Ropinirole sanexcel

Patient Information Leaflet

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 only. Do not give it to others. It may harm them, 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 areas of the brain have low levels of dopamine. Ropinirole works 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.

Tell the doctor if the patient, a family member, or caregiver notices new impulses, urges, or behaviors that the patient has not previously experienced and that the patient cannot resist. 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 decide it is necessary to adjust the dose or stop treatment.

Inform the doctor if the patient, their family, or caregivers notice episodes of excessive movement, 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 stop treatment.

➔ 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 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 change the dose or stop treatment.

Smoking and Ropinirole SaneXcel
Inform your doctor or nurse if you start or stop smoking while taking Ropinirole SaneXcel. The doctor or nurse may decide that a dose adjustment is necessary.

Ropinirole SaneXcel and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including herbal medicines and other medicines available without a prescription.

Remember to inform your doctor or pharmacist if starting a new medicine while taking Ropinirole SaneXcel.

Some medicines may affect the action of Ropinirole SaneXcel or increase the risk of side 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 for 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 together with the following medicines, additional blood tests will be necessary:

• 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.

Contact your doctor immediately if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant. The doctor will also provide advice if the patient is breastfeeding or planning to breastfeed. The doctor may recommend discontinuing Ropinirole SaneXcel.

Driving and using machines
Ropinirole SaneXcel may cause drowsiness. Sudden, irresistible sleepiness may occur, and sometimes sudden, unexpected sleep attacks without prior warning of sleepiness.

Hallucinations (seeing, hearing, or feeling things that are not actually present) may occur while taking ropinirole. If this happens, the patient should not drive or operate machinery.

If any of the above apply to the patient: do not drive, operate machinery, or perform any activity in which 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 or nurse if this situation is a problem 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 been previously diagnosed with an 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 colouring 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, meaning the 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
have any doubts, consult your doctor or pharmacist.
Ropinirole SaneXcel must not be given to children. ApoRopin is generally not prescribed for patients
under 18 years of age.
Ropinirole SaneXcel may be used as the sole treatment for the 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 a 24-hour period. 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. The tablets may be visible in the stool. If
this occurs, 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 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 effects of Ropinirole SaneXcel become noticeable.

How to take Ropinirole SaneXcel
Ropinirole SaneXcel should be taken once daily, at the same time each day.
The prolonged-release tablet(s) of Ropinirole SaneXcel must be swallowed whole with a glass of water.
Do not break, chew or crush the prolonged-release tablet(s) – doing so may result in overdose due to
too rapid release of the medicine in the body.

Switching treatment for patients currently taking ropinirole immediate-release coated tablets
Your doctor will determine the dose of Ropinirole SaneXcel prolonged-release tablets based on your
previous dose of immediate-release ropinirole coated tablets.
Take your usual dose of immediate-release ropinirole coated tablets on the day before switching. The
next morning, take Ropinirole SaneXcel prolonged-release tablets and do not take any further doses of
immediate-release ropinirole coated tablets.

Taking more than the recommended dose of Ropinirole SaneXcel
Seek immediate advice from your doctor or pharmacist. If possible, show the Ropinirole SaneXcel
packaging.
Symptoms of an overdose of Ropinirole SaneXcel may include: nausea, vomiting, dizziness (spinning
sensation), drowsiness, mental or physical fatigue, fainting, hallucinations.

Missing a dose of Ropinirole SaneXcel
Do not take an extra prolonged-release tablet or double the 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 instructed by your doctor.
Continue taking Ropinirole SaneXcel for as long as your doctor or nurse advises.
Do not stop taking it unless your doctor or nurse tells you to.
If Ropinirole SaneXcel is stopped abruptly, Parkinson's disease symptoms may worsen rapidly.
Sudden discontinuation may lead to a condition called neuroleptic malignant syndrome, which can 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 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 all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Adverse effects of Ropinirole SaneXcel may most commonly occur during initiation 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 the 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 warning signs of sleepiness (sudden sleep attacks)
• hallucinations (‘seeing’ things that do not exist in reality)
• vomiting
• dizziness (spinning sensation)
• heartburn
• abdominal pain
• constipation
• swelling of the legs, feet 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 feeling of daytime sleepiness (irresistible sleepiness)
• psychiatric disorders such as delirium (severe disorientation), delusions (irrational thoughts) or paranoia (unfounded suspiciousness).

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 medicines, higher than required to control motor symptoms, known as dopamine dysregulation syndrome)
• inability to resist the impulse, urge or temptation to perform certain actions which may be harmful to the patient or others, including:
  o strong tendency to gamble despite significant personal or family consequences.
  o changed or increased sexual interest and behaviour causing significant concern to the patient or others, for example increased libido.
  o uncontrolled excessive desire to shop or spend money.
  o 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).

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

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

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for 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 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 pack
after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must 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 packaging 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 blister packs, in cardboard cartons.
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: Рopinirol SaneXcel 2mg, 4mg, 8mg tablets with prolonged release
Hungary: Ropinirole SaneXcel 2 mg retard tablet
Ropinirole SaneXcel 4 mg retard tablet
Ropinirole SaneXcel 8 mg retard tablet
Romania: Ropinirol SaneXcel 2, 4, 8 mg prolonged-release tablets