PACKAGE LEAFLET: INFORMATION FOR THE USER

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Lecado 100/25 mg Modified-release Tablets Lecado 200/50 mg Modified-release Tablets

Active substances: levodopa and carbidopa

Read all of this leaflet carefully 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 pharmacist.

•    This medicine has been prescribed foryou. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Lecado is and what it is used for

2.    Before you take Lecado

3.    How to take Lecado

4.    Possible side effects

5.    How to store Lecado

6.    Further information

1 What Lecado is and what it is used for

Lecado is used in the treatment of Parkinson’s disease. 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 inhibitortablets with an immediate-release formulation (e.g. carbidopa) and if you suffer from sudden uncontrolled movements.

Lecado belongs to a class of drugs 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.

2 Before you take Lecado

Do not take Lecado

•    if you are allergic (hypersensitive) to levodopa or carbidopa, or any of the other ingredients of the tablets;

•    ifyou 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 drugs 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; drugs used in depression). You must stop taking these drugs for at least two weeks before starting treatment with Lecado. Lecado retard 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 Lecado

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 Lecado 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. Psychosis is 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.

•    if you are constantly tired and/or prone to falling asleep without warning. You must not drive or operate machines; your doctor will adjust your dose if necessary, or stop your treatment altogether;

•    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 levodopa/carbidopa dose is suddenly lowered or stopped, particularly if you are receiving drugs 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 coordinated movements (Huntington’s chorea). Use of Lecado 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.

•    Lecado could give rise to abnormalities in several laboratory tests. These include:

-    liver function tests

-    a false positive coombs test

-    decreased haemoglobin and haemotocrit, elevated serum glucode and white blood cells, bacteria and blood in the urine

-    when a test strip is used to determine ketonuria a false positive result for urinary ketone bodies can be shown. This reaction is not altered by boiling the urine sample.

-    false negative results can also occur in the examination if glycosuria with the use of glucose oxidase methods

•    the safety and efficacy of Lecado in newly-born infants and children underthe age of 18 has not been established; the use of Lecado in patients under the age of 18is 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, he may need to review your treatment.

Please tell your doctor if any one of the above-mentioned warnings applies to you, or has ever applied to you in the past.

Taking Lecado with other medicines

Lecado may interfere with the effects/ side effects of other drugs, and vice versa. This is particularly true in the case of:

•    drugs used to treat high blood pressure; your doctor will need to adjust the dosage;

•    drugs used to treat depression (see also section: “Do not take

Levodopa/Carbidopa”);    00000000

•    drugs that act on the central nervous system (anticholinergics; bronchodilators used in asthma), such as ipratropium and tiotropium. The effect of levodopa may be reduced; your doctor will adjust the dosage if necessary;

•    drugs used to treat psychosis;

•    isoniazid (a drug used to treat tuberculosis);

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

•    phenytoin (a drug used in epilepsy); the effect of Lecado may be reduced;

•    papaverine (a drug used to treat spasms in the gastrointestinal tract); the effect of Lecado may be reduced;

•    selegiline (a drug used in Parkinson’s disease); when used at the same time as Lecado, severe low blood pressure may occur;

•    COMT inhibitors (used in Parkinson’s disease); when used at the same time as Lecado, the levels of levodopa reaching the brain may increase. The Levodopa/Carbidopa dose may need to be adjusted;

•    amantadine (used in Parkinson’s disease). The side effects of levodopa may increase. The Levodopa/Carbidopa dose may need to be adjusted;

•    metoclopramide (a gastrointestinal drug)

•    drugs that act on the central nervous system

(sympathomimetics; bronchodilators used in asthma), such as apraclonidine, dipivefrin and brimonidine. Cardiovascular-related side effects may increase;

•    ferrous sulphate. Levodopa absorption may decrease.

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

Taking Lecado with food and drink

The effect of levodopa can sometimes be impaired in patients on a high-protein diet.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

•    Any woman of childbearing potential who is receiving Lecado must practise effective contraception.

•    Not enough is known about the use of Lecado during human pregnancies. It as shown to be harmful in animal experiments.

Do not take Lecado if you are pregnant, or trying to conceive.

•    Levodopa is excreted into breast milk.

You must therefore not breastfeed during treatment with Lecado.

Driving and using machines

Lecado can cause side effects such as

•    dizziness,

•    drowsiness,

•    double vision,

which may affect your ability to react.

You should bear this in mind if you intend driving or using machines.

Patients who are known to be prone to drowsiness and falling asleep without warning must not drive or use machines.

3 How to take Lecado

Dosage

Adults and the elderly

Your doctor has prescribed how much Lecado you should take. Generally speaking, the following doses apply:

If you have never been treated with levodopa:

Starting dose

1 Lecado 100/25 mg tablet twice daily or 1 Lecado 200/50 mg tablet twice daily.

Maximum starting dose

6 tablets of Lecado 100/25 mg daily or 3 tablets of Lecado 200/50 mg 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 Lecado tablets:

Such a switch should take place gradually and under the supervision of a doctor.

If you are currently being treated with levodopa alone (i.e. on its own):

Treatment with levodopa should be stopped for at least 12 hours before using Lecado. Starting dose in patients with a mild-to-moderate form of Parkinson’s disease:

1 Lecado 200/50 mg tablet twice daily or 2 Lecado 100/25 mg 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.

Swallow the tablet whole with a glass of water irrespective of meals; do not break or chew the tablet.

If you have the impression that the effect of Lecado is too strong or too weak, talk to your doctor or pharmacist.

Children and adolescents (under 18 years of age)

The use of Lecado in patients under the age of 18 is not recommended (see section “Take special care with Lecado”).

Length of treatment

Your doctor will tell you how long you must keep using Lecado. Do not stop treatment before you should; otherwise, your symptoms may return.

If you take more Lecado than you should

If you have taken too much Lecado, contact your doctor or pharmacist immediately.

Overdose symptoms may include: spasms of the orbicularis oculi muscle surrounding the eye (see also section 4: “Possible side effects”).

If you forget to take Lecado

Do not take a double dose of Lecado to make up for a forgotten dose. If you have forgotten a dose, you can still take it unless it is almost time for your next dose. If this occurs, continue on your normal dosage schedule.

Continued on the next page >>

If you stop taking Lecado

Your doctor will monitor you regularly if your dosage is suddenly lowered or if your treatment is stopped. Please read the section: “Take special care with Lecado”, particularly if you are using drugs in the treatment of psychosis (antipsychotic agents).

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

4 Possible side effects

Like all medicines, Lecado can cause side effects, although not everybody gets them. Side effects that may occur are:

• very common    in morethan one in 10 patients

• common    in morethan one in 100 patients, but less

than one in 10 patients

•    uncommon    in more than one in 1,000 patients, but less

than one in 100 patients

•    rare    in morethan one in 10,000 patients, but

lessthan one in 1,000 patients

•    very rare in less than one in 10,000 patients

Blood and lymphatic system disorders

Rare:

•    a blood disorder (lack of white blood cells) accompanied by an increased susceptibility to infections (leukopenia)

•    anaemia (haemolytic and non-haemolytic)

•    a blood disorder (lack of blood platelets) accompanied by bruising and a tendency to bleed (thrombocytopenia)

Very rare:

•    a very serious blood disorder (lack of white blood cells) accompanied by sudden high fever, severe sore throat and mouth ulcers (agranulocytosis).

Metabolism and nutrition disorders

Common:

•    loss of appetite (anorexia)

Uncommon:

•    weight loss

•    weight gain.

Psychiatric disorders

Common:

•    seeing things that are not there (hallucinations)

•    confusion

•    dizziness

•    nightmares

•    drowsiness

•    tiredness

•    sleeplessness

•    depression with (very rarely) suicidal tendencies

•    feeling of well-being (euphoria)

•    dementia

•    episodes of serious mental illness, during which control over one’s own conduct and behaviour is impaired (psychosis)

•    feeling of stimulation

Rare:

•    excitement (agitation)

•    anxiety

•    impaired ability to think

•    disorientation

•    headache

•    increased sexual desire

•    numbness

•    fits/seizures.

Unknown frequency:

•    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 sex 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 to discuss ways of managing or reducing the symptoms.

Drowsiness and (very rarely) constant daytime fatigue/ sudden attacks of sleep.

Nervous system disorders

Common:

•    movement disorders (dyskinesia)

•    a disorder characterised by sudden involuntary movements (chorea)

•    muscle tone disorder (dystonia)

•    movement disorders caused from outside the nervous system (extrapyramidal)

•    sudden changes in Parkinson’s symptoms ("on-off" symptoms)

•    slowdown in movements during "on-off" periods (bradykinesia)

Uncommon:

•    ataxia

•    increase in hand tremors Rare:

•    a serious condition as a result of using neuroleptics, which may manifest as muscle stiffness, a severe inability to sit still, high fever, sweating, increased salivation and impaired consciousness (neuroleptic malignant syndrome)

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

•    fits

•    gait disorders

•    lockjaw.

Eye disorders

Rare:

•    blurred vision

•    spasm of the orbicularis oculi muscle surrounding the eye (this may be a sign of overdosage)

•    activation of a pre-existing Horner's syndrome (an eye disorder)

•    double vision

•    dilated pupils

•    a deterioration in eye movements.

Cardiac (heart) disorders

Common:

•    palpitations

•    irregular heartbeat.

Vascular disorders

Common:

•    a drop in blood pressure caused e.g. by getting up too quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension)

•    tendency to faint

•    sudden loss of consciousness

Uncommon:

•    increase in blood pressure

Respiratory, thoracic (chest) and mediastinal disorders (i.e. the area between the lungs)

Uncommon:

•    hoarseness

•    chest pain

Rare:

•    breathlessness

•    abnormal breathing patterns.

Gastrointestinal disorders

Common:

•    nausea

•    vomiting

•    dry mouth

•    bitter taste

Uncommon:

•    constipation

•    diarrhoea

•    increased salivation

•    difficulties in swallowing (dysphagia)

•    wind

Rare:

•    impaired digestion with symptoms such as feelings of fullness in the upper abdomen, upper abdominal pain, belching, nausea, vomiting and heartburn (dyspepsia)

•    stomach and intestinal pain

•    dark saliva

•    bruxism (grinding of teeth)

•    hiccups

•    stomach and intestinal bleeding

•    burning tongue

•    duodenal ulcers.

Skin and subcutaneous tissue disorders

Uncommon:

•    fluid accumulation (oedema)

Rare:

•    sudden build-up of fluid in the skin and mucous membranes (e.g. throat and tongue), breathing difficulties and/or itching and skin rash, often appearing as an allergic reaction (angioedema)

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

•    itching

•    facial redness

•    hair loss

•    skin rash

•    increased sweating

•    dark sweat

•    in children, allergy-related bleeding in the skin and gastrointestinal tract wall (SchOnlein-Henoch purpura).

Musculoskeletal and connective tissue disorders

Uncommon:

•    muscle spasms.

Renal and urinary disorders

Uncommon:

•    dark urine

Rare:

•    urine retention

•    involuntary passing of urine

•    persistent erection (priapism).

General disorders and administration site conditions

Uncommon:

•    weakness

•    feeling of being unwell (malaise)

•    hot flushes.

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 Lecado

•    Children: Keep out of the reach and sight of children.

•    Use by Date: Do not take Lecado after the expiry date which is stated on the blister and the carton after Exp.

•    Storage conditions:

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater of household waste. Ask you pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further information

What Lecado contains

The active substances of Lecado 100/25 mg and 200/50 mg are: Levodopa and Carbidopa

One Lecado 100/25 mg tablet contains 100 mg levodopa and 25 mg carbidopa (as carbidopa monohydrate).

One Lecado 200/50 mg tablet contains 200 mg levodopa and 50 mg carbidopa (as carbidopa monohydrate).

The other ingredients (excipients) 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 Lecado looks like and contents of the pack

Appearance:

Lecado 100/25 mg: orange-brown, biconcave, round tablets with rounded edges.

Lecado 200/50 mg: orange-brown, round, biconvex tablets.

The prolonged-release tablets are packed in blister strips containing 30, 50, 60 or 100 tablets, which are packed in a box. Not all pack sizes will be marketed.

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park,

Frimley, Camberley,

Surrey, GU16 7SR, UK.

Manufacturers

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany.

This leaflet was last revised in 10/2012.

Rare:

• inflammation of the veins (phlebitis).

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