Packaging and pharmaceutical form

Each box contains 30 capsules.

Therapeutic effects and pharmacology:

One of the most common skin problems is acne, which occurs when skin pores become blocked with dead skin cells and sebum. Bacteria accumulate in these areas, leading to swelling, inflammation, redness, and the formation of pimples.
Isotretinoin, a derivative of vitamin A and part of the retinoid family, is used orally to treat severe acne in individuals who do not respond to conventional treatments. This medication reduces sebum production (a sticky, oily substance produced by sebaceous glands and located in the middle layers of the skin near hair follicles to maintain skin hydration and vitality) and decreases bacterial activity, thereby improving inflammation and acne.

Side effects:

Adverse effects with a likelihood of over 10%: increased triglycerides and decreased HDL, elevated serum creatine phosphokinase, increased liver enzymes, back pain, joint pain, dry mouth and nose.
Adverse effects with a likelihood of 1% to 10%: elevated serum cholesterol, reduced bone mineral density.

Rare complications:

Aggression, anxiety, depression, dizziness, fatigue, insomnia, seizures, voice changes, blurred vision, eye sensitivity, cataracts, corneal opacity, reduced night vision, decreased contact lens tolerance, photophobia, tinnitus, chest pain, edema, hot flashes, palpitations, thrombosis, fulminant acne, hair loss, contact dermatitis, eczema, photosensitivity, skin rash, urticaria, decreased libido, hirsutism, increased LDL, elevated blood glucose, increased blood urea, menstrual irregularities, weight loss, abdominal pain, constipation, diarrhea, reduced appetite, gum inflammation, inflammatory bowel disease (IBD), pancreatitis, vomiting, long-term bone changes, calcification of tendons and ligaments with long-term use, glomerulonephritis, and more…

Drug interactions:

Avoid using isotretinoin simultaneously with hormonal contraceptives, other supplements containing vitamin A, tetracyclines (demeclocycline, doxycycline, minocycline, oxytetracycline, and tetracycline), as well as other topical skin treatments for acne.
Other interactions include: inhaled tobramycin, mifepristone, methotrexate, cannabidiol, calcium, carbamazepine, ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, ofloxacin, ketoconazole, levoketoconazole, leflunomide, tretinoin, corticosteroids (methylprednisolone, hydrocortisone, cortisone, betamethasone, dexamethasone, triamcinolone, etc.), phenytoin, fosphenytoin, benzoyl peroxide, azelaic acid, drospirenone, fenofibrate, lenacapavir, letromovir, remdesivir, medroxyprogesterone, naltrexone, nevirapine, methoxsalen, and warfarin.
If you are taking any other medications (prescription or over-the-counter) or herbal products, be sure to inform your physician or pharmacist.

Precautions and warnings:

Liver function and blood lipid levels should be monitored before starting treatment, one month after starting treatment, and every three months during treatment (reduce or discontinue the treatment course if liver enzymes or blood lipid levels increase).
In case of neutropenia or agranulocytosis (rare), hearing disorders or tinnitus, or severe allergic reactions, discontinue the medication and consult your physician.
During the treatment period and up to 6 months after its completion, waxing, mole removal surgery, and skin laser treatments are prohibited.
Avoid exposure to UV light (including sunlight) during treatment and use sunscreen creams and lotions.
For dry mouth, use sugar-free candies; for dry eyes, use artificial tears; for dry skin, use moisturizers; and for dry lips, use lip balm.
If a dose is missed, take it as soon as you remember. However, if the next scheduled dose is near, skip the missed dose and continue the treatment as previously directed.
Do not recommend this medication to others under any circumstances.
This medication is highly teratogenic and can cause fetal defects; due to the possibility of skin absorption, pregnant women should avoid even touching the capsules.
Ensure you are not pregnant before starting treatment.
Avoid donating blood during treatment and for at least one month after using this medication.
Consult your physician or pharmacist before using this medication if you have any of the following conditions:
diabetes, dry eye syndrome, history of depression or under evaluation for depression, history of kidney stones, fluctuations in blood fructose levels, high blood pressure, dry skin, or history of kidney disorders.
If symptoms of psychiatric disorders such as depression, anxiety, or suicidal thoughts occur, inform your physician immediately.
This medication may potentially affect the ability to drive and operate machinery. Rarely, decreased night vision has been reported. Drowsiness, dizziness, and visual disturbances are very rare. If drowsiness or dizziness occurs, avoid driving or operating machinery.

Contraindications:

Concurrent use of this medication with the following drugs is contraindicated: demeclocycline, doxycycline, minocycline, oxytetracycline, and tetracycline. If symptoms of hypersensitivity such as shortness of breath or swelling of the face, tongue, or lips occur, inform your physician immediately. Use of this medication (except in special cases) is prohibited in individuals with the following conditions: This medication is strictly contraindicated in pregnant or breastfeeding women. Women of childbearing age must use reliable contraception (preferably two methods simultaneously) starting one month before treatment, throughout the treatment period, and for one month after discontinuation of therapy. Individuals with hypersensitivity to isotretinoin or other vitamin A derivatives, hepatic insufficiency, hyperlipidemia (high cholesterol or triglycerides), elevated serum vitamin A levels, diabetes, alcohol abuse, bone disorders such as osteomalacia or osteoporosis, and children under 12 years of age should avoid using this product.

Pregnancy and breastfeeding:

Use of this medication is strictly prohibited in pregnant or breastfeeding women.
Women of childbearing age must use reliable contraception (preferably two methods simultaneously) starting one month before treatment, throughout the treatment period, and for one month after the end of treatment.

Storage conditions:

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