Isotretinoin

• For severe forms of acne
• Capsules for oral use
• Can seriously harm an unborn baby
• Not to be used while pregnant or breastfeeding

The active ingredient isotretinoin is a substance related to Vitamin A, and one of a group of medicines called retinoids.

Isotretinoin is used to treat severe forms of acne, such as nodular, conglobate acne or cystic acne. Cystic acne involves deep, painful lumps under the skin called cysts and can lead to permanent scarring.

Isotretinoin is prescribed when your acne has not got better with other anti-acne treatments. This medicine should not be used to treat prepubertal acne and in children under 12 years of age.

Isotretinoin comes in capsule form. The capsules should be taken on a full stomach. The capsules should be swallowed whole with a drink or a mouthful of food.

Dosage

The usual starting dose is 0.5 mg per kg of body weight per day (0.5 mg/kg/day). After a few weeks your doctor may adjust your dose. If you have severe kidney problems, you will usually start on a lower dose.

A course of treatment usually lasts for 16 to 24 weeks. Most patients only need one course. Your acne may continue to improve for up to eight weeks after treatment.

Some people find their acne gets worse during the first weeks of treatment. It usually improves as treatment goes on.

Alcohol/driving

Isotretinoin can cause side effects such as dizziness, sleepiness and blurred vision. Do not drive if you experience these side effects.

Reduce or stop drinking alcohol while taking this medicine.

If you take more Isotretinoin than you should or miss a dose

If you take more Isotretinoin than you should, contact your doctor.

If you miss a dose, you may take it as soon as you remember unless it is almost time for your next scheduled dose. Never take a double dose to make up for the forgotten one.

Isotretinoin is not suitable for everyone. Do not use this medicine if:

• You are pregnant or breastfeeding, or think you may be pregnant (see section 'Pregnancy and breastfeeding').
• There is any chance you could become pregnant, but are not able or unwilling to take precautions to prevent pregnancy.
• You are allergic to any of the ingredients in this medicine (see section 'What Isotretinoin contains').
• You have a liver disease.
• You have very high levels of blood fats (e.g., high cholesterol or triglycerides).
• You have very high levels of Vitamin A in your body (hypervitaminosis A).
• You are receiving treatment with tetracyclines (a type of antibiotic) at the same time.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking Isotretinoin. Precautions and advice for all patients:

• You should not donate blood during treatment with this medicine and for one month after stopping the treatment.
• Tell your doctor if you have ever had any mental illness or if you are taking medicines for your condition.
• Avoid too much sun and do not use a sunlamp or sunbed. Your skin may become more sensitive to sunlight. Before you go out in the sun, use a sun-protection product with a high protection factor (SPF 15 or higher).
• Isotretinoin may make your skin more fragile. Don’t have any waxing (hair removal), dermabrasion or laser treatments (removing horny skin or scars) during treatment, or for at least six months after treatment. They could cause scarring, skin irritation, or rarely, changes in the colour of your skin.
• Cut down on intensive exercise and physical activity. Isotretinoin can cause muscle and joint pain particularly in children and teenagers undertaking vigorous physical activity.
• Isotretinoin commonly increases blood fats, such as cholesterol or triglycerides. Your doctor will test these levels before, during and after treatment with Isotretinoin.
• Isotretinoin has been associated with inflammatory bowel disease. Your doctor will take you off Isotretinoin if you have severe bloody diarrhoea without any history of gastrointestinal disorders.
• Isotretinoin may increase blood sugar levels. In rare cases, people become diabetic. Your doctor may monitor blood sugar levels during treatment, particularly if you already have diabetes, are overweight, or are an alcoholic.

For a complete list of precautions, see the package leaflet.

Pregnancy and breastfeeding

Isotretinoin is associated with a high risk of birth defects if pregnancy occurs before or during treatment or within one month of stopping. Isotretinoin is teratogenic at all therapeutic doses and durations of exposure. For this reason, the following strict rules have been established.

• You must not take isotretinoin if you are pregnant or want to become pregnant. You must not get pregnant for one month after stopping isotretinoin.
• You must not take isotretinoin if you are breastfeeding.
• You must take a pregnancy test before starting treatment and agree to monthly pregnancy testing during treatment for up to five weeks after stopping isotretinoin to rule out the chance of pregnancy.
• You must agree to use at least one highly effective method of contraception (e.g., the coil (IUD) or contraceptive implant) or two effective methods of contraception (e.g., a hormonal contraceptive pill plus a barrier method, such as a condom) before and during treatment with isotretinoin and for one month afterwards.
• If you become pregnant while using isotretinoin, stop taking isotretinoin and immediately seek medical help.

Attention: Women who could get pregnant are prescribed Isotretinoin under strict rules. Women must follow these rules to prevent pregnancy. For a complete list of rules, see the package leaflet.

Other medicines and Isotretinoin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines alongside Isotretinoin. This includes medicines that do not require a prescription.

Do not take Vitamin A supplements or tetracyclines (a type of antibiotic) while you are on Isotretinoin.

Do not use any irritating skincare products or topical keratolytic or exfoliative anti-acne agents while you are on Isotretinoin.

Isotretinoin may cause side effects, although not everybody gets them.

Very common side effects with Isotretinoin (may affect more than 1 in 10 people):

• Anaemia.
• Bruising, bleeding or clotting more easily.
• Dry or inflamed skin, skin rash, itching, scaling, red skin (especially of the face).
• Dry or chapped lips.
• Elevated liver enzymes.
• Back pain, muscle pain, joint pain, particularly in children and adolescents.
• Changed levels of fats in the blood (including HDL or triglycerides).
• Eyes feel dry and irritated, inflammation of the eye (conjunctivitis). If you get dry eyes and wear contact lenses, you may need to wear glasses instead.

Common side effects with Isotretinoin (may affect up to 1 in 10 people):

• Headache.
• Sore or inflamed throat and nose.
• More liable to get infections.
• Inside of the nose becomes dry and crusted, causing mild nosebleeds.
• Higher levels of cholesterol in the blood.
• Protein or blood in the urine.
• Allergic reactions such as rash, itchiness. If you have any allergic reaction, stop taking Isotretinoin and contact your doctor.

Seek medical help immediately if you have the following side effects:

• Allergic reaction
• Severe skin rash
• Mental health issues
• Problems with your bones or muscles
• Liver or kidney problems
• Problems with your nervous system
• Stomach or digestive problems
• Eye disorders and problems

For a list of uncommon and rare side effects, including serious side effects such as severe allergic reaction, please see the package leaflet. Consult a doctor if you experience side effects, also if the side effects are not listed in the package leaflet.

Each capsule of Isotretinoin contains 10 mg or 20 mg of the active substance isotretinoin. The other ingredients are:

• Capsule core: refined soya-bean oil, dl-alpha-tocopherol (E307a), edetate disodium, butylated hydroxyanisole (E320), vegetable oils, yellow beeswax.
• Capsule shell: gelatin, sorbitol (E420), purified water.
• Colouring agents in capsule coating:
  • 10 mg: cochineal red A (E124), iron oxide black (E172), titanium dioxide (E171).
  • 20 mg: cochineal red A (E124), indigo carmine (E132), titanium dioxide (E171).

The manufacturers of Isotretinoin are:

Actavis Group PTC ehf. Reykjavikurvegur 76-78
220 Hafnarfjördur
Iceland

Aurobindo Pharma B.V. Baarnsche Dijk 1
3741 LN Baarn
The Netherlands

Tjoapack Netherlands B.V. Nieuwe Donk 9
4879 AC Etten-Leur
The Netherlands

Read the package leaflet before use.