Roaccutane Side Effects

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Answer the side-effect intent for roaccutane without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Roaccutane?

Roaccutane contains the active ingredient Isotretinoin.

• Active ingredient — Isotretinoin
• Registration number — R/13.4.2/118; R/13.4.2/119
• Registration holder — Equity Pharmaceuticals (Pty) Ltd

It is approved for:

• Roaccutane is used to treat severe, resistant, nodular acne after other anti-acne medicines have failed to help
• It works by decreasing the activity of the sebaceous glands in the skin and prevents the formation of active acne lesions
• It takes about four weeks of treatment before the benefits of treatment can be noticed
• Roaccutane is given as a 4 – 8 month course of treatment, depending on the daily dose taken

Common side effects of Roaccutane

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• A treatment course is usually 4 – 8 months depending on the daily dose. After stopping treatment, many patients notice a further improvement and repeated courses are not usually needed. If a definite relapse does occur, a repeat course may then be given but should only be started at least 8 weeks after stopping the first course. NOTE: Roaccutane is only available on a doctor’s prescription. It is a criminal act to give it to any person who does not have a valid prescription. If you take more Roaccutane than you should Acute toxicity of Roaccutane is low. However, in case of overdose or accidental intake, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you forget to take Roaccutane If you miss a dose of Roaccutane take it as soon as you remember. If it is nearly time for the next dose, skip the missed dose and go back to your normal dosing schedule. Do not take a double dose to make up for the missed dose. 4. Possible side effects Roaccutane can have side effects. Not all side effects reported for Roaccutane are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Roaccutane, consult your doctor, pharmacist or other healthcare professional for advice. The following side effects and adverse events have been reported under Roaccutane therapy. Most of the side effects of Roaccutane are dose-related. If these effects continue, are severe or bother you, speak to your doctor or pharmacist
• Dry mouth, throat or nose
• Dry eyes and inflammation of the eye
• Dryness, itching or crusting of the skin
• Peeling of skin on palms of hands or soles of feet
• Headache or unusual tiredness
• Stomach upset
• Thinning of hair
• Burning, itching or redness of the eyes or lips
• Nose bleeds
• Skin infection, rash or scaling
• Bone or joint pain
• Raised liver enzymes
• Severe stomach pain, diarrhoea, nausea or vomiting
• Mood or mental changes
• Changes in vision or eye pain
• Severe headache or drowsiness
• Unusual bleeding
• Back pain, pain or stiffness of muscles
• Yellow eyes or skin
• Allergic reactions such as rash and itchiness
• A serious skin rash can occur in patients taking Roaccutane. Stop using Roaccutane and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like “pink eye”), a rash with fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel
• A rapid breakdown of skeletal muscle due to injury to muscle tissue (rhabdomyolysis) causing muscle pain and kidney failure. To avoid making any bone or muscle problems worse, cut down on intensive physical activity while you’re on Roaccutane

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• Tell your doctor and pharmacist if you are allergic to Roaccutane or to any of the ingredients of Roaccutane, to any other medicines, or to soya
• If you are pregnant or intend to become pregnant or breastfeeding your baby
• Tell your doctor and pharmacist if you have any other medical problems, especially high blood lipid levels, diabetes (high blood sugar), depression, liver or kidney problems

Use with care, and tell your doctor, if

• Tetracycline antibiotics, vitamin A and other anti-acne medicines should not be used whilst taking Roaccutane
• Please consult your doctor, pharmacist or other healthcare professional for advice, if you are taking other medicines on a regular basis, including complementary or traditional medicines, prescription medicines and medicines bought without a prescription, especially tetracycline antibiotics, vitamin A and other anti-acne medicines. The use of Roaccutane with these medicines may cause undesirable interactions
• Exfoliating anti-acne preparations should NOT be used while you are taking Roaccutane. Mild topical products may be used if recommended by your doctor. NOTE: It is important that you do not take vitamin A supplements while on Roaccutane. Make sure that any multivitamins you take do not contain vitamin A
• Do not have any wax treatment to remove hair while you take Roaccutane Capsules and for 6 months after you stop treatment
• Roaccutane makes your skin sensitive to the sun and UV radiation. Do NOT use a sunlamp. Avoid the sun as much as possible. Wear a good sunscreen, protective clothing and a hat when outdoors
• Roaccutane has been associated with serious skin reactions. Any rash may become serious. Stop using Roaccutane and call your doctor right away if you develop conjunctivitis (red or inflamed eyes like “pink eye”), a rash with fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel
• Roaccutane may cause dry eyes. If you wear contact lenses, you may need to use an eye- lubricating solution or wear your spectacles while you take Roaccutane
• Roaccutane may cause dry lips. Apply a lip ointment to help relieve this problem
• Roaccutane may change your night vision. If this happens, do not drive or do anything else that requires you to see well. Also, speak to your doctor. This will revert to normal after the treatment
• Do not donate blood while you are taking Roaccutane or for 30 days after you stop taking it
• This is to avoid the possibility of a pregnant woman receiving your blood that contains Roaccutane
• Roaccutane has been prescribed particularly for you. Never share medicines prescribed for you with others

Pregnancy and breastfeeding

• IMPORTANT WARNINGS FOR FEMALES Do not use Roaccutane if you are pregnant, intend becoming pregnant or are breastfeeding
• Roaccutane causes severe birth defects
• If you have child-bearing potential you must use two reliable methods of contraception while on Roaccutane, starting one month before Roaccutane therapy is started and continuing for one month after stopping Roaccutane
• Roaccutane therapy must start on the third day of menstruation
• A pregnancy test is done 2 weeks before starting treatment and may be done during Roaccutane treatment
• If you have child-bearing potential you must sign the Consent Form before starting Roaccutane therapy

Interactions and medicines to check

The approved leaflet names these interactions.

• If you are taking medicines on a regular basis, using Roaccutane at the same time with another medicine may cause undesirable interactions
• Please consult your doctor, pharmacist or other healthcare professional for advice
• Always tell your healthcare professional if you are taking other medicine
• (This includes complementary and traditional medicines)
• Roaccutane with food and drink Take Roaccutane with food or milk once or twice a day

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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