MADOPAR CR 100MG/25MG PROLONGED RELEASE HARD CAPSULES

Active substance: LEVODOPA

View full screen / Print PDF » Download PDF ⇩
Transcript
S0085-100-RM-PIL-16.07.2014

Assessed against UK PIL dated February 2014

Patient Information Leaflet

Madopar® CR 100mg/25mg
Prolonged Release Hard Capsules
levodopa and benserazide (as hydrochloride)
Your medicine is available using the above name but will be
referred to as Madopar CR throughout the remainder of this
leaflet.
Please 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. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Madopar CR is and what it is used for
2. What you need to know before you take Madopar CR
3. How to take Madopar CR
4. Possible side effects
5. How to store Madopar CR
By addisonf at 2:33 pm, Aug 19, 2014
6. Contents of the pack and other information

MOCK UP

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.

Other medicines and Madopar CR
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 sulfate (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.
 Strong painkillers - such as codeine or morphine.

Operations

The capsules are designed to release the medicines into your body
slowly. This is why they are called ‘CR’ which stands for ‘controlled
release’.

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.

2. What you need to know before you take
Madopar CR

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.

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: Contents of
the pack and other information).
 You have a problem with the pressure in your eyes called ‘narrowangle 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 ‘nonselective monoamine oxidase inhibitor’ (MAOI) in the last 14 days.
These medicines include isocarboxazid and phenelzine. See the
section on ‘Other medicines and Madopar’.
 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.

Warnings and precautions

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.

Talk to your doctor or pharmacist before taking Madopar CR if:
 You have a problem with the pressure in your eyes called ‘wideangle 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.

Patients NOT already treated with levodopa:

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 treatments.
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.

 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 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:

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.

 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.
 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.

5. How to store Madopar CR
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.

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.

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.







Do not store above 25°C.
Store in the original package in order to protect from moisture.
Keep out of the sight and reach of children.
Do not use Madopar CR after the expiry date printed on the pack.
If your doctor tells you stop taking this medicine, take any unused
capsules back to your doctor for safe disposal. Only keep them if
your doctor tells you to.
 If the capsules become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
 Keep bottle tightly closed.

6. Contents of the pack and other information
What Madopar CR contains
There are two active substances in Madopar CR.
Each capsule contains 100 mg levodopa and 25 mg benserazide as
the hydrochloride. Other ingredients in the capsules are: hypromellose,
hydrogenated vegetable oil, calcium hydrogen phosphate anhydrous
(E341), mannitol (E421), povidone K30, talc (E553b), magnesium
stearate (E572). Capsule shell, body: indigo carmine (E132), titanium
dioxide (E171), gelatin; capsule shell, cap: indigo carmine (E132),
yellow iron oxide (E172), titanium dioxide (E171), gelatin. Printing ink:
shellac, concentrated ammonia solution, red iron oxide, potassium
hydroxide and propylene glycol.

What Madopar CR looks like and contents of the pack
The capsules are green and blue in colour and have Roche printed in
red on each end. Madopar CR is supplied in amber coloured glass
bottles containing 100 capsules with integrated dessicant on the screw
cap.
Manufactured by: Roche Pharma AG, Emil-Barell-Str. 1, 79639
Grenzach-Wyhlen, Germany.
Procured from within the EU and repackaged by: Amimed Direct
Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial
Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL No: 33902/0085

This leaflet was last approved: 16.07.2014
Madopar® is a registered trademark of Roche Products Limited.
S0085-100-RM-PIL-16.07.2014

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
(web2)