Sinemet 25 / 250 Mg 20 Tablets

What this product is and what it is used for Sinemet® contains two different medicines called: levodopa and carbidopa. • Levodopa, an aromatic amino acid, turns into a substance called ‘dopamine’ in your brain. dopamine helps improve the signs of your Parkinson’s disease; • Carbidopa belongs to a group of medicines called ‘aromatic amino acid decarboxylase inhibitors’. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body. Sinemet®­­ is indicated for the treatment of Parkinson's disease and syndrome. Sinemet® improves the symptoms of Parkinson’s disease. Parkinson's disease is a long-term illness where: • you become slow and unsteady. • your muscles feel stiff. • you may develop shaking or trembling (called ‘tremor’). If not treated, Parkinson's disease can make it hard for you to continue your normal daily activities. 2. What you need to know before you use this product Do not take Sinemet® if: • you are allergic (hypersensitive) to levodopa or carbidopa or any of the other ingredients of Sinemet® (listed in Section 6). • you are taking certain medicines called MAOIs (Monoamine Oxidase Inhibitors) used for depression. You need to stop using these medicines at least two weeks before you start Sinemet® (see also under ‘Taking other medicines’ below). • you have a condition called ‘narrow-angle glaucoma’ that may cause a sudden build up of pressure in the eye. • you have a severe mental disorder. • you have a suspicious undiagnosed skin lesions or a history of melanoma. • you are pregnant, might become pregnant, or are breast-feeding. • you have ever had skin cancer or you have any unusual moles which have not been examined by your doctor Do not take Sinemet® if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Sinemet®. Take special care with Sinemet® Check with your doctor or pharmacist before taking your medicine if: • you have a history of fits (convulsions). • you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood. • you have had a heart attack, heart beat problems, circulation or breathing problems. • you have had kidney, liver or hormonal problems. • you have had depression or other mental problems. • you have a condition called ‘chronic wide-angle glaucoma’ that may cause a build up of pressure in the eye. You will need to have regular checks on the pressure in your eye. • you sometimes have sudden sleep attacks or sometimes feel very sleepy. • you are due to have surgery. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Sinemet®. ­­ Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviors are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to review your treatment. Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with Carbidopa/Levodopa. Affected patients show a compulsive pattern of excessive misuse of the product above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesia. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Sinemet® can affect the way some other medicines work. Also some other medicines can affect the way Sinemet ® works. In particular tell your doctor or pharmacist if you are taking any of the following medicines: • Medicines for Parkinson’s disease containing levodopa: - You will need to wait 12 hours after your last dose before starting Sinemet® (see section 3). - Tell the doctor or pharmacist even if you have only taken them in the past. • Medicines for Parkinson’s disease which do not contain levodopa will usually be continued. However, your dose may be changed. • Medicines for mental problems (including depression), tuberculosis (TB), high blood pressure, muscle spasms, epilepsy or other diseases related to involuntary movements. Your dose may need to be changed. • Anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine). Your dose may need to be changed. • Iron: ferrous sulfate or ferrous gluconate decrease the availability of carbidopa and/or levodopa. • Medicines called monoamine oxidase inhibitors. • Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones and risperidone) and isoniazid may reduce the therapeutic effects of levodopa. • Phenytoin which is used to treat fits (convulsions) and papaverine which is used to treat impotence in men have been reported to reverse the beneficial action of levopoda. • Antihypertensive agents: Symptomatic postural hypotension has occurred when Sinemet® is added to the treatment of patients receiving some antihypertensive drugs. Therefore, when therapy with Sinemet® is started, dosage adjustment of the antihypertensive drug may be required. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine. Your doctor or pharmacist has a more complete list of medicines to avoid while taking Sinemet®. Taking Sinemet® with food and drink Try to avoid taking your tablets with a heavy meal. If your diet contains too much protein (meat, eggs, milk, cheese), Sinemet® may not work as well as it should. Pregnancy and breast-feeding Do not take Sinemet® if you are pregnant, might become pregnant or are breast-feeding. Levodopa, one of the substances in Sinemet®, is passed into human milk. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines Levodopa may be associated with somnolence and very rarely episodes of sudden onset of sleep. In some cases, these episodes may occur without awareness or warning during daily activities. Patients must be cautious while driving or operating machines while being treated with levodopa, or other dopaminergic agents. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. 3. How to use this product. Always take Sinemet® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine • Take this medicine by mouth. • Although your medicine can have an effect after one day, it may take up to seven days to work. • Take your tablets at regular time intervals according to your doctor's instructions. • Do not change the times at which you take your tablets or take any other medicines for Parkinson's disease without first consulting your doctor. • Try to avoid taking your tablets with a heavy meal. • Dosage should be titrated to individual needs and this may require adjusting both the dose and the frequency of administration. • Sinemet® tablets are available in a 1:4 ratio of carbidopa to levodopa (Sinemet® 25/100 mg) as well as a 1:10 ratio (Sinemet® 25/250 mg). • Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage. (Each tablet of Sinemet® is designed to divide in half with minimal pressure). If you have not had levodopa before The usual starting dose is: • For Sinemet® 25/100 mg tablets: one tablet three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight tablets of Sinemet® 25/100 mg a day is reached. • For Sinemet® 25/250 mg, the initial dose is one-half tablet taken once or twice daily. However, this may not provide the optimal amount of carbidopa needed by many patients. If necessary, dosage may be increased by 1/2 tablet every day or every other day until optimal response is reached. Response has been observed in one day, and sometimes after one dose. Fully effective doses usually are reached within seven days as compared to weeks or months with levodopa alone. If you have had levodopa before Your doctor will ask you to stop taking your medicine for Parkinson’s disease for 12 hours before you start taking Sinemet®. The usual starting dose will depend on what you were taking before. More than one Sinemet® product dosage may be prescribed by your doctor. If you have been given different Sinemet® tablets to take, make sure that you are taking the correct one at the right time. Children under 18 years of age Sinemet® is not suitable for children under the age of 18 years.­­ If you take more Sinemet® than you should If you take too many tablets see your doctor immediately. If you forget to take Sinemet® Do not take a double dose to make up for a forgotten dose. If you stop taking Sinemet® Do not stop taking Sinemet® or change your dose without talking to your doctor first. When you stop taking Sinemet® the follo-wing can occur: stiff muscles, high temperature (fever) and mental changes. If you have any further questions on the use of this product, ask your doctor or pharmacist for more information. 4. Possible side effects Like all medicines, Sinemet® can cause side effects, although not everybody gets them. Stop taking Sinemet® and see your doctor straight away, if you notice any of the following side effects: The most common side effects reported with Sinemet® have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea. The following side effects have been reported with Sinemet®: - Body as a whole: chest pain, asthenia - Cardiovascular: cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation - Gastrointestinal: dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations, swelling of the salivary glands, grinding of the teeth - Hematologic: agranulocytosis, hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia - Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura, bullous lesions (including pemphigus-like reactions) - Musculoskeletal: back pain, shoulder pain, muscle cramps - Nervous system/psychiatric: psychotic episodes including delusions, hallucinations, and paranoid ideation, neuroleptic malignant syndrome, bradykinetic episodes ("on-off" phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms. Dopamine Dysregulation Syndrome (DDS). Convulsions also have occurred; however, a causal relationship with Sinemet® has not been established. - Respiratory: dyspnea, upper respiratory infection - Skin: rash, increased sweating, alopecia, dark sweat - Urogenital: urinary tract infection, urinary frequency, dark urine - Laboratory tests: decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea nitrogen (BUN), creatinine, uric acid, positive Coombs test, elevated serum glucose, white blood cells, bacteria, and blood in the urine. - High fever - Binge eating (eating large amounts of food in a short time period ) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) Other side effects that have been reported with levodopa alone and with various carbidopa-levodopa formulations, and may occur with Sinemet® are: - Body as a whole: abdominal pain and distress, fatigue - Cardiovascular: myocardial infarction - Gastrointestinal: gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups - Metabolic: edema, weight gain, weight loss - Musculoskeletal: leg pain - Nervous system/psychiatric: ataxia, extrapyramidal disorder, falling, anxiety, gait abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation, euphoria, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, increased tremor, numbness, muscle twitching, activation of latent Horner's syndrome, peripheral neuropathy - Respiratory: pharyngeal pain, cough - Skin: malignant melanoma, flushing - Special Senses: oculogyric crises, diplopia, blurred vision, dilated pupils - Urogenital: urinary retention, urinary incontinence, priapism - Miscellaneous: bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes, sense of stimulation - Laboratory tests: decreased white blood cell count and serum potassium, increased serum creatinine and uric acid, protein and glucose in urine. If any symptoms persist or you experience any other side effects not listed in the leaflet please tell your doctor or pharmacist. It will help if you make a note of what you experienced, when it started and how long it lasted. 5. How to store this product • Keep out of the reach and sight of children. • Do not store above 30°C. Protect from light and moisture. • Store in the original package. • Do not use Sinemet® after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month. • 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.­­­