Consumer Information for: APO-LORATADINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-LORATADINE provides:

  • fast relief from symptoms of allergies, including sneezing, runny nose and itchy nose, as well as itchy watery red burning eyes, caused by exposure to seasonal allergens (trees, grass, and ragweed pollen) and perennial (year round) allergens (dust mites, animal dander and moulds).
  • fast relief of allergic skin conditions, such as skin itch and hives.
What it does

APO-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.

APO-LORATADINE does not cause drowsiness. It lets you stay alert and focused while relieving allergy symptoms.

When it should not be used

APO-LORATADINE should not be used:

  • if you are allergic to loratadine, desloratadine or to any of the other product ingredients (see What the important non-medicinal ingredients are).
  • if you are pregnant or breastfeeding.
What the medicinal ingredient is

Loratadine

What the non-medicinal ingredients are

Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

What dosage form it comes in

Tablets, 10 mg

Warnings and precautions

BEFORE you use APO-LORATADINE talk to your doctor or pharmacist if you:

  • plan to become pregnant
  • have kidney disease
  • have liver disease as you may require a dose adjustment

Stop taking APO-LORATADINE 48 hours prior to any skin testing procedures.

Interactions with this medication

APO-LORATADINE may interact with drugs known to reduce liver metabolism.

If you are taking any medication, it is important to ask your doctor or pharmacist before taking APO-LORATADINE.

Alcohol has not been found to interact with APO-LORATADINE.

Proper use of this medication

Usual Dose

Adults and children (12 years of age and older): One tablet daily, with water. Adults and children (over 12 years of age) can take this medication for up to 6 months.

Overdose

If you think you have taken too much APO-LORATADINE, contact your healthcare professional, 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 than one dose in 24 hours.

Side effects and what to do about them

Along with its desired effects, APO-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, swelling 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.

Serious side effects, how often they happen and what to do about them
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 get immediate medical help
Common
Stomach discomfort - i.e. gastritis (inflammation of the stomach)    
Uncommon
Allergic reaction (rash, swelling, difficulty in breathing)    
Rare
Fast heart rate or heart palpitations    
Liver dysfunction    

This is not a complete list of side effects. For any unexpected effects while taking APO-LORATADINE, contact your doctor or pharmacist.

How to store

Store between 15°C and 30°C. Protect from exposure to excessive moisture.

Keep in safe place out of reach and sight of children.

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/health-canada/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 APO-LORATADINE:

  • Talk to your healthcare professional
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1- 800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: August 26, 2019