MADOPAR

levodopa + benserazide

62.5mg, 125mg or 250mg capsules

62.5mg dispersible tablet

125mg HBS capsule (controlled release capsule)

What is in this leaflet

This leaflet answers some common questions about Madopar tablets and capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Madopar against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Madopar is used for

The name of your medicine is Madopar. It contains two active ingredients called levodopa and benserazide.

Madopar belongs to a group of medicines called antiparkinsonian agents.

Antiparkinsonian agents are used to treat Parkinson's disease and work on the central nervous system. The symptoms of Parkinson's disease are caused by a deficiency of a natural substance in the nervous system. Madopar helps to replace this substance. By improving muscle control, Madopar allows more normal movements of the body.

Your doctor, however, may have prescribed Madopar for another purpose. Ask your doctor if you have any questions why Madopar has been prescribed for you.

Before you take Madopar

Do not take Madopar if:

• you have had an allergic reaction to any of the ingredients listed in the Ingredients section of this leaflet
• you have taken the non-selective monoamine oxidase (MAO) inhibitors tranylcypromine (Parnate®) or phenelzine (Nardil®) within the last 2 weeks
• you have taken a combination of a selective MAO-A inhibitor such as moclobemide (Aurorix®) with a selective MAO-B inhibitor such as selegiline (Eldepryl®, Selgene®, Apo-Selegiline®)
• you have untreated heart, liver, kidney or endocrine (hormonal) disease
• you have narrow angle glaucoma (high pressure in the eye)
• you are being treated for severe mental problems
• you are under the age of 25 years old
• you are pregnant or could become pregnant

Do not take Madopar after the expiry date printed on the pack. It may have no effect or, worse, an entirely unexpected effect if you take it after the expiry date. If the Pharmacist has repacked the medicine for you, there may not be an expiry date on the pack.

Do not take Madopar if the package is torn or shows signs of tampering.

If you are not sure if you should be taking Madopar, talk to your doctor.

You must tell your doctor if:

1. you are allergic to any other medicines, foods, dyes or preservatives
2. you have any other health problems including:
   • diabetes
   • glaucoma
   • depression or other psychological disorder
3. you are pregnant or intend to become pregnant. You should not take Madopar if you are pregnant or intend to become pregnant.
4. you are breastfeeding or wish to breastfeed. You should not take Madopar if you are breastfeeding or intend to breastfeed.

Taking certain foods

Madopar may not work as well as usual when taken with a protein rich meal.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood shop.

Other medicines may interfere with Madopar. These medicines include:

• those containing iron (Fergon^®, Ferrogradumet^®, Ferrograd C^®, Ferro-Grad Folic^® )
• metoclopramide (Maxolon^®, Metamide^®, Paramax^® )
• sympathomimetics eg. medicines containing ephedrine or pseudoephedrine (such as cough and cold medicines), adrenaline, isoprenaline, amphetamine
• blood pressure lowering medications containing reserpine
• some medications used to treat mental disorders
• general anaesthetics (medicines that put you to sleep before an operation). If you know you are going to have an operation, talk to your doctor beforehand.
• other antiparkinsonian agents
• opioids such as morphine, pethidine, methadone and codeine (may be present in some cough and cold or pain relieving medicines)
• antacids (medicines for heartburn, indigestion) should not be taken at the same time as Madopar HBS, as they interfere with the controlled release characteristics of Madopar HBS. Antacids can be taken at other times of the day.

Your doctor or pharmacist has a complete list of medicines to avoid while taking Madopar.

If you have not told your doctor about any of the above, tell them before you start taking Madopar.

Use Madopar exactly as your doctor has prescribed.

How to take Madopar

How much to take

Your doctor will tell you how many Madopar tablets or capsules to take each day.

The dose depends on your individual symptoms and your response. The dose of Madopar has to be carefully adjusted for each person as your Parkinson's symptoms will not be controlled if you take too little Madopar. If you take too much Madopar, you may experience unwanted effects. It may be several weeks before the best dose for you is reached.

Remember this is just a guide. This guide can be used for Madopar capsules or tablets.

Treatment with Madopar is usually started with low doses eg. one Madopar 62.5 three or four times a day. This may be increased over the next 4 to 6 weeks until you have reached your best dose. Usually, this dose will be Madopar 125 three to six times a day. Your doctor may prescribe other Madopar tablets or capsules to be taken as well as or instead of Madopar 125.

Madopar HBS is different from other Madopar products. It takes longer to start working but its effects last longer.

If you change from normal Madopar to Madopar HBS, you start on the same number of capsules or tablets, but this is gradually increased by your doctor.

Some people who change to Madopar HBS capsules might feel a little worse at first.

When you take Madopar HBS, your doctor may tell you to take a Madopar capsule or dispersible tablet in the morning as well to help maintain better control of your symptoms.

How to take it

Capsules should be swallowed whole with a glass of water or non-alcoholic drink.

Madopar 62.5 dispersible tablets are for people who have difficulty swallowing whole tablets or who require the medicine to work quickly. They may be dispersed in at least 25mL to 50mL of water. The tablets will disperse completely within a few minutes giving a milky-looking liquid which you should drink within 30 minutes. Remember to stir the liquid immediately before taking.

Madopar tablets can be broken across the score line. Any tablets which do not break cleanly along the line should not be taken.

When to take it

If possible, Madopar should be taken at least 30 minutes before a meal or one hour after a meal.

How long to take Madopar

When you start Madopar you will need to take it long term. You may need at least 6 months before deciding if Madopar is working for you.

Continue taking it until your doctor tells you to stop.

If you forget to take Madopar

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

Do not double a dose to make up for one you have missed.

In case of an overdose

Immediately telephone your doctor go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Madopar even, if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you take an overdose of Madopar, you will experience some or all of the symptoms described under unwanted effects but these symptoms will be more severe.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking Madopar

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking Madopar.

Do not take any other medicines whether they require a prescription or not without first telling your doctor.

Tell your doctor if you become pregnant while taking Madopar.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Things you must not do

Do not stop taking Madopar or lower the dose without first checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.

Do not give Madopar to anyone else even if their symptoms seem similar to yours.

Do not use Madopar to treat other complaints unless your doctor says to.

Things to be careful of

Be careful driving or operating machinery until you know how Madopar affects you.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Madopar.

Madopar helps most people with Parkinson's Disease but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

If side effects do occur, they may be:

• abnormal involuntary jerking movements of the body. These are usually caused if your dose is too high and will lessen or disappear when your dose is reduced.
• mental changes including agitation, anxiety, insomnia, hallucinations and delusions
• depression
• dizziness on standing up
• your urine may be a red colour.

Other common side effects especially if you have just started Madopar may be:

• nausea and vomiting
• loss of appetite
• diarrhoea
• loss of taste.

Tell your doctor if you notice any of the following and they worry you:

• palpitations
• diarrhoea
• confusion
• tiredness
• skin rash
• itching

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Madopar

Storage

Keep Madopar in a cool dry place.

Do not store it, or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep Madopar where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep your tablets or capsules in the bottle until it is time to take them.

If you take the tablets or capsules out of the bottle they may not keep well.

Disposal

If your doctor tells you to stop taking Madopar, or the tablets/capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product Description

What Madopar looks like

There are 5 Madopar products to meet individual needs.

Ingredients

Active ingredients:

• Madopar 62.5 capsules and dispersible tablets contain levodopa 50mg and benserazide 12.5mg.
• Madopar 125 capsules and Madopar HBS capsules contain levodopa 100mg and benserazide 25mg.
• Madopar 250 capsules contain levodopa 200mg and benserazide 50mg.

Inactive ingredients:

• Madopar Dispersible tablets contain:
  • citric acid
  • maize starch
  • microcrystalline cellulose
  • magnesium stearate
• Madopar 62.5, 125 and 250 capsules all contain:
  • microcrystalline cellulose
  • talc
  • povidone
  • magnesium stearate
  • indigo carmine (132)
  • titanium dioxide (171)
  • iron oxide (red, yellow or black - 172)
  • gelatin
  • Madopar 62.5 also contains mannitol.
• Madopar HBS capsules contain:
  • mannitol
  • talc
  • povidone
  • magnesium stearate
  • calcium hydrogen phosphate
  • hypromellose
  • hydrogenated vegetable oil
  • indigo carmine (132)
  • iron oxide yellow (172)
  • titanium dioxide (171)
  • gelatin

Appearance

Madopar 62.5 dispersible tablets are white with a break bar.

Madopar 62.5 are blue/grey coloured capsules.

Madopar 125 are blue/pink coloured capsules.

Madopar 250 are blue/brown coloured capsules.

Madopar HBS capsules are dark green/light blue in colour.

   Inhouse Pharmacy