2 mg, 4 mg, 8 mg prolonged-release tablet
What Ropinirole Teva is and what it is used for
The active substance in Ropinirole Teva 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 Teva 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 Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Teva
Do not take Ropinirole Teva
- if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6),
- if you have severe kidney disease,
- if you have liver disease.
Tell your doctor if you think any of the above apply to you.
Warnings and cautions
Talk to your doctor or pharmacist before taking Ropinirole Teva:
- 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 cravings and/or behaviors (such as excessive gambling or excessively sexual behavior) (See section 4 “Possible side effects”)
- 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 Teva is not suitable for you or that you need extra checks while you are taking it.
While taking Ropinirole Teva
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 can 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 you have stopped taking or reduced your ropinirole treatment (so-called withdrawal syndrome after treatment with a 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 Teva
Tell your doctor if you start or stop smoking while taking Ropinirole Teva. Your doctor may need to change dose one.
Other medicines and Ropinirole Teva
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 start taking a new medicine while taking Ropinirole Teva.
Some medicines may affect the effect of Ropinirole Teva, or make you more likely to get side effects. Ropinirole Teva may also affect the effectiveness of other medicines.
These medicines include:
- fluvoxamine, an antidepressant,
- medicines for other mental problems, such as sulpiride,
- HRT (hormone replacement therapy),
- metoclopramide used to treat nausea and heartburn,
- ciprofloxacin or enoxacin ( antibiotics ),
- other medicines for Parkinson’s disease.
Talk to your doctor if you are taking or have recently taken any of these medicines.
You will need to take additional blood samples if you are taking the following medicines with Ropinirole Teva:
- Vitamin K antagonists (used to reduce blood clot formation) such as warfarin (Warren).
Ropinirole Teva with food, drink, and alcohol
You can take Ropinirole Teva with or without food.
Concomitant consumption of alcoholic beverages and Ropinirole Teva is not recommended.
Pregnancy and breastfeeding
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 Teva is not recommended for use if you are pregnant, unless your doctor has determined that the benefits to you if you take Ropinirole Teva outweigh the risks to your unborn baby. Ropinirole Teva is not recommended for use if you are breastfeeding as it may affect your milk production.
Your doctor will also advise you if you are breastfeeding or planning to do so. Your doctor may advise you to stop taking Ropinirole Teva.
Driving and using machines
Ropinirole Teva can 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 increased vigilance. 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 Teva contains lactose and castor oil
Ropinirole Teva 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.
Ropinirole Teva contains castor oil
May cause stomach upset and diarrhea.
How to take Ropinirole Teva
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Do not give Ropinirole Teva to children. Ropinirole Teva is not normally prescribed for people under 18 years of age.
You can get Ropinirole Teva 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 movements ( dyskinesias ) when you start taking Ropinirole Teva. Tell your doctor if this happens as your doctor may need to adjust the doses of the medicine you are taking.
Ropinirole Teva is designed to release drugs over 24 hours. If you have a condition where your medicine passes through your body too quickly, e.g. diarrhea, the tablets may not dissolve completely and do not work optimally. You can see tablets in your stool. Contact your doctor as soon as possible if this occurs.
How much Ropinirole Teva do you need to take?
It may take some time to find the dose of Ropinirole Teva that is most suitable for you.
The recommended starting dose of Ropinirole Teva prolonged-release tablets is 2 mg once daily for the first week. Your doctor may increase your dose to 4 mg of Ropinirole Teva 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 Teva 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 Teva than your doctor has recommended.
It may take a few weeks before you get the effect of Ropinirole Teva.
How to take your dose of Ropinirole Teva
Take Ropinirole Teva once daily, at the same time each day.
|Swallow Ropinirole Teva 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 are switching from ropinirole film-coated tablets (faster release tablets )
To determine your dose of Ropinirole Teva 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 Teva prolonged-release tablets the next morning and do not take any more ropinirole film-coated tablets (tablets with faster release ).
If you take more Ropinirole Teva than you should
Contact a doctor or pharmacist immediately. If possible, show them the Ropinirole Teva package.
A person who has taken an overdose of Ropinirole Teva may experience any of the following symptoms: nausea, vomiting, dizziness (a rotating sensation), drowsiness, mental or mental exhaustion, fainting, and 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 Teva
Do not take extra prolonged-release tablets or a double dose to compensate for a missed dose.
If you forget to take Ropinirole Teva for a day or more, contact your doctor for advice on how to start treatment again.
If you stop taking Ropinirole Teva
Do not stop taking Ropinirole Teva suddenly without talking to your doctor. A sudden stop can lead to a serious medical condition called a malignant neuroleptic syndrome. Symptoms include akinesia (immobility), muscle stiffness, fever, unstable blood pressure, tachycardia (high heart rate), confusion, and decreased consciousness (eg coma ).
Take Ropinirole Teva for as long as your doctor prescribes it. Do not stop unless your doctor tells you to.
If you suddenly stop taking Ropinirole Teva, your symptoms of Parkinson’s disease can quickly get much worse.
If you need to stop taking Ropinirole Teva, your doctor will reduce your dose gradually.
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 Teva 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 side effects: may affect more than 1 in 10 people
Common side effects: may affect up to 1 in 10 people
- hallucinations (“seeing” things that do not exist)
- dizziness (rotating sensation)
- abdominal pain
- swollen legs, feet, or hands
Uncommon side effects: 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)
- feeling very tired during the day (extreme drowsiness)
- fall asleep very suddenly without first feeling sleepy (sudden sleep attacks)
- mental side effects such as delirium (pronounced confusion), delusions (irrational ideas), and paranoia (morbid suspicion).
Some patients may experience the following side effects
Has been reported: occurs in an unknown number of users
- allergic reactions such as red, itchy swelling of the skin ( hives ), swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing and rash or intense itching, changes in liver function, which have been shown in blood tests
- behave in an aggressive manner
- excessive use of Ropinirole Teva (request for a higher dose of your dopaminergic drug than is required to control motor problems, known as dopaminergic dysregulation syndrome)
- After your Ropinirole Teva treatment has been discontinued or reduced: Depression, apathy, anxiety, fatigue, sweating or pain may occur (withdrawal syndrome after dopamine agonist treatment)
- inability to resist an impulse to perform an act that may be harmful to you or others, which may include:
- 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)
Tell your doctor if you experience any of these behaviors. You will discuss ways to manage or reduce the symptoms.
If you are taking Ropinirole Teva at the same time as L-dopa
People taking Ropinirole Teva 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 Teva. 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.
How to store Ropinirole Teva
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 after EXP and on the 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
- The active substance is ropinirole. Each prolonged-release tablet contains 2 mg, 4 mg, or 8 mg ropinirole (as hydrochloride).
- The other ingredients are:
Ropinirole Teva 2 mg prolonged-release tablets:
hypromellose, lactose monohydrate, anhydrous colloidal silica, carbomer 4,000 11,000 mPa s, hydrogenated castor oil, magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), macro coil 400, yellow iron oxide (E172) in the film coating.
Ropinirole Teva 4 mg and 8 mg prolonged-release tablets:
hypromellose, lactose monohydrate, anhydrous colloidal silica, carbomer 4,000 11,000 mPa s, hydrogenated castor oil, magnesium stearate in the tablet core and hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) in the film coating.
What the medicine looks like and the contents of the pack
Ropinirole Teva 2 mg prolonged-release tablets: Pink, oval, biconvex tablets.
Ropinirole Teva 4 mg prolonged-release tablets: Light brown, biconvex, oval tablets.
Ropinirole Teva 8 mg prolonged-release tablets: Red-brown, biconvex, oval tablets.
Tablets are available in packs of 7, 21, 28, 42, 56, 84 and 100 prolonged-release tablets in OPA / Al / PVC // Al blister or in perforated OPA / Al / PVC // Al blister.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of approval for sale
Teva Sweden AB
251 10 Helsingborg
Novo Mesto, Slovenia
Teva Operations Poland Sp. Zoo