Ropinirole sanexcel

Package leaflet: Information for the user

Ropinirole SaneXcel, 2 mg, prolonged-release tablets
Ropinirole SaneXcel, 4 mg, prolonged-release tablets
Ropinirole SaneXcel, 8 mg, prolonged-release tablets
Ropinirolum
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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Ropinirole SaneXcel is and what it is used for
2. What you need to know before taking Ropinirole SaneXcel
3. How to take Ropinirole SaneXcel
4. Possible side effects
5. How to store Ropinirole SaneXcel
6. Contents of the pack and other information

1. What Ropinirole SaneXcel is and what it is used for

The active substance in Ropinirole SaneXcel 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.
Ropinirole SaneXcel is used to treat Parkinson's disease.
In patients with Parkinson's disease, certain parts of the brain have low levels of dopamine. Ropinirole acts like naturally occurring dopamine in the brain and thus helps to relieve the symptoms of Parkinson's disease.

2. Important information before taking Ropinirole SaneXcel

When not to use Ropinirole SaneXcel:

• 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 ➔ Inform your doctor or nurse if any of the above situations apply to the patient.

Warnings and precautions
Before starting treatment with Ropinirole SaneXcel, 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 specific impulses and (or) behaviors (see section 4)
• if the patient has intolerance to certain sugars (such as lactose).

If the patient experiences symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of ropinirole (known as dopamine agonist withdrawal syndrome or DAWS), inform the doctor. If symptoms persist for more than a few weeks, the doctor may decide to change the treatment.
Inform the doctor if the patient, a family member, or caregiver notices the emergence of new impulses, urges, or behaviors previously not observed in the patient, and that the patient cannot resist the urge, drive, or temptation to carry out certain actions that could harm themselves or others. This condition is known as impulse control disorders and may include behaviors such as compulsive gambling, excessive eating or spending, increased sexual drive, or intensified sexual thoughts or feelings. The doctor may consider it necessary to adjust the dose or discontinue the medicine.
Inform the doctor if the patient, their family, or caregivers notice episodes of excessive motor 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 adjust the dose or discontinue the medicine.
➔ Inform your doctor or nurse if any of the above situations apply to the patient. The doctor or nurse may decide that Ropinirole SaneXcel is not suitable for the patient or may recommend additional monitoring tests during treatment.

While taking Ropinirole SaneXcel
Inform the doctor if the patient or their family observe any unusual behaviors (such as uncontrollable urge to gamble or excessive sexual drive and (or) sexual behaviors) while taking Ropinirole SaneXcel. The doctor may decide to adjust the dose or discontinue the medicine.

Smoking and Ropinirole SaneXcel
Inform your doctor or nurse if the patient starts or stops smoking while taking Ropinirole SaneXcel. The doctor or nurse may determine that a dose adjustment is necessary.

Ropinirole SaneXcel and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal medicines and other medicines available without a prescription.
Remember to inform your doctor or pharmacist if the patient starts taking a new medicine while using Ropinirole SaneXcel.
Some medicines may affect the action of Ropinirole SaneXcel or increase the risk of adverse effects. Ropinirole SaneXcel may also affect the action of other medicines.
These include:

• the antidepressant fluvoxamine
• medicines used for other psychiatric disorders, for example sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, a medicine used to treat nausea and heartburn
• the antibiotics ciprofloxacin or enoxacin
• any other medicines used in Parkinson’s disease. ➔ Inform your doctor or nurse if the patient is taking or has recently taken any of these medicines.

For patients taking Ropinirole SaneXcel with the following medicines, additional blood tests will be required:

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

Ropinirole SaneXcel with food and drink
Ropinirole SaneXcel may be taken with or without food, depending on the patient’s preference.

Pregnancy and breastfeeding
Ropinirole SaneXcel is not recommended during pregnancy, unless the doctor determines that the benefit to the patient outweighs the risk to the unborn child.
Ropinirole SaneXcel should not be used during breastfeeding, as it may affect milk production in the patient.
Inform your doctor immediately if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. The doctor will also provide advice if the patient is breastfeeding or plans to breastfeed. The doctor may recommend discontinuing Ropinirole SaneXcel.

Driving and operating machinery
Ropinirole SaneXcel may cause drowsiness. Sudden, uncontrollable sleepiness may occur, and sometimes sudden, unexpected sleep attacks without prior warning of drowsiness.
Hallucinations (seeing, hearing, or sensing things that are not actually present) may occur during treatment with ropinirole. If hallucinations occur, the patient should not drive or operate machinery.
If the above applies to the patient: do not drive, operate machinery, or perform any activity in which drowsiness or falling asleep could place the patient (or others) at risk of serious injury or death. Do not perform such activities until symptoms have resolved.
➔ Talk to your doctor or nurse if this situation is a concern for the patient.

Ropinirole SaneXcel 2 mg contains lactose
Ropinirole SaneXcel 2 mg
Ropinirole SaneXcel 2 mg contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Ropinirole SaneXcel 4 mg contains sunset yellow (E 110)
Ropinirole SaneXcel 4 mg
Ropinirole SaneXcel 4 mg contains a coloring agent called sunset yellow (E110), which may cause allergic reactions.

Ropinirole SaneXcel contains sodium (applies to all strengths)
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet; therefore, this medicine is considered "sodium-free".

3. How to take Ropinirole SaneXcel

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Do not give Ropinirole SaneXcel to children. ApoRopin is generally not prescribed for patients under 18 years of age.
Ropinirole SaneXcel may be used as the sole treatment for symptoms of Parkinson’s disease.
It may also be used 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 Ropinirole SaneXcel.
If such symptoms occur, inform your doctor, who may adjust the doses of your medicines.
Ropinirole SaneXcel is designed to release the medicine gradually over 24 hours.
If your condition (e.g. during diarrhoea) causes the medicine to pass through your body too quickly, the tablets may not dissolve completely and may not work as intended.
You may notice the tablets in your stool. In such a case, contact your doctor as soon as possible.

How much Ropinirole SaneXcel should be taken
Finding the right dose of Ropinirole SaneXcel for you may take some time.
The recommended starting dose is 2 mg once daily for the first week.
Your doctor may increase the dose of Ropinirole SaneXcel 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 may then adjust the dose until the optimal dose for you is reached.
Some patients take up to 24 mg of Ropinirole SaneXcel 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 switching to a lower dose of ropinirole in the form of coated tablets (immediate-release) taken three times daily.

Do not take more Ropinirole SaneXcel than prescribed by your doctor or nurse.
It may take several weeks before the beneficial effect of Ropinirole SaneXcel becomes apparent.

How to take Ropinirole SaneXcel
Take Ropinirole SaneXcel 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 tablet(s) – doing so may lead to overdose due to too rapid release of the medicine in the body.

Switching treatment for patients currently taking immediate-release ropinirole tablets
Your doctor will determine the dose of Ropinirole SaneXcel 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 Ropinirole SaneXcel prolonged-release tablets and do not take any further immediate-release ropinirole tablets.

Taking more Ropinirole SaneXcel than prescribed
Contact your doctor or pharmacist immediately.
If possible, show them the Ropinirole SaneXcel packaging.
Symptoms of overdose may include: nausea, vomiting, dizziness (spinning sensation), drowsiness, mental or physical fatigue, fainting, hallucinations.

If you miss a dose of Ropinirole SaneXcel
Do not take an extra prolonged-release tablet or a double dose to make up for a missed dose.
If you miss a dose of Ropinirole SaneXcel for one day or longer, consult your doctor before restarting treatment.

Stopping Ropinirole SaneXcel
Do not stop taking Ropinirole SaneXcel unless your doctor advises you to do so.
Continue taking Ropinirole SaneXcel for as long as your doctor or nurse recommends.
Do not stop taking it unless instructed by your doctor or nurse.
If you stop taking Ropinirole SaneXcel suddenly, Parkinson’s symptoms may worsen rapidly.
Sudden discontinuation may lead to a condition called neuroleptic malignant syndrome, which can be life-threatening.
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 stop taking Ropinirole SaneXcel, your doctor or nurse 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 effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects of Ropinirole SaneXcel may occur most frequently at the beginning of treatment or shortly after increasing the dose.
They are usually mild and tend to become less bothersome after a short period of treatment. If a patient is concerned about adverse effects, they should talk to their doctor.

Very common adverse effects
May occur in more than 1 in 10 people taking Ropinirole SaneXcel

• fainting
• feeling sleepy
• nausea.

Common adverse effects
May occur in up to 1 in 10 people taking Ropinirole SaneXcel

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

Uncommon adverse effects
May occur in up to 1 in 100 people taking Ropinirole SaneXcel

• dizziness or fainting, especially upon sudden change to an upright position (caused by low blood pressure)
• very strong daytime sleepiness (irresistible sleepiness)
• psychiatric disturbances such as delirium (severe disorientation), delusions (irrational thoughts) or paranoia (unjustified suspicion).

The following adverse effects may occur in some patients (frequency unknown: cannot be estimated 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 detected in blood tests
• aggressive behaviour
• misuse of Ropinirole SaneXcel (the need to take high doses of dopaminergic medication, higher than required to control motor symptoms, known as dopaminergic dysregulation syndrome)
• inability to resist an impulse, drive or temptation to perform certain actions that may be harmful to the patient or others, including:
  - a strong tendency to gamble, despite significant personal or family consequences.
  - altered or increased sexual interest and behaviour causing significant concern to the patient or others, for example increased libido.
  - uncontrolled excessive desire to shop or spend money.
  - binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than needed to satisfy hunger).
• after stopping or reducing the dose of Ropinirole SaneXcel, the following may occur: depression, apathy, anxiety, lack of energy, sweating or pain (referred to as dopamine agonist withdrawal syndrome or DAWS).

Patients should inform their doctor if any of these behaviours occur, so that appropriate treatment or symptom relief can be arranged.

Taking Ropinirole SaneXcel with L-dopa
In patients taking Ropinirole SaneXcel together with levodopa, the following additional adverse effects may occur over time:

• uncontrolled movements (dyskinesias) are a very common adverse effect. If the patient is taking levodopa, uncontrolled movements (dyskinesias) may occur when starting treatment with Ropinirole SaneXcel. If these symptoms occur, the doctor should be informed, as they may need to adjust the doses of medicines being taken.
• confusion is a common adverse effect.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse effects 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported directly to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ropinirole SaneXcel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box
after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ropinirole SaneXcel contains

• The active substance is ropinirole. Each 2 mg prolonged-release tablet of Ropinirole SaneXcel contains 2 mg of ropinirole (as ropinirole hydrochloride). Each 4 mg prolonged-release tablet of Ropinirole SaneXcel contains 4 mg of ropinirole (as ropinirole hydrochloride). Each 8 mg prolonged-release tablet of Ropinirole SaneXcel contains 8 mg of ropinirole (as ropinirole hydrochloride).
• The other ingredients are:
  • tablet core: Ammonio methacrylate copolymer type B, hypromellose, sodium lauryl sulfate (E 487), copovidone, magnesium stearate.
  • tablet coating:

What Ropinirole SaneXcel looks like and contents of the pack
Ropinirole SaneXcel, 2 mg: pink, round, biconvex prolonged-release tablets with a diameter of 6.8 ± 0.1 mm and thickness of 5.5 ± 0.2 mm.
Ropinirole SaneXcel, 4 mg: light brown, oval, biconvex prolonged-release tablets with dimensions of 12.6 x 6.6 ± 0.1 mm and thickness of 5.3 ± 0.2 mm.
Ropinirole SaneXcel, 8 mg: red, oval, biconvex prolonged-release tablets with dimensions of 19.2 x 10.2 ± 0.2 mm and thickness of 5.2 ± 0.2 mm.
All strengths of the product are available in white, opaque PVC/PCTFE/Aluminium foil blisters, packed in cardboard boxes.
Pack sizes:
7, 21, 28, 30, 42, 84, 90, 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]
Manufacturer
Pharmathen S.A.
Dervenakion 6
153 51 Pallini, Attiki
Greece
Pharmathen International S.A.
Industrial Park Sapes Rodopi Prefecture
Building Block No 5
693 00 Rodopi
Greece
This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Ropinirole SaneXcel
Czech Republic: Ropinirol SaneXcel
Slovakia: Ropinirol SaneXcel 2 mg
Ropinirol SaneXcel 2 mg
Ropinirol SaneXcel 2 mg
Bulgaria: Ропинирол SaneXcel 2mg, 4mg, 8mg таблетки с удължено освобождаване
Hungary: Ropinirole SaneXcel 2 mg retard tabletta
Ropinirole SaneXcel 4 mg retard tabletta
Ropinirole SaneXcel 8 mg retard tabletta
Romania: Ropinirol SaneXcel 2, 4, 8 mg comprimate cu eliberare prelungită