)suchasvenlafaxine,and duloxetinefordepression.

• if youhavehadshortlivedsymptomsincludingchestpainandtightness.

Ifyoutake[Productname]toooftenthismayresultinyougettingachronicheadache.Insuchcasesyou shouldcontactyourdoctorasyoumayhavetostoptaking[Productname].

Pleasetellyourdoctororpharmacistaboutyoursymptoms.Yourdoctorwilldecideifyouhavemigraine. Youshouldtake[Productname]onlyforamigraineattack.[Productname]shouldnotbeusedtotreat headachesthatmightbecausedbyother,moreseriousconditions.

Children and adolescents

The use of [Product name] in children and adolescents under 18 years of age is not recommended.

Other medicines and [Product name]

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Thisincludesthoseyounormallytakefora migraine.Thisisbecause[Productname]canaffectthewaysomemedicineswork.Alsoothermedicinescan affect[Productname].

Donottake[Productname]

• ifyouarealreadytakinga5HT1B/1Dagonist(sometimesreferredtoas‘triptans’),suchassumatriptan, naratriptanorzolmitriptan.

• ifyouaretakingamonoamineoxidase(MAO)inhibitorsuchasmoclobemide,phenelzine, tranylcypromine,linezolid,orpargylineorifithasbeenlessthantwoweekssinceyoustoppedtaking anMAOinhibitor.

• ifyouuseergotamine-typemedicationssuchasergotamineordihydro-ergotaminetotreatyour migraine

• ifyouusemethysergidetopreventamigraineattack.

Theabovelistedmedicineswhentakenwith[Productname]mayincreasetheriskofsideeffects.

Youshouldwaitatleast6hoursaftertaking[Productname]beforeyoutakeergotamine-typemedications suchasergotamineordihydro-ergotamine ormethysergide.

You should wait at least 24 hours after taking ergotamine-type medications before taking [Product name].

Ask your doctor for instructionsandtherisksabouttaking[Productname]

^• ^if^y^ou^are^takⁱⁿ^g^pro^p^r^ano^l^ol^(see^s^e^ction^3:^“H^o^w^to^take^[Pr^o^d^u^ct^name]”)

• ifyouaretakingSSRIssuchassertraline,escitalopramoxalate,andfluoxetineorSNRIssuchas venlafaxine,andduloxetinefordepression.

[Productname]withfoodanddrink

[Productname]cantakelongertoworkifitistakenafterfood.Althoughitisbettertotakeitonanempty stomach,youcanstilltakeitifyouhaveeaten.

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Itisnotknownwhether[Productname]isharmfulto anunbornbabywhentakenbyapregnantwoman.

Breastfeedingshouldbeavoidedfor24hoursaftertreatment.

Askyourdoctororpharmacistforadvicebeforetakinganymedicine.

Drivingandusingmachines

Youmayfeelsleepyordizzywhiletaking[Productname].Ifthishappens,donotdriveoruseanytoolsor machines.

3. How to take [Product name]

Alwaystake this medicine exactly as your doctor or pharmacist has told you.Checkwithyourdoctoror pharmacistifyouarenotsure.

[Productname]isusedtotreatmigraineattacks.Take[Productname]assoonaspossibleafteryour migraineheadachehasstarted.Donotuseittopreventanattack.

Therecommendeddoseis10mg.

Ifyouarecurrentlytakingpropranololorhavekidneyorliverproblemsyoushouldusea5-mgdose.You shouldleaveatleast2hoursbetweentakingpropranololandrizatriptanuptoamaximumof2dosesina24- hourperiod.[Productname]cannotbedividedintoequaldoses,andisthereforenotsuitablefortreatmentof patientsthatrequireadoseof5mg.Ifyouneedthe5mgdoseyoushouldcontactyourdoctor.

Ifmigrainereturnswithin24hours

Insomepatients,migrainesymptomscanreturnwithina24-hourperiod.Ifyourmigrainedoesreturnyou cantakeanadditionaldoseof[Productname].Youshouldalwayswaitatleast2hoursbetweendoses.

Ifafter2hoursyoustillhaveamigraine

Ifyoudonotrespondtothefirstdoseof[Productname]duringanattack,youshouldnottakeaseconddose of[Productname]fortreatmentofthesameattack.Itisstilllikely,however,thatyouwillrespondto [Productname]duringthenextattack.

Donottakemorethan2dosesof[Productname]ina24-hourperiod,.Youshouldalways waitatleast2hoursbetweendoses.

Ifyourconditionworsens,seekmedicalattention.

Useinpatientsolderthan65years

Therehavebeennofullstudiestolookathowsafeandeffective[Productname]isamongstpatientsolder than65years.

Ifyoutakemore[Productname]thanyoushould

Ifyoutakemore[Productname]thanyoushould,talktoyourdoctororpharmaciststraightaway.Takethe medicinepackwithyou.Signsofoverdosagecanincludedizziness,drowsiness,vomiting,faintingandslow heartrate.

Ifyouhaveanyfurtherquestionsontheuseofthisproductaskyourdoctor,pharmacist or nurse.

4. Possible side effects

Likeallmedicines,this medicine cancausesideeffects,althoughnoteverybodygetsthem.Thefollowing sideeffectsmayhappenwiththismedicine.

In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.

Stop taking Rizatriptan Orifarm and contact a doctor or go to your nearest emergency department immediatelyif you experience any of the following:

Swelling of face, lips, tongue or throat; difficulty swallowing; hives and breathing difficulties – uncommon side effect.
Severe extensive skin damage (separation of the epidermis and superficial mucous membranes (toxic epidermal necrolysis)) – rare side effect.
Sudden hives, itching, flushing and/or swellings of e.g. eyes, lips or throat (anaphylaxis) – rare side effect.
Heart attack, spasm of blood vessels of the heart, stroke. They generally occur in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, man over 40 years of age, post-menopausal women, particular problem with the way your heart beats (bundle branch block)- rare side effect.
A serious condition called "serotonin syndrome", that may cause coma, unstable blood pressure, extremely high body temperature, lack of muscle co-ordination, agitation and hallucinations -rare side effect.
Seizure (convulsions/fits) – side effect with unknown frequency.

Common(may affect up to1in10people)

^• ^Tingling^(paraes^t^h^e^sⁱ^a),^headache,^d^ecreased^sensitivi^t^y^of^skin⁽^h^y^p^aesthesia),^decreased mentalsharpness,tremor.

• Fastorirregularheartbeat(palpitation),veryfastheartbeat(tachycardia).

• Flushing(rednessofthefacelastingashorttime), hot flushes, sweating.

• Throatdiscomfort,difficultybreathing(dyspnoea).

• Feelingsick(nausea),drymouth,vomiting,anddiarrhoea.

• Feelingofheavinessinpartsofthebody.

• Paininabdomenorchest.

Rash

Uncommon(may affectup to 1in100people)

• Unsteadinesswhenwalking(ataxia),dizziness(vertigo), blurred vision.

• Confusion, insomnia, nervousness

• Highbloodpressure(hypertension), thirst, indigestion (dyspepsia).

• Neckpain,feelingoftightnessinpartsofthebody,stiffness,muscleweakness.

Rare(may affectup to1in1,000people)

Bad taste in your mouth.

• Fainting(syncope)

• Facial pain, wheezing.

Notknown(frequency cannot be estimated from the available data):

• Spasmofbloodvesselsoftheextremitiesincludingcoldnessandnumbnessofthehandsorfeet.

• Spasm of the blood vessels of the colon (large bowel), which can cause abdominal pain.

• Muscle pain.

• Changes in the rhythm or rate of the heartbeat (arrhythmia), slow heartbeat (bradycardia), abnormalities of the electrocardiogram (a test that records the electrical activity of your heart).

Inaddition,tellyourdoctorifyouexperienceanysymptomsthatsuggestanallergicreaction(suchasarash oritching)aftertaking[Productname].

Reporting of side effects

Ifyou get anysideeffects, talk to your doctor, pharmacist or nurse. This includesanypossible sideeffectsnotlistedinthisleaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store [Product name]

Keep this medicine out of the sight and reach of children.

Donotusethis medicineaftertheexpirydatewhichisstatedonthepackage after EXP.Theexpirydaterefers tothelastdayofthatmonth.

Do not throw away any medicines via wastewater or household waste. Askyourpharmacisthowto throw awaymedicines younolongeruse.Thesemeasureswillhelpprotecttheenvironment.

6. Contents of the pack and other information

What[Productname]contains

- Theactivesubstanceisrizatriptan.Onetabletcontains10mgrizatriptanas14.53mgrizatriptan benzoate.

- Theotheringrediensarecellulose,microcrystalline;maizestarch;starch,pregelatinised;ironoxide red(E172);magnesiumstearate.

What[Productname]lookslikeandcontentsofthepack

[Productname]tablets

Pale, pink, round, biconvex tablets with a diameter of 8.0 mm with a scoreline.

PA/Aluminium/PVC/Aluminium blisterswith2,3,6or18tablets.

Notallpacksizesmaybemarketed.

MarketingAuthorisationHolderandManufacturer

[Tobecompletednationally]

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowingnames:

Denmark [Productname]

Norway [Productname]

Sweden [Productname]

Thisleafletwaslastrevisedin 2016-04-18