Ropiqual Xl 2 Mg Prolonged-Release Tablets
Package leaflet: Information for the user
ROPIQUAL XL 2 mg prolonged-release tablets
ROPIQUAL XL 4 mg prolonged-release tablets
ROPIQUAL XL 8 mg prolonged-release tablets
Ropinirole
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 more questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Don't pass it on to other people. It may harm them even if their signs of illness seem to be 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 ROPIQUAL XL is and what it is used for
2. What you need to know before you take ROPIQUAL XL
3. How to take ROPIQUAL XL
4. Possible side effects
5. How to store ROPIQUAL XL
6. Contents of the pack and other information
1. What ROPIQUAL XL is and what it is used for
ROPIQUAL XL prolonged-release tablets are used to treat Parkinson's disease. The active ingredient in ROPIQUAL XL is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists affect the brain in a similar way to a natural substance called dopamine.
People with Parkinson's disease have low levels of dopamine in some parts of their brains. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson's disease.
2. What you need to know before you take ROPIQUAL XL
Do not take ROPIQUAL XL
• if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6)
• if you have serious kidney disease
• if you have liver disease.
Tell your doctor if you think any of these may apply to you.
Warnings and precautions
Your doctor needs to know before you take ROPIQUAL XL:
• if you are pregnant or think you may be pregnant
• if you are breast feeding
• if you are under 18 years old
• if you have a serious heart complaint
• if you have a mental health problem
• if you have a history of any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour)
Tell your doctor if you think any of these may apply to you. Your doctor may decide that ROPIQUAL XL isn't suitable for you or that you need extra check-ups while you're taking it.
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.
Other medicines and ROPIQUAL XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines Some medicines can affect the way ROPIQUAL XL works, or make it more likely that you will have side effects. ROPIQUAL XL can also affect the way some other medicines work.
• the anti-depressant fluvoxamine
• HRT (hormone replacement therapy)
• the antibiotic ciprofloxacin or enoxacin
• medication for other mental health problems, for example sulpiride
• metoclopramide, which is used to treat nausea and heartburn
• cimetidine, used in the treatment of stomach ulcers
• theophylline, used for asthma, bronchitis or air trapped in the body (emphysema)
• any other medicine for Parkinson's disease.
Tell your doctor if you are taking, or have recently taken, any of these.
Taking ROPIQUAL XL with food, drink and alcohol
Swallow the tablets whole with a glass of water. You can take ROPIQUAL XL with or without food, as you prefer.
You should not drink alcohol while you are taking ROPIQUAL XL
Tell your doctor or nurse if you start smoking, or give up smoking, while you're taking ROPIQUAL XL. Your doctor or nurse may need to adjust your dose.
Pregnancy, breast-feeding and fertility
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 ROPIQUAL XL.
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. ROPIQUAL XL is not recommended if you are pregnant, unless the doctor advises that the benefit of you taking ROPIQUAL XL is greater than the risk to your unborn baby.
ROPIQUAL XL is not recommended if you are brest feeding, as it can affect your milk production.
Driving and using machines
Do not drive because ROPIQUAL XL can make you feel drowsy. It can make people feel extremely sleepy and it sometimes makes people fall asleep very suddenly without warning.
Do not operate or use any tools or machinery. Do not drive, do not operate machines and do not put yourself in any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Don't take part in these activities until you are no longer affected.
Talk to your doctor if this causes problems for you.
ROPIQUAL XL 2 mg prolonged-release tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
ROPIQUAL XL4 mg prolonged-release tablet contain the colouring agent sunset yellow, which may cause allergic reactions.
3. How to take ROPIQUAL XL
Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you're not sure.
The product is a prolonged-release tablet and should not be taken if the tablet is broken or damaged.
You may be given ROPIQUAL XL on its own to treat the symptoms of your Parkinson's disease or you may be given ROPIQUAL XL as well as another medicine called L-dopa (also called levodopa). If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking ROPIQUAL XL. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking.
The usual starting dose of ROPIQUAL XL prolonged-release tablets is 2 mg once daily for the first week. Your doctor may increase your dose to 4 mg of ROPIQUAL XL prolonged-release tablets once daily, from the second week of treatment. If you are very elderly, your doctor may increase your dose more slowly. After that, the doctor may adjust your dose until you are taking the dose that is best for you. Some people take up to 24 mg of ROPIQUAL XL prolonged-release tablets each day.
Do not give ROPIQUAL XL to children. ROPIQUAL XL is not normally prescribed for people under 18.
It may take a while to find out the best dose of ROPIQUAL XL for you.
Taking your dose of ROPIQUAL XL Take ROPIQUAL XL once a day, at the same time each day.
Swallow your ROPIQUAL XL prolonged-release tablet(s) whole, with a glass of water.
Do not break, chew or crush the prolonged-release tablet(s) - if you do, there is a danger you could overdose, because the medicine will be released into your body too quickly.
Black
If you are switching form ropinirole film-coated (immediate release) tablets
Your doctor or nurse will base your dose of ROPIQUAL XL on the dose of ropinirole you were taking. You will take the same or similar daily dose of ROPIQUAL XL to your previous dose of ropinirole but you will only take ROPIQUAL xL once a day.
Take your ropinirole as normal the day before you switch. Then take your ROPIQUAL XL on the next day and don't take any more ropinirole.
If you take more ROPIQUAL XL than you should
Contact a doctor or pharmacist immediately. If possible, show them the ROPIQUAL XL pack.
Someone who has taken an overdose of ROPIQUAL XL may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), feeling drowsy, mental or physical tiredness, fainting, hallucinations.
If you forget to take ROPIQUAL XL
Don't take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
If you have missed taking ROPIQUAL XL for more than a few days, ask your doctor for advice on how to start taking it again.
If you stop taking ROPIQUAL XL
Do not stop taking ROPIQUAL XL without advice.
Take ROPIQUAL XL for as long as your doctor recommends. Don't stop unless your doctor advises you to.
If you suddenly stop taking ROPIQUAL XL your Parkinson's disease symptoms may quickly get much worse.
If you need to stop taking ROPIQUAL XL your doctor will reduce your dose gradually. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can have side effects, although not everyone gets them.
Very common side effects (affects more than 1 in 10 people taking ROPIQUAL XL):
• fainting
• feeling drowsy
• feeling sick (nausea)
Common side effects (affects more than 1 in 100 people taking ROPIQUAL XL:
• hallucinations (sensing things that are not real)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet or hands
Uncommon side effects (affects more than 1 in 1,000 people taking ROPIQUAL XL:
• feeling dizzy or faint, especially when you stand up suddenly (this is caused by a drop in blood pressure)
• 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)
• feeling very sleepy during the day (extreme somnolence)
Tell your doctor if you experience any of these behaviors; they will discuss ways of managing or reducing the symptoms
If you’re taking ROPIQUAL XL with L-dopa (for Parkinson’s disease)
People who are taking ROPIQUAL XL with L-dopa may develop other side effects over time:
• uncontrollable movements (dyskinesia) are a very common side effect. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking
• feeling confused is a common side effect
Not known (cannot be estimated from the available data):
• changes in liver function, which have shown up in blood tests
• allergic reactions such as red, itchy swellings on the skin (hives), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or intense itching.
• 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)
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 Yellow Card Scheme at:www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ROPIQUAL XL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) shown on the carton, blister and bottle. The expiry date refers to the last day of that month.
Store ROPIQUAL XL below 25°C.
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 ROPIQUAL XL contains
The active substance in ROPIQUAL XL is ropinirole.
Each prolonged release tablet contains ropinirole hydrochloride equivalent to 2 mg, 4mg or 8 mg ropinirole.
The other ingredients are:
Tablet core: Ammonio methacrylate copolymer, type B, hypromellose, sodium lauryl sulfate, copovidone, magnesium stearate.
Tablet coating:
2mg: Hypromellose (E464), iron oxide red (E172), lactose monohydrate, titanium dioxide (E171), triacetin.
4mg: Macrogol 400, hypromellose (E464), sunset yellow (E110), titanium dioxide (E171), indigo carmine (E132).
8mg: Hypromellose (E464), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), macrogol 400, titanium dioxide (E171).
What ROPIQUAL XL looks like and contents of the pack
ROPIQUAL XL 2mg: pink prolonged-release round biconvex tablets 6.8 ± 0.1mm in diameter and 5.5 ± 0.2 mm in thickness.
ROPIQUAL XL 4mg: light brown prolonged-release oval biconvex tablets with dimensions 12.6*6.6 ± 0.1 and 5.3 ± 0.2 mm in thickness.
ROPIQUAL XL 8mg : red prolonged-release oval biconvex tablets with dimensions 19.2*10.2 ± 0.2 mm and 5.2 ± 0.2 mm in thickness .
All strengths are supplied in white opaque PVC/PCTFE-Aluminium foil blisters.
Pack sizes:
For 2 mg: 28, 30, 42 and 84 tablets For 4 mg & 8 mg: 28, 30 and 84 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Milpharm Limited Ares Block
Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
Manufacturer:
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
or
Pharmathen S.A 6th Dervanakion Str
Athens, Pallini 15351
Greece.
or
Pharmathen International S.A.
Industrial Park Sapes Rodopi Prefecture, Block No 5 Rodopi 69300 Greece