Hanzema: Uses, Side Effects and Dosage

Bearing in mind that any method of birth control can fail.

• You must use two effective and complementary methods of birth control at the same time, even if you have a history of infertility or are not sexually active.
• Microdosed progesterone preparations (minipills) are not a suitable method of contraception during HANZEMA therapy.
• Do not take HANZEMA until you are sure that you are not pregnant.
• You must have two negative pregnancy tests at least 3 weeks apart before you start HANZEMA. Take pregnancy tests at doctor’s visits on a monthly basis while on the drug and take a pregnancy test at a doctor’s visit one month after stopping treatment with HANZEMA. If your menstrual period is abnormal in length and intensity, tell your doctor. You must wait until the second or third day of your next normal menstrual period before you start HANZEMA.
• Your doctor can write a prescription for no more than 30 days of treatment. A new prescription is needed for more treatment. Each new prescription must be started within 11 days from the last negative pregnancy test.
• Stop taking HANZEMA and contact your doctor immediately if you do become pregnant while taking HANZEMA 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 HANZEMA. You should also discuss the desirability of continuing with your pregnancy.
• Do not breastfeed while taking HANZEMA.
• Do not take the supplement St John's Wort (Hypericum perforatum) if you are taking an oral contraceptive. St. John's Wort (Hypericum perforatum) can interact with oral contraceptives and may decrease their effectiveness in preventing pregnancy.

You should have been counseled using the manufacturer’s Patient Information and Pregnancy Prevention Program which includes:

• Comprehensive information about the risks of this drug
• A checklist of criteria you had to meet before receiving this drug
• Detailed information on birth control options
• An acknowledgement form for you to review and sign

Advice for men taking HANZEMA

Very low amounts of alitretinoin are present in the semen of men taking HANZEMA, but too little to harm the unborn baby of your partner.

All patients should read the rest of this Consumer Information.

Do not take HANZEMA unless you completely understand its possible risks and are willing to follow all of the instructions in this Consumer Information.

BEFORE you use HANZEMA tell your doctor or pharmacist if:

• you have ever had any mental health problems, including depression, suicidal behaviour or psychosis, or if you take medicines for any of these conditions.
• you have high blood cholesterol or triglycerides or have a blood lipid (fats) disorder, risk of heart problems or are obese, you may need blood tests more often. If your blood cholesterol or triglycerides stay high, your doctor may lower your dose, or take you off HANZEMA.

• you have been suffering from thyroid disease.

  HANZEMA may lower your thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe supplements.

• you plan vigorous physical activity during treatment with HANZEMA.
• you have any food or drug allergies.
• you are taking any vitamin preparations or health food supplements that contain Vitamin A.
• what brand of contraceptives you are taking. There are certain types of contraceptives that should not be taken while on HANZEMA.
• you are taking an antibiotic (particularly tetracyclines).
• you have liver disease, kidney disease or high lipid levels in your blood
• you have diabetes. HANZEMA may increase blood sugar levels. Your doctor may request periodic tests for blood sugar levels during treatment, particularly if you already have diabetes or are overweight.

While taking HANZEMA:

• Do not donate blood while you take HANZEMA and for one month after stopping HANZEMA. If someone who is pregnant gets your donated blood, her baby may be exposed to HANZEMA and may be born with birth defects.
• Do not share HANZEMA with other people. It can cause birth defects and other serious health problems.
• Minimise your exposure to sunlight and avoid exposure to sun lamps. Your skin may become more sensitive to sunlight. Before you go out in the sun, use a sun protection product with a high protection factor (SPF 15 or higher).
• Cut down on intensive physical activity: HANZEMA can cause muscle and joint pain.
• If you develop dry eyes, contact your doctor as soon as possible. This can be helped by the application of a lubricating eye ointment or tear replacement drops. If you wear contact lenses and experience dry eyes you may need to wear glasses for the duration of HANZEMA treatment. Dry eyes and sight problems normally return to normal once treatment is stopped
• If you experience any problems with your sight, tell your doctor immediately. You should not drive or operate machinery. HANZEMA may need to be stopped and your sight monitored.
• If you get a persistent headache, nausea or vomiting

• (feeling or being sick) and blurred vision, these may be signs of a condition called benign intracranial hypertension. Stop taking HANZEMA immediately and contact your doctor as soon as possible.
• If you have bloody diarrhea, severe diarrhea, abdominal pain or rectal bleeding, stop taking HANZEMA immediately and contact your doctor as soon as possible.
• HANZEMA may change your liver enzyme levels, cholesterol or triglyceride levels, blood sugar levels or thyroid function. Your doctor will test these during treatment.
• If you have a rash, swelling of your face or mouth, difficulty breathing, or feel unwell, you may be allergic to the ingredients in HANZEMA. Contact your doctor immediately.
• If your mood changes, you feel sad, angry, or notice other emotional problems, contact your doctor immediately.

Tell your doctor or pharmacist about all the medicines you take or have taken recently, including non-prescription or herbal medicines.

Tell your doctor or pharmacist if:

• you are taking ketoconazole, fluconazole, or miconazole (medicines used to treat fungal infections). Your doctor may decide to adjust your dose of HANZEMA.
• you are taking gemfibrozil (a medicine which is used to lower cholesterol), diosmin (used to treat hemorrhoids) or oxandrolone (an anabolic steroid). Your doctor may decide to adjust your dose of HANZEMA
• you are taking St John’s Wort (a herb extract used to treat depression), protease inhibitors (used to treat HIV or hepatitis C) or any medicines for epilepsy or seizures. These may reduce how well the contraceptive pill works.
• you are taking methotrexate, which can increase the risk of liver toxicity when taken with retinoids (such as HANZEMA).

Don’t take HANZEMA with these medicines:

• vitamin A supplements or tetracyclines (a type of antibiotic). This increases the risk of side effects.
• other retinoid medicines, such as isotretinoin or tazarotene

HANZEMA is not recommended with amiodarone (a medicine that helps to regulate heart rate).

HANZEMA can also affect how some other medicines work. These include:

• paclitaxel (used to treat cancer),
• rosiglitazone or repaglinide (used to treat diabetes).

Tell your doctor if you are taking any of these.

• pharmacist for suitable eye drops. If you wear contact lenses and get dry eyes, you may need to wear glasses instead.
• Blood and circulation: flushing, high blood pressure, inflammation of blood vessels, swelling of the hands, lower legs and feet
• Muscle and joint pain: back pain, muscle pain, joint pain. High levels of muscle breakdown products in your blood if you exercise vigorously.
• Skin, nail and hair problems: dryness of the skin, especially of the lips and face, inflamed skin, redness of the skin, itchy skin, skin peeling, rash, dry skin eczema, itchy skin rash, hair loss, increased sensitivity of the skin to sunlight, nail disorders, abnormal hair texture (e.g. curling of the hair)
• Liver problems: raised liver enzymes seen in blood tests
• Sensory problems: dizziness, persistent noise in the ears
• General: nausea, vomiting, dry mouth, lack of energy (fatigue)
• Ear, nose and throat problems: nose bleeding
• Bone disorders: extra growth of bone, including the spine disorder ankylosing spondylitis
• Stomach problems: indigestion
• Vision: blurred, distorted vision, difficulty seeing at night. If you suffer these problems, do not drive or operate machinery until these symptoms have passed. If vision problems persist, contact your doctor and your doctor may stop HANZEMA treatment and may refer you to an eye specialist.

Side effects of other medicines in the same family of medications as HANZEMA.

The following effects haven’t yet been seen in HANZEMA but have occurred in this product class and may occur.

• Diabetes

  Excessive thirst; frequent need to urinate; blood tests show an increase in your blood sugar.

• Bone disorders

  Arthritis; bone disorders (delayed growth, changes to bone density); growing bones may stop growing.

• Visual disorders

  Colour blindness and colour vision gets worse.

Depression and other mental problems including sad or empty mood, mood changes, tearfulness, and emotional disorder.

Some people have had thoughts about harming themselves or ending their lives, have attempted suicide or committed suicide. These people may not appear to be depressed. Your doctor can arrange help.

You should tell a family member or close friend that you can become depressed, or have significant changes in mood or behaviour, and ask them to read this leaflet. You might ask them to look after you.

Severe allergic reaction including swelling of the face or mouth causing difficulty in breathing (angioedema), raised and itchy rash (hives).

Immune reaction including vasculitis (swelling of the blood vessel) with symptom such as bruises and red patches.

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Benign Intracranial Hypertension

Lasting headache along with feeling sick (nausea), being sick (vomiting), and changes in your eyesight including blurred vision.

Stomach disorders

Severe abdominal (tummy) pain, with or without bloody diarrhea, feeling sick (nausea) and being sick (vomiting). These can be signs of serious abdominal conditions.

• Keep out of the sight and reach of children
• HANZEMA should be stored between 15° to 30°C. Store in the original carton to protect from light. Do not freeze.
• Return any unused capsules to your pharmacist at the end of treatment

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.