What Rosiver is used for and how to use it
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Rosiver - Consumer Medicine Information

Manufacture: Galderma Laboratories
Country: Canada
Condition: Rosacea
Class: Topical anti-infectives
Ingredients: ivermectin, carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimeticone 20 Cst, disodium edetate, glycerol, isopropyl palmitate, macrogol cetostearyl ether, methyl parahydroxybenzoate, oleyl alcohol, phenoxyethanol, propyl parahydroxybenzoate, propylene glycol, purified water, sodium hydroxide, sorbitan stearate, stearyl alcohol

Ivermectin Cream, 1% w/w

About This Medication

What the Medication is Used For

ROSIVER is used for the topical treatment of bumps and pimples found with rosacea.

Rosacea is a chronic, inflammatory skin condition that occurs in adults. It can produce small, red, pus- filled bumps or pimples on your nose, cheeks, forehead and chin (but not the same as whiteheads or blackheads found with acne). Rosacea symptoms can vary from person to person and severity is hard to predict.

What it Does

ROSIVER reduces the bumps and pimples of rosacea but the exact way it works in rosacea is unknown.

When it Should not be Used

If you are allergic to ivermectin or any of the ingredients in ROSIVER (see What the nonmedicinal ingredients are:) or the components of the container.

What the Medicinal Ingredient Is

ROSIVER contains the medicinal ingredient ivermectin that belongs to a group of medicines called avermectins.

What the Nonmedicinal Ingredients Are

Carbomer copolymer type B, cetyl alcohol, citric acid monohydrate, dimeticone 20 Cst, disodium edetate, glycerol, isopropyl palmitate, macrogol cetostearyl ether, methyl parahydroxybenzoate, oleyl alcohol, phenoxyethanol, propyl parahydroxybenzoate, propylene glycol, purified water, sodium hydroxide, sorbitan stearate, stearyl alcohol.

What Dosage Forms it Comes In

ROSIVER is a white to pale yellow topical cream supplied in 15g, 30g, 45g and 60g tubes. Physician samples are supplied in 2 g tubes.

Warnings and Precautions

ROSIVER is not recommended in children under the age of 18 years.

Not for oral, ophthalmic, or intravaginal use.

The use of ROSIVER is not recommended during pregnancy, because its effect on your unborn baby is unknown. If you are breast-feeding, you should not use this medicine or stop breastfeeding before you use it.

If irritation occurs during treatment discuss with your doctor. Your doctor may tell you to take the medicine less frequently, discontinue Rosiver temporarily or stop treatment with ROSIVER.

Do not cover the treated areas with dressings.

Avoid alcoholic cleansers, astringents, abrasives, peeling agents and any other irritants which can further irritate the skin of those with rosacea.

Avoid excessive exposure to sunlight, which could aggravate rosacea.

BEFORE you use ROSIVER talk to your doctor or pharmacist if:

  • you are pregnant or planning to become pregnant
  • you are breastfeeding or planning to breastfeed
  • you have any allergies to this drug or its ingredients or components of the container.

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 ROSIVER.

Proper use of This Medication

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

ROSIVER is only intended for adults and only for use on the skin of the face. Do not use this medicine on other parts of your body, especially moist surfaces such as your eyes or mouth. Do not swallow.

Usual Adult Dose

Before application, wash your hands, and wash the affected area with a mild cleanser and dry.

Apply a pea-size amount to each of the five areas of the face (i.e., forehead, chin, nose and each cheek) at bedtime. ROSIVER should be applied smoothly and evenly across the entire face. Do not spot treat. Wash hands after treatment.

Avoid contact with the eyes and lips. Should this occur, wash these areas immediately with water. If your eyes continue to hurt, see your doctor,

Do not apply cosmetics immediately before the daily application of ROSIVER. You should use these products only after the applied ROSIVER has dried.

You may notice a distinct improvement after 4 weeks of treatment. In the case of no improvement after 3 months, you should discontinue ROSIVER and consult your doctor.

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 (turn to the left). Then pull the cap off.



How to Close the Tube With a Child-Resistant Cap

Push down and turn clockwise (turn to the right).



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.

Missed Dose

If you forget to apply Rosiver at bedtime, simply resume your daily application at the next bedtime. Do not take a double dose of ROSIVER to make up for a forgotten dose.

Side Effects and What to do About Them

The most common side effects are:

  • Burning feeling of the skin

Uncommon side effects are:

  • Irritation of the skin
  • Itching of the skin
  • dry skin

In case of an allergic reaction or severe skin irritation, stop use and contact your doctor immediately.

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

How to Store It

Store at room temperature (15°C to 30°C). Keep out of reach and sight of children and pets.

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:

  • 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 0701D
      Ottawa, Ontaroi
      KIA 0K9

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