Roaccutane Information - Click to open file 

Roaccutane®

5 mg and 20 mg soft capsules Isotretinoin

Read all of this leaflet carefully before you start taking this medicine. Keep the leaflet. You may need to read it again. If you have more questions, ask your doctor or your pharmacist (chemist).

Remember this medicine is for you. Only a doctor can prescribe it for you. Never give it to other people. It could harm them, even if their symptoms seem the same as yours.

1. What Roaccutane is used for

Roaccutane contains isotretinoin – a substance related to vitamin A, and one of a group of medicines called retinoids.

Roaccutane is used to treat severe types of acne (such as nodular or conglobate acne, or acne that is at risk of causing permanent scarring). You will use Roaccutane when your acne has not got better with anti-acne treatments, including antibiotics and skin treatments.

Roaccutane treatment must be supervised by a dermatologist (a doctor specialised in the treatment of skin problems).

2. Before you take Roaccutane

Do not take Roaccutane:

• If you are allergic to peanuts, soya or any other ingredient of Roaccutane. This medicine contains peanut oil (also called arachis oil) and soya oil, as well as isotretinoin. See section 6 Further information at the end of this leaflet for a full list of ingredients.

• If you are pregnant or think you may be
• If you are breastfeeding
• If you have liver disease
• If you have very high levels of blood fats (e.g. high cholesterol or triglycerides)
• If you have very high levels of vitamin A in your body (hypervitaminosis A)
• If your doctor has told you that you have an intolerance to the sugars fructose or sorbitol.
• If any of these apply to you, go back to your doctor before taking any Roaccutane.

Do not use in children under 12.

Use in children over 12 only after puberty.

Special Precautions with Roaccutane Not to be taken when pregnant

Important advice for women

Roaccutane is likely to damage an unborn baby (in medical language it is teratogenic). It also increases the risk of miscarriage.

• You must not take Roaccutane when you’re pregnant.
• You must not take Roaccutane if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.
• You must not take it if you could get pregnant during treatment, or during the month after treatment.
• Women who could get pregnant are only prescribed Roaccutane under strict rules, because of the risk of birth defects (damage to the unborn baby).

These are the rules:

• You must only take Roaccutane if you have severe acne that has not got better after any other anti-acne treatments, including antibiotics and skin treatments.
• Your doctor must have explained the risk of birth defects: you understand why you must not get pregnant and what you need to do to prevent it.
• You must have discussed contraception (birth control) with your doctor. They will give you information on preventing pregnancy. He or she may refer you to a specialist for contraceptive advice.
• You must agree to use one or preferably two effective methods of contraception, including condoms or a cap plus spermicide, for a month before taking Roaccutane, during treatment and for a month afterwards. Before you start treatment your doctor will ask you to take a pregnancy test, which must be negative.
• You must use contraception even if you do not have periods or are not currently sexually active (unless your doctor decides this is not necessary).
• You must accept the need for monthly follow up visits and more pregnancy tests as decided by your doctor. You may have a test 5 weeks after stopping Roaccutane. You must not get pregnant during treatment and for a month afterwards.
• Your doctor may ask you (or a guardian) to sign a form that confirms that you have been told about the risks, and that you accept the necessary precautions.

Prescriptions for women who could get pregnant are limited to 30 days treatment. A new prescription is needed for more treatment. Each prescription is only valid for 7 days.

If you do get pregnant while taking Roaccutane, or in the month after treatment has stopped, stop taking the medicine straight away, and contact your doctor. He or she may refer you to a specialist for advice.

Your doctor has written information on pregnancy and contraception for the users of Roaccutane which he should show you. If you haven’t seen this material already, ask your doctor.

Advice for men

Roaccutane does not appear to damage sperm. Very low levels of isotretinoin are present in the semen of men taking Roaccutane, but too little to harm the unborn baby of your partner. You must remember not to share your medication with anyone, particularly not women.

Advice for all patients

• Tell your doctor if you have ever had any mental illness (including depression, suicidal behaviour or psychosis), or if you take medicines for any of these conditions.
• Roaccutane commonly increases blood fats, such as cholesterol or triglycerides. Your doctor will test these levels before, during and after Roaccutane treatment. Tell your doctor if you already have high blood fats, diabetes (high blood sugars), are overweight, or an alcoholic. You may need blood tests more often. If your blood fats stay high, your doctor may lower your dose, or take you off Roaccutane.
• Roaccutane may increase liver enzyme levels. Your doctor will do blood tests before, during and after Roaccutane treatment to check these levels. If they stay high, your doctor may lower your dose or take you off of Roaccutane.
• Roaccutane 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.
• Your skin is likely to get dry. Use a skin moisturising ointment or cream and a lip balm during treatment. To prevent skin irritation you should avoid using exfoliating or anti-acne products.
• Avoid too much sun and do not use a sun-lamp or sun-bed. 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).
• Don’t have any cosmetic skin treatments. Roaccutane 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 6 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. Roaccutane can cause muscle and joint pain.
• Do not take vitamin A supplements while taking Roaccutane. Taking both together may increase the risk of side effects.
• Do not donate blood while you are taking Roaccutane or for one month afterwards. If someone who is pregnant is given your blood, the baby may be born with birth defects.

Driving and using machines

You may not see as well at night during your treatment. This can happen suddenly. In rare cases this has continued after the treatment has stopped. Drowsiness and dizziness have been reported very rarely. If this happens to you, you should not drive or operate machinery.

Taking other medicines

Do not take vitamin A supplements or tetracyclines (a type of antibiotic), or use any skin treatments for acne while you are on Roaccutane. It is fine to use moisturisers and emollients (skin creams or preparations that prevent water loss and have a softening effect on the skin).

Tell your doctor or pharmacist if you are taking any other medicines – including herbal and non-prescription products – or if you have taken any recently.

3. How to take Roaccutane

Always take Roaccutane exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual starting dose is 0.5 mg per kilogram body weight per day (0.5mg/kg/day). So if you weigh 70 kg, your dose will usually start at 35mg a day.

Take the capsules once or twice daily.

Take on a full stomach. Swallow them whole, with a drink or a mouthful of food.

After a few weeks your doctor may adjust your dose. This depends on how you are getting on with your medicine. For most patients the dose will be between 0.5 and 1.0mg/kg/day. If you think that Roaccutane is too strong or too weak, talk to your doctor or pharmacist.

If you have severe kidney problems, you will usually start on a lower dose (such as 10mg/day) which will be increased up to the highest dose your body can tolerate. If your body can’t tolerate the recommended dose, you may be prescribed a lower dose: that can mean you are treated for longer and your acne might be more likely to come back.

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 8 weeks after treatment. You won’t usually start another course until then.

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

If you take more Roaccutane capsules than you should

If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital immediately.

If you forget to take a dose

If you miss a dose take it as soon as you can. However, if it is nearly time for your next dose, skip the missed dose and carry on as before. Do not take a double dose (two doses close together).

4. Possible side effects

Roaccutane can have side effects, though not everybody gets them. The effects often wear off, or stop when treatment is stopped. Your doctor can help you deal with them.

Mental problems

Rare effects (may affect up to 1 in every 1000 people)

• Depression or related disorders. Signs of this include sad or empty mood, mood changes, anxiety, crying spells, irritability, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down or trouble concentrating.
• Existing depression getting worse.
• Becoming violent or aggressive.

Very rare effects (may affect up to 1 in every 10, 000 people)

• Some people have had thoughts about hurting themselves or ending their own lives (suicidal thoughts), have tried to end their own lives (attempted suicide), or have ended their lives (suicide). These people may not appear to be depressed.
• Unusual behaviour.
• Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor straight away if you get signs of any of these mental problems. Your doctor may tell you to stop taking Roaccutane. That may not be enough to stop the effects: you may need more help, and your doctor can arrange this.

Allergic reactions

Rare effects (may affect up to 1 in every 1000 people)

• Serious (anaphylactic) reactions: difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips and mouth. Also sudden swelling of the hands, feet and ankles.
• Allergic reactions such as rash, itchiness.

If you have a serious reaction, get emergency medical help immediately.

If you have any allergic reaction, stop taking Roaccutane and contact your doctor.

Liver and kidney problems

Very common effects (may affect more than 1 in every 10 people)

• Raised liver enzymes seen in blood tests.

Very rare effects (may affect up to 1 in every 10, 000 people)

• Yellow skin or eyes, and feeling tired. These can be signs of hepatitis. Stop taking Roaccutane straight away and contact your doctor.
• Difficulty urinating (passing water), swollen and puffy eyelids, feeling excessively tired. These may be signs of kidney inflammation. Stop taking Roaccutane straight away and contact your doctor.

Nervous system problems

Common effects (may affect up to 1 in every 10 people)

• Headache.

Very rare effects (may affect up to 1 in every 10, 000 people)

• Lasting headache, along with feeling sick (nausea), being sick (vomiting) and change in your eyesight including blurred vision. These may be signs of benign intracranial hypertension, especially if Roaccutane is taken with antibiotics called tetracycline. Stop taking Roaccutane straight away and contact your doctor.
• Convulsions, drowsiness, dizziness.

Gut and stomach problems

Very rare effects (may affect up to 1 in every 10, 000 people)

• Severe abdominal (tummy) pain, with or without severe bloody diarrhoea, feeling sick (nausea) and being sick (vomiting). These can be signs of serious gut conditions. Stop taking Roaccutane straight away and contact your doctor.

Skin and hair problems

Very common effects (may affect more than 1 in every 10 people)

• Dryness of the skin, especially of the lips and face; inflamed skin, chapped and inflamed lips, rash, mild itching and slight peeling. Use a moisturising cream from the start of treatment.
• Skin becomes more fragile and redder than usual, especially the face.

Rare effects (may affect up to 1 in every 1000 people)

• Hair loss (alopecia). This is usually only temporary. Your hair should return to normal after the treatment ends.

Very rare effects (may affect up to 1 in every 10, 000 people)

• Acne can get worse in the first few weeks, but symptoms should improve with time.
• Skin inflamed, swollen, and darker than usual, especially on the face.
• Excess sweating or itching.
• Increased sensitivity to light.
• Bacterial infections at the base of the nail, changes to nails.
• Swellings, discharging, pus.
• Thickened scarring after surgery.
• Increased body hair.

Blood problems

Very common effects (may affect more than 1 in every 10 people)

• Bruising, bleeding or clotting more easily - if clotting cells are affected.
• Anaemia – weakness, dizziness, pale skin – if red blood cells are affected.
• More liable to get infections - if the white blood cells are affected.

Very rare effects (may affect up to 1 in every 10, 000 people)

• Lymph glands may become swollen.

Eye disorders

Very common effects (may affect more than 1 in every 10 people)

• Inflammation of the eye (conjunctivitis) and eyelid area; eyes feel dry and irritated. Ask a pharmacist for suitable eye drops. If you get dry eyes and wear contact lenses, you may need to wear glasses instead.

Very rare effects (may affect up to 1 in every 10, 000 people)

• You may see less well at night; colour blindness and colour vision gets worse.
• Sensitivity to light may increase; you may find that you need to wear sunglasses to protect your eyes from too bright sunlight.
• Other sight problems including blurred vision, distorted vision, cloudy surface on the eye (corneal opacity, cataracts).

If you get blurred vision, stop taking Roaccutane straight away and contact your doctor. If your sight is affected in any other way tell a doctor as soon as you can.

Ear, nose and throat problems

Common effects (may affect up to 1 in every 10 people)

• Inside of the nose becomes dry and crusted, causing mild nosebleeds.
• Sore or inflamed throat and nose.

Very rare effects (may affect up to 1 in every 10, 000 people)

• Dry throat, hoarseness.
• Sudden tight chest, shortness of breath and wheezing, particularly if you have asthma.
• Hearing difficulties.

Diabetes

Very rare effects (may affect up to 1 in every 10, 000 people)

• Excessive thirst; frequent need to urinate; blood tests show an increase in your blood sugar. These can all be signs of diabetes.

Bones and muscles

Very common effects (may affect more than 1 in every 10 people)

• Back pain; muscle pain; joint pain.

Very rare effects (may affect up to 1 in every 10, 000 people)

• Arthritis; bone disorders (delayed growth, extra growth and changes to bone density); growing bones may stop growing.
• Calcium deposits in soft tissue, sore tendons, high levels of muscle breakdown products in your blood if you exercise vigorously.

To avoid making any bone or muscle problems worse, cut down on intensive physical activity while you’re on Roaccutane.

Other types of reaction

Very common effects (may affect more than 1 in every 10 people)

• Changed levels of fats in the blood (including HDL or triglycerides).

Common effects (may affect up to 1 in every 10 people)

• Higher levels of cholesterol in the blood.
• Protein or blood in the urine.

Very rare effects (may affect up to 1 in every 10, 000 people)

• Generally feeling unwell.
• High levels of uric acid in the blood.
• Bacterial infections.
• Inflammation of the blood vessels (sometimes with bruising, red patches).

If you notice any side effects that you are worried about, whether they are listed in this leaflet or not, talk to your doctor.

5. Storing Roaccutane

Keep out of the reach and sight of children.

Do not store above 30ºC.

Store in the original package to protect from moisture and light.

Do not use after the expiry date (EXP) stated on the pack.

Return left over capsules to your pharmacist. Only keep them if your doctor tells you to.

6. Further information

The active substance in Roaccutane is isotretinoin.

Other ingredients are refined soya-bean oil, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil, yellow beeswax, gelatin, glycerol, sorbitol, mannitol, hydrogenated hydrolysed starch, titanium dioxide E171, canthaxanthin pigment E161 (containing gelatin, peanut oil, canthaxanthin, ascorbyl palmitate, α-tocopherol, silica), printing ink containing shellac, black iron oxide E 172, and (5mg capsule only) titanium dioxide E 171.

Roaccutane comes in soft capsules containing either 5mg or 20 mg isotretinoin.

The capsules are oval, opaque, coloured pale red-violet and white and marked R5 or ROA 20. The capsules come in blister packs of 30.

The marketing authorisation holder and manufacturer is Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.

You can find out more about Roaccutane from your doctor or pharmacist. Date of preparation: December 2006.