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, 150 mg / 37.5 mg / 200 mg, 175 mg / 43.75 mg / 200 mg, 200 mg / 50 mg / 200 mg film-coated tablets
levodopa / carbidopa / entacapone
What Levodopa / Carbidopa / Entacapone Rivopharm is and what it is used for
Levodopa / Carbidopa / Entacapone Rivopharm contains three active substances ( levodopa, carbidopa, and entacapone) in a film-coated tablet. Levodopa / Carbidopa / Entacapone Rivopharm is used for treating Parkinson’s disease.
Parkinson’s disease is due to low levels of the substance dopamine in the brain. Levodopa increases the amount of dopamine and therefore relieves the symptoms of Parkinson’s disease. Carbidopa and entacapone improve the effect of levodopa on Parkinson’s disease.
Levodopa/carbidopa/entacapone contained in Levodopa / Carbidopa / Entacapone Rivopharm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Levodopa / Carbidopa / Entacapone Rivopharm
Do not use Levodopa / Carbidopa / Entacapone Rivopharm if you
- If you are allergic to levodopa , carbidopa or entacapone or any of the other ingredients of this medicine (listed in section 6)
- If you have narrow-angle glaucoma (an eye disease)
- If you have a tumor in the adrenal gland
- 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 a history of neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used to treat severe mental illness)
- If you have previously had non-traumatic rhabdomyolysis (a rare muscle disease)
- If you have severe liver disease.
Warnings and cautions
Talk to your doctor or pharmacist before taking Levodopa / Carbidopa / Entacapone Rivopharm if you have or have had:
- a heart attack or any other heart disease including arrhythmias , or blood vessel disease
- asthma or other lung disease
- liver problems, your dose may then need to be adjusted
- kidney disease or hormone-related disease
- stomach ulcer or seizures
- if you experience prolonged diarrhea, consult a doctor as this may be a sign of colitis
- some form of serious mental illness, such as psychosis
- chronic wide-angle glaucoma. Your dose may then need to be adjusted and your eye pressure may need to be monitored.
Consult your doctor if you are taking:
- antipsychotics (drugs for the treatment of psychosis )
- medicines that can cause low blood pressure when you get up from a chair or bed. You should be aware that Levodopa / Carbidopa / Entacapone Rivopharm may aggravate this effect.
Ask your doctor if you are taking Levodopa / Carbidopa / Entacapone Rivopharm during treatment:
- experience that your muscles become stiff or jerky, or if you suffer from tremors, agitation, confusion, fever, rapid pulse or sharp fluctuations in blood pressure. If any of these happen to you , contact your doctor immediately .
- feeling depressed, having suicidal thoughts, or noticing that your behavior is changing.
- suddenly fall asleep, or feel very sleepy. If this happens, do not drive or use machines (see also the section Driving and using machines).
- get involuntary movements or if they worsen after starting Levodopa / Carbidopa / Entacapone Rivopharm treatment. If this happens, your doctor may need to change your dose of Parkinson’s medication .
- get diarrhea: your weight may need to be monitored to avoid any significant weight loss.
- experiences loss of appetite that worsens over time, lack of energy (weakness, fatigue) and weight loss within a short period of time. If this happens, a general medical examination including liver function tests should be considered.
- feel that you want to stop using Levodopa / Carbidopa / Entacapone Rivopharm, see the section “If you stop using Levodopa / Carbidopa / Entacapone Rivopharm”.
Tell your doctor if you or your family/caregiver finds that you are developing impulses or wanting to behave in ways that are unusual for you, or you can not resist the impulse, the urge, or the temptation to engage in a certain activity that may harm yourself or others. . This behavior is called impulse control disorder and may include compulsive gambling, excessive food intake or spending, an abnormally high sex drive, or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.
Your doctor may need to take regular samples of you during long-term treatment with Levodopa / Carbidopa / Entacapone Rivopharm.
If you need surgery, tell your doctor that you are taking Levodopa / Carbidopa / Entacapone Rivopharm.
Levodopa / Carbidopa / Entacapone Rivopharm is not recommended for the treatment of extrapyramidal symptoms (eg involuntary movements, tremors, muscle stiffness, and muscle contractions) caused by other medicines.
Children and young people
Experience in the treatment of patients under 18 years of age with Levodopa / Carbidopa / Entacapone Rivopharm is limited. Levodopa / Carbidopa / Entacapone Rivopharm is therefore not recommended for the treatment of children.
Other medicines and Levodopa / Carbidopa / Entacapone Rivopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Levodopa / Carbidopa / Entacapone Rivopharm 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 Rivopharm may potentiate the effects and side effects of certain medicines. This includes:
- antidepressants such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
- rimiterol and isoprenaline , which are used to treat respiratory diseases
- adrenaline , which is used in severe allergic reactions
- norepinephrine , dopamine and dobutamine , which are used to treat heart disease and low blood pressure
- alpha-methyldopa, is used to treat high blood pressure
- apomorphine, which is used to treat Parkinson’s disease .
Some medicines may weaken the effect of Levodopa / Carbidopa / Entacapone Rivopharm. These are:
- dopamine antagonists used to treat mental illness, nausea and vomiting
- phenytoin used to prevent convulsions
- papaverine used for muscle relaxation.
Levodopa / Carbidopa / Entacapone Rivopharm may impair the absorption of iron. Therefore, do not take Levodopa / Carbidopa / Entacapone Rivopharm and iron supplements at the same time, but at least 2-3 hours apart.
Levodopa / Carbidopa / Entacapone Rivopharm with food and drink
Levodopa / Carbidopa / Entacapone Rivopharm can be taken with or without food. In some patients, Levodopa / Carbidopa / Entacapone Rivopharm may be less well absorbed if taken at the same time as or shortly after eating a high protein diet (such as meat, fish, dairy products, seeds, and nuts). Contact 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not breastfeed while being treated with Levodopa / Carbidopa / Entacapone Rivopharm.
Driving and using machines
Levodopa / Carbidopa / Entacapone Rivopharm may lower your blood pressure, which may make you feel dizzy or dizzy. Therefore, be especially careful if you drive or use tools or machines.
If you feel very drowsy or if you sometimes suddenly fall asleep, wait until you feel fully awake before driving or doing anything else that requires your attention. Otherwise, you may expose yourself or others to injury or death.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Levodopa / Carbidopa / Entacapone Rivopharm 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 contains lactose .
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Levodopa / Carbidopa / Entacapone Rivopharm 100 mg / 25 mg / 200 mg contains lactose and allura red (E129).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Allura red (E129) may cause allergic reactions.
Levodopa / Carbidopa / Entacapone Rivopharm 150 mg / 37.5 mg / 200 mg contains lactose and azorubine (E122).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Azorubin (E122) may cause allergic reactions.
How to use Levodopa / Carbidopa / Entacapone Rivopharm
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
For adults and the elderly:
- Your doctor will tell you exactly how many Levodopa / Carbidopa / Entacapone Rivopharm tablets to take each day.
- The tablets are not meant to be split or broken into small pieces.
- You should only take one tablet at a time.
- Depending on how you respond to treatment, your doctor may suggest an increase or decrease in dose one.
- If you take Levodopa / Carbidopa / Entacapone Rivopharm 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, do not take more than 10 tablets per day.
- If you are taking Levodopa / Carbidopa / Entacapone Rivopharm 175 mg / 43.75 mg / 200 mg, do not take more than 8 tablets per day.
- If you are taking Levodopa / Carbidopa / Entacapone Rivopharm 200 mg / 50 mg / 200 mg, do not take more than 7 tablets per day.
If you have the impression that the effect of Levodopa / Carbidopa / Entacapone Rivopharm is too strong or too weak, or if you experience any side effects, talk to your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many side effects can be alleviated by adjusting the dose.
If you experience the following symptoms during treatment with Levodopa / Carbidopa / Entacapone Rivopharm, contact your doctor immediately:
- your muscles become stiff or jerky, you suffer from tremors, agitation, confusion, fever, rapid pulse or sharp fluctuations in blood pressure. These can be symptoms of malignant neuroleptic syndrome (NMS, a rare severe reaction to drugs used to treat diseases of the central nervous system ) or rhabdomyolysis (a rare severe muscle disease).
- allergic reaction , symptoms may include hives, itching , rash, swelling of the face, lips, tongue or throat. This may cause difficulty breathing or swallowing.
Very common: may affect more than 1 user in 10
- involuntary movements ( dyskinesias )
- nausea
- reddish-brown discoloration of the urine (harmless)
- muscle pain
- diarrhea.
Common: may affect up to 1 in 10 users
- dizziness or fainting due to low blood pressure , high blood pressure
- aggravated symptoms of Parkinson’s disease , dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth , constipation
- difficulty sleeping, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
- mental changes – including memory disorders, anxiety and depression (possibly with suicidal thoughts)
- heart or artery disease (eg chest pain), irregular heartbeat or rhythm
- increased tendency to fall
- shortness of breath
- increased sweating, rash
- muscle cramps, swelling of the legs
- dimsyn
- anemia
- decreased appetite, weight loss
- headache, joint pain
- urinary tract infection
Uncommon: may affect up to 1 in 100 people
- heart attack
- intestinal bleeding
- changes in the number of blood cells , which can result in bleeding, deviating liver function values
- cramps
- feeling of upset
- psychotic symptoms
- colitis ( inflammation of the colon)
- discoloration of e.g. skin, nails, hair, sweat
- difficulty swallowing
- inability to urinate.
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 perform an action that may be harmful, which may include:
- strong impulse to play extremely much despite serious personal or family consequences
- altered or increased sexual interest and behavior that significantly affects you or others, such as increased sexual desire
- uncontrolled excessive shopping or spending
- binge eating (eating large amounts of food for a short period of time) or compulsive food intake (eating more food than normal and more than is needed to satisfy your hunger).
Tell your doctor if you experience any of these symptoms; one will discuss how to manage or reduce these symptoms.
The Medical Products Agency
Box 26
751 03 Uppsala
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
How to store Levodopa / Carbidopa / Entacapone Rivopharm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and jar after EXP. or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Shelf life after first opening the jar: 175 days.
The medicine 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.
Contents of the package and other information
Content declaration
The active substances of Levodopa / Carbidopa / Entacapone Rivopharm are levodopa , carbidopa and entacapone.
Levodopa / Carbidopa / Entacapone Rivopharm 50 mg / 12.5 mg / 200 mg film-coated tablets:
- Each 50 mg / 12.5 mg / 200 mg tablet contains 50 mg levodopa , 12.5 mg carbidopa and 200 mg entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose , low-substituted hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate.
- The film coating contains titanium dioxide (E171), hypromellose, glycerol (E422), yellow iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium stearate.
Levodopa / Carbidopa / Entacapone Rivopharm 75 mg / 18.75 mg / 200 mg film-coated tablets:
- Each 75 mg / 18.75 mg / 200 mg tablet contains 75 mg levodopa , 18.75 mg carbidopa and 200 mg entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose , low-substituted hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate.
- The film coating contains titanium dioxide (E171), hypromellose, glycerol (E422), yellow iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium stearate.
Levodopa / Carbidopa / Entacapone Rivopharm 100 mg / 25 mg / 200 mg film-coated tablets:
- Each 100 mg / 25 mg / 200 mg tablet contains 100 mg levodopa , 25 mg carbidopa and 200 mg entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose , low-substituted hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate.
- The film coating contains titanium dioxide (E171), hypromellose, glycerol (E422), polysorbate 80, allura red aluminum lacquer (E129), carmine (E120) and magnesium stearate.
Levodopa / Carbidopa / Entacapone Rivopharm 125 mg / 31.25 mg / 200 mg film-coated tablets:
- Each 125 mg / 31.25 mg / 200 mg tablet contains 125 mg levodopa , 31.25 mg carbidopa and 200 mg entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose , low-substituted hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate.
- The film coating contains titanium dioxide (E171), hypromellose, glycerol (E422), yellow iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium stearate.
Levodopa / Carbidopa / Entacapone Rivopharm 150 mg / 37.5 mg / 200 mg film-coated tablets:
- Each 150 mg / 37.5 mg / 200 mg tablet contains 150 mg levodopa , 37.5 mg carbidopa and 200 mg entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose , low substituted hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate.
- The film coating contains titanium dioxide (E171), hypromellose, glycerol (E422), polysorbate 80, red iron oxide (E172), azorubine aluminum lacquer (E122) and magnesium stearate.
Levodopa / Carbidopa / Entacapone Rivopharm 175 mg / 43.75 mg / 200 mg film-coated tablets:
- Each 175 mg / 43.75 mg / 200 mg tablet contains 175 mg levodopa , 43.75 mg carbidopa and 200 mg entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose , low-substituted hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate.
- The film coating contains titanium dioxide (E171), hypromellose, glycerol (E422), yellow iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium stearate.
Levodopa / Carbidopa / Entacapone Rivopharm 200 mg / 50 mg / 200 mg film-coated tablets:
- Each 200 mg / 50 mg / 200 mg tablet contains 200 mg levodopa , 50 mg carbidopa and 200 mg entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose , low-substituted hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate.
- The film coating contains titanium dioxide (E171), hypromellose, glycerol (E422), yellow iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium stearate.
What the medicine looks like and contents of the pack
Levodopa / Carbidopa / Entacapone Rivopharm 50 mg / 12.5 mg / 200 mg: Round, biconvex, light brown film-coated tablet marked with “50” on one side and smooth on the other side. Dimensions: approx. 14 mm in diameter.
Levodopa / Carbidopa / Entacapone Rivopharm 75 mg / 18.75 mg / 200 mg: Oval, biconvex, light orange film-coated tablet marked with “75” on one side and smooth on the other side. Dimensions: approx. 16×10 mm.
Levodopa / Carbidopa / Entacapone Rivopharm 100 mg / 25 mg / 200 mg: Oblong, biconvex, light red film-coated tablet marked with “100” on one side and smooth on the other. Dimensions: approx. 17×9 mm.
Levodopa / Carbidopa / Entacapone Rivopharm 125 mg / 31.25 mg / 200 mg: Round, biconvex, amber film-coated tablet marked with “125” on one side and smooth on the other. Dimensions: approx. 14 mm in diameter.
Levodopa / Carbidopa / Entacapone Rivopharm 150 mg / 37.5 mg / 200 mg: Oval, biconvex, dark red film-coated tablet marked with “150” on one side and smooth on the other. Dimensions: approx. 16×10 mm.
Levodopa / Carbidopa / Entacapone Rivopharm 175 mg / 43.75 mg / 200 mg: Ellipse, biconvex, light brown film-coated tablet marked with “175” on one side and smooth on the other side. Dimensions: approx. 17×10 mm.
Levodopa / Carbidopa / Entacapone Rivopharm 200 mg / 50 mg / 200 mg: Oblong, biconvex, brown film-coated tablet marked with “200” on one side and smooth on the other. Dimensions: approx. 17×9 mm.
Levodopa / Carbidopa / Entacapone Rivopharm is available in pack sizes of 10, 28, 30, 50, 60, 90, 98, 100, 130, 150, 175, 200 or 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland
Agent:
SanoSwiss UAB
Love 25-701
LT-09320 Vilnius
Lithuania
info@sanoswiss.com