Soriatane

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Soriatane (Acitretine). If you are concerned about side effects, discuss the risks and benefits of Soriatane (Acitretine) with your doctor.

When acitretin is first started, you may experience more redness, itching, skin scaling, peeling, and dry skin for the first month as your body adjusts to the medication. This will normally fade as treatment continues. It is important that you see your doctor regularly (preferably once a month) and report any side effects that become bothersome.

The following side effects have been reported by at least 1% of people taking Soriatane (Acitretine). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• abnormal hair texture
• back pain
• change in appetite
• cold or clammy skin
• Diarrhea
• dry eyes
• Dry Mouth, chapped lips (especially in the first few weeks)
• dry skin
• earache
• fatigue
• fluid retention
• gum swelling or bleeding
• hair loss (especially in the first few weeks)
• headache
• impotence
• increased appetite
• increased saliva
• increased sweating
• infection
• inflammation around the fingernails
• Insomnia (difficulty sleeping)
• itchiness (especially in the first few weeks)
• mouth sores
• muscle pain
• nail disorders
• nausea
• nervousness
• nosebleeds
• numbness
• rash
• rhinitis (runny nose)
• ringing in the ears
• sensitivity of skin or eyes to light
• skin peeling or scaling (especially in the first few weeks)
• skin ulcers
• sore joints
• sticky skin
• taste disturbances
• thirst

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal vision
• aches or pains in bones or joints
• Arthritis
• bleeding or inflammation of the gums
• blurred vision
• dark urine
• decrease in night vision
• difficulty in moving
• eye irritation
• eye pain
• eye sensitivity to light
• flu-like symptoms
• Headaches
• hearing problems
• nausea (severe)
• other visual problems
• persistent feeling of dry eyes
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• vomiting
• yellowing of the skin or eyes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of a Heart Attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with Fever or discomfort
• signs of Stroke (e.g., sudden headache, weakness or numbness in an arm or leg, difficulty speaking or understanding, sudden vision difficulty, dizziness)
• signs of retinoic acid syndrome (e.g., fever, shortness of breath, swelling or puffiness of the arms, legs and feet, weight gain, difficulty in urination, yellowing of the skin or eyes)

10 mg
Each brown and white, hard gelatin capsule (No. 4) with "ACTAVIS" in black lettering contains acitretin 10 mg. Nonmedicinal ingredients: gelatin, glucose (liquid, spray-dried), microcrystalline cellulose, and sodium ascorbate; gelatin capsule shell: iron oxide (yellow, black, and red) and titanium dioxide.

25 mg
Each brown and yellow, hard gelatin capsule (No. 1) with "ACTAVIS" in black lettering contains acitretin 25 mg. Nonmedicinal ingredients: gelatin, glucose (liquid, spray-dried), microcrystalline cellulose, and sodium ascorbate; gelatin capsule shell: iron oxide (yellow, black, and red) and titanium dioxide.

Do not take acitretin if you:

• are allergic to acitretin, vitamin A, or any of the ingredients of the medication
• have certain types of abnormal cholesterol levels
• have excess vitamin A in the body
• have severely reduced kidney or liver function
• are taking Methotrexate or tetracyclines

A woman capable of becoming pregnant must not take acitretin unless ALL of the following criteria are met:

• She is able to use 2 effective birth control methods.
• She is reliable in understanding and carrying out instructions.
• She has had 2 negative pregnancy tests before the start of treatment (the first at the screening appointment and the second up to 3 days before the first dose of acitretin).
• She will have pregnancy tests at 28-day intervals throughout treatment.
• She has received and understands information regarding the risks of having babies with deformities associated with acitretin exposure.
• She has severe psoriasis or other severe skin disease, as judged by the doctor.
• She will have pregnancy tests every 1 to 3 months for at least 3 years after the last dose of acitretin.

Acitretin must not be taken by pregnant women. As well, women must not become pregnant while taking acitretin and should use effective birth control for at least 3years after stopping Soriatane (Acitretine). Women should not breast-feed while taking acitretin or for 3 years after stopping the medication.

Alcohol must not be consumed while taking acitretin and for 2 months after stopping the treatment.

There may be an interaction between acitretin and any of the following:

• alcohol
• any medications or products containing vitamin A (including multivitamins)
• any medications or products related to vitamin A
• Carbamazepine
• methotrexate
• Phenytoin
• progestin-only birth control
• sulfonylureas (e.g., Glyburide)
• tetracyclines (e.g., Tetracycline, doxycycline, Minocycline)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Soriatane (Acitretine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Soriatane (Acitretine).

Alcohol: Alcohol must not be consumed while taking acitretin and for 2 months after stopping the treatment. This includes alcohol in foods, drinks, and medicines.

Benign intracranial hypertension: Acitretin has been known to cause a condition called benign intracranial hypertension. Contact your doctor if you experience headaches, nausea and vomiting, or changes in vision.

Blood donation: Do not donate blood while taking acitretin and for at least 3 years after your last dose of acitretin, as your blood should not be given to pregnant women.

Cholesterol: Acitretin has been found to cause an increase in cholesterol and other lipids in the blood. You are more likely to experience this if you are already at an increased risk of developing High Cholesterol, for example if you have Diabetes or a family history of high cholesterol, are overweight, or have an increased alcohol intake.

If you are at any increased risk of developing increased blood lipids, discuss with your doctor how Soriatane (Acitretine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soriatane (Acitretine), and whether any special monitoring is needed.

Contact lenses: If you wear contact lenses, you may find them uncomfortable during and after treatment with acitretin due to dry eyes.

Decreased night vision: Acitretin may cause decreased night vision. Do not drive or operate heavy machinery at night until you know how Soriatane (Acitretine) affects you.

Depression and suicidal thoughts: Retinoid medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Soriatane (Acitretine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soriatane (Acitretine), and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, or notice them in a family member who is taking Soriatane (Acitretine), contact your doctor as soon as possible.

Diabetes: Acitretin can cause changes in glucose tolerance for people with diabetes. If you have diabetes, discuss with your doctor how Soriatane (Acitretine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soriatane (Acitretine), and whether any special monitoring is needed.

Excessive bone growth: Long-term use of acitretin may lead to excessive bone growth or unusual bone formation. Your doctor may request that you have yearly X-rays to monitor for bone changes.

Liver function: Retinoids like acitretin have been linked to inflammation of the liver in some cases. If you have liver problems, discuss with your doctor how Soriatane (Acitretine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Soriatane (Acitretine).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor as soon as possible.

Stomach and bowels: Other retinoid medications have occasionally caused inflammatory bowel disease (IBD). If you have inflammatory bowel disease, discuss with your doctor how Soriatane (Acitretine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soriatane (Acitretine), and whether any special monitoring is needed.

If you experience severe abdominal pain, rectal bleeding or severe diarrhea, you should stop using Soriatane (Acitretine) and contact your doctor.

Sun sensitivity: Acitretin may make you more likely to burn in the sun. Use appropriate measures to prevent excessive exposure to the sun. Wear a hat and sunglasses when out in the sun, use a sunscreen with an SPF of 30 or higher, and avoid going out in the sun between 10 am and 2 pm when the sun is at its strongest. Avoid using sun lamps and tanning beds.

Women capable of becoming pregnant: See "Who should not take Soriatane (Acitretine)?"

Pregnancy: Acitretin can cause birth defects. Soriatane (Acitretine) must not be taken during pregnancy. If you become pregnant while taking acitretin, contact your doctor immediately.

Breast-feeding: Soriatane (Acitretine) passes into breast milk. If you are a breast-feeding mother and are taking acitretin, it may affect your baby. Breast-feeding mothers must not take Soriatane (Acitretine).

Children: The safety and efficacy of using Soriatane (Acitretine) have not been established for children.