ROACCUTANE 10 MG (ISOTRETINOIN) - Official Roche, Switzerland Supplier

Roaccutane 10mg

General information:

Manufacturer: Roche, Switzerland
Substance: Isotretinoin
Pack: 30 caps (10 mg/cap)

How does it work?

Roaccutane capsules contain the active ingredient isotretinoin. (NB. Isotretinoin capsules are also available without a brand name, ie as the generic medicine.) Isotretinoin belongs to a group of medicines known as retinoids, which are derivatives of vitamin A. Isotretinoin taken by mouth works by reducing the production of the skin’s natural oil (sebum).

Acne occurs due to an excessive production of sebum from over-active sebaceous glands in the skin. The sebum blocks the sebaceous glands, which prevents the oil from flowing freely out and causes an accumulation of sebum under the skin. The bacteria associated with acne thrive in these conditions. They feed on the sebum, and produce waste products and fatty acids that irritate the sebaceous glands, making them inflamed and causing spots.

Isotretinoin decreases the size and activity of the sebaceous glands in the skin, which reduces the amount of sebum that is produced. This stops the glands becoming blocked, and means bacteria are less likely to thrive. It also reduces the inflammation in the skin.

Isotretinoin can have serious side effects and its use must be supervised by a dermatologist. It is reserved for the treatment of severe acne (such as nodular or conglobate acne or acne at risk of permanent scarring) that has not improved with standard treatment involving oral antibiotics and topical medicines.

Your acne may worsen at the start of treatment, but this usually subsides within 7 to 10 days of continued treatment. In most cases, complete or near-complete clearing of acne is achieved with a 12 to 16 week course of treatment, and you are likely to remain free of acne for a long time. Repeat courses are not normally recommended, unless a definite relapse is seen after treatment is stopped. Repeat courses should not be started until at least eight weeks after stopping treatment, as your acne may still improve in this time.
What is it used for?

* Severe acne that has not responded to standard treatment with oral antibiotics and topical medicines.

Warning!

* Isotretinoin causes major birth defects (serious malformations of a developing foetus) if taken during pregnancy. For this reason your doctor will not prescribe the treatment to women who could get pregnant, unless the following conditions of the Pregnancy Prevention Programme are met: At least one, but preferably two (for example the pill and condoms), effective methods of contraception must be used at all times to prevent pregnancy. Contraception must start at least four weeks before starting treatment, be used at all times during treatment and for at least four weeks after stopping treatment, even if you don't have a period. Your doctor cannot prescribe isotretinoin until you have been using effective contraception for at least a month and have had a negative pregnancy test. Your doctor is only allowed to prescribe 30 days supply of isotretinoin at a time, and the prescription will only be valid for seven days. You will need to have a follow-up visit every month, at which you will have to have a negative pregnancy test before a new prescription can be issued. Five weeks after stopping treatment you should have a final pregnancy test to make sure you have not fallen pregnant. If you think there is a chance you could be pregnant, either during treatment, or in the first month after stopping treatment, you must consult your doctor immediately.
* There is no evidence to suggest that children fathered by men who are taking isotretinoin will be affected by the medicine, but men should remember not to give this medicine to anyone, particularly females.
* You should never give this medicine to another person and you should return any unused medicine to your pharmacist at the end of treatment.
* People taking this medicine must not donate blood during treatment, and for at least four weeks after stopping treatment. This is due to the potential risk of the medicine to an unborn child if the blood transfusion was received by a pregnant woman.
* You should avoid exposing your skin to intense sunlight or UV light while taking this medicine. You should use a sunscreen of at least SPF 15 when necessary.
* Isotretinoin is likely to make your skin and lips very dry, so it is recommended that you use a moisturiser and lip balm from the start of treatment.
* You should avoid waxing any part of your body while taking isotretinoin, and for at least six months after stopping treatment, as this could cause stripping of the top layer of skin. Chemical dermabrasion and cutaneous laser treatment should also be avoided during treatment with isotretinoin and for five to six months after stopping treatment, as this could cause scarring.
* Isotretinoin can make your eyes dry. This can be relieved with artificial tear drops. Ask your doctor or pharmacist for advice. If you wear contact lenses you may find that they become uncomfortable during treatment and you have to wear glasses instead. Decreased night vision may also occur during treatment and after treatment has been stopped, and can occur suddenly. For this reason you are advised to be cautious when driving or operating any vehicle at night. If you experience any visual difficulties, inform your doctor so that your vision can be monitored. It may sometimes be necessary to stop treatment.
* This medicine may rarely cause depression, anxiety, aggression and mood changes and very rarely psychotic symptoms (eg delusions or hallucinations) and thoughts of suicide or suicide attempts. For this reason, if you start to feel depressed, or experience any other changes in your mood or behaviour during treatment, it is very important to talk to your doctor straight away.
* You will need to have a blood test to monitor your liver function before you start treatment with this medicine, one month after starting and then at further three-monthly intervals.
* The amount of lipids (fats such as cholesterol and triglycerides) in your blood should also be monitored before treatment, one month after starting treatment and at three-monthly intervals. If your blood level of triglycerides becomes too high, your isotretinoin dose may need to be reduced and you may have to go on a low fat diet. If your triglycerides cannot be controlled, you may have to stop treatment with isotretinoin.
* This medicine may increase your blood sugar level. People with diabetes may need to monitor their blood sugar more frequently during treatment with this medicine. Ask your doctor for advice.

Use with caution in

* Women who could get pregnant.
* History of depression.
* Decreased kidney function.
* Alcoholism.
* Diabetes.
* Obesity.
* Lipid metabolism disorders.

Not to be used in

* Pregnancy.
* Breastfeeding.
* Woman who could get pregnant, unless all the criteria described in the warning section above are met.
* Acne that has developed before reaching puberty (prepubertal acne).
* Decreased liver function.
* People with high levels of fats (lipids) such as cholesterol and triglycerides in their blood (hyperlipidaemia).
* A condition resulting from the excessive consumption of vitamin A (hypervitaminosis A).
* People taking tetracycline-type antibiotics.
* Soya allergy (Roaccutane capsules contain soya oil).
* Rare hereditary problems of fructose intolerance (Roaccutane capsules contain sorbitol).
* This medicine is not recommended for children under 12 years of age.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

* Isotretinoin MUST NOT be used during pregnancy as it causes major birth defects and serious malformations of the foetus. Women who could get pregnant will only be prescribed this medicine if all the conditions of the Pregnancy Prevention Programme listed in the warning section above are met. At least one and preferably two effective methods of contraception must be used to prevent pregnancy for at least one month before starting treatment, during treatment and for at least one month after finishing treatment. If you think you could be pregnant at any point during treatment or in the month after stopping treatment you must consult your doctor immediately.
* This medicine must not be used by breastfeeding mothers, as it passes into breast milk and could have adverse effects on the nursing infant. Seek medical advice from your doctor.