SPIROCO XL 2 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

SPIROCO XL

2 mg, 4 mg and 8 mg prolonged-release tablets

ropinirole

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. See section 4.

What is in this leaflet :

1. What SPIROCO XL is and what it is used for 2. What you need to know before you take SPIROCO XL

• 3. How to take SPIROCO XL

• 4. Possible side effects

• 5. How to store SPIROCO XL

• 6. Contents of the pack and other information

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What 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.

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What you need to know before you take SPIROCO XL

Do NOT TAKE SPIROCO XL if you

• are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6).
• have serious kidney disease.
• have liver disease.

Tell your doctor if you think any of these may apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking SPIROCO XL:

• if you are pregnant or think you might 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 serious mental health problem. if you have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour) (see 4“Possible side effects”).
• if you have an intolerance to some sugars (such as lactose).

Tell your doctor if you think any of these may apply to you. Your doctor may decide that SPIROCO XL is not suitable for you, or that you 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 if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your SPIROCO XL treatment (called dopamine agonist withdrawal syndrome or DAWS). If the problems persist more than a few weeks, your doctor may need to adjust your treatment.

Smoking and SPIROCO XL

Tell your doctor if you start smoking, or give up smoking, while you are taking SPIROCO XL. Your doctor may need to adjust your dose.

Other medicines and SPIROCO XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Remember to tell your doctor or pharmacist if you begin taking a new 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 (hormone replacement therapy);
• metoclopramide, which is used to treat nausea and heartburn;
• the antibiotics ciprofloxacin or enoxacin;
• any other medicine for Parkinson’s di­sease. Tell your doctor if you are taking or have recently taken any of these.
• You will require additional blood tests if you are taking these medicines with SPIROCO XL: Vitamin K antagonists (used to reduce blood clotting) such as Warfarin (coumadin).

SPIROCO XL with food, drink and alcohol

You can take SPIROCO XL with or without food. Concomitant intake of alcoholic beverages and SPIROCO XL is not recommended.

Pregnancy and breast-feeding

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.

SPIROCO XL is not recommended if you are pregnant, unless your doctor advises that the benefit to you of taking SPIROCO XL is greater than the risk to the unborn baby. SPIROCO XL is not recommended if you are breast-feeding, as it can affect your milk production.

Your doctor will advise you if you 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. Talk to your doctor if this causes problems for you.

SPIROCO XL can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

SPIROCO XL contains 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

SPIROCO XL contains castor oil

May cause stomach upset and diarrhea.

How to take SPIROCO XL

Always take this medicine exactly as your doctor has told you. 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.

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). If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking SPIROCO XL. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking.

SPIROCO XL tablet(s) are designed to release drug over a 24hr period. If you have a condition where your medicine passes through your body too quickly, e.g., diarrhea, the tablet(s) may not dissolve completely and may not work properly. You may see tablet(s) in your stool. If this happens, let your doctor know as soon as possible.

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 recommended 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 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 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.

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.

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 extra prolonged-release tablets or a double dose to make up for a forgotten dose. If you have missed taking SPIROCO XL for one day or more, ask your doctor for advice on how to start taking it again.

If you stop taking SPIROCO XL

Do not stop using SPIROCO XL suddenly without talking to your doctor. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include: akinesia (loss of muscle movement), rigid muscles, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depressed level of consciousness (e.g. coma).

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.

If you need to stop taking SPIROCO 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.

Q Possible side effects

Like all medicines, this medicine 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:

These may affect more than 1 in 10 people taking SPIROCO XL

• fainting
• feeling sleepy (somnolence)
• feeling sick (nausea)

Common side effects:

These may affect up to 1 in 10 people taking SPIROCO XL

• hallucinations (“seeing” things that are not really there)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet or hands

Uncommon side effects:

These may affect up to 1 in 100 people taking SPIROCO XL

• 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

Frequency not known: frequency cannot be estimated from the available data

• 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.
• act in an aggressive manner
• excessive use of SPIROCO XL (craving for large doses of dopaminergic drugs in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome)
• after stopping or reducing your SPIROCO XL treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS)
• 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. If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking SPIROCO XL. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking.
• feeling confused (a common side effect).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store SPIROCO XL

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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 30°C.

Store in the original package in order to protect from moisture.

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.

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Contents of the pack and other information

What SPIROCO XL contains

• – The active substance is ropinirole. Each prolonged-release tablet contains 2 mg, 4 mg or 8 mg ropinirole (as hydrochloride).

• – The other ingredients are:

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/Al/PVC//Al 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 July 2020.

PL 15773/0886–88

EAS1143c 183126.07-GB xxxxxx