Oratane Side Effects

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

What is Oratane?

Oratane contains the active ingredient Isotretinoin.

• Active ingredient — Isotretinoin
• Registration number — 34/13.4.2/0356; 34/13.4.2/0357
• Registration holder — Adcock Ingram Limited

It is approved for:

• ACNETANE contains per capsule 10 mg or 20 mg isotretinoin
• ACNETANE is a chemical derivative of vitamin A and it 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 therefore prevents the formation of acne lesions
• ACNETANE is given as a 16-24 week first course of treatment, depending on the daily dose taken

Common side effects of Oratane

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.

Frequent side effects

• Anaemia (weakness, tiredness, pale skin)
• More liable to get infections (occurs if white blood cells are affected)
• Bruising, bleeding or clotting more easily (occur if clotting cells are affected)
• Headache
• Red, swollen and itchy eyelids
• Dry eyes, Conjunctivitis (Pink Eye)
• Nose bleeds and dry nose
• Raised liver enzymes (seen in blood tests)
• Chapped lips
• Dryness, itching or crusting of the skin
• Peeling of skin on palms of hands or soles of feet
• Red or pink skin rash
• Skin fragility
• Joint pain, back pain or muscle pain
• Changed levels of fats in the blood (including HDL or triglycerides)
• Decreased high-density lipoprotein
• Increased blood sugar
• Blood in urine
• Protein in urine

Less frequent side effects

• Swollen lymph nodes
• Excessive thirst; frequent need to urinate; blood tests show an increase in your blood sugar. These can all be signs of diabetes
• High calcium in urine
• Depression
• Aggressive tendencies
• Anxiety
• Mood changes
• Suicidal thoughts or suicide attempt
• Headache with visual disturbances
• Seizures
• Drowsiness (Sleepiness)
• Blurry or cloudy vision
• Decreased night vision
• Colour blindness
• Cloudy surface on the eye
• Sensitivity of eyes to light
• Poor hearing
• Inflammation of blood vessels
• Wheezing or coughing
• Hoarseness (voice change)
• Severe stomach pain, bloody diarrhoea, nausea or vomiting
• Yellowing of the eyes or skin
• Hair loss
• Excessive facial, chest and back hair in women
• Severe or worsened acne
• Inflammation and abnormal changes to the nails
• Redness of the face or cheeks
• Sensitivity of the skin to heat
• Darkening of areas on the skin
• Increased sweating
• Increase of small, red ,“Cobberstone-like” bumps on skin
• General feeling of unwellness or discomfort
• Bacterial infection

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

• if you are hypersensitive (allergic) to isotretinoin or any of the other ingredients of ACNETANE, to any other medicines, or to soya (listed in section 6)
• If you are pregnant or intend to become pregnant or breastfeeding your baby
• 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 you are receiving treatment with tetracyclines (a type of antibiotic) at the same time

Use with care, and tell your doctor, if

• 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 ACNETANE with these medicines may cause undesirable

Pregnancy and breastfeeding

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

Interactions and medicines to check

The approved leaflet names these interactions.

• Exfoliating anti-acne preparations should NOT be used while you are taking ACNETANE. 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 ACNETANE. Make sure that any multivitamins you take do not contain vitamin A
• Do not have any wax treatment to remove hair while you take ACNETANE Capsules and for 6 months after you stop treatment
• ACNETANE 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
• ACNETANE has been associated with serious skin reactions. Any rash may become serious. Stop using ACNETANE 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
• ACNETANE 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 ACNETANE
• ACNETANE 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 ACNETANE or for 30 days after you stop taking it
• This is to avoid the possibility of a pregnant woman receiving your blood that contains ACNETANE
• Acnetane can affect your liver. Liver function tests should be conducted prior to onset of therapy and one month after commencement of treatment. Thereafter liver function tests should be conducted at three monthly intervals. IMPORTANT INSTRUCTIONS AND WARNINGS FOR FEMALE PATIENTS:
• There have been reported cases of a disorder related to high pressure in the brain. Call your doctor if you experience visual disturbances, headache, nausea and vomiting
• Acnetane may lead to psychosis, depression and infrequently suicidal behaviour
• Acnetane may result in an increase in cholesterol levels
• Acnetane therapy can cause abdominal pain, severe diarrhoea or rectal bleeding. Contact your doctor immediately if you experience these symptoms
• Acnetane can cause skeletal disorders associated with bone overgrowth, hardening of muscles and tendons that cause stiffness
• Patients with renal insufficiency should be started on a low dose and your doctor can increase the dose up to the maximum tolerated dose
• ACNETANE has been prescribed particularly for you. Never share medicines prescribed for you with others. Other medicines and ACNETANE Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Concomitant treatment with tetracyclines is contraindicated as cases of benign intracranial hypertension have been reported. Concomitant use of Vitamin A, including dietary supplements is not recommended due to their additive toxic effects which may result in hypervitaminosis A. ACNETANE with food and drink Take ACNETANE 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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