SINEMET 25/250 mg

Trade Name:

SINEMET

Carbidopa/levodopa

25/250 mg tablets

Composition:

Active ingredients:

levodopa 250 mg 

carbidopa 25 mg

Inactive ingredients:

microcrystalline cellulose

magnesium stearate

pregelatinised maize starch

Corn starch

Indigotine (E-132)

Properties:

SINEMET is used to treat some of the symptoms of Parkinson’s disease. This is a disease of the nervous system that mainly affects body movement. The three main symptoms are shaking (tremor), muscle stiffness and slow and unsteady movement. People with Parkinson’s disease often walk with a shuffle as they have difficulty in initiating movement.

If untreated, Parkinson’s disease can cause difficulty in performing normal daily activities.

SINEMET is most helpful in improving slow movement and muscle stiffness. It is also frequently helpful in treating shaking, difficulty in swallowing and drooling.

The symptoms of Parkinson’s disease are caused by a lack of dopamine, a naturally

occurring chemical, produced by certain brain cells. Dopamine relays messages in the part of the brain that controls muscle movement.

When too little dopamine is produced, slowness of movement results.

SINEMET contains two active ingredients, levodopa and carbidopa. Levodopa is a

chemical closely related to dopamine which allows the body to make its own dopamine.

Carbidopa makes sure that enough levodopa gets the brain where it is needed. In many patients, SINEMET reduces some of the symptoms of Parkinson’s disease.

Contraindications:

Do not take SINEMET if:

-you have an allergy to any of the ingredients listed above

-you have any unusual skin lumps or moles which have not been examined by your doctor, or if you have ever had skin cancer or melanoma.

-you have a type of glaucoma called narrow-angle glaucoma.

-you had a  treatment for depression with certain medicines called monoamine oxidase inhibitors (MAOI). 

-you are breast-feeding or plan to breast-feed

-use in children below the age of 18

Warnings and precautions:

Before you start to take it, tell your doctor if:

1. you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefits of using SINEMET during pregnancy.
2. you have or have had any medical conditions, especially the following:

depression or mental disturbances

heart disease, including irregular heart beat, also known as arrhythmia

lung disease, including asthma

kidney, liver or hormonal problems

convulsions or fits glaucoma, peptic ulcer disease

3. 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 if:

-you have previously been or are currently being treated with levodopa.

-you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

-you are taking any other medicines, including any that you buy without a

prescription from your pharmacy, supermarket or health food shop. 

Some medicines and SINEMET may interfere with each other. These include:

-some medicines used to treat high blood pressure

-some medicines used to treat depression

-some medicines used to treat psychiatric problems

-some medicines used to treat diseases related to involuntary movements

-phenytoin, a medicine used to treat convulsions

-isoniazid, a medicine used to treat tuberculosis

-selegiline, another medicine used to treat -parkinson’s disease iron supplements or multivitamins containing iron

Directions for use:

!Take SINEMET only when prescribed by your doctor.

Your doctor will tell you how many tablets to take each day. The dose varies considerably from patient to patient.

• The usual starting dose is one 25/100 mg tablet taken three times a day. Your doctor will then adjust this dose depending on the severity of your condition, your response to treatment and whether you are taking other medicines.
• SINEMET helps control some of your symptoms of Parkinson’s disease, but does not cure it. Therefore SINEMET must be taken every day. Continue taking SINEMET for as long as your doctor prescribes.
• Do not stop taking SINEMET, or lower the dosage, without checking with your doctor. 
• Do not take a double dose to make up for the dose that you missed.
• If you take too much (overdose), immediately telephone your doctor 
• If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up. You may feel light-headed or dizzy while taking SINEMET. This is because your blood pressure is falling suddenly. Standing up slowly, especially when you get up from bed or chairs will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, tell your doctor.
• If you plan to have surgery that needs a general anesthetic, tell your doctor or dentist that you are taking SINEMET.
• If you become pregnant while taking SINEMET, tell your doctor.
• Be careful driving or operating machinery until you know how SINEMET affects you.
• 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.
• Be careful not to eat a diet high in protein. The amount of levodopa absorbed by the body may be impaired if you eat a diet high in protein. Ask your doctor, pharmacist or dietician to check your diet.
• If you are diabetic, check with your doctor or pharmacist before using urine sugar tests. SINEMET may cause false test results with some urine sugar tests.

Side effects:

-abnormal uncontrolled movements, including muscle twitching or spasms, which may or may not resemble your Parkinson’s symptoms dizziness, -light-headedness when standing quickly

feeling sick (also called nausea), 

-vomiting, loss of appetite, diarrhea

-discolouration of urine, sweat and/or saliva, 

-dream abnormalities, sleepiness or sudden onset of sleep, slow movements

-twitching or spasm of the eyelids

-hair loss

-strong impulses to gamble

-increased sexual drive

-uncontrollable excessive shopping, or spending

-binge/compulsive eating

-taking medicines and repetitive purposeless activities

Tell your doctor immediately if you notice any of the following:

• blood in the urine

difficult or painful urination, changes in mood such as depression, forgetfulness

signs of anemia, such as tiredness, being short of breath, and looking pale,

signs of frequent or worrying infections such as fever, severe chills, sore throat or

mouth ulcers, bruising or bleeding more easily than normal, nose bleeds, fainting

skin rash, itchiness, pinkish, itchy swellings on the skin, also called hives or nettle rash, numbness or tingling in the hands or feet, signs of melanoma, such as new skin spots or changes to the size, shape, color or edges of an existing skin spot, freckle or mole.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

• Swelling of the face, lips, mouth, throat or tongue which may cause difficulty in

Swallowing or breathing bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea, vomiting blood or material that looks like coffee grounds, chest pain

• fast or irregular heartbeats, also called palpitations, muscle stiffness accompanied by fever, mental changes such as feeling very fearful or paranoid, hallucinations shortness of breath, difficulty breathing

Storage

Store at a temperature not exceeding  30°C

Package:

Carton box contains 100 tablets and paper instructions.