Royal Isotretinoine 30 tablets


Manufacturer: Royal Pharma.

Substance: Isotretinoine. 

Package: 30 tabs (20 mg/tab).

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Isotretinoin is used for:

Treating severe acne in patients who do not respond to other medicines. It may also be used for other conditions as determined by your doctor.

Isotretinoin is a retinoid. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin.
Do NOT use isotretinoin if:

  •     you are allergic to any ingredient in isotretinoin or to vitamin A
  •     you are pregnant, may become pregnant, or if you are planning to become pregnant
  •     you are breast-feeding
  •     you do not understand the possible risks of isotretinoin or you are not able to follow all of the instructions in the Medication Guide
  •     you are taking tetracycline antibiotics (eg, doxycycline) or vitamin A-type medicines (eg, etretinate, vitamin A)

Contact your doctor or health care provider right away if any of these apply to you.

Before using isotretinoin:

Some medical conditions may interact with isotretinoin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  •     if you are pregnant, planning to become pregnant, or are breast-feeding
  •     if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  •     if you have allergies to medicines, foods, or other substances
  •     if you are woman and unable to use 2 effective forms of birth control or avoid sexual intercourse
  •     if you have a personal or family history of mental or mood problems (eg, depression), or suicidal thoughts or actions
  •     if you have a personal or family history of asthma, diabetes, high blood cholesterol or triglyceride levels, heart disease, liver problems, bone loss (osteoporosis) or other bone problems (eg, weak bones), or an eating disorder (eg, anorexia)
  •     if you have a history of hearing problems (eg, ringing in the ears, hearing loss), stomach or bowel problems (eg, severe stomach pain, rectal bleeding, persistent or severe diarrhea), pancreas problems (eg, pancreatitis), or irregular menstrual periods
  •     if you are taking medicines that may decrease bone strength (eg, corticosteroids, such as prednisone; medicines for seizures, such as phenytoin)

Some MEDICINES MAY INTERACT with isotretinoin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  •     Tetracyclines (eg, doxycycline) because the risk of increased pressure in the brain may be increased
  •     St. John's wort because an increased risk of failure of hormonal contraceptives (eg, birth control pills) may occur
  •     Vitamin A-type medicines (eg, etretinate, vitamin A) because they may increase the risk of isotretinoin's side effects
  •     Progestin-only birth control (eg, "mini-pill") because their effectiveness may be decreased by isotretinoin

This may not be a complete list of all interactions that may occur. Ask your health care provider if isotretinoin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use isotretinoin:

Use isotretinoin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  •     Isotretinoin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get isotretinoin refilled.
  •     Some brands of isotretinoin should be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you should take your brand of isotretinoin with food.
  •     Swallow the capsule with a full glass of water or other liquid. Do not break, crush, chew, or suck on the capsule before swallowing. This will help prevent the medication inside the capsule from irritating your throat.
  •     For best results, take isotretinoin regularly. Taking isotretinoin at the same time each day will help you remember to take it.
  •     Isotretinoin can only be dispensed through a special program. You must sign a consent form stating that you will follow your doctor's instructions before you can take isotretinoin. This will be necessary each time you refill your prescription.
  •     You will get no more than a 30-day supply of isotretinoin at a time to ensure you check in with your doctor each month to discuss side effects.
  •     If you miss a dose of isotretinoin, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use isotretinoin.

Important safety information:

  •     Isotretinoin may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use isotretinoin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  •     Do NOT take more than the recommended dose or take isotretinoin for longer than prescribed without checking with your doctor. Doing so will not improve your condition faster and may increase your risk for side effects.
  •     A sudden decrease in night vision may occur while you are taking isotretinoin. Use caution when driving at night and avoid driving at night if you experience decreased night vision.
  •     If you wear contact lenses, you may have difficulty wearing them during and after therapy.
  •     Do not donate blood while taking isotretinoin and for 1 month after you stop taking isotretinoin.
  •     Do not drink alcohol while taking isotretinoin.
  •     Worsening of acne may occur during the first part of therapy. This does not suggest failure or a need to stop the medicine.
  •     To prevent cracking of lips, use a lip moisturizer or balm.
  •     Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking isotretinoin and for at least 6 months after you stop taking it. Isotretinoin can increase your chance of scarring from these procedures.
  •     Isotretinoin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to isotretinoin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  •     Some patients have become depressed or developed serious mental or mood problems while taking isotretinoin. Stop using isotretinoin and tell your health care provider right away if you have any new, worsened, or sudden symptoms, such as feeling sad or having crying spells; feeling anxious; becoming more irritable, angry, or aggressive than usual; losing pleasure or interest in social or sports activities; sleeping too much or too little; changes in weight or appetite; feeling like you have no energy; having trouble concentrating; or having thoughts about taking your life or hurting yourself (suicidal thoughts).
  •     Isotretinoin may cause decreased bone strength in some patients. Patients who play vigorous impact sports may be at increased risk of bone problems (eg, fractures). Discuss any questions or concerns with your doctor.
  •     Women who may become pregnant must use 2 effective forms of birth control at least 1 month before starting therapy, during therapy, and for 1 month after stopping the medicine. Your health care provider should conduct pregnancy tests on a monthly basis while you are taking isotretinoin.
  •     Do not use progestin-only pills or "minipills" (pills that do not contain estrogen) for birth control because they may not work as well with isotretinoin. Ask your doctor or pharmacist if you are not sure what type of birth control pills you are using.
  •     Women who use hormonal birth control should avoid the use of the herbal supplement St. John's wort because it may decrease the effectiveness of hormonal birth control.
  •     Diabetes patients - Isotretinoin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  •     Lab tests, including pregnancy tests, cholesterol and lipid levels, liver function, blood sugar levels, and white blood cell counts, may be performed while you use isotretinoin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  •     Isotretinoin may affect normal growth in some CHILDREN. Caution is advised when using isotretinoin in children; they may be more sensitive to its effects. Consult your doctor for more details.
  •     Isotretinoin should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  •     PREGNANCY and BREAST-FEEDING: Do not use isotretinoin if you are pregnant. It has been shown to cause serious birth defects, miscarriage, early birth, or death of the fetus. Avoid becoming pregnant while you are taking it. If you have sex at any time without using 2 forms of effective birth control, become pregnant, think you may be pregnant, or miss your menstrual period, stop using isotretinoin and call your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while taking isotretinoin and for 1 month after stopping isotretinoin.

Possible side effects of isotretinoin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Chapped lips; dizziness; drowsiness; dry eyes, mouth, or skin; dry nose that may lead to nosebleeds; headache; temporary worsening of acne.

Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal hair growth; bleeding, redness, or swelling of the gums; bone pain; change in the amount of urine produced; chest pain; dark urine; difficult or painful swallowing; excessive thirst; fainting; fast heartbeat; hearing problems or ringing in the ears; joint or back pain; muscle pain or weakness; nausea; new or worsening heartburn; new or worsening mental, mood, or behavior changes (eg, bizarre, aggressive, or violent behavior; depression); red patches or bruises on the legs or arms; red, swollen, blistered, or peeling skin; seizures; severe headache; shortness of breath; stomach pain or tenderness; suicidal thoughts or actions; swollen glands; symptoms of increased pressure in the brain (eg, eye pressure, nausea, vomiting, vision changes); symptoms of infection (eg, fever, chills, sore throat); symptoms of a stroke (eg, confusion, one-sided weakness, slurred speech); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); symptoms of stomach or bowel problems (eg, severe stomach or bowel pain, rectal bleeding, persistent or severe diarrhea); tightness in the lungs; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; voice changes; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

Royal Pharma

Specific References