SINEMET® 10 mg/100 mg Tablets

SINEMET® Plus 25 mg/100 mg Tablets

SINEMET® 25 mg/250 mg Tablets

(carbidopa/levodopa)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1 What Sinemet is and what it is used for
2 What you need to know before you take Sinemet
3 How to take Sinemet
4 Possible side effects
5 How to store Sinemet
6 Contents of the pack and other information

1 What Sinemet is and what it is used for
Sinemet improves the signs 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.

Sinemet contains two different medicines called: levodopa and carbidopa.

levodopa turns into a material called ‘dopamine’ in your brain. The dopamine helps to 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.

2 What you need to know before you take Sinemet
Do not take Sinemet:
if you are allergic to carbidopa or levodopa or any of the other ingredients of this medicine (listed in section 6)
if you have ever had skin cancer or you have any unusual moles which have not been examined by your doctor
if 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 ‘Other medicines and Sinemet’ below)
if you have a condition called ‘narrow-angle glaucoma’ that may cause a sudden build up of pressure in the eye
if you have a severe mental disorder
if you are pregnant, might become pregnant, or are breast-feeding.
Do not take Sinemet if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Sinemet.

Warning and precautions
Talk to your doctor, pharmacist or nurse before taking Sinemet:

if you have a history of fits (convulsions)
if you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood
if you have had a heart attack, heart beat problems, circulation or breathing problems
if you have had kidney, liver or hormonal problems
if you have had depression or other mental problems
if 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
if you sometimes have sudden sleep attacks or sometimes feel very sleepy
if you are due to have surgery.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Sinemet.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Sinemet and other medicines used to treat Parkinson’s disease.

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 behaviours 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 treatments.

Other medicines and Sinemet
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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:
If they are ‘slow release’, you will need to wait 24 hours after your last dose before starting Sinemet.
If they are ‘normal release’, you will need to wait 12 hours after your last dose before starting Sinemet.
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.
Medicines to treat low iron. Your dose may need to be changed.
Medicines called ‘MAOIs’ (see also ‘Do not take Sinemet’).
Anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine). Your dose may need to be changed.
Phenytoin which is used to treat fits (convulsions).
Papaverine which is used to treat impotence in men.
If you are not sure if any of the above apply 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.

Tests while you are taking Sinemet
This medication can affect some laboratory tests that your doctor may perform on blood or urine samples. Please remind your doctor if you are taking Sinemet and are having any tests.

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
Sinemet affects different people in different ways. Some people have side effects which affect their ability to drive or use tools or machines (see section 4 Possible side effects). Do not drive or use tools or machines if you get these effects.
Sinemet can also make you sleepy or cause 'sudden sleep attacks'. If this happens to you, you must not drive or use tools or machines. Your doctor will tell you if you can start driving again if these attacks stop.

3 How to take Sinemet
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine
If the tablet breaks when you remove it from the blister pack, make sure you have all of the tablet pieces (the full dose). If you do not have all the pieces of a broken tablet, throw away the pieces and take another tablet from the blister pack.
Taking only part of a tablet (a partial dose) may cause symptoms to get worse.
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 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.
Try to avoid taking your tablets with a heavy meal.
If you have not had levodopa before
The recommended dose is:

for Sinemet Plus 25 mg/100 mg Tablets: one tablet three times a day.
for Sinemet 10 mg/100 mg Tablets: one tablet three or four times a day.
If you have had levodopa before
your doctor will ask you to stop taking your medicine for Parkinson’s disease before you start taking Sinemet.
The recommended dose is:

for Sinemet Plus 25 mg/100 mg Tablets and Sinemet 25 mg/250 mg Tablets: one tablet three or four times a day.
for Sinemet 10 mg/100 mg Tablets it will depend on what you were taking before.
More than one Sinemet product 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.

Use in children and adolescents
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 following can occur: stiff muscles, high temperature (fever) and mental changes.

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

4 Possible side effects
Like all medicines, this medicine 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:
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
urinary tract infections (frequency: very common).
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 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.
inability to resist the impulse to perform an action that could be harmful, which may include:
strong impulse to gamble excessively despite serious personal or family consequences
altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
uncontrollable excessive shopping or spending
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.

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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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
Keep this medicine out of the sight and reach of children.
Sinemet 10 mg/100 mg Tablets: Store in the original package in order to protect from light and moisture. This medicinal product does not require any special temperature storage conditions..
Sinemet Plus 25 mg/100 mg Tablets and Sinemet 25 mg/250 mg Tablets: Do not store above 25°C. Store in the original package in order to protect from light and moisture.
Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP.’ The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information
What Sinemet contains
The active substances in Sinemet 10 mg/100 mg Tablets are carbidopa (equivalent to 10 mg anhydrous carbidopa) and levodopa (100 mg).
The active substances in Sinemet Plus 25 mg/100 mg Tablets are carbidopa (equivalent to 25 mg anhydrous carbidopa) and levodopa (100 mg).
The active substances in Sinemet 25 mg/250 mg Tablets are carbidopa (equivalent to 25 mg anhydrous carbidopa) and levodopa (250 mg).
The other ingredients in Sinemet 10 mg/100 mg Tablets, Sinemet Plus 25 mg/100 mg Tablets and Sinemet 25 mg/250 mg Tablets are microcrystalline cellulose, magnesium stearate, pregelatinised starch and corn starch. Additionally Sinemet Plus 25 mg/100 mg Tablets contain quinoline yellow (E104) and Sinemet 10 mg/100 mg Tablets and Sinemet 25 mg/250 mg Tablets contain Indigotine (E- 132).
What Sinemet looks like and contents of the pack
Sinemet 10 mg/100 mg Tablets:

Dark dapple blue, oval tablets, with '647' and a score line on one side and plain on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Sinemet Plus 25 mg/100 mg Tablets:

Yellow, oval tablets with '650' on one side and plain on the other.

Sinemet 25 mg/250 mg Tablets:

Light dapple blue, oval tablets, with '654' and a score line on one side and plain on the other. The tablet can be divided into equal doses.

Sinemet 10 mg/100 mg Tablets, Sinemet Plus 25 mg/100 mg Tablets and Sinemet 25 mg/250 mg Tablets are available in blister packs of 100 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

Organon Pharma (UK) Limited
The Hewett Building
14 Hewett Street
London
EC2A 3NP
United Kingdom
Manufacturer:

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN
Haarlem
The Netherlands
This leaflet was last revised in August 2023.

© 2023 Organon group of companies. All rights reserved.

PIL.SEM.23.UK.0222.UTI-Scoreline_removal-LDN.RCN003205

Write a review