Aknetrent (Generic Roaccutane) Isotretinoin Capsules

AKNETRENT (Generic Roaccutane) soft gelatin capsule is taken orally.

WARNING

CAN SERIOUSLY DAMAGE AN UNBORN BABY Women should use effective contraception.

Do not use if you are pregnant or think you may be pregnant.

▼ This drug is subject to additional monitoring. This triangle will enable rapid identification of new safety information. You can help by reporting any side effects that occur. See the end of section 4 for how to report side effects.

1. What is AKNETRENT (Generic Roaccutane) and what is it used for?

• AKNETRENT contains isotretinoin as an active ingredient, which is related to vitamin A and belongs to a group called retinoids.

• Each AKNETRENT package contains 30 soft gelatin capsules in duplex (PVC/PE/PVDC/Alu) blisters of 10 capsules. Capsules are oval, red-orange in color.

• AKNETRENT, for severe types of acne [eg; It is used in the treatment of lumpy (nodular), round (conglobate) acne or acne with the risk of permanent scarring. You will use AKNETRENT if your acne does not improve with anti-acne treatments, including antibiotics and skin treatments.

AKNETRENT treatment should be supervised by a dermatologist (a physician who specializes in the treatment of skin problems).

2. How to use AKNETRENT (Generic Roaccutane) ?

Always take AKNETRENT (Generic Roaccutane) exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Instructions for proper use and dose/frequency of administration

• The usual starting dose is 0.5 mg per day (0.5 mg/kg/day) per body weight (kg). E.g; if you weigh 70 kg, you will start treatment with a dose of 35 mg per day.

• Take the capsules once or twice a day on a full stomach.

• After a few weeks, your doctor may adjust the dose of your medicine. It depends on how you adjust to the drug. For most patients, the dose will be between 0.5 and 1.0 mg/kg/day.

• Treatment generally lasts between 16 and 24 weeks. For most patients, 1 treatment period is sufficient. Your acne may continue to improve for up to 8 weeks after treatment. Do not start a new treatment during this time.

Some patients find that their acne worsens during the first weeks of their treatment. This condition improves as treatment continues.
Application route and method

Capsules are taken orally, on a full stomach. Swallow whole with a drink or meal.
different age groups
Use in children

Use in the elderly

Use in the elderly:

No dosage adjustment is required in elderly patients.
Special use cases
Kidney failure

If you have severe kidney problems, you will generally start with a low dose (such as 10 mg per day) and this dose will then be increased to the highest dose your body can tolerate. If your body cannot stand the recommended dose, you may be prescribed a lower dose; this may mean you have to be treated for a long time and your acne may recur.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in AKNETRENT (Generic Roaccutane).

If any of the following occur, stop using AKNETRENT (Generic Roaccutane) and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department.

• Severe (anaphylactic) reactions: Breathing and swallowing difficulties with sudden swelling of the throat, face, lips and mouth. Also sudden swelling of the hands, feet, and ankles

These are all very serious side effects. If you have one of these, it means you have a serious allergy to AKNETRENT (Generic Roaccutane). You may need emergency medical attention or hospitalization.

Side effects are classified as shown in the following categories:

Very common: may occur in at least 1 in 10 patients.

Common: less than 1 in 10 patients, but more than 1 in 100 patients.

Uncommon: less than 1 in 100 patients, but more than 1 in 1,000 patients.

Rare: less than 1 in 1,000 patients, but more than 1 in 10,000 patients

Very rare: less than 1 in 10,000 patients.

Not known: Cannot be estimated from the available data.

Side effects that require urgent medical attention

skin problems