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Details for: EPURIS

Company: CIPHER PHARMACEUTICALS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02396971EPURISISOTRETINOIN10 MGCAPSULEORAL
02396998EPURISISOTRETINOIN20 MGCAPSULEORAL
02397005EPURISISOTRETINOIN30 MGCAPSULEORAL
02397013EPURISISOTRETINOIN40 MGCAPSULEORAL
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Summary Safety Review - Oral Retinoid Products - Assessing the Potential Risk of Impotence (erectile dysfunction)

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

EPURIS® is a medicine used to treat severe acne (nodular and or inflammatory acne) that cannot be cleared up by other acne treatments, including antibiotics.

What it does
  • The mechanism of action of isotretinoin is not known. It is believed to act on the sebaceous glands (oil/wax producing glands) to reduce sebum excretion. This may indirectly reduce bacterial activity associated with acne and improve the condition.
  • EPURIS® contains the active ingredient isotretinoin. This is a vitamin A derivative, belonging to the retinoid class of medicines. Retinoids are normally used to treat skin problems.
  • During the first few weeks of treatment, your acne may seem to get worse. Redness and itching of the affected skin are common initial effects. These should disappear as you continue to take isotretinoin. Most often, the first signs of healing occur after two to three weeks of treatment. It may take one to two months before beneficial effects are seen. Most patients with severe acne notice a marked improvement after one or two courses of treatment with isotretinoin.

When it should not be used

  • Do not use if pregnant.
  • Do not get pregnant while taking EPURIS® and stop taking immediately if you do get pregnant (See SERIOUS WARNINGS AND PRECAUTIONS).
  • Do not breast feed while taking EPURIS® and for one (1) month after stopping isotretinoin. Isotretinoin may pass through your milk and harm the baby.
  • Do not take tetracyclines with isotretinoin. For some antibiotics, you may have to stop taking isotretinoin until the antibiotic treatment is finished. Use of tetracyclines with isotretinoin together can increase the chances of getting increased pressure in the brain. Certain antibiotics interfere with the effectiveness of birth control pills.
  • Do not take Vitamin A supplements. Vitamin A in high doses has many of the same side effects as isotretinoin. Taking both together may increase your chance of getting side effects.
  • Do not take EPURIS® if you have liver or kidney disease.
  • Do not take EPURIS® if you have high blood fat (lipid) levels.
  • Do not take EPURIS® if you are sensitive to retinoids, or stearoyl macrogolglycerides, soybean oil, sorbitan monooleate or propyl gallate (See What the nonmedicinal ingredients are).
What the medicinal ingredient is

Isotretinoin, USP

What the non-medicinal ingredients are

Stearoyl macrogolglycerides, soybean oil, sorbitan monooleate and propyl gallate. Gelatin capsules contain the following dye systems: 10 mg – iron oxide (yellow) and titanium dioxide; 20 mg – iron oxide (red) and titanium dioxide; 30 mg – iron oxide (yellow, red and black) and titanium dioxide; and 40 mg – iron oxide (yellow, red, and black) and titanium dioxide.

What dosage form it comes in

EPURIS® capsules 10 mg, 20 mg, 30 mg and 40 mg are available in boxes of 30 capsules (3 x 10 Blister Cards).

Warnings and precautions

Serious Warnings and Precautions

All patients must sign the informed consent form prior to initiating therapy.

All Females: Birth defects: Isotretinoin can cause birth defects (deformed babies). It can also cause miscarriage, premature birth, or death of the baby. Therefore, adequate birth control measures are essential when taking EPURIS®. See “What are the important warnings for females taking EPURIS®?”.

All Patients: Mental health problems and suicide: Some patients, while taking isotretinoin or soon after stopping isotretinoin, have become depressed or developed other serious mental health problems. Signs of these problems include feelings of sadness, irritability, unusual tiredness, trouble concentrating, and loss of appetite. 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. No one knows if isotretinoin caused these behaviors or if they would have happened even if the person did not take isotretinoin. For other possible serious side effects of isotretinoin, see the table: “Serious side effects and what to do about them.”

EPURIS® can cause serious side effects. Before starting EPURIS®, discuss with your doctor how bad your acne is, the possible benefits of EPURIS®, and its possible side effects, to decide if EPURIS® is right for you. Your doctor will ask you to read and sign a form indicating you understand some of the serious risks of EPURIS®.

Possible serious side effects of taking EPURIS® include birth defects and mental health problems.

There have been reports of serious skin reactions occurring with the use of isotretinoin, such as erythema multiforme (EM), Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) which can result in hospitalization, disability and/or death.

Stop using EPURIS® and call your doctor immediately if you develop a serious skin reaction with symptoms such as 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.

What are the important warnings for females taking EPURIS®?

  • Do not take isotretinoin if you are pregnant.
  • If you become pregnant, stop taking isotretinoin and contact your doctor immediately.
  • Isotretinoin can cause deformed babies. There is an extremely high risk that your baby will be deformed if you are pregnant while taking EPURIS®. This risk exists even if EPURIS® 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 EPURIS®.
  • You must avoid becoming pregnant while you are taking EPURIS® and for at least one month after you stop taking EPURIS®.
  • You must discuss effective birth control with your doctor before beginning EPURIS® treatment, and you must use effective birth control:
    • For at least one month before you start EPURIS®;
    • While you are taking EPURIS®; and
    • For at least one month after you stop taking EPURIS®.
    • Bearing 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 EPURIS® until you are sure that you are not pregnant.
  • You must have two negative pregnancy tests before you start EPURIS®. You will need to take a test on a monthly basis while on the drug and one month after you stop taking EPURIS®. If your menstrual period is abnormal in length and intensity, first contact your doctor. (see the EPURIS ® PEER™ PROGRAM)
  • You must wait until the second or third day of your next normal menstrual period before you start EPURIS®.
  • Stop taking EPURIS® and contact your doctor immediately if you do become pregnant while taking EPURIS® 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 EPURIS®. You should also discuss the desirability of continuing with your pregnancy.
  • Do not breast feed while taking EPURIS®.

You should have been counseled using the EPURIS® PEER™ PROGRAM which includes:

  • Comprehensive information about the risks of this drug
  • A line drawing of a deformed baby
  • A checklist of criteria you had to meet before receiving this drug
  • Detailed information on birth control options
  • A chart: “EPURIS® PEER ™ PROGRAM”
  • An informed consent for you to review and sign. A copy of this form should be given to you by your doctor.

Please note that the manufacturer of EPURIS® provides confidential contraception counseling (from a health care professional). For more information, please contact Cipher Pharmaceuticals Inc. at 1-855-437-8747 (1-855-4EPURIS).

If you were not counseled using the EPURIS® PEER™ PROGRAM, please contact your doctor for more information.

* To ensure that you are using two reliable methods of birth control at the same time.
** Duration of therapy is typically 3-4 months.
***To ensure that you are using two reliable methods of birth control at the same time and to detect any side effects that you may have from the treatment.

All patients should read the rest of the Consumer Information.

Do not take EPURIS® unless you completely understand its possible risks

What should you tell your doctor before starting EPURIS®?

  • Tell your doctor if you or someone in your family has ever had any mental illness, including depression, suicidal behavior, or psychosis. Psychosis means a loss of contact with reality, such as hearing voices or seeing things that are not there. Also, you should tell your doctor if you are taking medicines for any of these problems.
  • Tell your doctor if you or any member of your family have liver disease, kidney disease, heart disease, high cholesterol, diabetes or asthma.
  • Tell your doctor if you plan vigorous physical activity during treatment with EPURIS®.
  • Tell your doctor if you have any food or drug allergies.
  • Tell your doctor if you are taking any vitamin preparations or health food supplements that contain Vitamin A.
  • Tell your doctor the brand of contraceptives you are taking. There are certain types of contraceptives that should not be taken while on EPURIS®.
  • Tell your doctor if you are taking an antibiotic (particularly tetracyclines).

What should you avoid while taking EPURIS®?

  • Do not give blood while you take EPURIS® and for one (1) month after stopping EPURIS®. If someone who is pregnant gets your donated blood, her baby may be exposed to isotretinoin and may be born with birth defects.
  • Do not have cosmetic procedures to smooth your skin, such as waxing, dermabrasion, or laser procedures, while you are using EPURIS® and for at least 6 months after you stop. Isotretinoin can increase your chance of scarring or inflammation of the skin 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. Isotretinoin may make your skin more sensitive to ultraviolet light. When necessary, sunscreen with a high protection factor of at least SPF 15 should be used
  • Avoid the use of exfoliative anti-acne agents.
  • Do not share EPURIS® with other people. It can cause birth defects and other serious health problems.
  • Do not take Vitamin A.
  • Do not take antibiotics unless you have discussed with your doctor. See “When it should not be used”.
  • Avoid strenuous physical activity or vigorous exercise. EPURIS® may affect your muscles and bones, which can cause serious harm or death after physical activity.
Interactions with this medication

  • Do not use low dose birth control pills. They may not work while you take EPURIS®.
  • The following medications may interact with isotretinoin or isotretinoin may interfere with the actions of: low-dose contraceptives, antibiotics, corticosteroids, phenytoin, and natural health products such as herbs (i.e., St. John’s Wort).

Proper use of this medication

Usual Dose

  • Read your prescription label carefully and be sure to take the exact amount of medicine prescribed by your doctor. Your doctor may change your prescribed dose from time to time, therefore, it is important that you check the label each time you fill your EPURIS® prescription. If you have any questions, call your doctor.
  • If you are of childbearing age, your doctor will limit your EPURIS® prescription to 30 days, so that continued treatment will require a new prescription. Be sure to have your new prescription filled within 7 days after seeing your doctor.
  • Take EPURIS® with food.
  • Be sure to return to your doctor as scheduled. It is important for your doctor to see you regularly, every month, when you are taking EPURIS®. Blood tests and other tests allow your doctor to check your response to EPURIS®. Discuss your progress and any concerns with your doctor.

Overdose

In case of an overdose or suspected overdose, contact your doctor, hospital emergency department or the regional poison control centre, even if there are no symptoms.

Missed Dose

If you forget to take a dose of EPURIS® it may be taken later the same day, but, do not take more EPURIS® in one day than your doctor has prescribed.

Do not double dose.

Side effects and what to do about them

Serious side effects you must immediately tell your doctor about:

If you get these symptoms, you must tell your doctor immediately because it may be necessary to stop EPURIS®. These symptoms could lead to serious health problems requiring treatment even if EPURIS® is stopped.

Serious side effects and what to do about them
Effect Signs and Symptoms Tell your doctor immediately
Mental health problems such as depression or psychosis (severe mental disturbance)
  • changes in your mood such as becoming depressed, feeling sad, or having crying spells,
  • losing interest in your usual activities,
  • changes in your normal sleep patterns,
  • becoming more irritable or aggressive than usual (for example, temper outbursts, thoughts of violence),
  • losing your appetite,
  • becoming unusually tired,
  • having trouble concentrating,
  • withdrawing from family and friends,
  • having thoughts about taking your own life (suicidal thoughts)
Your doctor may recommend a consultation with a specialist if you become depressed or experience these changes in mood		 ✔
Inflammation of the liver, pancreas, or intestines (bowel)
  • severe stomach pain, diarrhea, rectal bleeding; yellowing of the skin or eyes and/or dark urine
 ✔
Bone and muscle changes:
  • aches or pains in bones or joints, back pain, or difficulty in moving, muscle pain, especially after vigorous exercise dark coloured urine that is brown, red or tea-coloured.
  • If a bone breaks
 ✔
Hypersensitivity (allergic) reactions
  • hives, swollen face or mouth, trouble breathing, fever, rash, red patches, bruises
  • In some patients a rash can be serious. These include; conjunctivitis (red or inflamed eyes, like “pink eye”), a rash with fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel
 ✔
Increased pressure in the brain
  • bad headaches, blurred vision, dizziness, nausea, vomiting
✔
Hearing and vision differences
  • changes in your hearing or ringing in your ears
  • changes in your vision especially at night. Decreased night vision may occur and be sudden in some patients. Take caution when driving at night In addition, some loss may occur in the sharpness of your vision (acuity) which is most often reversible when you stop EPURIS®. In some cases this loss may not be completely reversible.
  • persistent feelings of dry eyes
 ✔
Heart Problems
  • chest pain, palpitations, vascular thrombotic disease, stroke, leg swelling, seizures (convulsions), slurred speech, problems moving or any other serious unusual problems
✔
Problems with blood sugar levels
  • fainting, become very thirsty, urinating a lot, feeling weak
 ✔

EPURIS® may affect blood fat, cholesterol, or sugar levels. Therefore it is important for you to see your doctor at regularly scheduled visits.

It is important to watch for the special symptoms listed in the table above as these may be signs of serious side effects.

The side effects listed below are generally temporary and disappear when isotretinoin treatment is stopped; however, you must tell your doctor if any of your side effects do not clear up in a few weeks after you stop taking isotretinoin. You must also check with your doctor, if these effects become bothersome, to see if any change in your medication is needed.

  • Some of the most common side effects are: dryness of the skin, lips, mouth, and lining of the nose. It is recommended that you use a skin-moisturizing ointment or cream and a lip balm from the start of treatment of EPURIS®.
  • Some other side effects that may occur include: facial or body rash, flaking of the skin, itching, peeling of the palms and soles, increased sensitivity to the sun, sunburn, inflammation of the lips, mild nose bleed, bleeding and inflammation of the gums, easily injured skin and increased fatigue. You may experience some redness, dryness, or irritation of the eyes
  • In some patients variable amounts of hair loss have occurred. In rare cases, this hair loss persisted after treatment was completed.
  • If you wear contact lenses, you may find them uncomfortable during treatment because isotretinoin may cause dry eyes. This may continue after treatment has stopped. Dry eyes can be helped by applying a lubricating eye ointment or tear replacement therapy.

These are not all of the possible side effects associated with isotretinoin. Your doctor or pharmacist can give you more detailed information that is written for health care professionals.

How to store

Keep out of the reach and sight of children.

  • EPURIS® should be stored at 20 - 25ºC. Store in the original package. Protect from light.
  • EPURIS® does not need to be refrigerated.

SPECIAL HANDLING INSTRUCTIONS

It is recommended that EPURIS® not be disposed of in household waste or waste water. Please return any unused EPURIS® to the pharmacist or use an established “collection system” if available in your location.

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 MedEffect (www.healthcanada.gc.ca/medeffect);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 1908C
      Ottawa, ON
      K1A 0K9
      • Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This Consumer Information is only a summary of some important information about EPURIS®. Medicines are sometimes prescribed for purposes other than those listed in a Consumer Information. If you have any concerns or questions about EPURIS®, ask your doctor. Do not use EPURIS® for a condition for which it was not prescribed.

This document plus the full product monograph, prepared for health professionals can be found at: www.epuris.ca, or by contacting Cipher Pharmaceuticals Inc. at 1-855-437-8747 (1- 855-4EPURIS).

This leaflet was prepared by

Cipher Pharmaceuticals Inc.
209 Oak Park Blvd, Suite 501
Oakville, Ontario
L6H 0M2 Canada

Last revised: August 25, 2020

For information about birth control or for confidential counseling call Cipher Pharmaceuticals Inc. at 1-855-437-8747 (1-855-4EPURIS) or visit the EPURIS® website at www.epuris.ca

Date modified: