Patient Medication Information: uses, side effects, how to take - Auro-Levocarb
Serious Warnings and Precautions box
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What AURO-LEVOCARB is used for:
AURO-LEVOCARB is used to treat the symptoms of Parkinson’s disease in adults.
How AURO-LEVOCARB works:
AURO-LEVOCARB contains two ingredients:
- Levodopa: this acts to replenish dopamine in the brain.
- Carbidopa: ensures that enough levodopa gets to the brain where it is needed.
It is believed that the symptoms of Parkinson’s disease are caused by a lack of dopamine. Dopamine is a naturally occurring chemical produced by certain brain cells. It has the role of relaying messages in certain regions of the brain that control muscle movement. Difficulty in movement results when too little dopamine is produced.
In many patients, AURO-LEVOCARB helps to reduce the symptoms of Parkinson’s disease.
The ingredients in AURO-LEVOCARB are:
Medicinal ingredients: Levodopa and Carbidopa
Non-medicinal ingredients: Crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and pre-gelatinised starch.
AURO-LEVOCARB 100 mg / 10 mg and 250 mg / 25 mg tablets also contain FD&C Blue No. 2 Aluminium Lake.
AURO-LEVOCARB 100 mg / 25 mg tablets also contain D & C yellow No. 10 Lake.
AURO-LEVOCARB comes in the following dosage forms:
Tablets: 100 mg / 10 mg (light blue), 100 mg / 25 mg (light yellow) and 250 mg / 25 mg (light blue) levocarb / carbidopa.
AURO-LEVOCARB tablets are available in a levodopa: carbidopa 4:1 ratio AURO-LEVOCARB (100 mg/25 mg) and in a 10:1 ratio of levodopa to carbidopa AURO-LEVOCARB (100 mg/10 mg and 250 mg/25 mg).
Do not use AURO-LEVOCARB if:
- you are allergic to levodopa, carbidopa, or to any other ingredients in AURO-LEVOCARB.
- you are taking certain monoamine oxidase inhibitors (MAOIs)(such as those used to treat depression). Most MAOIs should be stopped at least two weeks before starting therapy with AURO-LEVOCARB.
- you have an untreated heart, liver, kidney, lung, blood or hormonal disease.
- you have a serious eye condition called narrow-angle glaucoma.
you have been told that you should not take sympathomimetic medicines such as:
- isoproterenol (used to treat asthma and certain heart conditions)
- amphetamines (used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable urge to sleep))
- epinephrine (used to treat life-threatening allergic reactions)
- you have any suspicious skin lesions (moles) which have not been examined by your healthcare professional or if you have ever had skin cancer.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AURO-LEVOCARB. Talk about any health conditions or problems you may have, including if you:
- are taking or have taken levodopa in the past.
- have a history of heart problems (heart attack or irregular heartbeat). Your healthcare professional should carefully monitor you in an appropriate facility when you first start taking AURO-LEVOCARB.
- have or have had ulcers in your gut (called "duodenal" or "peptic” ulcers).
- have a history of convulsions/seizures.
- have dyskinesia, which are severe uncontrolled involuntary movements that can look like fidgeting, writhing or swaying.
- have any unusual conditions related to your eyes or eyesight (glaucoma).
- are going to have an operation that requires general anesthesia.
- suffer from a medical condition called psychosis.
- have or had skin cancer (melanoma).
are pregnant, think you might be pregnant or become pregnant while taking AURO-LEVOCARB. Your healthcare professional will advise whether you should take AURO-LEVOCARB while you are pregnant.
- are breastfeeding or wish to breastfeed. Your healthcare professional will decide whether you should take AURO-LEVOCARB while breastfeeding.
- have allergies.
- have problems with your lungs, kidneys, or liver.
- have hormonal problems.
Other warnings you should know about:
Driving and using machines: Do not drive or operate machinery until you know how to respond to AURO-LEVOCARB. Some people have suddenly fallen asleep while doing activities of daily living while taking AURO-LEVOCARB. If you become drowsy or if you feel sleepy, you should not drive or operate machines and to immediately contact your health care professional.
Laboratory tests and monitoring: When you take AURO-LEVOCARB for a prolonged time, your healthcare professional may:
- monitor your liver, kidney and heart function
- do blood tests
Physical activity: As you improve on AURO-LEVOCARB you may increase your physical activity slowly depending if you have any other medical conditions.
Uncontrollable movements: AURO-LEVOCARB may cause uncontrollable movements and “on and off” episodes. This may happen soon after you take AURO-LEVOCARB.
Mental health changes/disturbances: AURO-LEVOCARB may cause changes to your mental health.
- Tell your healthcare professional right away if you start to feel depressed or have thoughts of suicide.
- Hallucinations (seeing or hearing things that are not there) can occur when taking AURO-LEVOCARB.
Neuroleptic malignant syndrome: This is a disorder that causes you to have a high fever, confusion, altered states or consciousness and stiffness in your muscles. Neuroleptic malignant syndrome may happen if you suddenly:
- Reduce your dose
- Stop taking AURO-LEVOCARB
- Switch medicines
Your healthcare professional should monitor you when your dose is reduced or when you stop taking AURO-LEVOCARB, especially if you take antipsychotic medicines.
Compulsive behaviours: While taking AURO-LEVOCARB, you may have unusual urges and/or behaviours such as excessive:
- gambling
- sexual behaviour
- eating
- spending
You or your caregiver should tell your healthcare professional if either of you notice that you have new or changes to your behaviour.
Skin: People with Parkinson’s disease have a higher risk of developing skin cancer (melanoma). Your healthcare professional should monitor you for skin cancer while you are taking AURO-LEVOCARB. Tell your healthcare professional if you have:
- suspicious, undiagnosed changed patches of pigmented skin
- irritated or irregular moles
- moles in which you have noticed changes
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions:
Serious Drug Interactions with AURO-LEVOCARB include:
Ask your healthcare professional if you are unsure. |
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The following may also interact with AURO-LEVOCARB:
- antihypertensive medicines (used to treat high blood pressure)
- some medications used to treat psychiatric conditions or mental depression (including phenothiazines, butyrophenones, risperidone, selegiline, and tricyclic antidepressants)
- phenytoin (used to treat and control seizures)
- papaverine (used to treat intestinal spasms)
- tetrabenazine (used to treat conditions related to involuntary movements such as Huntington’s Disease)
- isoniazid (used to treat tuberculosis)
- anesthetics (medicines used during surgery)
- iron salts (such as multivitamins tablets)
- metoclopramide (used to relieve nausea and vomiting)
- Foods that are high in protein. This includes meat, fish, dairy products, seeds and nuts
How to take AURO-LEVOCARB:
- Swallow tablets whole with a glass of water. Do not chew, divide or crush tablets.
DO NOT:
- stop taking AURO-LEVOCARB, reduce the amount of AURO-LEVOCARB you take or change your dose unless your healthcare professional tells you to. If you suddenly stop or reduce your dose, you may experience the following symptoms: stiff muscles, fever and mental changes.
- take any other medicines used to treat Parkinson’s disease without first consulting your healthcare professional. This includes other medicines containing levodopa and carbidopa.
- give AURO-LEVOCARB to other people.
- use AURO-LEVOCARB for any other condition.
Usual dose:
- Your healthcare professional will tell you how many tablets of AURO-LEVOCARB you will need take each day and when you should take them. Take AURO-LEVOCARB exactly as your healthcare professional has told you.
- Tell your healthcare professional right away if you notice any changes in your symptoms during your treatment, such as nausea or abnormal movements. Your healthcare professional may need to adjust your dose.
Overdose:
| If you think you, or a person you are caring for, have taken too much AURO-LEVOCARB, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
If you have missed a dose, take it as soon as you remember. If it is almost time to take your next dose, do not take the dose you have missed, and take your next dose as scheduled.
Possible side effects from using AURO-LEVOCARB:
These are not all the possible side effects you may have when taking AURO-LEVOCARB. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Nausea or vomiting
- Slow movements
- Sleepiness, abnormal dreams, difficulty to fall asleep or stay asleep
- Headache
- Dizziness
- Mental changes, confusion, feeling agitated
- Hair loss
- Dark-coloured saliva, urine and sweat
- Chest pain
- Feeling weak and tired
- Changes in blood pressure
- Dry mouth, changes in tastes, drooling, burning sensation of the tongue, grinding or clenching of the teeth
- Diarrhea, constipation, stomach pain, heartburn, gas
- Back, shoulder or leg pain
- Muscle cramps
- Bladder infection
- Hiccups
- Changes in weight, eating disorder (anorexia)
- Blurred or double vision
- Spasms that move the eye(s) into a fixed position (oculogyric crisis)
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | medical help In all cases | ||
| Very common | |||
| Dyskinesia: severe uncontrolled movements | √ | ||
| Common | |||
| Hallucinations: seeing or hearing things that are not there | √ | ||
| Rare | |||
| Allergic reactions: hives, itching, rash, swelling of the face, lips, mouth, tongue or throat, trouble breathing and/or swallowing | √ | ||
| Compulsive Behaviour: Inability to resist the impulse to perform an action that could be harmful such as gambling too much, increased sexual urges, uncontrollable urge to eat or spend money, or repeating meaningless actions | √ | ||
| Convulsion: seizure, spasms, shaking or fits | √ | ||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. If you have a history of depression, your depression may become worse | √ | ||
| Excessive sleepiness or falling asleep without warning while doing normal activities | √ | ||
| Feeling of lightheaded-ness as when standing quickly | √ | ||
| Melanoma (skin cancer): Changed patches of pigmented skin, including irritated or irregular moles, or moles in which you have noticed changes | √ | ||
Neuroleptic Malignant Syndrome: pronounced muscle stiffness or inflexibility with high fever, rapid or irregular heartbeat, sweating, state of confusion or reduced consciousness | √ | ||
| Priapism: Long-lasting (greater than 4 hours in duration) and painful erection of the penis | √ | ||
| Uneven (irregular) heartbeat, palpitations, chest pain and/or discomfort, pain in jaw, shoulders, arm and/or back, shortness of breath, sweating, nausea or light- headedness | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
| You can report any suspected side effects associated with the use of health products to Health Canada by: |
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NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store at room temperature (15 °C–30 °C). Protect from light and moisture.
- Keep out of reach and sight of children.
- Do not use outdated medicine.
If you want more information about AURO-LEVOCARB:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); manufacturer’s website http://www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Authorization: 2025-07-08