Aporopin

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
Please read all of this leaflet carefully before 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, please 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 any side effects worsen or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What ApoRopin is and what it is used for
2. What you need to know 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 in ApoRopin is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act in the brain in a similar way to the naturally occurring substance called dopamine.
ApoRopin, prolonged-release tablets, are 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 like naturally occurring dopamine in the brain and thus helps to relieve the symptoms of Parkinson's disease.

2. Important information before using ApoRopin

When not to take ApoRopin

• if the patient is allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe kidney disease;
• if the patient has liver disease.

You should inform your doctor if any of the above situations apply to the patient.

Warnings and precautions

Before starting treatment with ApoRopin, discuss the following with your doctor or pharmacist:

• if the patient is pregnant or suspects she may be pregnant;
• if the patient is breastfeeding;
• if the patient is under 18 years of age;
• if the patient has severe heart disease;
• if the patient has severe psychiatric disorders;
• if the patient has particular tendencies and/or behaviours (see section 4);
• if the patient has intolerance to certain sugars (such as lactose).

If the patient experiences symptoms such as depression, apathy, anxiety, lack of energy, sweating or pain after stopping or reducing the dose of ApoRopin (known as dopamine agonist withdrawal syndrome – DAWS), you should inform the doctor. If symptoms persist for longer than a few weeks, the doctor may decide to modify the dose.

Inform the doctor if the patient, their family or caregivers notice unusual, compulsive or uncontrolled behaviours in the patient, or if the patient is unable to resist an impulse, urge or compulsion to perform certain actions that could harm themselves or others. These behaviours are known as impulse control disorders and may include gambling addiction, binge eating or compulsive spending, increased sexual drive or heightened interest in sex, including more frequent thoughts and feelings related to sex. The doctor may decide to change the dose or discontinue the medicine.

Inform the doctor if the patient, their family or caregivers observe episodes of excessive physical activity, excitement or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). The doctor may decide to change the dose or discontinue the medicine.

Inform the doctor if any of the above situations apply to the patient. The doctor may decide that ApoRopin is not suitable for the patient or may recommend additional monitoring during treatment.

While taking ApoRopin

Inform the doctor if the patient or their family observe any unusual behaviours (such as uncontrollable gambling tendencies or excessive sexual drive and/or sexual behaviours) during treatment with ApoRopin. The doctor may decide to change the dose or discontinue the medicine.

Smoking and ApoRopin

Inform the doctor if the patient starts or stops smoking while taking ApoRopin. The doctor may need to adjust the dose.

ApoRopin and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal and over-the-counter medicines, as well as any medicines the patient plans to take. Also remember to inform the doctor or pharmacist if the patient starts taking any new medicine during treatment with ApoRopin.

Some medicines may affect the action of ApoRopin or increase the risk of side effects. ApoRopin may also affect the action of other medicines. This includes:

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

Inform the doctor if the patient is taking or has recently taken any of these medicines.

Additional blood tests are required if the patient is taking the following medicines together with ApoRopin:

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

ApoRopin with food and drink

ApoRopin may be taken with or without food, depending on patient preference.

Pregnancy and breastfeeding

ApoRopin is not recommended during pregnancy unless the doctor decides that the benefits of treatment outweigh the risks to the unborn child.

ApoRopin is not recommended during breastfeeding, as it may affect milk production in the patient.

Immediately inform the doctor if the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child. The patient should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

ApoRopin may cause drowsiness. Sudden and irresistible sleepiness may occur, sometimes accompanied by sudden, unexpected episodes of falling asleep without prior warning.

Hallucinations (seeing, hearing or sensing things that are not actually present) may occur during treatment with ApoRopin. If the patient experiences hallucinations, they should not drive or operate machinery.

If any of the above apply to the patient: do not drive, operate machinery or perform any activity where drowsiness or falling asleep could put the patient (or others) at risk of serious injury or death. Do not perform such activities until symptoms have resolved.

Talk to your doctor if this situation causes difficulties for the patient.

ApoRopin contains lactose and castor oil

ApoRopin prolonged-release tablets contain lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

ApoRopin contains castor oil. This medicine may cause indigestion and diarrhoea.

The medicine contains less than 1 mmol (23 mg) of sodium per 2 mg, 4 mg and 8 mg dose, meaning the medicine is considered "sodium-free".

3. How to use ApoRopin

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Use in children and adolescents
ApoRopin should not be given to children. ApoRopin is generally not prescribed to
patients under 18 years of age.
ApoRopin may be used as a single treatment for symptoms of Parkinson's disease. It may also be
used in combination with another medicine called L-dopa (also known as levodopa). When
a patient is taking L-dopa, involuntary movements (dyskinesia) may occur upon starting
ApoRopin. If such symptoms occur, inform the doctor, who may adjust the doses of the
medicines the patient is taking.
ApoRopin tablets are designed to release the medicine gradually over a period of more than 24
hours. If, due to the patient's condition (e.g. during diarrhoea), the medicine passes through the body
too quickly, the tablets may not dissolve completely and may not work as intended. The tablets may
be visible in the stool. In such a case, contact a doctor as soon as possible.
What doses of ApoRopin should be used
Determining the appropriate dose of ApoRopin for a patient may take time.
The recommended starting dose of ApoRopin prolonged-release tablets is 2 mg once daily for the
first week. The doctor may increase the dose of ApoRopin prolonged-release tablets to 4 mg once
daily from the second week of treatment. If the patient is elderly, the doctor may increase the dose
more slowly. The doctor may then adjust the dose until the optimal dose for the patient is reached.
Some patients may take up to 24 mg of ApoRopin prolonged-release tablets per day.
If the patient experiences intolerable side effects at the beginning of treatment, inform the doctor.
The doctor may recommend switching to lower doses of ropinirole in coated tablets (immediate-release), to be taken three times daily.
Do not take more ApoRopin than prescribed by the doctor.
It may take several weeks before the beneficial effect of ApoRopin becomes apparent.
Method of administration
ApoRopin should be taken once daily, at the same time each day.
The prolonged-release ApoRopin tablet(s) should be swallowed whole with a glass of water.
Do not break, chew or crush the prolonged-release tablets. Doing so may lead to a risk of
overdose due to too rapid release of the medicine in the body.
Switching treatment in patients previously taking ropinirole coated tablets
(immediate-release)
The doctor will determine the dose of ApoRopin prolonged-release tablets based on the previous
dose of immediate-release ropinirole tablets.
Take the previously prescribed dose of immediate-release ropinirole tablets on the day before
switching treatment. The next morning, take ApoRopin prolonged-release tablets and do not take
any further immediate-release ropinirole tablets.
Taking more ApoRopin than prescribed
Seek immediate advice from a doctor or pharmacist. If possible, show the ApoRopin packaging.
In patients who take more than the prescribed dose of ApoRopin, symptoms such as nausea,
vomiting, dizziness (spinning sensation), drowsiness, mental or physical fatigue, fainting, or
hallucinations may occur.
Missing a dose of ApoRopin
Do not take a double dose or extra prolonged-release tablets to make up for a missed dose.
If a dose of ApoRopin is missed for one day or longer, consult a doctor regarding resuming
treatment with ApoRopin.
Stopping ApoRopin treatment
Do not stop taking ApoRopin unless instructed by a doctor.
ApoRopin should be taken for as long as prescribed by the doctor. Do not stop taking it unless
instructed by a doctor.
If ApoRopin is stopped suddenly, symptoms of Parkinson's disease may worsen rapidly. Abrupt
discontinuation may lead to a condition known as neuroleptic malignant syndrome, which may be
a serious health risk. Symptoms include: akinesia (loss of muscle movement), muscle rigidity,
fever, unstable blood pressure, tachycardia (rapid heartbeat), confusion, and reduced level of
consciousness (e.g. coma).
If it becomes necessary to discontinue ApoRopin, the doctor will gradually reduce the dose.
If there are any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are more likely after first-time use of ApoRopin or following an increase in dose. They are usually mild and tend to become less troublesome after a short period of treatment. If a patient is concerned about adverse reactions, they should speak with their doctor.

Very common:
May affect more than 1 in 10 people taking ApoRopin:

• fainting;
• feeling sleepy;
• nausea.

Common:
May affect up to 1 in 10 people taking ApoRopin:

• sudden sleep attacks (falling asleep suddenly without prior warning signs of sleepiness);
• hallucinations (seeing things that are not really there);
• vomiting;
• dizziness (sensation of spinning);
• heartburn;
• abdominal 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 suddenly changing to an upright position (caused by a drop in blood pressure);
• low blood pressure (hypotension);
• excessive daytime sleepiness (irresistible drowsiness);
• psychiatric disturbances such as delirium (severe disorientation), delusions (irrational thoughts), or paranoia (unfounded suspicion).

In some patients, the following adverse reactions may occur (frequency cannot be determined
from available data):

• allergic reactions such as red, itchy swellings on the skin (urticaria), swelling of the face, lips, throat, or tongue, which may cause difficulty in swallowing or breathing, rash and itching (see section 2);
• changes in liver function observed in blood tests;
• aggressive behaviour;
• misuse of ApoRopin (need to take high doses of dopaminergic drugs, higher than required to control motor symptoms, known as dopamine dysregulation syndrome);
• inability to resist the impulse, urge, or temptation to carry out certain activities that may harm the patient or others, including:
• compulsive gambling, despite significant personal or family consequences;
• change or increase in sexual interest, and behaviour that is particularly troubling to the patient or others, such as increased libido;
• uncontrolled, excessive shopping or spending;
• binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than needed to satisfy hunger).
• episodes of excessive motor activity, excitement, and irritability;
• after stopping or reducing the dose of the medicine: depression, apathy, anxiety, lack of energy, sweating, or pain (referred to as dopamine agonist withdrawal syndrome or DAWS).

If any of the above behaviours occur, inform the doctor so that possible ways of alleviating or managing the symptoms can be discussed.
Taking ApoRopin with levodopa
In patients taking ApoRopin together with levodopa, other adverse reactions may occur after some time:

• involuntary movements (dyskinesias) – very common. When a patient is taking levodopa, involuntary movements may occur when starting ApoRopin treatment. If these symptoms (dyskinesias) occur, the doctor should be informed, as they may adjust the doses of medicines being taken;
• feeling of disorientation – common.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ApoRopin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. 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. 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).
• Other ingredients are: hypromellose, sodium croscarmellose, maltodextrin, lactose monohydrate, hydrogenated castor oil, colloidal anhydrous silica, 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, mottled, oval tablets, embossed with the mark "2x" on one side.
ApoRopin 4 mg prolonged-release tablets:
Brown, mottled, oval tablets, embossed with the mark "4x" on one side.
ApoRopin 8 mg prolonged-release tablets:
Dark pink, mottled, oval tablets, embossed with the mark "8x" on one side.
Pack sizes:
ApoRopin prolonged-release tablets are available in blister packs containing:
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.
Sokratesa 13D lok. 27
01-909 Warsaw
Poland
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta