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, 200 mg / 50 mg / 200 mg film-coated tablets
levodopa / carbidopa / entacapone
What Sastravi is and what it is used for
Sastravi contains three active substances ( levodopa, carbidopa, and entacapone) in a film-coated tablet. Sastravi is used to treat 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, and entacapone found in Sastravi may also be approved for the treatment of other conditions not mentioned in this product information. . Ask your doctor, pharmacist, or another healthcare professional if you have any further questions and always follow their instructions.
What you need to know before taking Sastravi
Do not take Sastravi if you
- is allergic to levodopa, carbidopa, entacapone, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
- have narrow-angle glaucoma (an eye disease)
- has a tumor in the adrenal gland
- taking certain medicines to treat depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors )
- previously had neuroleptic malignant syndrome (NMS – this is a rare reaction to drugs used to treat severe mental illness)
- previously had non-traumatic rhabdomyolysis (a rare muscle disease)
- have serious liver disease.
Warnings and cautions
Talk to your doctor or pharmacist before taking Sastravi if you have or have had:
- a heart attack or any other heart disease including arrhythmias, or blood vessel disease
- asthma or another lung disease
- liver problems, your dose may 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 Sastravi may aggravate this effect.
Ask your doctor if you are taking Sastravi 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, have suicidal thoughts, or notice 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 treatment with Sastravi. If this happens, your doctor may need to change your dose of Parkinson’s medicine
- to get diarrhea: your weight may need to be monitored to avoid a possible
- sharp weight loss
- experiences loss of appetite that worsens over time, lack of energy (weakness, fatigue), and weight loss within a short period. If this happens, a general medical examination including liver function tests should be considered.
- feel that you want to stop using Sastravi, see the section “If you stop taking Sastravi”.
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 Sastravi and other medicines used to treat Parkinson’s disease.
Tell your doctor if you or your family/caregiver notice that you develop a strong desire or desire to behave in ways that are unusual for you, or you can not resist the impulse, drive, or temptation to perform certain activities that can 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 or feelings. Your doctor may need to re-evaluate your treatment.
Your doctor may need to take regular samples of you during long-term treatment with Sastravi.
If you need surgery, tell your doctor that you are taking Sastravi.
Sastravi is not recommended for the treatment of extrapyramidal symptoms (eg involuntary movements, tremors, muscle stiffness, and muscle contractions) caused by other medicines.
Talk to your doctor or pharmacist before taking Sastravi if you are not sure if any of the above applies to you.
Children and young people
Experience in the treatment of patients under 18 years of age with Sastravi is limited. Sastravi is therefore not recommended for the treatment of children or adolescents.
Other medicines and Sastravi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Sastravi if you are taking certain medicines to treat depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors ).
Sastravi 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 Sastravi. These are:
- dopamine antagonists used to treat mental illness, nausea, and vomiting
- phenytoin used to prevent convulsions
- papaverine is used for muscle relaxation.
Sastravi may impair the absorption of iron. Therefore, do not take Sastravi and iron supplements at the same time, but at least 2-3 hours apart.
Sastravi with food and drink
Sastravi can be taken with or without food. In some patients, Sastravi may be less well absorbed if taken concomitantly with or shortly after eating a high-protein diet (such as meat, fish, dairy products, seeds, and nuts). Contact your doctor if you think this may affect 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 Sastravi.
Driving and using machines
Sastravi 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 cause serious injury or death to yourself or others.
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.
Sastravi contains lecithin (soy) and sodium
Sastravi contains lecithin (soy)
If you are allergic to peanuts or soy, do not take this medicine.
Sastravi contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to take Sastravi
If you use more Sastravi than you should
In the event of an overdose, you may feel confused or upset, your heart rate may be slower or faster than normal or your skin, tongue, eyes or urine may change color.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Sastravi
Do not take a double dose to make up for a forgotten tablet.
If it is more than 1 hour until the next dose:
Take one tablet as soon as you remember, and take the next tablet at the usual time.
If it is less than 1 hour until the next dose:
Take one tablet as soon as you remember, wait 1 hour and then take another tablet. After that, you can continue as usual.
Always make sure that there is at least one hour between Sastravidos, to avoid any side effects.
If you stop using Sastravi
Do not stop taking Sastravi unless your doctor tells you to. In such a case, your doctor may need to change your other antiparkinsonian medication, especially levodopa, to maintain adequate symptom control. If you suddenly stop taking Sastravi and other antiparkinsonian drugs, it may lead to unwanted side effects.
If you have any further questions on the use of this product, ask 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 Sastravi, 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 the 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, and 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 people):
- 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
- feeling weak
- abnormal gait
- headache, joint pain
- urinary tract infection
Uncommon (may affect up to 1 in 100 people):
- heart attack
- intestinal bleeding
- altered blood cell count (which may lead to bleeding), abnormal liver function values
- seizures
- feelings of upset
- psychotic symptoms
- colitis ( inflammation of the colon)
- discoloration of other than urine (eg skin, nails, hair, sweat)
- difficulty swallowing
- inability to urinate
- feeling sick
No known frequency (cannot be calculated from the available data):
- Ask for a higher dose of Sastravi that is greater than what is needed to control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience severe abnormal involuntary movements ( dyskinesias ), mood swings, or other side effects after taking larger doses of Sastravi.
The following side effects have also been reported:
- hepatitis ( inflammation of the liver)
- itching
You may experience the following side effects:
- 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 your family
- altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
- uncontrolled 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).
Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce the symptoms.
How to store Sastravi
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 can and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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 packaging and other information
Content declaration
- The active substances of Sastravi are levodopa , carbidopa and entacapone.
- Each film-coated tablet contains 50 mg levodopa, 12.5 mg carbidopa (as monohydrate), and 200 mg entacapone.
- Each film-coated tablet contains 75 mg levodopa, 18.75 mg carbidopa (as monohydrate), and 200 mg entacapone.
- Each film-coated tablet contains 100 mg levodopa, 25 mg carbidopa (as monohydrate), and 200 mg entacapone.
- Each film-coated tablet contains 125 mg levodopa, 31.25 mg carbidopa (as monohydrate), and 200 mg entacapone.
- Each film-coated tablet contains 150 mg levodopa, 37.5 mg carbidopa (as monohydrate), and 200 mg entacapone.
- Each film-coated tablet contains 175 mg levodopa, 43.75 mg carbidopa (as monohydrate), and 200 mg entacapone.
- Each film-coated tablet contains 200 mg levodopa, 50 mg carbidopa (as monohydrate), and 200 mg entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, hydroxypropylcellulose, trehalose dihydrate, cellulose powder, sodium sulfate (anhydrite), microcrystalline cellulose, and magnesium stearate.
- Film coating: Polyvinyl alcohol, partially hydrolyzed, talc, titanium dioxide (E171), macrogol, red iron oxide (E172), lecithin (soy) (E322), yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Sastravi 50 mg / 12.5 mg / 200 mg: Brown red, oval, film-coated tablet, cupped, 6.85 x 14.2 mm, marked with “50” on one side and “LEC” on the other side.
Sastravi 75 mg / 18.75 mg / 200 mg: Brown red, oval, film-coated tablet, cupped, 7.04 x 14.7 mm, marked with “75” on one side and “LEC” on the other side.
Sastravi 100 mg / 25 mg / 200 mg: Brown red, oval, film-coated tablet, cupped, 7.23 x 15.3 mm, marked with “100” on one side and “LEC” on the other side.
Sastravi 125 mg / 31.25 mg / 200 mg: Brown red, oval, film-coated tablet, cupped, 7.5 x 15.8 mm, marked with “125” on one side and “LEC” on the other side.
Sastravi 150 mg / 37.5 mg / 200 mg: Brown red, oval, film-coated tablet, cupped, 7.68 x 16.2 mm, marked with “150” on one side and “LEC” on the other side.
Sastravi 175 mg / 43.75 mg / 200 mg: Brown red, oval, film-coated tablet, cupped, 7.92 x 16.6 mm, marked with “175” on one side and “LEC” on the other side.
Sastravi 200 mg / 50 mg / 200 mg: Brown red, oval, film-coated tablet, cupped, 8.21 x 17.2 mm, marked with “200” on one side and “LEC” on the other side.
Pack sizes:
Tablet jar with screw cap:
10, 30, 100, 130, and 175 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.,
Reykjavikurvegur 76-78,
220 Hafnarfjörður,
Iceland
Manufacturer
Balkanpharma-Dupnitsa AD,
3 Samokovsko Shosse Str.,
Dupnitsa 2600,
Bulgaria