Details for: ACT LEVOFLOXACIN
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02315424 | ACT LEVOFLOXACIN | LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) | 250 MG | TABLET | ORAL |
| 02315432 | ACT LEVOFLOXACIN | LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) | 500 MG | TABLET | ORAL |
| 02315440 | ACT LEVOFLOXACIN | LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) | 750 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment
Summary Safety Review - Fluoroquinolones - Assessing the potential risk of aneurysm (a balloon-like bulge) and dissection (a separation or tear in the layers of the wall) of the aorta (a major blood vessel)
Summary Safety Review - Systemic and Inhaled Fluoroquinolone Antibiotics - Assessing the Potential Risk of Heart Valve Regurgitation
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ACT LEVOFLOXACIN is used to treat bacterial infections in the:
- Skin
- Kidneys
- Urinary tract (bladder or prostate).
- Sinuses.
- Lungs.
What it does
ACT LEVOFLOXACIN is in a group of antibiotics called quinolones (kwin-o-lones) that:
- Stop growth of bacteria.
- Kill the bacteria.
- Reduce the infection.
Some infections are caused by viruses, such as the common cold. ACT LEVOFLOXACIN does not kill viruses.
When it should not be used
Do not use ACT LEVOFLOXACIN if:
- You have allergic reaction to this drug or to other quinolone antibiotics (such as ciprofloxacin, moxifloxacin).
- You have a history of tendinitis (inflammation of tendon or tendon rupture). This condition causes pain and tenderness just outside of joint in shoulders, elbows, wrists, knees, heels, etc.
What the medicinal ingredient is
levofloxacin (levofloxacin hemihydrate)
What the non-medicinal ingredients are
Each tablet contains either 250, 500 or 750 mg of levofloxacin (as levofloxacin hemihydrate) as the active
ingredient and the following inactive ingredients: colloidal anhydrous silica, crospovidone,
hydroxypropylcellulose, microcrystalline cellulose and sodium stearyl fumarate.
The film coatings contain:
| 250 mg: | FD&C blue #1, FD&C red #40, FD&C yellow #6, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. |
| 500 mg: | iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. |
| 750 mg: | polyethylene glycol, polyvinyl alcohol, titanium oxide and talc |
What dosage form it comes in
ACT LEVOFLOXACIN comes in the following dosage forms:
Tablets
ACT LEVOFLOXACIN 250 mg tablets: Pink, film-coated, oval-shaped, biconvex tablet with ‘LO 250’ on one side and “ ” on the other.
ACT LEVOFLOXACIN 500 mg tablets: Peach-coloured, film-coated, oval-shaped, biconvex tablet with ‘LO 500’ on one side and “ ” on the other.
ACT LEVOFLOXACIN 750 mg tablets: White to off-white, film-coated, oval-shaped, biconvex tablet with ‘LO 750’ on one side and “ ” on the other.
Warnings and precautions
Serious Warnings and Precautions
Talk to your doctor,if you:
- Have serious allergic reaction to levofloxacin or similar antibiotics such as ciprofloxacin, moxifloxacin, and others
- Have seizures (convulsions). Tell your doctor if you have any problems in the brain, including epilepsy. Your doctor will tell you whether you should use this medication.
- Have muscle problems (e.g. weakness, joint problems). Do not use levofloxacin if you have or have had myasthenia gravis.
- Have previous history of inflamed tendon (fiber that connects bones to muscles in the body) and tendon rupture. Your risk for tendon problem is greater, if you are over 60 years of age, and if you are taking steroid medication, or if you have had kidney, heart or lung transplant.
- Have family history of long QT syndrome (Prolongation of the heartbeat on an electrocardiogram test).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACT LEVOFLOXACIN. Talk about any health conditions or problems you may have, including if you:
- have kidney problems.
- have epilepsy.
- have or have had a seizures (convulsions).
- have had any problems with your heart rhythm, heart rate, or problems with low potassium.
- have a diabetes and are taking anti-diabetic medication (it may interfere with blood sugar levels).
- have a disease that causes muscle weakness (myasthenia gravis).
- experience any symptoms of muscle weakness, including breathing difficulties (e.g., shortness of breath).
- have a history of tendon problems associated with antibiotics.
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. Talk to your doctor about how to feed your baby while you are taking ACT LEVOFLOXACIN.
Other warnings you should know about:
Blood Sugar Changes
Medicines like ACT LEVOFLOXACIN can cause blood sugar levels to rise and drop in patients with
diabetes. Serious cases of hypoglycemia (low blood sugar levels) that caused coma or death have been seen
with medicines like ACT LEVOFLOXACIN. If you have diabetes, check your blood sugar levels often while
taking ACT LEVOFLOXACIN.
If you have diabetes, you may develop a hypoglycemic reaction (low blood sugar) with common symptoms such as:
- Dizziness.
- Excessive hunger.
- Lack of coordination.
- Headache.
- Fatigue.
- Fainting. or a hyperglycemic reaction (high blood sugar) with common symptoms such as:
- Excessive thirst
- Excessive urination.
Interactions with this medication
The following may interact with ACT LEVOFLOXACIN:
- antacids, multi-vitamins, or products containing metals (such as aluminum, calcium, iron, magnesium or zinc). See How to take ACT LEVOFLOXACIN.
- medicines used for ulcers (such as sucralfate). See How to take ACT LEVOFLOXACIN.
- medicines used for heartburn or gout (such as probenecid, cimetidine, etc).
- medicines used for treatment of asthma or chronic obstructive pulmonary disease (COPD) (such as theophylline).
- medications for arthritis (nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen).
- blood sugar medicines (such as metformin, gliclazide, insulin,etc).
- medicines used for any heart conditions.
- blood thinner medications (such as warfarin, etc.) that used to thin the blood and prevent clots – may predispose you to the development of bleeding problems.
This medication may interfere with certain laboratory tests (such as urine screening for opiates), possibly causing false test results.
Proper use of this medication
How to take ACT LEVOFLOXACIN:
You should swallow the whole tablet with or without food.
Try to take the tablet at the same time and drink plenty of fluids while taking this medicine unless otherwise
directed by your doctor.
Do not share your medicine with anyone.
Antibacterial drugs like ACT LEVOFLOXACIN treat only bacterial infections. They do not treat viral infections. Although you may feel better early in the treatment, ACT LEVOFLOXACIN should be used exactly as directed. Misuse or overuse of ACT LEVOFLOXACIN could lead to the growth of bacterial that will not be killed by ACT LEVOFLOXACIN (resistance). This means that ACT LEVOFLOXACIN may not work in the future.
Ask your pharmacist about the other products you take. Some medicines will affect the way that your body absorbs ACT LEVOFLOXACIN. Take ACT LEVOFLOXACIN at least 2 hours before or 2 hours after taking these medicines. Some examples include: vitamins/minerals (including iron and zinc supplements), and products containing magnesium, aluminum, or calcium (such as antacids, calcium supplements).
Usual Dose
You should take this medication by mouth as directed by your doctor.
The dosage and length of the treatment depends on your kidney function, medical condition, and response to treatment. It may last for 3, 5, 7, 10, 14 or 28 days depending on your condition.
Tell your doctor if your condition does not improve
Overdose
Symptoms of overdose may include: severe dizziness.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Side effects and what to do about them
Self-Limiting Side Effects
- Feeling lightheaded
- Insomnia (difficulty sleeping)
- Nightmares
You should call your doctor if you experience any of these symptoms.
Allergic Reaction:
If you develop one of the following:
- Hives.
- Itching.
- Skin rash.
- Difficulty breathing or swallowing.
- Swelling in the face, tongue or throat.
- Other symptoms of an allergic reaction.
You should stop taking this medication and call your doctor.
Operating Heavy Machinery: You should know that use of ACT LEVOFLOXACIN may cause dizziness. Please make sure that you know how to react if you are:
- driving a car.
- operate any machinery at working place.
- perform work that needs mental alertness or coordination.
Exposure to Sunlight:
You should not expose yourself to sunlight or artificial ultraviolet light while you are taking ACT
LEVOFLOXACIN. Use sunscreen and wear protective clothing if out in the sun.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
These are not all the possible side effects you may feel when taking ACT LEVOFLOXACIN. If you experience any side effects not listed here, contact your healthcare professional.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| VERY COMMON | |||
| Nausea | ✔ | ||
| Headache | ✔ | ||
| Diarrhea (having slightly soft to watery stool) | ✔ | ||
| Insomnia (lack of sleep) | ✔ | ||
| Dizziness (drowsiness, light headedness) | ✔ | ||
| Constipation (hard to pass stool) | ✔ | ||
| COMMON | |||
| Abdominal or stomach pain or discomfort | ✔ | ||
| Vomiting. | ✔ | ||
| Dyspepsia (discomfort or pain in the upper abdomen) | ✔ | ||
| Dyspnea (shortness of breath). | ✔ | ||
| Moniliasis (yeast infection of the mouth and throat). | ✔ | ||
| Skin rash | ✔ | ||
| Pruritus (itching) | ✔ | ||
| Vaginal itching and discharge | ✔ | ||
| Vaginal itching and discharge | ✔ | ||
| Edema (swelling caused by excess fluid in your body). | ✔ | ||
| Chest pain. | ✔ | ||
| RARE | |||
| Stomach cramps or pain (severe) | ✔ | ||
| Agitation (purposeless movements) | ✔ | ||
| Blisters | ✔ | ||
| confusion | ✔ | ||
| diarrhea (watery and severe) which may also be bloody | ✔ | ||
| feeling that others can hear your thoughts or control your behavior | ✔ | ||
| fever | ✔ | ||
| pain, inflammation, or swelling in the calves of the legs, shoulders, or hands, including tendon rupture or swelling of the tendon (tendinitis) | ✔ | ||
| redness and swelling of the skin | ✔ | ||
| seeing, hearing, or feeling things that are not there | ✔ | ||
| sensation of burning on the skin | ✔ | ||
| severe mood or mental changes | ✔ | ||
| Neuropathy (problems in the nerves such as pain, burning, tingling, numbness or weakness) | ✔ | ||
| skin rash, itching, or redness – sun sensitivity (photosensitivity), which can appear as skin eruption or severe sunburn | ✔ | ||
| trembling | ✔ | ||
| unusual behavior | ✔ | ||
| severe/persistent headache | ✔ | ||
| vision changes | ✔ | ||
| shaking (tremors), seizures (convulsions) | ✔ | ||
| severe/persistent headache | ✔ | ||
| vision changes | ✔ | ||
| shaking (tremors), seizures (convulsions) | ✔ | ||
| severe dizziness, fainting | ✔ | ||
| fast/irregular heartbeat | ✔ | ||
Mental Health Problems:
|
✔ | ||
Neurological Problems:
|
✔ | ||
Rise in the pressure within your skull:
|
✔ | ||
Hypoglycemia (Low blood sugar):
|
✔ | ||
| signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark 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, talk to your healthcare professional.
How to store
ACT LEVOFLOXACIN tablets should be stored at 15-30°C in well-closed containers.
Keep out of reach and sight of children.
Do not use after the expiry date. Generally, all expired medications should be returned to your pharmacist.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
If you want more information about ACT LEVOFLOXACIN:
- 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; the manufacturer’s website www.tevacanada.com, or
- by calling 1-800-268-4127 ext. 3.
- By e-mail: druginfo@tevacanada.com
- Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada
M1B 2K9
www.tevacanada.com
Last Revised: April 29, 2019