INGREDIENT FORMULA:

Active ingredient: Isotretinoin 10mg.
Ingredients excipients: refined soya oil, yellow beeswax, hydrogenated soya oil, partially hydrogenated vegetable oil, capsule shell.

INDICATIONS: Treatment of severe acne (ganglion eggs and fish eggs agglomeration). When other acne treatments are ineffective (using antibiotics in combination with topical prescription).

DOSAGE – DOSAGE:

The usual dose for people with acne

Severe acne: you use 0.5-1 mg / kg / day in 2 divided doses. If the condition is severe (such as a scar or acne on the body), you may need up to 2 mg / kg / day.

Usual adult dose for melanoma – metastasis

Combination therapy with alpha interferon: you take 60mg / day, divided into 3 equal doses, for 6 months.

Usual Adult Dose for Granuloma Annulare

You use 0.5-1mg / kg / day, divided into 2 times.

Usual pediatric dose

Severe acne in children 12 years and older: children give 0.5 to 1mg / kg / day, divided into 2 times.

The usual dose in children with non-congestive acute leukemia

Children from 1 month of age and older: you give your child 100mg / m2 skin / day for 4 weeks.

You should consult a doctor before giving medicine to children.

CONTRAINDICATIONS:

Women who are pregnant and breastfeeding.
Women of childbearing age but not using any effective contraception.
Hypersensitivity to any components of the drug

Special precautions and precautions when using:

Before taking isotretinoin, you should tell your doctor or pharmacist if:

You are allergic to isotretinoin, vitamin A or any ingredient in isotretinoin capsules;
You are taking prescription and over-the-counter medicines, vitamins, herbal products, and nutritional supplements you are taking or plan to take. Be sure to tell your doctor epileptic medications such as phenytoin (Dilantin®); medicine for mental illness; steroid drugs such as dexamethasone (Decadron®, Dexone®), methylprednisolone (Medrol®) and prednisone (Deltasone®); tetracycline antibiotics such as demeclocycline (Declomycin®), doxycycline (Monodox®, Vibramycin®, others), minocycline (Minocin®, Vectrin®), oxytetracycline (Terramycin®) and tetracycline (Sumycin®, Tetrex®, others) and vitamin A supplements;
You or anyone in your family who has thought of or attempted suicide, has had depression, mental illness, diabetes, asthma, osteoporosis, brittle bones (weak bones due to lack of vitamin D or difficulty absorbing vitamins this), other conditions that cause weak bones, high triglycerides (blood fats), lipid metabolism disorders, anorexia, heart or liver disease. You also tell your doctor if you are overweight or if you have been or are addicted to alcohol.
Do not breastfeed while you are taking isotretinoin and for 1 month after stopping isotretinoin.
In addition, you need to limit your exposure to sunlight and wear coats, suede skirts, sunglasses and sunscreen because isotretinoin makes the skin sensitive to sunlight.
Isotretinoin can cause changes in thinking, behavior or mental health. Some patients taking isotretinoin have depression or mental disorders, they become violent, think about killing or injuring themselves. You or your family should call your doctor right away if you experience any of the following symptoms: anxiety, sadness, crying, loss of interest in activities you often enjoy, ineffective study and work, sleep more than usual, overslept or drowsiness, irritability, anger, aggression, cravings or weight changes, difficulty concentrating, separation from friends or family, lack of energy, feeling useless or sin, thinking about killing or hurting yourself, acting on dangerous thoughts (seeing or hearing things that don’t exist).
Isotretinoin can cause dry eyes, so you should not wear contact lenses during and after treatment.
Isotretinoin can affect vision in the dark. This condition begins suddenly at any time during treatment and may continue after you stop treatment. Be careful when driving or operating machinery at night.
You should avoid hair removal, laser keloid treatment to soften the skin while using isotretinoin and for 6 months after treatment. Isotretinoin increases the risk of scarring from these treatments.
You need to tell your doctor before engaging in physical activities such as sports. If you fracture during treatment, be sure to tell your doctor that you are taking isotretinoin.
Because isotretinoin can be absorbed through the skin and lungs and is harmful to the fetus, pregnant or pregnant women should not take this medication.

ADVERSE EFFECTS: Most common are dry skin, itching, dry nose, nose bleeds, mouth sores, dry mouth, eye inflammation and joint pain. More rarely are skin infections, sunburn and hepatitis. Rarely, brain edema can cause nausea, vomiting, headache and vision changes.

OVERDOSE AND TREATMENT:

In case of an emergency or overdose, call 911 immediately or go to the nearest local health clinic. Also, write down and bring along a list of all the medicines you have taken, including medicines prescription and over-the-counter medications.

Overdose symptoms include:

Vomiting;
Secretion;
Cracked lips;
Stomachache;
Headache;
Dizzy;
Overbalance.

STORAGE: Under 30 ֯ C, protected from light and moisture.

SHELF LIFE: 03 years from date of manufacture.

QUALITY STANDARDS: Manufacturer.

MANUFACTURER: GAP S.A. 46, Agissilaoy Str., Ag.Dimitrios Attiki, 17341. Greece – Greece.