Levodopa/carbidopa/entacapone Teva-Ratiopharm 100/25/200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levodopa/Carbidopa/Entacapone Teva-ratiopharm 100 mg/25 mg/200 mg film-coated tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Levodopa/Carbidopa/Entacapone Teva-ratiopharm is and what it is used for
2. What you need to know before taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm
3. How to take Levodopa/Carbidopa/Entacapone Teva-ratiopharm
4. Possible side effects
5. How to store Levodopa/Carbidopa/Entacapone Teva-ratiopharm
6. Contents of the pack and other information

1. What Levodopa/Carbidopa/Entacapona Teva-ratiopharm is and what it is used for

Levodopa/Carbidopa/Entacapona Teva-ratiopharm contains three active substances (levodopa, carbidopa and entacapona) in a film-coated tablet. Levodopa/Carbidopa/Entacapona Teva-ratiopharm is used to treat Parkinson's disease.

Parkinson's disease is caused by low levels in the brain of a substance called dopamine. Levodopa increases the amount of dopamine and thereby reduces the symptoms of Parkinson's disease. Carbidopa and entacapona enhance the anti-Parkinson effects of levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm

Do not take Levodopa/Carbidopa/Entacapone Teva-ratiopharm

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm if you have or have ever had:

• A heart attack or any other heart or blood vessel disease, including arrhythmias.
• Asthma or any other lung disease.
• A liver problem, as your dose may need to be adjusted.
• Any kidney disease or hormone-related disorder.
• Stomach ulcer or seizures.
• Prolonged diarrhea. Consult your doctor, as this may be a sign of inflammation of the colon.
• Any form of serious mental disorder, such as psychosis.
• Open-angle glaucoma, as your dose may need to be adjusted and your intraocular pressure monitored.

Talk to your doctor if you are taking:

• Antipsychotics (medicines used to treat psychosis).
• Any medicine that may cause a drop in blood pressure when standing up from sitting or lying down. Be aware that Levodopa/Carbidopa/Entacapone Teva-ratiopharm may worsen these reactions.

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

• Experience severe muscle stiffness or violent muscle contractions, or develop tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. If any of these occur, contact your doctor immediately.
• Feel depressed, have suicidal thoughts, or notice unusual changes in your behavior.
• Notice sudden episodes of falling asleep, or feel excessively sleepy. If this happens, do not drive or operate tools or machinery (see also section “Driving and use of machines”).
• Develop new or worsening uncontrollable movements. If this occurs, your doctor may need to adjust your dose.
• Experience diarrhea; weight monitoring is recommended to prevent excessive weight loss.
• Experience progressive loss of appetite, asthenia (weakness, fatigue), and weight loss over a relatively short period. In such cases, a full medical evaluation including liver function tests should be considered.
• Are considering stopping treatment with Levodopa/Carbidopa/Entacapone Teva-ratiopharm; refer to the section "If you stop taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm".

Inform your doctor if you, or your family/caregiver, notice that you are developing symptoms similar to addiction, leading to a desire for high doses of Levodopa/Carbidopa/Entacapone Teva or other medicines used to treat Parkinson’s disease.

Inform your doctor if you or your family/caregiver notice that you are developing urges or a tendency to behave in ways that are unusual for you or that you cannot resist the impulse, drive, or temptation to carry out certain activities that may harm you or others. These behaviors are known as impulse control disorders and may include gambling addiction, compulsive eating, excessive spending, or abnormally increased sex drive or preoccupation with sexual thoughts or feelings. Your doctor may need to review your treatment.

During long-term treatment with Levodopa/Carbidopa/Entacapone Teva-ratiopharm, your doctor may perform regular blood tests.

If you are scheduled for surgery, inform your doctor that you are taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm.

Levodopa/Carbidopa/Entacapone Teva-ratiopharm is not recommended for the treatment of extrapyramidal symptoms (e.g., involuntary movements, restlessness, muscle rigidity, and muscle contractions) caused by other medicines.

Children and adolescents

Experience with the use of Levodopa/Carbidopa/Entacapone Teva-ratiopharm in patients under 18 years of age is limited. Therefore, administration of Levodopa/Carbidopa/Entacapone Teva-ratiopharm is not recommended in children.

Taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Levodopa/Carbidopa/Entacapone Teva-ratiopharm if you are taking certain medicines to treat depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Levodopa/Carbidopa/Entacapone Teva-ratiopharm may increase the effect and also the adverse effects of certain medicines. These include:

• Medicines used to treat depression, such as moclobemide, amitriptyline,
• Desipramine, maprotiline, venlafaxine, and paroxetine
• Zimelidine and isoprenaline, used to treat respiratory diseases
• Adrenaline, used for 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.

Certain medicines may reduce the effects of Levodopa/Carbidopa/Entacapone Teva-ratiopharm.

These medicines are:

• Dopamine antagonists used to treat mental disorders, nausea, and vomiting
• Phenytoin, used to prevent seizures
• Papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapone Teva may interfere with the gastrointestinal absorption of iron. Therefore, do not take Levodopa/Carbidopa/Entacapone Teva at the same time as iron supplements. If you take either, wait at least 2 to 3 hours between taking them.

Taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm with food and drinks

Levodopa/Carbidopa/Entacapone Teva-ratiopharm may be taken with or without food.

In some patients, Levodopa/Carbidopa/Entacapone Teva-ratiopharm may not be well absorbed if taken with high-protein foods (meats, fish, dairy products, cereals, and nuts) or shortly after consuming them. Consult your doctor if you think this applies to you.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

You must not breastfeed while being treated with Levodopa/Carbidopa/Entacapone Teva-ratiopharm.

Driving and use of machines

Levodopa/Carbidopa/Entacapone Teva-ratiopharm may lower your blood pressure, which could cause dizziness or fainting. Therefore, take special care when operating tools or machinery.

If you feel very tired or notice sudden episodes of falling asleep, wait until you are fully awake again before driving or doing any other activity requiring alertness. Otherwise, you may put yourself and others at risk of serious or even fatal accidents.

Levodopa/Carbidopa/Entacapone Teva-ratiopharm contains lactose and Allura Red AC (E129)

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine also contains Allura Red AC (E129), which may cause allergic reactions.

3. How to take Levodopa/Carbidopa/Entacapone Teva-ratiopharm

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and elderly patients:

• Your doctor will tell you the exact number of Levodopa / Carbidopa / Entacapone Teva-ratiopharm tablets you should take each day.
• The tablets must not be split or divided into smaller pieces.
• Take only one tablet at a time.
• Depending on how you respond to treatment, your doctor may instruct you to increase or decrease the dose.
• If you are taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm 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.

Talk to your doctor or pharmacist if you think the effect of Levodopa/Carbidopa/Entacapone Teva-ratiopharm is too strong or too weak, or if you experience possible adverse effects.

If you take more Levodopa/Carbidopa/Entacapone Teva-ratiopharm than you should

If you have accidentally taken more Levodopa/Carbidopa/Entacapone Teva-ratiopharm tablets than you should, contact your doctor or pharmacist immediately or call the Spanish Poison Information Service (Tel: 915 620 420), indicating the medicine and the amount taken. In case of overdose, you may feel confused or agitated, your heart rate may be slower or faster than normal, or you may notice a change in the color of your skin, tongue, eyes, or urine.

If you forget to take Levodopa/Carbidopa/Entacapone Teva-ratiopharm

Do not take a double dose to make up for missed doses.

If more than 1 hour remains until the next dose:

Take one tablet as soon as you remember, and take the next one at the usual time.

If less than 1 hour remains until the next dose:

Take one tablet as soon as you remember, wait 1 hour, and then take another tablet. After that, continue as usual.

There must always be at least a 1-hour interval between doses of Levodopa/Carbidopa/Entacapone Teva-ratiopharm to avoid possible adverse effects.

If you stop taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm

Do not stop taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm unless your doctor tells you to do so. In such a case, your doctor may need to adjust the dose of your other Parkinson's medications, especially levodopa, to ensure adequate symptom control. If you stop taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm and other Parkinson's medications suddenly, you may experience unwanted adverse effects.

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

4. Possible adverse effects

Like all medicines, Levodopa/Carbidopa/Entacapona Teva-ratiopharm may produce adverse effects, although not everyone experiences them. Many of these can be relieved by adjusting the dose.

If you experience any of the following symptoms during treatment with Levodopa/Carbidopa/Entacapona Teva-ratiopharm, contact your doctor immediately:

• Severe muscle stiffness or violent muscle contractions, tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare serious reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare and serious muscle disorder).
• Allergic reaction characterized by signs such as hives, itching, rash, and swelling of the face, lips, tongue, or throat. This reaction may cause difficulty breathing or swallowing.

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

• Involuntary movements (dyskinesias)
• Feeling unwell (nausea)
• Harmless reddish-brown discoloration of the urine
• Muscle pain
• Diarrhea

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

• Fainting or collapse due to low blood pressure, hypertension
• Worsening of parkinsonism symptoms, dizziness, drowsiness
• Vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation
• Difficulty sleeping; hallucinations; confusion; abnormal dreams (including nightmares); fatigue
• Changes in mental state – including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• Heart or blood vessel problems (e.g., chest pain), irregular heart rate
• Increased frequency of falls
• Shortness of breath
• Increased sweating, rashes
• Muscle cramps, swelling of the legs
• Blurred vision
• Anaemia
• Decreased appetite, weight loss
• Headache, joint pain
• Urinary tract infections

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

• Heart attack
• Intestinal bleeding
• Changes in blood cell counts that may lead to bleeding; abnormalities in liver function tests
• Seizures
• Feeling of restlessness
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Changes in pigmentation other than urine (e.g., skin, nails, hair, sweat)
• Difficulty swallowing
• Inability to urinate

Unknown frequency (cannot be estimated from available data):

Craving for higher doses of levodopa/carbidopa/entacapone than required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients may experience severe abnormal involuntary movements (dyskinesias), mood changes, or other side effects after taking high doses of levodopa/carbidopa/entacapone.

The following adverse effects have also been reported:

• Hepatitis (inflammation of the liver)
• Itching

You may experience the following adverse effects:

• Inability to resist the impulse to carry out an action that could be harmful, which may include:

• A strong urge to gamble excessively despite serious personal or family consequences;

• Increased or altered interest in sex and behavior that is concerning to you or others, such as increased sexual urges;

• Excessive or uncontrolled spending or shopping;

• Eating excessively (consuming large amounts of food in short periods) or compulsively (eating more than usual and more than needed to satisfy hunger).

Inform your doctor if you experience any of these behaviors; they will discuss how to manage or reduce these symptoms.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levodopa/Carbidopa/Entacapone Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

Store below 25 ºC.

Take the tablets within the first 175 days after opening the bottle for the first time.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Levodopa/Carbidopa/Entacapone Teva-ratiopharm

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

• Each tablet of Levodopa/Carbidopa/Entacapone Teva-ratiopharm 100 mg/25 mg/200 mg contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
• The other components of the tablet core are microcrystalline cellulose, lactose, hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate.
• The coating components are titanium dioxide (E171), hypromellose, glycerol (E422), polysorbate 80, Allura Red AC (E129), cochineal (E120) and magnesium stearate.

Appearance of the product and contents of the container

Levodopa/Carbidopa/Entacapone Teva-ratiopharm 100 mg/25 mg/200 mg: pale red, oblong, biconvex tablets, unmarked on one side and smooth on the other. Dimensions: approx. 17 x 9 mm.

Levodopa/Carbidopa/Entacapone Teva-ratiopharm is available in the following pack sizes: bottles containing 10, 28, 30, 50, 60, 90, 98, 100, 130, 150, 175, 200 or 250 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura 11. Edificio Albatros B. planta 1ª.

28108, Alcobendas. Madrid

Spain

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

This medicinal product is authorized in Member States under the following names:

Date of the most recent review of this leaflet: November 2019

Other sources of information

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79022/P_79022.html