For Healthcare Professionals | FrançaisFr

What You Need to Know

Know the facts

The following pages discuss some of the important things you need to know before you start taking Clarus®. If you have any questions, please talk to your doctor. If you are a woman taking Clarus, please pay special attention to the Pregnancy Prevention section of this guide.

Facts for everyone taking CLARUS

Do not use Clarus if you are pregnant. Clarus can cause birth defects (deformed babies). There is an extremely high risk that your baby will be deformed if you are pregnant while taking isotretinoin. This risk exists even if Clarus is taken for a short time. If you are a female of childbearing potential, your physician should have discussed this risk with you, and explained how to avoid becoming pregnant while taking Clarus.
You must avoid becoming pregnant while taking Clarus and for one month after you stop taking Clarus. (Isotretinoin can cause serious birth defects.)
  • You must discuss effective birth control with your doctor before beginning Clarus treatment, and you must use effective birth control:
    • For at least one month before you start Clarus.
    • While you are taking Clarus; and
    • For at least one month after you stop taking Clarus.
    • Keep in mind that any method of birth control can fail.
  • It is recommended that you either abstain from sexual intercourse or use two reliable methods of birth control at the same time, even if you have a history of infertility or are not sexually active.
  • Do not take Clarus until you are sure that you are not pregnant.
  • You must have two negative pregnancy tests, one of them must be done in a lab, before you start Clarus. You will need to take a test every month while on the drug and one month after you stop taking Clarus. If your menstrual period is abnormal in length and intensity, first contact your doctor.
  • You must wait until the second or third day of your next normal menstrual period before you start Clarus.
  • Stop taking Clarus and contact your doctor immediately if you do become pregnant while taking Clarus or during the first month after treatment has stopped, if you miss your period, or if you have sexual intercourse without using effective birth control. You should discuss with your doctor the serious risk of your baby having severe birth deformities because you are taking or have taken Clarus. You should also discuss the desirability of continuing with your pregnancy.
Do not breastfeed while taking Clarus and for one month after treatment. Clarus may pass through your milk and harm the baby.
If you become depressed or have any serious mental problems tell your doctor immediately. It may be necessary to stop Clarus treatment. Signs of mental health problems include:

  • Changes in your mood, such as becoming depressed, feeling sad, or having crying spells
  • Losing interest in your usual activities that you once enjoyed
  • Changes in your normal sleep patterns
  • Becoming more irritable or aggressive than usual (for example, temper outbursts, thoughts of violence)
  • Losing your appetite or a change in your body weight
  • Becoming unusually tired
  • Feeling like you have no energy
  • Having trouble concentrating
  • Having feelings of worthlessness or guilt
  • Withdrawing from family and friends
  • Having thoughts about hurting yourself or taking your own life (suicidal thoughts)
  • Starting to act on dangerous impulses
  • Starting to see or hear things that are not real

Some patients taking isotretinoin have had thoughts about putting an end to their own lives (suicidal thoughts), tried to end their own lives, and some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent.
Do not give blood while taking Clarus and for one month after treatment. If someone who is pregnant gets your donated blood, her baby may be exposed to Clarus and may be born with birth defects.
Do not take Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Clarus. Taking both together may increase your chance of getting side effects.
Stop using Clarus and get immediate medical help if you develop a serious skin reaction.
  • Symptoms of a skin reaction include blisters, peeling skin, severe red/purple rash, multiple lesions and sores, particularly in your mouth, nose, eyes and genitals, as well as facial and tongue swelling.
  • Some patients taking Clarus have had serious skin reactions, such as erythema multiforme (EM), Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), which can result in hospitalization, disability and/or death.
Do not take low-dose contraceptives, antibiotics, corticosteriods, phenytoin, and natural health products such as herbs (i.e. St. John's Wort) with Clarus unless you talk to your doctor. These medications may interact with Clarus or Clarus may interfere with the actions of these medications.
Do not use abrasive cleansers or exfoliative anti-acne agents on your skin while taking Clarus. Some skin products, like exfoliants, may be irritating to your skin while you are taking Clarus.
Do not have cosmetic procedures to smooth your skin such as waxing, dermabrasion, or laser procedures while taking Clarus and for at least 6 months after you stop. Clarus can increase your chance of scarring or skin inflammation from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
Avoid the use of artificial ultraviolet lights (such as the ones used in tanning machines) and protect yourself from excessive sunlight. Clarus may make your skin more sensitive to the ultraviolet light. When necessary, sunscreen with a high protection factor of at least SPF 15 should be used.
Do not share Clarus with anyone. Clarus is a prescription product that can cause serious side effects. A doctor must prescribe it.
Do not take tetracyclines with Clarus . For some antibiotics, you may have to stop taking Clarus until the antibiotic treatment is finished. Use of tetracyclines with Clarus together can increase the chances of getting increased pressure in the brain. Certain antibiotics interfere with the effectiveness of birth control pills.
Avoid drinking alcohol while on Clarus You are at a greater risk of liver damage with the combination of isotretinoin and alcohol.
See your doctor regularly. Isotretinoin may affect lipids, cholesterol, or sugar levels so it’s important to see your doctor regularly.
Tell all healthcare practitioners (i.e. your family doctor, dentist, cosmetic surgeon) that you are taking Clarus. Isotretinoin can interfere with other prescriptions and treatments.
Do not take Clarus if you have liver or kidney disease or if you have high blood fat (lipid) levels. Tell your doctor if you have any of these problems.
Do not take Clarus if you are sensitive to any of its ingredients, including retinoids, soybean oil, or any other non-medicinal ingredients listed.
  • If you have an allergic reaction while taking Clarus, stop taking Clarus and contact your doctor immediately.
  • 10 mg capsules contain Ammonium hydroxide, beeswax yellow, gelatin, glycerin, hydrogenated vegetable oil, isopropyl alcohol, lecithin, medium chain triglyceride, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, red iron oxide, SDA 35A alcohol, soybean oil and synthetic black iron oxide.
  • 40 mg capsules contain Ammonium hydroxide, beeswax yellow, gelatin, glycerin, hydrogenated vegetable oil, isopropyl alcohol, lecithin, medium chain triglyceride, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, red iron oxide, SDA 35A alcohol,soybean oil, synthetic black iron oxide, titanium dioxide and yellow iron oxide.

Pregnancy Prevention

Important Information about Prevention while taking Clarus Click Here.

A Guide For Patients

All the information you need about your medicine in a handy booklet.
Download PDF here

Birth Control Information

For more information about birth control or for confidential counselling call the toll-free number at 1-855-500-9991