Ropinirole 5 Mg Film-Coated Tablets
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ROPINIROLE 5 mg FILM-COATED TABLETS
PACKAGE LEAFLET INFORMATION FOR THE USER
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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Ropinirole is and what it is used for
2. What you need to know before you take Ropinirole
3. How to take Ropinirole
4. Possible side effects
5. How to store Ropinirole
6. Contents of the pack and other information
WHAT ROPINIROLE IS AND WHAT IT IS USED FOR
Ropinirole belongs to a group of medicines called dopamine agonists. This group of medicines mimicks the effect of dopamine (a compound in the brain), which activates dopamine receptors.
Ropinirole is used to treat patients with Parkinson's disease (used alone or in combination with another medicine).
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROPINIROLE
Do not take Ropinirole
• if you are allergic (hypersensitive) to ropinirole, Ponceau 4R or any of the other ingredients of Ropinirole
• if you have severe kidney problems
• if you have liver problems.
Warnings and precautions
Talk to your doctor before taking Ropinirole
• if you become sleepy or drowsy, or have episodes of sudden sleep onset (your dosage may need to be adjusted or treatment stopped)
• if you have major psychiatric or psychotic disorders
• if you have severe heart disease (blood pressure monitoring is recommended)
• if you are taking any medicines used to treat high blood pressure and medicines used to suppress fast rhythms of the heart.
Tell your doctor if you 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 yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.
Children and adolescents
Ropinirole is not recommended for use in children and adolescents below 18 years.
Other medicines and Ropinirole
Talk to your doctor if you are taking any of the following:
• high doses of oestrogens (hormone replacement therapy)
• medicines known to inhibit the cytochrome P450 isoenzyme CYP1A2, such as ciprofloxacine (an antibiotic), enoxacin (an antibiotic) or fluvoxamine (used to treat depression)
• stop or start smoking (your dose may need to be adjusted)
• antipsychotic medicines and other medicines that block dopamine receptors in the brain, such as sulpiride (used to treat schizophrenia) or metoclopramide (used to treat nausea and vomiting).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Ropinirole with food and drink
Ropinirole should be taken with food to improve your ability to tolerate this medicine.
Pregnancy, breast-feeding and fertility
Ropinirole is not recommended if you are pregnant, unless your doctor advises that the benefit to you of taking ropinirole is greater than the risk to your unborn baby. Ropinirole is not recommended if you are breast-feeding, as it can affect your milk production. Tell your doctor immediately if you are pregnant, if you think you might be pregnant, or if you are planning to become pregnant. Your doctor will also advise you if you are breast-feeding or planning to do so. Your doctor may advise you to stop taking ropinirole.
Driving and using machines
Ropinirole may cause some people to become sleepy or drowsy and/or develop sudden sleep episodes. If this happens to you, do not drive or take on activities where impaired alertness may put you or others at risk of serious injury or death (e.g. operating machines) until the sleepiness or drowsiness and/or sudden sleep episodes have disappeared.
Important information about some of the ingredients of Ropinirole
If you have been told by your doctor that you have an intolerance to some sugars (lactose), contact your doctor before taking Ropinirole.
^ HOW TO TAKE ROPINIROLE
Always take Ropinirole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The initial dose is 0.25 mg three times a day for 1 week (0.75 mg/day). Afterwards, the dose can be increased by 0.25 mg three times a day in the following weeks. The dose may be increased up to a maximum of 24 mg/day.
For doses not possible with this medicinal product other strengths of this medicinal product are available.
Use in Children and Adolescents
Ropinirole is not recommended for use in children and adolescents below 18 years.
Elderly
The dose should be increased in those over 65 years. This increase should be gradual.
Method of administration
The film-coated tablets should be swallowed whole with liquid and should be taken with food.
If you take more Ropinirole than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Ropinirole
If you forget to take a tablet, just carry on with the next one as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Ropinirole
Contact your doctor if your symptoms get worse when you stop taking Ropinirole.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Position for pharmacode
Position for pharmacode
POSSIBLE SIDE EFFECTS
Like all medicines, Ropinirole can cause side effects, although not everybody gets them.
The following side effects have been reported at the approximate frequencies shown:
Very common (affecting more than one person in 10):
• fainting
• feeling drowsy
• feeling sick (nausea).
Common (affecting fewer than one person in 10 but more than one person in 100):
• hallucinations (seeing things that are not really there)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• abdominal pain
• swelling of the legs.
Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):
• feeling dizzy or faint, especially when you stand up suddenly (this is caused by a drop in blood pressure)
• feeling very sleepy during the day (extreme somnolence)
• falling asleep very suddenly without feeling sleepy first (sudden sleep onset episodes)
• mental problems such as delirium (severe confusion), delusions (unreasonable ideas) or paranoia (unreasonable suspicions).
Very rare (affecting fewer than one person in 10,000):
• a very small number of people have had changes in liver function, which have shown up in blood tests.
Some patients may have the following side effects:
• Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
• strong impulse to gamble excessively despite serious personal or family consequences
• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
• uncontrollable excessive shopping or spending
• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
• Ponceau 4 R may cause allergic reactions.
When Ropinirole is taken with Levodopa/L-Dopa
you may also experience the following side effects:
Very common:
• uncontrollable jerky movement.
Common:
• feeling confused.
If any of the side effects get serious, if you notice any side effects not listed in this leaflet or if you experience any of these behaviors, please tell your doctor or pharmacist they will discuss ways of managing or reducing the symptoms.
^ HOW TO STORE ROPINIROLE
Keep out of the sight and reach of children.
Do not use Ropinirole after the expiry date that is stated on the blister foil and carton after EXP The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original container.
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 to protect the environment.
[6 CONTENTS OF THE PACK AND OTHER INFORMATION
What Ropinirole contains
The active substance is ropinirole hydrochloride. Each Ropinirole 5 mg film-coated tablet contains 5.70 mg ropinirole hydrochloride, equivalent to 5 mg ropinirole.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium and magnesium stearate.
The tablet coating (Opadry II 85F30590) contains: poly(vinyl alcohol) - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, FD&C Blue #2/ Indigo Carmine Aluminium E132 and Ponceau 4R Aluminium Lake E124.
What Ropinirole looks like and contents of the pack
Ropinirole 5 mg is a blue, round slightly arched film-coated tablet, debossed "R 5" on one side and plain on the other.
Ropinirole 5 mg comes in pack sizes of 15, 21, 30, 60, 84, 90 and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG This leaflet was last revised in October 2012
PL 00289/1196
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TEVA UK LIMITED 62407-B