WHAT IS IN ISOTRETINOIN CAPSULES?

Each capsule contains either 5 or 20mg of the active substance Isotretinoin. Each pack contains 56 capsules.

The capsules also contain refined soya-bean oil, yellow beeswax, hydrogenated soya-bean oil and partially hydrogenated vegetable oil. 

The capsules are made from gelatin, glycerol, titanium dioxide (E171), ferrous oxide red (E172) and ferrous oxide yellow (E172). The printing ink (432BL) contains brilliant blue FCF dye, sorbitol, maltitol, phosphatidylcholine and lysophosphatidylcholine.

WHY HAVE I BEEN PRESCRIBED ISOTRETINOIN CAPSULES?

This medicine is used to treat severe acne, for patients whose acne has not responded to other treatments. The use of Isotretinoin Capsules must be supervised by a dermatologist (a doctor who specialises in the treatment of skin problems).
Isotretinoin Capsules should not be used to treat acne occurring before the onset of puberty.

WILL ISOTRETINOIN CAPSULES BE OK FOR ME?

Tell your doctor or pharmacist if any of the following apply:

• you are pregnant or think you may be pregnant.
• you have liver disease.
• you are breast-feeding.
• you are taking certain antibiotics called tetracyclines.
• you are allergic to Isotretinoin Capsules or any of the ingredients it contains.
• You are allergic to soya.
• you take high-dose vitamin A supplements or have high levels of cholesterol or triglycerides (a fat like substance) in your blood.
• you, or members of your family, have a history of high triglyceride or cholesterol levels in the blood. Your doctor may do some blood tests to check your liver and blood before, during and at the end of your treatment.
• you or members of your family, have diabetes mellitus (sugar diabetes). Isotretinoin Capsules may increase your blood sugar levels, so your doctor may want to monitor this during treatment.
• You are allergic to peanuts
• You or members of your family have a rare intolerance to some sugars.
• you regularly drink a lot of alcohol.
• you have or have had depression.

WHAT SHOULD I LOOK OUT FOR WHILST TAKING ISOTRETINOIN CAPSULES?

In some patients taking Isotretinoin, levels of fat-like substances in the blood may increase. Because of this, it is best that you stop, or reduce the amount of alcoholic drinks you usually drink while you are on treatment. If your doctor finds that you have got high levels of triglycerides while taking this medicine, you may need to reduce the Isotretinoin dosage and go on a low-fat diet.

Do not take more than the recommended daily dietary allowance of vitamin A, (i.e. 4000 to 5000 International Units). If you take vitamins, check the label to see how much vitamin A they contain. If you are not sure, ask your doctor or pharmacist.

If you get severe diarrhoea, stop taking Isotretinoin Capsules straight away and contact your doctor.

Your night vision may be affected by this medicine and you may develop dry eyes or sight problems, but these rarely persist after treatment. If this happens, tell your doctor immediately, so he can monitor your vision. These changes can happen quite suddenly, so always be cautious when driving or operating machinery at night.

You may become more sensitive to sunlight while taking this medicine. Avoid too much sun and do not use a sunlamp or sunbed. Before going out in the sun apply a sun block to exposed skin, particularly in strong sunlight.

Isotretinoin may make your skin more fragile, so vigorous abrasion of the skin and wax epilation during and for at least 6 months after treatment should be avoided as they could cause scarring or irritation of the skin.

You should not use any other acne treatments unless told to do so by your doctor.

CAN I DONATE BLOOD?

Do not donate blood during therapy or for at least one month after treatment with isotretinoin.

Isotretinoin will damage an unborn baby so:

• You must not take Isotretinoin Capsules if you are pregnant or think you may be pregnant.
• You must not take Isotretinoin Capsules if you are breast-feeding.
• You must use an effective method of birth control for one month before Isotretinoin treatment, during treatment and for one month after treatment ends.
• Your doctor will ask you to take a pregnancy test before, during and after your treatment.  These must be negative. You should start taking Isotretinoin Capsules on the second or third day of your menstrual cycle.
• You must not become pregnant at any time during treatment or for one month after treatment ends.
• Contact your dermatologist immediately if you do become pregnant or think you may be pregnant during treatment or in the first month after treatment ends.

WHAT ARE THE CONCERNS FOR MALE PATIENTS?

Isotretinoin treatment does not appear to damage sperm. Isotretinoin and its metabolites are present at very low levels in your semen. These levels are considered too low to harm the unborn baby of your female partner.

HOW DO I TAKE ISOTRETINOIN CAPSULES?

Always take the capsules as your doctor tells you to.  Your doctor will tell you how many capsules to take, which may change after a few weeks of treatment. This will depend on how you respond to your medicine. Normally, you should not take more than 1mg of isotretinoin per kilogram of bodyweight per day.
 
The capsules can be taken either once a day or in two divided doses during the day. Take them with a meal or with a glass of milk. Swallow the capsules whole, do not suck or chew them.

For a few patients, the acne may get worse during the first 7 - 10 days of treatment. Your acne should improve with continued treatment.  A course of treatment generally lasts for 12 to 16 weeks after which you are likely to remain free of acne for a long time. Repeated courses of therapy are not normally needed, but if your acne does re-occur significantly, your dermatologist may decide on a further course of treatment. However, only if a definite relapse is seen in the post-treatment period should a repeated course be considered.

If your acne has not completely cleared after finishing treatment you can expect it to continue to improve over the next few months. Do not carry on taking this medicine unless your dermatologist tells you to.

WHAT IF I FORGET TO TAKE MY ISOTRETINOIN CAPSULES?

If you miss a dose, take it as soon as possible. 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.

WHAT IF I TAKE TOO MUCH OR SOMEONE ELSE TAKES ANY CAPSULES?

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

Your doctor has prescribed this medicine for you. Never give it to others as it may harm them, even if their symptoms are the same as yours.

DOES THIS MEDICINE CAUSE UNDESIRABLE EFFECTS?

As with all medicines Isotretinoin Capsules may cause some undesirable effects in some patients. These effects often wear off as your treatment continues and your doctor can help you to deal with them. 

The most common of these are dryness of the skin, especially of the lips and face and you may get inflamed or chapped lips, a rash, some mild itching and slight peeling.

Dryness of the throat may cause hoarseness. The skin may become more fragile and redder than usual. This dryness can be relieved by the regular use of a good moisturising cream from the start of treatment. Petroleum jelly is particularly good. The inside of the nose may become dry and "crusted", which may lead to mild nosebleeds. Applying a thin layer of petroleum jelly gently to the inside of the nose will help.

Your eyes may feel dry and slightly irritated. This may especially be a problem if you wear contact lenses. Ask your pharmacist to suggest some suitable eye drops to help.
Some people have muscle aches and pains and occasionally soreness of the tendons when they are on this medicine. This may be more likely to occur if you take vigorous exercise. Also, you may experience some arthritic pain.

You may notice some changes to your hair (either a loss or, rarely, an increase) after taking this medicine for a while. This is usually only temporary and persistent hair thinning is rare. Your hair should return to normal after the treatment ends.

Some people have experienced mood changes (depression or symptoms of mental disorders) and in rare cases suicide and attempts of suicide whilst taking Isotretinoin.

Other less common undesirable effects include headaches, feeling sick, tiredness, sweating, menstrual changes, slight loss of hearing, changes in vision (including colour vision disturbances), jaundice, liver disease, anaemia, seizures, inflammatory bowel disease, inflammation of the pancreas, systemic infections, local bacterial infections such as infection of the tissue around the base of the nail, changes in the nails, increased facial pigmentation, swellings discharging pus, swollen glands, inflammation of blood vessels (sometimes with bruising and red patches), blood in the urine, diabetes, changes in blood glucose levels especially in diabetics and asthma especially in people who have previously suffered from asthma or have allergies to certain substances. Most of the unwanted effects of Isotretinoin will disappear when you stop treatment.

More rarely, the levels of a substance in your blood known as uric acid may increase. If you suffer from gout, this could trigger an attack. Very high levels of uric acid may affect your kidney function.

In a few people, the cells involved with the clotting of your blood may be affected, which means that you may bruise or bleed more easily.

Leukocytes, which are cells in your blood involved in fighting infections, may also decrease in number. This makes you more at risk of developing an infection.

If your sight is affected by this medicine tell your doctor straight away and do not drive or operate machinery.

Use of high doses of Isotretinoin for periods in excess of the normal course of treatment may cause bone changes, but these are very unlikely during a normal course of treatment.

If you are concerned about these or any other unwanted effects talk to your doctor.

WHAT IS THE EXPIRY DATE?

The expiry date is printed on the outside of the pack with the product batch number.

HOW SHOULD I STORE ISOTRETINOIN CAPSULES?

Keep this medicine out of the reach and sight of children.

This medicine must not be used after the expiry date printed on the pack. Return any left over medicine to your pharmacist.

Do not store above 25°C.  Store in the original container to protect from light.

HOW CAN I GET FURTHER INFORMATION?

This leaflet does not include all the information about this medicine.  If you have any questions or are not sure about anything, ask your doctor or pharmacist.