MADOPAR CR 100MG/25MG CAPSULES

Active substance: LEVODOPA

View full screen / Print PDF » Download PDF ⇩

Transcript
1. What Madopar CR is and what it is used for
Madopar CR capsules contain two medicines called levodopa and benserazide. They are used to treat Parkinson’s disease.
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’.

DATE:

Take special care with Madopar CR
Check with your doctor or pharmacist before you take Madopar CR if:
• You have a problem with the pressure in your eyes called ‘wide-angle glaucoma’.
• You have problems with your hormones, kidneys, lungs or liver.
• You have diabetes (high blood sugar).
• You have heart problems, particularly an uneven heart beat (arrhythmia) or you have had a heart attack.
• You have any mental illness, such as depression.
• You have a ‘peptic ulcer’, an ulcer in your stomach, or in the tube leading from it (‘duodenal ulcer’).
• You have something called ‘osteomalacia’ which causes problems with the strength of your bones.
Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you
or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These
behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally
high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.

DATE:

CUSTOMER
APPROVED:

UK PIL GRANTED 6TH DECEMBER 2012
MULTIPLE MANUFACTURERS
INCLUDING LEVODOPA
CONTAINING SAFETY WARNING

6464/2591F

07/01/13
DATE OF PROOF:

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Madopar CR.

CODE:

DT
ARTWORKER:
PRODUCT: Madopar CR 100mg 25mg caps

04-1957
PRE-PRESS NO.:
CUSTOMER:Waymade

Q.A.
APPROVED:

2. Before you take Madopar CR
Do not take Madopar CR if:
• You are allergic (hypersensitive) to levodopa, benserazide or any of the other ingredients of Madopar CR (listed in Section
6: Further information).
• You have a problem with the pressure in your eyes called ‘narrow-angle glaucoma’.
• You have serious problems with your kidneys, liver or heart.
• You have a serious problem with your hormones, such as an overactive thyroid gland.
• You have a severe mental problem which may make you distressed and anxious, or may make you lose contact with
reality and become unable to think and judge clearly.
• You have depression and have taken a medicine called a ‘non-selective monoamine oxidase inhibitor’ (MAOI) in the last
14 days. These medicines include isocarboxazid and phenelzine. See the section on ‘Taking other medicines’.
• You are pregnant or trying to become pregnant. See the section on ‘Pregnancy and breast-feeding’.
• You are under 25 years of age. This is because your bones may not have finished developing.
• You have ever had skin cancer.
Do not take Madopar CR if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take
Madopar CR.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you
buy without a prescription and herbal medicines.
This is because Madopar CR can affect the way some medicines work. Also some other medicines can affect the way Madopar CR
works.
Do not take Madopar CR if you have taken a medicine for depression called a ‘non-selective monoamine oxidase inhibitor’ (MAOI)
in the last 14 days.
These medicines include isocarboxazid and phenelzine. If this applies to you, do not take Madopar CR and ask your doctor or
pharmacist for advice.
In particular, tell your doctor or pharmacist if you are taking the following medicines:
• Other medicines for Parkinson’s disease, such as amantadine, ‘anticholinergics’ called orphenadrine and benzhexol,
‘dopamine agonists’ called pergolide and ropinirole and a ‘COMT inhibitor’ called entacaprone.
• Ferrous sulphate (used to treat low levels of iron in the blood).
• Antacids (used for stomach acid if you have indigestion).
• Metoclopramide (used to treat problems with digestion).
• Phenothiazines – such as chlorpromazine, promazine and prochloroperazine (used to treat mental illness).
• Thioxanthenes – such as flupentixol and zuclopenthixol (used to treat mental illness).
• Butyrophenones – such as haloperidol and benperidol (used to treat mental illness).
• Diazepam (used to treat anxiety and insomnia).
• Tetrabenazine (used to help problems controlling your muscle movement).
• Papaverine (used to improve blood flow around the body).
• Treatment for high blood pressure (hypertension), in particular reserpine.
• ‘Sympathomimetics’ – such as epinephrine, norepinephrine and isoproterenol (used to treat problems with your heart or
asthma).
• Amphetamines – medicines used for attention deficit disorder, feeling sleepy during the day (narcolepsy) or to help control
appetite and weight gain.
Operations
If you are going to have an operation, tell the doctor that you are taking Madopar CR. This is because you may need to stop taking
it before you have a general anaesthetic.
Tests
If you need to have tests on your blood or urine, tell the doctor or nurse that you are taking Madopar CR. This is because the
medicine may affect the results of some tests.
Pregnancy and breast-feeding
Do not take Madopar CR if you are pregnant, trying to get pregnant or breast-feeding. This is because Madopar CR may affect
your baby. It is important for women to use contraception while taking the medicine.
If you get pregnant while taking Madopar CR, talk to your doctor straight away.
Driving and using machines
Talk to your doctor about driving and using machines or tools, when you take Madopar CR. This is because one of the medicines
in Madopar CR, levodopa, can make you feel very sleepy. This can happen very quickly, even during the day.
You must not drive or use machines if this happens to you. If you are in any doubt about whether you can do a particular activity,
talk to your doctor.
3. How to take Madopar 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.

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

In this leaflet:
1. What Madopar CR is and what it is used for
2. Before you take Madopar CR
3. How to take Madopar CR
4. Possible side effects
5. How to store Madopar CR
6. Further information

PROOF HISTORY:
v.1 - waymade - 07/01/13

Leaflet Flat Size = 180 x 429

Please 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 become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This medicine is known as Madopar CR 100mg/25mg Capsules but will be referred to as Madopar CR throughout this leaflet.

WARNING!

27mm

MADOPAR CR® 100mg/25mg CAPSULES
(Levodopa/benserazide hydrochloride)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000F

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Stopping 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.
4. Possible side effects
Like all medicines Madopar CR can cause side effects, although not everyone will get them.

PROOF HISTORY:
v.1 - waymade - 07/01/13

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.
• Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds.
Other possible side effects
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.

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.

UK PIL GRANTED 6TH DECEMBER 2012
MULTIPLE MANUFACTURERS
INCLUDING LEVODOPA
CONTAINING SAFETY WARNING

CODE:

6464/2591F

07/01/13

DATE:

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.

DATE OF PROOF:

PRODUCT:

04-1957
PRE-PRESS NO.:

DT
Madopar CR 100mg 25mg caps

CUSTOMER: Waymade

ARTWORKER:

Q.A.
APPROVED:

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.

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.
• Changes to how things taste or a loss of taste.
• Redness of the face or neck.
• Sweating.
• 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.
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.







5. How to store Madopar CR
Store in the original package. Keep bottle tightly closed
Do not store above 25 °C.
Keep out of the reach and sight of children.
Do not use after the expiry date printed on the pack.
Do not throw away any left over capsules. Instead, return them to your pharmacist so that they can be disposed of
carefully. Only keep them if your doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacist who will advise you what to do.

6. Further information
What Madopar CR contains
Each capsule contains 100mg of levodopa and 25mg benserazide (as the hydrochloride) in a prolonged release formulation.
Other ingredients in the capsules are
mannitol (E421), hypromellose, hydrogenated vegetable oil, calcium hydrogen phosphate, povidone, talc, titanium dioxide (E171),
yellow iron oxide (E172), indigo carmine (E132), gelatin and magnesium stearate.
What Madopar CR looks like and contents of the pack
Each capsule is marked with the name 'Roche' in red on the dark green cap and also on the light blue body.
Madopar CR is available as bottles of 100 capsules.
Product Licence Holder and Manufacturer
POM

PL No: 6464/2591

This product is manufactured for F. Hoffman La Roche, CH-4002 Basle, Switzerland, or, Roche Polska sp. z.o.o., ul Domaniewska
39B, 02-672 Warsaw, Poland and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 4.1.2013

WARNING!

DATE:

CUSTOMER
APPROVED:

Heart and circulation:
• Feeling dizzy when you stand up. This usually gets better if your dose is lowered.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Leaflet Flat Size = 180 x 429

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.

WARNING!

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

27mm

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.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)