Patient Medication Information: uses, side effects, how to take - Novo-Loratadine
ABOUT THIS MEDICATION
What the medication is used for:
NOVO-LORATADINE Tablets provide:
fast relief from symptoms of allergies, including
sneezing, runny nose and itchy nose, as well as itchy watery red eyes, caused by exposure to seasonal allergens (trees, grass, and ragweed pollen) and perennial (year round) allergens (dust mites, animal dander and molds).
fast relief of allergic skin conditions, such as
skin itch and hives.
What it does:
NOVO-LORATADINE contains a long-acting antihistamine, which blocks the action of histamine and relieves allergy symptoms. Histamine is a chemical released by the immune system – the body’s defence against invading substances – when the body is affected by substances that you are allergic to (allergens).
Most people will feel relief of allergy symptoms within 2 hours of taking the medication.
Symptom relief will be maintained for 24 hours.
NOVO-LORATADINE does not cause drowsiness. It lets you stay alert and focused while relieving allergy symptoms.
When it should not be used:
NOVO-LORATADINE should not be used:
if you are allergic to loratadine or to any of the
other product ingredients (see What the nonmedicinal ingredients are).
if you are pregnant or nursing.
What the medicinal ingredient is:
Loratadine
What the important nonmedicinal ingredients are:
Corn starch, lactose monohydyrate, magnesium stearate, polysorbate 80, povidone, and sodium starch glycolate.
What dosage forms it comes in:
Tablets, 10mg
WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- If you have severe liver disease, take 5mg once daily or 10mg every other day.
BEFORE you use NOVO-LORATADINE talk to your doctor or pharmacist if:
- you have severe liver disease
Stop taking NOVO-LORATADINE 48 hours prior to any skin testing procedures.
MPRTANT: PLEASE READ
I
INTERACTIONS WITH THIS MEDICATION
NTERACTIONS WITH THIS MEDICATION
NOVO-LORATADINE may interact with drugs known to reduce liver metabolism.
If you are taking any medication, it is important to ask your physician or pharmacist before taking NOVO-LORATADINE.
Alcohol has not been found to interact with loratadine.
PROPER USE OF THIS MEDICATION
PROPER USE OF THIS MEDICATION
Usual dose:
Adults and adolescents (12 years of age and older): One tablet daily, with water
Adults and adolescents (12 years of age and older) can take this medication for up to 6 months.
Do not give NOVO-LORATADINE to children between 2 and 12 years of age for longer than 14 days, unless recommended by your doctor.
| IMPORTANT: PLEASE READ | |||||||
Overdose:
| In case of drug overdose, contact a health care | ||
| practitioner, hospital emergency department or | ||
| regional Poison Control Centre immediately, even if | ||
| there are no symptoms. |
Missed Dose:
If you miss taking your dose on time, do not worry; take your dose when you remember. Do not exceed more that one dose in 24 hours.
SIDE EFFECTS AND WHAT TO DO ABOUT
THEM
AT TO DO ABOUT
Along with its desired effects, NOVO-
LORATADINE may cause undesirable effects.
Mild side effects that may occur include fatigue, headache, dry mouth, sedation, stomach and digestive discomfort such as gastritis (inflammation of the stomach) and nausea.
Uncommon side effects include: increase in appetite, coughing, and dizziness. Rarely you may experience allergic reactions to the medication that may appear as a rash or difficulty in breathing. Additionally, hair loss, abnormal liver function, and abnormally fast heart rate or heart palpitations may occur rarely. Convulsions and seizures may occur very rarely.
Uncommon side effects in children include nervousness and nervous ticks as well as side effects involving the stomach or intestines.
ND WHAT TO
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||||
Only if severe | IIn all cases | |||||
| Common | Stomach discomfort - i.e. gastritis (inflammation of the stomach) | √ | ||||
| Uncommon | Allergic reaction (rash, difficulty in breathing) | √ | ||||
| Rare | Fast heart rate or heart | √ | ||||
| palpitations | |||||
| Rare | Liver dysfunction | √ | |||
DO ABOUT This is not a complete list of side effects. For any unexpected effects while taking NOVO-LORATADINE contact your doctor or pharmacist. HOW TO STORE IT
Store bottles between 15° and 30°C and blister packs between 15° and 25°C. Protect from exposure to excessive moisture.
ORTANT: PLEASE READ
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
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$ Report online at
www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345 $ Complete a Canada Vigilance Reporting
Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701D Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited at:
1-800-268-4127 ext. 5005 (English);
or 1-877-777-9117 (French)
or druginfo@tevacanada.com
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Last revised: November 30, 2010
| IMPORTANT: PLEASE READ |