Details for: MINT-ACITRETIN
Company: MINT PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02468840 | MINT-ACITRETIN | ACITRETIN | 10 MG | CAPSULE | ORAL |
| 02468859 | MINT-ACITRETIN | ACITRETIN | 25 MG | CAPSULE | ORAL |
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
MINT-ACITRETIN (acitretin) is used in the treatment of:
- Severe psoriasis
- Other disorders of keratinization in adult patients who have not responded to standard treatments.
What it does
MINT-ACITRETIN (acitretin) is a retinoid. It works by leading to a more normal pattern of growth for skin cells.
When it should not be used
MINT-ACITRETIN can cause severely deformed
babies. In order to take this drug, a female patient
must use an effective birth control method 4 weeks
before the start of treatment, during treatment and
until at least 3 years after the last dose of MINT-ACITRETIN .
Do not consume alcohol during the treatment and until
at least 2 months after the last dose of MINT-ACITRETIN .
Do not breastfeed during treatment and until at least
3 years after the last dose of MINT-ACITRETIN
Do not use MINT-ACITRETIN if you:
- Are allergic to acitretin, or other retinoids, or Vitamin A, or its metabolites, or any of the other ingredients in MINT-ACITRETIN
- Are pregnant or plan to get pregnant
- Are breastfeeding
- Have severe liver or kidney disease
- Have consistent high blood lipid levels
- Take tetracyclines
- Take methotrexate
- Have high vitamin A levels (hypervitaminosis A)
Information for the patient (male and female):
MINT-ACITRETIN can cause severely deformed babies
if it is taken by a female before or during pregnancy and
for at least 3 years after stopping
What the medicinal ingredient is
Acitretin
What the non-medicinal ingredients are
maltodextrin, cellulose microcrystalline, sodium ascorbate, disodium edetate, poloxamer 407, gelatin, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide, shellac glaze~45%, propylene glycol
What dosage form it comes in
Each MINT-ACITRETIN capsule contains either 10 mg or 25 mg of acitretin.
Warnings and precautions
Serious Warnings and Precautions
You must avoid becoming pregnant while you are taking
MINT-ACITRETIN and until at least 3 years after you stop
taking MINT-ACITRETIN (discuss this with your doctor).
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 MINT-ACITRETIN ;
- while you are taking MINT-ACITRETIN; and
- for at least 3 years after you stop taking MINT-ACITRETIN (discuss this with your doctor); and
- bearing 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 (Micronor 28) may not be an effective method to prevent pregnancy during treatment with MINT-ACITRETIN and is not recommended for use.
Do not take MINT-ACITRETIN until you are sure that you are not pregnant:
- You must have 2 negative pregnancy tests before you start MINT-ACITRETIN. The first test (with a negative result) is obtained at screening when MINT-ACITRETIN treatment is under consideration. A second (confirmatory) test (with a negative result) must be obtained not older than 3 days before the first dose.
- You must wait until the second or third day of your next menstrual period before you start MINT-ACITRETIN.
- During treatment, you must have a pregnancy test at 28- day intervals. A negative pregnancy test, from a licensed laboratory, not older than 3 days is mandatory before you can receive another prescription for MINT-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
MINT-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 MINT-ACITRETIN.
Contact your doctor immediately if you do become
pregnant while taking MINT-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 MINT-ACITRETIN ,
as well as available options, with your
doctor.
Do not breastfeed while taking MINT-ACITRETIN and
until at least 3 years after the treatment has stopped.
Male and female patients should avoid consuming alcohol
while taking MINT-ACITRETIN and until least 2 months
after the treatment has stopped.
Male and female patients should not donate blood
while taking MINT-ACITRETIN and until at least 3
years after the treatment has stopped.
You should have been counselled using the manufacturer’s MINT-ACITRETINPregnancy 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 MINT-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 MINT-ACITRETIN
Pregnancy Prevention Program, please contact the marketing
agent for Canada, Mint Pharmaceuticals Inc. Medical Safety
Information Line at (toll-free) 1-877-398- 9696.
Before taking MINT-ACITRETIN, talk to your doctor if
you have any of the following conditions:
- high cholesterol or triglycerides
- high blood sugar
- liver or kidney problems
- mood changes
- skin problems
- high pressure in the brain (intracranial hypertension)
- eye problems or wear contact lenses. MINT-ACITRETIN may cause dry eyes, light sensitivity, or other eyes problems.
While taking MINT-ACITRETIN you should avoid prolonged
exposure to sunlight or sun lamps. Use protective clothing or
hat or sunscreen with SPF 30 or more.
MINT-ACITRETIN is not recommended for use in children.
Interactions with this medication
Before taking MINT-ACITRETIN tell your doctor or pharmacist about all other medications you take including medications that you bought without prescription, vitamins, and natural products. Particularly if you are taking the following:
- Vitamin A
- Methotrexate
- Tetracyclines, phenytoin
- Glyburide, or a sulfonylurea
- St John’s Wort
- Alcohol because it can convert MINT-ACITRETN to etretinate, a chemical that also causes birth defects and stays in the body longer.
- Low dose of progesterone-only contraceptive (Micronor 28)
Proper use of this medication
You should take MINT-ACITRETIN as told by your doctor.
Usual dose
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
Take MINT-ACITRETIN once daily with food or after a meal.
OVERDOSE
MISSED DOSE:
If you miss a dose, take it as soon as you remember on the same day. Skip that dose if you do not remember until the next day.
Side effects and what to do about them
Side effects and what to do about them:
The first few weeks before you begin to see any healing, you
may begin to have some side effects.
Side effects of MINT-ACITRETIN include the following:
Very common:
Dry eyes, particularly if you wear contact lenses; Dry mouth,
chapped lips, runny or dry nose;
Dry skin, peeling of fingertips and/or palms and soles,
itchiness, rash, sticky skin, brittle nails;
Chills, joint pain, increased sensitivity to touch.
Most patients experience some degree of hair loss or
abnormal hair texture but the condition varies among
patients. The extent of hair loss that you may experience and
whether or not all your hair will return to normal after
treatment cannot be predicted.
Common:
Nosebleeds;
Ear problems such as pain, wax build-up, or buzzing in the
ear;
Eye problems such as blurred vision, light sensitivity, pain,
impaired vision;
Inflammation along the edge of the eyelid (blepharitis),
inflammation or infection of the membrane lining the eyelids
(conjunctivitis);
Tiredness, pain, thirst;
Swelling of leg, foot, ankle (oedema);
Bleeding or inflammation of the gums, or inflammation of
the mucous lining of the mouth;
Nausea or abdominal pain;
Infections, including skin around the finger nail; Decreased
or increased appetite;
Back pain, bone pain or muscle pain; Headache, trouble
sleeping;
Skin problems such as cold sweat, excessive sweating,
sensitivity to sunlight, inflamed, ulcerated, and oily or
cracked skin.
Uncommon:
Decrease in night vision, or other eye problems, impaired
hearing.
These are not all the possible side effects of MINT-ACITRETIN .
For more information, ask your prescriber or
pharmacist.
SERIOUS SIDE EFFECTS:
Seek emergency treatment, if you experience any of the
following symptoms:
- Shortness of breath, dizziness, nausea, chest pain, weakness or trouble speaking as these can be signs of a heart attack, or stroke.
- Swelling of a leg, foot, ankle or arm as these can be signs of a blood clot.
- Worsening depression, suicidal thoughts or thoughts of self-harm.
OTHER SERIOUS SIDE EFFECTS:
- Headaches, abdominal pain, diarrhea, rectal bleeding, nausea, vomiting, blurred vision, other visual problems.
- Decrease in night vision.
- Persistent feeling of dry eyes
- Yellowing of the skin or eyes and/or dark urine, flu-like symptoms.
Aches or pains in bones or joints, or difficulty in moving. Bone changes have been detected by X-ray examination in patients taking acitretin. The extent of any harm from these changes is not presently known.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Abdominal pain | ✔ | ||
| Diarrhea | ✔ | ||
| Headache | ✔ | ||
| Nausea | ✔ | ||
| Vomiting | ✔ | ||
| Fragile skin | ✔ | ||
| Hair loss | ✔ | ||
| Inflamed lips | ✔ | ||
| Itching | ✔ | ||
| Peeling of Fingertips | ✔ | ||
| Peeling skin all over the body | ✔ | ||
| Redness or Rash | ✔ | ||
| Sticky Skin | ✔ | ||
| Uncommon | |||
| Blurred vision, | ✔ | ||
| Dizziness | ✔ | ||
| Persistent feeling of dry eyes | ✔ | ||
| Yellowing of the skin or eyes and/or flu-like symptoms and/or dark urine | ✔ | ||
| Shortness of breath, | ✔ | ||
| Weakness | ✔ | ||
| Nausea | ✔ | ||
| Dizziness | ✔ | ||
| Chest Pain, | ✔ | ||
| Trouble Speaking, | ✔ | ||
| Swelling of a leg, ankle, foot or arm | ✔ | ||
| Rare/Very Rare | |||
| Decreased night vision | ✔ | ||
| Impaired Hearing | ✔ | ||
| Aches or Pain in Joints or Difficulty Moving | ✔ | ||
| Rectal bleeding | ✔ | ||
| Changes in Mood/ depression, | ✔ | ||
| Thoughts of suicide | ✔ | ||
| Aggressive behaviour | ✔ | ||
| Unknown frequency | |||
| Allergic reactions: Rash, hives, itching, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing | ✔ | ||
| Capillary leak syndrome: Sudden swelling in one part or all over your body, weight gain, fever, lightheadedness, feeling faint or muscle aches | ✔ | ||
| Exfoliative dermatitis: Red, swollen, itchy, painful or peeling skin. It can begin in a small area and then spread over large areas of your body. | ✔ | ||
| Madarosis: Eyelash and sometimes eyebrow loss | ✔ | ||
This is not a complete list of side effects. For any unexpected
effects while taking MINT-ACITRETIN contact your doctor
or pharmacist.
THIS SUMMARY DOES NOT CONTAIN ALL KNOWN
INFORMATION ABOUT MINT-ACITRETIN. TALK TO
YOUR DOCTOR IF YOU HAVE ANY QUESTIONS.
How to store
Store at 15-30°C. Protect MINT-ACITRETIN capsules from
sunlight, heat and humidity. Store in original package. MINT-ACITRETIN
does not need to be refrigerated. MINT-ACITRETIN
should not be used after the expiry date (EXP)
shown on the package.
Keep MINT-ACITRETIN and all medications out of the
reach of children.
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.
More information
This document plus the full product monograph, prepared for
health professionals can be found by contacting the sponsor,
Mint Pharmaceuticals Inc. at: 1.877.398.9696 or
www.mintpharmaceuticals.com
This leaflet was prepared by:
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit 1,
Mississauga, Ontario
L5T 1J6
Date of Preparation: October 4, 2017