Consumer Information for: LORATADINE SOFT GEL CAPSULES

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

LORATADINE SOFT GEL CAPSULES 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

LORATADINE SOFT GEL CAPSULES contain a longacting 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.

LORATADINE SOFT GEL CAPSULES do not cause drowsiness. It lets you stay alert and focused while relieving allergy symptoms.

When it should not be used

LORATADINE SOFT GEL CAPSULES 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 LORATADINE SOFT GEL CAPSULES every other day.

BEFORE taking LORATADINE SOFT GEL CAPSULES 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 LORATADINE SOFT GEL CAPSULES, call your doctor
Stop taking LORATADINE SOFT GEL CAPSULES 48 hours prior to any skin testing procedures.
Interactions with this medication

LORATADINE SOFT GEL CAPSULES may interact with other medications. Always tell your doctor and pharmacist what prescription and non-prescription 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

LORATADINE SOFT GEL CAPSULES: 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 LORATADINE SOFT GEL CAPSULES, 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 LORATADINE SOFT GEL CAPSULES 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 LORATADINE SOFT GEL CAPSULES, 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 adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • 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 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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

If you want more information about LORATADINE SOFT GEL CAPSULES:

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

Last revised: May 31, 2019

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