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 Nironovo SR is and what it is used for

• 2. 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 Nironovo SR is and what it is 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, certain parts of the brain become less active and there is a decrease in the amount of dopamine. Ropinirole works by acting in place of dopamine to help control the symptoms of Parkinson's disease.

2. 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, tell your doctor if:

• you are pregnant or think you may be pregnant;
• you are breast-feeding;
• you are under 18 years old;
• you have severe heart disease;
• you have severe mental health problems;
• you have had any unusual urges or habits in the past (see section 4);
• you have intolerance to some sugars (e.g. lactose).

If you stop taking Nironovo SR or reduce the dose, you may experience withdrawal symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain (called dopamine agonist withdrawal syndrome or DAWS). If these symptoms continue 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 urges or habits, such as excessive gambling, increased sex drive, or compulsive eating or shopping. Your doctor may need to adjust your dose or advise you to stop taking Nironovo SR.

While taking Nironovo SR

Tell your doctor if you or your family/carer notice that you are developing unusual urges or habits (such as excessive gambling or increased sex drive) while taking Nironovo SR. Your doctor may need 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 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 such as 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 Nironovo SR with any of the following medicines, you may need to have regular blood tests:

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

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 unborn baby.
Nironovo SR should not be used during breast-feeding as it may affect milk production.
Tell your doctor if you are pregnant or think you may be pregnant or are planning to become pregnant.Your doctor will discuss with you whether you should continue to take Nironovo SR.
Tell your doctor if you are breast-feeding or planning to breast-feed. Your doctor will discuss with you whether you should continue to take Nironovo SR.

Driving and using machines

Nironovo SR may cause drowsiness. Sudden onset of sleepis a rare side effect of Nironovo SR. This can happen at any time during treatment.
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 doing anything where you might put yourself or others at risk of serious harm or death if you are affected by drowsiness or sudden sleepiness.
Do not drive or operate machinery until these effects have stopped.
If you are unsure, talk to 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 uncontrollable movements (dyskinesia) when you first start taking Nironovo SR. If these occur, tell your doctor, who may adjust the dose of your medicines.
The tablets are designed to release the active substance slowly over 24 hours. If you have problems that affect the movement of food through your digestive system, such as diarrhoea, the tablet may not move through your digestive system at the correct speed and you may not get the right dose of medicine. The tablet may also be broken down too quickly in the body, which can cause side effects. If this happens, you should contact your doctor.

What dose of Nironovo SR to take

It may take a few weeks to find the best dose of Nironovo SR 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 are taking the dose that is best for you. Some people take up to 24 mg of Nironovo SR once daily.
If you experience any 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 recommended.

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, you may be at risk of overdose, because the medicine may be released into your body too quickly.

Switching from ropinirol immediate-release tablets

Your doctor will tell you how to take Nironovo SR if you are already taking ropinirole immediate-release tablets.
Take your last dose of ropinirole immediate-release tablets the day before you start taking Nironovo SR. The next morning, take your dose of Nironovo SR 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 packet.
If you take more Nironovo SR than you should, you may experience nausea, vomiting, dizziness, drowsiness, confusion, hallucinations, or convulsions.

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.

Stopping treatment with Nironovo SR

Do not stop taking Nironovo SR without advice

Take Nironovo SR for as long as your doctor recommends. 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 medical condition called neuroleptic malignant syndrome which may be life-threatening. The symptoms include:
akinesia (loss of movement), rigidity, high temperature, unstable blood pressure, fast heart rate, confusion, decreased consciousness (e.g. coma).
If your doctor decides to stop your treatment with Nironovo SR, they will normally reduce the dose gradually.

4. Possible side effects

Like all medicines, Nironovo SR 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 of the following side effects, tell your doctor as soon as possible:

• very common (may affect more than 1 in 10 people):
• orthostatic hypotension (low blood pressure when standing up);
• drowsiness;
• nausea;

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

• sudden sleepiness;
• hallucinations;
• vomiting;
• dizziness;
• heartburn;
• abdominal pain;
• constipation;
• swelling of the legs, feet, or hands.

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

• low blood pressure when standing up, which can cause dizziness or fainting;
• excessive drowsiness during the day;
• mental health problems, such as confusion, delusions, or paranoia;
• hiccups.

Some side effects are rare (may affect up to 1 in 1,000 people)

• allergic reactions such as rash, itching, or hives;
• changes in liver function, which have been identified by blood tests;
• aggressive behaviour;
• dependence on Nironovo SR (craving for large doses of dopaminergic medicines, more than needed for control of movement, known as dopamine dysregulation syndrome);
• impulse control disorders, such as compulsions, obsessive thoughts, or addictive behaviours (e.g. excessive gambling, hypersexuality, binge eating, or compulsive shopping);

After stopping or reducing the dose of Nironovo SR, the following side effects can 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

Taking Nironovo SR with L-dopa

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

• uncontrollable movements (dyskinesia) are very common. If you are taking L-dopa, you may experience uncontrollable movements when you first start taking Nironovo SR. If these occur, tell your doctor, who may adjust the dose of your medicines;
• disorientation (common).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet

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 website. 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.
Store in a dry place. 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, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated vegetable oil, silica colloidal anhydrous, 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, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated vegetable oil, silica colloidal anhydrous, 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