Patient leaflet - CO-CARELDOPA 25/100 MG TABLETS, SINEMET PLUS TABLETS
(carbidopa / levodopa)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Sinemet Plus Tablets and will be referred to as Sinemet throughout the rest of this leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Sinemet 10mg/100mg Tablets and Sinemet 25mg/250mg Tablets.
In this leaflet:
Q What Sinemet is and what it is used for
Q Before you take Sinemet
Q How to take Sinemet
Q Possible side effects
Q How to store Sinemet
0 Further information
o 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.
0 Before you take Sinemet
Do not take Sinemet if:
-
you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of Sinemet (listed in Section 6)
-
you have ever had skin cancer or you have any unusual moles which have not been examined by your doctor
-
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 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.
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 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.
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:
-
– 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 if’ ).
-
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.
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
-
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.
0
How to take Sinemet
(carbidopa / levodopa)
Patient Information Leaflet (continued)
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 product, ask your doctor or pharmacist.
Q 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:
-
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 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
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).
Genral
-
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, 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: 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.
0
How to store Sinemet
-
Keep out of the sight and reach of children
-
Do not store above 25°C. Store in the original package in order to protect from light.
-
Do not use Sinemet after the expiry date which is stated on the label after ‘EXP’. 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.
0 Further information
What Sinemet contains
-
The active substances are carbidopa equivalent to 25mg anhydrous carbidopa and 100mg levodopa
-
The other ingredients are microcrystalline cellulose, pregelatinised starch, maize starch, magnesium stearate, and quinoline yellow (E104).
What Sinemet looks like and contents of the pack
(carbidopa / levodopa)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Co-careldopa Plus Tablets and will be referred to as Co-careldopa throughout the rest of this leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Co-carel-dopa 10mg/100mg Tablets and Co-careldopa 25mg/250mg Tablets.
In this leaflet:
0 What Co-careldopa is and what it is used for
Q Before you take Co-careldopa
0 How to take Co-careldopa
0 Possible side effects
0 How to store Co-careldopa
n Further information
Q What Co-careldopa is and what it is used for
Co-careldopa 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.
Co-careldopa 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.
0 Before you take Co-careldopa
Do not take Co-careldopa if:
-
you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of Co-careldopa (listed in Section 6)
-
you have ever had skin cancer or you have any unusual moles which have not been examined by your doctor
-
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 Co-careldopa (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 are pregnant, might become pregnant, or are breast-feeding.
Do not take Co-careldopa if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Co-careldopa.
Take special care with Co-careldopa
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 apply to you, talk to your doctor or pharmacist before taking Co-careldopa.
Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Co-careldopa 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.
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 Co-careldopa can affect the way some other medicines work. Also some other medicines can affect the way Co-careldopa 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 Co-careldopa.
-
– If they are ‘normal release’, you will need to wait 12 hours after your last dose before starting Co-careldopa.
-
– 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 Co-careldopa if’ ).
-
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 Co-careldopa.
Tests while you are taking Co-careldopa
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 Co-careldopa and are having any tests.
Taking Co-careldopa 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) Co-careldopa may not work as well as it should.
Pregnancy and breast-feeding
Do not take Co-careldopa if you are pregnant, might become pregnant or are breast-feeding. Levodopa, one of the substances in Co-careldopa, 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
-
Co-careldopa 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.
-
Co-careldopa 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.
0
How to take Co-careldopa
(carbidopa / levodopa)
Patient Information Leaflet (continued)
If you take more Co-careldopa than you should
If you take too many tablets see your doctor immediately.
If you forget to take Co-careldopa
Do not take a double dose to make up for a forgotten dose.
If you stop taking Co-careldopa
Do not stop taking Co-careldopa or change your dose without talking to your doctor first. When you stop taking Co-careldopa 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.
Q Possible side effects
Like all medicines, Co-careldopa can cause side effects, although not everybody gets them.
Stop taking Co-careldopa 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 Co-careldopa 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 Co-careldopa.
-
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 Co-careldopa.
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
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, 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: 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.
0
How to store Co-careldopa
-
Keep out of the sight and reach of children
-
Do not store above 25°C. Store in the original package in order to protect from light.
-
Do not use Co-careldopa after the expiry date which is stated on the label after ‘EXP’. 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.
Q Further information
What Co-careldopa contains
-
The active substances are carbidopa equivalent to 25mg anhydrous carbidopa and 100mg levodopa
-
The other ingredients are microcrystalline cellulose, pregelatinised starch, maize starch, magnesium stearate, and quinoline yellow (E104).
What Co-careldopa looks like and contents of the pack
The tablets are yellow, oval-shaped, one side plain and the other scored and marked ‚650‘. They come in packs of 50, 90 or 100.
Manufacturer and Licence Holder
This medicine was manufactured by Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN – Haarlem, The Netherlands and is procured from within the EU and repackaged by the Product Licence Holder Lexon (UK) Ltd, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM PL No: 15184/1255
Revision date: 22/09/21
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet in a format suitable for you
Eyes:
-
drooping eyelid and dilated pupil
-
changes in vision, irregular movement of the eye