APOROPIN 2 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet:
2. What ApoRopin is and what it is used for
3. Important information before taking ApoRopin
   1. When not to take ApoRopin
   2. Warnings and precautions
   3. ApoRopin with other medicines
   4. ApoRopin with food and drink
   5. Pregnancy and breast-feeding
   6. Driving and using machines
   7. ApoRopin contains lactose and hydrogenated castor oil
4. How to take ApoRopin
   1. Use in children and adolescents
   2. What dose of ApoRopin to take
   3. How to take ApoRopin
   4. Switching from ropinirole immediate-release tablets to ApoRopin prolonged-release tablets
   5. Taking too much ApoRopin
   6. Missing a dose of ApoRopin
   7. Stopping treatment with ApoRopin
5. Possible side effects
   1. Very common:
   2. Common:
   3. Uncommon:
   4. Some patients may experience the following side effects (frequency cannot be estimated from the available data):
   5. If you experience any of these behaviours, tell your doctor, so that you can discuss possible ways to alleviate the symptoms or manage them.
   6. Taking ApoRopin with levodopa
6. How to store ApoRopin
7. Contents of the pack and other information
   1. What ApoRopin contains
   2. What ApoRopin looks like and contents of the pack
   3. Marketing authorisation holder and manufacturer
   4. Aurovitas Pharma Polska Sp. z o.o.

Package Leaflet: Information for the User

ApoRopin, 2 mg, prolonged-release tablets
ApoRopin, 4 mg, prolonged-release tablets
ApoRopin, 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, or if any side effects get worse, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

• 1. What ApoRopin is and what it is used for
• 2. Important information before taking ApoRopin
• 3. How to take ApoRopin
• 4. Possible side effects
• 5. How to store ApoRopin
• 6. Contents of the pack and other information

1. What ApoRopin is and what it is used for

The active substance of ApoRopin 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. ApoRopin, prolonged-release tablets, are 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, helping to alleviate the symptoms of Parkinson's disease.

2. Important information before taking ApoRopin

When not to take ApoRopin

• 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 ApoRopin, discuss 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 serious mental health problems;
• if you have a history of or experience impulsive behaviours (see section 4);
• if you have intolerance to some sugars (such as lactose).

If you experience any of the following side effects after stopping or reducing the dose of ApoRopin, 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 ApoRopin. Tell your doctor if you, your family, or your caregiver notice that you are developing unusual behaviours (such as an excessive desire to gamble or increased libido) while taking ApoRopin. Your doctor may decide to adjust the dose or stop the treatment. Smoking and taking ApoRopin Tell your doctor if you start or stop smoking while taking ApoRopin. Your doctor may need to adjust the dose.

ApoRopin with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription, herbal products, and other medicines available without a prescription. Also, tell your doctor or pharmacist if you start taking any new medicine while taking ApoRopin. Some medicines may affect the action of ApoRopin, or ApoRopin may affect the action of other medicines. This includes:

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

Tell your doctor if you are taking, or have recently taken, any of these medicines. Additional blood tests may be neededif you are taking the following medicines with ApoRopin:

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

ApoRopin with food and drink

ApoRopin can be taken with or without food, as preferred.

Pregnancy and breast-feeding

ApoRopin should not be used during pregnancy unless your doctor considers it essential. ApoRopin should not be used during breast-feeding, as it may affect milk production. Tell your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant. Before taking this medicine, consult your doctor or pharmacist.

Driving and using machines

ApoRopin may cause drowsiness. Sudden, uncontrollable sleepiness, or sudden sleep attacks, may occur. If you experience hallucinations (seeing, hearing, or feeling things that are not there), do not drive or operate machinery. If you experience any of these effects, do not drive, operate machinery, or perform tasks that may put you (or others) at risk of serious injury or death. Do not perform such tasks until the effects have resolved. Talk to your doctor if this is a problem for you.

ApoRopin contains lactose and hydrogenated castor oil

ApoRopin, prolonged-release tablets, contain lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. ApoRopin contains hydrogenated castor oil. The medicine may cause stomach upset and diarrhoea. The medicine contains less than 1 mmol (23 mg) of sodium per 2 mg, 4 mg, and 8 mg dose, which is essentially 'sodium-free'.

3. How to take ApoRopin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Use in children and adolescents

ApoRopin should not be given to children. ApoRopin is not usually prescribed for patients under 18 years old. ApoRopin can be used alone to treat the symptoms of Parkinson's disease. It can also be used with another medicine called L-dopa (also known as levodopa). If you are taking L-dopa, when you start taking ApoRopin, you may experience involuntary movements (dyskinesias). If you experience these symptoms, tell your doctor, who may adjust the doses of your medicines. ApoRopin tablets are designed to release the active substance slowly over a period of more than 24 hours. If, due to your condition (e.g., during diarrhoea), the medicine passes through your body too quickly, the tablets may not dissolve completely and may not work properly. You may see the tablets in your stool. In this case, contact your doctor as soon as possible.

What dose of ApoRopin to take

It may take some time to find the dose of ApoRopin that is right for you. The recommended starting dose of ApoRopin prolonged-release tablets is 2 mg once daily for the first week. Your doctor may increase the dose of ApoRopin prolonged-release tablets 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 ApoRopin prolonged-release tablets once daily. If you experience unpleasant side effects at the start of treatment, tell your doctor. Your doctor may prescribe a lower dose of ropinirole in the form of immediate-release tablets, which you will take three times a day. Do not take more ApoRopin than your doctor has prescribed. It may take several weeks for ApoRopin to start working.

How to take ApoRopin

Take ApoRopin once daily, at the same time each day. Swallow the ApoRopin 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 may be released into your body too quickly.

Switching from ropinirole immediate-release tablets to ApoRopin prolonged-release tablets

Your doctor will decide the dose of ApoRopin prolonged-release tablets based on the dose of ropinirole immediate-release tablets you were taking. Take the same dose of ropinirole immediate-release tablets on the day before you switch to ApoRopin prolonged-release tablets. The next morning, take ApoRopin prolonged-release tablets and do not take any more ropinirole immediate-release tablets.

Taking too much ApoRopin

See a doctor or pharmacist immediately. If possible, show them the ApoRopin pack. If you have taken too much ApoRopin, you may experience: nausea (feeling sick), vomiting, dizziness (spinning sensation), drowsiness, mental fatigue or physical fatigue, fainting, or hallucinations.

Missing a dose of ApoRopin

Do not take extra tablets or a double dose to make up for a missed dose. If you have missed a dose of ApoRopin for a day or more, consult your doctor for advice on restarting ApoRopin.

Stopping treatment with ApoRopin

Do not stop taking ApoRopin without consulting your doctor. ApoRopin should be taken for as long as your doctor recommends. Do not stop taking ApoRopin unless your doctor tells you to. If you suddenly stop taking ApoRopin, your Parkinson's symptoms may quickly get much worse. Stopping treatment suddenly can also cause serious side effects, such as: stiffness, tremors, fever, changes in blood pressure, rapid heart rate, confusion, decreased consciousness (e.g., coma). If your doctor decides to stop your treatment with ApoRopin, they will gradually reduce the 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, ApoRopin can cause side effects, although not everybody gets them. Side effects are more likely to happen when you first start taking ApoRopin or when your dose is increased. They are usually mild and may disappear within a few days of treatment. If you are concerned about side effects, talk to your doctor.

Very common:

May affect more than 1 in 10 people taking ApoRopin:

• fainting;
• drowsiness;
• nausea (feeling sick).

Common:

May affect up to 1 in 10 people taking ApoRopin:

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

Uncommon:

May affect up to 1 in 100 people taking ApoRopin:

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

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

• allergic reactions, such as red, itchy swellingof the skin (hives), swelling of the face, lips, throat, or tongue, which may cause difficulty swallowing or breathing, rash, and itching (see section 2);
• changes in liver function, which have been seen in blood tests;
• aggressive behaviour;
• abuse of ApoRopin (a need to take more than the prescribed dose, known as dopamine dysregulation syndrome);
• inability to resist the impulse, drive, or temptation to perform an action that could be harmful to you or others, which may include:
• a strong desire to gamble, despite significant personal or family problems;
• altered or increased interest in sex, and unusual or disturbing behaviour, such as an increased libido;
• uncontrolled, excessive shopping or spending;
• binge eating (eating large amounts of food in a short time) or compulsive eating (eating more than needed to satisfy hunger).
• episodes of excessive restlessness, excitement, or irritability;
• after stopping or reducing the dose of ApoRopin, the following may occur: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS).

If you experience any of these behaviours, tell your doctor, so that you can discuss possible ways to alleviate the symptoms or manage them.

Taking ApoRopin with levodopa

In patients taking ApoRopin with levodopa, the following side effects may occur after some time:

• involuntary movements (dyskinesias) are very common. If you are taking levodopa, when you start taking ApoRopin, you may experience involuntary movements. If you experience these symptoms, tell your doctor, who may adjust the doses of your medicines;
• disorientation is common.

If you experience any side effects, or any not listed in this leaflet, tell your doctor or pharmacist. Reporting of side effects
If you experience any side effects, or any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ApoRopin

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date (EXP) stated on the pack. 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. This will help protect the environment.

6. Contents of the pack and other information

What ApoRopin 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: hypromellose, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated castor oil, colloidal silicon dioxide, magnesium stearate; colouring mixture: [2 mg, prolonged-release tablets]iron oxide red (E 172), iron oxide yellow (E 172), lactose monohydrate; [4 mg and 8 mg, prolonged-release tablets]iron oxide red (E 172), iron oxide yellow (E 172), lactose monohydrate, iron oxide black (E 172).

What ApoRopin looks like and contents of the pack

ApoRopin, 2 mg, prolonged-release tablets:
Pink, speckled, oval tablets, with "2x" engraved on one side.
ApoRopin, 4 mg, prolonged-release tablets:
Brown, speckled, oval tablets, with "4x" engraved on one side.
ApoRopin, 8 mg, prolonged-release tablets:
Dark pink, speckled, oval tablets, with "8x" engraved on one side.
Pack sizes:
ApoRopin, prolonged-release tablets, are available in blister packs of:
28, 30, 42, 56, 84, and 90 prolonged-release tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Date of last revision of the leaflet:15.12.2022