Ropinirole Kern Pharma 2 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ropinirol Kern Pharma 2 mg prolonged-release tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Ropinirol Kern Pharma is and what it is used for

The active substance of Ropinirol Kern Pharma is ropinirol, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in the same way as a natural substance found in the brain called dopamine.

Ropinirol Kern Pharma 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. Ropinirol has an effect similar to natural dopamine and thus reduces the symptoms of Parkinson's disease.

2. What you need to know before starting Ropinirol Kern Pharma

Do not take Ropinirol Kern Pharma

• if you are allergic to ropinirol or any of the other ingredients of Ropinirol Kern Pharma.
• if you have severe kidney disease.
• if you have any liver disease.

Tell your doctor if you think you are in any of these situations.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ropinirol Kern Pharma:

• if you are pregnant or think you might be pregnant,
• if you are breastfeeding,
• if you are under 18 years of age,
• if you have any serious heart condition,
• if you have any serious mental disorder,
• if you experience any impulsive behaviour and/or abnormal behaviour (such as an overwhelming urge to gamble or excessive sexual behaviour),
• if you have an intolerance to certain sugars (e.g.: lactose).

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

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

While taking Ropinirol Kern Pharma

Tell your doctor if you or your family/caregiver 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. These are called impulse control disorders and may include behaviours such as compulsive gambling, eating, or spending, abnormally high sex drive, or increased sexual thoughts or feelings. Your doctor may need to adjust or discontinue your treatment.

Smoking and Ropinirol Kern Pharma

Tell your doctor if you have started or stopped smoking while taking Ropinirol Kern Pharma. Your doctor may need to adjust your dose.

Taking Ropinirol Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Remember to inform your doctor or pharmacist if you start taking a new medicine while taking Ropinirol Kern Pharma.

Some medicines may affect the action of ropinirol, or make it more likely that you will experience adverse effects. Ropinirol 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 called HRT).
• metoclopramide, used to treat nausea and stomach acidity.
• 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 medicines.

Taking Ropinirol Kern Pharma with food, drink, and alcohol

You may take Ropinirol Kern Pharma with or without food.

Alcoholic drinks are not recommended while taking ropinirol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The use of ropinirol during pregnancy is not recommended unless your doctor considers that the benefit to you outweighs any possible risk to the fetus. Ropinirol should not be used during breastfeeding, as milk production may be affected.

Tell 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 stop treatment with ropinirol.

Driving and using machines

Ropinirol may cause drowsiness and sudden episodes of falling asleep. If this happens, you should not drive or engage in activities where reduced alertness could put you or others at risk of death or serious injury (e.g. operating machinery) until these episodes and/or drowsiness have resolved.

Ropinirol may cause hallucinations (seeing, hearing, or feeling things that are not present). If this occurs, do not drive or use machinery.

Ropinirol Kern Pharma contains lactose and hydrogenated castor oil.

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

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

3. How to take Ropinirol Kern Pharma

Follow exactly the dosing instructions for Ropinirol provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Use in children and adolescents

Do not give Ropinirol Kern Pharma to children. Ropinirol is normally not prescribed for patients under 18 years of age.

You may have been prescribed ropinirol 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 sudden uncontrolled movements when you start taking ropinirol. Consult your doctor if this occurs, as you may need to reduce your dose of L-dopa.

What dose of Ropinirol Kern Pharma should you take?

It may take some time to determine the optimal dose of ropinirol for you.

The usual starting dose of prolonged-release ropinirol tablets is 2 mg once daily during the first week. From there, your doctor may increase the dose to 4 mg of prolonged-release ropinirol tablets once daily during the second week of treatment. In 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 patients may take up to 24 mg of prolonged-release ropinirol tablets daily.

If you experience adverse effects at the beginning of treatment that you cannot tolerate, consult your doctor. Your doctor may advise switching to a lower dose of film-coated ropinirol tablets (immediate-release) to be taken three times daily.

Do not take more Ropinirol Kern Pharma tablets than your doctor has prescribed.

It may take several weeks for ropinirol to take effect.

How to take your dose of Ropinirol Kern Pharma

Take Ropinirol Kern Pharma once daily, at the same time each day.

Swallow the Ropinirol Kern Pharma tablets whole with a glass of water.

DO NOT break, chew, or crush the prolonged-release tablets. Doing so may result in a dangerous overdose, as the medicine would be released too quickly into your body.

If switching from film-coated ropinirol tablets (immediate-release)

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

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

If you take more Ropinirol Kern Pharma than you should

If you have taken more ropinirol than prescribed, contact your doctor or go to the nearest hospital immediately, or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medication and the amount ingested. If possible, show the package.

A person who has overdosed on ropinirol may experience symptoms such as nausea, vomiting, dizziness, somnolence, fatigue (mental or physical tiredness), feeling faint, or hallucinations.

If you forget to take Ropinirol Kern Pharma

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

If you have forgotten to take Ropinirol Kern Pharma for one or more days, consult your doctor for advice on how to restart treatment.

If you stop taking Ropinirol Kern Pharma

Do not stop treatment with Ropinirol Kern Pharma without first consulting your doctor.

Take Ropinirol Kern Pharma for as long as your doctor recommends. Do not discontinue treatment unless instructed by your doctor.

If you stop treatment with Ropinirol Kern Pharma abruptly, your Parkinson's disease symptoms may worsen rapidly.

If you need to discontinue treatment with Ropinirol Kern Pharma, 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, ropinirol may cause adverse effects, although not everyone experiences them.

The adverse effects of Ropinirol Kern Pharma are most likely to occur at the beginning of treatment or when the dose is increased. These 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 (may affect more than 1 in 10 patients):

• feeling faint,
• somnolence,
• nausea.

Common adverse effects (may affect up to 1 in 10 patients):

• hallucinations (seeing things that are not really there),
• vomiting,
• dizziness,
• heartburn,
• stomach pain,
• constipation,
• swelling of the legs, feet, or hands.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• dizziness or fainting, especially when standing up suddenly (this is due to a drop in blood pressure),
• feeling very sleepy during the day (excessive somnolence),
• falling asleep suddenly without feeling sleepy beforehand (sudden sleep episodes),
• mental problems such as delirium (severe confusion), delusional thoughts (irrational ideas), or paranoia (irrational suspicions),
• hiccups.

Adverse effects with unknown frequency:

• after stopping or reducing treatment with Ropinirol Kern Pharma: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS),
• spontaneous penile erection.

Some patients may experience the following adverse effects:

• allergic reactions such as redness, skin rash with itching (urticaria), swelling of the face, lips, mouth, tongue, or throat which may cause difficulty swallowing or breathing, rash, or intense itching,
• changes in liver function, which may be detected by blood tests,
• inability to resist the impulse, desire, or temptation to carry out an action that could be harmful to yourself or others, which may include:
  • Strong impulse to gamble excessively despite serious personal or family consequences.
  • Altered or increased sexual interest and behavior causing significant concern to yourself or others, for example, increased sexual desire.
  • Uncontrollable excessive shopping or spending.
  • Appetite disorders (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than necessary to satisfy hunger).

Inform your doctor if you have experienced any of these behaviors; they will discuss how to manage or reduce the symptoms.

If you are taking ropinirol with L-dopa

People who take ropinirol with L-dopa may develop other adverse effects after some time:

• very common adverse effects are uncontrolled, sudden movements,
• a common adverse effect is confusion.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Ropinirol Kern Pharma

Keep out of sight and reach of children.

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

Do not store above 30 °C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ropinirol Kern Pharma 2 mg prolonged-release tablets

• The active substance is Ropinirol. Each prolonged-release tablet contains 2 mg of Ropinirol (as hydrochloride).
• The other components are:

Tablet core: hypromellose 2208, lactose monohydrate, colloidal anhydrous silica, carbomer 4,000-11,000 mPa.s, hydrogenated castor oil, magnesium stearate.

Coating: hypromellose 2910, titanium dioxide (E171), macrogol 400, iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the container

Ropinirol Kern Pharma 2 mg are prolonged-release tablets, pink in colour, biconvex and oval-shaped.

The tablets are available in blister packs (OPA/Al/PVC//Al) containing 21, 28, 42 or 84 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

Date of the most recent revision of this leaflet: May 2023

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