PATIENT INFORMATION LEAFLET

Tilolec 100/25mg and 200/50mg Prolonged Release Tablets (Levodopa and Carbidopa Monohydrate)			1	1

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.    What this medicine is and what it is used for

2.    Before you take

3.    How to take

4.    Possible side effects

5.    How to store

6.    Further information

1.    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.

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. Cardiovascular-related 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

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 have never been treated with Levodopa:

Starting dose

One Tilolec 100/25mg tablet twice daily or one Tilolec 200/50mg tablet twice daily

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.

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 “on-off” 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.