Levodopa/carbidopa/entacapone Teva: detailed information

Patient Information Leaflet

Levodopa/Carbidopa/Entacapone Teva 50 mg/12.5 mg/200 mg film-coated tablets, 75 mg/18.75 mg/200 mg film-coated tablets, 100 mg/25 mg/200 mg film-coated tablets, 125 mg/31.25 mg/200 mg film-coated tablets, 150 mg/37.5 mg/200 mg film-coated tablets, 175 mg/43.75 mg/200 mg film-coated tablets, 200 mg/50 mg/200 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Levodopa/Carbidopa/Entacapone Teva is and what it is used for
What you need to know before taking Levodopa/Carbidopa/Entacapone Teva
How to take Levodopa/Carbidopa/Entacapone Teva
Possible side effects
How to store Levodopa/Carbidopa/Entacapone Teva
Contents of the pack and other information

1. What Levodopa/Carbidopa/Entacapone Teva is and what it is used for

Levodopa/Carbidopa/Entacapone Teva contains three active substances (levodopa, carbidopa and entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone Teva 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 thereby reduces the symptoms of Parkinson's disease.
Carbidopa and entacapone enhance the anti-Parkinson effects of levodopa.

2. What you should know before taking Levodopa/Carbidopa/Entacapone Teva

DO NOT take Levodopa/Carbidopa/Entacapone Teva if:

you are allergic to levodopa, carbidopa, entacapone, or any of the other ingredients of this medicine (listed in section 6)
you have closed-angle glaucoma (a disease of the eye)
you have a tumour of the adrenal gland
you are taking medicines to treat depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors)
you have ever had neuroleptic malignant syndrome (NMS, a rare reaction to medicines used to treat severe mental disorders)
you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
you have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Teva if you have or
have ever had:

a heart attack or any other heart or blood vessel disease, including cardiac arrhythmias
asthma or any other lung disease
liver problems, as your dose may need to be adjusted
kidney or hormonal disorders
stomach ulcers or seizures
prolonged diarrhoea – consult your doctor, as this may be a sign of inflammation of the colon
any form of severe mental disorder such as psychosis
chronic open-angle glaucoma, as your dose may need to be adjusted and eye pressure kept under medical supervision.

Talk to your doctor if you are taking:

antipsychotics (medicines used to treat psychosis)
a medicine that may cause low blood pressure when standing up from sitting or lying down. You should know that Levodopa/Carbidopa/Entacapone Teva may worsen these reactions.

Talk to your doctor if, during treatment with Levodopa/Carbidopa/Entacapone Teva:

you notice that your muscles become very stiff or contract violently, or if you experience tremors, agitation, confusion, fever, increased pulse rate, or wide fluctuations in blood pressure. If any of the above occur, contact your doctor immediately.
you feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
you fall asleep suddenly or feel very drowsy. In this case, do not drive or operate tools or machinery (also see section “Driving and using machines”).
uncontrolled movements start or worsen after you started taking Levodopa/Carbidopa/Entacapone Teva. In this case, your doctor may wish to change the dose of your anti-Parkinson’s medicines.
you develop diarrhoea: monitoring of body weight is recommended to avoid potentially excessive weight loss
you experience progressive anorexia, asthenia (weakness, feeling exhausted), and weight loss within a relatively short period of time. In such cases, a general medical examination including assessment of liver function should be considered.
if you feel the need to stop using Levodopa/Carbidopa/Entacapone Teva, see section “If you stop taking Levodopa/Carbidopa/Entacapone Teva”.

Inform your doctor if you or a family member/carer notice the development of
behavioural symptoms similar to addiction, leading to a desire for high doses of
Levodopa/Carbidopa/Entacapone Teva and other medicines used to treat Parkinson’s disease.
Inform your doctor if you or your family/carer notice the development of
impulses or strong urges to behave in ways that are unusual for you, or if you cannot resist the impulse,
desire, or temptation to carry out certain activities that could harm you or others.
These behaviours are known as impulse control disorders and may include pathological gambling,
compulsive eating, compulsive shopping, increased libido, or hypersexuality. Your doctor may need to review your treatment.
During long-term treatment with Levodopa/Carbidopa/Entacapone Teva, your doctor may wish to
perform regular laboratory tests.
If you are due to undergo surgery, inform your doctor that you are taking
Levodopa/Carbidopa/Entacapone Teva.
Levodopa/Carbidopa/Entacapone Teva is not recommended for the treatment of extrapyramidal symptoms
(e.g. involuntary movements, tremors, muscle rigidity, and muscle contractions)
caused by other medicines.
Children and adolescents
Experience with levodopa/carbidopa/entacapone in patients under 18 years of age is limited.
The use of Levodopa/Carbidopa/Entacapone Teva is not recommended in these patients.
Other medicines and Levodopa/Carbidopa/Entacapone Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not take Levodopa/Carbidopa/Entacapone Teva if you are taking certain medicines for depression (combinations of selective MAO-A and MAO-B inhibitors or non-selective MAO inhibitors).
Levodopa/Carbidopa/Entacapone Teva may enhance the effects and side effects of certain medicines. These include:

medicines used to treat depression, such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine, and paroxetine
rimiterol and isoprenaline, used to treat respiratory diseases
adrenaline, used to treat severe allergic reactions
noradrenaline, dopamine, and dobutamine, used to treat heart conditions and low blood pressure
alpha-methyldopa, used to treat high blood pressure
apomorphine, used to treat Parkinson’s disease.

The effects of Levodopa/Carbidopa/Entacapone Teva may be reduced by certain medicines. These include:

dopaminergic antagonists used to treat mental disorders, nausea, and vomiting
phenytoin, used to prevent seizures
papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapone Teva may make it more difficult for iron to be absorbed. Therefore,
do not take Levodopa/Carbidopa/Entacapone Teva and iron supplements at the same time. After taking one, wait at least 2 to 3 hours before taking the other.
Levodopa/Carbidopa/Entacapone Teva with food and drink
Levodopa/Carbidopa/Entacapone Teva can be taken with or without food. In some patients,
Levodopa/Carbidopa/Entacapone Teva may not be well absorbed if taken with, or immediately after consuming, high-protein foods (such as meat, fish, dairy products, seeds, and nuts). If you think this may apply to you, consult your doctor.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not breastfeed while being treated with Levodopa/Carbidopa/Entacapone Teva.
Driving and using machines
Levodopa/Carbidopa/Entacapone Teva may lower your blood pressure, causing confusion or dizziness. Therefore, exercise particular caution when driving or operating any tools or machinery.
If you experience drowsiness or sudden sleep attacks, wait until you are fully awake before driving or performing any other activity requiring alertness. Otherwise, you may put yourself or others at risk of injury or death.
[50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 125 mg/31.25 mg/200 mg, 175 mg/43.75 mg/200 mg and 200 mg/50 mg/200 mg]
Levodopa/Carbidopa/Entacapone Teva contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Levodopa/Carbidopa/Entacapone Teva 100 mg/25 mg/200 mg contains lactose and Allura Red (E129).
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Allura Red (E129) may cause allergic reactions.
Levodopa/Carbidopa/Entacapone Teva 150 mg/37.5 mg/200 mg contains lactose and Carmoisine (E122).
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Carmoisine (E122) may cause allergic reactions.

3. How to take Levodopa/Carbidopa/Entacapone Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and elderly:

Your doctor will tell you exactly how many tablets of Levodopa/Carbidopa/Entacapone Teva to take each day.
The tablets must not be divided or broken into smaller pieces.
You must take one tablet at a time.
Depending on your response to treatment, your doctor may recommend a higher or lower dose.
If you are taking Levodopa/Carbidopa/Entacapone Teva 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 tablets, do not take more than 10 tablets per day.
If you are taking Levodopa/Carbidopa/Entacapone Teva 175 mg/43.75 mg/200 mg tablets, do not take more than 8 tablets of this strength per day.
If you are taking Levodopa/Carbidopa/Entacapone Teva 200 mg/50 mg/200 mg tablets, do not take more than 7 tablets of this strength per day.

Consult your doctor or pharmacist if you think that the effect of Levodopa/Carbidopa/Entacapone Teva is too strong or too weak, or if you experience possible side effects.

If you take more Levodopa/Carbidopa/Entacapone Teva than you should
If you have accidentally taken more Levodopa/Carbidopa/Entacapone Teva tablets than prescribed, inform your doctor or pharmacist immediately. In case of overdose, you may feel confused or agitated, your heart rate may slow down or become faster than normal, or the colour of your skin, tongue, eyes or urine may change.

If you forget to take Levodopa/Carbidopa/Entacapone Teva
Do not take a double dose to make up for a forgotten tablet.

If more than 1 hour remains until your next dose:
Take one tablet as soon as you remember, then take the next tablet at your usual time.

If less than 1 hour remains until your next dose:
Take one tablet as soon as you remember, wait 1 hour, then take another tablet.
After this, continue as usual.

To avoid possible side effects, always leave at least one hour between successive doses of Levodopa/Carbidopa/Entacapone Teva.

If you stop taking Levodopa/Carbidopa/Entacapone Teva
Do not stop taking Levodopa/Carbidopa/Entacapone Teva unless your doctor tells you to. In such a case, your doctor may wish to adjust the dose of your other anti-Parkinson's medicines, particularly levodopa, to ensure adequate control of your symptoms. If you suddenly stop treatment with Levodopa/Carbidopa/Entacapone Teva and other anti-Parkinson's medicines, this may cause unwanted side effects.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Many of the side effects can be relieved by adjusting the dose.
If you experience any of the following symptoms while taking Levodopa/Carbidopa/Entacapone Teva, contact your doctor immediately:

Muscles become very stiff or contract violently, tremors, agitation, confusion, fever, increased pulse, or wide fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare but serious reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare, serious muscle disorder).
Allergic reaction: signs may include hives, itching, skin rash, swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing.

Very common (may affect more than 1 in 10 people):

Involuntary movements (dyskinesia)
Feeling unwell (nausea)
Harmless red-brown discoloration of urine
Muscle pain
Diarrhoea

Common (may affect up to 1 in 10 people):

Dizziness or fainting due to low blood pressure, increased blood pressure
Worsening of Parkinson's symptoms, dizziness, drowsiness
Vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
Insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
Mental disorders including memory problems, anxiety and depression (possibly with suicidal thoughts)
Cardiac or vascular events (e.g. chest pain), irregular heartbeat or heart rate
Increased frequency of falls
Shortness of breath
Increased sweating, skin rash
Muscle cramps, swelling of the legs
Blurred vision
Anaemia
Loss of appetite, weight loss
Headache, joint pain
Urinary tract infection

Uncommon (may affect up to 1 in 100 people):

Heart attack
Intestinal bleeding
Changes in blood cells which may cause bleeding, abnormal liver function tests
Seizures
Feeling of restlessness
Psychotic symptoms
Colitis (inflammation of the colon)
Change in skin, nail, hair, or sweat colour
Difficulty swallowing
Inability to urinate

Not known (frequency cannot be estimated from the available data):
Desire for higher-than-needed doses of Levodopa/Carbidopa/Entacapone Teva, beyond what is required to control motor symptoms, known as dopamine dysregulation syndrome.
Some patients experience severe, abnormal involuntary movements (dyskinesias), mood changes, or other side effects after taking high doses of Levodopa/Carbidopa/Entacapone Teva.
The following side effects have also been reported:

Hepatitis (inflammation of the liver)
Itching

You may experience the following side effects:

Inability to resist the impulse to carry out an action that could be harmful, including:
Strong urge to gamble excessively despite serious family or personal consequences
Change or increase in sexual interest and behaviour causing significant concern to you or others, for example increased libido
Excessive and uncontrollable shopping or spending
Compulsive eating (consuming large amounts of food in a short period of time) or binge eating (eating more food than normal and more than needed to satisfy hunger)

Inform your doctor if you experience any of these behaviours; your doctor will advise you on how to manage or reduce the symptoms.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levodopa/Carbidopa/Entacapone Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer carton after EXP.
The expiry date refers to the last day of that month.
Store below 25°C.
Shelf life after first opening the bottle: 175 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levodopa/Carbidopa/Entacapone Teva contains
The active substances in Levodopa/Carbidopa/Entacapone Teva are levodopa, carbidopa and entacapone.

Each Levodopa/Carbidopa/Entacapone Teva 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.
The other components of the tablet core are microcrystalline cellulose, lactose, low-substituted hydroxypropylcellulose, povidone (K-30), anhydrous colloidal silica and magnesium stearate.
The coating components are titanium dioxide (E171), hypromellose, glycerol (E422), yellow iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium stearate.