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Details for: ALLERTIN LIQUID GEL CAPSULES, 10MG

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02390388ALLERTINLORATADINE10 MGCAPSULEORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Loratadine - Abnormal heart rhythm (QT interval prolongation)

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

ALLERTIN provide:

  • 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

ALLERTIN contain 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.

ALLERTIN do not cause drowsiness. It lets you stay alert and focused while relieving allergy symptoms.

When it should not be used

ALLERTIN should not be used:

  • if you are allergic to loratadine, desloratadine or to any of the other product ingredients (see What the nonmedicinal ingredients are).
  • if you are pregnant or breastfeeding.

What the medicinal ingredient is

Loratadine

What the non-medicinal ingredients are

FD&C blue #1, gelatin, glycerin, mono and di-glycerides, polysorbate, povidone, purified water, sorbitol sorbitan solution and triglycerides.

What dosage form it comes in

Capsules, 10 mg

Warnings and precautions

Serious Warnings and Precautions

  • Tell your doctor if you have or have ever had liver disease. If appropriate, your doctor may recommend that you take one capsule (10 mg) of ALLERTIN every other day.

BEFORE taking ALLERTIN talk to your doctor or pharmacist if you:

  • have kidney disease
  • have liver disease as you may require a dose adjustment
  • plan to become pregnant. If you become pregnant while taking ALLERTIN, call your doctor.

Stop taking ALLERTIN 48 hours prior to any skin testing procedures.

Interactions with this medication

ALLERTIN may interact with other medications. Always tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking. It is important to mention other colds and allergies medications you are taking.

Proper use of this medication

Usual Dose

ALLERTIN:Adults and children (12 years of age and older): One capsule daily, with water. Adults and children (over 12 years of age) can take this medication for up to 6 months. However prolonged use should only be on the advice of a physician.

Overdose

If you think you have taken too much ALLERTIN, 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 ALLERTIN may cause undesirable effects.

Mild side effects that may occur include: fatigue, headache, dry mouth, sleepiness, stomach and digestive discomfort such as gastritis (inflammation of the stomach) and nausea.

Tell your doctor if any of these symptoms are severe or do not go away.

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 or swallowing, wheezing, swelling of eyes, face, lips, tongue, throat. Additionally, hair loss, abnormal liver function, and abnormally fast heart rate or heart palpitations may occur rarely. Convulsions and seizures may occur very rarely.

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 talk with your doctor or pharmacist
Common
Stomach discomfort – i.e. gastritis (inflammation of the stomach)    
Uncommon
Allergic reaction (rash, difficulty in breathing, wheezing, swelling of the eyes, face, lips, tongue, throat.)    
Rare
Fast heart rate or heart palpitations    
Liver dysfunction    

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

How to store

Store at room temperature 15°C to 30°C. Protect from exposure to excessive moisture.

Keep out of reach 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/healthcanada/services/drugs-health-products/medeffectcanada/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 ALLERTIN:

  • 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: September 25, 2019

Date modified: