Ropinirole 5 Mg Film-Coated Tablets
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Package leaflet: Information for the patient
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Ropinirole Film-coated Tablets are and what they are used for
2. What you need to know before you take Ropinirole Film-coated Tablets
3. How to take Ropinirole Film-coated Tablets
4. Possible side effects
5. How to store Ropinirole Film-coated Tablets
6. Contents of the pack and other information
1. What Ropinirole Film-coated Tablets are and what they are used for
Ropinirole belongs to a group of medicines called dopamine agonists. Dopamine agonists act like a naturally occurring chemical in your brain called dopamine.
Ropinirole Film-coated Tablets are used to treat Parkinson's Disease.
The cause of Parkinson's Disease is a lack of the substance dopamine in the brain. Ropinirole acts in a similar way to the natural dopamine, so helping the symptoms of Parkinson's Disease.
Ropinirole Film-coated Tablets may be used alone or in combination with other medicines against Parkinson's disease, to achieve a more effective treatment.
2. What you need to know before you take Ropinirole Film-coated Tablets
Do not take Ropinirole Film-coated Tablets:
• if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.
• if you are breast feeding.
If you are unsure, it is essential to talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ropinirole Film-coated Tablets if you:
• have serious kidney disease
• have liver disease
• have a serious heart complaint
• have a serious mental health problem
• have a history of any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour)
• have an intolerance to some sugars (such as lactose)
In these situations your doctor should carefully supervise your treatment.
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.
During treatment with Ropinirole Film-coated Tablets take special care when you drive or operate machinery. If you suffer from extreme sleepiness or suddenly fall asleep without apparently feeling sleepy, do not drive or use machinery, and contact your doctor.
Children
Ropinirole Film-coated Tablets are not recommended for use in children.
Other medicines and Ropinirole Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This applies also to herbal medicines as well as strong vitamins and minerals.
The effect of Ropinirole Film-coated Tablets may be increased or decreased by other medicines, and vice versa.
These medicines include:
• ciprofloxacin (an antibiotic)
• fluvoxamine (a drug used to treat depression)
• cimetidine (a drug used to treat stomach ulcers)
• theophylline (a drug used to treat asthma)
• hormone replacement therapy (also called HRT)
• anti-psychotics and other drugs that block dopamine in the brain (e.g. sulpiride or metoclopramide)
Tell your doctor if:
• you are already receiving any other medicines for Parkinson's Disease
• you are taking medicines to treat high blood pressure, or for heart problems
• you give up or start smoking while taking Ropinirole Film-coated Tablets. Your doctor may need to adjust your dose.
• you are taking Ropinirole Film-coated Tablets and the doctor is going to prescribe you any other medicine.
Ropinirole Film-coated Tablets with food, drink and alcohol
Always swallow the tablets whole with water and preferably with food. Do not chew them.
Taking Ropinirole Film-coated Tablets with food may reduce the likelihood of you feeling or being sick.
You should not drink alcohol while you are taking this medicine.
Pregnancy and breast-feeding
Women who are pregnant or breast-feeding must not take Ropinirole Film-coated Tablets.
Tell your doctor immediately if you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby. Your doctor will advise you to stop taking Ropinirole Film-coated Tablets.
Women taking Ropinirole Film-coated Tablets should use adequate precautions to avoid becoming pregnant.
Driving and using machines
This medicine does not usually affect people's normal activities. However, Ropinirole Film-coated Tablets can cause extreme sleepiness (somnolence) in some people and may cause them to fall asleep suddenly without any apparent warning. Contact your doctor if you experience either of these effects. If you do suffer from these effects then DO NOT drive or operate machinery, and do not put yourself in any situation where sleepiness or falling asleep may put you (or others) at risk of serious injury or death.
Ropinirole Film-coated Tablets contain lactose
Patients who are intolerant to lactose should note that each Ropinirole Film-coated Tablet contains a small amount of 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.
3. How to take Ropinirole Film-coated Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the Ropinirole Film-coated Tablet(s) whole with water. You can take the tablets with or without food. However, taking Ropinirole Film-coated Tablets with food may decrease the occurrence of nausea (feeling sick) which is a possible side-effect of the tablets. Do not chew the tablet(s). Do not take more than your doctor has recommended.
When you first start taking Ropinirole Film-coated Tablets, the amount you take will be increased gradually.
The exact dose of ropinirole that 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.
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When treating Parkinson's Disease, the starting dose is 0.25 mg three times per day for one week. The dose is then gradually increased in accordance with the following:
1st Week: 0.25 mg three times daily 2nd Week: 0.5 mg three times daily 3rd Week: 0.75 mg three times daily 4th Week: 1 mg three times daily
Hereafter, your doctor may increase or decrease the dose that you are taking to get the best effect. The usual dose is between 1 mg and 3 mg taken three times daily (a total daily dose of 3 mg to 9 mg), but if sufficient effects are not achieved or maintained then the total daily dose may be gradually increased up to a maximum of 24 mg.
Ropinirole Film-coated Tablets may also be used in combination with other medicines that act against Parkinson's Disease.
Your doctor may then increase or decrease the amount of ropinirole that you are taking to get the best effect.
Please read the pharmacist's label carefully. If you have any questions about Ropinirole Film-coated Tablets and how to take them, ask your doctor or pharmacist.
If you take more Ropinirole Film-coated Tablets than you should
You should never take more tablets than your doctor recommends.
Someone who has taken an overdose may experience; feeling or being sick, dizziness (or a spinning sensation), feeling drowsy, fatigue (mental or physical tiredness), stomach pain, fainting or nervousness.
If you take too many tablets, or if someone else has taken your medicine, tell a doctor or pharmacist straight away. Show them your pack of tablets.
If you forget to take Ropinirole Film-coated Tablets
Remember to take your medicine. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you do forget to take a dose, leave out that dose completely. Take your next dose at the normal time.
Do not take a double dose to make up for a forgotten tablet.
If you have missed taking your tablets for more than a few days, consult your doctor for advice on restarting.
If you stop taking Ropinirole Film-coated Tablets
You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to start to work. If you have the impression that the effect of your medicine is too strong or too weak, talk to your doctor or pharmacist.
If you wish to stop the treatment, this has to be done gradually. You must not stop taking Ropinirole Film-coated Tablets without your doctor's advice. If your symptoms worsen after you stop treatment with Ropinirole Film-coated Tablets, you should contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The more common side effects of Ropinirole Film-coated Tablets sometimes occur 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.
Parkinson's Disease
The side effects reported in people taking ropinirole for Parkinson's Disease are listed below:
Very Common Side Effects (they occur in more than 1 per 10 patients who receive treatment)
Nausea (feeling sick), drowsiness
Common Side Effects (they occur in between 1 and 10 per 100 patients who receive treatment)
Hallucinations, dizziness (including vertigo), vomiting, stomach ache, heartburn, swelling of the legs, fainting, feeling dizzy or faint especially when you stand up suddenly (this is caused by a drop in blood pressure)
Uncommon Side Effects (they occur in between 1 and 10 per 1000 patients who receive treatment)
Mental side effects other than hallucinations, such as delirium, delusion, and paranoia,
Extreme sleepiness or sudden sleep onset episodes (suddenly falling asleep without any apparent warning)
Very rare (they occur in less than 1 per 10,000 patients who receive treatment)
Altered liver function (abnormal blood tests),
Allergic reactions such as red, itchy swellings on the skin
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(hives), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or intense itching
When ropinirole is taken with other medicines for Parkinson's Disease the following additional side effects have been reported:
Very Common Side Effects (they occur in more than 1 per 10 patients who receive treatment)
Unwanted jerky movements
Common Side Effects (they occur in between 1 and 10 per 100 patients who receive treatment)
Confusion
You may experience the following side effects:
• inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
• Strong impulse to gamble excessively despite serious personal or family consequences.
• Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
• Uncontrollable excessive shopping or spending.
• Binge eating (eating large amounts of food in a short time period) 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 behaviours; they will discuss ways of managing or reducing the symptoms.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to store Ropinirole Film-coated Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from light. HDPE containers only: Keep the container tightly closed in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton and blister foil.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ropinirole Film-coated Tablets contain
The active substance is ropinirole (as ropinirole hydrochloride).
The other ingredients are:
Tablet Core
• Lactose Monohydrate
• Microcrystalline cellulose
• Pregelatinised starch
• Magnesium stearate
Film Coating
Opadry II 85F20521 (Polyvinyl alcohol, Titanium dioxide, Macrogol 3350, Talc, Indigo carmine aluminium lake (E132))
What Ropinirole Film-coated Tablets look like and contents of the pack
The 5 mg film-coated tablets are blue, round, biconvex and 10.5 mm in diameter.
They are marked R5 on one side.
Pack sizes:
The tablets are available in blister packs of 84 tablets. Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland
Manufacturer:
Actavis Ltd
B16 Bulebel Industrial Estate
Zejtun ZTN08
Malta
This leaflet was last revised in November 2013
actavis
|
Ropinirole 5mg Film-coated tablets PIL - UK |
colours/plates: | ||
|
1. Black | |||
|
Actavis creating value In pharmaceuticals t 0044 1271 311400 f 00441271311449 |
item no: AAAG2365 |
dimensions: 190 x 380 |
2. |
|
print proof no: 2 |
pharmacode: |
3. | |
|
4. | |||
|
origination date: 20.11.13 |
min pt size: 9pts |
5. | |
|
originated by: DR |
6. | ||
|
approved for print/date |
revision date: 05.12.13 |
Technical Approval |
Non Printing Colours |
|
1. | |||
|
revised by: DR |
date sent: NA | ||
|
2. | |||
|
supplier: Malt Zejtun |
technically app. date: |
3. | |