Repinex Xl 8 Mg Prolonged-Release Tablets
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RepinexXL 2mg prolonged-release tablets RepinexXL 4mg prolonged-release tablets RepinexXL 8mg prolonged-release tablets
Ropinirole
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou haveanymorequestions,askyourdoctoror pharmacist.
• This medicine has been prescribed foryou personally.
Don’t pass it on to other people. It may harm them even if their symptoms seem to be the same as yours.
• If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What RepinexXL is and what it is used for
2. Before you take RepinexXL
3. How to take RepinexXL
4. Possible side effects
5. How to store RepinexXL
6. Further information
1. What RepinexXL is and what it is used for
The active ingredient in RepinexXL 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.
RepinexXL prolonged-release tablets are used to treat Parkinson’s disease.
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. Before you take RepinexXL
Do not take RepinexXL
• ifyou are allergic (hypersensitive) to ropinirole or any of the other ingredients of RepinexXL (see section 6)
• ifyou haveseriouskidneydisease
• ifyou have liver disease
Tell your doctor ifyou think any of these may apply to you.
Take special care with RepinexXL
Tell your doctor ifyou or your family/carer notice that you are developing urges or cravings to behave in ways that are unusual foryou 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 adjustor stop your dose.
Your doctor needs to know before you take RepinexXL:
• ifyou are pregnant orthinkyou may be pregnant
• ifyou are breast-feeding
• ifyou are under 18years old
• ifyou have a serious heart complaint
• ifyou have a serious mental health problem
• ifyou experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour)
• ifyou have an intolerance to some sugars (such as lactose). Tell your doctor ifyou think any of these may apply to you. Your doctor may decide that RepinexXL is not suitable foryou or that you need extra check-ups while you are taking it.
Driving and using machines
RepinexXL can make you feel drowsy. It can make people feel extremely sleepy, and it sometimes makes people fall asleep very suddenly without warning.
Ifyou could be affected: 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. Do not take part in these activities until you are no longer affected.
Talk to your doctor if this causes problems for you.
Smoking and RepinexXL
Tell your doctor ifyou start smoking, or give up smoking, while you are taking RepinexXL. Your doctor may need to adjust yourdose.
Taking other medicines
Please tell your doctor or pharmacist if you’re taking, or have recently taken, any other medicines, including any herbal medicines or other medicines you obtained without a prescription.
Remember to tell your doctor or pharmacist ifyou begin taking a new medicine while you are taking RepinexXL.
Some medicines can affect the way RepinexXL works, or make it more likely that you will have side effects. RepinexXL can also affect the way some other medicines work.
These include:
• the anti-depressantfluvoxamine
• medication forother mental health problems,
for example sulpride
• HRT (hormone replacementtherapy)
• metoclopramide, which is used totreat nausea and heartburn
• the antibiotics ciprofloxacin or enoxacin
• anyothermedicinefor Parkinson’s disease.
Tell your doctor ifyou are taking, or have recently taken, anyof these.
Taking RepinexXL with food and drink
You can take RepinexXL with or without food, as you prefer.
Pregnancy and breast-feeding
RepinexXL is not recommended ifyou are pregnant, unless yourdoctor advises that the benefitto you oftaking RepinexXL is greater than the risk to your unborn baby. RepinexXL is not recommended ifyou are breast-feeding, as it can affect your milkproduction.
Tell your doctor immediately ifyou are pregnant, ifyou think you mightbe pregnant, or ifyou are planningto become pregnant. Your doctor will also advise you ifyou are breastfeeding or planning to do so. Your doctor may advise you to stop taking RepinexXL.
Important information about some of the ingredients of RepinexXL
RepinexXL2mg prolonged-release tablets contain a sugar called lactose. Ifyou have been told byyourdoctorthatyou have an intolerance to some sugars, contact your doctor before takingthis medicinal product.
RepinexXL4mg prolonged-release tablets contain a colouring agent called sunset yellow (E110), which may cause allergic reactions.
3. Howto take RepinexXL
Always ta ke Repinex XL exactly as you r doctor has told you to.
You should check with your doctor or pharmacist ifyou are not sure.
Do not give Repinex XL tochildren. Repinex XL is not normally prescribed for people under 18.
You may be given RepinexXL on its own to treat the symptoms of your Parkinson’s disease. Or you may be given RepinexXL as well as another medicine called L-dopa (also called levodopa). Ifyou are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking RepinexXL. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking.
How much Repinex XL will you need to take?
It may take a while to find out the best dose of RepinexXL foryou.
The usual starting dose is 2mg once daily for the first week. Your doctor may increase your dose to 4 mg of RepinexXL prolonged-release tablets once daily, from the second week of treatment. In the very elderly, the doctor may increase the dosage 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 RepinexXL prolonged-release tablets each day.
If at the start of your treatment, you experience side effects that you find difficult to tolerate, speak to your doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated (immediate-release) tablets which you will take three times a day.
Do not take any more Repinex XL than your doctor has recommended.
It may take a few weeks for RepinexXL to work for you.
Taking your dose of Repinex XL Take Repinex XLonce a day, at the same time each day. Swallow your Repinex XL prolonged-release tablet(s) whole, with a glass of water.
Don’t break, chew or crush the prolonged-release tablet(s) -ifyou do, there is a danger you could overdose, because the medicine will be released into your body too quickly.
Ifyou are switching from ropinirole film-coated (immediate-release) tablets
Your doctor will base yourdose of Repinex XL prolonged-release tablets on the dose of ropinirole film-coated (immediate-release) tablets you were taking.
Take your ropinirole film-coated (immediate-release) tablets as normal the day before you switch. Then take your Repinex XL prolonged-release tablets next morning and do not take any more ropinirole film-coated (immediate-release) tablets.
Ifyou take more Repinex XL than you should Contact a doctor or pharmacist immediately. If possible, show them the RepinexXLpack.
Someone who has taken an overdose of Repinex 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.
Ifyou forget to take RepinexXL
Do not take extra prolonged-release tablets or a double dose to make up for a missed dose.
Ifyou have missed taking Repinex XL for one day or more,
ask your doctor for advice on howto start taking it again.
Ifyou stop taking RepinexXL
Do not stop taking Repinex XL without advice.
Take Repinex XL for as long as yourdoctor recommends.
Do not stop unless your doctor advises you to.
Ifyou suddenly stop taking RepinexXL, your Parkinson’s disease symptoms may quicklyget much worse.
Ifyou need to stop taking RepinexXL, your doctor will reduce yourdose gradually.
Ifyou have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, RepinexXL can cause side effects, although not everyone gets them.
The side effects of RepinexXL are more likely to happen when you first start taking it, or when yourdose has just been increased.
They are usually mild, and may become less troublesome after you have taken the dose for a while. Ifyou are worried about side effects, talk to yourdoctor.
Very common side effects
These may affect more than 1 in 10 people taking RepinexXL:
• fainting
• feeling drowsy
• feeling sick (nausea).
Common side effects
These may affect up to 1 in 10 people taking RepinexXL:
• hallucinations (‘seeing’ things that are notreallythere)
• beingsick(vomiting)
• feelingdizzy(a spinningsensation)
• heartburn
• stomach pain
• constipation
• swell ing of the legs, feetor hands.
Uncommon side effects
These may affect up to 1 in 100 people taking RepinexXL:
• feelingdizzyorfaint, 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 onsetepisodes)
• mental problemssuch asdelirium (severe confusion), delusions(unreasonable ideas) orparanoia (unreasonable suspicions)
Some patients may have the following side effects
• 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 (see Section 2).
• changes in liverfunction, which have shown up in blood tests. You may experience 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:
1 strong impulse to gamble excessively despite serious personal or family consequences.
1 altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
1 uncontrollable excessive shopping or spending.
1 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). Tell your doctor if you experience any of these behaviours; he or she will discuss ways of managing or reducing the symptoms.
If you’re taking Repinex XL with L-dopa
People who are taking Repinex XL with L-dopa may develop other side effects over time:
• uncontrollable movements (dyskinesias) are a very common side effect. If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking Repinex XL. 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.
If you get side effects
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Repinex XL
Keep out of the sight and reach of children.
Do not use Repinex XL after the expiry date which is stated on the blister, on the bottle and on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
HDPE bottle: Shelf life after first opening is 60 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Repinex XL contains
The active substance in Repinex XL is ropinirole.
One prolonged-release tablet contains 2mg, 4mg or 8mg of ropinirole (as hydrochloride).
The other ingredients are:
• Prolonged-release tablet cores: Methacrylic acid copolymer type RS,HPMC (E464), SLS, Copovidone, Mg stearate (E572).
• film coats:
|
2mg prolonged-release tablet |
Hypromellose (E464), iron oxide red (E172), lactose monohydrate, titanium dioxide (E171), triacetin |
|
4mg prolonged-release tablet |
Macrogol 400, hypromellose (E464), sunset yellow aluminium lake (E110), titanium dioxide (E171), indigo carmine aluminium lake (E132) |
|
8mg prolonged-release tablet |
Hypromellose (E464), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), macrogol 400, titanium dioxide (E171) |
What Repinex XL looks like and contents of the pack
Repinex XL 2mg :
pink prolonged-release round biconvex tablets 6.8 ± 0.1mm in diameter and 5.5 ± 0.2 mm in thickness.
Repinex XL 4mg :
light brown prolonged-release oval biconvex tablets, with dimensions 12.6*6.6 ± 0.1 mm and 5.3 ± 0.2 mm in thickness. Repinex 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 and white opaque HDPE bottles with white cylindrical caps of polypropylene with three break points on the tamper-evident ring and aperture of desiccant insert. Pack sizes of
Blister: 7, 21, 28, 30, 42, 84, 90, 100 prolonged-release tablets Bottle: 7, 21, 28, 30, 42, 84, 90, 100 prolonged-release tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aspire Pharma Ltd,
Antrobus House Business Centre,
18 College Street,
Petersfield,
Hampshire,
GU314AD,
United Kingdom
Manufacturer
or Pharmathen International SA, Industrial Park Sapes,
Rodopi Prefecture,
Block No 5,
Rodopi 69300,
Greece
Pharmathen SA,
6 Dervenakion Str,
153 51, Pallini Attiki,
Greece
Distributed by:
Lupin (Europe) Limited,
Victoria Court,
Bexton Road,
Knutsford,
Cheshire, WA16 0PF,
United Kingdom
This leaflet was last approved in
02/2013
1010112-P3.3A