Patient Medication Information: uses, side effects, how to take - Mint-Levetiracetam Solution
What is MINT-LEVETIRACETAM SOLUTION used for?
MINT-LEVETIRACETAM SOLUTION is used to help reduce the number of your seizures, or your child’s seizures when taken together with other seizure medications.
How does MINT-LEVETIRACETAM SOLUTION work?
MINT-LEVETIRACETAM SOLUTION belongs to the family of medicines called antiepileptics. The exact way that MINT-LEVETIRACETAM SOLUTION works to treat seizures is not known.
What are the ingredients in MINT-LEVETIRACETAM SOLUTION?
Medicinal ingredients: Levetiracetam
Non-medicinal ingredients: Ammonium glycyrrhizinate, Citric acid monohydrate, Glycerol, Grape flavour (contains propylene glycol), Maltitol, Methyl parahydroxy benzoate, Potassium acesulfame, Propyl parahydroxy benzoate, Purified water, Sodium citrate dihydrate
MINT-LEVETIRACETAM SOLUTION comes in the following dosage forms:
Solution: 100 mg/mL
Do not use MINT-LEVETIRACETAM SOLUTION if:
- you or your child are allergic to levetiracetam; or to any of the other ingredients in MINT-LEVETIRACETAM SOLUTION (see What are the ingredients in MINT-LEVETIRACETAM SOLUTION?).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MINT-LEVETIRACETAM SOLUTION, or give it to your child. Talk about any health conditions or problems you or your child may have, including if you (or your child):
- have or have had a history of any heart problems or problems with the way your heart beats. You may develop these even if you’ve never had a heart problem before;
- take any medicines that affect the heart or how it beats;
- take certain medicines that can cause an electrolyte imbalance;
- have any health problems, including ones you or your child have had in the past;
- have kidney disease;
- have had an allergic reaction, such as swelling of the face, lips, eyes, tongue and throat; trouble swallowing or breathing, and hives (anaphylaxis or angioedema) to other antiepileptic medicines in the past;
- are taking any medication, including ones you can get without a prescription;
- have recurrent infections or blood coagulation disorders;
are pregnant or thinking about becoming pregnant. Taking more than one antiepileptic medication during pregnancy increases the risk of your baby having birth defects.
- You and your doctor will have to decide if MINT-LEVETIRACETAM SOLUTION is right for you while you are pregnant.
- If you decide to take MINT-LEVETIRACETAM SOLUTION while you are pregnant, ask your healthcare provider about joining the North American Antiepileptic Drug Pregnancy Registry. You can join by calling the toll-free number (888) 233-2334. Women who are pregnant and planning to take MINT-LEVETIRACETAM SOLUTION should join the pregnancy registry. It will enable the collection of valuable data about MINT-LEVETIRACETAM SOLUTION use in pregnancy;
- are breast-feeding or planning to breast-feed. Levetiracetam is known to pass into breast milk and may harm your baby. You and your doctor should decide whether you should take MINT-LEVETIRACETAM SOLUTION or breast-feed, but not both.
Other warnings you should know about:
Changes in behaviour: You should pay attention to any mental changes, especially sudden changes in your or your child’s mood, behaviours, thoughts, or feelings. These changes are seen more commonly in children than in adults.
Call your doctor or your child’s doctor right away, if you or your child have any changes in behaviour that are new, worse, or worry you. These changes could include:
- feeling depressed, nervous, or anxious
- feeling angry, agitated or hostile
- in some people, psychotic symptoms, such as hallucinations (seeing or hearing things that are not really there); delusions (false or strange thoughts or beliefs), and unusual behaviour.
A small number of people may have thoughts of suicide (harming or killing themselves) when taking antiepileptic drugs such as MINT-LEVETIRACETAM SOLUTION. If at any time you or your child have these thoughts, get medical help right away. Do NOT stop MINT-LEVETIRACETAM SOLUTION on your own.
Trouble with coordination and driving and operating machinery: MINT-LEVETIRACETAM SOLUTION may affect your or your child’s coordination. It may also make you or your child feel sleepy and tired. It is more likely to happen at the beginning of your or your child’s treatment or after an increase in the dose. You should not drive or operate machinery until you know how MINT-LEVETIRACETAM SOLUTION affects you.
Severe Allergic Reaction Involving the Skin and Other Organs: There is no way to tell if a mild skin rash will become a severe reaction. The following serious skin reactions have been reported with levetiracetam:
- Stevens-Johnson Syndrome (SJS)
- Toxic Epidermal Necrolysis (TEN)
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Although very rare, severe forms of these reactions may lead to death.
Get help right away if you or your child gets any combination of the following:
- a rash or any serious skin reaction such as blistering or peeling of the lips, eyes or mouth;
- fever;
- swollen glands;
- joint pain;
- problems related to the liver, kidneys, heart, lungs or other organs;
- a serious allergic reaction (anaphylaxis or angioedema) such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives.
Tell your healthcare professional about all the medicines you or your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with MINT-LEVETIRACETAM SOLUTION:
- other antiepileptic medicines (such as carbamazepine, topiramate);
- Oral contraceptives (used for birth control);
- Methotrexate (used to treat certain types of cancer and arthritis);
- Polyethylene glycol laxatives (PEG, Macrogol). You should not take or give to your child PEG or Macrogol orally for one hour before and for one hour after taking MINT-LEVETIRACETAM SOLUTION
How MINT-LEVETIRACETAM SOLUTION is given to you or your child:
You will need to ask your pharmacist for the right sized dosing syringe, so you can correctly measure the amount of MINT-LEVETIRACETAM SOLUTION your doctor has told you to take or give to your child. The pharmacist will give you the right sized dosing syringe based on the dose prescribed by your or your child’s doctor.
Use only the dosing syringe given to you by your pharmacist to measure the dose. Do NOT use a household teaspoon.
Ask your pharmacists for instructions on how to measure the correct dose using the syringe. MINT-LEVETIRACETAM SOLUTION is taken:
- twice a day
with or without food
Recommended dosing syringe sizes
| Patient age | Recommended dosing syringe |
|---|---|
| 1 month to less than 6 months old | 1 mL |
| 6 months to less than 4 years old | 3 mL |
| Children over 4 years old | 10 mL |
Tell your doctor if you or your child’s seizures get worse or if you or your child have any new types of seizures.
Remember: This medicine has been prescribed only for you or your child. Do NOT give it to anybody else.
Usual dose:
Your doctor will decide how much MINT-LEVETIRACETAM SOLUTION you will need to take or give to your child. Your dose, or your child’s dose will depend on your, or your child’s age, weight, and medical history. It is important you take MINT-LEVETIRACETAM SOLUTION exactly as your doctor has told you.
Stopping treatment: If your doctor decides to stop your or your child’s treatment with MINT-LEVETIRACETAM SOLUTION, he/she will decrease the dose slowly. This is to help prevent your or your child’s symptoms from coming back again or becoming worse.
- Do NOT stop taking / giving MINT-LEVETIRACETAM SOLUTION or any other seizure medicines unless your doctor has told you to. Stopping a seizure medicine suddenly can cause you or your child to have seizures that will not stop (status epilepticus). This can be very serious.
- Never change the dose yourself.
Overdose:
| If you think you, or a person you are caring for, have taken too much MINT-LEVETIRACETAM SOLUTION, 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 symptoms. |
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Missed Dose:
If you forget to take a dose or forget to give it to your child and:
- It has only been a few hours: take it or give it to your child as soon as you remember. Then go on as usual.
- If it is almost time for you to take your next dose or give the next dose to your child: skip the dose you forgot and take or give the next dose and the same time.
Do not take two doses at the same time.
What are possible side effects from using MINT-LEVETIRACETAM SOLUTION?
These are not all the possible side-effects you or your child may have when taking MINT-LEVETIRACETAM SOLUTION. If you experience any side effects not listed here, tell your healthcare professional.
Side effects include:
- Feeling sleepy and tired / feeling tired. This side effect generally occurs in the first few weeks of treatment and may improve over time, however, it may return if you are taking MINT-LEVETIRACETAM SOLUTION for a long period of time.
- Headache
- Lack or loss of strength
- Feeling irritated
- Infection
- Bruising
- Feeling dizzy
- Sore throat
- Runny and stuffy nose, sneezing
- Vomiting
- Abdominal pain
- Diarrhea
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Nasal congestion, infection | √ | ||
| Convulsions, worsening seizures, balance disorder, dizziness, lethargy (weakness or lack of energy) | √ | ||
| Decreased appetite | √ | ||
| UNCOMMON | |||
Mood and Behaviour changes: aggression, agitation, anger, anxiety, apathy (lack of enthusiasm), depression, hostility, mood swings, personality disorder, nervousness/irritability Psychotic symptoms such as hallucinations (seeing or hearing things that are not really there) and delusions (false or strange thoughts or beliefs) | √ | ||
| RARE | |||
| Worsening seizures | √ | ||
| Thought of suicide or hurting yourself | √ | ||
| Severe Allergic Reactions: swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives and generalized itching, rash, fever, abdominal cramps, chest discomfort or tightness, difficulty breathing, unconsciousness | √ | ||
| Stevens-Johnson syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin | √ | ||
| and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache; cough, body aches or swollen glands | |||
| Toxic Epidermal Necrolysis (TEN) (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | √ | ||
| Extreme sleepiness and tiredness and/or difficulty coordinating, and weakness | √ | ||
| Rhabdomyolysis (breakdown of damaged muscle): muscle spasms, weakness, red-brown (tea coloured) urine. | √ | ||
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store at room temperature (15-30 °C) in the original container to protect from light. Store in an upright position. Throw it away 7 months after opening. Keep out of the reach and sight of children. Do not use if the safety seal is broken.
If you want more information about MINT-LEVETIRACETAM SOLUTION:
- 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 Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.mintpharma.com, or by calling 1-877-398-9696.
6575 Davand Drive
Mississauga, Ontario, L5T 2M3
