Isotretinoin (Isotretinoin 0.05% gel)



Information specific to: Isotretinoin 0.05% gel when used in Acne.

Isotretinoin (Eye-soh-tret-in-oh-in) is a medicine which is used in treating acne.

The information in this Medicine Guide for isotretinoin varies according to the condition being treated and the particular preparation used.

Your medicine

Isotretinoin works by increasing the rate at which old skin cells die and new skin cells are produced. It also stops the formation of blackheads or whiteheads.

Isotretinoin can cause your skin to become more sensitive to all forms of UV light. While you are using Isotretinoin, it is important to protect the skin from the effects of UV light. You should try reducing the time you are exposed to direct sunlight. Areas which have been treated with Isotretinoin should not be exposed to the sun and should be covered with appropriate clothing or a high protection sun screen. You should also avoid using tanning beds or lamps while you are using Isotretinoin. You must not use Isotretinoin if your skin is sunburnt.

You should be careful not to get Isotretinoin in or around your eyes, mouth, nose or mucous membranes. Do not apply Isotretinoin onto irritated skin or onto skin with eczema. You must be careful when applying Isotretinoin to your neck or other areas of sensitive skin. For more information about using Isotretinoin on areas of sensitive skin, talk to your prescriber.

Other information about Isotretinoin:

  • you may need to use Isotretinoin for several weeks before you can expect to see any benefits from using this medicine. For more information about when you would expect to see these benefits and how long your treatment with Isotretinoin will last for, talk to your prescriber
  • if you are using other skin preparations to treat acne while you are using Isotretinoin, you may need to apply the other skin preparations at a different time of day to when you would usually use Isotretinoin. For more information about when to use other skin preparations to treat acne and which preparations may cause skin irritation, talk to your prescriber, pharmacist or read the patient information leaflet that comes with your medicine

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should use. It also tells you how often you should use your medicine. This is the dose that you and your prescriber have agreed you should use. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Whether this medicine is suitable for you

Isotretinoin is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

  • are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
  • are breast-feeding
  • are pregnant
  • have dermatitis around the mouth
  • have facialrosacea
  • have had a photoallergic reaction
  • have had problems tolerating Isotretinoin or similar retinoid products in the past
  • have or have a family history of skin cancer

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child who has not started puberty.

Over time it is possible that Isotretinoin can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Isotretinoin has become unsuitable, it is important that the prescriber is contacted immediately.


Alcohol can interact with certain medicines.

In the case of Isotretinoin:

  • there are no known interactions between alcohol and Isotretinoin


Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Isotretinoin:

  • there are no specific foods that you must exclude from your diet when using Isotretinoin

Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicinesIsotretinoin can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Isotretinoin:

  • you must not use Isotretinoin during pregnancy. If you could become pregnant, you must use effective contraception or abstain from penetrative sex. You must contact your prescriber if you become pregnant, or think you have become pregnant, while using Isotretinoin
  • Isotretinoin is a medicine which has implications for pregnancy as it may harm a baby. You must not become pregnant while you are using it, and for at least one month after you stop using this medicine

This medicine is not suitable during pregnancy. It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

If you are planning to become pregnant, you should discuss your personal circumstances with your doctor so that together you can make a decision about what treatment you may need during your pregnancy.


Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Isotretinoin:

  • women who are breast-feeding must not use this medicine

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed.

Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Isotretinoin:

  • benzoyl peroxide

If you are taking Isotretinoin and any of the above medicines, make sure your prescriber knows about it.

Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Isotretinoin.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

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