Patient Leaflet Updated 30-Apr-2019 | Alliance Pharmaceuticals
Package leaflet: Information for the user
ISOTRETINOIN 5MG AND 20MG CAPSULES
CAN SERIOUSLY HARM AN UNBORN BABY
Women must use effective contraception
Do not use if you are pregnant or you think you may be pregnant
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Isotretinoin is and what it is used for
2. What you need to know before you take Isotretinoin Capsules
3. How to take Isotretinoin Capsules
4. Possible side effects
5. How to store Isotretinoin Capsules
6. Contents of the pack and other information
1. WHAT ISOTRETINOIN IS AND WHAT IT IS USED FOR
Isotretinoin belongs to a group of medicines known as retinoids that are normally used to treat skin problems.
Isotretinoin Capsules are used to treat severe acne (such as nodular or conglobate acne, or acne that is at risk of causing permanent scarring) in adults and adolescents from 12 years of age only after puberty. Isotretinoin Capsules are for patients whose acne has not responded to other treatments.
Their use must be supervised by a dermatologist (a doctor who specialises in the treatment of skin problems).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOTRETINOIN CAPSULES
Do not take Isotretinoin Capsules if:
Warnings and precautions
Talk to your doctor or pharmacist before taking Isotretinoin Capsules.
Pregnancy prevention programme
Women who are pregnant must not take Isotretinoin Capsules
This medicine can seriously harm an unborn baby (the medicine is said to be ‘teratogenic’) – it can cause serious abnormalities of the unborn baby’s brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland). It also makes a miscarriage more likely. This may happen even if Isotretinoin capsules is taken only for a short time during pregnancy.
Women who could get pregnant are prescribed Isotretinoin Capsules under strict rules. This is because of the risk of serious harm to the unborn baby.
These are the rules:
Women must use effective contraception before, during and after taking Isotretinoin Capsules
Women must agree to pregnancy testing before, during and after taking Isotretinoin Capsules
If you get pregnant while taking Isotretinoin Capsules, stop taking the medicine straight away, and contact your doctor. Your doctor may send you to a specialist for advice.
Also, if you become pregnant within one month after you stop taking Isotretinoin Capsules, you should contact your doctor. Your doctor may send you to a specialist for advice.
Your doctor has written information on pregnancy and contraception for the users of Isotretinoin Capsules which he or she should show you. If you haven’t seen this material already, ask your doctor.
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.
Advice for men
The levels of oral retinoid in the semen of men taking Isotretinoin Capsules are too low to harm their partners’ unborn baby. However, you must never share your medication with anyone.
Mental health problems
You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that you are taking this medicine. They may notice these changes and help you quickly identify any problems that you need to talk to your doctor about.
Advice for all patients:
You should never give this medicinal product to another person. Please take any unused Isotretinoin Capsules to your pharmacist at the end of treatment.
You should not donate blood during treatment with this medicine and for 1 month after stopping Isotretinoin Capsules because an unborn baby could be harmed if a pregnant patient receives your blood.
Children and adolescents
The use of Isotretinoin Capsules in children under the age of 12 is not recommended.
This is because it is not known if it is safe or effective in this age group.
Use in adolescents over 12 years of age only after puberty.
Other medicines and Isotretinoin Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines including herbal and non-prescription products.
Isotretinoin Capsules with alcohol
It is best that you do not drink alcoholic drinks or that you at least reduce the amount you usually drink while on treatment.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
For more information on pregnancy and contraception, see section 2 “Pregnancy and prevention programme”.
Isotretinoin Capsules must not be used during pregnancy. If you are able to get pregnant, you should use effective contraception one month before, during and up to one month after isotretinoin treatment.
If you do get pregnant while taking Isotretinoin Capsules, 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.
If used during pregnancy, Isotretinoin Capsules are likely to damage your unborn baby (in medical language it is teratogenic). It also increases the risk of miscarriage.
Isotretinoin Capsules can cause serious abnormalities of brain, face, ear, eye, heart and some glands (called the thymus gland and parathyroid gland) of the unborn baby.
You must not take Isotretinoin Capsules if you are breast-feeding. The medicine is likely to pass into your breast milk and may harm your baby.
Driving and using machinery
Your night vision may be affected by this medicine and you may develop dry eyes or sight problems. These changes can happen quite suddenly, so always be cautious when driving or operating machinery at night. Other visual disturbances, drowsiness or dizziness have been reported very rarely. If you experience any of these, you should not drive or operate machinery.
Isotretinoin Capsules contain sorbitol, maltitol and soya
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Isotretinoin Capsules contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
3. HOW TO TAKE ISOTRETINOIN CAPSULES
Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure.
Adolescents, adults and the elderly:
The recommended starting dose is 0.5mg/kg daily, e.g. if you weigh 60kg your starting dose will be 30mg/day. Normally, you should not take more than 1mg of isotretinoin per kilogram of bodyweight per day.
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. For most patients the dose will be between 0.5 and 1.0 mg/kg/day. If you think that Isotretinoin Capsules are 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 10 mg/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 normal course of treatment lasts between 16-24 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.
For a few patients, the acne may get worse during the first 7-10 days of treatment. Your acne should improve with continued treatment and may continue to improve for a few months after completion of the treatment course. Do not carry on taking this medicine unless your doctor tells you to.
Use in children:
Isotretinoin must NOT be used to treat children less than 12 years of age or before the onset of puberty.
If you take more Isotretinoin Capsules than you should
If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.
If you forget to take 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 to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Some of the side effects associated with the use of isotretinoin are related to the dose. The side effects are generally reversible after changing the dose or stopping treatment, however some may continue after treatment has stopped.
Stop taking the capsules and contact your doctor IMMEDIATELY if any of the following occur:
Contact your doctor IMMEDIATELY if you get any of the following symptoms.
Rare effects (may affect up to 1 in every 1,000 people)
Very rare effects (may affect up to 1 in every 10,000 people)
Contact your doctor straight away if you get signs of any of the above mentioned mental problems. Your doctor may tell you to stop taking Isotretinoin Capsules. That may not be enough to stop the effects: you may need more help, and your doctor can arrange this.
Other side effects:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Rare side effects (may affect up to 1 in every 1,000 people):
Very rare side effects (may affect up to 1 in every 10,000 people):
Unknown frequency: (frequency cannot be estimated from the available data)
Most of the unwanted effects of Isotretinoin will disappear when you stop treatment.
If you are concerned about these or any other side effect talk to your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE ISOTRETINOIN CAPSULES
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container to protect from light. Do not use this medicine after the expiry date printed on the pack. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Isotretinoin Capsules contain:
Each capsule contains 5 or 20mg of the active ingredient isotretinoin.
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.
What Isotretinoin Capsules look like and contents of the pack:
The soft gelatin capsules are red/orange, the 5mg are marked ‘P5’, the 20mg are marked ‘P20’. Each pack contains either 30 or 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This leaflet was last revised in February 2019.
Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2019.
Isotretinoin 5 & 20mg PIL UK 007
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
+44 (0)1249 466 966
+44 (0)1249 466 977