Patient Medication Information: uses, side effects, how to take - Epuris
Serious warnings and precautions box
Informed Consent Form:
Pregnancy Prevention:
Mental Health Problems including Depression and Suicide:
Brain Problems (benign intracranial hypertension):
|
What EPURIS® is used for:
EPURIS® is used to treat patients with the following conditions of severe acne:
- Severe Nodular and Inflammatory Acne
- Acne Conglobata
- Recalcitrant Acne
EPURIS® can cause serious side effects. It is only used in patients whose acne cannot be cleared up by other medicines.
EPURIS® will be prescribed to you by a doctor with experience in treating patients with medicines like EPURIS®. They will talk to you about the possible serious side effects of EPURIS® including birth defects and mental health problems. Your doctor will also assess your mental health including if you have had mental illness in the past. You will be given an informed consent form that you must sign before taking EPURIS®.
It is not known if EPURIS® is safe and effective in patients under 12 years of age.
How EPURIS® works:
EPURIS® belongs to a group of medicines called retinoids (vitamin A derived). The way EPURIS® works is not known. It is thought to treat acne by reducing oil production in the skin.
During the first few weeks of treatment, your acne may seem to get worse. It may take one to two months before you see improvement.
The ingredients in EPURIS® are:
Medicinal ingredient: isotretinoin
Non-medicinal ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl macrogolglycerides
Gelatin capsule shells contain the following ingredients:
- 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.
EPURIS® comes in the following dosage forms:
Capsules in 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin
Do not use EPURIS® if:
- you are pregnant or plan to become pregnant.
- you become pregnant while taking EPURIS®. You must stop taking EPURIS® immediately if you become pregnant (see Serious Warnings and Precautions).
- you are breastfeeding.
- you have high levels of vitamin A in your body which can happen if you take supplements that contain vitamin A.
- you are taking a tetracycline medicine which is an antibiotic used to treat infections.
- you have liver problems.
- you have kidney problems.
- you have high blood fat levels.
- you are allergic to isotretinoin or to any of the other ingredients in EPURIS®.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take EPURIS®. Talk about any health conditions or problems you may have, including if:
- you or a family member has ever had any mental illness, including depression, mood disturbances, loss of contact with reality or aggression (see Serious Warnings and Precautions).
- you or a family member has diabetes.
- you are obese.
- you regularly drink alcohol.
- you have dry eyes.
- you have any bone problems, including a condition called osteoporosis or osteomalacia.
- you are taking medicines called corticosteroids used to treat various conditions.
- you are taking anti-epileptic medicines used to treat seizures.
- you have an eating disorder called anorexia that causes low body weight.
- you play or plan to play high impact sports or engage in vigorous exercise.
- you plan to donate blood. You should not donate blood while you are taking EPURIS® and for one month after you stop taking it.
- you are taking supplements that contain vitamin A. You should not take these while you are taking EPURIS®.
Other warnings you should know about:
Pregnancy Prevention in Females:
- You must not take EPURIS® if you are pregnant or plan to become pregnant.
- EPURIS® can cause miscarriage and birth defects. There is an extremely high risk that your baby will be deformed if you take isotretinoin while pregnant. This risk exists even if EPURIS® is taken for a short time.
- Your doctor will only prescribe EPURIS® to you if you meet all conditions for pregnancy prevention.
You must not get pregnant:
- 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®.
- You must discuss effective birth control with your doctor before taking EPURIS®. You must use two effective forms of birth control at the same time. At least one of these needs to be a primary form of birth control. These include birth control pills or injections and intrauterine devices. Secondary forms include condoms and diaphragms.
- Before you start taking EPURIS® you must take two pregnancy tests in a licensed laboratory. Both tests need to show that you are not pregnant. The first test will be done once your doctor agrees that EPURIS® treatment may be right for you. The second test must be done within 11 days of you starting to take EPURIS®.
- You must wait until the second or third day of your next normal menstrual period before you start taking EPURIS®.
- You will need to take a pregnancy test every month while taking EPURIS®. You will receive a 30-day prescription if this test shows you are not pregnant. You will need to take an additional test one month after you stop taking EPURIS®.
Stop taking EPURIS® and contact your doctor immediately if:
- you become pregnant while taking EPURIS®.
- you become pregnant during the first month after stopping your treatment.
- you miss your period.
- you have sex without using effective birth control.
Talk with your doctor about the risk of your baby having birth defects and whether you want to continue with your pregnancy.
Your doctor will counsel you using the EPURIS® PEER™ PROGRAM before you take EPURIS®. This includes the following:
- Information on the risks of EPURIS®
- A line drawing of a deformed baby
- A checklist of conditions you must meet before receiving EPURIS®
- Detailed information on birth control options
- A flowchart detailing the steps in the EPURIS® PEER™ PROGRAM
- Monthly pregnancy reminder slips
- An informed consent form from your doctor for you to review and sign
Confidential birth control counselling is available. For more information, please contact Cipher Pharmaceuticals Inc. at 1-855-437-8747 (1-855-4EPURIS).
If you were not counselled using the EPURIS® PEER™ PROGRAM, contact your doctor for more information.
Male patients:
EPURIS® may be released into semen. Male patients should use a condom or avoid sex to prevent passing EPURIS® to a female partner.
Tests and Check-ups:
Stay under your doctor’s care while you are taking EPURIS®. You must see your doctor regularly. For most patients this means seeing your doctor every month. For female patients, a pregnancy test is needed every month and at one month after stopping treatment.
Your doctor will perform the following tests before you start taking EPURIS®, at one month and then as decided by your doctor:
- check of blood fat levels, including triglyceride levels
- check of liver function
- check of kidney function
- check of sugar levels in your blood
* 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
Eyes:
EPURIS® may change your vision and ability to drive at night. Be cautious when driving any vehicle at night. EPURIS® can make your eyes dry. This can be helped by using lubricating eye ointment or artificial tears. Talk to your doctor about how to help your dry eyes. You might need to wear glasses during treatment instead of contact lenses if your eyes get dry.
Hair:
EPURIS® can cause hair loss. This can persist after you stop treatment.
Skin:
- Your acne may get worse when you first start taking EPURIS®. This should last only a short while. Talk with your doctor if this is a concern for you.
- You should not have chemical procedures on your skin, dermabrasion or laser treatments while you are taking EPURIS®. This is because EPURIS® can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
- Avoid the use of artificial ultraviolet (UV) lights such as the ones used in tanning machines and protect yourself from excessive sunlight. EPURIS® may make your skin more sensitive to UV light. When necessary, use sunscreen with a high protection factor of at least SPF 15.
- Avoid the use of anti-acne products for acne that exfoliate your skin since this can irritate your skin.
- You should use moisturizing skin cream and lip balm while you are taking EPURIS®. This is because EPURIS® can make your skin and lips dry.
Serious Skin Reactions:
EPURIS® can cause serious skin reactions such as erythema multiforme (EM),
Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). These can result in hospitalization, disability or death. Stop taking EPURIS® and get immediate medical help if you get any symptoms of a serious skin reaction. These include severe red / purple rash especially if associated with fever and not feeling well, red or inflamed eyes, blisters, peeling skin, multiple lesions and sores (especially in your mouth, nose, eyes and genitals), and facial and tongue swelling.
Sexual Dysfunction:
While taking EPURIS®, you may have the inability to get or maintain an erection, dryness in the vagina or vulva, reduced interest in sex, orgasm difficulties and loss of sensation or tingling in the genital area. This may continue after treatment. Tell your healthcare professional if you experience signs of sexual dysfunction before, during or after taking EPURIS®.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with EPURIS®:
- Low dose birth control pills. Low dose birth control pills that contain progesterone only (mini pills) may not work while you are taking EPURIS®.
- Antibiotics (such as Tetracyclines; e.g., minocycline, tetracycline) used to treat infections.
- Corticosteroids (such as hydrocortisone, prednisone, etc.) used to treat inflammatory conditions.
- Phenytoin, used to treat seizures.
- Vitamin supplements that contain vitamin A
- St. John’s Wort, used to treat depression.
How to take EPURIS®:
- Always take EPURIS® exactly as your doctor has told you to.
- It will be prescribed to you by a doctor who knows how to safely use products like EPURIS®. They will discuss the risks of EPURIS® with you.
- You must sign the informed consent form before you start taking EPURIS®.
- Swallow the capsules whole with a full glass of liquid.
- Do not chew or open the capsules.
You can take EPURIS® with or without food.
- Check with your doctor if you are not sure how to take EPURIS®.
- You must stay under your doctor’s care while you are taking EPURIS®.
- Do not change between EPURIS® and other isotretinoin products. EPURIS® is not the same as other isotretinoin products.
Usual dose:
The dose you receive will be specific to you. It will depend on your weight and other factors. Your doctor will prescribe the dose that is right for you. They will tell you when to take EPURIS® and for how long. Most patients take EPURIS® for 12 to 16 weeks. Your doctor may change your dose during treatment.
Overdose:
| If you think you, or a person you are caring for, have taken too much EPURIS®, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
Missed Dose:
If you forget to take a dose of EPURIS® take it later that same day. Then, take your next dose at the regular time. Do not take a double dose to make up for a missed dose.
Possible side effects from using EPURIS®:
These are not all the possible side effects you may have when taking EPURIS®. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- dryness of the skin, lips, mouth, and lining of the nose
- 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
- fatigue
- redness, dryness, or irritation of the eyes
- upper respiratory tract infection (common cold)
- inability to develop and maintain an erection
You may experience following side effects while EPURIS® and even after you stop taking it: inability to have or maintain an erection during sex, dryness in the vagina or vulva, reduced sexual drive interest, orgasm difficulties and loss of sensation or tingling in the genital area.
Serious side effects and what to do about them
| Symptom / Effect | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Mental health problems such as depression or psychosis (a 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) | √ | ||
| Liver problems: Nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine | √ | ||
| Pancreatitis (Inflammation of the pancreas): Severe upper stomach pain, often with nausea and vomiting | √ | ||
| Intestine (bowel) problems: Fever, abdominal pain, diarrhea (usually with blood and mucus), loss of weight, rectal bleeding | √ | ||
| Symptom / Effect | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Bone and muscle problems: 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, muscle weakness with or without pain can be a sign of serious muscle damage, breaking of a bone | √ | ||
| 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 | √ | ||
| Benign intracranial hypertension (Increased pressure in the brain): Headaches, blurred vision, dizziness, nausea, vomiting, seizures (convulsions) and stroke. Symptoms of stroke include sudden numbness or weakness of your arm, leg or face, trouble walking or loss of balance. | √ | ||
| Hearing and vision problems: Changes in your hearing or ringing in your ears, changes in your vision especially at night, decreased night vision may occur suddenly in some patients (take caution when driving at night), persistent feelings of dry eyes. In addition, some loss may occur in the sharpness of your vision (acuity). | √ | ||
| Heart problems: Chest pain, palpitations, stroke, leg swelling, seizures (convulsions), slurred speech, problems moving or any other serious unusual problems, vascular thrombotic disease (formation of a blood clot within the blood vessels that can occur both within the arteries and veins): pain in one leg (usually the calf or inner thigh), swelling in the leg or arm, chest pain, numbness or weakness on one side of the body, sudden change in your mental state | √ | ||
| Pregnancy issues during or after treatment: Birth defects, miscarriage, premature birth or death of baby | √ | ||
| Problems with blood sugar levels: Fainting, become very thirsty, urinating a lot, feeling weak | √ | ||
| Symptom / Effect | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Serious Skin Reactions such as erythema multiforme (EM), Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN): Severe red / purple rash, fever or not feeling well, red or inflamed eyes, facial and tongue swelling, blisters, peeling skin, multiple lesions and sores, especially in your mouth, nose, eyes and genitals | √ | ||
| Unknown Frequency | |||
| Sexual Dysfunction: Inability to get or maintain an erection, dryness in the vagina or vulva, reduced interest in sex, orgasm difficulties and loss of sensation or tingling in the genital area. | √ | ||
| Sacroiliitis (inflammation in the lower spine and pelvis joints): Pain in lower back or buttocks. Pain may travel down legs. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
Keep out of reach and sight of children.
- EPURIS® should be stored at 20 - 25°C. Store in the original package. Protect from light.
- Return any unused EPURIS® to your pharmacist.
If you want more information about EPURIS®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.epuris.ca, or by contacting Cipher Pharmaceuticals Inc. at 1-855-437-8747 (1-855-4EPURIS).
Cipher Pharmaceuticals Inc. Mississauga ON L4W 0A9
Date of Authorization: 2025-05-13