Nironovo Sr

Package Leaflet: Information for the User

Nironovo SR, 2 mg, prolonged-release tablets

Nironovo SR, 4 mg, prolonged-release tablets

Nironovo SR, 8 mg, prolonged-release tablets

Ropinirole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects not mentioned in this leaflet, or if any of the side effects get serious, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet1.
What is Nironovo SR and what is it used for

• 2. Important information before taking Nironovo SR
• 3. How to take Nironovo SR
• 4. Possible side effects
• 5. How to store Nironovo SR
• 6. Contents of the pack and other information

1. What is Nironovo SR and what is it used for

The active substance of Nironovo SR is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in the brain in a similar way to a natural substance called dopamine. Nironovo SR is used to treat Parkinson's disease. In patients with Parkinson's disease, there is a low level of dopamine in some parts of the brain. Ropinirole works in a similar way to dopamine in the brain and helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking Nironovo SR

When not to take Nironovo SR

• 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.

Tell your doctor if any of these conditions apply to you.

Warnings and precautions

Before starting treatment with Nironovo SR, discuss this with your doctor or pharmacist.

• 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 severe mental health problems;
• if you have had any special tendencies or behaviors in the past (see section 4);
• if you have an intolerance to some sugars (e.g., lactose).

If you experience any of the following symptoms after stopping or reducing the dose of ropinirole, tell your doctor: depression, apathy, anxiety, fatigue, sweating, or pain (called dopamine agonist withdrawal syndrome, or DAWS). If the symptoms persist for more than a few weeks, your doctor may decide to adjust the dose of your medicine. Tell your doctor if you or your family members notice any unusual behaviors, such as an irresistible impulse, compulsion, or urge to perform certain actions, which may be harmful to you or others. Such behaviors are called impulse control disorders and may include: a strong impulse to gamble, despite significant personal or family consequences; altered or increased sexual interests or behaviors of importance to you or others, e.g., increased libido; compulsive, uncontrolled spending or buying; binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more food than is needed to satisfy hunger). If you think any of these situations may apply to you, tell your doctor. Your doctor may decide that Nironovo SR is not suitable for you or that you need additional monitoring during treatment.

While taking Nironovo SR

Tell your doctor if you or your family members notice any unusual behaviors (such as an irresistible impulse to gamble or increased sexual urges and behaviors) while taking Nironovo SR. Your doctor may decide to adjust the dose of your medicine.

Smoking and Nironovo SR

Tell your doctor if you start or stop smoking while taking Nironovo SR. Your doctor may decide to adjust the dose of your medicine.

Nironovo SR and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take. Some medicines may affect the action of Nironovo SR or increase the risk of side effects. Nironovo SR may also affect the action of other medicines. These medicines include:

• the antidepressant fluvoxamine;
• medicines used in other mental health disorders, such as sulpiride;
• hormone replacement therapy (HRT);
• metoclopramide, which is used to treat nausea and heartburn;
• antibiotics: ciprofloxacin and enoxacin;
• any other medicines used to treat Parkinson's disease.

Tell your doctor if you are taking, or have recently taken, any of these medicines. If you are taking any of the following medicines with Nironovo SR, you may need to have additional blood tests:

• vitamin K antagonists (medicines used to reduce blood clotting), such as warfarin.

Nironovo SR with food and drink

Nironovo SR can be taken with or without food, as needed.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Nironovo SR should not be used during pregnancy, unless your doctor considers that the benefits to you outweigh the risks to your unborn baby. Nironovo SR should not be used during breast-feeding, as it may affect milk production. Tell your doctor immediatelyif you are pregnant or think you may be pregnant, or if you plan to become pregnant. Your doctor will also advise you if you are breast-feeding or plan to breast-feed.

Driving and using machines

Nironovo SR may cause drowsiness. Sudden, uncontrollable sleepiness may occur, as well as sudden, unexpected sleep attacks without feeling sleepy. If you experience hallucinations (seeing, hearing, or feeling things that are not there), do not drive or operate machinery. If you think you may experience these symptoms, do not drive or operate any machinery. Avoid situations where feeling drowsy or falling asleep may put you or others at risk of serious injury or death. Do not perform such activities until the symptoms have resolved. If you have any doubts, discuss them with your doctor.

Nironovo SR contains lactose

Nironovo SR contains a sugar called lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Nironovo SR contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, which is considered to be essentially sodium-free.

3. How to take Nironovo SR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Nironovo SR should not be used in children. Nironovo SR is not intended for use in patients under 18 years old. Nironovo SR can be used to treat the symptoms of Parkinson's disease as a single medicine or in combination with another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, you may experience uncontrolled movements (dyskinesias) when you start taking Nironovo SR. If you experience these symptoms, tell your doctor, who may adjust the dose of your medicines. The tablets of Nironovo SR are designed to release the active substance over 24 hours. If you have conditions that cause the medicine to pass through your digestive system too quickly, such as diarrhea, the tablets may not dissolve completely and the medicine may not work properly. The tablet may also be eliminated in the stool. If this happens, tell your doctor immediately.

What dose of Nironovo SR to take

It may take some time to find the right dose of Nironovo SR for you. The recommended starting dose of Nironovo SRis 2 mg once daily for the first week. Your doctor may increase the dose of Nironovo SR to 4 mg once daily from the second week of treatment. If you are elderly, your doctor may increase the dose more slowly. Your doctor will then adjust the dose until you reach the dose that is right for you. Some patients take up to 24 mg of Nironovo SR once daily. If you experience side effects that are difficult to tolerate at the start of treatment, tell your doctor. Your doctor may recommend reducing the dose of ropinirole in the form of immediate-release tablets, which you will take three times a day.

Do not take more Nironovo SR than your doctor recommends.

It may take several weeks for the full effect of the medicine to develop.

Taking your dose of Nironovo SR

Take Nironovo SR once daily, at the same time each day. Swallow the prolonged-release tablet(s) whole, with a glass of water. Do not break, chew, or crush the prolonged-release tablets. If you do, there is a risk of overdose, as the medicine will be released too quickly into your body.

If you are switching from ropinirol immediate-release tablets

Your doctor will determine the dose of Nironovo SR based on the dose of ropinirole immediate-release tablets you were taking. Take your usual dose of ropinirole immediate-release tablets on the day before you switch to Nironovo SR. The next morning, take Nironovo SR and do not take any more ropinirole immediate-release tablets.

If you take more Nironovo SR than you should

Seek medical advice immediately. If possible, show the medicine pack to your doctor or pharmacist. If you take more Nironovo SR than you should, you may experience: nausea, vomiting, dizziness, drowsiness, mental fatigue or physical fatigue, fainting, hallucinations.

If you forget to take Nironovo SR

Do not take a double dose to make up for a forgotten dose. If you miss a dose of Nironovo SR for a day or longer, consult your doctor for advice on restarting treatment with Nironovo SR.

Stopping treatment with Nironovo SR

Do not stop taking Nironovo SR without consulting your doctor.

Nironovo SR should be taken for as long as your doctor recommends. Do not stop taking it unless your doctor tells you to. If you suddenly stop taking Nironovo SR, your Parkinson's disease symptoms may quickly get much worse. Stopping treatment suddenly may cause a condition called neuroleptic malignant syndrome, which can be life-threatening. The symptoms include: akinesia (loss of movement), muscle stiffness, fever, unstable blood pressure, tachycardia (rapid heart rate), confusion, decreased level of consciousness (e.g., coma). If you need to stop taking Nironovo SR, your doctor will gradually reduce your dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nironovo SR can cause side effects, although not everybody gets them. The side effects of Nironovo SR are usually mild and may become less troublesome after you have taken the medicine for a while. If you are concerned about side effects, talk to your doctor. Very common - may affect more than 1 in 10 people:

• fainting;
• drowsiness;
• nausea.

Common - may affect up to 1 in 10 people:

• sudden sleepiness, without feeling sleepy (sudden onset of sleep);
• hallucinations (seeing things that are not there);
• vomiting;
• dizziness (feeling of spinning);
• heartburn;
• stomach pain;
• constipation;
• swelling of the legs, feet, or hands.

Uncommon - may affect up to 1 in 100 people:

• dizziness or fainting, especially when standing up quickly (related to low blood pressure);
• very strong drowsiness during the day (excessive daytime sleepiness);
• mental health problems, such as confusion (severe disorientation), delusions (irrational thoughts), or paranoia (unfounded suspicion);
• hiccups.

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

• allergic reactions, such as itchy skin rash, swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing, rash, and itching;
• changes in liver function, which have been seen in blood tests;
• aggressive behavior;
• abuse of Nironovo SR (a desire to take more of the medicine than is needed to control movement, known as dopamine dysregulation syndrome);
• impulse control disorders, which may include: a strong impulse to gamble, despite significant personal or family consequences; altered or increased sexual interests or behaviors of importance to you or others, e.g., increased libido; compulsive, uncontrolled spending or buying; binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more food than is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors, so that you can discuss ways to control or reduce them.

Taking Nironovo SR with L-dopa

Some patients taking Nironovo SR with L-dopa may experience other side effects after some time:

• uncontrolled movements (dyskinesias) are a very common side effect. If you are taking L-dopa, you may experience uncontrolled movements when you start taking Nironovo SR. If you experience these symptoms, tell your doctor, who may adjust the dose of your medicines;
• feeling disoriented (common side effect).

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the https://smz.ezdrowie.gov.plwebsite. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nironovo SR

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 carton and blister after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. 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

What Nironovo SR contains

The active substance is ropinirole.Each prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as ropinirole hydrochloride). The other ingredients are:

Nironovo SR, 2 mg, prolonged-release tablets:

Core:hypromellose, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated castor oil, silica colloidal anhydrous, magnesium stearate

Coating:iron oxide red (E 172), iron oxide yellow (E 172), and lactose monohydrate.

Nironovo SR, 4 mg and 8 mg, prolonged-release tablets:

Core:hypromellose, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated castor oil, silica colloidal anhydrous, magnesium stearate

Coating:iron oxide red (E 172), iron oxide yellow (E 172), lactose monohydrate, and iron oxide black (E 172).

What Nironovo SR looks like and contents of the pack

Nironovo SR, 2 mg, prolonged-release tablets are pink, mottled, oval, with the marking "2x" on one side. Nironovo SR, 4 mg, prolonged-release tablets are brown, mottled, oval, with the marking "4x" on one side. Nironovo SR, 8 mg, prolonged-release tablets are dark pink, mottled, oval, with the marking "8x" on one side. Nironovo SR, 2 mg, is available in packs of 21 or 28 prolonged-release tablets. Nironovo SR, 4 mg and 8 mg, are available in packs of 28 prolonged-release tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Tel: +48 22 732 77 00

Manufacturer

Actavis Ltd.

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Poland: Nironovo SR

Date of last revision of the leaflet:07.2023