Consumer Medicine Information
NEOTIGASON®
Acitretin
10 mg or 25 mg capsules
What is in this leaflet
This leaflet answers some common questions about NEOTIGASON 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 your taking NEOTIGASON capsules against the benefits expected 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 is NEOTIGASON used for?
NEOTIGASON contains the active ingredient acitretin.
NEOTIGASON is used to treat severe psoriasis (skin disease with thickened patches of red skin, often with silvery scales) and other severe disorders of the skin.
NEOTIGASON belongs to a group of medicines called retinoids, which are very similar to Vitamin A. Vitamin A, which we obtain from food, is important for the normal growth and development of the body, especially the skin. In severe psoriasis and some other skin disorders, where there is a problem with the normal development of the skin, NEOTIGASON helps return the skin to normal.
Your doctor may have prescribed NEOTIGASON for another purpose. Ask your doctor if you have any questions why NEOTIGASON has been prescribed for you.
NEOTIGASON is available only with a doctor's prescription.
Before you take NEOTIGASON
Do not take NEOTIGASON if:
- you are pregnant, or there is a possibility that you may be pregnant. The possibility that you may be pregnant must be ruled out by you and your doctor before you start taking NEOTIGASON. A pregnancy test must be negative when performed within two weeks before beginning of treatment. NEOTIGASON is highly teratogenic and there is an extremely high risk that a severely deformed baby will result. You must use effective contraception, without interruption, for one month before treatment with NEOTIGASON, during treatment and for 2 years after treatment has stopped. Low dose progesterone only contraceptive pills ("mini-pills") are NOT a sufficiently reliable form of contraception, and alternative forms of contraception should be used.
- you are breastfeeding. Breastfeeding must be stopped before treatment starts and not started again while you are taking NEOTIGASON.
- you are taking Vitamin A, or preparations containing Vitamin A or other Vitamin A like substances (retinoids)
- you are taking tetracycline antibiotics such as doxycycline (Doxine®, Doxy-50®), minocycline (Minomycin®, Minotabs®)
- you have severe liver or kidney disease or abnormally high fat levels in your blood
- you are taking methotrexate (Methoblastin®)
- you have had an allergic reaction to NEOTIGASON, Vitamin A, other retinoids or any ingredients listed in the Ingredients section of this leaflet
Do not take NEOTIGASON after the expiry date (EXP) printed on the pack. It may have no effect or an entirely unexpected effect if you take it after the expiry date.
Do not take NEOTIGASON if the package is torn or shows signs of tampering.
If you are not sure if you should be taking NEOTIGASON, talk to your doctor or pharmacist.
You must tell your doctor if:
You are allergic to any other medicines, foods, dyes or preservatives
You have any other health problems including:
- diabetes
- liver disease
- high blood fat levels (cholesterol or triglyceride levels) in the blood
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood shop.
Other medicines may interfere with NEOTIGASON. These medicines include:
- tetracycline antibiotics such as doxycycline (Doxine®, Doxy-50®), minocycline (Minomycin®, Minotabs®)
- Vitamin A supplements, or preparations containing Vitamin A or other Vitamin A like substances (retinoids)
- phenytoin (Dilantin®)
- methotrexate (Methoblastin®)
Your doctor or pharmacist has a complete list of medicines to avoid while taking NEOTIGASON.
If you have not told your doctor about any of the above, tell them before you start taking NEOTIGASON.
Use in Children
NEOTIGASON should only be used in children if all alternative therapies either cannot be used or have been tried and have not worked. If you or your child have any concerns regarding using NEOTIGASON, talk to your doctor.
How to take NEOTIGASON
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
How much to take
Take NEOTIGASON exactly as your doctor has prescribed.
Your doctor will tell you how many NEOTIGASON capsules to take each day. This quantity will be especially matched to your needs and whether you develop any side effects.
The initial dose for adults is usually 25 mg (one 25 mg capsule) or 30 mg (three 10 mg capsules) per day for 2 to 4 weeks. Your dose is likely to then be adjusted, probably to around 25mg to 50mg per day for another 6 to 8 weeks. The usual maximum daily dose is 75mg per day.
For children the daily dose is about 0.5mg per kg bodyweight. Higher doses of 1mg per kg bodyweight may be used for short periods up to a maximum of 35mg per day.
You may notice the first signs of improvement during the first week but, more often, after 2 or 3 weeks. It may take 2 to 3 months before the full effect is seen.
The affected skin will either peel off or gradually clear. Sometimes there will be more redness or itching at first, but this will normally improve as treatment continues.
How to take NEOTIGASON
Capsules should be swallowed whole with a glass of water or milk.
When to take it
NEOTIGASON is usually taken once daily and should be taken with meals or with a glass of milk.
How long to take NEOTIGASON
Continue taking NEOTIGASON until your doctor tells you to stop.
If you forget to take NEOTIGASON
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.
Do not double a dose to make up for one you have missed.
If you are not sure what to do, ask your doctor or pharmacist. If you have
trouble remembering your dose, ask your pharmacist for some hints.
In case of overdose
Immediately telephone your doctor or the National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency, if you think that you or anyone else may have taken too much NEOTIGASON. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep telephone numbers for these places handy.
Symptoms of overdose are the same as those with excessive Vitamin A, and include headache, vertigo (a sensation of spinning or whirling) and/or dizziness. You should recover without any after effects. You may need some tests to see if your liver has been affected.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking NEOTIGASON
Things you must do
Tell all doctors, dentists, and pharmacists who are treating you that you are taking NEOTIGASON.
You must use effective contraception, without interruption, for at least
1 month before you start NEOTIGASON and for the whole time you are taking
NEOTIGASON and for at least 2 years after you finished taking NEOTIGASON.
Therapy should be started on the second or third day of your next normal
menstrual period.
Stop taking NEOTIGASON immediately and tell you doctor if you do become pregnant while you are taking NEOTIGASON. You must also tell your doctor if you become pregnant in the two years following the end of treatment.
Tell your doctor immediately 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.
Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor may want to do some blood, liver function and other tests from time to time to check on your progress and detect any unwanted side effects.
You should not take alcohol during treatment. Alcohol should also be avoided for 2 months after stopping treatment with NEOTIGASON.
Things you must not do
Do not stop taking NEOTIGASON or lower the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not donate blood during treatment or for at least 1 year after stopping treatment.
Do not give NEOTIGASON to anyone else even if their symptoms seem similar to yours.
Do not use NEOTIGASON to treat other complaints unless your doctor says to.
Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or consulting a pharmacist.
Things to be careful of
Normally your ability to drive cars or operate machinery will not be affected by NEOTIGASON, but your night vision may be affected. You should be sure that your vision is undisturbed before you drive a car or operate machinery at night after taking NEOTIGASON.
Wearing contact lenses during treatment and for a little while after treatment with NEOTIGASON may cause discomfort. An eye lubricant, or artificial tears, should assist with this problem. Otherwise you may temporarily need to wear glasses.
Your skin may become more sensitive to sunburn while on NEOTIGASON. Avoid excessive sun exposure and apply a sunscreen when outside while taking NEOTIGASON.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NEOTIGASON.
NEOTIGASON helps most people with skin conditions but it may have unwanted side effects in some 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. Ask your doctor or pharmacist to answer any questions you may have.
If side effects do occur they may be:
- dryness of the lips, mouth, nose, eyes and skin. A moisturizer or petroleum jelly can be used to soften the lining of the nose, lips and the skin. Occasionally this may lead to nosebleeds, chapping and/or cracking of the lips, inflammation of the lips, nasal membranes, gums or mouth, or disturbed vision or taste
- increased occurrence of vaginal thrush
- thinning or peeling of the skin that was not previously affected (for example, hands and feet)
- sticky skin, rash, redness of the skin, blistering or itchiness may occur
- hair loss or a change of hair texture sometimes occurs
- inflammation of the nails, or nails that easily break can occur
- dry mouth, thirstiness
- flushing
- swelling, puffiness
- diarrhoea
- rarely, increased sensitivity to the sun
These side effects will probably stop after the dose of NEOTIGASON is lowered or stopped.
Tell your doctor if you notice any of the following:
- unusually severe or persistent headaches
- nausea and/or vomiting
- visual disturbances
- tenderness or stiffness in your joints or muscles or bones
- yellowing of the skin (jaundice)
These side effects could mean that the dose of NEOTIGASON needs to be adjusted.
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. Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking NEOTIGASON
Keep your capsules in the blister pack until it is time to take them. If you take the capsules out of the blister pack they may not keep well.
Keep NEOTIGASON capsules in a cool, dry place where the temperature stays below 25°C. Do not store it, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.
Protect NEOTIGASON from light.
Keep NEOTIGASON 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.
Disposal
If your doctor tells you to stop taking NEOTIGASON, or the capsule has passed its expiry date, you should return any capsules remaining to your doctor or pharmacist.
Product Description
What NEOTIGASON looks like
NEOTIGASON 10mg capsules are oval shaped with one half brown and one half white. "Roche" is printed on each half.
NEOTIGASON 25mg capsules are oval shaped with one half brown and one half yellow. "Roche" is printed on each half.
Ingredients
NEOTIGASON contains the active ingredient acitretin.
NEOTIGASON Capsules come in 2 strengths, containing 10 mg or 25 mg acitretin. The capsules also contain the following inactive excipients: gelatin, glucose liquid spray-dried, sodium ascorbate and microcrystalline cellulose. The capsule shells are coloured with iron oxide black (E172), iron oxide yellow (E172), iron oxide red (E172) and titanium dioxide (E171).
NEOTIGASON capsules are gluten free and lactose free.
NEOTIGASON capsules come in cartons of 100.
Distributor
NEOTIGASON is distributed by:
Roche Products (New Zealand) Ltd
P O Box 12-492
Penrose
AUCKLAND
Telephone: (09) 633 0700
Toll Free: 0800 656 464
This leaflet was last prepared on 28 June 2007.
Reference: New Zealand Data Sheet dated 28 June 2007.