ROACCUTANE

This medicine contains the active ingredient isotretinoin which belongs to a group of products known as retinoids that are used for the treatment of acne. Acne occur when the skin pores are blocked and the sebum (oil) is not able to come to the surface of the skin. Isotretinoin is prescribed for the treatment of acne that did not respond to other treatments, usually after the period of puberty.

Is Isotretinoin suitable for me?

Isotretinoin is not suitable for everyone. Do not use it

• If you are pregnant or might me pregnant
• If you are breastfeeding
• If you are allergic to isotretinoin, peanut or soya or other ingredients of this medicine
• If you have liver disease
• If you have very high levels of blood fats (high cholesterol or triglycerides)
• If you have very high levels of vitamin A in your body  
• If you are receiving treatment with tetracyclines (antibiotic)

In particular, you must tell the doctor if you:

• have or have had any mental illness
• have diabetes mellitus
• have a dry eye condition
• have kidney or liver problems
• are alcoholic

Isotretinoin interacts with other medicines. It is most important that you tell the doctor all the medications and herbal supplements that you are currently taking.

See the package leaflet for a complete list of possible contraindications and warnings.

How should I take Isotretinoin?

This medicine is available in form of a capsule.

You should take isotretinoin exactly as instructed by your doctor or pharmacist. The dose will be prescribed according to your body weight.

• The usual starting dose is 0.5 mg/kg daily. The increased dose should not be higher than 1 mg of isotretinoin per kilogram of bodyweight per day.
• The capsules should be taken with a meal.

Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered. Also, this medicine works best if there is steady amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

Read the information leaflet provided with your medication for additional information. Talk to your doctor if you have any additional questions.

What are Isotretinoin side effects?

Like all medicines isotretinoin can cause side effects, including:

Very common:

• inflammation, dryness and cracking of the skin and lips
• skin rash, itching, redness
• inflammation of the eyelids
• dry, irritated eyes
• conjunctivitis
• back pain
• muscle and joint aches and pains
• blood or protein in the urine
• changes in blood glucose levels
• increased blood cholesterol
• anemia
• headaches

 Rare side effects:

• changes to your hair
• depression

Very rare side effects:

• tiredness
• feeling sick
• sweating
• diabetes
• dizziness, drowsiness, fits
• worsening of acne
• swellings
• abdominal pain, diarrhea,
• inflammatory bowel disease
• inflammation of the pancreas
• inflammation of the liver
• kidney disease

Consult a doctor if the side effects are severe. See the package leaflet for a complete list of side effects.