ROPINIROLE KERN PHARMA 8 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Ropinirol Kern Pharma 8 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 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.

Contents of the pack and other information:

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

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

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

Ropinirol Kern Pharma 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 brain. Ropinirole has a similar effect to natural dopamine and helps to reduce the symptoms of Parkinson's disease.

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

Do not take Ropinirol Kern Pharma

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

Tell your doctor if you think you may have any of these conditions.

Warnings and precautions

Consult your doctor or pharmacist before taking Ropinirol Kern Pharma:

• 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 severe heart disease,
• if you have a severe mental health problem,
• if you have a history of impulse control disorders (such as compulsive gambling, binge eating, or hypersexuality),
• if you have an intolerance to some sugars (e.g. lactose).

Tell your doctor if you think you may have any of these conditions. Your doctor will decide if your treatment with Ropinirol Kern Pharma is suitable for you, or if you need closer monitoring while taking it.

Tell your doctor if you notice 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 desires to behave in ways that are unusual for you and that you cannot resist the impulse, desire, or temptation to perform certain activities that could harm you or others. These are called impulse control disorders and can include behaviors such as compulsive gambling, excessive eating, or increased libido. Your doctor may need to adjust or stop your treatment.

Smoking and Ropinirol Kern Pharma

Tell your doctorif you start or stop smoking while taking Ropinirol Kern Pharma. Your doctor may need to adjust your dose.

Using Ropinirol Kern Pharma with other medicines

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

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

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

These medicines include:

• the antidepressant fluvoxamine.
• medicines for mental health problems, such as sulpiride.
• hormone replacement therapy (also called HRT).
• metoclopramide, which is used to treat nausea and stomach acid.
• 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.

Using Ropinirol Kern Pharma with food, drink, and alcohol

You can take Ropinirol Kern Pharma with or without food.

It is not recommended to drink alcohol while taking ropinirole.

Pregnancy and breast-feeding

Consult your doctor or pharmacist before taking any medicine.

Ropinirole is not recommended during pregnancy, unless your doctor advises you that the benefit for you is greater than the risk to your baby. Ropinirole should not be used during breast-feeding, as milk production may be affected.

Tell your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will advise you on what to do if you are breast-feeding or plan to breast-feed. Your doctor may recommend that you stop taking ropinirole.

Driving and using machines

Ropinirole can cause drowsiness and sudden episodes of sleep. If this happens, do not drive or operate machinery until these episodes have stopped.

Ropinirole can cause hallucinations (seeing, hearing, or feeling things that are not there). If this happens, do not drive or operate machinery.

Ropinirol Kern Pharma contains lactose and hydrogenated castor oil.If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Ropinirol Kern Pharma

Take Ropinirol Kern Pharma exactly as your doctor has told you.

Ask your doctor or pharmacist if you are not sure.

Use in children and adolescents

Do not give Ropinirol Kern Pharma to children.Ropinirol is not normally prescribed for people under 18 years old.

You may have been prescribed ropinirol on its own to treat your Parkinson's disease symptoms, or you may have been prescribed ropinirol as well as another medicine called L-dopa (also called levodopa). If you are taking L-dopa, you may experience some uncontrolled jerky movements when you first start taking ropinirol. Talk to your doctor if this happens, as you may need to have your L-dopa dose reduced.

What dose of Ropinirol Kern Pharma should you take?

It may take a while to find the best dose of ropinirol for you.

The usual starting doseof ropinirol prolonged-release tablets is 2 mg once a day for the first week. After this, your doctor may increase your dose to 4 mg of ropinirol prolonged-release tablets once a day, during the second week of treatment. In elderly people, the doctor may increase the dose more slowly. After this, your doctor may adjust your dose until you are taking the dose that is best for you. Some people take up to 24 mg of ropinirol prolonged-release tablets once a day.

If you experience side effects that you cannot tolerate when you first start treatment, talk to your doctor. Your doctor may advise you to switch to a lower dose of ropinirol immediate-release tablets, which you will take three times a day.

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

It may take several weeks for ropinirol to start working.

How to take your dose of Ropinirol Kern Pharma

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

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

Do not break, chew, or crushthe prolonged-release tablets. If you do, you may be at risk of receiving a higher dose of the medicine, because it will be released too quickly into your body.

If you switch from ropinirol immediate-release tablets

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

Take your ropinirol immediate-release tablets as usual on the day before you switch. Then, take your ropinirol prolonged-release tablets the next morning, and do not take any more ropinirol immediate-release tablets.

If you take more Ropinirol Kern Pharma than you should

If you have taken more ropinirol than you should, talk to a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. If possible, show them the pack or the leaflet or both.

Someone who has taken an overdose of ropinirol may have some of the following symptoms: nausea, vomiting, dizziness, drowsiness, fatigue, feeling faint, or hallucinations.

If you forget to take Ropinirol Kern Pharma

Do not take a double dose to make up for a forgotten dose.

If you have missed taking Ropinirol Kern Pharma for one or more days, ask your doctor for advice on how to start taking it again.

If you stop taking Ropinirol Kern Pharma

Do not stop taking Ropinirol Kern Pharma without talking to your doctor first.

Take Ropinirol Kern Pharma for as long as your doctor recommends. Do not stop taking Ropinirol Kern Pharma unless your doctor tells you to.

If you suddenly stop taking Ropinirol Kern Pharma, your Parkinson's disease symptoms may quickly get much worse.

If you need to stop taking Ropinirol Kern Pharma, your doctor will reduce your dose gradually.

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

4. Possible side effects

Like all medicines, ropinirol can cause side effects, although not everybody gets them.

The side effects of Ropinirol Kern Pharma are more likely to happen when you first start taking the medicine, or when your dose is increased. These are usually mild and may become less troublesome after 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):

• feeling faint,
• drowsiness,
• nausea.

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

• dizziness or fainting, especially when standing up quickly (this is due to low blood pressure),
• feeling very sleepy during the day (excessive daytime sleepiness),
• suddenly falling asleep without warning (sudden sleep episodes),
• mental problems such as confusion (severe confusion), delirium (abnormal thoughts), or paranoia (unreasonable suspicions),
• hypersalivation.

Side effects with frequency not known:

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

Some patients may have the following side effects

• allergic reactions such as redness, skin inflammation with itching (urticaria), 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 can be detected by blood tests.
• inability to resist the impulse, desire, or temptation to perform an action that could be harmful to you or others, which may include:
• • Strong impulse to gamble excessively despite severe personal or family consequences.
  • Altered or increased sexual interest and behavior of significant concern to you or others, for example, an increased sexual desire.
  • Uncontrollable and excessive shopping or spending.
  • Eating disorders (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).

Tell 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 side effects after some time:

• very common side effects are uncontrolled jerky movements,
• a common side effect is confusion.

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 the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Storage of Ropinirol Kern Pharma

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

Do not use Ropinirol Kern Pharma after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

Do not store above 30°C.

Store in the original package 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 help protect the environment.

6. Contents of the pack and other information

Composition of Ropinirol Kern Pharma 8 mg prolonged-release tablets

• The active substance is ropinirole. Each prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride).
• The other ingredients are:

Core of the tablet: 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, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

Appearance and packaging of the product

Ropinirol Kern Pharma 8 mg are reddish-brown, biconvex, and oval prolonged-release tablets.

The tablets are available in packs of 21, 28, 42, and 84 prolonged-release tablets in blisters (OPA/Al/PVC//Al).

Not all pack sizes may be marketed.

Marketing authorisation 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 last revision of this leaflet: May 2023

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