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

Patient leaflet - RALNEA XL 2 MG PROLONGED-RELEASE TABLETS

Ralnea XL 2 mg

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 Ralnea XL is and what it is used for
2. What you need to know before you take Ralnea XL
3. How to take Ralnea XL
4. Possible side effects
5. How to store Ralnea XL
6. Contents of the pack and other information

| 1. WHAT RALNEA XL IS AND WHAT IT IS USED FOR |

The active ingredient in Ralnea 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.

Ralnea 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RALNEA XL

Do NOT TAKE Ralnea 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

Talk to your doctor or pharmacist before taking Ralnea 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 serious mental health problem
if you have experienced any unusual urges and/or behaviours

(see section 4)

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 Ralnea XL is not suitable for you, or that you need extra check-ups while you are 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.

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your ropinirole 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.

While you are taking Ralnea XL

Tell your doctor if you or your family notices that you are developing any unusual behaviours (such as an unusual urge to gamble or increased sexual urges and/or behaviours) while you are taking Ralnea XL. Your doctor may need to adjust or stop your dose.

Smoking and Ralnea XL

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

Other medicines and Ralnea XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including any herbal medicines or other medicines you obtained without a prescription.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Ralnea XL.

Some medicines can affect the way Ralnea XL works, or make it more likely that you will have side effects. Ralnea XL can also affect the way some other medicines work.

These include:

the anti-depressant fluvoxamine;
medication 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 Ralnea XL:

Vitamin K antagonists (used to reduce blood clotting) such as Warfarin (coumadin).

Ralnea XL with food and drink

You can take Ralnea XL with or without food.

Pregnancy and breast-feeding

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

Tell your doctor immediately if you are pregnant, think you may 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 Ralnea XL.

Driving and using machines

Ralnea XL can make you feel drowsy. It can make people feel extremely sleepy , and it sometimes makes people fall asleep very suddenly without warning. Ropinirole can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

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.

Ralnea 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.

| 3. HOW TO TAKE RALNEA XL |

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use in children and adolescents

Do not give Ralnea XL to children. Ralnea XL is not normally prescribed for people under 18.

You may be given Ralnea XL on its own to treat the symptoms of your Parkinson’s disease. Or you may be given Ralnea 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 Ralnea XL. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking.

Ralnea 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., diarrhoea, 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 Ralnea XL will you need to take?

It may take a while to find out the best dose of Ralnea XL for you.

The recommended starting dose of Ralnea XL prolonged-release tablets is 2 mg once daily for the first week. Your doctor may increase your dose to 4 mg of Ralnea 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 Ralnea 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

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switch to a lower dose of ropinirole immediate-release tablets which you will take three times a day.

Do not take any more Ralnea XL than your doctor has recommended.

It may take a few weeks for Ralnea XL to work for you.

Taking your dose of Ralnea XL

Take Ralnea XL once a day , at the same time each day.

Swallow your Ralnea 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 Ralnea 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 Ralnea XL prolonged-release tablets next morning and do not take any more ropinirole immediate-release tablets.

If you take more Ralnea XL than you should

Contact a doctor or pharmacist immediately. If possible, show them the Ralnea XL pack.

Someone who has taken an overdose of Ralnea 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 Ralnea XL

Do not take extra prolonged-release tablets or a double dose to make up for a forgotten dose.

If you have missed taking Ralnea XL for one day or more, ask your doctor for advice on how to start taking it again.

If you stop taking Ralnea XL

Do not stop taking Ralnea XL without talking to your doctor.

Take Ralnea XL for as long as your doctor recommends. Do not stop unless your doctor advises you to.

If you suddenly stop taking Ralnea XL, your Parkinson’s disease symptoms may quickly get much worse. 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).

If you need to stop taking Ralnea 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 cause side effects, although not everyone gets them.

The side effects of Ralnea 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 (may affect more than 1 in 10 people)

fainting
feeling drowsy
feeling sick (nausea).
falling asleep very suddenly without feeling sleepy first (sudden sleep onset episodes)
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.
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)
mental problems such as delirium (severe confusion), delusions (unreasonable ideas) or paranoia (unreasonable suspicions).
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 liver function, which have shown up in blood tests
act in an aggressive manner
excessive use of Ralnea XL (craving for large doses of dopaminergic drugs in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome)
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).

depression, apathy, anxiety, lack of energy, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS) after stopping or reducing your Ralnea XL treatment.

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms

If you are taking Ralnea XL with L-dopa

People who are taking Ralnea 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 Ralnea 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.

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 Yellow Card Scheme, Website: yellowcard 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.

5. how to store ralnea 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.

| 6. CONTENTS OF THE PACK AND OTHER INFORMATION |

What Ralnea XL contains

The active substance is ropinirole.

Each prolonged-release tablet contains 2 mg ropinirole (as hydrochloride).

The other ingredients are: hypromellose type 2208, lactose monohydrate, colloidal anhydrous silica, carbomers 4,000–11,000 mPa.s, hydrogenated castor oil, magnesium stearate in the tablet core and hypromellose type 2910, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172) in the film-coating.

What Ralnea XL looks like and contents of the pack

Tablets are pink, biconvex and oval.

Tablets are available in cartons of 21, 28, 42 and 84 prolonged-release tablets in blisters (OPA/Alu/PVC//Alu).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d, Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d, Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

Distributed by

Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.