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Details for: TARO-ACITRETIN

Company: TARO PHARMACEUTICALS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02466074TARO-ACITRETINACITRETIN10 MGCAPSULEORAL
02466082TARO-ACITRETINACITRETIN25 MGCAPSULEORAL
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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

Taro-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

Taro-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
Taro-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 Taro-Acitretin.

Do not consume alcohol during the treatment and until at least 2 months after the last dose of Taro-Acitretin.

Do not breastfeed during treatment and until at least 3 years after the last dose of Taro-Acitretin.
  • Are allergic to acitretin, or other retinoids, or Vitamin A, or its metabolites, or any of the other ingredients in Taro-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):

Taro-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

Ammonium hydroxide, Gelatin, Iron oxide black, Iron oxide red, Iron oxide yellow, Maltodextrin, Microcrystalline cellulose, Potassium hydroxide, Propylene glycol, Shellac, Sodium lauryl sulfate, Sorbic acid, and Titanium dioxide.

What dosage form it comes in

Each Taro-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 Taro-Acitretin and until at least 3 years after you stop taking Taro-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 Taro-Acitretin;
  • while you are taking Taro-Acitretin; and
  • for at least 3 years after you stop taking Taro-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 Taro-Acitretin and is not recommended for use.

Do not take Taro-Acitretin until you are sure that you are not pregnant:

  • You must have 2 negative pregnancy tests before you start Taro-Acitretin. The first test (with a negative result) is obtained at screening when Taro-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 Taro-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 Taro-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 Taro-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 Taro-Acitretin.

Contact your doctor immediately if you do become pregnant while taking Taro-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 Taro-Acitretin, as well as available options, with your doctor.

Do not breastfeed while taking Taro-Acitretin and until at least 3 years after the treatment has stopped.

Male and female patients should avoid consuming alcohol while taking Taro-Acitretin and until least 2 months after the treatment has stopped.

Male and female patients should not donate blood while taking Taro-Acitretin and until at least 3 years after the treatment has stopped.

You should have been counselled using the manufacturer’s Taro-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 Taro-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 Taro-Acitretin Pregnancy Prevention Program, please visit www.taro-acitretin.ca for important information or contact Taro Canada Customer Service at (toll-free) 1-800-268-1975.

Before taking Taro-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. Taro-Acitretin may cause dry eyes, light sensitivity, or other eye problems

While taking Taro-Acitretin you should avoid prolonged exposure to sunlight or sun lamps. Use protective clothing or hat or sunscreen with SPF 30 or more.

Taro-Acitretin is not recommended for use in children.

Interactions with this medication

Before taking Taro-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 Taro-Acitretin 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 Taro-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 Taro-Acitretin once daily with food or after a meal.

Overdose

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

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

The first few weeks before you begin to see any healing, you may begin to have some side effects.

Side effects of Taro-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 Taro-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, flulike symptoms.

Aches or pains in bones or joints, or difficulty in moving. Bone changes have been detected by X-ray examination in patients taking Taro-Acitretin. The extent of any harm from these changes is not presently known.

Serious side effects, how often they happen and what to do about them
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 behavior    
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 Taro-Acitretin contact your doctor or pharmacist.

THIS SUMMARY DOES NOT CONTAIN ALL KNOWN INFORMATION ABOUT TARO-ACITRETIN. TALK TO YOUR DOCTOR IF YOU HAVE ANY QUESTIONS.

How to store

Store at 15-25°C. Protect Taro-Acitretin capsules from heat, light and moisture. Store in original package. Taro-Acitretin does not need to be refrigerated. Taro-Acitretin should not be used after the expiry date (EXP) shown on the package.

Keep Taro-Acitretin and all medications out of the reach and sight of children.

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.

More information

This document plus the full product monograph, prepared
for health professionals can be found at:
www.taro.ca

or by contacting the sponsor,
Taro Pharmaceuticals Inc., at: 1-800-268-1975

Important safety information about Taro-Acitretin and Taro-Acitretin Pregnancy Prevention Program is also available from :

  • Online: www.taro-acitretin.ca

This leaflet was prepared by :
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1

TARO is a registered trademark of Taro Pharmaceuticals Inc.

Last prepared: July 07, 2017

Date modified: