ROPINIROLE 0.25MG, 0.5MG & 2MG FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Ropinirole is and what it is used for
- 2. Before you take Ropinirole
- 3. How to take Ropinirole
- 4. Possible side effects
- 5. How to store Ropinirole
- 6. Further information
What Ropinirole Is And What It Is Used For
Ropinirole belongs to a group of medicines called dopamine agonists.
Dopamine is natural substance occurring in the brain. Dopamine agonists (such as ropinirole) work in the same way as dopamine found in the body.
Ropinirole is used
for the treatment of moderate-to-severe Restless Legs Syndrome
Restless Legs Syndrome is a disorder in which patients feel an irresistible urge to move their legs and (occasionally) the arms. They suffer from unpleasant sensations such as pins and needles, burning or stabbing pains in their arms or legs. Such sensations occur when the patient is at rest or inactive (e.g. whilst sitting or lying down, particularly in bed). These symptoms are more pronounced in the evening or at night. Usually, they can only be improved by walking about or moving the affected limbs, which often leads to sleeping problems.
Moderate to severe Restless Legs Syndrome is typically represented by patients who have difficulty sleeping or severe discomfort in their legs or arms.
Ropinirole relieves discomfort and reduces the uncontrollable urge to move the limbs that disrupts night time sleep.
Ropinirole may also be used to treat conditions other than those mentioned in the leaflet. If you are unsure why you have been prescribed this medicine talk to your doctor.
Before You Take Ropinirole
Do not take Ropinirole
- if you are allergic (hypersensitive) to the active substance (ropinirole) or any of the other ingredients of Ropinirole.
- if you suffer from severe liver dysfunction.
- if you suffer from severe kidney dysfunction.
Talk to your doctor if you are not sure.
Take special care with Ropinirole
Before taking Ropinirole, it is important that you tell your doctor:
- if you are pregnant or think you may be pregnant.
- if you are breastfeeding.
- if your liver is not working properly.
- if you suffer from a severe cardiovascular (heart) complaint.
- if you have a serious mental health problem.
- if there is evidence that you are obsessed by pathological gambling or by compulsive sexual drive.
- if you intend to give up or start smoking because your doctor may need to adjust your dose.
In these situations, your doctor should carefully monitor your treatment.
Due to possible additive effects, please be particularly careful when taking Ropinirole at the same time as sedative medications or alcohol.
Restless Legs Syndrome
If during treatment your symptoms become worse, start earlier in the day or after less time at rest, or affect other parts of your body such as your arms, your doctor may adjust the dose of Ropinirole that you are taking.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Ropinirole can affect the way in which some medicines work, and vice versa. Such medicines include:
- ciprofloxacin (an antibiotic)
- enoxacin (an antibiotic)
- fluvoxamine (used to treat depression)
- antipsychotics (drugs used to treat psychiatric disorders)
- other medicines that block dopamine in the brain (e.g. sulpiride or metoclopramide)
- hormone replacement therapy (also called HRT)
Please tell your doctor if
- you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- you are taking Ropinirole and your doctor wants to prescribe you another medicine.
Taking Ropinirole with food and drink
Taking Ropinirole with a meal reduces your chances of feeling sick.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Ropinirole is not recommended during pregnancy.
Tell your doctor immediately
- if you are pregnant
- if you think that you might be pregnant
- if you are planning to become pregnant.
Your doctor will discuss with you what to do next.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Ropinirole is not recommended if you are breast-feeding, as milk production may be affected. Tell your doctor immediately if
- you are breast-feeding or
- you are planning to start breast-feeding.
Your doctor will advise you to discontinue this medicine.
Driving and using machines
This medicine does not usually affect people's normal activities. However, Ropinirole can cause dizziness, extreme sleepiness (somnolence) and sudden sleep onset episodes. If you suffer from these effects you must not drive or put yourself in a situation where sleepiness or falling asleep may put you at risk of serious injury or death (for example using machinery) until these episodes have been resolved.
Important information about some of the ingredients of Ropinirole
Ropinirole contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Ropinirole
Always take Ropinirole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the Ropinirole tablet(s) whole with water preferably with food. Taking Ropinirole with food may decrease the occurrence of nausea (feeling sick), which is a possible side effect of Ropinirole. Do not chew the tablets.
For doses not realisable/practicable with this strength other strengths of this medicinal product are available.
There are 3 strengths of Ropinirole film-coated tablets available:
0.25mg, 0.5mg, and 2mg.
Take Ropinirole once a day, every day at about the same time. Ropinirole is usually taken just before bedtime, but can be taken up to 3 hours before going to bed. The exact dose of Ropinirole people take can be different. Your doctor will decide on the dose you need to take each day and you should follow the doctor's instructions. When you begin taking Ropinirole, the dose you take will be increased gradually.
The starting dose is 0.25 mg once daily. After two days your doctor will probably increase your dose to 0.5 mg once daily for the remainder of your first week of treatment. Then your doctor may increase your dose by 0.5 mg per week over three weeks to a dose of 2 mg per day. In some patients with insufficient improvement, the dose may be increased gradually up to a maximum of 4 mg daily.
After three months of treatment with Ropinirole, your doctor may adjust your dose or discontinue your treatment depending on your symptoms and how you feel.
Do not forget to take your medication. Ask your doctor or pharmacist for advice if you have problems in remembering to take your tablets.
Keep taking your tablets, even if - at first - you do not notice any obvious improvement. It can take a few weeks before any effect of the medicine is felt. If you have the impression that the effect of Ropinirole is too strong or too weak, talk to your doctor or pharmacist. Do not exceed the tablet dose recommended by your doctor.
Patients with mild to moderate kidney dysfunction
If you belong to this group, your dose will not need adjusting.
Elderly patients
Any increase in your number of tablets should be gradual and adjusted to your individual response to treatment. Follow your doctor's instructions exactly.
Children and adolescents
Ropinirole is not recommended for children and adolescents under 18 years of age.
If you take more Ropinirole than you should
Someone who has taken an overdose may experience
- fainting,
- feeling drowsy,
- feeling/being sick,
- experiencing hallucinations,
- heartburn,
- stomach pain,
- dizziness (or spinning sensation),
- swelling of the legs.
If you take more Ropinirole than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately. Show them your pack of tablets.
If you forget to take Ropinirole
If you find you have forgotten to take your dose of Ropinirole do not take an extra dose to make up for forgotten individual doses.
When you do remember to take Ropinirole, take your next dose of Ropinirole at the usual time. Consult your doctor if you have forgotten to take Ropinirole for more than several days. He/she will tell you how to start taking your tablets
again.
If you stop taking Ropinirole
Do not stop taking Ropinirole unless your doctor tells you to. If stopping treatment the dose should always be reduced gradually. Your doctor will advise you.
If you should feel worse at the end of treatment with Ropinirole, please see your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Ropinirole can cause side effects, although not everybody gets them. Tell your doctor if you notice any side effects and they worry you.
The more common side effects of Ropinirole can happen
- when patients first start their therapy and/or
- when the dose is increased.
The side effects are generally mild and may become less after you have taken the medicine for a short time.
The following frequencies are used in evaluating side effects:
Very common: more than one in 10 patients treated
Common: less than one in 10, but more than 1 in 100 patients treated
Uncommon: less than one in 100, but more than 1 in 1,000 patients treated
Rare: less than one in 1,000, but more than 1 in 10,000 patients treated
Very rare: less than one in 10,000 patients treated, or unknown
Possible side effects:
Very common:
- feeling drowsy
- fainting (syncope)
- feeling or being sick
Common:
- experiencing hallucinations (seeing things that aren't really there)
- dizziness (or spinning sensation)
- fatigue (mental or physical tiredness)
- nervousness
- leg swelling
- heartburn
- stomach pain
Uncommon:
- a drop in blood pressure that may make you feel dizzy or faint especially when standing up from a sitting or lying position
- Ropinirole can cause excessive daytime somnolence (excessive drowsiness) and very rarely sudden sleep onset episodes where patients fall asleep suddenly without apparently feeling sleepy
- other psychotic reactions in addition to hallucinations such as delirium, delusion, and irrational suspiciousness (paranoia).
Very rare:
- altered liver function (abnormal blood tests)
There are some reports of patients treated with medicinal products of this group of substance (dopamine agonists) who showed pathological compulsive gambling or compulsive and excessive sexual drive. These adverse effects were reversible when doses were reduced or treatment was stopped.
If you're taking Ropinirole with levodopa
People who are taking Ropinirole with levodopa may develop other side effects over time:
- uncontrolled jerky movements are a very common side effect
- feeling confused is a common side effect
Tell your doctor immediately if you notice any severe changes in your behaviour or senses of perception. During treatment with Ropinirole you may experience unusual worsening of Restless Legs Syndrome symptoms (e.g. symptoms become worse, start earlier in the day or after less time at rest, or affect other parts of your body such as your arms). If this occurs, you should see your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Ropinirole
Keep out of the reach and sight of children.
Do not use Ropinirole after the expiry date which is stated on the blister or bottle label and outer carton after “EXP”. The date refers to the last day of that month.
PVC/Aclar/Aluminium blister: Do not store above 25 °C. In order to protect from moisture store in the
original package.
HDPE bottles: Do not store above 30 °C. In order to protect from moisture keep the bottle tightly closed.
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.
Further Information
What Ropinirole contains:
The active substance is: ropinirole
Ropinirole 0.25 mg: One film-coated tablet contains 0.285 mg ropinirole hydrochloride equivalent to 0.25 mg ropinirole
Ropinirole 0.5 mg: One film-coated tablet contains 0.57 mg ropinirole hydrochloride equivalent to 0.50 mg ropinirole
Ropinirole 2 mg: One film-coated tablet contains 2.28 mg ropinirole hydrochloride equivalent to 2.0 mg ropinirole
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80
Ropinirole 0.5 mg:
yellow iron oxide (E172),
red iron oxide (E172)
Ropinirole 2 mg:
red iron oxide (E172),
yellow iron oxide (E172) and
indigo carmine aluminium lake (E132)
What Ropinirole looks like and contents of the pack
Ropinirole 0.25 mg are round, white film-coated tablets.
Ropinirole 0.25 mg is available in packs of 12 (bottles) of 12 film coated tablets.
Ropinirole 0.5 mg are round, yellow film-coated tablets.
Ropinirole 0.5 mg is available in packs (bottles) of 28 film coated tablets.
Ropinirole 2 mg are round, pink film-coated tablets.
Ropinirole 2 mg is available in bottles with 84 film-coated tablets.
Marketing Authorisation Holder
Manufacturer
‘Winthrop’ is a registered trademark. © 2008 Winthrop Pharmaceuticals
This leaflet was last revised in August 2008.
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