SINEPAR 200 mg. / 50 mg. 100 tablets

What Sinepar and what it is used
Sinepar is a drug which contains two drugs - carbidopa monohydrate (53.50 mg carbidopa monohydrate equivalent to 50 mg of carbidopa), and 200 mg of levodopa in the ratio of 50 mg / 200 mg.
Sinepar a medicinal product which combines the aromatic amino acid carbidopa monohydrate (decarboxylase inhibitor) levodopa (metabolic precursor of dopamine), in the extended release tablet formulation of the active substance. It is intended to treat the symptoms of Parkinson's disease.

Why does my doctor has prescribed Sinepar?
Your doctor has prescribed Sinepar to treat the symptoms of Parkinson's disease.
Parkinson's disease is a chronic disease characterized by a slow and unstable movements, muscle rigidity, and tremor. If untreated, Parkinson's can hamper your daily activities.

How does Sinepar in the treatment of Parkinson's disease?
Tablets Sinepar slowly release the two active ingredients - levodopa and carbidopa.
It is believed that the symptoms of Parkinson's disease due to deficiency of dopamine, a chemical substance normally produced by a particular class of neural cells. Dopamine transmits signals to the parts of the brain controlling a muscle movements. The reduced production of dopamine leads to difficulty in movement.
Levodopa ensures the proper amount of dopamine in the brain, while carbidopa ensures delivery of the necessary amount of levodopa, where necessary. In most patients, this leads to an improvement in the symptoms of Parkinson's disease. Formulation of extended release maintain a constant amount of levodopa in your body.

2. What you need to know before taking Sinepar
Do not take Sinepar prolonged-release tablets:
if you are allergic to the active substances or any of the other ingredients of this medicine (for a list of all substances contained in the tablets, see. pt. 6);
if you have a suspicious skin changes (moles) are not examined by a doctor or have been suffering from skin cancer;
if you are treated for depression with MAOIs (except for type B MAO inhibitors, such as selegiline hydrochloride);
if you have narrow-angle glaucoma.
Warnings and Precautions
Talk to your doctor or pharmacist before using Sinepar.
Tell your doctor if you have or have had any health problems, such as:
allergies;
depression and mental disorders;
lung and heart diseases;
renal and hepatic diseases;
hormonal disorders;
ulcers;
glaucoma;
seizures.
Tell your doctor if you or your family / caregiver notice that develop incentive or compelling desires to behave in ways that are unusual for you or you can not resist the impulse, desire or temptation to perform any activities that might injure you or others around you. These behaviors are called disorders of impulse control and may include an addiction to gambling, excessive eating or excessive binge shopping unusually strong sexual desire or increased sexual thoughts or feelings. You may need your doctor to review your treatment.

Tell your doctor if you are being treated with levodopa!

What you should know before taking Sinepar?
During treatment with Sinepar, be especially careful when driving or operating machinery. If you experience increased sleepiness or even sudden sleep onset episodes, refrain from driving and operating machines, and contact your doctor.

Children and adolescents
The safety and efficacy of Sinepar in infants and children have not been established and its use is not recommended in patients under 18 years of age.

Taking Sinepar with other medicines
Although Sinepar can be given with other medicines, there are exceptions. Your doctor can warn you of incompatibility with certain other medicines such as:
antihypertensive drugs (drugs that lower high blood pressure - nifedipine, propranolol, enalapril). Please tell your doctor, as you'll probably need to change the dose of antihypertensive medication;
tricyclic antidepressants - simultaneous intake may cause hypertension (high blood pressure);
anticholinergic drugs - detrusitol, akinestat;
iron and iron supplements;
medications for mental illness and depression - risperidone, phenothiazines, butyrophenones;
drugs used to treat TB - isoniazid;
phenytoin;
papaverine.
Your doctor and pharmacist have more information on medicinal products to avoid when treating with Sinepar.

Tell your doctor about all medicines you are taking or plan to take, including those obtained without a prescription.

Pregnancy, lactation and fertility
It is unclear exactly what effect Sinepar on pregnancy. Levodopa passes into human milk. If you are pregnant or planning to become pregnant or breast-feeding, tell your doctor before starting treatment with Sinepar. It will assess the benefit of treatment and the possible risk.

Driving and using machines
The individual response to the tablets may vary. Some side effects have been reported for Sinepar may affect some patients' ability to drive or operate machinery (see. Pt. 4).
Sinepar may cause drowsiness and sudden sleep onset episodes. Therefore, avoid driving or engaging in activities in which reduced alertness could put yourself or others at risk of injury or death (eg. Operating machines) until such recurrent episodes and somnolence be controlled.

3. How to take Sinepar
Always take this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
The dosage of Sinepar may be different and the doctor will determine, depending on the stage of the disease and your tolerated.
The slow and gradual release of the active ingredients of Sinepar no grinding or chew the tablets.
For best results, take Sinepar every day. It is very important to follow your doctor's recommendations about when and how to take the product.
Inform your doctor promptly about any changes in your condition, especially if you have nausea or abnormal movements, as this may require changes in your prescription.
Do not suddenly stop taking this medicine unless your doctor tells you to do.

If you take more dose Sinepar.
If you make a mistake and take many tablets, contact your doctor you be timely medical attention.

If you forget to take Sinepar.
Try to take your tablets as your doctor has told you. Do not take a double dose to make up for a forgotten tablet. Just take the next tablet as usual.

If you stop taking Sinepar.
Do not stop treatment or reduce the dose without consulting your doctor. This can lead to the onset of muscle stiffness, fever, and psychological changes.

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

4. Possible side effects
Like all medicines, Sinepar can cause side effects, although not everybody gets them.

If you notice any of these side effects, please inform your doctor immediately or go to the emergency centers of the nearest hospital:
Fever and serious deterioration of your general condition;
Allergic reactions: swelling of the face, hands, feet, lips, tongue or throat, or trouble breathing or swallowing.
This is a very serious but rare side effect. It may need urgent medical attention or hospitalization.

Common side effects (may affect up to 1 in 10 people):
Depression, in serious cases, suicidal thoughts.
Uncommon side effects (may affect up to 1 in 100 people):
psychotic disorders with delusions (naludnachavi thoughts) and paranoia (persecution mania).
Rare side effects:
Muscle stiffness, sweating heavily (neuroleptic malignant syndrome);
Swelling of the face, lips and tongue, which can cause blockage of the airway.
Not common (from the available data can not be estimated):
Irregular heartbeat;
Disease due to a shortage of white blood cells (leukopenia and agranulocytosis), which can cause weakness, tendency to inflammation or infection, especially sore throat and fever;
Severe disease due to a decreased number of red cells (anemia), which may cause fatigue, headaches, shortness of breath, dizziness, pallor and sometimes yellowing of the skin and eyes. Immediately contact your doctor;
Bleeding from the skin and mucous membranes and bruises due to changes in blood (too few platelets);
Spasms of the eye muscles with eyes staring up;
Spontaneous bleeding from the skin and / or mucous membranes, pain and swelling of the joints, often with severe abdominal pain and bleeding (purpura of Henon-Shonlayn);
Skin cancer. Immediately contact your doctor if new scars on the body or birthmarks increase or change in some way;
Prolonged, painful erection.
Casual side effects
Very common side effects (may affect up to or more than 1 in 10 people):
Abnormal involuntary movements.
Common to very common side effects (may affect 1 in 10 people to more than 1 in 100 people):
Hallucinations (can be severe);
Palpitations;
Dizziness;
Nausea, dry mouth, which can increase the risk of caries;
Confusion.
Common side effects (may affect up to 1 in 10 people):
Involuntary movements and stranded occurring movements like throwing, throwing and suddenly twitch;
Unusual tiredness and sleepiness. Very rarely extreme daytime sleepiness and sudden twitch;
Difficulty breathing. In some people can become a serious adverse reaction;
Dizziness and possible loss of consciousness when changing body position from lying down to sitting or from sitting to standing, due to low blood pressure;
Alternating periods of excess movements expressed full stiffness;
Headache;
Burning sensation, tingling of the skin;
Very slow twisting movements;
Diarrhea, vomiting, constipation, digestive problems;
Muscle spasms;
Loss of appetite;
Chest pain;
Fainting and weakness;
Abnormal dreams, insomnia.
Uncommon side effects (may affect up to 1 in 100 people):
Weight loss;
Fainting;
Involuntary movements of the body;
Reduced mental acuity;
Stomachache;
Hives;
Tendency to fall, unusual gait;
Agitation;
Oversexed;
Uncontrollable passion for gambling.
Rare side effects (may affect up to 1 in 1000 people):
Anxiety, disorientation;
Blurred vision;
Dark saliva, dark urine;
Itching, hair loss, rash, dark sweat, redness;
Fatigue.
Not known (from the available data can not be estimated):
Skin cancer. Contact your doctor immediately if you experience new scars or birthmarks increase / change in some way;
Difficulty urinating, stop urinating. In some people can become a serious adverse reaction;
Inflammation of a vein with pain and swelling in the course of the vein. In some people can become a serious adverse reaction. Ask your doctor;
High blood pressure. Ask your doctor. High blood pressure requires treatment. Too high blood pressure is a serious condition;
Increased volume of body fluids;
Weight gain;
Memory loss;
Bitter taste;
Enhanced hands trembling, uncertain movements;
Pupillary constriction, narrowing floppy eyelid and the eye slit (Horner's syndrome);
Stiffness;
Feeling agitated;
Double vision, dilated pupils, spasms of the eyelid;
Hoarseness of voice, a special way of breathing, hiccups;
Salivation, difficulty swallowing, flatulence, burning sensation of the tongue;
Urinary incontinence;
Increased sweating, hot flushes;
Muscle cramps, spasms of the muscles of mastication;
Tiredness;
A feeling of weakness;
Euphoria;
Gnashing of teeth.
You may experience the following side effects:
Inability to resist the impulse to perform an action that could be harmful and may include:
Strong momentum for excessive betting gambling despite serious personal and family consequences;
Changed or increased sexual interest and behavior that is disturbing to others, as increased sexual desire;
Uncontrollable excessive shopping or spending;
Overeating (eating large amounts of food in a short period of time) or majeure binge eating (eating more than normal amount of food and more than enough to quench the hunger).
If you notice any of these behaviors contact your doctor. It will consider ways to reduce or cope with the symptoms.

In addition Sinepar can cause side effects that you will not feel normal. These are changes in some laboratory results, for example. indicators of liver function, kidney, a high blood glucose.
Your doctor or pharmacist has a complete list of side effects. Some of them may be serious. If you get unusual symptoms, tell your doctor or seek immediate medical attention.
If you get any side effects, contact your doctor, pharmacist or nurse. This includes all listed in this leaflet.

5. How to store Sinepar
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
Store at 25 ° C.
Store in the original container.