Patient leaflet - Co-careldopa 25/100 mg tablets, Sinemet Plus tablets
What Sinemet is and what it is used for
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* 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.
Sinemet improves the signs of Parkinson’s disease. Parkinson’s disease is a long-term illness where:
* you become slow and unsteady
Tests while you are taking Sinemet
* your muscles feel stiff
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.
* 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’.
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.
It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
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.
Before you take Sinemet
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Do not take Sinemet if:
Driving and using machines
* you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of Sinemet (listed in Section 6)
* 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.
* 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).
* 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.
* 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
How to take Sinemet
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* 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.
Always take Sinemet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take special care with Sinemet
Taking this medicine
Check with your doctor or pharmacist before taking your medicine if: * you have a history of fits (convulsions)
* Take this medicine by mouth.
* Although your medicine can have an effect after one day, it may take up to seven days to work.
* you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood
* 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.
* 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.
If you have not had levodopa before
The usual starting 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.
* 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.
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.
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.
The usual starting 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.
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.
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.
Children under 18 years of age
Ref: 1255/220921/1/B
Patient Information Leaflet (continued)
If you take more Sinemet than you should
If you take too many tablets see your doctor immediately.
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.
If you forget to take Sinemet
Do not take a double dose to make up for a forgotten dose.
Sexual:
* persistent abnormal erection of the penis
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.
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
Possible side effects
* weight gain or loss, swelling in the limbs
* flushing, hot flushes, increased sweating
* feeling weak, faint or tired
Like all medicines, Sinemet can cause side effects, although not everybody gets them.
* 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.
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
Reporting of side effects
* chest pain
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.
* 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).
How to store Sinemet
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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
* 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.
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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).
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).
What Sinemet 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
Sinemet is a registered trademark of Merck & Co Inc.
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
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