Rizatriptan Orifarm

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PACKAGE LEAFLET

Package leaflet: Information for the patient

[Product name] 10 mg orodispersible tablets

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 anythesideeffects, talk to your doctor, pharmacist or nurse. This includes any possiblesideeffectsnotlistedinthisleaflet. 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

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

[Productname]belongstoaclassofmedicinescalledselectiveserotonin5-HT₁_B_/_1D receptoragonists.

[Productname] is usedtotreattheheadachephaseofyourmigraineattack 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

• 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

• 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]

• ifyouarealreadytakinga5HT_1B/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.

Youshouldwaitatleast24hoursaftertakingergotamine-typemedicationsbeforetaking[Productname].

Askyourdoctorforinstructionsandtherisksabouttaking[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,breast-feeding and fertility

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.

Itisnotknownif[Productname]affectsthefertility.

Askyourdoctororpharmacistforadvicebeforetakinganymedicine.

Drivingandusingmachines

Youmayfeelsleepyordizzywhiletaking[Productname].Ifthishappens,donotdriveoruseanytoolsor machines.

[Productname] contains phenylalanine

Theorodispersibletabletscontainsasourceofphenylalanine.Maybeharmfulforpeoplewith phenylketonuria.Each[Productname]orodispersibletabletcontains2.90mgaspartame(whichcontains phenylalanine).

3. How to take [Product name]

Alwaystakethis medicineexactlyasyourdoctor or pharmacisthastoldyou.Checkwithyourdoctoror pharmacistifyouarenotsure.

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

Therecommendeddoseis10mg.

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

[Productname]isavailableasanorodispersibletabletsthatdissolvesinthemouth.Theorodispersible tabletsshouldbeplacedonyourtongue,whereitdissolvesandcanbeswallowedwiththesaliva.Itcanbe usedinsituationswhereliquidsarenotavailable,ortoavoidthenauseaandvomitingthatmayaccompany theingestionoftabletswithliquids.

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 affectup to1in10people)

Tingling (paraesthesia), headache, decreased sensitivity of skin (hypaesthesia), decreased mental sharpness, tremor.
Fast or irregular heart beat (palpitation), very fast heartbeat (tachycardia).
Flushing (redness of the face lasting a short time), hot flushes, sweating.
Throat discomfort, difficulty breathing (dyspnoea).
Feeling sick (nausea), dry mouth, vomiting, and diarrhoea.
Feeling of heaviness in parts of the body.
Tiredness, pain in abdomen or chest.
Rash.

Uncommon(may affectup to1in100people)

Unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision.
Confusion, insomnia, nervousness.
High blood pressure (hypertension), thirst, indigestion (dyspepsia).

Neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness.

Rare(may affectup to1in1,000people)

Bad taste in your mouth.
Fainting (syncope).
Facial pain, wheezing.

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

Spasm of blood vessels of the extremities including coldness and numbness of the hands or feet.
Spasm of 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 or the electrocardiogram (a test that records the electrical activity of your heart).

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.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 andreachofchildren.

Donotusethis medicineaftertheexpirydatewhichisstatedonthepackage after EXP.Theexpirydaterefers tothelastdayofthatmonth.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What[Productname]contains

- Theactivesubstanceisrizatriptan.Onetabletcontains10mgrizatriptanas14.53mgrizatriptan benzoate.

- Theotheringredientsarecellulose,mikrocrystalline;maizestarch;silica,colloidalanhydrous; aspartame(E951);mintpowder;magnesiumstearate.

What[Productname]lookslikeandcontentsofthepack

[Productname]orodispersibletablet

White, round, biconvex tablets with a score line on one side and a diameter of 10.0 mm.

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

Notallpacksizesmaybemarketed.

MarketingAuthorisationHolderandManufacturer

[Tobecompletednationally]

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowingnames:

Denmark [Productname]

Norway [Productname]

Sweden [Productname]

Thisleafletwaslastrevisedin

2016-04-18