Requip-Prolib 8 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

REQUIP-PROLIB 8 mg prolonged-release tablets

ropinirole

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What REQUIP-PROLIB is and what it is used for

The active substance in REQUIP-PROLIB is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act in a similar way to a natural substance found in the brain called dopamine.

REQUIP-PROLIB prolonged-release tablets are used for the treatment of Parkinson's disease.

People with Parkinson's disease have low levels of dopamine in certain parts of the brain. Ropinirole has an effect similar to natural dopamine and thus reduces the symptoms of Parkinson's disease.

2. What you need to know before starting REQUIP-PROLIB

Do not take REQUIP-PROLIB

• if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney disease
• if you have liver disease.
  • Inform your doctor if you think you may be in any of these situations.

Warnings and precautions

Talk to your doctor or pharmacist before starting REQUIP-PROLIB:

• if you are pregnant or think you may be pregnant
• if you are breastfeeding
• if you are under 18 years of age
• if you have a serious heart condition
• if you have a severe mental disorder
• if you experience impulsive behaviour and/or abnormal behaviour (see section 4)
• if you have an intolerance to certain sugars (e.g.: lactose).

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with REQUIP-PROLIB (known as dopamine agonist withdrawal syndrome or DAWS). If problems persist after a few weeks, your doctor may need to adjust your treatment.

Inform your doctor if you or your family/carer notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, urge, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorders and may include behaviours such as pathological gambling, compulsive eating, excessive spending, abnormally increased sexual desire, or increased sexual thoughts or feelings. Your doctor may need to adjust or stop your treatment.

Inform your doctor if you or your family/carer notice episodes of hyperactivity, euphoria, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). Your doctor may need to adjust or stop your treatment.

? Inform your doctor if you think you are in any of these situations. Your doctor will decide whether treatment with REQUIP-PROLIB is suitable for you, or whether you need additional monitoring while taking it.

While taking REQUIP-PROLIB

Inform your doctor if you or your family notice that you are developing any abnormal behaviour (such as an unusual urge to gamble or increased sexual urges and/or behaviours) while taking REQUIP-PROLIB. Your doctor may need to adjust or stop your dosage.

Smoking and REQUIP-PROLIB

Inform your doctor if you have started or stopped smoking while taking REQUIP-PROLIB. Your doctor may need to adjust your dose.

Other medicines and REQUIP-PROLIB

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

Remember to inform your doctor or pharmacist if you start taking a new medicine while on REQUIP-PROLIB.

Some medicines may affect the action of REQUIP-PROLIB, or make it more likely that you will experience side effects. REQUIP-PROLIB may also alter the way other medicines work.

These medicines include:

• the antidepressant fluvoxamine
• medicines for mental disorders, such as sulpiride
• hormone replacement therapy (also known as HRT)
• metoclopramide, used to treat nausea and acid reflux
• the antibiotics ciprofloxacin or enoxacin
• any other medicines for Parkinson's disease.

? Inform your doctor if you are taking or have recently taken any of these medicines.

If you are taking the following medicines with REQUIP-PROLIB**, you may need additional blood tests:**

• vitamin K antagonists (used to reduce blood clotting) such as Warfarin.

Taking REQUIP-PROLIB with food and drink

You may take REQUIP-PROLIB with or without food, as you prefer.

Pregnancy and breastfeeding

REQUIP-PROLIB is not recommended during pregnancy, unless your doctor determines that the benefit to you outweighs any potential risk to the fetus. REQUIP-PROLIB must not be used during breastfeeding, as milk production may be affected.

Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will advise you on what to do if you are breastfeeding or planning to breastfeed. Your doctor may recommend that you discontinue treatment with REQUIP-PROLIB.

Driving and using machines

REQUIP-PROLIB may make you feel sleepy. Some people may feel extremely sleepy or fall suddenly asleep without warning.

REQUIP-PROLIB may cause hallucinations (seeing, hearing, or feeling things that are not there). If this occurs, do not drive or operate machinery.

If you experience any of these effects: do not drive, do not operate machinery, and avoid situations where feeling sleepy or falling asleep could place you or others at risk of serious injury or death. Do not engage in such activities until you are no longer affected.

? Consult your doctor to determine whether this may affect you.

REQUIP-PROLIB contains lactose, sodium, and hydrogenated castor oil

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, essentially “sodium-free”.

This medicine may cause stomach discomfort and diarrhea because it contains hydrogenated castor oil.

3. How to take REQUIP-PROLIB

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Do not give REQUIP-PROLIB to children. REQUIP-PROLIB is normally not prescribed for individuals under 18 years of age.

You may have been prescribed REQUIP-PROLIB alone for the treatment of your Parkinson's disease symptoms, or you may also have been prescribed another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you might experience some involuntary movements (dyskinesias) when you start taking REQUIP-PROLIB. Inform your doctor if this occurs, as you may need adjustments in the doses of your medications.

The prolonged-release tablets of REQUIP-PROLIB have been designed to release the active ingredient over a 24-hour period. If you are in a condition where medicines pass through your body very quickly, for example with diarrhea, the tablet may not dissolve completely and may not work properly. You may see tablets in your stools. If this happens, inform your doctor as soon as possible.

What dose of REQUIP-PROLIB should you take?

It may take some time to determine the best dose of REQUIP-PROLIB for you.

The recommended starting dose of REQUIP-PROLIB prolonged-release tablets is 2 mg once daily during the first week. From there, your doctor may increase the dose to 4 mg of REQUIP-PROLIB prolonged-release tablets once daily during the second week of treatment. In very elderly patients, the doctor may increase the dose more slowly. Afterwards, your doctor may adjust the dose until reaching the most appropriate dose for you. Some people take up to 24 mg of REQUIP-PROLIB prolonged-release tablets daily.

If you experience adverse effects at the beginning of treatment that you cannot tolerate, consult your doctor. Your doctor may advise you to switch to a lower dose of REQUIP film-coated tablets (immediate-release) which you will take three times a day.

Do not take more REQUIP-PROLIB tablets than your doctor has recommended.

It may take several weeks for REQUIP-PROLIB to take effect.

How to take your dose of REQUIP-PROLIB

Take REQUIP-PROLIB once daily, at the same time each day.

Swallow the REQUIP-PROLIB tablets whole with a glass of water.

Do not break, chew, or crush the prolonged-release tablets. If you do, there may be a risk of receiving an excessive dose, as the medicine would be released into your body too quickly.

If you are switching from REQUIP film-coated tablets (immediate-release)

Your doctor will adjust your dose of REQUIP-PROLIB prolonged-release tablets based on the dose of REQUIP film-coated tablets (immediate-release) you are currently taking.

Take your REQUIP film-coated tablets (immediate-release) as usual the day before the switch. Then, take your REQUIP-PROLIB prolonged-release tablets the following morning, and do not take any further REQUIP film-coated tablets (immediate-release).

If you take more REQUIP-PROLIB than you should

Contact your doctor or pharmacist immediately. If possible, show them the REQUIP-PROLIB packaging.

Someone who has overdosed on REQUIP-PROLIB may experience some of these symptoms: nausea, vomiting, dizziness, drowsiness, fatigue (mental or physical tiredness), feeling faint, hallucinations.

If you forget to take REQUIP-PROLIB

Do not take extra tablets or a double dose to make up for missed doses.

If you have forgotten to take REQUIP-PROLIB for one or more days, consult your doctor for advice on how to resume treatment.

If you stop taking REQUIP-PROLIB

Do not stop treatment with REQUIP-PROLIB without first consulting your doctor.

Take REQUIP-PROLIB for as long as your doctor tells you to. Do not stop treatment unless instructed by your doctor.

If you stop treatment with REQUIP-PROLIB abruptly, your Parkinson's disease symptoms may worsen rapidly. A sudden interruption of treatment could cause a condition known as neuroleptic malignant syndrome, which may pose a serious health risk. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, decreased level of consciousness (e.g., coma).

If you need to discontinue treatment with REQUIP-PROLIB, your doctor will gradually reduce the dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse reactions to REQUIP-PROLIB usually occur more likely at the beginning of treatment or when the dose is increased. Adverse reactions are generally mild and may become less bothersome over time. Inform your doctor if you are concerned about any adverse effects.

Very common adverse effects

These may affect more than 1 in 10 people taking REQUIP-PROLIB:

• fainting
• drowsiness
• nausea.

Common adverse effects

These may affect up to 1 in 10 people taking REQUIP-PROLIB:

• falling asleep suddenly without prior warning of sleepiness (sudden sleep episodes)
• hallucinations (seeing things that are not really there)
• vomiting
• dizziness (a spinning sensation)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet, or hands.

Uncommon adverse effects

These may affect up to 1 in 100 people taking REQUIP-PROLIB:

• dizziness or faintness, especially when standing up suddenly (this is due to a drop in blood pressure)
• low blood pressure (hypotension)
• feeling excessively sleepy during the day (excessive somnolence)
• mental problems such as delirium (severe confusion), delusional thoughts (irrational ideas), or paranoia (irrational suspicions)
• hiccups.

Some patients may experience the following adverse effects (frequency not known: cannot be estimated from available data)

• allergic reactions such as redness, skin inflammation with itching (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, rash, or intense itching (see section 2)

• changes in liver function, which may be detected through blood tests

• acting in an aggressive manner

• excessive use of REQUIP-PROLIB (compulsion to take excessive doses of dopaminergic medication beyond what is needed to control motor symptoms, known as dopamine dysregulation syndrome)

• inability to resist the impulse, desire, or temptation to carry out certain actions that may be harmful to you or others, which may include:

• strong urge to gamble excessively, despite significant personal or family consequences

• altered or increased sexual interest, and behavior that is troubling to you or others, such as excessive sexual behavior

• uncontrollable excessive shopping or spending

• binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than needed to satisfy hunger)

• episodes of hyperactivity, euphoria, or irritability

• after stopping or reducing treatment with REQUIP-PROLIB: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS)

• spontaneous penile erection.

Inform your doctor if you experience any of these behaviors; they will advise you on ways to manage or reduce the symptoms.

If you are taking REQUIP-PROLIB with L-dopa

People taking REQUIP-PROLIB with L-dopa may develop additional adverse effects over time:

• very common adverse effects are involuntary movements (dyskinesias). If you are taking L-dopa, you may experience some involuntary movements (dyskinesias) when starting REQUIP-PROLIB. Inform your doctor if this occurs, as you may need dose adjustments of your medications
• a common adverse effect is confusion.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of REQUIP-PROLIB

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of REQUIP-PROLIB

The active substance in REQUIP-PROLIB is ropinirole.

One prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride).

The other components are:

• Core of the prolonged-release tablet: hypromellose, hydrogenated castor oil, sodium carmellose, povidone (K29-32), maltodextrin, magnesium stearate, lactose monohydrate, colloidal anhydrous silica, mannitol (E421), yellow iron oxide (E172), glycerol dibehenate.
• Film coating: OPADRY Red 03B25227 (hypromellose, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), macrogol 400, red iron oxide (E172)).

Appearance of the product and pack contents

REQUIP-PROLIB 8 mg is presented as red, capsule-shaped, prolonged-release tablets, marked with "GS" on one side and "5CC" on the other.

REQUIP-PROLIB 8 mg is supplied in blister packs containing 28 or 84 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Procedure number: FR/H/111/009

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany, Austria, Belgium, Ireland, Luxembourg, Netherlands: Requip modutab

Finland and Sweden: Requip Depot

France and Portugal: Requip LP

Greece: Requip XL

Italy: Requip

Spain: Requip Prolib

Date of the most recent review of this summary: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/