SINEMET CR TABLETS - Patient leaflet, side effects, dosage

|3. HOW TO TAKE SINEMET Cl

Always take Sinemet CR 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. You must swallow your tablets whole. Do not break, crush or chew the tablets.
• Although your medicine can have an effect after one day, it may take up to seven days to work.
• Take them 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. You should not take Sinemet CR or Half Sinemet CR tablets at intervals of less than 4 hours apart.
• Try to avoid taking your tablets with a heavy meal.

If you have not had levodopa before

The usual starting dose for Sinemet CR is one tablet twice a day.

If you have had levodopa before

• your doctor will ask you to stop taking your medicine for Parkinson’s disease for 8 hours before you start taking Sinemet CR.

The usual starting dose for Sinemet CR is one tablet twice a day. Your doctor may ask you to take Half Sinemet CR to help in determining the correct dose.

A combination of more than one Sinemet or Sinemet CR product may be prescribed by your doctor. If you have been given different Sinemet or Sinemet CR tablets to take make sure that you are taking the correct one at the right time. Remember: Half Sinemet CR is a lower dose tablet than Sinemet CR.

Children under 18 years of age

Sinemet CR is not suitable for children under the age of 18 years.

If you take more Sinemet CR than you should

If you take too many tablets see your doctor immediately.

If you forget to take Sinemet CR

Do not take a double dose to make up for a forgotten dose.

If you stop taking Sinemet CR

Do not stop taking Sinemet CR or change your dose without talking to your doctor first. When you stop taking Sinemet CR the following 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.

. POSSIBLE SIDE EFFECTSl

Like all medicines, Sinemet CR can cause side effects, although not everybody gets them.

Stop taking Sinemet CR and see your doctor straight away, if you notice any of the following side effects:

• allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat. This may cause difficulty in breathing or swallowing
• chest pain
• uneven (irregular) heart beat or palpitations
• dizziness on standing-up quickly
• bleeding from your gut which may be seen as blood in your faeces or darkened faeces (gastro-intestinal bleeding)
• blood problems, the signs may include pale skin (pallor), tiredness, fever, sore throat or mild bruising and prolonged bleeding after injury
• stiff muscles, high fever
• mental changes including delusions, hallucinations and depression
• fits (convulsions).

The most common side effects are

• abnormal movements such as twitching or spasms (which may or may not be like your Parkinson’s sym­ptoms)
• nausea.

Other side effects include

• fainting, anorexia, high blood pressure
• inflammation of the veins, being sick (vomiting), diarrhoea, discoloration of urine, sweat or saliva
• on-off phenomenon, characteristic of some people with long-standing Parkinson’s di­sease. This is when you can have unpredictable changes from being mobile – “on” – to a sudden inability to move – “off”. “Off” to “on” can occur just as suddenly.
• dizziness; sleepiness (including excessive drowsiness or sudden sleep onset episodes), pins and needles
• dream abnormalities, confusion, feeling agitated, shortness of breath, hair loss.

You may experience the following side effects:

• Craving for large doses of Sinemet CR in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of Sinemet CR.
• inability to resist the impulse to perform an action that could be harmful, which may include:

o strong impulse to gamble excessively despite serious personal or family consequences

o altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

o uncontrollable excessive shopping or spending

o 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)

Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.

Side effects that have been reported with medicines containing levodopa.

These may be experienced when taking Sinemet CR.

Nervous system:

• loss of control over the voluntary movements of everyday life
• numbness, increased hand tremor, muscle twitching, muscle cramp, irregular movement of jaw muscles resulting in difficulty opening the mouth
• difficulty sleeping, feeling anxious or high, falling over and abnormal walking patterns
• headache

Eyes:

• drooping eyelid and dilated pupil
• changes in vision, irregular movement of the eye

Digestive system:

• indigestion, dry mouth, bitter taste
• swelling of the salivary glands, difficulty swallowing, grinding of the teeth
• hiccups, abdominal pain and distress, constipation, wind
• burning sensation of the tongue

Sexual:

• persistent abnormal erection of the penis

Urinary:

• difficulty passing urine or incontinence (inability to control urine flow)

Skin:

• changed patches of pigmented skin, including, irritated or irregular moles, or moles in which you have noticed changes (melanoma)

General:

• weight gain or loss, swelling in the limbs
• flushing, hot flushes, increased sweating
• feeling weak, faint or tired
• hoarseness, general feeling of being unwell
• increased energy or activity, unusual breathing pattern

If any symptoms persist or you experience any other side effects 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

|5. HOW TO STORE SINEMET Cl

• Do not store your tablets above 30°C.
• Keep your medicine out of the sight and reach of children.
• Please check the expiry date of the product which can be found on the blister strip or pack. Do not use after the expiry date stated. 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.
• If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do.
• Each tablet contains the active ingredients carbidopa equivalent to 50mg anhydrous carbidopa and 200mg of levodopa in a modified release formulation. The tablets are peach, oval shaped biconvex compressed tablets marked ‘521’ and breakline on one side and plain on the reverse.
• Sinemet CR also contains the following inactive ingredients: Hyprolose, magnesium stearate, poly (vinyl acetate-crotonic acid), quinoline yellow (E104), red iron oxide (E172).

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.