levodopa/carbidopa tablets
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Levo/Carbidopa Sandoz.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risk of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.
WHAT LEVO/CARBIDOPA SANDOZ IS USED FOR
This medicine is used to treat some of the symptoms of Parkinson’s disease which 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. Levo/Carbidopa Sandoz is most helpful in improving slow movement and muscle stiffness. It can also be helpful in treating shaking, difficulty in swallowing and drooling. It contains the active ingredients levodopa and carbidopa.
The symptoms of Parkinson’s disease are caused by a deficiency of dopamine, a natural substance produced by the brain. The brain requires dopamine to control muscle movements. When too little dopamine is produced in the brain, this results in slowness of movement. Levo/Carbidopa Sandoz contains two active ingredients, levodopa and carbidopa. Levodopa is a chemical closely related to dopamine which allows the body to make its own dopamine. Levodopa works by increasing the level of dopamine in the brain. Carbidopa makes sure that enough levodopa gets to the brain where it is needed.
Ask your doctor if you have any questions about why this medicine was prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is only available with a doctor’s prescription.
This medicine is not addictive.
BEFORE YOU TAKE LEVO/CARBIDOPA SANDOZ
When you must not take it
Do not take this medicine if you have an allergy to:
- levodopa/carbidopa, the active ingredients, or any of the other ingredients listed at the end of this leaflet under Product Description
- any other similar medicines.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
Do not take this medicine if you have or have had any of the following medical conditions:
- any unusual skin lumps or moles which have not been checked by your doctor, or if you ever had skin cancer or melanoma
- a type of glaucoma called narrow-angle glaucoma
- depression treated with certain medicines called monoamine oxidase inhibitors (MAOI) or you have taken a MAOI within the last 14 days. Some examples of MAOIs are phenelzine (Nardil) and tranylcypromine (Parnate). If you are not sure whether you are taking one of these medicines, please ask your doctor or pharmacist.
Do not give this medicine to a child under the age of 18 years, unless advised by the child’s doctor. Safety and effectiveness in children younger than 18 years have not been established.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
- depression or mental illness
- heart disease, including irregular heart beat, also known as arrhythmia
- lung disease, including asthma
- kidney, liver or hormonal problems
- convulsions or fits or a history of them
- glaucoma
- stomach ulcer (peptic ulcer / duodenal ucler)
- uncontrollable movements (eg twitching or jerking of the body)
- high blood pressure.
Tell your doctor if you are currently taking levodopa, or have taken it in the past. Some examples of other medicines containing levodopa are Madopar and Sinemet.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start taking Levo/Cabidopa Sandoz.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Levo/Carbidopa Sandoz may interfere with each other. These include:
- medicines used to treat high blood pressure
- medicines used to treat depression
- medicines used to treat mental illness or psychiatric problems
- 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.
These medicines may be affected by Levo/Carbidopa Sandoz or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
HOW TO TAKE LEVO/CARBIDOPA SANDOZ
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.
Follow the instructions they give you. If you take the wrong dose, Levo/Carbidopa Sandoz may not work as well and your problem may not improve.
The usual starting dose is half a tablet taken once or twice a day.
Your doctor will then adjust this dose depending on your condition, your response to this medicine and whether you are taking other medicines.
How to take it
Swallow the tablets with a full glass of water.
If you need to break Levo/Carbidopa Sandoz tablets, hold tablet with both hands and snap along break line.
How long to take Levo/Carbidopa Sandoz
Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
Do not stop taking Levo/Carbidopa Sandoz, or change the amount you take, without checking with your doctor.
If you forget to take it
Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Levo/Carbidopa Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
WHILE YOU ARE TAKING LEVO/CARBIDOPA SANDOZ
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Levo/Carbidopa Sandoz.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
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 Levo/Carbidopa Sandoz. 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 experience times where Levo/Carbidopa Sandoz does not appear to be working as well as it did previously, tell your doctor. After taking this medicine for long periods of time, such as a year or more, some people suddenly lose the ability to move. This loss of movement may last from a few minutes to several hours. The person is then able to move as before. This condition may unexpectedly occur again and again. This problem is called the “on-off” effect. If this happens, your doctor may want to adjust your medication.
Things you must not do
Do not take Levo/Carbidopa Sandoz to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This may help reduce the possibility of withdrawal symptoms such as muscle stiffness, fever and mental changes.
Things to be careful of
Be careful driving or operating machinery until you know how Levo/Carbidopa Sandoz affects you. This medicine may cause dizziness, light-headedness, sudden onset of sleep or sleepiness. Very rarely it can cause extreme sleepiness and sudden onset of sleep in the middle of daytime activities, sometimes without warning. If you have any of these symptoms do not drive or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness or light-headedness may be worse.
Be careful not to eat a diet high in protein, as the amount of levodopa absorbed by the body may be reduced. 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. Levo/Carbidopa Sandoz may cause false test results with some urine sugar tests.
If you need to have any other blood or urine tests, tell your doctor that you are taking Levo/Carbidopa Sandoz. Levo/Carbidopa Sandoz may affect the results of some tests.
SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Levo/Carbidopa Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- abnormal uncontrolled movements including muscle twitching or spasms, which may or may not resemble your Parkinson’s symptoms
- dizziness, light-headedness when standing up quickly
- feeling sick (nausea), vomiting, loss of appetite
- dark saliva
- dream abnormalities
- extreme sleepiness or sudden onset of sleep in the middle of daytime activities
- slow movements
- muscle twitching
- spasm of the eyelids
- increased desire for sex
- compulsive gambling, shopping, eating, medication use, and punding (repetitive purposeless activity).
These are mostly mild side effects of the medicine and are short-lived.
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 anaemia, 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.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
If any of the following happen, stop taking Levo/Carbidopa Sandoz, and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
- swelling of the face, lips, mouth or throat, 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.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
AFTER TAKING LEVO/CARBIDOPA SANDOZ
Storage
Keep your medicine in the original container. If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C. Protect from light.
Do not store Levo/Carbidopa Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
PRODUCT DESCRIPTION
What it looks like
Levo/Carbidopa Sandoz 250mg/25mg – off-white, round tablets with a score notch on one side.
Available in blisters of 100 tablets.
Ingredients
Active ingredients
- Levo/Carbidopa Sandoz 250mg/25mg – 250mg levodopa and 25mg carbidopa as carbidopa monohydrate.
Inactive ingredients
- microcrystalline cellulose
- croscarmellose sodium
- hypromellose
- colloidal anhydrous silica
- magnesium stearate
- glyceryl behenate
- PEG-8 behenate.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Supplier
Sandoz Pty Ltd
ABN 60 075 449 553
Level 2, 19 Harris Street
Pyrmont NSW 2009
Australia
Tel: 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Auckland 0754
New Zealand
Tel: 0800 354 335
This leaflet was revised in March 2012.
Australian Register Number(s)
250mg/25mg tablets: AUST R 99119 (blisters)
Published by MIMS May 2014