Spiroco Xl 8 Mg Prolonged-Release Tablets
Out of date information, search anotherSPIROCO XL 2 mg, 4 mg AND 8 mg PROLONGED-RELEASE TABLETS Ropinirole
PACKAGE LEAFLET: INFORMATION FORTHE USER
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Read all of this leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are 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:
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1. What SPIROCO XL is and what it is used for
2. Before you take SPIROCO XL
3. How to take SPIROCO XL
4. Possible side effects
5. How to store SPIROCO XL
6. Further information
OWHAT SPIROCO XL IS AND WHAT IT IS USED FOR
The active substance in SPIROCO 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.
SPIROCO XL 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.
0 BEFORE YOU TAKE SPIROCO XL
Do NOT TAKE SPIROCO XL if you:
• are allergic (hypersensitive) to ropinirole or any ofthe other ingredients of SPIROCO XL ^_^§Y®_serious_kjdney_disease_ _
* have liver disease.
Tell your doctor if you think any of these may apply to you.
Take special care with SPIROCO XL
Your doctor needs to know before you take SPIROCO XL:
* ifyou have a serious heart complaint
* if you have a serious mental health problem
• ifyou have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour).
Tell your doctor ifyou think any ofthese may apply to you.Your doctor may decide that SPIROCO XL is not suitable foryou, orthatyou need extra check-ups while you are taking it.
While you are taking SPIROCO XL
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.
Tell your doctor ifyou start smoking, or give up smoking, while you are taking SPIROCO XL. Your doctor may need to adjust your dose.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Remember to tell your doctor or pharmacist ifyou begin taking anew medicine while you are taking SPIROCO XL
Some medicines can affect the way SPIROCO XL works, or make it more likely that you will have side effects. SPIROCO XL can also affect the way some other medicines work.
These include:
• the anti-depressant fluvoxamine • medicines for other mental health problems, for example sulpiride • HRT(hormonereplacementtherapy)
• metoclopramide,which isusedto treat nausea and heartburn
• theantibioticsciprofloxacinor enoxacin
• any other medicine for Parkinson's disease.
Tell your doctor ifyou are taking or have recently taken any of these.
Taking SPIROCO XL with food and drink
You can take SPIROCO XL with or without food.
Concomitant intake of alcoholic beverages and SPIROCO XL is not recommended.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. SPIROCO XL is not recommended ifyou are pregnant, unless your doctor advises that the benefit to you of taking SPIROCO XL is greater than the risk to your unborn baby. SPIROCO XL is not recommended ifyou are breast-feeding, as it can affect your milk production.
Tell your doctor immediately ifyou are pregnant, ifyou thinkyou might be pregnant, or if you are planning to become pregnant. Your doctor will also adviseyou ifyou are breast-feeding or planning to do so. Your doctor may advise you to stop taking SPIROCO XL.
Driving and using machines
SPIROCO XL can make you feel drowsy. It can make people feel extremely sleepy, and it sometimes makes people fall asleep very suddenly without warning.
If you 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. Talktoyour doctor if this causes problems for you.
Important information about some of the ingredients of SPIROCO XL
SPIROCO XL contains lactose. Ifyou have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
^3 HOW TO TAKE SPIROCO XL
Alwaystake-S-PI-ROGO-XL-exactly-a-s — your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Do not give SPIROCO XL to children.
SPIROCO XL is not normally prescribed for people under 18 years of age.
You may be given SPIROCO XL on its own to treat the symptoms of your Parkinson's disease. Or you may be given SPIROCO XL as well as another medicine called L-dopa (also called levodopa). Ifyouare taking L-dopayou may experience some uncontrolled jerky movements when you first start taking SPIROCO XL. Tell your doctor if this happens, as your doctor may need to reduce the dose of L-dopa you are taking.
How much SPIROCO XL will you need to take?
It may take a while to find out the best dose of SPIROCO XL for you.
The usual starting dose of SPIROCO XL prolonged-release tablets is 2 mg once daily for the first week.Your doctor may increase your dose to 4 mg of SPIROCO 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 SPIROCO XL prolonged-release tablets each day.
If at the start ofyour treatment, you experience side effects that you find difficult to tolerate, speakto your doctor. Your doctor may advise you to switch to a lower dose of ropinirole immediate-release tablets which you will take three times a day.
Do not take any more SPIROCO XL than your doctor has recommended.
It may take a few weeks for SPIROCO XL to work for you.
Taking your dose of SPIROCO XL
Take SPIROCO XL once a day, at the same time each day.
Swallow your SPIROCO XL prolonged-release tablet(s) whole, with a glass of water.
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DONOTbreak, 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.
If you are switching from ropinirole immediate-release tablets
Your doctor will base your dose of SPIROCO XL prolonged-release tablets on the dose of ropinirole immediate-release tablets you were taking.
Take your ropinirole immediate-release tablets as normal the day before you switch.Then take your SPIROCO XL prolonged-release tablets next morning and do not take any more ropinirole immediate-release tablets.
If you take more SPIROCO XL than you should
Contact a doctor or pharmacist immediately. If possible, show them the SPIROCO XL pack.
Someone who has taken an overdose of SPIROCO 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 SPIROCO XL
Do not take a double dose to make up for a forgotten dose.
Ifyou have missedtaking SPIROCO XL for one day or more, askyour doctor for advice on how to start taking it again.
If you stop taking SPIROCO XL
Do not stop taking SPIROCO XL without advice.
Take SPIROCO XL for as long as your doctor recommends. Do not stop unless your doctor advises you to.
If you suddenly stop taking SPIROCO XL, your Parkinson's disease symptoms may quickly get much worse.
Ifyou need to stop taking SPIROCO XL, your doctor will reduce your dose gradually.
If you have any further questions on the use ofthis product, ask your doctor or pharmacist.
Q POSSIBLE SIDE EFFECTS
Like all medicines, SPIROCO XL can cause side effects, although not everybody gets them.
The side effects of SPIROCO XL are more likely to happen when you first start taking it, or when your dose has just been increased.They are usually mild, and may become less troublesome after you have taken the dose for a while. If you are worried about side effects, talk to your doctor.
Very common side effects (affects more than 1 user in 10)
• Fainting
• Feeling sleepy (somnolence)
• Feelingsick(nausea).
Common side effects (affects 1 to 10 users in 100)
• hallucinations ('seeing' things that are not really there)
• beingsick(vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• stomach pain
• constipation
• swellingofthelegs,feetorhands.
Uncommon side effects (affects 1 to 10 users 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 apparent warning (sudden sleep onset episodes)
• mental problems such as delirium (severe confusion), delusions (unreasonable ideas) or paranoia (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
• changes in liver function, 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:
• 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).
Tell your doctor if you experience any of these behaviours; they will discuss
ways of managing or reducing the -
symptoms.
If you are taking SPIROCO XL with L-dopa
People who are taking SPIROCO XL with L-dopa may develop other side effects over time:
• uncontrollable movements (dyskinesias) are a very common side effect. Ifyou are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking SPIROCO XL.Tell your doctor if this happens, asyour doctor may need to adjust the doses of the medicines you are taking.
• feeling confused (a common side effect).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE SPIROCO XL
Keep out of the reach and sight of children.
Do not use SPIROCO XL after the expiry date which is stated on the blisters and carton after EXP The expiry date refers to the last day of that month.
Do not store above 30oC.
Store in the original package in order to protect from moisture.
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 balp-to-protectthe environment_________
Q further information
What SPIROCO XL contains
• The active substance is ropinirole.
Each prolonged-releasetablet contains 2 mg, 4 mg or 8 mg ropinirole (as hydrochloride).
• The other ingredients are:
SPIROCO XL 2 mg prolonged-release tablets:
hypromellose, lactose monohydrate, colloidal anhydrous silica, carbomers
4.000- 11,000 mPa.s, hydrogenated castor oil, magnesium stearate in the tablet core and hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172) in the film-coating.
SPIROCO XL 4 mg and 8 mg prolonged-release tablets: hypromellose, lactose monohydrate, colloidal anhydrous silica, carbomers
4.000- 11,000 mPa.s, hydrogenated castor oil, magnesium stearate in the tablet core and hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) in the film-coating.
What SPIROCO XL looks like and
contents of the pack
SPIROCO XL 2 mg prolonged-release
tablets: Tablets are pink, oval, biconvex
tablets.
SPIROCO XL 4 mg prolonged-release tablets: Tablets are light off-brown, biconvex, oval tablets.
SPIROCO XL 8 mg prolonged-release tablets: Tablets are brownish-red, biconvex, oval tablets.
Tablets are available in boxes of 7, 21,
28, 42, 56, 84 and 100 prolonged-release tablets in OPA/AI/PVC/AI blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ratiopharm GmbH, Graf-Arco-Strasse 3,
89079 Ulm, Germany.
Manufacturer
Merckle GmbH, Ludwig-Merckle-Str,
3, Weiler, 89143 Blaubeuren, Germany.
This leaflet was last amended April 2014.
PL 157 73/08 86-88 88247-D
265401 <-
183126.03-GB
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This code may update prior to production