0.25 mg, 1 mg, 2 mg, 5 mg film-coated tablet
ropinirole (as hydrochloride)
What Requip is and what it is used for
The active substance in Requip 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 is used in the treatment of 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.
What you need to know before taking Requip
Do not take Requip:
- if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in 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:
- 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 experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing your treatment with Requip (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 is not suitable for you or that you need extra checks while you are taking it.
While taking Requip
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. Your doctor may need to change your dose or stop treatment.
Driving and using machines
Requip 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 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 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.
- Talk to your doctor if this becomes a problem for you.
Smoking and Requip
Tell your doctor if you start or stop smoking while taking Requip. Your doctor may need to change dose one.
Other medicines and Requip
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.
Some medicines may affect the effect of Requip, or make you more likely to get side effects. Requip can also affect the effectiveness of other medicines.
These medicines include:
- fluvoxamine, an antidepressant
- 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:
- vitamin K antagonists (used to reduce blood clot formation) such as warfarin (Warren).
Intake of Requip with food and drink
Taking Requip with food may reduce the risk of nausea and vomiting. It is therefore best to take the tablets with food if you can.
Pregnancy and breastfeeding
Requip is not recommended for use if you are pregnant unless your doctor has determined that the benefits to you if you take Requip outweigh the risks to your unborn baby. Requip is not recommended for use if you are breastfeeding as it may affect your 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.
Important information about some of the ingredients in Requip
Requip tablets contain a small amount of 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.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Requip
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
You can get Requip 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 ).
Do not give Requip to children. Requip is not normally prescribed to persons under 18 years of age.
How much Requip do you need to take?
It may take a while to find the dose that is best for you.
The usual starting dose is 0.25 mg ropinirole three times daily for the first week. Thereafter, your doctor will increase your dose every week for the next three weeks. After that, your doctor will gradually increase your dose to the dose that works best for you. The usual dose is 1 mg to 3 mg three times daily (which means that the total daily dose is 3 mg to 9 mg). If the symptoms of Parkinson’s disease have not improved enough, your doctor may decide to gradually increase the dose a little more. Some people take up to 8 mg of Requip three times daily (a total of 24 mg per day).
If you are also taking other medicines for Parkinson’s disease, your doctor may advise you to gradually reduce the dose of one of the other medicines. If you take L-dopa, you may experience involuntary movements ( dyskinesias ) when you start taking Requip. Tell your doctor if this happens as your doctor may need to adjust the doses of the medicine you are taking.
Do not take more Requip than your doctor has recommended.
It may take several weeks before you get the effect of Requip.
Ta din dos Requip
Take Requip three times daily.
Swallow the Requip tablets with a glass of water. It is best to take Requip with food as it may make you less likely to get nauseous.
If you take more Requip than you should
Contact a doctor or pharmacist immediately. If possible, show them your Requip packaging.
A person who has taken an overdose of Requip 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
Do not take extra tablets or a double dose to make up for a forgotten dose. Take your next dose at the usual time.
If you have missed taking Requip for a day or more, contact your doctor for advice on how to start treatment again.
If you stop taking Requip
Do not stop taking Requip without a doctor’s advice.
Take Requip for as long as your doctor recommends it. Do not stop unless your doctor tells you to. If you suddenly stop taking Requip, 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, 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 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:
Occurs in more than 1 in 10 people taking Requip:
- fainting
- somnolence
- nausea.
Common side effects:
Occurs in less than 1 in 10 people taking Requip:
- hallucinations (“seeing” things that do not exist)
- vomiting
- dizziness (rotating sensation)
- heartburn
- abdominal pain
- swollen legs, feet, or hands.
Uncommon side effects:
Occurs in less than 1 in 100 people taking Requip:
- dizziness and fainting especially when suddenly getting up (this is due to a drop in blood pressure)
- low blood pressure ( hypotension )
- feeling very tired during the day (extreme drowsiness)
- fall asleep very suddenly without first feeling sleepy (sudden sleep attacks)
- Psychological side effects are such as delirium (pronounced confusion), delusions (irrational ideas), and paranoia (morbid suspicion).
Some patients may experience the following side effects (no known frequency: may not 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 may cause difficulty in swallowing or breathing as well as rash or intense itching (see section 2).
- aggression
- excessive use of Requip (request for high dose dopaminergic drugs that are higher than needed to control motor symptoms, known as dopamine dysregulation syndrome).
- Depression, lethargy, anxiety, fatigue, sweating, or pain may occur after you stop taking or reduce your treatment with Requip (known as discontinuation syndrome after treatment with dopamine agonist or DAWS)
- changes in liver function, which have been demonstrated in blood tests.
You may experience the following side effects:
- Inability to resist an impulse to perform an action that can be harmful 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)
- periods of overactivity, elation, or irritability
Tell your doctor if you experience any of these behaviors. You will discuss ways to manage or reduce the symptoms.
If you are taking Requip at the same time as L-dopa
People taking Requip 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. 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
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 label/blister and the carton
after EXP. 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
What Requip contains
The active substance is ropinirole.
A film-coated tablet contains 0.25, 1, 2 or 5 mg ropinirole (as hydrochloride).
Other ingredients are:
Tablet core:
Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
| Film coating: | |
| 0.25 mg tablet: | hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433). |
| 1 mg tablet: | hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), and indigo carmine aluminum (E132). |
| 2 mg tablet: | hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172). |
| 5 mg tablet: | hypromellose, macrogol 400, titanium dioxide (E171), indigo carmine aluminum (E132), polysorbate 80 (E433). |
Requires look and feel
Requip is pentagonal, film-coated tablets marked “SB” on one side.
| Requip 0.25 mg: | white tablets, marked “4890” on the other side. |
| Requip 1 mg: | green tablets, marked “4892” on the other side. |
| Requip 2 mg: | pink tablets, marked “4893” on the other side. |
| Requip 5 mg: | blue tablets, marked “4894” on the other side. |
0.25 mg tablets are available in blister packs containing 21, 84, or 210 tablets.
1 mg, 2 mg, and 5 mg tablets are available in blister packs containing 21 and 84 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
This medicinal product is authorized under the European Economic Area under the names:
Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, Malta, the Netherlands, Poland, Spain, and Sweden: Requip.