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TILOLEC 200/50MG TABLETS

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PATIENT INFORMATION LEAFLET

Tilolec 100/25mg and 200/50mg
Prolonged Release Tablets
(Levodopa and Carbidopa Monohydrate)
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 further questions, please ask your doctor or
pharmacist.
This medicine has been prescribed for you personally and
you should not pass it on to other people. It may harm
them even if their symptoms are the same as yours.
If any of the side effects become serious or you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What this medicine is and what it is used for
Before you take
How to take
Possible side effects
How to store
Further information
What this medicine is and what it is used for

Tilolec belongs to a class of medicines used to treat Parkinson’s
disease.
The symptoms of this disease are probably caused by a lack of
dopamine, a substance that is normally produced by the brain.
Dopamine plays a role in controlling muscle movement. A lack
of it causes problems in muscle movement. Levodopa
compensates for the lack of dopamine, whilst Carbidopa
ensures that enough Levodopa reaches the brain.
The “on-off” phenomenon is a characteristic of some but not all
people with long-standing Parkinson’s disease. It can best be
described as an unpredictable shift from mobility - “on” - to a
sudden inability to move - “off”.
It reduces the “off” time (a sudden onset of muscle stiffness that
can last for minutes or even hours) if you are being treated with
Levodopa alone, levodopa/decarboxylase inhibitor tablets with
an immediate-release formulation (e.g. Carbidopa) and if you
suffer from sudden uncontrolled movements.
2.

Before you take

Do not take Tilolec:

If you are allergic (hypersensitive) to Levodopa, Carbidopa
or any of the other ingredients in the tablets (these are
listed in Section 6, Further information)

if you have increased eye pressure (narrow-angle
glaucoma)

if you are suffering from severe heart failure

if you have a serious heart rhythm disorder

in the event of a sudden stroke

if you are not allowed to use medicines that act on the
central nervous system (sympathomimetic agents)

if you are using non-selective monoamine oxidase
inhibitors and selective, type-A MAO inhibitors (MAO
inhibitors; medicines used in depression). You must stop
taking these medicines for at least two weeks before
starting treatment with Tilolec
Tilolec may be co-administered with the recommended
dose of a MAO inhibitor which is selective for MAO type B
(e.g. selegiline)

Take special care with Tilolec – Tell your doctor if any of
the following apply to you:

if you are currently being, or have ever been, treated with
Levodopa on its own. You must wait for at least 12 hours
before you can start taking Tilolec tablets

if you suffer from movement disorders such as facial
muscle twitches, muscle rigidity and stiffness, difficulties in
starting to move, trembling of the fingers or hands. It may
be necessary to reduce the dose

If you have ever suffered from involuntary movements in
the past

if you have ever had a psychotic episode or suffered from
psychosis (a severe mental illness whereby control over
one’s own conduct and behaviour is impaired). Very rarely,
there have been reports of patients who became depressed
and who later developed suicidal tendencies. If you think
that this also applies to you, you are advised to contact
your doctor immediately (See Section 4 Possible side
effects)

if you are constantly tired and/or prone to falling asleep
without warning. You must not drive or operate machinery.
Your doctor will adjust your dose if necessary, or stop your
treatment altogether (See Section 2, Driving or using
machinery)

if you have a severe cardiovascular condition

if you have a severe lung disease or if you experience
sudden attacks of breathlessness caused by muscular
spasms and swelling of the mucous membrane inside the
airways, often accompanied by coughing and the
production of phlegm (bronchial asthma)

if you have a kidney or liver disorder, or if you have
problems with your endocrine system (glands that secrete
hormones internally into the blood stream)

if you have ever had stomach or intestinal ulcers, as there
is a greater risk of stomach bleeding

if you are vomiting blood

if you have ever had seizures/convulsions

if you have recently had a heart attack and are still suffering
from heart rhythm disorders

if you have chronic glaucoma (increased eye pressure)

if your Tilolec dose is suddenly lowered or stopped,
particularly if you are receiving medicines to treat psychosis
as this may trigger off a change in your mental condition;
muscle rigidity and increased body temperature may occur

if you have an hereditary disease characterised by sudden
involuntary but co-ordinated movements (Huntington’s
chorea). Use of Tilolec is not recommended

if you have ever had a malignant melanoma

if you have a skin condition that has not yet been
diagnosed by your doctor

Tilolec could cause abnormalities in several laboratory
tests. These include liver function test, a false positive
coombs test, blood tests, urine tests

the safety and efficacy of Tilolec in newly-born infants and
children under the age of 18 has not been established; the
use of Tilolec in patients under the age of 18 is therefore
not recommended

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. Tell your doctor if this
occurs as they may need to review your treatment (See
Section 4 Possible side effects)

Taking other medicines
Please inform your doctor or pharmacist if you are taking, or
have recently taken, any other medicines, including medicines
obtained without a prescription.

If you have never been treated with Levodopa:
Starting dose
One Tilolec 100/25mg tablet twice daily or one Tilolec
200/50mg tablet twice daily

Medicines which may interact with Tilolec

medicines used to treat high blood pressure - your doctor
will need to adjust the dosage

medicines used to treat depression (See Section 2, Do not
take)

medicines that act on the central nervous system e.g.
ipratropium and tiotropium (anticholinergics,
bronchodilators used in asthma). The effect of Levodopa
may be reduced - your doctor will adjust the dosage if
necessary

other medicines that act on the central nervous system
(sympathomimetics; bronchodilators used in asthma) e.g.
apraclonidine, dipivefrin and brimonidine. Cardiovascularrelated side effects may increase

medicines used to treat psychosis

medicines used to treat tuberculosis e.g. isoniazid

benzodiazepines (certain sleeping pills and tranquilisers)
such as diazepam, oxazepam and lormetazepam - the
effect of Tilolec may be reduced

medicines used to treat epilepsy e.g. phenytoin - the effect
of Tilolec may be reduced

papaverine (a medicine used to treat spasms in the
gastrointestinal tract) - the effect of Tilolec may be reduced

selegiline (a medicine used to treat Parkinson’s disease).
When used at the same time as Tilolec, severe low blood
pressure may occur. (See Section 2, Do not take)

COMT inhibitors (medicines used to treat Parkinson’s
disease). When used at the same time as Tilolec, the levels
of Levodopa reaching the brain may increase. The Tilolec
dose may need to be adjusted

amantadine (a medicine used to treat Parkinson’s disease).
The side effects of Levodopa may increase. The Tilolec
dose may need to be adjusted

metoclopramide (a gastrointestinal medicine)

ferrous sulphate as Levodopa absorption may decrease

Maximum starting dose
Six Tilolec 100/25mg tablets daily or three Tilolec 200/50mg
tablets daily (600 mg of Levodopa per day)
Doses should be taken at intervals of at least 6 hours.

Taking Tilolec with food and drink
The effect of Levodopa can sometimes be impaired in patients
on a high-protein diet.
Pregnancy and breast-feeding
If you are pregnant, suspect you are pregnant, trying to become
pregnant or breast-feeding (Levodopa is excreted into breast
milk), Tilolec must not be taken.
Any woman of childbearing potential who is taking Tilolec
must use effective contraception.
Ask your doctor for advice before taking any medicine.
Driving or using machinery
There is no known data on the effect of Tilolec Tablets on the
ability to drive. Certain side effects such as sleepiness and
dizziness may influence the ability to drive or operate
machinery.
3.

How to take

Always take Tilolec as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.




Swallow the tablet whole (do not chew) with a glass of water
Do not break the tablet
Tilolec may be taken either with food or between meals

Adults and the Elderly

If you are switching from normal Levodopa/Carbidopa
tablets to prolonged release tablets:
Such a switch should take place gradually and under the
supervision of a doctor.
If you are currently being treated with Levodopa on its own:
Treatment with Levodopa should be stopped for at least 12
hours before using Tilolec.
Starting dose in patients with a mild-to-moderate form of
Parkinson’s disease:
One Tilolec 200/50mg tablet twice daily or two Tilolec 100/25mg
tablets twice daily.
Maintenance dose:
Your doctor will monitor you on a regular basis and adjust your
dosage if necessary.
An interval of at least three days should be allowed between
each dose adjustment.
Do not change your dose unless your doctor tells you to do so.
If you taken more Tilolec than you should
If you accidentally take too many tablets, contact your doctor or
nearest hospital emergency department immediately for
advice. Remember to take this leaflet or any remaining tablets
with you.
The symptoms of overdose include: spasms of the orbicularis
oculi muscle surrounding the eye (See Section 4, Possible side
effects).
If you forget to take Tilolec
Take it as soon as you remember, unless it is nearly time for
your next dose. If you miss a dose do not take a double dose to
make up for a forgotten tablet.
If you stop taking/using Tilolec
It is important that you keep on taking Tilolec until the
prescribed dose has finished. Do not stop taking the tablets
even though you may feel better. Do not stop or change your
treatment before talking to your doctor.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4.

Possible side effects

Like all medicines, Tilolec can cause side effects, although not
everybody gets them.
Stop taking Tilolec and seek medical advice immediately if
you develop the following:

Sudden high fever, severe sore throat and mouth ulcers
(these are symptoms of a very serious blood disorder)

Sudden build-up of fluid in the skin, throat and tongue,
breathing difficulties and/or itching and skin rash
(symptoms of an allergic reaction)

Skin rash with severe itching and the formation of wheals
(urticaria)

Muscle cramps and tremors, fever, unstable blood
pressure and changes in consciousness such as



agitation, delirium, or coma. Although rare, these side
effects could indicate symptoms of (Neuroleptic
Malignant Syndrome - NMS)
Common side effects (affects 1-10 users in 100)

Loss of appetite

Seeing things that are not there (hallucinations)

Confusion

Dizziness

Sleep disorders (nightmares, drowsiness, tiredness,
sleeplessness)

Depression (with (very rarely) suicidal tendencies (See
Section 2 Take special care)

Intense feelings of well-being, elation, excitement
(euphoria)

Dementia

Episodes of serious mental illness, during which control
over conduct and behaviour is impaired (psychosis)

Feeling of stimulation

Movement disorders (sudden involuntary movements,
muscle tone, sudden changes in Parkinson’s symptoms
(“on-off” symptoms), slowdown in movements during “onoff” periods) – See Section 1, What this medicine is and
what it is used for

Feeling your heartbeat (palpitations)

Irregular heartbeat

A drop in blood pressure caused by getting up too quickly
from a sitting or lying position (sometimes with dizziness)

Tendency to faint or sudden loss of consciousness

Feeling or being sick (nausea/vomiting)

Dry mouth

Bitter taste
Uncommon side effects (affects 1-100 users in 1000)

Weight loss or gain

Lack of voluntary co-ordination of muscle movements
(ataxia)

Increase in hand tremors

Increase in blood pressure

Hoarseness

Chest pain

Constipation

Diarrhoea

Increased amounts of saliva in mouth

Difficulties in swallowing

Wind

Excessive build-up of fluid in the body (oedema)

Muscle spasms

Dark urine

Weakness

Feeling of being unwell (malaise)

Hot flushes
Rare side effects (affects 1-1000 users in 10,000)

Blood disorders (lack of white blood cells with an
increased susceptibility to infections, anaemia, lack of
blood platelets with bruising and a tendency to bleed)

Excitement (agitation)

Anxiety

Impaired ability to think

Disorientation

Headache

Increased sexual desire

Numbness

Fits/seizures

Feelings of prickling, tingling and itchiness without any
apparent cause (paraesthesia)

Deviation from normal walking (gait disorders)



















A condition in which the mouth is held shut by sustained
spasm of the jaw muscle (lockjaw)
Eye disorders (blurred vision, double vision, dilated
pupils, a deterioration in eye movements)
Spasm of the orbicularis oculi muscle surrounding the
eye (this may be a sign of overdose) (See Section 3 If
you take more Tilolec than you should)
Inflammation of the veins (phlebitis)
Breathlessness or abnormal breathing patterns
Digestion problems (feelings of fullness, stomach pain,
belching, feeling or being sick, heartburn)
Stomach and intestinal pain
Dark saliva
Grinding of teeth
Hiccups
Stomach and intestinal bleeding
Burning tongue
Duodenal ulcers
Itching, facial redness, skin rash
Hair loss (alopecia)
Increased sweating, dark sweat
Passing water less frequently (urine retention) or the
involuntary passing of water (incontinence)
Persistent erection

Other side effects of unknown frequency

Inability to resist the impulse to perform an action that could
be harmful, which may include
o Strong impulse to gamble excessively despite
serious personal or family consequences
o Altered or increased sexual interest and
behaviour of significant concern to you or to
others e.g. an increased sex drive
o Uncontrollable
excessive
shopping
or
spending
o 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
to discuss way of managing or reducing the symptoms.
(See Section 2 Take special care)

Drowsiness and (very rarely) constant daytime
fatigue/sudden attacks of sleep
If any of the side effects gets serious or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
5.

How to store

Keep out of the reach and sight of children.
Do not use Tilolec after the expiry date which is stated on the
carton/blister after “EXP”. The expiry date refers to the last day
of that month.
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.
6.

Further information

What Tilolec contains:
The active ingredient in each tablet is:
Tilolec 100/25mg contains 100mg Levodopa and 25mg
Carbidopa (as Carbidopa Monohydrate)
Tilolec 200/50mg contains 200mg Levodopa and 50mg
Carbidopa (as Carbidopa Monohydrate)

Other ingredients are:
Hypromellose, colloidal anhydrous silica, fumaric acid, sodium
stearyl fumarate, macrogol 6000, quinoline yellow (E104),
yellow and red iron oxide (E172), titanium dioxide (E171)
What Tilolec looks like and contents of the pack:
Tilolec 100/25 mg: orange-brown, biconcave, round tablets with
rounded edges
Tilolec 200/25 mg: orange-brown, round, biconvex tablets
Tilolec is available in packs of:
30, 50, 60, 100 or 200 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Tillomed Laboratories Limited
3 Howard Road
Eaton Socon
St Neots
Cambridgeshire, PE19 8ET
United Kingdom
Manufacturers:
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben
Germany
Product Licence Numbers:
Tilolec (Levodopa/Carbidopa) 100/25mg Tablets - PL
11311/0193
Tilolec (Levodopa/Carbidopa) 200/50mg Tablets - PL
11311/0194
The leaflet was last revised in January 2013.

Expand Transcript

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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