Isotretinoin Orion

This medicine treats severe acne that hasn't improved with other treatments.

Form
kapseli, pehmeä
Strength
20 mg
Active Ingredient
Isotretinoin
Manufacturer
Pharmathen S.A.

How to Use

Dosage

Your doctor will tell you how much to take. It usually starts at 0.5 mg for each kilogram of your body weight per day. Most people take between 0.5 and 1.0 mg per kilogram per day.

Method

Take the capsules once or twice a day with food or a drink. Swallow them whole.

Important

The doctor will decide your maximum daily dose, usually up to 1.0 mg per kilogram of body weight per day.

Possible Side Effects

COMMON
  • Dry skin, especially on lips and face; skin inflammation; chapped and inflamed lips; rash; mild itching and some peeling.
  • Skin becomes more fragile and redder than usual, especially on the face.
  • Back pain; muscle pain; joint pain, especially in children and teenagers.
  • Eye inflammation (conjunctivitis) or eyelid inflammation. Eyes feel dry and irritated.
  • High liver enzyme levels shown in blood tests.
  • Changes in blood fat levels (e.g., HDL cholesterol or triglycerides).
  • Increased tendency for bruising, bleeding, or blood clotting (if blood cells affecting clotting are affected).
  • Anemia (low red blood cells) – causing weakness, dizziness, pale skin.
  • Headache.
  • High cholesterol levels in blood.
  • Protein or blood in urine.
  • Increased risk of infections (if white blood cells are affected).
  • Dry and crusty nasal lining, possibly causing mild nosebleeds; sore and inflamed throat and nose.
  • Allergic reactions such as rash and itching.
RARE
  • Hair loss (alopecia). This is usually temporary, and hair should return to normal after treatment.
  • Depression or similar mood disorders. Signs include feeling sad, mood changes, anxiety, or emotional difficulties.
  • Worsening depression.
  • Violent or aggressive behavior.
  • Severe allergic reactions: sudden swelling of the throat, face, lips, and mouth causing difficulty breathing or swallowing. Also sudden swelling of the hands, feet, and ankles.
  • Thoughts of harming oneself or suicide attempts.
  • Abnormal behavior.
  • Psychosis: loss of touch with reality, such as hearing or seeing things that are not there.
  • Sudden chest tightness, shortness of breath, and wheezing (especially if you have asthma).
  • Yellow skin or eyes, feeling tired. These can be signs of hepatitis (liver inflammation).
  • Difficulty urinating, swollen eyelids, extreme tiredness. These can be signs of kidney inflammation.
  • Ongoing headache with nausea, vomiting, and vision changes like blurred vision. These can be signs of increased pressure in the brain, especially if taken with tetracycline antibiotics.
  • Severe stomach pain, with or without bloody diarrhea, nausea, and vomiting. These can be signs of serious bowel disease.
  • Blurred vision.
  • Worsened night vision; color blindness and impaired color vision.
  • Increased sensitivity to light; you may need sunglasses to protect your eyes from bright sunlight.
  • Other vision problems, such as blurred vision, distorted vision, or clouding of the cornea (cataracts).
  • Increased thirst, frequent urination, blood tests showing high blood sugar. These can be signs of diabetes.
  • Acne symptoms may worsen during the first few weeks, but usually get better over time.
  • Inflamed, swollen, and darker skin than usual, especially on the face.
  • Excessive sweating or itching.
  • Joint inflammation, bone changes (delayed growth, excessive growth, changes in bone density), growing bones may stop growing.
  • Calcium deposits in soft tissues, tendon pain, high levels of muscle breakdown products in blood if you exercise heavily.
  • Bacterial infections at the nail root, nail changes.
  • Swelling, pus formation.
  • Thickened scars after surgery.
  • Increased body hair.
  • Seizures, drowsiness, dizziness.
  • Swollen lymph nodes.
  • Dry throat, hoarseness.
  • Hearing difficulties.
  • General feeling of being unwell.
  • High uric acid levels in blood.
  • Bacterial infections.
  • Blood vessel inflammation (sometimes with bruising, red spots).
  • Dark or cola-colored urine.
  • Erectile dysfunction.
  • Decreased sexual desire.
  • Breast enlargement with or without tenderness in men.
  • Vaginal dryness.
  • Sacroiliitis, a type of inflammatory back pain causing pain in the buttocks or lower back.
  • Urethritis (inflammation in the urethra).
  • Severe skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), possibly life-threatening.
  • Muscle weakness (potentially deadly), difficulty moving arms/legs; painful, swollen, bruised areas; dark urine; reduced or stopped urination; confusion; dehydration. These can be signs of rhabdomyolysis (muscle tissue breakdown leading to kidney failure).

Important Warnings

  • This medicine can seriously harm an unborn baby. Women must use effective birth control. Do not use if you are pregnant or think you might be pregnant.
  • Tell your doctor if you have ever had mental health problems, including depression, aggression, mood swings, or thoughts of harming yourself.
  • Stop taking the medicine and contact your doctor immediately if you develop a severe skin rash, such as widespread blistering or peeling skin.
  • Reduce intense exercise and physical activity, as this medicine can cause muscle and joint pain, especially in children and teenagers.
  • Isotretinoin has been linked to inflammatory bowel disease. If you get severe bloody diarrhea and have not had bowel problems before, your doctor may stop the treatment.
Show 3 more warnings
  • This medicine can cause dry eyes, contact lens irritation, and vision problems, including poor night vision. Tell your doctor if you experience any of these symptoms.
  • Do not donate blood during treatment or for one month after treatment, as your blood could harm an unborn baby if given to a pregnant woman.
  • Never give this medicine to anyone else.