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levodopa + benserazide - Madopar
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   Madopar

 Madopar  Product Name :   Madopar (Sold under the brand name Prolopa in the U.S.)
Product Type :   Levodopa and benserazide hydrochloride
Packaging and Product :  
62.5mg (50mg levodopa – 12.5 mg beserazide) Capsules in Bottles of 100 Capsules or
125mg (100mg levodopa – 25 mg beserazide) Capsules in Bottles of 100 Capsules or
250mg (200mg levodopa – 50 mg beserazide) Capsules in Bottles of 100 Capsules or
125mg HBS (Controlled release) (100mg levodopa – 25 mg beserazide) Capsules in Bottles of 100 Capsules

Manufacturer :   Roche

  Madopar: Manufacturers Information Sheet
  Madopar: Manufacturers Information Sheet for Patients

** This Product has been Discontinued and we can no longer supply it.

 General Information about Madopar

Madopar (Prolopa)HBS is a controlled-release preparation and is not as popular with people with Parkinson's because the onset of clinical improvement is slower than with standard levodopa preparations. However, this preparation can be useful at night time and for people with levodopa-related motor fluctuations.

How does it work?

This medicine contains the active ingredients levodopa and benserazide hydrochloride. It is used in Parkinson’s disease to increase the levels of dopamine in the brain.

Dopamine is a substance known as a neurotransmitter. Neurotransmitters are present in the brain and nervous system and are involved in transmitting messages between nerves. These messages allow the normal functioning of the body. The neurotransmitter dopamine is known to be reduced or absent in the brains of people with Parkinson's disease, and this is thought to be the cause of the disease symptoms.

When you take levodopa, it is converted into dopamine in the brain. This replaces the lost dopamine and therefore reduces some of the symptoms of the disease.

Unfortunately, levodopa is also converted into dopamine in the rest of the body, which can cause unwanted side effects such as nausea and palpitations. Benserazide hydrochloride is used in combination with the levodopa to prevent this happening. It blocks the conversion of levodopa to dopamine in the body and so prevents these side effects. (Benserazide cannot pass into the brain and so does not affect the conversion of levodopa to dopamine in the brain.)

The combination of levodopa and benserazide is therefore effective in the treatment of Parkinson's disease, while minimising the side effects caused by levodopa on the rest of the body.

What is it used for?

Parkinson's disease

Warning!

You should not suddenly stop taking this medicine unless your doctor tells you otherwise.

People with diabetes should monitor their blood sugar carefully during treatment with this medicine.

This medicine may be harmful to an unborn baby. Women of child-bearing age should use a reliable contraceptive method to prevent pregnancy while using this medicine.

You should have regular tests to monitor the function of your liver, blood, kidney and heart while taking this medicine.

This medicine may colour your urine red. This is not harmful.

If your symptoms start to improve on this medicine make sure you resume your normal activities gradually. Try not to do too much too quickly as you may risk injury.

This medicine may cause drowsiness or psychiatric disturbances in certain people. If you are affected in this way, do not drive or operate machinery.

This medicine may affect the results of certain laboratory tests, including those for testing glucose levels in blood or urine. If you have diabetes ask your doctor for further information about this. Tell your doctor that you are taking this medicine if you have any blood or urine tests.

Use with caution in

  • asthma
  • chronic obstructive airways disease
  • diabetes mellitus
  • disease involving the heart and blood vessels (cardiovascular disease)
  • disorders relating to hormone producing glands (endocrine disorders)
  • high blood pressure (hypertension)
  • history of heart attack
  • history of irregular heart beats (arrhythmias)
  • kidney disease
  • liver disease
  • lung disease
  • open angle glaucoma
  • peptic ulcer
  • psychiatric disorders
  • softening of the bones when there is lack of Vitamin D in the body (osteomalacia)

Not to be used if you have or are

  • breastfeeding
  • closed angle glaucoma
  • a history of skin cancer (malignant melanoma)
  • under 25 years of age
  • pregnant
  • a severe disease of the hormone producing glands (endocrine disease)
  • a severe heart disease
  • a severe kidney disease
  • a severe liver disease
  • a severe psychotic illness

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy as it may be harmful to the unborn baby. Women of child bearing potential should use adequate contraception to prevent pregnancy while taking this medicine. Seek medical advice from your doctor.

This medicine may pass into breast milk, therefore mothers taking this medicine must not breastfeed. Discuss with your doctor.

Label warnings

Take this medication with or after food.

This medication may cause your urine to be coloured.

Side Effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

  • difficulty in sleeping (insomnia)
  • a drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension)
  • drowsiness
  • sweating
  • blood disorders
  • involuntary movements with prolonged use of medicine
  • red colouration of urine
  • abnormal heart beats (arrhythmias)
  • flushing
  • mood changes, strange thoughts or depression
  • loss of appetite
  • bleeding from the stomach or intestine
  • skin reactions such as rash and itch
  • anxiety and agitation
  • disturbances of the gut such as nausea, vomiting, diarrhoea or abdominal pain

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

This medicine should not be taken at the same time as, or within two weeks of stopping a monoamine oxidase inhibitor antidepressant (MAOI), with the exception of moclobemide or selegiline.

The following medicines should be avoided while taking this medicine as they may interfere with the effect of levodopa:

  • opioids, eg morphine
  • phenothiazines, eg chlorpromazine, prochlorperazine
  • butyrophenones, eg haloperidol, benperidol
  • thioxanthines, eg flupentixol, zuclopenthixol
  • reserpine
  • tetrabenazine
  • metoclopramide
  • amphetamines
  • papaverine

If they are essential, you and your doctor should keep a look out for any increased or decreased effects and any unusual side effects while taking the combination.

If this medicine is taken with medicines to treat high blood pressure (antihypertensives), your blood pressure may drop too low, making you feel dizzy or lightheaded. Your doctor may need to adjust the dose of the antihypertensive.

Sympathomimetic medicines, such as the following, may increase the risk of side effects on the heart and should only be used in combination with this medicine on medical advice:

  • decongestants, eg ephedrine, phenylephrine
  • asthma relievers, eg salbutamol, salmeterol
  • amphetamines

Iron preparations, eg ferrous sulphate, may decrease the absorption of this medicine from the gut.

Benzodiazepines, eg diazepam, may decrease the therapeutic effects of this medicine.

Tricyclic antidepressants, eg amitriptyline, may decrease the therapeutic effects of this medicine, and may also rarely increase the risk of a dangerous rise in blood pressure (hypertensive crisis).

This medicine can be used with other medicines for Parkinson’s disease, eg anticholinergics, amantadine, dopamine agonists or COMT inhibitors, however both the desired effects and side effects of treatment may be intensified. Your doctor may need to adjust the dose of one or more of your medicines to get the correct balance.


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