2 mg, 4 mg, and 8 mg prolonged-release tablet is
ropinirole
What Ropinirole Sandoz is and what it is used for
The active substance in Ropinirole Sandoz is ropinirole which belongs to a group of medicines called dopamine agonists. Dopamine agonists affect the brain in a similar way to a natural substance called dopamine.
Ropinirole Sandoz prolonged-release tablets are used to treat Parkinson’s disease.
People with Parkinson’s disease have low levels of dopamine in certain parts of the brain.
Ropinirole acts similarly to natural dopamine, which is why it helps reduce the symptoms of Parkinson’s disease.
Ropinirole contained in Ropinirole Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Ropinirole Sandoz
Do not take Ropinirole Sandoz if you:
- is allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6)
- have a severe kidney disease
- have a liver disease
Tell your doctor if you think any of the above apply to you.
Warnings and cautions
Tell your doctor or pharmacist before taking Ropinirole Sandoz:
- if you are pregnant or think you may be pregnant
- if you are breast-feeding
- if you are younger than 18 years
- if you have severe heart problems
- if you have severe mental health problems
- if you have had any unusual desires and/or behaviors (such as excessive gambling or excessively sexual behavior)
- if you do not tolerate certain sugars (such as lactose ).
Tell your doctor if you think any of the above apply to you. Your doctor may decide that Ropinirole Sandoz is not suitable for you or that you need extra checks while you are taking it. It may be necessary to change the dose according to the clinical response.
While taking Ropinirole Sandoz
Tell your doctor if you or your family/caregiver notice that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to adjust your dose or discontinue treatment.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing your ropinirole treatment (so-called withdrawal syndrome after treatment with dopamine agonist or DAWS). If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.
Smoking and Ropinirole Sandoz
Tell your doctor if you start or stop smoking while taking Ropinirole Sandoz. Your doctor may need to change dose one.
Other medicines and Ropinirole Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Remember to tell your doctor or pharmacist if you are starting to take a new medicine while taking Ropinirole Sandoz.
Some medicines may affect the effect of Ropinirole Sandoz, or make you more likely to get side effects. Ropinirole Sandoz may also affect the effectiveness of other medicines.
These medicines include:
- fluvoxamine is used for depression;
- medicines for other mental problems, e.g. sulpiride;
- HRT (hormone replacement therapy);
- metoclopramide, which is used to treat nausea and heartburn;
- ciprofloxacin or enoxacin, which are antibiotics;
- other drugs for the treatment of Parkinson’s disease.
Talk to your doctor if you are taking or have recently taken any of the above medicines.
You will need to take additional blood samples if you are taking the following medicines with Ropinirole Sandoz:
- Vitamin K antagonists (used to reduce blood clot formation) such as warfarin (Warren).
Ropinirole Sandoz with food, drink, and alcohol
You can take Ropinirole Sandoz with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ropinirole Sandoz is not recommended for use if you are pregnant unless your doctor has determined that the benefit to you if you take Ropinirole Sandoz outweighs the risk to your unborn baby. Ropinirole Sandoz is not recommended for breastfeeding as it may affect milk production.
Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will also advise you if you are breastfeeding or planning to do so. Your doctor may advise you to stop taking Ropinirole Sandoz.
Driving and using machines
Ropinirole Sandoz may make you feel sleepy. The medicine can make you feel extremely sleepy and sometimes you can fall asleep very suddenly without any warning.
If you get such problems: do not drive, do not use machines, and do not put yourself in any situation where drowsiness or falling asleep can put you (or others) at risk of serious injury or danger to life. Do not participate in any of these activities until the discomfort has resolved.
Talk to your doctor if this becomes a problem for you.
Ropinirole can cause hallucinations (see, hear or feel things that are not there). Do not drive or use machines if you are affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ropinirole Sandoz contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Ropinirole Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Do not give Ropinirole Sandoz to children. Ropinirole Sandoz is not normally prescribed to people under 18 years of age.
You can get Ropinirole Sandoz as the only treatment to treat the symptoms of Parkinson’s disease. It can also be given with another medicine called L-dopa (also called levodopa ). If you take L-dopa, you may experience involuntary jerky movements when you start taking Ropinirole Sandoz. Tell your doctor if this happens as your doctor may need to adjust the doses of the medicine you are taking.
Ropinirole Sandoz is designed to release drugs over 24 hours. If you have a condition where your medicine passes through the body too quickly, e.g. diarrhea, the tablets may not dissolve completely and may not work properly. You can see tablets in your stool. If this happens, contact your doctor as soon as possible.
How much Ropinirole Sandoz do you need to take?
It may take some time to find the dose of Ropinirole Sandoz that is most suitable for you.
The recommended starting dose of Ropinirole Sandoz prolonged-release tablets is 2 mg once daily for the first week. Your doctor may increase your dose to 4 mg of Ropinirole Sandoz prolonged-release tablet once a day from the second week of treatment. If you are very old, your doctor may increase your dose more slowly. The doctor can then adjust your dose until you get the dose that is best for you. Some people take up to 24 mg of Ropinirole Sandoz prolonged-release tablets every day.
If you experience side effects at the beginning of your treatment that you can not accept, talk to your doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated tablets (tablets with faster release ) that you should take three times a day.
Do not take more Ropinirole, Sandoz, than your doctor advised.
It may take a few weeks before you get the effect of Ropinirole Sandoz.
Take Ropinirole Sandoz once daily, at the same time each day.
Swallow Ropinirole Sandoz prolonged-release tablets 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 because the drug will be absorbed into your body too quickly.
If you switch from ropinirole tablets to a faster release
To determine your dose of Ropinirole Sandoz prolonged-release tablets, your doctor will prescribe the dose of ropinirole film-coated tablets (tablets with faster release ) that you have taken.
Take your ropinirole film-coated tablets (tablets with faster release ) as usual the day before you change. Then take your Ropinirole Sandoz prolonged-release tablets the next morning and do not take any more ropinirole film-coated tablets (faster-release tablets ).
If you take more Ropinirole, Sandoz, than you should
Contact a doctor or pharmacist immediately. If possible, show them the packaging.
A person who has taken an overdose may experience any of the following symptoms: nausea, vomiting, dizziness (a rotating sensation), drowsiness, mental or physical fatigue, fainting, or hallucinations.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Ropinirole Sandoz
Do not take extra prolonged-release tablets or double doses to compensate for a missed dose.
If you forget to take your dose of Ropinirole Sandoz for one or more days, ask your doctor for advice on how to start taking it again.
If you stop taking Ropinirole Sandoz
Do not stop taking Ropinirole Sandoz without advice.
Take Ropinirole Sandoz for as long as your doctor prescribes it for you. Do not stop unless your doctor tells you to.
If you suddenly stop taking Ropinirole Sandoz, your symptoms of Parkinson’s disease can quickly get much worse.
If you need to stop taking Ropinirole Sandoz, your doctor will gradually reduce your dose.
If you have Parkinson’s disease, do not stop taking Ropinirole Sandoz suddenly. A sudden stop can lead to a medical condition called neuroleptic malignant syndrome (NMS) which can pose a major health risk. Symptoms include:
- immobility
- stiff muscles
- fever
- unstable blood pressure
- increased heart rate
- confusion
- decreased consciousness (eg coma ).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of Ropinirole Sandoz are more likely to occur at the beginning of treatment and/or when the dose is increased. They are usually mild and may decrease after a period of use of the drug. If you are concerned about any side effects, talk to your doctor.
Very common (may affect more than 1 user in 10)
- fainting
- somnolence
- nausea.
Common (may affect up to 1 in 10 people)
- hallucinations (“seeing” things that do not exist)
- dizziness (rotating sensation)
- fall asleep very suddenly without first feeling sleepy (sudden sleep attacks)
- vomiting
- abdominal pain
- heartburn
- abdominal pain
- constipation
- swollen legs, feet, or hands.
Uncommon (may affect up to 1 in 100 people)
- dizziness and fainting especially when suddenly getting up (this is due to a drop in blood pressure)
- drop in blood pressure when sitting or getting up
- feeling very tired during the day (extreme drowsiness)
- mental side effects such as delirium (pronounced confusion), delusions (irrational ideas), and paranoia (morbid suspicion).
Has been reported (occurs in an unknown number of users):
- changes in liver function, which have been shown in blood tests (elevated liver values)
- allergic reactions such as redness, itchy swelling of the skin ( hives ), swelling of the face, lips, mouth, tongue, or throat which may cause difficulty swallowing or breathing ( angioedema ), and rash or intense itching
- intake of increasing amounts of drugs in violation of the doctor’s prescription and in significantly higher doses than those required to treat the motor disorders ( Dopamine Dysregulation Syndrome (DDS))
- inability to resist impulses urges, or temptations to perform actions that may be harmful to you or others such as:
- a strong impulse to excessive gambling despite serious consequences for you personally or your family
- altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive.
- uncontrollable and excessive need to buy things and spend money
- binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- aggression (has been associated with psychotic reactions as well as impulse symptoms).
- after your Ropinirole Sandoz treatment has been discontinued or reduced: Depression, apathy, anxiety, fatigue, sweating or pain may occur (withdrawal syndrome after dopamine agonist treatment).
Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce the symptoms.
If you are taking Ropinirole Sandoz at the same time as L-dopa
People taking Ropinirole Sandoz at the same time as L-dopa may experience other side effects after a while:
- Involuntary movements ( dyskinesias ) are a very common side effect. If you take L-dopa, you may experience involuntary movements ( dyskinesias ) when you start taking Ropinirole Sandoz. Tell your doctor if this happens as your doctor may need to adjust the dose of one of the medicines you are taking.
- Confusion is a common side effect.
- drowsiness and nausea have been reported commonly in clinical trials with adjunctive therapy.
How to store Ropinirole Sandoz
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 blister and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Moisture sensitive.
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 to protect the environment.
Contents of the packaging and other information
Content declaration
The active substance is ropinirole.
Ropinirole Sandoz 2 mg prolonged-release tablets are :
Each prolonged-release tablet contains 2 mg ropinirole (as hydrochloride).
Ropinirole Sandoz 4 mg prolonged-release tablets:
Each prolonged-release tablet contains 4 mg of ropinirole (as hydrochloride).
Ropinirole Sandoz 8 mg prolonged-release tablets:
Each prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride).
Other ingredients are:
Ropinirole Sandoz 2 mg prolonged-release tablets:
hypromellose (type 2208), lactose monohydrate, anhydrous colloidal silica, carbomers 4000-11000 cP, hydrogenated castor oil, magnesium stearate in the tablet core, and hypromellose (type 2910), titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow172 iron in the drag ring.
Ropinirole Sandoz 4 mg and 8 mg prolonged-release tablets:
hypromellose (type 2208), lactose monohydrate, anhydrous colloidal silica, carbomers 4000-11000 cP, hydrogenated castor oil, magnesium stearate in the tablet core, and hypromellose (type 2910), titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow172 iron, black iron oxide (E172) in the coating.
What the medicine looks like and the contents of the pack
Ropinirole Sandoz 2 mg prolonged-release tablets:
The tablets are light red, biconvex, and oval.
Ropinirole Sandoz 4 mg prolonged-release tablets:
The tablets are light brown, biconvex, and oval.
Ropinirole Sandoz 8 mg prolonged-release tablets:
The tablets are brownish red, biconvex, and oval.
The tablets are supplied in cartons of 7, 10, 14, 21, 28, 30, 42, 60, 84 and 90 prolonged-release tablets in blisters (OPA / Al / PVC // Al).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia
or
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany