Patient Medication Information: uses, side effects, how to take - Ran-Isotretinoin

Serious Warnings and Precautions

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

All Females:

Birth defects

RAN-ISOTRETINOIN can cause birth defects (deformed babies). It can also cause miscarriage, premature birth, or death of the baby. Adequate birth control measures are required when taking RAN-ISOTRETINOIN (see “What are the important warnings for females taking RAN-ISOTRETINOIN?”)

All Patients:

Mental health problems and suicide

Some patients, while taking RAN-ISOTRETINOIN or soon after stopping RAN-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 RAN-ISOTRETINOIN have had thoughts about ending 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 RAN-ISOTRETINOIN becoming aggressive or violent.

Neurologic (brain) problems

Some patients have experienced benign intracranial hypertension while taking RAN-ISOTRETINOIN. This can happen if you take RAN-ISOTRETINOIN with certain antibiotics (tetracyclines). If you experience headaches, nausea, vomiting and visual disturbances talk to your doctor immediately.

For other possible serious side effects of RAN-ISOTRETINOIN, see the “Serious Side Effects and What to do About Them” table.

What is RAN-ISOTRETINOIN used for?

RAN-ISOTRETINOIN is used to treat severe acne (nodular and or inflammatory acne). It is used when the acne cannot be cleared up by other treatments, including antibiotics.

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

How does RAN-ISOTRETINOIN work?

The way RAN-ISOTRETINOIN works is not known. It is thought to reduce sebum, an oily substance that is produced by small glands in the skin, called sebaceous glands. This may reduce bacteria and improve the acne.
RAN-ISOTRETINOIN 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 RAN-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 see a noticeable improvement after one or two courses of treatment with isotretinoin.

What are the ingredients in RAN-ISOTRETINOIN?

Medicinal ingredients: isotretinoin

Non-medicinal ingredients: Ammonium Hydroxide, Butylated Hydroxyanisole, Edetate Disodium, Ferric Oxide (Red), Gelatin, Glycerin, Hydrogenated Soybean Oil, Hydrogenated Vegetable Oil, Iron Oxide Black, Isopropyl Alcohol, Light Mineral Oil, Methanol, Methylparaben, N-Butyl Alcohol, Propylparaben, Propylene Glycol, Shellac, Soybean Oil, Titanium Dioxide and White Wax.

RAN-ISOTRETINOIN comes in the following dosage forms:

RAN-ISOTRETINOIN Capsules, 10 mg are available in blister packages of 10 capsules.

Do not use RAN-ISOTRETINOIN under these conditions:

Do not use RAN-ISOTRETINOIN if pregnant
Do not get pregnant while taking RAN-ISOTRETINOIN and stop taking immediately if you do get pregnant (see Serious Warnings and Precautions Box).
Do not breastfeed while taking RAN-ISOTRETINOIN and for 1 month after stopping RAN-ISOTRETINOIN. Isotretinoin may pass through your milk and harm the baby.
Do not take Vitamin A supplements. Vitamin A in high doses has many of the same side effects as RAN-ISOTRETINOIN. Taking both together may increase your chance of getting side effects.
Do not take RAN-ISOTRETINOIN if you have liver or kidney disease.
Do not take RAN-ISOTRETINOIN if you have high blood fat (lipid) levels.
Do not take RAN-ISOTRETINOIN if you are sensitive to retinoids, or hydrogenated soybean oil, parabens, partially hydrogenated soybean oil, or any other non-medicinal ingredient listed under: “What are the ingredients in RAN-ISOTRETINOIN?”

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RAN-ISOTRETINOIN. Talk about any health conditions or problems you may have, including if:

you or someone in your family has ever had any mental illness, including depression, suicidal behaviour, 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.
you or someone in your family have liver disease, kidney disease, heart disease or high cholesterol or, diabetes or asthma.
you have had any bone disorders or anorexia (an eating disorder that causes abnormally low body weight).
you or someone in your family have a history of alcoholism.
you plan vigorous physical activity during treatment with RAN-ISOTRETINOIN.
you have any food or drug allergies.

Other warnings you should know about:

Important warnings for females taking RAN-ISOTRETINOIN

Do not take RAN-ISOTRETINOIN if you are pregnant.
If you become pregnant, stop taking RAN-ISOTRETINOIN and contact your doctor immediately.
RAN-ISOTRETINOIN can cause deformed babies. There is an extremely high risk that your baby will be deformed if you are pregnant while taking RAN-ISOTRETINOIN. This risk exists even if RAN-ISOTRETINOIN 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 RAN-ISOTRETINOIN.
You must avoid becoming pregnant while you are taking RAN-ISOTRETINOIN and for at least one month after you stop taking RAN-ISOTRETINOIN.
You must discuss effective birth control with your doctor before beginning RAN-ISOTRETINOIN treatment, and you must use effective birth control:
- For at least one month before you start RAN-ISOTRETINOIN;
- While you are taking RAN-ISOTRETINOIN; and
- For at least one month after you stop taking RAN-ISOTRETINOIN;

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 RAN-ISOTRETINOIN until you are sure that you are not pregnant.
You must have two negative pregnancy tests before you start RAN-ISOTRETINOIN, one of them must be done in a lab, before you start RAN-ISOTRETINOIN. You will need to take a test every month while on the drug and one month after you stop taking RAN-ISOTRETINOIN. If your menstrual period is abnormal in length and intensity, first contact your doctor (see the RAN-ISOTRETINOIN PREGNANCY PREVENTION PLAN).
You must wait until the second or third day of your next normal menstrual period before you start RAN-ISOTRETINOIN.
Stop taking RAN-ISOTRETINOIN and contact your doctor immediately if you do become pregnant while taking RAN-ISOTRETINOIN 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 RAN-ISOTRETINOIN. You should also discuss the desirability of continuing with your pregnancy.
Do not breast feed while taking RAN-ISOTRETINOIN.

You should have been counselled using the manufacturer’s PREGNANCY PREVENTION PLAN 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: “RAN-ISOTRETINOIN PREGNANCY PREVENTION PLAN”
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 RAN-ISOTRETINOIN provides confidential contraception counselling (from a healthcare professional). For more information, please contact Ranbaxy Pharmaceuticals Canada Inc.

If you were not counselled using the PREGNANCY PREVENTION PLAN, please contact your doctor for more information.

All patients should read the rest of this Patient Medication Information.

Do not take RAN-ISOTRETINOIN unless you completely understand its possible risks and are willing to follow all of the instructions in this Patient Medication Information.

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 RAN-ISOTRETINOIN:

Low-dose contraceptives (birth control pills). Low dose birth control pills may not work while you are taking RAN-ISOTRETINOIN.
Antibiotics (such as tetracyclines),
Corticosteroids,
Phenytoin
Vitamin Supplements including Vitamin A
St. John’s Wort.

What you should avoid while taking RAN-ISOTRETINOIN:

Do not give blood while you take RAN-ISOTRETINOIN and for 1 month after stopping RAN-ISOTRETINOIN. If someone who is pregnant gets your donated blood, the baby may be exposed to RAN-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 RAN-ISOTRETINOIN and for at least 6 months after you stop. RAN-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. RAN-ISOTRETINOIN may make your skin more sensitive to ultraviolet (UV) 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.

How to take RAN-ISOTRETINOIN:

If you are of childbearing age, your doctor will limit your RAN-ISOTRETINOIN prescription to 30 days, so that continued treatment will require a new prescription. Be sure to have your new prescription filled at your pharmacy within 7 days after seeing your doctor.

Do not share RAN-ISOTRETINOIN with other people. It can cause serious health problems.

Take RAN-ISOTRETINOIN with food or just after a meal.

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 RAN-ISOTRETINOIN prescription. If you have any questions, call your doctor.
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 RAN-ISOTRETINOIN. Blood tests and other tests allow your doctor to check your response to RAN-ISOTRETINOIN. Discuss your progress and any concerns with your doctor.

Overdose:

If you think you have taken too much RAN-ISOTRETINOIN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take a dose of RAN-ISOTRETINOIN it may be taken later the same day, but, do not take more

RAN-ISOTRETINOIN in one day than your doctor has prescribed. Do not double dose.

What are possible side effects from using RAN-ISOTRETINOIN?

These are not all the possible side effects you may feel when taking RAN-ISOTRETINOIN. If you experience any side effects not listed here, contact your healthcare professional.

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 RAN-ISOTRETINOIN.
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,
redness, dryness, or irritation of the eyes.

If you wear contact lenses, you may find them uncomfortable during treatment because RAN-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.

In some patients variable amounts of hair loss have occurred. In rare cases, this hair loss persisted after treatment was completed.

Serious side effects and what to do about them

Symptom/effect	Talk to your healthcare professional	Stop taking 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) 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 intestine (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 muscle weakness with or without pain can be a sign of serious muscle damage Tell a healthcare provider you are taking RAN-ISOTRETINOIN if you break a bone.			✓
Hyper-sensitivity (allergic) reactions hives, swollen face or mouth, trouble breathing, fever, rash, red patches, bruises			✓
Increased pressure in the brain bad headaches, blurred vision, dizziness, nausea, vomiting, seizures (convulsions) and stroke.			✓
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 suddenly in some patients (take caution when driving at night), 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.			✓
Pregnancy issues during or after treatment Birth defects, miscarriage, premature birth or death of baby. Do not take RAN-ISOTRETINOIN if you are pregnant.			✓

Problems with blood sugar levels

fainting, become very thirsty, urinating a lot, feeling weak.

✓

Serious Skin Reactions such as erythema multiforme (EM), Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)

blisters, peeling skin, severe red/purple rash, fever, conjunctivitis (red or inflamed eyes)
multiple lesions and sores, particularly in your mouth, nose, eyes and genitals

✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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.
RAN-ISOTRETINOIN should be stored at 15°C to 30°C and protected from sunlight and heat.
RAN-ISOTRETINOIN does not need to be refrigerated.

It is recommended that RAN-ISOTRETINOIN not be disposed of in household waste or waste water. Please return any unused RAN-ISOTRETINOIN to the pharmacist or use an established "collection system" if available in your location.

If you want more information about:

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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling Ranbaxy Pharmaceuticals Canada Inc., at: 1-866-840-1340.

Ranbaxy Pharmaceuticals Canada Inc.,

Brampton, ON L6T 1C1

Last Revised: December 19, 2019

All trademarks are property of their respective owners.

Rx or OTC	Prescription (Rx)?
DIN	02309173
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Isotretinoin 10 MG
Dosage form(s)	Capsule
Route(s) of administration	Oral
Drug class (WHO ATC)	D Dermatologicals D10 Anti-acne preparations D10B Anti-acne preparations for systemic use D10BA Retinoids for treatment of acne D10BA01 Isotretinoin
Company	RANBAXY PHARMACEUTICALS CANADA INC.
Current status	Cancelled Pre Market
Current status date	June 16, 2025

Ran-Isotretinoin: Uses, Side Effects and Dosage