Sinemet ® Tablets

Your doctor has prescribed SINEMET to treat the symptoms of Parkinson's disease. Parkinson’s disease is a chronic disorder characterised by slow and unsteady movement, muscular stiffness and tremor. If untreated, Parkinson’s disease can cause difficulty in performing normal daily activities.

HOW DOES SINEMET TREAT PARKINSON’S DISEASE?

SINEMET contains two active ingredients, levodopa and carbidopa. It is believed that the symptoms of Parkinson’s disease are caused by a lack of dopamine, a naturally occurring chemical produced by certain brain cells. Dopamine has the role of relaying messages in certain regions of the brain that control muscle movement. Difficulty in movement results when too little dopamine is produced. Levodopa acts to replenish dopamine in the brain, while carbidopa ensures that enough levodopa gets to the brain where it is needed. In many patients, this reduces the symptoms of Parkinson’s disease.

Do not take SINEMET if you:

• are allergic to any of its ingredients
• have any suspicious skin lesions (moles) which have not been examined by your doctor or if you have ever had skin cancer
• are being treated for depression with certain MAO inhibitor drugs
• have narrow-angle glaucoma.

Tell your doctor or healthcare professional before taking SINEMET

Tell your doctor about any medical problems you have or have had including: Allergies, depression or mental disturbance, lung, kidney, liver, heart or hormonal problems, peptic ulcer disease, convulsions or glaucoma. Let your doctor know if you have previously been treated with levodopa. Tell your doctor if you or your family member/caregiver notices you are developing urges to gamble, increased sexual urges, excessive eating or spending and/or other intense urges that could harm yourself or others. These behaviours are called impulse control disorders. Your doctor may need to review your treatments.

Take special care with SINEMET

Use in children

Use of SINEMET by patients below the age of 18 is not recommended.

Pregnancy and breastfeeding

It is not known what effect SINEMET may have on human pregnancy. Levodopa, one of the components of SINEMET, is passed into human milk. If you are pregnant, may become pregnant or intend to breastfeed, tell your doctor, who will help you weigh the benefits of the medicine against possible hazards.

Driving and using machinery

Individual responses to medication may vary. Certain side effects that have been reported with SINEMET may affect some patients ability to drive or operate machinery (see “POSSIBLE SIDE EFFECTS” ). SINEMET can cause somnolence (excessive drowsiness) and sudden sleep onset episodes. Therefore, you must refrain from driving or engaging in activities where impaired alertness may put yourself or others at risk of injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved.

Taking other medicines with SINEMET

Although SINEMET can generally be given with other medicines, there are exceptions. Your doctor may warn against use with certain medications used to treat psychiatric conditions or mental depression, iron or iron supplements, tuberculosis, high blood pressure, muscle spasms or convulsions or other diseases related to involuntary movements. Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)

Do not share medicines prescribed for you with any other person. Always take SINEMET exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The dosage of SINEMET is variable and your doctor will adjust it according to the severity of your disease and your response to treatment. Tablets may be broken in half if so prescribed.

For best results take SINEMET every day. It is important to carefully follow your doctor's advice on how much SINEMET to take and how often to take it. Promptly inform your doctor of any change in your condition such as nausea or abnormal movements, as this may require an adjustment in your prescription. Do not stop taking this medicine abruptly, unless advised to do so by your doctor.

If you take more SINEMET than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forgot to take or missed a dose of SINEMET

Try to take SINEMET as prescribed. However, if you have missed a tablet, take it as soon as you remember. If it is almost time to take your next tablet, do not take the missed tablet, but resume your normal schedule.

Effect when treatment with SINEMET is stopped

Do not stop taking SINEMET or lower the dosage without checking with your doctor. A group of symptoms may occur including: Muscle stiffness, fever and mental changes.

Not all side effects reported for SINEMET are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

SINEMET can have side effects.

The most frequent side effects are: Abnormal movements including twitching or spasms (which may or may not resemble your Parkinson's symptoms) and nausea. Other possible side effects include: Mental changes, dream abnormalities, hair loss, discolouration of urine, sweat and/or saliva, diarrhoea, fainting, palpitations, feeling of light headedness when standing up quickly, dizziness, sleepiness, sudden sleep onset episodes, vomiting, loss of appetite, slow movement and melanoma. You may also experience an inability to resist the impulse to perform an action that could be harmful, which may include: Strong impulses to gamble, increased sexual drive, uncontrollable excessive shopping or spending, binge/compulsive eating and/or other urges. Tell your doctor if you experience any of these behaviours. Hypersensitivity reactions may occur such as hives, itching, rash and swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing. Contact your doctor immediately if these symptoms occur. Your doctor or pharmacist has a more complete list of side effects. Some of these may be serious. If you experience any unusual symptoms, inform your doctor or seek medical attention immediately.

Do not use this medicine after the month and year following EXP.: on the container. Store at or below 25 °C. Protect from light. Keep SINEMET in the original container and keep the container tightly closed.

Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).