Ropinirole 2 Mg Film-Coated Tablets
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Ropinirole 0.25 mg Film-coated Tablets Ropinirole 0.5 mg Film-coated Tablets Ropinirole 1 mg Film-coated Tablets Ropinirole 2 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.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, askyour doctor or pharmacist. •This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even iftheir signs ofillness arethesameas yours.
• Ifyou get any side effects, talktoyour doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What RopiniroleFilm-coatedTablets areand what theyare used for
2. Whatyou need to knowbeforeyou takeRopiniroleFilm-coated Tablets
3. How to take Ropinirole Film-coated Tablets
4. Possible side effects
5. How to store Ropinirole Film-coated Tablets
6. Contents ofthepackand other information
1. What Ropinirole Film-coated Tablets are and what they are used for
Ropinirolebelongs to a groupofmedicines called dopamineagonists. Dopamine agonists act like a naturally occurring chemical in your brain called dopamine.
Ropinirole Film-coated Tablets are used to treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome.
Moderate to severe Restless Legs Syndrome is typically represented by patients who have difficulty sleeping or severe discomfort in their legs or arms. It is a condition characterised by an irresistible urge to move the legs and occasionally the arms, usually accompanied by uncomfortable sensations such as tingling, burning or prickling.These feelings occur during periods ofrest orinactivity such as sitting or lying down, especially in bed, and areworsein the evening or at night. Usuallythe only reliefis obtained by walking about ormoving theaffected limbs, which often leads to problems sleeping.
Ropinirole Film-coated Tablets relieve the discomfort and reduce the urge to move the limbs that disrupts night time sleep.
Ropinirole is also authorised to treat other conditions which are not mentioned in this leaflet. Askyour doctor or pharmacist ifyou have furtherquestions.
2. What you need to know before you take Ropinirole Film-coated Tablets
Do not take Ropinirole Film-coated Tablets:
• ifyou areallergictoropiniroleor any oftheother ingredients of this medicine (listed in section 6).
• ifyou have serious liver disease.
• ifyou have serious kidney disease.
Ifyou are unsure, it is essential to talktoyour doctor.
Warnings and precautions
Talktoyour doctor or pharmacist before taking RopiniroleFilm-coated Tablets ifyou:
• are pregnant or thinkyou may be pregnant
• are breast-feeding
• haveliver disease
• have a serious heart complaint
• have a serious mental health problem
• haveahistoryofany unusual urges and/orbehaviours (such as excessive gambling or excessive sexual behaviour)
In thesesituationsyour doctorshould carefully superviseyour treatment.
During treatment with Ropinirole Film-coated Tablets take special carewhenyou driveoroperatemachinery. Ifyou suffer from extreme sleepiness or suddenly fall asleep without apparently feeling sleepy, do not drive or use machinery, and contact your doctor.
Tell your doctor ifyou or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourselfor others. Theseare called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive oran increasein sexual thoughts or feelings. Your doctor mav need to adjust orstop vourdose.
During treatment for Restless Legs Syndrome: Ifyour symptoms become worse, start earlier in the day or after less time at rest, or affect other parts ofyourbodysuch asyourarms, you should seeyour doctor who may adjust thedoseofropinirole thatyou aretaking.
Children and adolescents
Ropinirole Film-coated Tablets are not recommended for use in children and adolescents.
Taking other medicines and Ropinirole Film-coated Tablets
Tell your doctor or pharmacist ifyou are taking, have recently taken or might takeany other medicines.This applies also toherbal medicines as well as strong vitamins and minerals.
Theeffect ofRopiniroleFilm-coated Tablets may be increased or decreased by other medicines, and vice versa. These medicines include:
• ciprofloxacin (an antibiotic)
• enoxacin (an antibiotic)
• fluvoxamine (a drug used to treat depression)
• theophylline (a drug used to treat asthma)
• hormone replacement therapy (also called HRT)
• anti-psychotics and other drugs that block dopamine in the brain (e.g. sulpiride or metoclopramide)
Tell yourdoctor if:
• you are taking medicines totreat high blood pressure, orfor heart problems
• you giveup or start smoking while taking RopiniroleFilm-coated Tablets. Your doctor may need to adjust your dose.
• you are taking RopiniroleFilm-coated Tablets and the doctor is going to prescribe you any other medicine.
Ropinirole Film-coated Tablets with food, drink and alcohol
Always swallowthetabletswholewithwaterand 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 not drinkalcohol whileyou are taking this medicine. Pregnancy and breast-feeding
Ifyou arepregnantorbreast-feeding, thinkyou maybepregnant orare planning to have a baby, askyour doctor for advice before taking this medicine.
Ropinirole is not recommended if you are pregnant, unless your doctor advises thatthe benefit toyou oftaking it is greater than the risk toyour unborn baby.
Ropinirole is not recommended if you are breast feeding, as it can
affect your milk production.
Your doctorwill adviseyou ifyou are breast feeding or planning todo so. Your doctor may advise you to stop taking Ropinirole.
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 cause them to fall asleep suddenly without any apparent warning. Contact your doctor ifyou experience eitheroftheseeffects. Ifyou do suffer from theseeffects then DONOT drive or operate machinery, and donot putyourself in any situation wheresleepiness or falling asleep may putyou (or others) at riskofserious injuryor death.
Ropinirole Film-coated Tablets contain lactose
Patients who are intolerant to lactose should note that each Ropinirole Film-coated Tablet contains a small amount oflactose. Ifyou have been told byyourdoctor thatyou havean intolerancetosomesugars, contact your doctor before taking this medicinal product.
3. How to take Ropinirole Film-coated Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Checkwith your doctor or pharmacist ifyou are not sure.
Swallow the Ropinirole Film-coated Tablet(s) whole with water. You can take the tablets with or without food. However, taking Ropinirole Film-coated Tabletswith food may decreasetheoccurrence ofnausea (feeling sick)which is a possibleside-effect ofthetablets. Donot chew the tablet(s). Do not take more than your doctor has recommended.
When you first start taking Ropinirole Film-coated Tablets, the amount you take will be increased gradually.
Theexact dose ofropinirole thatpeople take can bedifferent. Your doctor will decideon thedoseyou need totakeeach day andyou should follow the doctor's instructions.
When treating Restless Legs Syndrome, Ropinirole Film-coated Tablets should be taken once a day, at about the same time each day. They are usually takenjust beforebedtime, but can betaken upto3 hours before going tobed.
The starting dose is 0.25 mg once daily. After two days your doctor will probably increase your dose to 0.5 mg once daily for the remainder of your firstweekoftreatment. Yourdoctor may then increaseyour dose by 0.5 mg per week over threeweeks to a dose of2mg perday. In some patients with insufficient improvement, the dose may be increased gradually up to a maximum of4 mg daily.
Afterthreemonths oftreatmentwith RopiniroleFilm-coated Tablets, your doctor may adjust your dose or discontinue your treatment depending on your symptoms and how you feel.
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Please read the pharmacist's label carefully. Ifyou have any questions about RopiniroleFilm-coated Tablets and howto takethem, ask your doctor or pharmacist.
If you take more Ropinirole Film-coated Tablets than you should
You should never take more tablets than your doctor recommends. Someonewhohas taken an overdosemay experience; feeling or being sick, dizziness (or a spinning sensation), feeling drowsy, fatigue (mental or physical tiredness), stomach pain, fainting or nervousness.
Ifyou taketoomany tablets, or ifsomeoneelsehas taken your medicine, tell a doctor or pharmacist straight away. Show them your pack of tablets.
If you forget to take Ropinirole Film-coated Tablets
Remember to takeyourmedicine. Ifyou have trouble remembering when totakeyour medicine, askyour pharmacist for some hints.
Ifyou do forget totakeadose, leaveout that dosecompletely.Takeyour next dose at the normal time.
Do not take a double dose to make up for a forgotten tablet.
Ifyou have missed taking your tablets for more than a few days, consult your doctor for advice on restarting.
If you stop taking Ropinirole Film-coated Tablets
You should continue to take your medicine even ifyou do not feel better, as it may takeanumber ofweeks foryour medicinetostart to work. Ifyou have the impression that the effect ofyour medicine is too strong or tooweak, talktoyour doctoror pharmacist.
Ifyou wish to stop the treatment, this has to be done gradually. You must notstop taking RopiniroleFilm-coated Tablets withoutyour doctor's advice. Ifyour symptomsworsen afteryou stop treatmentwith Ropinirole Film-coated Tablets, you should contact your doctor.
Ifyou have any further questions on the useofthis medicine, askyour doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The more common side effects ofRopinirole Film-coated Tablets sometimes occurwhen patients first start their therapy and/orwhen the doseis increased.The sideeffects are generally mild and may become less afteryou havetaken the medicinefor a short time.
Restless Legs Syndrome
The side effects reported in people taking ropinirole for Restless Legs Syndrome are listed below;
Very Common Side Effects (they occur in more than 1 per 10 patients who receive treatment)
Vomiting, nausea (feeling sick)
Common SideEffects (they occur in between 1 and 10per 100 patients who receive treatment)
Nervousness, fainting, drowsiness, dizziness (or a spinning sensation), stomach ache, fatigue (mental or physical tiredness)
Uncommon Side Effects (they occur in between one and ten per 1000 patients who receive treatment)
Confusion, hallucinations, lowblood pressure which maymakeyou feel dizzy or faint especially when standing up from a sitting or lying position
Very rare (they occurin less than oneper 10.000 patientswho receive treatment)
Hepaticreactions (mainly increaseofliver enzymes), extremesleepiness or sudden sleep onset episodes (suddenly falling asleep without any apparentwarning)
Some patients may have the following side effects
• allergic reactions such as red, itchy swellings on the skin (hives), swelling oftheface, lips, mouth, tongueor throat which may cause difficulty in swallowing or breathing, rash or intense itching (see Section 2)
• other psychotic reactions in addition to hallucinations, such as severe confusion (delirium), irrational ideas (delusions) and irrational suspiciousness (paranoia)
You may experience the following side effects:
• inability to resist the impulse, drive or temptation to perform an action thatcould beharmful toyou or others, which may include;
- Strong impulse to gamble excessively despite serious personal or family consequences.
-Altered or increased sexual interest and behaviour ofsignificant concern toyou or to others, for example, an increased sexual drive.
- Uncontrollable excessive shopping or spending.
- Binge eating (eating large amounts offood in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
During treatment with Ropinirole Film-coated Tablets you may experienceunusual worsening ofsymptoms (e.g. symptoms become worse, start earlier in the day or after less time at rest, or affect other parts ofyour body such as your arms). Ifthis occurs, you should seeyour doctor.
Ifyou get any sideeffects, talktoyourdoctor or pharmacist.This includes any side effects not listed in this leaflet.
5. How to store Ropinirole Film-coated Tablets
Keep this medicine out ofthesight and reach ofchildren.
Do not store above 25°C.
Store in the original package in order to protect from light.
HDPE containers only; Keep the container tightly closed in order to protect from moisture.
Donot usethis medicineafter the expirydatewhich is stated on the carton and blister foil.
The expiry daterefers tothelast day ofthat month.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how tothrowaway medicines you nolongeruse. These measures will help protect the environment.
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
0.25 mg: Opadry II 85F18378 (Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350,Talc)
0.5 mg: Opadry II 85F32111 (Polyvinyl alcohol, Titanium dioxide
(E171), Macrogol 3350,Talc, Iron oxideyellow (E172))
1 mg: Opadry II 85F21676 (Polyvinyl alcohol, Titanium dioxide
(E171), Macrogol 3350,Talc, Iron oxideyellow (E172), Brilliant bluealuminium lake (E133), Iron oxide black(E172))
2mg: Opadry II 85F24026 (Polyvinyl alcohol, Titanium dioxide
(E171), Macrogol 3350,Talc, Iron oxideyellow (E172), Iron oxidered (E172))
What Ropinirole Film-coated Tablets look like and contents of the pack
The 0.25mg film-coated tablets arewhite. round, biconvex and7 mm in diameter.
They are marked R0.25 on one side.
The 0.5 mg film-coated tablets areyellow, round, biconvex and7 mm in diameter.
They are marked R0.5 on one side.
The 1 mg film-coated tablets are green, round, biconvex and 7 mm diameter.
They are marked R1 on one side.
The 2mg film-coated tablets are pink, round, biconvexand 7 mm in diameter.
They are marked R2 on one side.
Pack sizes:
Ropinirolefilm-coated tablets areavailablein blisterpacks of 12, 28 or 84 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder;
CADUCEUS PHARMA LIMITED 6,h Floor
94WigmoreStreet
London
W1U3RF
UK
Manufacturer;
Acta vis Ltd
B16 Bulebel Industrial Estate
Zejtun ZTN08
Malta
This leaflet was last revised in 11/2012
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