Each capsule contains:

Active Ingredients	Amount
Isotretinoin	20 mg

Take as prescribed by the doctor.

Isotretinoin administration may initially worsen acne, but with continued use, it gradually alleviates acne.

This medication should be administrated with a meal and a full glass of water.

If you experience dry mouth, use sugar-free lozenges.

Capsules should be swallowed whole; do not crush or chew the capsule.

Packaging and Dosage Form:

Each box contains 30 Licap^® capsules.

Therapeutic and pharmacological effects:

One of the common skin conditions is acne, which occurs when skin pores become blocked with dead skin cells and oil, leading to the accumulation of bacteria. This results in swelling, inflammation, redness, and the formation of pimples. Isotretinoin, a derivative of vitamin A and part of the retinoid family, is taken orally to treat severe acne in individuals who do not respond to standard treatments. This medication reduces the production of sebum (a sticky, oily substance produced by sebaceous glands that is found in the middle layers of the skin, near hair follicles, helping to keep the skin fresh and moisturized) and decreases bacterial activity, thereby improving inflammation and acne.

Side effects:

Common side effects (>10%): Increased triglycerides and decreased HDL, elevated serum creatine phosphokinase, elevated liver enzymes, back pain, joint pain, and dryness of the mouth and nose.

Uncommon side effects (1-10%): Elevated serum cholesterol, decreased bone mineral density.

Rare: Aggression, anxiety, depression, dizziness, fatigue, insomnia, seizures, voice changes, blurred vision, eye sensitivity, cataracts, corneal opacity, decreased night vision, reduced tolerance to contact lenses, photophobia, tinnitus, chest pain, edema, hot flashes, palpitations, thrombosis, fulminant acne, hair loss, contact dermatitis, eczema, photosensitivity, skin rash, hives, decreased libido, hirsutism, increased LDL, increased blood glucose, increased blood urea, menstrual issues, weight loss, abdominal pain, constipation, diarrhea, decreased appetite, gum inflammation, IBD, pancreatitis, vomiting, long-term bone changes, calcification of tendons and ligaments with prolonged use, glomerulonephritis.

Drug interactions:

Avoid concurrent use of isotretinoin with hormonal contraceptives, other supplements containing vitamin A, or tetracyclines (demeclocycline, doxycycline, minocycline, oxytetracycline and tetracycline), as well as other topical acne treatments.

Other drug interactions: Tobramycin inhalation, mifepristone, methotrexate, cannabidiol, calcium, carbamazepine, ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, ofloxacin, ketoconazole, Levoketoconazole, leflunomide, tretinoin, corticosteroids (methylprednisolone, hydrocortisone, cortisone, betamethasone, dexamethasone, triamcinolone and…), phenytoin, fosphenytoin, benzoyl peroxide, azelaic acid, drospirenone, fenofibrate, lenacapavir, letermovir, remdesivir, medroxyprogesterone, naltrexone, nevirapine, methoxsalen, and warfarin.

Inform your doctor or pharmacist if you are taking any other medications (prescription or over-the-counter) or herbal supplements.

Warnings and precautions:

Liver function and blood lipid levels should be monitored before starting treatment, one month after the start of treatment, and every three months during treatment. Treatment may be reduced or discontinued if there is an increase in blood lipid levels or liver enzymes.

If neutropenia and agranulocytosis (rare), hearing disturbances, tinnitus, or severe allergic reactions occur, discontinue the medication and consult your doctor.

During treatment and for at least 6 months after completing the treatment, waxing, mole surgery, and skin laser treatments are prohibited.

During treatment, avoid exposure to UV light (including sunlight) and use sunscreen lotions and creams.

If you experience dry mouth, use sugar-free lozenges; for dry eyes, use artificial tears; for dry skin, use a moisturizer; and for dry lips, use lip balm.

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue your treatment as usual.

Do not recommend this medication to others.

This medication is highly teratogenic and may cause fetal harm. Due to the potential for absorption through the skin, pregnant women should avoid even touching the capsules.

Ensure that you are not pregnant before starting treatment.

Avoid donating blood during treatment and for at least one month after using this medication.

Consult your doctor or pharmacist before using this medication if you have any of the following conditions:

Diabetes, dry eye syndrome, a history of depression or being evaluated for depression, a history of kidney stones, fluctuations in blood glucose levels, elevated blood pressure, dry skin, or a history of kidney disorders. If you experience symptoms of psychiatric disorders such as depression, anxiety, or suicidal thoughts, immediately contact your doctor.

Use of this medication may potentially affect your ability to drive or operate machinery. In rare cases, night vision impairment has been reported. Drowsiness, dizziness, and visual disturbances are very rare. If you experience drowsiness or dizziness, avoid driving or operating machinery.

Contraindications:

Individuals who are allergic to isotretinoin or other vitamin A derivatives, peanut or soya; have liver failure, high blood lipid levels (such as high cholesterol or triglycerides), elevated serum vitamin A levels, diabetes, alcohol abuse, or bone disorders such as osteomalacia (soft bones) or osteoporosis; or are under 12 years of age should avoid using this product.

Concurrent use of this medication with the following drugs is contraindicated: Tetracycline, demeclocycline, doxycycline, minocycline, and oxytetracycline.

If you experience any signs of allergic reactions, including shortness of breath, or swelling of the face, tongue, or lips, immediately inform your doctor.

It is contraindicated (except for special cases) in people who have the following medical problems:

This medication is strictly contraindicated in pregnant or breastfeeding women.

Women of childbearing age should use reliable contraception methods (preferably two methods simultaneously) starting one month before treatment, during treatment, and for one month after completing treatment.

Pregnancy and Breastfeeding:

This medication is strictly contraindicated in pregnant or breastfeeding women.

Women of childbearing age should use reliable contraception methods (preferably two methods simultaneously) starting one month before treatment, during treatment, and for one month after completing treatment.

Storage conditions:

Store at temperatures below 25°C, away from light, and moisture, and out of reach of children.