Nironovo sr

Patient Information Leaflet

Nironovo SR, 2 mg, prolonged-release tablets
Nironovo SR, 4 mg, prolonged-release tablets
Nironovo SR, 8 mg, prolonged-release tablets
Ropinirole
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Nironovo SR is and what it is 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 Nironovo SR is and what it is used for
The active substance in Nironovo SR is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act in the brain similarly to a naturally occurring substance called dopamine.
Nironovo SR is used in the treatment of Parkinson's disease. In patients with Parkinson's disease, there is a low level of dopamine in certain parts of the brain. Ropinirole acts similarly to dopamine in the brain and thereby 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.

You should inform your doctor if any of these situations 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 breastfeeding;
• if you are under 18 years of age;
• if you have severe heart disease;
• if you have severe psychiatric disorders;
• if you have previously experienced particular urges and (or) behaviours (see section 4);
• if you have intolerance to certain sugars (e.g. lactose).

If you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of ropinirole [known as dopamine agonist withdrawal syndrome (DAWS)], you should inform your doctor. If symptoms persist for longer than a few weeks, your doctor may decide to modify the dose of the medicine.
You should inform your doctor if you or your family members notice unusual behaviours resulting from irresistible impulses, compulsions, or obsessive performance of certain activities that are harmful to you or others. These behaviours are known as impulse control disorders and may include gambling addiction, compulsive or binge eating, excessive sexual drive, or increased sexual thoughts and feelings. Your doctor may decide to modify the dose or discontinue the medicine.
If you think any of the above situations may apply to you, you should tell your doctor. Your doctor may decide that treatment with Nironovo SR is not suitable for you, or that you require additional monitoring during treatment.
During treatment with Nironovo SR
You should inform your doctor if you or your family members notice unusual behaviours (such as unusual compulsion to gamble or increased sexual urges and (or) behaviours) while taking Nironovo SR. Your doctor may decide to modify the dose of the medicine.
Smoking and Nironovo SR
You should inform your doctor if you start or stop smoking during treatment with Nironovo SR. Your doctor may decide to modify the dose of the medicine.
Nironovo SR and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as 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 include:

• the antidepressant fluvoxamine;
• medicines used for other psychiatric disorders, such as sulpiride;
• HRT (hormone replacement therapy);
• metoclopramide, a medicine used to treat nausea and heartburn;
• antibiotics: ciprofloxacin and enoxacin;
• any other medicines used for Parkinson's disease.

You should inform your doctor if you are taking or have recently taken any of these medicines.
If you are taking any of the following medicines together with Nironovo SR, additional blood tests may be required:

• vitamin K antagonists (medicines used to reduce blood clotting), e.g. warfarin.

Nironovo SR with food and drink
Nironovo SR may be taken with food or independently of meals, depending on need.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should consult your doctor or pharmacist before using this medicine.
Nironovo SR is not recommended during pregnancy, unless your doctor determines that the benefit to you outweighs the risk to the unborn child. Nironovo SR is not recommended during breastfeeding, as it may affect milk production.
You should inform your doctor immediately if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Your doctor will also advise you if you are breastfeeding or planning to breastfeed. Your doctor may recommend discontinuing Nironovo SR.
Driving and using machines
Nironovo SR may cause drowsiness. Sudden and uncontrollable drowsiness may occur, as well as sudden and unexpected sleep attacks, not preceded by sleepiness.
Hallucinations (seeing, hearing, or feeling things that are not actually present) may occur during treatment with ropinirole. If you experience hallucinations, you should not drive or operate machinery.
If you suspect such symptoms may occur, do not drive or operate any machinery. Avoid situations in which drowsiness or falling asleep could place you or others at risk of serious injury or death. Do not perform such activities until symptoms resolve.
If you have any doubts, you should discuss this with your doctor.
Nironovo SR contains lactose.
Nironovo SR contains a sugar called lactose. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
Nironovo SR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e. the medicine is considered "sodium-free".

3. How to take Nironovo SR
You must always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Nironovo SR should not be used in children. Nironovo SR is not intended for use in patients under 18 years of age.
Nironovo SR may be used in the treatment of symptoms of Parkinson's disease either as monotherapy or in combination with another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, involuntary movements (dyskinesias) may occur when starting treatment with Nironovo SR. If such symptoms occur, inform your doctor, who may decide to modify the dose of your medicines.
Nironovo SR tablets have been designed to release the medicine over 24 hours. If you have conditions causing the medicine to pass too quickly through the gastrointestinal tract, e.g. diarrhoea, the tablets may not dissolve completely and the medicine may not work properly. The tablet may also be excreted in the stool. In such a case, you should inform your doctor immediately.

What dose of Nironovo SR should be taken
Determining the appropriate dose of Nironovo SR for you may take time.
The recommended starting dose of Nironovo SR prolonged-release tablets is 2 mg once daily for the first week. Your doctor may increase the dose of Nironovo SR prolonged-release tablets to 4 mg once daily starting from the second week of treatment. If you are elderly, your doctor may increase the dose more slowly.
Your doctor may then adjust the dose until the optimal dose for you is reached. Some patients take up to 24 mg of Nironovo SR prolonged-release tablets per day.
If you experience side effects that are difficult to tolerate at the beginning of treatment, inform your doctor. Your doctor may recommend reducing the dose of immediate-release ropinirole tablets, which you would take three times daily.
Do not take a higher dose of Nironovo SR than prescribed by your doctor.
It may take several weeks before the beneficial effect of the medicine becomes apparent.

How to take Nironovo SR
Nironovo SR should be taken once daily, at the same time each day.
The prolonged-release tablet(s) of Nironovo SR should be swallowed whole with a glass of water.
Do not break, chew, or crush the prolonged-release tablet(s). Doing so may lead to overdose due to rapid release of the medicine into the body.

Switching treatment in patients previously taking ropinirole immediate-release tablets
Your doctor will determine the dose of Nironovo SR prolonged-release tablets based on your previous dose of immediate-release ropinirole tablets.
Take your usual dose of immediate-release ropinirole tablets on the day before switching treatment. The next morning, take Nironovo SR prolonged-release tablets and do not take any further immediate-release ropinirole tablets.

Taking more Nironovo SR than recommended
Contact your doctor or pharmacist immediately. If possible, show the medicine packaging.
Symptoms in a person who has taken an overdose of Nironovo SR may include: nausea, vomiting, dizziness, drowsiness, mental or physical fatigue, fainting, hallucinations.

If you miss a dose of Nironovo SR
Do not take a double dose to make up for a missed dose.
If you miss a dose of Nironovo SR for one day or longer, consult your doctor about resuming treatment.

Stopping Nironovo SR
Do not stop taking Nironovo SR unless instructed by your doctor.
Nironovo SR should be taken for as long as your doctor recommends. Do not stop unless your doctor advises it.
If Nironovo SR is stopped suddenly, symptoms of Parkinson's disease may worsen rapidly.
Sudden discontinuation may lead to a condition known as neuroleptic malignant syndrome, which may be life-threatening. Symptoms include: akinesia (loss of movement), muscle rigidity, fever, unstable blood pressure, tachycardia (rapid heartbeat), confusion, and reduced level of consciousness (e.g. coma).
If it is necessary to discontinue Nironovo SR, your doctor will gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions to Nironovo SR may occur most frequently when starting treatment
or shortly after increasing the dose. Adverse reactions are usually mild and become less
bothersome after a short period of treatment. If you have any concerns about adverse reactions,
consult your doctor.

Very common - may affect more than 1 in 10 people:

• fainting;
• feeling sleepy;
• nausea.

Common - may affect up to 1 in 100 people:

• sudden onset of sleep without prior warning signs (sudden sleep attacks);
• hallucinations (seeing things that do not really exist);
• vomiting;
• dizziness (spinning sensation);
• heartburn;
• abdominal pain;
• constipation;
• swelling of the legs, feet, or hands.

Uncommon - may affect up to 1 in 1,000 people:

• dizziness or fainting, especially upon sudden change to an upright position (related to low blood pressure);
• excessive daytime sleepiness (irresistible sleepiness);
• psychiatric disorders such as delirium (severe confusion), delusions (irrational thoughts), or paranoia (unfounded suspicion);
• hiccups.

The following adverse reactions may occur in some patients (frequency unknown:
cannot be estimated from 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 tests observed in blood examinations;

• aggressive behaviour;

• misuse of Nironovo SR (craving for taking high doses of dopaminergic medicines, higher than necessary for motor control, known as dopamine dysregulation syndrome);

• inability to resist impulses, urges, or compulsions to perform actions that may be harmful to the patient or others; these include:
  - strong impulse towards uncontrollable gambling despite serious personal or family consequences,
  - altered or increased sexual interests and behaviours of significance to the patient or others, e.g. increased libido,
  - compulsive, uncontrolled spending or shopping,
  - binge eating (consuming very large amounts of food in a short time)
  or compulsive eating (eating larger amounts of food than normal and more than needed to satisfy hunger).

• depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of Nironovo SR (referred to as dopamine agonist withdrawal syndrome or DAWS);

• spontaneous erection. You should inform your doctor if any of these behaviours occur so that ways of managing or reducing these symptoms can be discussed.

Taking Nironovo SR together with L-dopa
In patients taking Nironovo SR in combination with L-dopa, other adverse reactions may occur over time:

• involuntary movements (dyskinesias) are a very common adverse reaction. If the patient is taking L-dopa, involuntary movements (dyskinesias) may occur when starting treatment with Nironovo SR. If these symptoms occur, inform your doctor, who may adjust the doses of medicines being taken;
• feeling of disorientation (common adverse reaction).

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur,
inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the 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 stated on the carton and blister marked as: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging 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:
Tablet core: hypromellose, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated castor oil, colloidal anhydrous silica, 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:
Tablet core: hypromellose, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated castor oil, colloidal anhydrous silica, 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, marbled, oval-shaped, with "2x" engraved on one side.
Nironovo SR, 4 mg prolonged-release tablets are brown, marbled, oval-shaped, with "4x" engraved on one side.
Nironovo SR, 8 mg prolonged-release tablets are dark pink, marbled, oval-shaped, with "8x" engraved on one side.

Nironovo SR, 2 mg is available in packs containing 21 or 28 prolonged-release tablets.
Nironovo SR, 4 mg and 8 mg are available in packs containing 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 for sale in the European Economic Area countries under the following names:
Poland: Nironovo SR