2 mg, 4 mg, 8 mg prolonged-release tablet
ropinirole
What Requip Depot is and what it is used for
The active substance in Requip Depot 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.
Requip Depot prolonged-release tablet is 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, thus helping to reduce the symptoms of Parkinson’s disease.
What you need to know before taking Requip Depot
Do not take Requip Depot:
- if you are allergic to ropinirole or any of the other ingredients of this medicine (see section 6)
- if you have a 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 Requip Depot:
- 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 (see section 4)
- if you do not tolerate certain sugars (such as lactose ).
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing your treatment with Requip Depot (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.
Tell your doctor if you or your family/carer 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 or your family/carer notice that you develop periods of overactivity, elation, or irritability (symptoms of mania). These may occur together with, or without, symptoms of disturbed impulse control (see above). Your doctor may need to adjust your dose or discontinue treatment.
- Tell your doctor if you think any of the above apply to you. Your doctor may decide that Requip Depot is not suitable for you or that you need extra checks while taking it.
While taking Requip Depot
Tell your doctor if you or your family notice that you develop any unusual behaviors (such as unusual gambling or increased sexual desire and/or behavior ) while taking Requip Depot. Your doctor may need to change your dose or stop treatment.
Smoking and Requip Depot
Tell your doctor if you start or stop smoking while taking Requip Depot. Your doctor may need to change dose one.
Other medicines and Requip Depot
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription or over-the-counter medicines.
Remember to tell your doctor or pharmacist if you start taking a new medicine while taking Requip Depot.
Some medicines may affect the effect of Requip Depot, or make you more likely to get side effects. Requip Depot may also affect the effectiveness of other medicines.
These medicines include:
- fluvoxamine, an antidepressant with l
- drugs for other mental problems, such as sulpiride
- HRT (hormone replacement therapy)
- metoclopramide, which is 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 the above medicines.
You will need to take additional blood tests if you are taking the following medicines with Requip Depot:
- vitamin K antagonists (used to reduce blood clot formation) such as warfarin (Warren).
Requip Depot with food and drink
You can take Requip Depot with or without food, as you prefer.
Pregnancy and breastfeeding
Requip Depot is not recommended for use if you are pregnant unless your doctor has determined that the benefits to you if you take Requip Depot, outweigh the risks to your unborn baby. Requip Depot is not recommended for use if you are 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 Requip Depot.
Driving and using machines
Requip Depot can make you feel drowsy. The medicine can make you feel extremely sleepy and sometimes you can fall asleep very suddenly without any warning.
Requip Depot can cause hallucinations (see, hear or feel things that are not there). Do not drive or use machines if you are affected.
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.
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.
- Talk to your doctor if this is causing you a problem.
Important information about some of the ingredients of Requip Depot
Requip Depot prolonged-release tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Requip Depot.
The 4 mg prolonged-release tablets contain a dye called para-orange FCF (E110) which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Requip Depot
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 Requip Depot to children. Requip Depot is not normally prescribed to persons under 18 years of age.
You can get Requip Depot 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 Requip Depot. Tell your doctor if this happens as your doctor may need to adjust the doses of the medicine you are taking.
Requip Depot tablets are designed to release drugs over 24 hours. If you have a disease that causes your drug to pass through the body too fast e.g. in case of diarrhea, the tablets may not dissolve completely and may not work properly. You may see tablets in your stool. If this happens, contact your doctor as soon as possible.
How much Requip Depot do you need to take?
It may take a while to find the dose of Requip Depot that is most suitable for you.
The recommended starting dose of Requip Depot prolonged-release tablets is 2 mg once daily for the first week. Your doctor may increase your dose to 4 mg of Requip Depot 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 Requip Depot prolonged-release tablet 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 Requip Depot than your doctor has recommended.
It may take a few weeks before you get the effect of Requip Depot.
How to take your dose of Requip Depot
Take Requip Depot once daily, at the same time each day.
Swallow the Requip Depot 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 as the medicine 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 Requip Depot tablets, your doctor will start with 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 Requip Depot tablets the next morning and do not take any more ropinirole film-coated tablets (faster release tablets ).
If you take more Requip Depot than you should
Contact a doctor or pharmacist immediately. If possible, show them the Requip Depot package.
A person who has taken an overdose of Requip Depot may experience any of the following symptoms: nausea, vomiting, dizziness (a rotating sensation), drowsiness, mental or mental exhaustion, fainting, and hallucinations.
If you forget to take Requip Depot
Do not take extra prolonged-release tablets or double doses to compensate for a missed dose.
If you have missed taking Requip Depot for a day or more, contact your doctor for advice on how to start treatment again.
If you stop taking Requip Depot
Do not stop taking Requip Depot without a doctor’s advice.
Take Requip Depot for as long as your doctor advised. Do not stop unless your doctor tells you to.
If you suddenly stop taking Requip Depot, your symptoms of Parkinson’s disease can quickly get much worse. A sudden stop can cause you to develop a medical condition called malignant neuroleptic syndrome that can pose a major health risk. Symptoms include akinesia (loss of muscle mobility), stiff muscles, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, and decreased level of consciousness (eg coma ).
If you need to stop taking Requip Depot, your doctor will gradually reduce your dose.
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 Requip Depot are more likely to occur at the beginning of treatment and/or when the dose is increased. They are usually mild and may diminish after a period of use of the drug. If you are concerned about any side effects, talk to your doctor.
Very common side effects are
It May affect more than 1 in 10 people taking Requip Depot:
- fainting
- drowsiness
- nausea.
Common side effects are
It May affect less than 1 in 10 people taking Requip Depot:
- fall asleep very suddenly without first feeling sleepy (sudden sleep attacks)
- hallucinations (“seeing” things that do not exist)
- vomiting
- dizziness (rotating sensation)
- heartburn
- abdominal pain
- constipation
- swollen legs, feet, or hands.
Uncommon side effects are
May affect less than 1 in 100 people taking Requip Depot:
- dizziness and fainting especially when getting up suddenly (this is due to a drop in blood pressure)
- low blood pressure ( hypotension )
- feeling very tired during the day (extreme drowsiness)
- mental side effects such as delirium (pronounced confusion), delusions (irrational ideas), and paranoia (morbid suspicion).
Some patients may experience the following side effects (no known frequency: cannot be calculated from the available data)
- allergic reactions such as red, itchy swelling of the skin ( hives ). Swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing as well as rash or intense itching (see section 2)
- changes in liver function, which have been shown in blood tests
- aggressive behavior
- excessive use of Requip Depot (request for high dose dopaminergic drugs that are higher than needed to control motor symptoms, known as dopamine dysregulation syndrome)
- inability to resist impulses urges, or temptations to perform actions 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)
- periods of overactivity, elation, or irritability
- Depression, lethargy, anxiety, fatigue, sweating, or pain may occur after you stop taking or reduce your treatment with Requip Depot (known as withdrawal symptoms after treatment with dopamine agonist or DAWS).
Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce the symptoms.
If you are taking Requip Depot at the same time as L-dopa
People taking Requip Depot 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 Requip Depot. 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 Requip Depot
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 the carton. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package. Sensitive to light.
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 pack and other information
Content declaration
The active substance in Requip Depot is ropinirole.
One prolonged-release tablet contains 2 mg, 4 mg, or 8 mg ropinirole (as hydrochloride).
Other ingredients are:
Prolonged-release tablet core:
Hypromellose, hydrogenated castor oil, carmellose sodium, povidone (K 29-32), maltodextrin, magnesium stearate, lactose monohydrate, anhydrous colloidal silica, mannitol (E 421), yellow iron oxide (E 172), glycerol behenate.
Film coating:
| 2 mg prolonged-release tablet: | OPADRY pink OY-S-24900 (hypromellose, yellow iron oxide (E 172), titanium dioxide (E 171), macrogol 400, red iron oxide (E 172)). |
| 4 mg prolonged-release tablet: | OPADRY light brown OY-27207 (hypromellose, titanium dioxide (E 171), macrogol 400, para-orange FCF Aluminum Lake (E 110), indigo carmine Aluminum Lake (E 132)). |
| 8 mg prolonged-release tablet: | OPADRY red 03B25227 (hypromellose, yellow iron oxide (E 172), titanium dioxide (E 171), black iron oxide (E 172), macrogol 400, red iron oxide (E 172)). |
Requip Depot look and feel
Requip Depot (all strengths) are capsule-shaped prolonged-release tablets marked “GS” on one side.
Requip Depot 2 mg: Pink prolonged-release tablet marked “3V2” on the other side.
Requip Depot 4 mg: Light brown prolonged-release tablets marked “WXG” on the other side.
Requip Depot 8 mg: Red prolonged-release tablets marked “5CC” on the other side.
All strengths: Blister packs of 28 or 84 prolonged-release tablets.
2 mg prolonged-release tablets: Also available in a blister pack of 42 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline AB
Box 516
169 29 Solna
Tel .: 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer:
Glaxo Wellcome SA
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain
This medicinal product is authorized under the European Economic Area under the names:
Austria, Belgium, Germany, Ireland, Luxembourg, Netherlands: Requip modutab
Finland and Sweden: Requip Depot
France and Portugal: Requip LP
Greece: Requip XL
Italy: Requip
Spain: Requip Prolab