Jamp Acitretin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

You must sign the informed consent form before you start taking JAMP Acitretin.

Female patients:

Birth defects (deformed babies)

• Do NOT take JAMP Acitretin if you are pregnant or want to become pregnant. JAMP Acitretin can cause severely deformed babies.

• You must discuss effective birth control with your doctor before beginning treatment and you must use effective birth control without interruption as follows:

  • for at least one month before you start JAMP Acitretin;
  • while you are taking JAMP Acitretin; and
  • for at least 3 years after you stop taking JAMP Acitretin (discuss this with your doctor); and
• Bear in mind that any method of birth control can fail. It is recommended that you either abstain from sexual intercourse or use two effective methods of birth control at the same time (discuss this with your doctor).
• Low dose progesterone-only may not be an effective method to prevent pregnancy during treatment with JAMP Acitretin and is not recommended for use.

• Do NOT take JAMP Acitretin until you are sure that you are not pregnant:

  • You must have 2 negative pregnancy tests before you start JAMP Acitretin. The first test will be done at screening when JAMP Acitretin treatment is under consideration. A second (confirmatory) test must be done within 3 days before the first dose is taken. Both tests must show you are not pregnant.
  • You must wait until the second or third day of your next menstrual period before you start JAMP Acitretin.
• During treatment, you must have a pregnancy test at 28-day intervals in a licensed laboratory. The test must be no older than 3 days and show you are not pregnant before you can receive another prescription for JAMP Acitretin.
• After stopping treatment, you must have pregnancy tests every 1-3 months for at least 3 years after your last dose.
• Every time you start a new course of treatment with JAMP Acitretin, however long the intervening period may have been, you must use effective and uninterrupted birth control, during treatment and for at least 3 years after you stop taking JAMP Acitretin.
• Contact your doctor immediately if you do become pregnant while taking JAMP Acitretin or after treatment has stopped. You should discuss the serious risk of having a baby with severe birth deformities because you are taking or have taken JAMP Acitretin, as well as available options, with your doctor.
• Do NOT breastfeed while taking JAMP Acitretin and until at least 3 years after the treatment has stopped.

All patients:

• Do NOT consume alcohol while taking JAMP Acitretin and for at least 2 months after the treatment has stopped.
• Do NOT donate blood while taking JAMP Acitretin and until at least 3 years after the treatment has stopped. If someone who is pregnant gets your donated blood, the baby may be exposed to JAMP Acitretin and be born with birth defects.

JAMP Acitretin can cause serious side effects, including:

• Liver problems

  • Cases of jaundice, toxic hepatitis (inflammation of the liver) and liver injury have been reported in patients taking acitretin.
  • Before starting treatment and during treatment with JAMP Acitretin, your healthcare professional will do blood tests to check how your liver is working.
• Pseudotumor cerebri (benign intracranial hypertension). This is a condition where there is an increased pressure in the brain.

• Mood changes (including irritability, aggression, depression, suicide and thoughts of suicide and self-harm)

  • Before you take JAMP Acitretin, your healthcare professional will assess you for mood changes, including depression.
  • Tell your healthcare professional right away if you have any symptoms of new depression or worsening depression.
• Psychotic disorder (hallucinations or delusions): This may cause you to experience hallucinations (seeing or hearing things) or delusions (have false beliefs).

What is JAMP Acitretin used for?

JAMP Acitretin is used in the treatment of:

• Severe psoriasis
• Other disorders of keratinization in adult patients who have not responded to standard treatments.

How does JAMP Acitretin work?

JAMP Acitretin is a retinoid. It works by leading to a more normal pattern of growth for skin cells.

What are the ingredients in JAMP Acitretin?

Medicinal ingredient: Acitretin

Non-medicinal ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, maltodextrin, sodium ascorbate, sodium lauryl sulfate.

Composition of capsule shell: Gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulfate, titanium dioxide.

Composition of imprinting ink: Iron oxide black, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.

JAMP Acitretin comes in the following dosage forms:

Capsules: 10 mg and 25 mg

Do not use JAMP Acitretin if you:

• are pregnant, or plan to become pregnant.

• become pregnant while taking JAMP Acitretin. You must stop taking JAMP Acitretin immediately. See

  “Serious warnings and precautions” box.

• are breastfeeding.
• are allergic to acitretin, or any of the other ingredients in JAMP Acitretin.
• are allergic to other retinoids, or Vitamin A, or its metabolites.
• consume alcohol (in drinks, food or medicines).
• have severe liver problems.
• have severe kidney problems.
• have consistent high blood lipid levels.
• take tetracyclines, medicines used to treat bacterial infections.
• take methotrexate, medicine used to treat cancer and other conditions caused by an overactive immune system.
• have high vitamin A levels (hypervitaminosis A).

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

• have high cholesterol or triglycerides.
• have high blood sugar, or have a family history of diabetes. You may need to check your blood sugar levels more frequently at the beginning of treatment.
• have liver problems.
• have kidney problems.
• have or have had depression, or have a family history of depression.
• have eye problems or wear contact lenses. JAMP Acitretin may cause dry eyes, light sensitivity, or other eye problems.

Other warnings you should know about:

• JAMP Acitretin Pregnancy Prevention Program

  You should have been counselled using the manufacturer’s JAMP Acitretin Pregnancy Prevention Program which includes:

  • Comprehensive information about the risks of this drug
  • A line drawing of a deformed baby
  • A checklist of the criteria you had to meet before receiving this drug
  • Detailed information on birth control options
  • A chart outlining the JAMP Acitretin Pregnancy Prevention Program
  • An informed consent form for you to review and sign (for males and females)

If you were not counselled using the JAMP Acitretin Pregnancy Prevention Program, please visit www.jampinfo.com or call the toll-free number 1-866-399-9091 for important information.

• Skin

  • Avoid prolonged exposure to sunlight or sun lamps while taking JAMP Acitretin. Use protective clothing or hat or sunscreen with SPF 30 or more. JAMP Acitretin may make your skin more sensitive to UV light.
  • Avoid cosmetic procedures that smooth your skin (such as waxing, dermabrasion or laser procedures), while taking JAMP Acitretin and for a period of time after stopping. JAMP Acitretin may cause scarring or inflammation of the skin from these procedures. Check with your healthcare professional for advice about when you can have cosmetic procedures.
  • Avoid the use of anti-acne agents that exfoliate your skin since it can irritate your skin.
  • You should use a skin moisturizing ointment or cream and a lip balm while taking JAMP Acitretin. This is because JAMP Acitretin can make your skin and lips dry.

• Check-ups and testing

  • You will have regular visits with your healthcare professional during your treatment with JAMP Acitretin. They will:

    • Do blood tests to check blood lipid levels (cholesterol, triglycerides), sugar levels and liver health.
    • Assess you for mood changes.
    • Examine you for signs of bone abnormalities and vision problems.
  • In female patients, your healthcare professional will ask you to have pregnancy tests before treatment with JAMP Acitretin and regularly during and after treatment. During treatment, a pregnancy test is needed every 28 days. After stopping treatment, pregnancy tests must be done every 1-3 months for 3 years after your last dose.

• Driving and using machinery

  • JAMP Acitretin may change your vision and ability to drive at night. Be cautious when driving any vehicles or doing tasks that require special attention, especially at night.

• Children (younger than 18 years of age)

  • You should not take JAMP Acitretin if you are younger than 18 years of age.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious Drug Interactions:

The following may also interact with JAMP Acitretin:

• Phenytoin, medicine used to treat seizures
• Glyburide, or a sulfonylurea, medicines used to treat diabetes
• St John’s Wort
• Low dose birth control pills. Low dose birth control pills that contain progesterone only (mini pills) may not work while you are taking JAMP Acitretin.

How to take JAMP Acitretin:

• Always take JAMP Acitretin exactly as your healthcare professional tells you.

• Take by mouth once daily with food or after a meal.

Usual dose:

Your dose will depend on your medical condition and the recommendations of your healthcare professional. Your healthcare professional may change or stop your dose depending on how well JAMP Acitretin is working for you.

For severe psoriasis: starting dose of 25 mg once daily; maintenance daily dose from 25 mg to 50 mg; maximum daily dose of 75 mg.

For other disorders of keratinization: 10 mg once daily; maximum daily dose of 50 mg.

Overdose:

Missed Dose:

• If you miss a dose of JAMP Acitretin, take it as soon as you remember on the same day. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your regular time.
• Do NOT take a double dose to make up for a missed dose.

Serious drug interactions with JAMP Acitretin include:

• Vitamin A or retinoids.
• Methotrexate. Taking JAMP Acitretin with methotrexate may increase your risk of hepatitis.
• Tetracyclines. Taking JAMP Acitretin with tetracyclines may increase your risk of increased pressure in the skull (intracranial pressure).
• Alcohol. It converts acitretin to etretinate, a chemical that also causes birth defects and stays in the body longer.

If you think you, or a person you are caring for, have taken too much JAMP Acitretin, 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.

What are possible side effects from using JAMP Acitretin?

These are not all the possible side effects you may have when taking JAMP Acitretin. If you experience any side effects not listed here, tell your healthcare professional.

• Back pain, bone pain or muscle pain
• Brittle nails
• Bleeding or inflammation of the gums, or inflammation of the mucous lining of the mouth
• Chills, increased sensitivity to touch
• Dry eyes, particularly if you wear contact lenses
• Dry mouth, chapped lips, runny or dry nose
• Decreased or increased appetite
• Ear problems such as pain, wax build-up, or buzzing in the ear
• Eye problems such as light sensitivity, pain, impaired vision
• Hair loss or abnormal hair texture. Whether all your hair will return to normal after treatment cannot be predicted
• Infections, including skin around the fingernail
• Inflammation along the edge of the eyelid (blepharitis), inflammation or infection of the membrane lining the eyelids (conjunctivitis)
• Nose bleeds
• Skin problems such as cold sweat, excessive sweating, sensitivity to sunlight, inflamed, ulcerated, and oily or cracked skin
• Tiredness, pain, thirst
• Trouble sleeping

Serious side effects and what to do about them

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:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

Storage:

• Store at 15-25^oC. Protect from heat and light. The product is sensitive to moisture, keep in original packaging.
• Keep out of reach and sight of children.
• Do not use after the expiry date (EXP) shown on the packaging.

If you want more information about JAMP Acitretin:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091.

• Important safety information about JAMP Acitretin and the JAMP Acitretin Pregnancy Prevention Program is also available from www.jampinfo.com or by calling the toll-free number

  1-866-399-9091.

1310 rue Nobel

Boucherville, Québec

J4B 5H3, Canada

Last revised: FEB 6, 2026