APOROPIN 4 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. Table of Contents of the Leaflet:
2. What is ApoRopin and what is it used for
3. Important information before taking ApoRopin
   1. When not to take ApoRopin
   2. Warnings and precautions
   3. ApoRopin with food and drink
   4. Pregnancy and breast-feeding
   5. Driving and using machines
   6. 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. If you are switching from ropinirole immediate-release tablets
   5. If you take more ApoRopin than you should
   6. If you forget to take 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 the above behaviors, tell your doctor, who can discuss ways to alleviate the symptoms or cope with 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 authorization 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 of the side effects or any other side effects not mentioned in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is ApoRopin and what is it 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 is ApoRopin and what is it 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 naturally occurring 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

Tell your doctor if any of the above applies to you.

Warnings and precautions

Before taking ApoRopin, discuss with your doctor or pharmacist:

If you experience any of the following side effects after stopping or reducing the dose of ApoRopin, tell your doctor: depression, apathy, anxiety, lack of energy, 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 caregivers notice that you are developing unusual behaviors such as an excessive desire to gamble, increased libido, or uncontrolled spending. These behaviors are called impulse control disorders and can be treated. Tell your doctor if you, your family, or caregivers notice that you are experiencing episodes of excessive restlessness, excitement, or irritability. Your doctor may decide to adjust the dose or stop the treatment. Tell your doctor if any of the above applies to you. Your doctor may decide that ApoRopin is not suitable for you or may recommend additional monitoring while taking the medicine.

ApoRopin with food and drink

ApoRopin can be taken with or without food, according to your preference.

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. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

ApoRopin may cause drowsiness. Sudden sleepiness or sudden attacks of sleep without warning may occur. If you experience hallucinations, do not drive or operate machinery. If you experience any of the above, 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 symptoms 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. This may cause stomach upset or diarrhea. 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 in combination with another medicine called L-dopa (also known as levodopa). When starting ApoRopin, you may experience involuntary movements (dyskinesias). If you experience these symptoms, tell your doctor, who may adjust the doses of your medicines. ApoRopin prolonged-release tablets are designed to release the active substance over a period of more than 24 hours. If the medicine passes through your body too quickly (e.g., during diarrhea), the tablets may not dissolve completely and may not work as well as they should. You may see the tablets in your stool. If this happens, 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 side effects that are difficult to tolerate at the start of treatment, tell your doctor. Your doctor may recommend switching to a lower dose of ropinirole in the form of immediate-release tablets, which you would take three times a day. Do not take more ApoRopin than your doctor has recommended. 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 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 due to the rapid release of the active substance.

If you are switching from ropinirole immediate-release tablets

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

If you take more ApoRopin than you should

Contact your doctor or pharmacist immediately. If possible, show them the pack of ApoRopin. If you take more ApoRopin than you should, you may experience: nausea, vomiting, dizziness, drowsiness, mental fatigue, or fainting.

If you forget to take ApoRopin

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose of ApoRopin for one day or longer, consult your doctor for advice on restarting treatment.

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 it 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 a serious syndrome called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (loss of movement), muscle stiffness, fever, unstable blood pressure, rapid heartbeat, confusion, and reduced consciousness (e.g., coma). If your doctor decides to stop your treatment with ApoRopin, they will gradually reduce your dose. If you have any further questions on the use of this product, 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 improve after a few weeks 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.

Common:

May affect up to 1 in 10 people taking ApoRopin:

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

Uncommon:

May affect up to 1 in 100 people taking ApoRopin:

• dizziness or fainting, especially when standing up (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 hiveson the skin (urticaria), 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 behavior;
• overuse of ApoRopin (a need to take higher doses of dopaminergic medicines than required to control motor symptoms, called dopamine dysregulation syndrome);
• inability to resist the impulse, drive, or temptation to perform certain activities that could be harmful to you or others, which may include:
• a strong desire to gamble, despite significant personal or family consequences;
• changes in or increased interest in sex, and behaviors that are disturbing to you or others, such as increased libido;
• uncontrolled, excessive shopping or spending;
• overeating (eating large amounts of food in a short time) or compulsive eating (eating more food 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, lack of energy, sweating, or pain (called dopamine agonist withdrawal syndrome or DAWS).

If you experience any of the above behaviors, tell your doctor, who can discuss ways to alleviate the symptoms or cope with 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. When starting 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, including any not listed in this leaflet, 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 Medicines Adverse Reaction Monitoring Department, 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. You can also report side effects to the marketing authorization holder.

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 which is stated on the packaging 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 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, silica colloidal anhydrous, magnesium stearate; coloring 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 authorization holder and manufacturer

Marketing authorization 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