Ropinirole 5 Mg Film-Coated Tablets
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Package leaflet: Information for the patient
Ropinirole 5 mg Film-coated Tablets
Ropinirole (as hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keepthis leaflet. You may need to read it again.
• Ifyou have anyfurtherquestions, askyour doctor or pharmacist.
• ■This medicine has been prescribed foryou only. Do not pass it on to others. It may harmthem, even iftheir signs of illness arethe same as yours.
• Ifyou get anyside effects, talktoyourdoctor or pharmacist. This includes any possible side effects not listed inthis leaflet.
What is in this leaflet
1. What Ropinirole Film-coated Tablets are and whattheyare used for
2. Whatyou need to know beforeyou take Ropinirole Film-coated Tablets
3. Howto take Ropinirole Film-coated Tablets
4. Possible side effects
5. Howto store Ropinirole Film-coated Tablets
6. Contents ofthe pack and other information
1. What Ropinirole Film-coated Tablets are and what they are used for
Ropinirole belongs to a group of medicines called dopamine agonists. Dopamineagonists act like a naturally occurring chemical in your brain called dopamine.
Ropinirole Film-coated Tablets are used to treat Parkinson's Disease.
The cause of Parkinson's Disease is a lackofthesubstance dopamine in the brain. Ropiniroleacts in a similarwayto the natural dopamine, so helping the symptoms ofParkinson's Disease.
Ropinirole Film-coated Tablets may be used alone or in combination with other medicines against Parkinson's disease, to achieve a more effective treatment.
2. What you need to know before you take Ropinirole Film-coated Tablets
Do not take Ropinirole Film-coated Tablets:
• ifyou are allergic to ropinirole orany ofthe other ingredients ofthis medicine(listed in section 6).
• ifyou are pregnant orthinkyou may be pregnant.
• ifyou are breast feeding.
Ifyou are unsure, it is essential to talktoyourdoctor. Warnings and precautions
Talktoyour doctor or pharmacist before taking Ropinirole Film-coated Tablets ifyou:
• have serious kidneydisease
• have liverdisease
• have a serious heart complaint
• have a serious mental health problem
• have a historyofany unusual urges and/or behaviours (such as excessivegambling orexcessive sexual behaviour)
• have an intolerance to some sugars (such as lactose)
In these situationsyourdoctor should carefullysupervise your treatment.
Tell yourdoctor ifyou or your family/carer notices that you aredeveloping urges or cravingsto behave in waysthatare unusual foryou and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourselforothers.These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive oran increase in sexual thoughts orfeelinas.Your doctor mav need to adjust or stop vourdose.
During treatment with Ropinirole Film-coated Tablets take special care when you drive oroperate machinery. Ifyou suffer from extreme sleepiness or suddenly fall asleep without apparentlyfeeling sleepy, do not drive or use machinery, and contact yourdoctor.
Children
Ropinirole Film-coated Tablets are not recommended for use in children.
Other medicines and Ropinirole Film-coated Tablets
Tell your doctor or pharmacist ifyou are taking, have recently taken or mighttake anyother medicines. This applies also to herbal medicines as well as strong vitamins and minerals.
The effect of Ropinirole Film-coated Tablets may be increased ordecreased byother medicines,and viceversa.
These medicines include:
• ciprofloxacin (an antibiotic)
• fluvoxamine(a drug used totreatdepression)
• cimetidine (a drug used to treat stomach ulcers)
• theophylline (a drug used to treat asthma)
• hormone replacementtherapy(also called HRT)
• anti-psychotics and other drugs that block dopamine in the brain (e.g. sulpiride or metoclopramide)
Tell your doctor if:
• you are already receiving any other medicines for Parkinson's Disease
• you aretaking medicinestotreat high blood pressure, or for heart problems
• you give up orstartsmoking while taking Ropinirole Film-coated Tablets. Yourdoctor may need to adjustyourdose.
• you are taking Ropinirole Film-coated Tablets and the doctor is going to prescribeyou anyother medicine.
Ropinirole Film-coated Tablets with food, drink and alcohol
Always swallowthetablets wholewith water and preferably with food. Do not chew them.
Taking Ropinirole Film-coated Tablets with food may reduce the likelihood ofyou feeling or being sick.
You should notdrinkalcohol whileyou aretaking this medicine.
Pregnancy and breast-feeding
Women who are pregnant or breast-feeding must nottake Ropinirole Film-coated Tablets.
Tell yourdoctor immediately ifyou are pregnant or breast-feeding,thinkyou may be pregnant orare planning to have a baby. Your doctorwill adviseyou to stop taking Ropinirole Film-coated Tablets.
Women taking Ropinirole Film-coated Tablets should use adequateprecautionstoavoid becoming pregnant.
Driving and using machines
This medicine does not usually affect people's normal activities. However, Ropinirole Film-coated Tablets can cause extreme sleepiness (somnolence) in some people and may causethem to fall asleep suddenly without anyapparent warning. Contact your doctor ifyou experience either ofthese effects. Ifyoudosufferfrom these effects thenDO NOT drive oroperate machinery, and do not putyourselfin anysituation where sleepiness or falling asleep may put you (or others) at risk of serious injury or death.
Ropinirole Film-coated Tablets contain lactose
Patients whoare intolerant to lactose should note that each Ropinirole Film-coated Tablet contains a small amount of lactose. Ifyou have been told byyour doctorthatyou have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Ropinirole Film-coated Tablets
Always takethis medicine exactly as yourdoctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are notsure.
Swallowthe RopiniroleFilm-coatedTablet(s) whole with water. You can takethetablets with orwithout food. However,taking Ropinirole Film-coated Tablets with food maydecreasethe occurrence ofnausea (feeling sick) which is a possible side-effect ofthetablets. Do notchewthetablet(s). Do not take morethan your doctor has recommended.
When you first start taking Ropinirole Film-coated Tablets, the amount you take will be increased gradually.
The exact dose of ropinirole that peopletake can be different. Yourdoctor will decide on the doseyou need totake each day and you should followthedoctor's instructions.
AAAE5268
When treating Parkinson's Disease,the starting dose is 0.25 mg threetimes perdayforoneweek.The dose is then gradually increased in accordance with the following:
1st Week: 0.25 mgthreetimesdaily 2ndWeek:0.5 mg threetimes daily 3rd Week: 0.75 mg threetimes daily 4th Week: 1 mgthreetimesdaily
Hereafter, your doctor mayincrease or decrease the dose thatyou aretaking to getthe besteffect. The usual dose is between 1 mgand3mg taken threetimes daily(a total daily dose of3 mg to 9 mg), but ifsufficient effects are notachieved or maintained then the total daily dose may be gradually increased uptoa maximumof24mg.
Ropinirole Film-coated Tablets may also be used in combination with other medicines that act against Parkinson's Disease.
Yourdoctor maythen increase ordecreasethe amount of ropinirole that you aretaking toget the best effect.
Please read the pharmacist's label carefully. Ifyou haveany questions about Ropinirole Film-coated Tablets and howto take them, askyourdoctor or pharmacist.
If you take more Ropinirole Film-coated Tablets than you should
You should nevertake moretabletsthan yourdoctor recommends.
Someone who has taken an overdose may experience; feeling or being sick, dizziness (or a spinning sensation),feeling drowsy, fatigue (mental or physical tiredness),stomach pain, fainting or nervousness.
Ifyou taketoo manytablets,or ifsomeoneelse hastaken your medicine,tell a doctoror pharmacist straight away. Show them your packoftablets.
If you forget to take Ropinirole Film-coated Tablets
Remembertotakeyour medicine. Ifyou havetrouble remembering when totake your medicine, askyour pharmacist for some hints.
Ifyou do forget to take a dose, leave outthatdosecompletely. Take your next dose at the normal time.
Do nottakeadoubledoseto make up fora forgotten tablet.
Ifyou have missed taking yourtablets for morethan a few days, consult your doctor for advice on restarting.
If you stop taking Ropinirole Film-coated Tablets
You should continuetotakeyour medicine even ifyou do not feel better,as it maytake a numberofweeks foryour medicine tostartto work. Ifyou havethe impression thatthe effect of your medicine istoo strong ortoo weak,talktoyourdoctor or pharmacist.
Ifyou wish to stop the treatment, this has to be done gradually. You must notstoptaking Ropinirole Film-coated Tablets withoutyourdoctor's advice. If your symptoms worsen afteryou stoptreatmentwith Ropinirole Film-coated Tablets, you should contactyour doctor.
Ifyou haveanyfurther questions onthe useofthis medicine, askyourdoctor or pharmacist.
4. Possible side effects
Like all medicines,this medicinecan causeside effects, although noteverybodygetsthem.
The more common sideeffects of Ropinirole Film-coated Tablets sometimes occur when patients firststarttheirtherapy and/or when the dose is increased. The side effects are generally mild and may become less afteryou havetaken the medicine for a short time.
Parkinson's Disease
Thesideeffects reported in people taking ropinirole for Parkinson's Disease are listed below:
VervCommon Side Effects (thevoccur in morethan 1 per10 patients who receive treatment)
Nausea (feeling sick), drowsiness
Common Side Effects (thevoccur in between 1 and 10 per 100 patients who receive treatment)
Hallucinations, dizziness (including vertigo), vomiting, stomach ache, heartburn,swelling ofthe legs, fainting, feeling dizzyorfaintespeciallywhen you stand up suddenly (this is caused byadrop in blood pressure)
Uncommon Side Effects (thevoccur in between 1 and 10 per 1000 patients who receive treatment)
Mental sideeffects otherthan hallucinations,such as delirium, delusion,and paranoia,
Extreme sleepiness orsudden sleep onset episodes (suddenly falling asleep withoutanyapparent warning)
Very rare (they occur in less than 1 per 10,000 patients who receivetreatment)
Altered liverfunction (abnormal blood tests),
Allergic reactions such as red, itchy swellings on the skin AAAE5268 (hives),swelling oftheface, lips, mouth, tongue orthroat which may cause difficulty in swallowing or breathing, rash or intense itching
When ropinirole is taken with other medicines for Parkinson's Diseasethefollowing additional side effects have been reported:
VervCommon Side Effects (thevoccur in morethan 1 per10 patients who receive treatment)
Unwanted jerky movements
Common Side Effects (thevoccur in between 1 and 10 per 100 patients who receive treatment)
Confusion
You may experience the following side effects:
• inability to resist the impulse, driveortemptationto perform an actionthat could be harmful toyou or others, which may include:
• Strong impulse to gamble excessivelydespite serious personal or family consequences.
• Altered or increased sexual interest and behaviour of significant concerntoyou orto others, for example, an increased sexual drive.
• Uncontrollable excessive shopping or spending.
• Binge eating (eating largeamounts offood in a short time period) or compulsive eating (eating more food than normal and morethan is needed to satisfyyour hunger).
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Ifyou getanysideeffects,talktoyour doctoror pharmacist. This includes any side effects not listed in this leaflet.
5. How to store Ropinirole Film-coated Tablets
Keepthis medicine out ofthe sight and reach ofchildren.
Do not storeabove 25°C.
Store in the original package in orderto protectfrom light. HDPE containers only: Keepthecontainertightlyclosed in orderto protect from moisture.
Do not usethis medicine afterthe expirydate which is stated on the carton and blister foil.
The expiry date refers to the last day ofthat month.
Do not throw awayany medicines via wastewater or household waste. Askyour pharmacist howtothrow away medicinesyou no longer use.These measures will help protect theenvironment.
6. Contents of the pack and other information
What Ropinirole Film-coated Tablets contain
The active substance is ropinirole (as ropinirole hydrochloride).
The other ingredients are:
Tablet Core
• Lactose Monohydrate
• Microcrystalline cellulose
• Pregelatinised starch
• Magnesium stearate
Film Coating
Opadry II 85F20521 (Polyvinyl alcohol,Titanium dioxide, Macrogol 3350,Talc, Indigo carminealuminium lake (E132))
What Ropinirole Film-coated Tablets look like and contents of the pack
The 5 mg film-coatedtabletsareblue,round,biconvex and 10.5 mm in diameter.
They are marked R5 on one side.
Pack sizes:
The tablets are available in blister packs of84 tablets. Marketing Authorisation Holder and Manufacturer
MarketingAuthorisation Holder:
CADUCEUS PHARMA LIMITED 6th Floor
94 Wigmore Street London W1U3RF UK
Manufacturer:
Actavis Ltd
B16 Bulebel Industrial Estate
Zejtun ZTN08
Malta
This leaflet was last revised in 11/2012