100 mg / 25 mg, 200 mg / 50 mg prolonged-release tablet
levodopa / carbidopa
What Levocar is and what it is used for
Levocar is used to treat Parkinson’s disease. It reduces the “off” time (sudden muscle stiffness that can last for minutes or even hours) if you are treated with levodopa alone, tablets with levodopa/decarboxylase inhibitors with immediate-release (eg carbidopa) and if you have sudden uncontrolled movements.
Levocar belongs to a class of medicines used to treat Parkinson’s disease. The symptoms of this disease are probably caused by a deficiency of dopamine, a substance normally produced by the brain. Dopamine is important for the control of muscle movements. Lack of this causes problems with muscle movements. Levodopa compensates for the lack of dopamine, while carbidopa ensures that enough levodopa reaches the brain.
Levodopa and carbidopa contained in Levocar 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 take Levocar
Do not take Levocar
- if you are allergic (hypersensitive) to levodopa or carbidopa or any of the other ingredients of the tablet
- if you have increased pressure in your eyes ( narrow-angle glaucoma )
- if you have severe heart failure
- if you have a severe arrhythmia in your heart
- in case of sudden stroke
- if you are not allowed to take medicines that act on the central nervous system (sympathomimetics)
- If using non-selective monoamine oxidase inhibitors , and selective MAO inhibitors of type A ( MAO inhibitors are drugs used for depression). You must stop taking these medicines for at least two weeks before starting treatment with Levocar.
Levocar can be given at the same time as the recommended dose of one MAO inhibitor that is selective for MAO type B (eg selegiline ).
Warnings and cautions
Take special care with Levocar
- if you are currently being treated or have been treated with levodopa alone . Then you must wait at least 12 hours before you can start taking Levocar tablets
- if you have any movement disorders such as twitching of the facial muscles, muscle stiffness and stiffness, difficulty starting a movement, tremors in fingers or hands. Then it may be necessary to reduce dose one.
- if you have had involuntary movements in the past
- if you have ever had a psychotic event or have had psychosis . Psychosis is a severe mental illness in which control over one’s own behavior and behavior is impaired.
In very rare cases, there have been reports of patients who have become depressed and who have later developed suicidal tendencies. If you think this also applies to you, it is advisable to contact your doctor immediately. - if you are constantly tired and / or prone to falling asleep without warning. You may not drive or use machines. Your doctor will adjust the dose as needed or discontinue treatment altogether.
- if you have a severe cardiovascular disease
- if you have a severe lung disease or if you have sudden attacks of shortness of breath caused by muscle spasms and swelling of the mucous membranes of the airways, often accompanied by cough and mucus production ( bronchial asthma )
- if you have any kidney or liver disease, or if you have any problems with the endocrine system ( glands that secrete hormones into your bloodstream)
- if you have had stomach or intestinal ulcers, as there is a greater risk of stomach bleeding
- if you vomit blood
- if you have had seizures / seizures
- if you have recently had a heart attack and still have arrhythmias in your heart
- if you have chronic glaucoma (increased pressure in the eyes)
- if your levodopa / carbidopa dose is suddenly lowered or treatment is stopped suddenly, especially if you are taking medicines to treat psychosis as this may trigger a change in your mental state. Muscle stiffness and elevated body temperature may occur.
- if you have a hereditary disease that manifests itself as sudden involuntary but coordinated movements (Huntington’s korea). Then Levocar is not recommended.
- if you have had malignant melanoma
- if you have any skin disease that has not yet been diagnosed by a doctor
- Levocar may cause abnormalities in several laboratory tests. These include:
- liver function tests
- false positive Coombs test
- decreased hemoglobin and decreased hematocrit , elevated serum glucose and increased white blood cell count , bacteria and blood in the urine
- When test strip is used to determine ketoneuria, a false positive result on ketone bodies in the urine may be displayed. This reaction is not changed by boiling the urine sample.
- false negative results can also occur when examining glucosuria using glucose oxidase methods.
If you or your family/caregiver notices that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities that may harm you or Others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Tell your doctor if this happens; your doctor may need to re-evaluate your treatment.
Tell your doctor if you or your family/caregiver notice that you are developing addictive symptoms that lead to a craving for higher doses of Levocar and other medicines used to treat Parkinson’s disease.
Children and young people
The safety and efficacy of Levocar in neonates and children under 18 years of age have not been established. Therefore, the use of Levocar in patients under 18 years of age is not recommended.
Tell your doctor if any of the above warnings apply to you, or if they have affected you in the past.
Other medicines and Levocar
Levocar may affect the effects/side effects of other medicines and vice versa. This is especially true:
- drugs for the treatment of hypertension ; your doctor adjusts dose one
- medicines to treat depression (see also section “Do not take Levocar”)
- drugs that affect 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 dose as needed
- drugs for the treatment of psychosis
- isoniazid (a medicine used to treat tuberculosis )
- benzodiazepines (certain hypnotics and sedatives) such as diazepam , oxazepam and lormetazepam. The effect of Levocar may be reduced
- phenytoin (a medicine used in epilepsy ). The effect of Levocar may be reduced
- papaverine (a medicine used to treat gastrointestinal spasms ). The effect of Levocar may be reduced
- selegiline (a medicine used to treat Parkinson’s disease ). When used concomitantly with Levocar, a sharp drop in blood pressure may occur
- COMT inhibitors (used in Parkinson’s disease ). When used at the same time as Levocar, the levels of levodopa that reach the brain may increase. Dose one of Levocar may need to be adjusted
- amantadine (used in Parkinson’s disease ). The side effects of levodopa may be increased. Dose one of Levocar may need to be adjusted
- metoclopramide (a medicine for gastrointestinal problems)
- drugs that affect the central nervous system ( sympathomimetics , bronchodilators used in asthma ) such as apraclonidine, dipivephrine and brimonidine. Cardiovascular-related side effects may increase
- dopamine depleting agents (eg tetrabenazine which leads to dopamine deficiency in the central nervous system . They inhibit specific transport proteins called monoamine transporters that transport monoamines (such as dopamine ) to and from the cells) or other drugs known to deplete monoamine reserves.
- ferrous sulfate . Absorption of levodopa may decrease.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Levocar with food and drink
The effect of levodopa can sometimes be reduced in patients on a high protein diet.
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.
- All women who can have children and take Levocar must use an effective method of contraception.
- There is insufficient knowledge about the use of Levocar in human pregnancy. The drug has been shown to be harmful in animal studies.Do not take Levocar if you are pregnant or trying to become pregnant.
- Levocar is excreted in human milk.Therefore, you must not breast-feed during treatment with Levocar.
Driving and using machines
Levocar may cause side effects such as
- dizziness
- drowsiness
- double vision
which can affect your ability to react.
You should keep this in mind if you plan to drive or use machines. If you tend to become drowsy and fall asleep without warning, do not drive or use machines.
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.
Levocar contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per prolonged-release tablet, it is essential ‘sodium-free’.
How to take Levocar
Dosage
Adults and the elderly
Your doctor has prescribed how much Levocar to take. In general, the following applies:
If you have never been treated with levodopa:
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Starting dose
1 prolonged-release tablet Levocar 100 mg / 25 mg twice daily or 1 prolonged-release tablet Levocar 200 mg / 50 mg twice daily.
Maximum starting dose
6 prolonged-release tablets are Levocar 100 mg / 25 mg daily or 3 prolonged-release tablets are Levocar 200 mg / 50 mg daily (600 mg levodopa per day).
Amounts are to be taken at least 6 hours apart.
If you switch from standard levodopa/carbidopa tablets to delayed-release Levocar tablets:
Such a change must take place gradually and under the supervision of a doctor.
If you are currently being treated with levodopa alone:
Treatment with levodopa must be discontinued at least 12 hours before using Levocar.
The starting dose in patients with mild to moderate Parkinson’s disease:
1 prolonged-release tablet Levocar 200 mg / 50 mg twice daily or 2 prolonged-release tablets Levocar 100 mg / 25 mg twice daily.
Maintenance dose:
Your doctor will check you at regular intervals and change your dose as needed.
There should be at least three days between each dose change.
Swallow prolonged-release tablet whole with a glass of water, regardless of meals. Do not divide or chew prolonged-release tablets.
If you have the impression that the effect of Levocar is too weak or too strong, talk to your doctor or pharmacist.
Use for children and adolescents (under 18 years)
The use of Levocar in patients under 18 years of age is not recommended (see section “Take special care with Levocar”).
Duration of treatment
Your doctor will tell you how long to continue taking Levocar. Do not stop treatment before you go, otherwise, your symptoms may return.
Possible side effects
Like all medicines, Levocar can cause side effects, although not everybody gets them.
Side effects that can occur are:
The blood and lymphatic system
Rare: may affect up to 1 in 1,000 users
- blood disorder (lack of white blood cells ) accompanied by increased susceptibility to infection ( leukopenia )
- anemia (hemolytic and non-hemolytic)
- anemia ( platelet deficiency ) accompanied by bruising and bleeding tendency ( thrombocytopenia )
Very rare: may affect up to 1 in 10,000 people
- a very serious blood disorder (lack of white blood cells ) accompanied by sudden high fever, severe sore throat and cold sores ( agranulocytosis )
Metabolism and nutrition disorders
Common: may affect up to 1 in 10 users
- loss of appetite
Uncommon: may affect up to 1 in 100 people
- weight loss
- weight gain
Mental disorders
Common: may affect up to 1 in 10 users
- that you see things that do not exist (hallucinations)
- confusion
- dizziness
- nightmares
- drowsiness
- fatigue
- insomnia
- depression with (in very rare cases) suicidal tendencies
- feeling of well-being ( euphoria )
- events of serious mental illness during which control over one’s own behavior and behavior is impaired ( psychosis )
- feeling of stimulation
Rare: may affect up to 1 in 1,000 users
- arousal ( agitation )
- anxiety
- impaired thinking ability
- disorientation
- headache
- increased sexual drive
- loss of sensation
- seizures / seizures
Has been reported (occurs in the unknown number of users):
- dementia
- inability to resist an impulse to perform an action that may be harmful such as:
- a strong impulse to excessive gambling despite serious consequences for you personally or for your family
- altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
- uncontrollable and excessive need to buy things and spend money
- binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- request higher doses of Levocar that are greater than those required to control motor systems, known as dopaminergic dysregulation syndrome . Some patients experience severe abnormal involuntary movements ( dyskinesias ), mood swings or other side effects after taking larger doses of Levocar
Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce the symptoms.
Central and peripheral nervous system
Common: may affect up to 1 in 10 users
- movement disorders ( dyskinesia )
- a disorder characterized by sudden involuntary movements (korea)
- muscle tone disorder ( dystonia )
- movement disorders caused outside the nervous system (extrapyramidal)
- sudden changes in Parkinson’s symptoms (“on-off” symptoms)
- slow movements during the on-off periods ( bradykinesia )
Uncommon: may affect up to 1 in 100 people
- ataxi
- increase in tremors in the hands
Rare: may affect up to 1 in 1,000 users
- a serious condition as a result of the use of neuroleptics , which can manifest itself in muscle stiffness, very difficult to sit still, high fever, sweating, increased salivation and decreased level of consciousness (malignant neuroleptic syndrome)
- feeling of tingling, ant crawling and itching without any obvious cause ( paresthesia )
- fall accidents
- gait disorders
- locked jaw
Has been reported (occurs in the unknown number of users):
- drowsiness and (in very rare cases) constant fatigue during the day / sudden sleep attacks.
Eyes
Rare: may affect up to 1 in 1,000 users
- dimsyn
- spasm in the orbicularis oculi muscle around the eye (this may be a sign of overdose)
- activation of pre-existing Horner’s syndrome (an eye disease)
- double vision
- dilated pupil is
- impaired ability to move the eyes
The heart
Common: may affect up to 1 in 10 users
- palpitation
- irregular heartbeats
Blood vessels
Common: may affect up to 1 in 10 users
- drop in blood pressure when e.g. rises too quickly from a sitting or lying position, sometimes accompanied by dizziness ( orthostatic hypotension )
- fainting tendency
- sudden unconsciousness
Uncommon: may affect up to 1 in 100 people
- high blood pressure
Rare: may affect up to 1 in 1,000 users
- inflammation of the veins ( phlebitis )
Respiratory, thoracic, and mediastinal disorders (ie the area between the lungs)
Uncommon: may affect up to 1 in 100 people
- huskiness
- chest pain
Rare: may affect up to 1 in 1,000 users
- respiratory distress
- deviating breathing patterns
The gastrointestinal tract
Common: may affect up to 1 in 10 users
- nausea
- vomiting
- dry mouth
- bitter taste
Uncommon: may affect up to 1 in 100 people
- constipation
- diarrhea
- increased salivation
- difficulty swallowing (dysphagia)
- gases
Rare: may affect up to 1 in 1,000 users
- indigestion with symptoms such as feeling full in the upper abdomen, pain in the upper abdomen, belching, nausea, vomiting and heartburn ( dyspepsia )
- pain in the stomach and intestines
- dark-colored saliva
- squeaking of teeth
- hiccup
- bleeding in the stomach and intestines
- burning sensation in the tongue
- sores on the duodenum a
Skin and subcutaneous tissue disorders
Uncommon: may affect up to 1 in 100 people
- accumulation of fluid ( edema )
Rare: may affect up to 1 in 1,000 users
- sudden accumulation of fluid in the skin and mucous membranes (eg throat and tongue), difficulty breathing and / or itching and rash, often occurs as an allergic reaction ( angioedema )
- skin rash with severe itching and rashes ( hives )
- itching
- flushing
- hair loss
- rash
- increased sweating
- dark sweat
- in children, allergy-related bleeding in the skin and the walls of the gastrointestinal tract (Schönlein-Henoch purpura).
Has been reported: occurs an unknown number of users
malignant skin cancer ( melanoma )
Musculoskeletal and connective tissue disorders
Uncommon: may affect up to 1 in 100 people
- muscle spasms
Kidneys and urinary tract
Uncommon: may affect up to 1 in 100 people
- dark-colored urine
Rare: may affect up to 1 in 1,000 users
- difficulty urinating
- involuntary urination
- persistent erection (priapism)
General disorders and administration site conditions
Uncommon: may affect up to 1 in 100 people
- weakness
- feeling sick
- hot flashes
How to store Levocar
- 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 blister and on the carton after EXP. or EXP. The expiration date is the last day of the specified month.
- This medicine does not require any special storage instructions.
- 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.
Contents of the pack and other information
Content declaration
The active substances are levodopa and carbidopa.
One prolonged-release tablet of Levocar 100 mg / 25 mg contains 100 mg of levodopa and 25 mg of carbidopa (as carbidopa monohydrate).
One prolonged-release tablet of Levocar 200 mg / 50 mg contains 200 mg of levodopa and 50 mg of carbidopa (as carbidopa monohydrate).
The 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 the medicine looks like and contents of the pack
Levocar 100 mg / 25 mg prolonged-release tablets: orange-brown, round tablet.
Levocar 200 mg / 50 mg prolonged-release tablets: orange-brown, round tablet.
The prolonged-release tablets are packaged in blisters containing 30, 50, 60, 100, or 200 tablets, which are packaged in a carton. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Lek SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland