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TREMAPECIL 100MG/25MG/200MG

Active substance(s): CARBIDOPA / ENTACAPONE / LEVODOPA

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Your doctor may take some regular
laboratory tests during a long term
treatment with Tremapecil.
Package leaflet: Information for the user

Placement for Pharmacode no.

Tremapecil
50 mg/12.5 mg/200 mg
film-coated tablets
Tremapecil
75 mg/18.75 mg/200 mg
film-coated tablets
Tremapecil
100 mg/25 mg/200 mg
film-coated tablets
Tremapecil
125 mg/31.25 mg/200 mg
film-coated tablets
Tremapecil
150 mg/37.5 mg/200 mg
film-coated tablets
Tremapecil
200 mg/50 mg/200 mg
film-coated tablets
levodopa/carbidopa/entacapone
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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Tremapecil is and what it is used
for
2. What you need to know before you take
Tremapecil
3. How to take Tremapecil
4. Possible side effects
5. How to store Tremapecil
6. Contents of the pack and other
information

1. What Tremapecil is and
what it is used for
Tremapecil contains three active
substances (levodopa, carbidopa and
entacapone) in one film coated tablet.
Tremapecil is used for the treatment of
Parkinson’s disease.
Parkinson’s disease is caused by low
levels of a substance called dopamine in
the brain. Levodopa increases the amount
of dopamine and hence reduces the
symptoms of Parkinson’s disease.
Carbidopa and entacapone improve the
antiparkinson effects of levodopa.

2. What you need to know
before you take Tremapecil
Do not take Tremapecil if you
- are allergic to levodopa, carbidopa or
entacapone, or any of the other
ingredients of this medicine (listed in
section 6)
- have narrow-angle glaucoma (an eye
disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating
depression (combinations of selective
MAO-A and MAO-B inhibitors, or
non-selective MAO-inhibitors)
- have ever had neuroleptic malignant
syndrome (NMS - this is a rare reaction
to medicines used to treat severe mental
disorders)
- have ever had non-traumatic
rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Tremapecil if you have or have ever
had:
- a heart attack or any other diseases of
the heart including cardiac arrhythmias,
or of the blood vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may
need to be adjusted
- kidney or hormone-related diseases
- stomach ulcers or convulsions
- if you experience prolonged diarrhoea
consult your doctor as it may be a sign of
inflammation of the colon
- any form of severe mental disorder like
psychosis
- chronic wide-angle glaucoma, because
your dose may need to be adjusted and
the pressure in your eyes may need to
be monitored.
Consult your doctor if you are currently
taking:
- antipsychotics (medicines used to treat
psychosis)
- a medicine which may cause low blood
pressure when rising from a chair or bed.
You should be aware that Tremapecil
may make these reactions worse.
Consult your doctor if during the treatment
with Tremapecil you:
- notice that your muscles get very rigid or
jerk violently, or if you get tremors,
agitation, confusion, fever, rapid pulse, or
wide fluctuations in your blood pressure.
If any of this happens, contact your
doctor immediately
- feel depressed, have suicidal thoughts,
or notice unusual changes in your
behaviour
- find yourself suddenly falling asleep, or if
you feel very drowsy. If this happens,
you should not drive or use any tools or
machines (see also section 'Driving and
using machines')
- notice that uncontrolled movements
begin or get worse after you started to
take Tremapecil. If this happens, your
doctor may need to change the dose of
your antiparkinson medicine
- experience diarrhoea: monitoring of your
weight is recommended in order to avoid
potentially excessive weight loss
- experience progressive anorexia,
asthenia (weakness, exhaustion) and
weight decrease within a relatively short
period of time. If this happens, a general
medical evaluation including liver
function should be considered
- feel the need to stop using Tremapecil,
see section 'If you stop taking
Tremapecil'.
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
a preoccupation with an increase in sexual
thoughts or feelings. Your doctor may
need to review your treatments.

Size : 150 x 700 mm

If you must undergo surgery, please tell
your doctor that you are using Tremapecil.
Tremapecil is not recommended to be
used for treatment of extrapyramidal
symptoms (e.g. involuntary movements,
shaking, muscle rigidity and muscle
contractions) caused by other medicines.
Children and adolescents
Experience with Tremapecil in patients
under 18 years is limited. Therefore, the
use of Tremapecil in children is not
recommended.
Other medicines and Tremapecil
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Do not take Tremapecil if you are taking
certain medicines for treating depression
(combinations of selective MAO A and
MAO B inhibitors, or non selective MAO
inhibitors).
Tremapecil may increase the effects and
side effects of certain medicines.
These include:
- medicines used to treat depression such
as moclobemide, amitryptiline,
desipramine, maprotiline, venlafaxine
and paroxetine
- rimiterole and isoprenaline, used to treat
respiratory diseases
- adrenaline, used for severe allergic
reactions
- noradrenaline, dopamine and
dobutamine, used to treat heart diseases
and low blood pressure
- alpha-methyldopa, used to treat high
blood pressure
- apomorphine, which is used to treat
Parkinson’s disease.
The effects of Tremapecil may be
weakened by certain medicines.
These include:
- dopamine antagonists used to treat
mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions
- papaverine used to relax the muscles.
Tremapecil may make it harder for you to
digest iron. Therefore, do not take
Tremapecil and iron supplements at the
same time. After taking one of them, wait
at least 2 to 3 hours before taking the
other.
Tremapecil with food and drink
Tremapecil may be taken with or without
food. For some patients, Tremapecil may
not be well absorbed if it is taken with, or
shortly after eating protein-rich food (such
as meats, fish, dairy products, seeds and
nuts). Consult your doctor if you think this
applies to you.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
You should not breast-feed during
treatment with Tremapecil.
Driving and using machines
Tremapecil may lower your blood
pressure, which may make you feel
light-headed or dizzy. Therefore, be
particularly careful when you drive or
when you use any tools or machines.
If you feel very drowsy, or if you
sometimes find yourself suddenly falling
asleep, wait until you feel fully awake
again before driving or doing anything else
that requires you to be alert. Otherwise,
you may put yourself and others at risk of
serious injury or death.

3. How to take Tremapecil
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
For adults and elderly:
- Your doctor will tell you exactly how
many tablets of Tremapecil to take each
day.
- The tablets are not intended to be split or
broken into smaller pieces.
- You should take only one tablet each
time.
- Depending on how you respond to
treatment, your doctor may suggest a
higher or lower dose.
- If you are taking Tremapecil 50 mg/12.5
mg/200 mg, 75 mg/18.75 mg/200 mg,
100 mg/25 mg/200 mg, 125 mg/31.25
mg/200 mg or 150 mg/37.5 mg/200 mg
film-coated tablets, do not take more
than 10 tablets per day.
- If you are taking Tremapecil 200 mg/50
mg/200 mg film-coated tablets, do not
take more than 7 tablets of this strength
per day.
Talk to your doctor or pharmacist if you
think the effect of Tremapecil is too strong
or too weak, or if you experience possible
side effects.
If you take more Tremapecil than you
should
If you have accidentally taken more
Tremapecil than you should, talk to your
doctor or pharmacist immediately. In case
of an overdose you may feel confused or
agitated, your heart rate may be slower or
faster than normal or the color of your
skin, tongue, eyes or urine may change.
If you forget to take Tremapecil
Do not take a double dose to make up for
a forgotten tablet.
If it is more than 1 hour until your next
dose:
Take one tablet as soon as you remember,
and the next tablet at the normal time.
If it is less than 1 hour until your next
dose:
Take a tablet as soon as you remember,
wait 1 hour, then take another tablet. After
that carry on as normal.
Always leave at least an hour between
Tremapecil, to avoid possible side effects.
If you stop taking Tremapecil
Do not stop taking Tremapecil unless your
doctor tells you to. In such a case your
doctor may need to adjust your other
antiparkinson medicines, especially
levodopa, to give sufficient control of your
symptoms. If you suddenly stop taking
Tremapecil and other antiparkinsonian
medicines it may result in unwanted side
effects.

Placement for Pharmacode no.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Placement for internal code no.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them. Many of the side effects can be
relieved by adjusting the dose.

Placement for Pharmacode no.

If you during the treatment with Tremapecil
experience the following symptoms,
contact your doctor immediately:
- Your muscles get very rigid or jerk
violently, you get tremors, agitation,
confusion, fever, rapid pulse, or wide
fluctuations in your blood pressure.
These can be symptoms of neuroleptic
malignant syndrome (NMS, a rare
severe reaction to medicines used to
treat disorders of the central nervous
system) or rhabdomyolysis (a rare
severe muscle disorder).
- Allergic reaction, the signs may include
hives (nettle rash), itching, rash, swelling
of your face, lips, tongue or throat. This
may cause difficulties in breathing or
swallowing.
Very common (may affect more than 1 in
10 people):
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discoloration of
urine
- muscle pain
- diarrhoea
Common (may affect up to 1 in 10 people):
- light-headedness or fainting due to low
blood pressure, high blood pressure
- worsening of Parkinson`s symptoms,
dizziness, drowsiness
- vomiting, abdominal pain and discomfort,
heartburn, dry mouth, constipation
- inability to sleep, hallucinations,
confusion, abnormal dreams (including
nightmares), tiredness
- mental changes – including problems
with memory, anxiety and depression
(possibly with thoughts of suicide)
- heart or artery disease events (e.g. chest
pain), irregular heart rate or rhythm
- more frequent falling
- shortness of breath
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection
Uncommon (may affect up to 1 in 100
people):
- heart attack
- bleeding in the gut
- changes in the blood cell count which
may result in bleeding, abnormal liver
function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g.
skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate
The following side effects have also been
reported:
- hepatitis (inflammation of the liver)
- itching

crospovidone (Type B), povidone K-30,
magnesium stearate and sodium citrate.
- The ingredients in the film-coating are
hypromellose, macrogol 6000, titanium
dioxide (E171), polysorbate 80, iron
oxide red (E172) and iron oxide yellow
(E172) (for 50 mg/12.5 mg/200 mg,
100 mg/25 mg/200 mg and 150 mg/
37.5 mg/200 mg).
What Tremapecil looks like and
contents of the pack
Tremapecil 50 mg/12.5 mg/200 mg
film-coated tablets: Light brown to grayish
red colored, round, approximately 11.3 mm
in diameter, biconvex, film-coated tablets
with debossed “50” on one side and plain
on other side.
Tremapecil 75 mg/18.75 mg/200 mg
film-coated tablets: Light brown to light
pink colored, oval shaped, approximately
15.2 mm in length and 7.2 mm in width,
film-coated tablets with debossed “75” on
one side and plain on other side.
Tremapecil 100 mg/25 mg/200 mg
film-coated tablets: Light brown to grayish
red colored, oval shaped, approximately
16.7 mm in length and 7.7 mm in width,
film-coated tablets with debossed “100” on
one side and plain on other side.
Tremapecil 125 mg/31.25 mg/200 mg
film-coated tablets: Light brown to light
pink colored, elongated-ellipse shaped,
approximately 15.2 mm in length and 9.7
mm in width, film-coated tablets with
debossed “125” on one side and plain on
other side.
Tremapecil 150 mg/37.5 mg/200 mg
film-coated tablets: Light brown to grayish
red colored, elongated-ellipse shaped,
approximately 16.2 mm in length and 10.2
mm in width, film-coated tablets with
debossed “150” on one side and plain on
other side.
Tremapecil 200 mg/50 mg/200 mg
film-coated tablets: Dark brownish red
colored, oval shaped, approximately 19.15
mm in length and 9.05 mm in width,
film-coated tablets with debossed "200" on
one side and plain on other side.
Tremapecil comes in three different pack
sizes (30, 100 or 130 tablets). Not all pack
sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Manufacturer :
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Wessling Hungary Kft.,
Fóti út 56., Budapest
1047, Hungary
Pharmacare Premium Ltd.
HHF 003 Hal Far Industrial Estate,
Hal Far, Birzebbugia
BBG 3000, Malta
This leaflet was last revised in 04/2016.

You may experience the following side
effects:
- Inability to resist the impulse to perform
an action that could be harmful, which
may include:
- strong impulse to gamble excessively
despite serious or personal 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 behaviors; they will discuss ways of
managing or reducing the symptoms.
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 via
For UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
For Malta
ADR Reporting
Website:
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Tremapecil
HDPE bottle pack should be used within 6
months after first opening.
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the bottle and the
carton after EXP. The expiry date refers to
the last day of that month.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help to protect the environment.

6. Contents of the pack and
other information
What Tremapecil contains
- The active substances of Tremapecil are
levodopa, carbidopa and entacapone.
- Each Tremapecil 50 mg/12.5 mg/200 mg
film-coated tablet contains 50 mg of
levodopa, 12.5 mg of carbidopa and
200 mg of entacapone.
Each Tremapecil 75 mg/18.75 mg/
200 mg film-coated tablet contains 75 mg
of levodopa, 18.75 mg of carbidopa and
200 mg of entacapone.
Each Tremapecil 100 mg/25 mg/200 mg
film-coated tablet contains 100 mg of
levodopa, 25 mg of carbidopa and 200 mg
of entacapone.
Each Tremapecil 125 mg/31.25 mg/
200 mg film-coated tablet contains
125 mg of levodopa, 31.25 mg of
carbidopa and 200 mg of entacapone.
Each Tremapecil 150 mg/37.5 mg/200
mg film-coated tablet contains 150 mg of
levodopa, 37.5 mg of carbidopa and
200 mg of entacapone.
Each Tremapecil 200 mg/50 mg/200 mg
film-coated tablet contains 200 mg of
levodopa, 50 mg of carbidopa and 200 mg
of entacapone.
- The other ingredients in the tablet core
are microcrystalline cellulose,

Size : 150 x 700 mm

Placement for Pharmacode no.

xxxxxxx-xxxx

Placement for internal code no.

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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.

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