Active ingredient
- isotretinoin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 00031/0158, PL 00031/0160.
Roaccutane 10mg and 20mg Soft Capsules
Package leaflet: Information for the user
Roaccutane 10 mg and 20 mg soft capsules
isotretinoin
WARNING
CAN SERIOUSLY HARM AN UNBORN BABY
Women must use effective contraception
Do not use if you are pregnant or 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 Roaccutane is and what it is used for
2. What you need to know before you take Roaccutane
3. How to take Roaccutane
4. Possible side effects
5. How to store Roaccutane
6. Contents of the pack and other information
1. What Roaccutane is and what it is used for
Roaccutane contains isotretinoin – a substance related to vitamin A, and one of a group of medicines called retinoids (for treatment of acne).
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) in adults and adolescents from 12 years of age only after puberty. 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. What you need to know before you take Roaccutane
Do not take Roaccutane:
If any of these apply to you, go back to your doctor before taking any Roaccutane.
Warnings and precautions
Talk to your doctor or pharmacist before taking Roaccutane:
Pregnancy prevention programme
Women who are pregnant must not take Roaccutane
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 Roaccutane is taken only for a short time during pregnancy.
Women who could get pregnant are prescribed Roaccutane 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 Roaccutane
Women must agree to pregnancy testing before, during and after taking Roaccutane
If you get pregnant while taking Roaccutane, 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 Roaccutane, you should contact your doctor. Your doctor may send you to a specialist for advice.
Your doctor has written information on pregnancy prevention for the users of Roaccutane which should be given to you.
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 Roaccutane are too low to harm their partners’ unborn baby. However, you must never share your medication with anyone.
Additional precautions
You should never give this medicinal product to another person. Please take any unused 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 Roaccutane because an unborn baby could be harmed if a pregnant patient receives your blood.
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
Children and adolescents
The use of Roaccutane 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 Roaccutane
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal and non-prescription products.
Pregnancy and breast-feeding
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 contraception, pregnancy and breast-feeding, see section 2 “Pregnancy prevention programme”.
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.
Roaccutane contains sorbitol and soya-bean oil
This medicine contains 2.00 mg – 3.05 mg sorbitol in each 10 mg capsule.
This medicine contains 3.20 mg - 4.86 mg sorbitol in each 20 mg capsule.
If you are allergic to peanut or soya, do not use this medicine.
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 (0.5 mg/kg/day). So if you weigh 60 kg, your dose will usually start at 30 mg 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 1.0 mg/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 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 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
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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. Some side effects can be serious and you must immediately contact your doctor.
Side effects requiring immediate medical attention:
Skin problems
Frequency not known (frequency cannot be estimated from available data)
If you develop a serious rash or these skin symptoms, stop taking Roaccutane and contact your doctor immediately.
Mental problems
Rare effects (may affect up to 1 in every 1000 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 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)
Very rare effects (may affect up to 1 in every 10,000 people)
If you have a serious reaction, get emergency medical help immediately.
If you have any allergic reaction, stop taking Roaccutane and contact your doctor.
Bones and muscles
Frequency not known (frequency cannot be estimated from available data)
Liver and kidney problems
Very rare effects (may affect up to 1 in every 10,000 people)
Nervous system problems
Very rare effects (may affect up to 1 in every 10,000 people)
Gut and stomach problems
Very rare effects (may affect up to 1 in every 10,000 people)
Eye disorders
Very rare effects (may affect up to 1 in every 10,000 people)
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.
Other side effects:
Very common side effects with Roaccutane: (may affect more than 1 in 10 people)
To avoid making any bone or muscle problems worse, cut down on intensive physical activity while you’re on Roaccutane.
Common side effects with Roaccutane: (may affect up to 1 in 10 people)
Rare side effects with Roaccutane: (may affect up to 1 in 1,000 people)
Very rare side effects with Roaccutane: (may affect up to 1 in 10,000 people)
Unknown frequency: (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Roaccutane
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the pack and blister.
Do not store above 25° C.
Store in the original package and keep blister in the outer carton in order to protect from moisture and light.
Return left over capsules to your pharmacist. Only keep them if your doctor tells you to.
6. Contents of the pack and other information
What Roaccutane contains:
What Roaccutane looks like and contents of the pack:
Roaccutane comes in soft capsules containing either 10 mg or 20 mg isotretinoin.
The 10 mg capsules are oval, opaque, coloured brown-red and marked ROA 10.
The 20 mg capsules are oval, opaque, coloured brown-red and white and marked ROA 20.
The capsules come in blister packs of 20, 30, 50 or 100 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium, Estonia, Ireland, Latvia, Lithuania, Luxembourg, Slovenia, United Kingdom: Roaccutane Hungary: Roaccutan
This leaflet was last revised in October 2020
Other sources of information
Detailed information on this medicine is available on the web site of the member state.
United Kingdom
The Medicines and Healthcare Products Regulatory Agency (www.mhra.gov.uk)
uk-pil-roaccutane-clean-201008-10mg-20mg-caps
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