Patient Medication Information: uses, side effects, how to take - Odan-Amantadine Syrup
What is ODAN-AMANTADINE SYRUP used for?
ODAN-AMANTADINE SYRUP is used:
- to treat the symptoms of Parkinson’s disease in adults. It may also be used to treat extrapyramidal symptoms. This includes involuntary or uncontrollable movements, tremors and muscle contractions.
- to prevent and treat the symptoms of a virus called “Influenza A” in adults and children 1 year of age or older when unable to be vaccinated.
How does ODAN-AMANTADINE SYRUP work?
It is not known exactly how amantadine hydrochloride works. When used to treat Parkinson’s disease it is thought to have an effect on the brain and nervous system that help with the symptoms of Parkinson’s disease. When used to prevent or treat “Influenza A” virus, it is thought that amantadine hydrochloride works by interfering with the ability of the virus to infect the body.
What are the ingredients in ODAN-AMANTADINE SYRUP?
Medicinal ingredients: amantadine hydrochloride
Non-medicinal ingredients: Cherry Flavor Natural and Artificial, citric acid anhydrous, dextrose, fructose, methylparaben, propylparaben, purified water, sorbitol solution.
ODAN-AMANTADINE SYRUP comes in the following dosage forms:
SYRUP: 10 mg/mL
Do not use ODAN-AMANTADINE SYRUP if:
- You or your child are allergic to amantadine hydrochloride or any of the non-medicinal ingredients in ODAN-AMANTADINE SYRUP.
- you have very poor kidney function (End Stage Renal Disease). If you are not sure about your kidney function, ask your healthcare professional.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ODAN-AMANTADINE SYRUP. Talk about any health conditions or problems you may have, including if you:
- have any liver or kidney disease
- have or have had heart problems or heart failure
- have a history of swelling in the legs or hands (peripheral edema)
- have a history of feeling lightheaded, dizzy or fainting when you stand up from sitting or lying down (orthostatic hypotension)
- have a history of seizures (fits) or epilepsy
- have a history of eczema (itchy red bumps on the skin).
- have depression, suicidal thoughts, hallucinations, a substance use disorder or other mental problems.
- have glaucoma (eye disease).
- have urges to gamble, increased sexual urges, excessive eating, or spending, and/or other intense urges that could harm yourself or others. These behaviors are called impulse control disorders.
- are taking central nervous system stimulants such as amphetamine and modafinil
- are pregnant, think you may be pregnant or planning to become pregnant
- are breastfeeding or planning to breast-feed are 65 years of age or older
- drive or operate machinery.
Other warnings you should know about:
If you are taking ODAN-AMANTADINE SYRUP to treat Parkinson’s disease:
- Do NOT stop taking ODAN-AMANTADINE SYRUP without talking to your healthcare professional first, as it may cause your symptoms to get worse. Suddenly stopping ODAN-AMANTADINE SYRUP can also cause a life-threatening side effect called neuroleptic malignant syndrome (muscle stiffness with high fever, rapid or irregular heartbeat, sweating, state of confusion or reduced consciousness).
- Suicide attempts, some of which have been fatal, have occurred in some people taking amantadine who had a history of mental illness and some people who did not have a history of mental illness. Amantadine can make psychiatric symptoms in people with a history of mental health problems or a history of substance abuse worse. Talk to your healthcare professional right away if you have changes in your mood, behaviors, or thoughts, including thoughts about hurting or killing yourself.
- Restart normal activities slowly and cautiously. Talk to your healthcare professional is you are not sure.
Driving and using machines:
- ODAN-AMANTADINE SYRUP may cause blurred vision. Give yourself time after taking ODAN-AMANTADINE SYRUP to see how you feel before driving a vehicle or using machinery.
Pregnancy and birth control:
- Avoid becoming pregnant while you are being treated with ODAN-AMANTADINE SYRUP and for at least 5 days after your treatment has stopped. ODAN-AMANTADINE SYRUP may harm an unborn baby. Your healthcare professional will discuss the potential risks with you.
- Use a highly effective birth control method while you are being treated with ODAN-AMANTADINE SYRUP and for at least 5 days after stopping your treatment.
- If you discover that you are pregnant while taking ODAN-AMANTADINE SYRUP, contact your healthcare professional as soon as possible. If you are currently taking ODAN-AMANTADINE SYRUP, you and your healthcare professional will decide if you should continue to take it while you are pregnant.
Breast-feeding:
- ODAN-AMANTADINE SYRUP can pass into your breast milk and harm a breast-fed baby. Therefore, you should not take ODAN-AMANTADINE SYRUP during breast-feeding.
- Talk to your healthcare professional about the best way to feed your baby while you take ODAN-AMANTADINE SYRUP.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ODAN-AMANTADINE SYRUP:
- Live attenuated influenza vaccine intranasal (nasal flu vaccine)
- Central nervous system stimulants such as amphetamine and modafinil
Alcohol
- Anticholinergic drugs such as benztropine (used to treat Parkinson’s disease)
- Antipsychotic drugs such as chlorpromazine, haloperidol (used to improve disturbed thoughts, feelings or behaviors in certain mental problems)
- Drugs that are used to reduce the acidity of urine such as potassium citrate (UROCIT®-K)
How to take ODAN-AMANTADINE SYRUP:
- Take ODAN-AMANTADINE SYRUP exactly as your healthcare professional has told you. Do not increase, decrease or stop taking ODAN-AMANTADINE SYRUP without first talking to your healthcare professional. Check with your healthcare professional if you are not sure.
- Do not increase or decrease your dose of ODAN-AMANTADINE SYRUP without first talking to your healthcare professional.
- Do not suddenly stop taking ODAN-AMANTADINE SYRUP, without first talking to your healthcare professional, because your symptoms may get worse.
If you are taking antipsychotics (used to treat mental disturbances) and you suddenly stop taking ODAN-AMANTADINE SYRUP, you may develop a collection of symptoms including: pronounced muscle stiffness or inflexibility with high fever, rapid or irregular heartbeat, sweating, confusion or reduced consciousness. If you develop any of these
symptoms you should contact your healthcare professional immediately.
Remember: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.
Usual dose:
If you are taking this drug to treat Parkinson’s syndrome:
- The usual daily dose is 10 mL (100 mg) once a day for the first week. Your healthcare professional may then increase your dose to 10 mL twice a day (200 mg per day).
- Your healthcare professional may give you a lower dose if you have certain medical conditions or other medication you are taking.
- Based on how you respond to and tolerate ODAN-AMANTADINE SYRUP, your healthcare professional may increase your dose.
If you are taking this drug to prevent or treat Influenza A:
Adults
The usual daily dose is 200 mg as either:
- 200 mg (20 mL) taken as a single dose
OR
- 100 mg (10 mL) taken twice a day
Children (1 to 18 years of age)
Your healthcare professional will decide which dose is right for your child.
Overdose:
If you think you, o r a person you are caring for, have taken too much ODAN-AMANTADINE SYRUP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.
What are possible side effects from using ODAN-AMANTADINE SYRUP?
These are not all the possible side effects you may have when taking ODAN-AMANTADINE SYRUP. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects are:
- nausea or feeling sick
- dizziness or light-headedness
- difficulty sleeping
Other common side effects may include:
- swollen hands, arms, feet, ankles, or legs
- loss of appetite
- anxiety
- depression
- hallucinations (seeing or hearing things that are not there)
- feeling tired / sleepy
- feeling weak
- feeling overexcited
- difficulty concentrating
- feeling nervous
- abnormal dreams
- muscle pain
- headache
- dry mouth
- dry nose
- constipation
- diarrhea
- sweating
- slurred speech
- red-blue patches on the skin
- difficulty emptying your bladder
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| COMMON | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Changes in mental condition such as hallucinations, depression, worsening of hallucinations or depression | ✓ | ||
Orthostatic hypotension: feeling lightheaded, dizzy or fainting after standing up | ✓ | ||
| UNCOMMON | |||
Blurred vision or other problem with your eyes | ✓ | ||
| Hyperkinesia: abnormal increase in muscle activity and movement | ✓ | ||
| Vomiting | ✓ | ||
| Congestive Heart Failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | ✓ | ||
| RARE | |||
| Abnormal thoughts and behaviour: agitation, anxiety, confusion, hallucinations, delusions, memory loss, more outgoing or aggressive behaviour than normal | ✓ | ||
| Loss of bladder control | ✓ | ||
| Shakiness | ✓ | ||
| Difficulty moving or controlling movements | ✓ | ||
| Diarrhea: severe, at least 3 loose or liquid bowel movements in a day | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Skin rash / itchy skin | ✓ | ||
| Behavior and mood changes: agitation including aggressive behavior or hostility (such as temper tantrums in children), | ✓ | ||
| Developing urges to gamble, increased sexual urges, excessive eating, or spending, and/or other intense urges that could harm yourself or others | ✓ | ||
| Suicidal thoughts or actions: thoughts or attempts to hurt or kill yourself | ✓ | ||
| Bacterial keratitis (infection of the eye): eye pain or redness, watery eyes, excess tears or discharge from your eye, decreased vision, sensitivity of the eye to light, swelling of the eye or eyelid, feeling like something is in your eye | ✓ | ||
| Neuroleptic Malignant Syndrome: pronounced muscle stiffness or inflexibility with high fever, rapid or irregular heartbeat, sweating, state of confusion or reduced consciousness | ✓ | ||
| Seizures (fits): uncontrollable shaking with or without loss of consciousness | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Allergic reactions: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Paresthesia: tingling sensation in hands, arms, legs orfeet | ✓ | ||
| Fever | ✓ | ||
| Pulmonary edema: breathing difficulties caused by fluid in the lungs | ✓ | ||
| Breathing difficulties | ✓ | ||
| Arrhythmia (abnormal heart rhythms): rapid, slow or irregular heartbeat | ✓ | ||
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:
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 to 30°C).
- Protect from humidity.
- Protect from freezing.
- Keep out of reach and sight of children.
- Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.
If you want more information about ODAN-AMANTADINE SYRUP:
- 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; or by calling the manufacturer’s phone number, 1-888-666-6326.
Odan Laboratoires Ltd
Pointe-Claire, QC H9R 2Y6
Last Authorized: June 6, 2023