Patient Medication Information: uses, side effects, how to take - Loratadine (Mylan Pharmaceuticals)
ABOUT THIS MEDICATION
What the medication is used for:
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:
LORATADINE Tablets 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.
LORATADINE Tablets do not cause drowsiness. It lets you stay alert and focused while relieving allergy symptoms.
When it should not be used:
LORATADINE Tablets should not be used:
if you are allergic to loratadine or to any of the other product ingredients (see What the important non-medicinal ingredients are).
if you are pregnant or nursing.
What the medicinal ingredient is:
Loratadine.
What the important non-medicinal ingredients are:
Corn starch, lactose monohydrate and magnesium stearate.
What dosage forms it comes in:
Tablets, 10 mg, the tablet cannot be split.
WARNINGS AND PRECAUTIONS
BEFORE you use LORATADINE Tablets talk to your doctor or pharmacist if:
- you have severe liver disease
Stop taking LORATADINE Tablets 48 hours prior to any skin testing procedures.
INTERACTIONS WITH THIS MEDICATION
LORATADINE Tablets 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 LORATADINE Tablets.
Alcohol has not been found to interact with LORATADINE Tablets.
PROPER USE OF THIS MEDICATION
Do not split the tablet.
Usual dose:
Adults and adolescents (12 years of age and older): One tablet daily, with water.
Adults and adolescents (12 years of age) can take this medication for up to 6 months.
Children 6 through 12 years old and with a body weight of more than 30 Kg: Give 10 mg once daily no longer than 14 days unless recommended by a physician.
LORATADINE should not be administered to children between 6 and 12 years of age and a body weight less than or equal to 30 Kg.
Overdose:
Contact your Poison Control Centre, physician or pharmacist as soon as possible.
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 Tablets 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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In 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 | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking LORATADINE Tablets, contact your doctor or pharmacist.
HOW TO STORE IT
Loratadine tablets: Between 15o and 30oC. Use immediately upon opening tablet blister package. Protect from exposure to excessive moisture. Keep out of reach of children.
| 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. |
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:
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
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
Etobicoke, Ontario M8Z 2S6
Prepared on/Revised on: April 23, 2013
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca