Details for: ONRELTEA
Company: GALDERMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02421208 | ONRELTEA | BRIMONIDINE (BRIMONIDINE TARTRATE) | 0.33 % / W/W | GEL | TOPICAL |
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
ONRELTEA is used for the topical skin treatment of facial redness of rosacea in adult patients.
What it does
This gel contains brimonidine tartrate, which constricts the blood vessels in the skin thereby reducing the redness of rosacea.
When it should not be used
ONRELTEA should not be used:
- if you are allergic to brimonidine or any of its ingredients (see What the nonmedicinal ingredients are) or the packaging material of this medicine
- in children below 2 years
What the medicinal ingredient is
brimonidine (as brimonidine tartrate)
What the non-medicinal ingredients are
Carbomer, glycerol, methylparahydroxybenzoate, phenoxyethanol, propylene glycol, purified water, titanium dioxide, sodium hydroxide
What dosage form it comes in
ONRELTEA is supplied commercially in 30 g child-resistant tubes.
Warnings and precautions
ONRELTEA is not recommended in children and adolescents between 2 and 18 years.
Do not use ONRELTEA on irritated skin (including following laser therapy) or open wounds as this may result in low blood pressure and dizziness.
Avoid contact with the eyes and mucous membranes such as the mouth and inside of the nose. In case of accidental contact, rinse with water. Also, avoid using the product near the eyes.
BEFORE you use ONRELTEA talk to your doctor or pharmacist if:
- if you are pregnant or planning to become pregnant
- if you are breastfeeding or planning to breastfeed
- you have heart problems
- you have or have had in the past kidney or liver problems
- you have depression, circulatory problems or decreased blood flow of the brain or the heart, blood pressure disorder, circulatory problems or decreased blood flow of the hands, feet or skin, or Sjögren’s syndrome (chronic autoimmune disease in which a person’s white blood cells attack their moisture-producing glands)
- you have any allergies to this drug or its ingredients or components of the container
- Worsening of skin redness, flushing or burning feeling of the skin: Some patients experience the return of their redness worse than it was initially. Such worsening of redness usually develops within the first 2 weeks of treatment with ONRELTEA. Generally, it resolves spontaneously after treatment is stopped. The effect should gradually disappear within a few days in most cases.
- You may also get:
- redness in parts of your body where you did not have this before.
- redness where you did not apply the product.
- flushing (feeling of heat) or flushing with redness.
- Before you restart the treatment with ONRELTEA, test it on a small area of the face on a day when you can stay at home, at least one day before full re-treatment. If you do not experience worsening of redness or burning, continue with the usual treatment.
- In case of worsening or unexpected redness, discontinue the treatment and contact your doctor.
- This product contains propylene glycol and methylparahydroxybenzoate which may cause skin irritation.
- Do not:
- apply more product than directed.
- apply more often than directed.
The safety of higher doses is not known.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
No drug interactions studies were done for ONRELTEA.
The following may interact with ONRELTEA:
- monoamine oxidase (MAO) inhibitors (class of antidepressant) as it may result in hypotension (low blood pressure).
- anaesthetics, sedatives, opiates, barbiturates or alcohol
- medications which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine
- concomitant treatments which may interfere with the activity of ONRELTEA such as oral or transdermal alpha adrenergic receptor agonists (other alpha agonists, e.g. clonidine ; so-called alpha blockers or alpha antagonists, e.g. prazosin, isoprenaline which are most often used for treatment of high blood pressure, slow heart rate or asthma).
Proper use of this medication
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
ONRELTEA is only intended for use in adults.
Not for oral, ophthalmic, or intravaginal use.
Wash hands before and after use.
As for many people, this product should start to relieve the redness in your face within 30 minutes with maximum effect at about 3 hours. Take this for as long as directed by your doctor. If the product does not improve your symptom within 5 days, contact your doctor.
Usual adult dose:
Initital Dose: In the first week, use less than the maximum amount described below. If your reaction to this product is good, then slowly increase the dose to the maximum dose if needed.
Apply a small pea-size amount once daily to each of the five areas of the face (i.e., forehead, chin, nose, each cheek) avoiding the eyes and lips. ONRELTEA should be applied smoothly and evenly across all application areas.
Five small pea size amounts, estimated to be no more than 1 g in total weight, is the maximum daily recommended dose. Do not exceed the total daily recommended dose (5 pea size amounts). If you experience worsening of redness or burning you should stop using ONRELTEA and contact your doctor if needed.
How to open the tube with a child-resistant cap:
To avoid spilling, do not squeeze the tube while opening or closing.
Push down on the cap and turn counterclockwise (to the left a quarter of a turn). Then pull the cap off.
How to close the tube with a child-resistant cap:
Align grooves on the cap and tube. Push down and turn clockwise (to the right a quarter of a turn).
You should wash your hands immediately after applying ONRELTEA.
Cosmetics may be applied after the application of ONRELTEA.
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.
Side effects and what to do about them
The most common side effects are:
- redness
- itching
- flushing
- skin burning sensation
- excessive whitening (pallor) where the gel is applied
Uncommon side effects are:
- acne
- dry mouth
- feeling cold in hands and feet
- feeling hot
- headache
- nasal congestion
- skin disease or discomfort
- tingling or stinging at application site
- skin irritation
- warm skin sensation
- swelling of the eyelid, swelling of the face, urticaria
- worsening of rosacea
- (cutaneous) pain
- rash
- dry skin
- dizziness
In case of an allergic reaction or severe skin irritation, stop use and contact your doctor immediately.
Rare side effects are:
Angioedema (a serious allergic reaction usually with swelling of
the face, mouth or tongue), slow heart rate and hypotension (blood
pressure decreased) have been rarely reported. Low blood pressure
and feeling faint may happen when you get up too quickly when
taking Onreltea (orthostatic hypotension). Stop treatment with
ONRELTEA if this occurs.
This is not a complete list of side effects. For any unexpected effects while taking ONRELTEA, contact your doctor or pharmacist.
How to store
Store at room temperature (15°C to 30°C). Protect from freezing.
Keep out of reach and sight of children and pets.
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 3 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 1908C
Ottawa, Ontario
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
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.galderma.ca
or by contacting the sponsor, Galderma Canada Inc., at:
1-800-467-2081
This leaflet was prepared by Galderma Canada Inc.,Thornhill, ON L3T 7V9
Last revised August 2, 2018