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 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 information1.
What is Nironovo SR and what is it used for

• 2. Important information before you take 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 deficiency of dopamine in some parts of the brain. Ropinirole works in a similar way to dopamine in the brain, helping to alleviate the symptoms of Parkinson's disease.

2. Important information before you take 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 apply to you.

Warnings and precautions

Before taking Nironovo SR, discuss the following with your doctor or pharmacist:

• if you are pregnant or think you might 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 unusual impulses or behaviours (see section 4);
• if you have intolerance to some sugars (e.g. lactose).

If you experience any of the following side effects 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 your dose.
Tell your doctor if you or your family/carer notice that you are developing unusual behaviours (such as an unusual urge to gamble, increased sexual urges, or uncontrolled spending). These behaviours are called impulse control disorders.
If you notice any of these behaviours, you should tell your doctor.
Your doctor may decide to adjust your dose or stop your treatment with Nironovo SR.

While taking Nironovo SR

Tell your doctor if you or your family/carer notice any unusual behaviours (such as an unusual urge to gamble, increased sexual urges, or uncontrolled spending) while you are taking Nironovo SR. Your doctor may decide to adjust your dose.

Smoking and Nironovo SR

Tell your doctor if you start or stop smoking while taking Nironovo SR. Your doctor may need to adjust your dose.

Nironovo SR and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may affect the way Nironovo SR works, or may increase the risk of side effects. Nironovo SR may also affect the way some other medicines work.
These include:

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

Tell your doctor if you are taking any of these medicines.
If you are taking any of these medicines, your doctor may need to carry out blood tests to check how well your liver is working.

Nironovo SR with food and drink

Nironovo SR can be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning 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 advises that the potential benefit for you outweighs the potential risk to your baby.
Nironovo SR should not be used during breast-feeding as it may affect milk production.
Tell your doctor if you become pregnant or suspect you are pregnant while taking Nironovo SR.Your doctor will need to advise whether you should continue to take Nironovo SR.
Your doctor will also need to advise if you are breast-feeding or planning to breast-feed.

Driving and using machines

Nironovo SR may cause drowsiness. Sudden sleep onset or somnolencemay occur.
During treatment with ropinirole, hallucinations (seeing, hearing, or feeling things that are not there) may occur. If you experience hallucinations, do not drive or operate machinery.
If you experience any of these effects, do not drive or operate machinery. Avoid situations where drowsiness or falling asleep could put you or others at risk of serious harm or death. Do not engage in these activities until these effects have stopped.
If you are unsure, consult your doctor.

Nironovo SR contains lactose

Nironovo SR contains a sugar called 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.

Nironovo SR contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially 'sodium-free'.

3. How to take Nironovo SR

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 alone 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 effects, tell your doctor, who may need to adjust your dose of other medicines you are taking.
The tablets are designed to release the active substance slowly over 24 hours. If you have problems with your digestive system that may affect the way your body absorbs the medicine, such as diarrhoea, the tablet may not release the medicine properly. The tablet may be broken down too quickly in the body, which may lead to increased side effects. The tablet may also be excreted in the stool. If this happens, tell your doctor.

What dose of Nironovo SR to take

It may take some time to find the dose of Nironovo SR that is right for you.
The recommended starting dose of Nironovo SR is 2 mg once daily for the first week.Your doctor may increase your dose of Nironovo SR to 4 mg once daily from the second week of treatment onwards. If you are elderly, your doctor may increase your dose more slowly.
Your doctor will then adjust your dose until you reach the dose that is best for you. Some people take up to 24 mg of Nironovo SR once daily.
If you experience unpleasant side effects at the start of treatment, tell your doctor. Your doctor may reduce the dose of ropinirole you are taking.

Do not take more Nironovo SR than your doctor has prescribed

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

How to take Nironovo SR

Take Nironovo SR once daily, at the same time each day.
Swallow the tablet(s) whole with a glass of water.
Do not break, chew, or crush the tablet(s). If you do, there is a risk of increased side effects due to the rapid release of the active substance.

If you are switching from ropinirol immediate-release tablets

Your doctor will calculate your dose of Nironovo SR based on your previous dose of ropinirole immediate-release tablets.
Take your last dose of ropinirole immediate-release tablets on the day before you start taking Nironovo SR. Take your first dose of Nironovo SR the following morning and do not take any more ropinirole immediate-release tablets.

If you take more Nironovo SR than you should

See a doctor or pharmacist immediately. If possible, show them the Nironovo SR pack.
A person who has taken too much Nironovo SR may experience nausea, vomiting, dizziness, drowsiness, mental fatigue, fainting, or hallucinations.

If you forget to take Nironovo SR

Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose of Nironovo SR for one day or more, ask your doctor for advice on how to start taking it again.

If you stop taking Nironovo SR

Do not stop taking Nironovo SR without consulting your doctor.

Nironovo SR should be continued as long as your doctor has advised.Do not stop taking Nironovo SR without first talking to your doctor. If you suddenly stop taking Nironovo SR, your Parkinson's symptoms may quickly get much worse.
Sudden stopping of Nironovo SR can lead to a neurological condition called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (loss of movement), muscle stiffness, fever, unstable blood pressure, rapid heart rate, confusion, decreased consciousness (e.g. coma).
If you need to stop taking Nironovo SR, your doctor will gradually reduce your dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects of Nironovo SR are mild and may become less troublesome after a few days' treatment. If you experience any side effects, talk to your doctor or pharmacist.

Very common (may affect more than 1 in 10 people):

• fainting;
• drowsiness;
• nausea.

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

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

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

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

Not known (frequency cannot be estimated from the available data)

• allergic reactions, such as itchy skin rash, swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing, rash, and itching;
• changes in liver function, which have been shown in blood tests;
• aggressive behaviour;
• overdose of Nironovo SR (a desire to take large doses of dopaminergic medicines, larger than those required to control movement, known as dopamine dysregulation syndrome);
• impulse control disorders, such as:

strong impulse to gamble, despite severe personal or family consequences;
altered or increased sexual interest or behaviour, of significant concern to the patient or others;
uncontrollable and excessive shopping 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).

• after stopping or reducing the dose of Nironovo SR, the following effects may occur: depression, apathy, anxiety, fatigue, sweating, or pain (dopamine agonist withdrawal syndrome or DAWS);
• spontaneous erections.

Tell your doctor if you experience any of these behaviours, so that your doctor can discuss ways of managing or reducing the symptoms.

When taking Nironovo SR with L-dopa

When taking Nironovo SR with L-dopa, you may experience other side effects:

• 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 effects, tell your doctor, who may need to adjust your dose of other medicines you are taking;
• 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.
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 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, croscarmellose sodium, maltodextrin, lactose monohydrate, hydrogenated castor oil, colloidal anhydrous silica, magnesium stearate
Coating:red iron oxide (E 172), yellow iron oxide (E 172), and lactose monohydrate.
Nironovo SR, 4 mg and 8 mg, prolonged-release tablets:
Core:hypromellose, croscarmellose sodium, maltodextrin, lactose monohydrate, hydrogenated castor oil, colloidal anhydrous silica, magnesium stearate
Coating:red iron oxide (E 172), yellow iron oxide (E 172), lactose monohydrate, and black iron oxide (E 172).

What Nironovo SR looks like and contents of the pack

Nironovo SR, 2 mg, prolonged-release tablets are pink, mottled, oval, with "2x" engraved on one side.
Nironovo SR, 4 mg, prolonged-release tablets are brown, mottled, oval, with "4x" engraved on one side.
Nironovo SR, 8 mg, prolonged-release tablets are dark pink, mottled, oval, with "8x" engraved 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