Brand Name Choices
No generic medication is available for Prolopa CR (Benserazide Hydrochloride/Levodopa)
What Prolopa CR is and what it is used for
Madopar CR capsules contain two medicines called levodopa and benserazide. They are used to treat
People with Parkinson’s disease do not have enough dopamine in certain parts of their brains. This can
result in slow movements, stiff muscles and tremor.
Madopar CR works like this:
• In your body the levodopa is changed into dopamine. Dopamine is the active medicine that is needed in your brain to help Parkinson’s disease.
• The benserazide allows more of the levodopa you take to get into your brain, before it is changed into dopamine. The capsules are designed to release the medicines into your body slowly. This is why they are called ‘CR’ which stands for ‘controlled release’.
How to take Prolopa CR
Always take Madopar CR exactly as your doctor has told you. You should check with your doctor if you are
not sure. How much you take and when you take it is different for different people.
• Swallow the capsules whole with a little water (do not crush or chew them).
• Take them with or without food. Patients NOT already treated with levodopa:
• The usual starting dose is 1 capsule (100 mg levodopa), three times a day with meals.
• The starting dose should not be more than 6 capsules (600 mg levodopa) a day.
• Your doctor will then increase your dose every 2 to 3 days until they find the right dose for you.
• Some people may also need to take another medicine for Parkinson’s disease with their first morning dose of Madopar CR. This is because Madopar CR releases the medicines slowly into the body. Patients already treated with levodopa:
• Your doctor will start by giving you one Madopar CR capsule to replace each 100 mg of levodopa you have been taking.
• Your doctor will then increase your dose every 2 to 3 days until they find the right dose for you. This may take up to 4 weeks.
• At the start of treatment your condition may become worse, until the right dose is found for you. Your doctor may want to supervise you closely during this time. 4 uk-madopar-pl-clean-150810-125-CR If you forget to take Madopar CR
• If you forget to take a dose, skip the missed dose. Then take the next dose when it is due.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking Madopar CR You must not stop taking your capsules without talking to your doctor first. This is because if you stop taking the capsules suddenly it can cause something called ‘neuroleptic malignant-like syndrome’ (NMLS). Early signs include increased shaking, sudden high body temperature and muscle problems including stiffness and trouble with balance and keeping upright (postural instability) especially if seen with sweating, paleness and fast heart beat. NMLS can be life threatening. If the above apply to you, talk to a doctor or go to a hospital straight away. If you take more Madopar CR than you should If you take more Madopar CR than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen if you have taken more capsules than you should: changes in your heart beat, confusion, difficulty sleeping, feeling or being sick and unusual movements of different parts of the body that you cannot control. If someone else takes your Madopar CR capsules by mistake, they should talk to a doctor or go to a hospital straight away. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines Madopar CR can cause side effects, although not everyone will get them.
See your doctor as soon as possible if you get the following side effects:
• Allergic reactions. The signs include a rash and feeling itchy.
• Heart beat that is uneven or is faster or slower than normal.
• Bleeding in your stomach or intestines. You may see blood in your stools (they may look black and tarry) or blood when you are sick (this may look like coffee grounds).
• Low numbers of all types of white blood cells. The signs include infections of your mouth, gums, throat and lungs.
• Reduced numbers of red blood cells, white blood cells and platelets in your blood. This may make you feel tired, get infections more easily, or bruise more easily or have nose bleeds. Other possible side effects:
Not known (frequency cannot be estimated from the available data) Stomach and gut:
• Loss of appetite, feeling sick or being sick or diarrhoea, particularly at the start of your treatment. To help with this, your doctor may tell you to take Madopar CR with some food or drink or increase your dose more slowly.
• A change in the colour of your saliva, tongue, teeth or inside of your mouth. Heart and circulation:
• Feeling dizzy when you stand up. This usually gets better if your dose is lowered. Blood:
• Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, palpitations (a fluttering sensation in your heart) and being short of breath.
• Changes to your liver or blood
•shown in a blood test. 5 uk-madopar-pl-clean-150810-125-CR Mental problems:
• Feeling excited, anxious, agitated, depressed, aggressive or disorientated (the feeling of being lost).
• Believing things which are not true, hallucinations (seeing and possibly hearing things that are not really there) or losing contact with reality.
• Feeling sleepy, sometimes during the daytime.
• Falling asleep suddenly.
• Having difficulty sleeping. Impulse Control Disorders: You may experience an inability to resist the impulse to perform an action that could be harmful, 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 Others:
• Unusual movements of different parts of your body which you cannot control. This may affect your hands, feet, face or tongue. Your doctor may change your dose of Madopar CR to help with these effects.
• You may experience 'on-off' effects. This is where you can switch quite suddenly between being 'on' and able to move, and being 'off' and immobile.
• An irresistible urge to move the legs and sometimes the arms.
• Changes to how things taste or a loss of taste.
• Redness of the face or neck.
• Your urine (water) may become slightly red. This is not a cause for concern. It is caused by your body getting rid of the medicine.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Malta ADR Reporting Website: https://www.medicinesauthority.gov.mt/adrportal United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
How to Store Prolopa CR
• Store Madopar CR capsules in their bottle, with the lid closed to protect the capsules from moisture.
• Do not store Madopar CR capsules above 25°C.
• Keep out of the sight and reach of children.
• Do not use Madopar CR after the expiry date printed on the pack.
• Do not throw away any medicines via household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
2 to 3 weeks on average
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