contains the active ingredient isotretinoin
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Rocta capsules. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Rocta capsules against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Rocta is used for
Rocta contains the active ingredient isotretinoin.
Rocta is used to treat acne.
Rocta belongs to a group of medicines called retinoids, which are similar to vitamin A.
The retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands in your skin, reducing bacteria, reducing inflammation and opening clogged pores.
There are many different types of medicines used to treat acne. Rocta is used for more severe cases.
Your doctor, however, may have prescribed Rocta for another purpose.
Ask your doctor if you have any questions about why Rocta has been prescribed for you. This medicine is available only with a doctor’s prescription.
Rocta is not addictive.
Before you take it
When you must not take it
Do not take Rocta if:
- you are pregnant, or for at least one month before you plan to fall pregnant
If you fall pregnant while taking Rocta there is an extremely high risk of having a baby that is severely deformed. You must use effective contraception for one month before, during and one month after treatment. - you are breastfeeding
Breastfeeding must stop before treatment begins. Do not breastfeed while taking Rocta. - you have had an allergic reaction to Rocta, vitamin A, other retinoids or any other ingredients of Rocta (listed at the end of this leaflet)
- you are taking tetracycline antibiotics (such as Akamin®, Vibramycin®, Doxycycline hydrochloride, Doryx®, Frakas®, Minomycin®)
- you have severe liver disease
- you have very high fat levels (cholesterol, triglycerides) in your blood
- you have hypervitaminosis A
This is a condition caused by an excessive amount of vitamin A in the diet. - the packaging is torn or shows signs of tampering
- the expiry date (EXP) printed on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should start taking Rocta, contact your doctor.
Do not give Rocta to children. There is limited information on the use of Rocta in children before puberty.
Before you start to take it
Tell your doctor if:
- you have any allergies to any other medicines, foods, preservatives or dyes
Rocta capsules contain soya oil, which may contain traces of arachidic acid (a component of peanut oil) - you have or have had any other health problems or issues including:
- diabetes, or a history of diabetes in your family
- depression
- liver disease
- kidney disease
- lipid (cholesterol or triglyceride) disorder
- hormone disorder
- stomach or bowel disease
- you drink large amounts of alcohol.
If you have not told your doctor about any of the above, tell them before you start taking Rocta.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription, from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Rocta. These include:
- tetracycline antibiotics (such as Akamin, Doxycycline hydrochloride, Frakas, Vibramycin, Doryx, Minomycin)
- vitamin A, or preparations containing vitamin A (including vitamin supplements)
- other medicines you are using to treat your acne
- the “mini-pill”, a progestogen-only oral contraceptive pill.
These medicines may be affected by Rocta, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Rocta.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
How to take it
How much to take
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
Take Rocta exactly as your doctor has prescribed. Your doctor will tell you how many Rocta capsules to take each day.
This dose will be calculated to suit your individual needs and your body weight. This dose may be adjusted during treatment when the doctor knows how you respond to Rocta.
How to take it
Capsules should be swallowed whole with a glass of water or milk.
Do not open the capsules and do not take any capsules that are damaged.
When to take it
Rocta may be taken once or twice a day and must always be taken with meals.
Female patients should wait until the 2nd or 3rd day of the next normal menstrual period before starting Rocta treatment. This helps ensure that you aren’t pregnant before you start taking Rocta.
How long to take it
Continue taking Rocta for as long as your doctor prescribes.
Acne treatment with Rocta will usually last 4 to 8 months. In the first few weeks of treatment your acne will probably get a little worse before it gets better.
Do not worry about this, it is a sign that Rocta is working.
At the end of this time your acne should have cleared up significantly. Most patients notice their skin condition continues to improve even after Rocta treatment is finished. Please note that Rocta cannot improve scars or pitting that were present before treatment started, but it will help prevent such skin damage in the future.
If you forget to take it
Do not try to make up for missed doses by taking an extra dose. This may increase the chance of getting an unwanted side effect.
If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.
If you have missed several doses, please inform your doctor and follow the advice given to you.
If you take too much (overdose)
Immediately telephone your doctor, or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Rocta. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Signs of overdose include transient headache; vomiting; facial flushing; reddened, cracked lips; stomach pain; headache; dizziness and unsteady walking.
Keep telephone numbers for these places handy.
While you are taking it
Things you must do
If you become pregnant while taking Rocta, stop taking it and tell your doctor immediately. Rocta can cause birth defects (damage to unborn babies). You must use strict birth control, starting at least 1 month before you begin taking Rocta, for the whole time you are taking Rocta and for 1 month after you finish taking Rocta.
There is no known risk to males who wish to father children.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Rocta.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel Rocta capsules are not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor may ask you to have regular blood tests to monitor your liver function, blood sugar levels and blood cholesterol levels.
If you are intending to do a lot of heavy lifting or exercise, tell your doctor. Your muscles and joints may be more prone to tenderness or stiffness if you do a lot of heavy exercise while taking Rocta.
Things you must not do
Do not stop taking Rocta or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give Rocta to anyone else even if their symptoms seem similar to yours.
Do not use Rocta to treat other complaints unless your doctor says to.
Do not donate blood during treatment with Rocta or for at least 1 month after stopping treatment.
Things to be careful of
Be careful driving or operating machinery until you know how Rocta affects you. Normally Rocta would not affect your ability to drive a car or operate machinery. However altered night vision and other visual disturbances may occur when taking Rocta. Make sure you know how you react to Rocta before you drive a car, operate machinery or do anything else that may be dangerous if your vision is affected.
Wearing contact lenses during treatment with Rocta may cause discomfort. Rocta may cause dry eyes. An eye lubricant or artificial tears, available from your pharmacist, should relieve this problem. Otherwise, you may temporarily need to wear your lenses for shorter periods or wear glasses instead.
Avoid excessive sun exposure and solariums and apply a sunscreen while taking Rocta. Your skin may be more prone to sunburn while on Rocta.
Avoid waxing and dermabrasion while taking Rocta and for 5 to 6 months after stopping Rocta treatment. Your skin may be more sensitive while on Rocta. Waxing may cause dermatitis and dermabrasion may cause scarring during and for several months after Rocta treatment.
Avoid using facial peels, electrolysis and some hair treatments. Your skin and hair may be more delicate during treatment and for a while after Rocta treatment.
Side effects
Rocta helps most people with acne but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- dryness of the lips, mouth, nose and skin
A moisturiser or petroleum jelly can be used to soften the lining of the nose, lips and the skin areas not affected by the acne - fragile skin
- change in colour of the skin
- peeling palms of the hands and soles of the feet
- itchy skin rash
- an increased susceptibility to sunburn
- sweating
- changes to the nails
- eye problems such as dry, sore, swollen or itchy eyes, discharge or trouble seeing at night
- nosebleeds
- tenderness or stiffness in your bones, joints or muscles
- tiredness
- headache
- hair loss (sometimes occurs and is usually temporary but in rare cases, has persisted)
- excessive hairiness
- hoarseness
These side effects are usually mild and dose related. Most of them disappear completely in a few days to a few weeks after the dose of Rocta is lowered or stopped.
Tell your doctor immediately if you experience any of the following:
- nausea
- vomiting
- persistent headache
- blurred vision or visual disturbances
- changes in your hearing or ringing in your ears
- severe upper stomach pain
- blood in stools or severe diarrhoea
- severe bruising
- sudden red, often itchy spots, similar to the rash of measles starting on the face, hands or feet. The spots may blister or change to flat round raised, red, pale-centred marks. Also, you may have fever, sore throat, headache and/or diarrhoea
- painful red areas, that change to large blisters and end with peeling of layers of skin, that may occur on lips, mouth, eyes, nose and genitals. Those affected may have fever and chills, aching muscles and generally feel unwell
- thinking, seeing or hearing things that are not real
- feeling depressed, with or without suicidal thoughts
Symptoms of depression may include:
- feeling sad or having crying spells
- losing interest in activities you once enjoyed
- sleeping too much or having trouble sleeping
- changes in your appetite or body weight
- having trouble concentrating
- withdrawing from your friends or family
- feeling like you have no energy
- feelings of worthlessness or inappropriate guilt
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don’t understand anything in this list.
After taking it
Storage
Keep your capsules in the blister pack until it is time to take them. If you take the capsules out of the packaging they will not keep well.
Keep the blister pack in a cool dry place where the temperature stays below 25°C.
Do not store Rocta, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep Rocta where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Protect Rocta from light.
Disposal
If your doctor tells you to stop taking Rocta, or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules that are left over.
Product description
Availability
Rocta capsules come in two strengths, 10 mg and 20 mg.
Rocta 10 mg and 20 mg capsules are available in packs of 60 capsules.
What the tablets look like
- 10 mg – red-orange, size 3, oval, soft gelatin capsules marked P10
- 20 mg – red-orange, size 6, oval, soft gelatin capsules marked P20
Ingredients
Active ingredient – isotretinoin
- each 10 mg capsule contains 10 mg isotretinoin
- each 20 mg capsule contains 20 mg isotretinoin.
Inactive ingredients –
The capsules also contain:
- Soya oil,
- beeswax – yellow,
- soya oil – hydrogenated and – partially hydrogenated.
The capsule shell contains
- gelatin,
- glycerol,
- titanium dioxide,
- ferrous oxide red and yellow.
The printing uses Videojet Inksource 16-9000 ink, which contains Brilliant Blue FCF and shellac.
Manufacturer
Rocta is distributed in Australia by:
Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Registration Number
10 mg: AUST R 165124
20 mg: AUST R 165125
Sponsor
Southern Cross Pharma Pty Ltd
56 Illabunda Drive
Malua Bay NSW 2536
ABN 47 094 447 677
Date of Information:
December 2012
Published by MIMS October 2015