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This leaflet answers some of the common questions about NOVATRETIN capsules.
It does not contain all the information that is known about NOVATRETIN. 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 taking NOVATRETIN against the benefits they expect it will have for you. If you have any concerns about taking NOVATRETIN capsules, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
The active ingredient in NOVATRETIN capsules is acitretin, which belongs to a group of medicines called retinoids. It is very similar to Vitamin A which is obtained from our diet and is vital for the normal growth and development of the body, especially the skin.
Psoriasis is a skin disease with thickened patches of red skin, often with silvery scales. NOVATRETIN is used to treat severe psoriasis and other severe skin disorders. NOVATRETIN works to return skin to normal when problems with the normal development of the skin are present, as in the case of severe psoriasis and some other skin disorders.
You may have been prescribed NOVATRETIN by your doctor for another reason. If you have any questions about why NOVATRETIN has been prescribed for you, ask your doctor.
NOVATRETIN is only accessible with a doctor’s prescription.
Do not take NOVATRETIN capsules if:
Do not use NOVATRETIN capsules after the expiry date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.
Do not use NOVATRETIN capsules if the packaging is torn or shows signs of tampering. In such case, please return it to your pharmacist or talk to your doctor.
You must tell your doctor if:
If you are on any other medicine, including medicine bought from a pharmacy, supermarket or health shop, you must tell your doctor. Some medicines may interfere with NOVATRETIN.
These include: tetracycline antibiotics (such as Doxine®, Doxy®, Achromycin® and Minomycin®), phenytoin, the “mini-pill”, a low-dose progestogen oral contraceptive, vitamin A, or formulations that contain vitamin A.
Your doctor or pharmacist has an entire list of medicines to be avoided while taking NOVATRETIN. If you have not told your doctor about any of the above, tell her or him before starting NOVATRETIN capsules. Take NOVATRETIN capsules exactly as your doctor has prescribed to you.
NOVATRETIN capsules should only be taken by children where alternative therapy cannot be used.
Always take NOVATRETIN exactly as your doctor or pharmacist tells you to. The directions given may differ from information contained in this leaflet.
Take NOVATRETIN capsules exactly as your doctor has prescribed to you. Your doctor will determine exactly how many NOVATRETIN capsules to take each day for your condition. This will be matched especially to your needs and your bodyweight and whether you develop any side effects.
The starting dose is usually either 25 mg (1 x 25 mg capsule) or 30 mg (3 x 10 mg capsules) per day for 2 to 4 weeks. Your dose will probably then be adjusted by your doctor when it is known how you respond to NOVATRETIN capsules.
The initial signs of improvement may be seen in the first week but, more often, after 2 or 3 weeks. It may take 2 to 3 months until the full effect is seen. Affected skin areas will either peel off or steadily clear. Sometimes more redness or itching may be present at first, but this will normally improve as treatment continues.
NOVATRETIN capsules should be swallowed whole with a glass of water or milk.
NOVATRETIN capsules should be taken once daily with meals or with a glass of milk. Female patients should wait until the 2nd or 3rd day of their menstrual period before starting NOVATRETIN capsules. This helps to ensure that you are not pregnant before you start to take NOVATRETIN therapy.
Continue taking NOVATRETIN capsules for as long as your doctor prescribes.
If you forget to take NOVATRETIN take it as soon as you remember and then go back to taking it as you would normally. However, if it is nearly time for your next dose, skip the dose you missed and take your next dose when you are supposed to.
You should not make up for missing the dose by doubling (two doses at the same time) the next dose. If you are unsure what to do, consult your doctor or pharmacist.
If you have issues remembering your dose, consult your pharmacist who can offer you some hints.
Immediately, telephone your doctor or the National Poisons and Hazardous Chemicals Information Centre (0800 POISON – 0800 764 766) or go to the Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much NOVATRETIN. Do this even if there are no signs of discomfit or poisoning. You may require urgent medical attention.
Currently, no information is available on the effects of overdose with NOVATRETIN. In spite of this, based on experience with excessive vitamin A and other drugs similar to NOVATRETIN, signs of overdosage may include transient headache, vomiting, flushed face, dry skin and lips, pain in the stomach, dizziness and unco-ordination. You should recover without any after effects but may need some tests to determine if your liver has been affected.
Please keep these telephone numbers handy. If you are unsure about what to do, ask your doctor or pharmacist.
Tell all doctors, dentists and pharmacists who are treating you that you are on NOVATRETIN capsules. NOVATRETIN capsules can cause birth defects. This means that you must use strict birth control for at least 1 month before you start NOVATRETIN, the whole time you are using NOVATRETIN capsules and for at least 2 years after you finish taking NOVATRETIN capsules.
NOVATRETIN treatment should be started on the second or third day of your next normal menstrual period.
If you become pregnant while taking NOVATRETIN capsules, stop taking it immediately and inform your doctor. You must also tell your doctor immediately if you become pregnant in the 2 years following the end of treatment.
Inform your doctor if, for any reason, you have not taken this medicine exactly as prescribed. Otherwise, your doctor may think this medicine was not effective and change your treatment unnecessarily.
It is critical to keep all of your appointments with your doctor so your progress with NOVATRETIN therapy can be monitored regularly. Your doctor may ask you to do some blood, liver function and other tests from time to time in order to check your progress and pick up any unwanted side effects.
Inform your doctor if you take vitamin supplements that contain greater than 2500 IU of Vitamin A. If you are unsure about this, please check with your doctor or pharmacist.
Consumption of alcohol should be avoided during treatment. Alcohol intake should also be avoided for 2 months after finishing treatment with NOVATRETIN.
Normally NOVATRETIN capsules would not affect your ability to drive a car or operate machinery. However visual disturbances may occur while taking NOVATRETIN capsules. Make sure you know how you react to NOVATRETIN capsules before you drive a car, operate machinery or do anything else that might be dangerous if your vision is altered.
Wearing contact lenses during treatment and shortly after treatment with NOVATRETIN capsules may cause discomfort. NOVATRETIN capsules cause dry eyes so an eye lubricant, or artificial tears (available from your pharmacist) might be necessary. Otherwise you might need to compensate by wearing your glasses.
Avoid excessive sun exposure, and always apply sunscreen while taking NOVATRETIN capsules. Your skin may be more prone to sunburn while on NOVATRETIN.
Tell your doctor or pharmacist as soon as possible if you do not feel well while taking NOVATRETIN capsules. NOVATRETIN helps most people with skin conditions, however in addition to the beneficial effects; it is possible that unwanted side effects will occur in some people during treatment, even when it is used as directed. All medicines have side effects. Sometimes they are serious but most of the time they are not. You may require
medical treatment if you get some of the side effects. Ask your doctor or pharmacist to answer any questions that you may have.
If side effects occur, they may be:
These side effects will most likely stop after the dose of NOVATRETIN is lowered or stopped. Tell your doctor if you have any of the following side effects and they worry you:
These side effects are dose related and indicate that the dose of NOVATRETIN needs to be adjusted.
Stop taking NOVATRETIN capsules and contact your doctor immediately if you experience any of the following:
Nausea, Vomiting, Headache, Blurred vision or visual disturbances.
This is not an entire list of all possible side effects. Others may arise in some people and there may be some side effects not yet known. Tell your doctor if you have anything else that is making you unwell. Other side effects not listed above may occur in some people. Consult your doctor or pharmacist if there is anything you do not understand in this list. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Keep your NOVATRETIN capsules in the blister pack until it is time to take them. If you take the capsules out of the packaging they may not keep well. Keep NOVATRETIN capsules in a cool dry place where the temperature stays below 25°C. Do not keep the capsules, or any other medicine, in a bathroom or near a sink.
Do not leave the capsules in the car or on window sills. Both heat and dampness can destroy some medicines. Protect NOVATRETIN capsules from light.
Keep NOVATRETIN where children cannot reach them. A good place to store medicines is in a locked cupboard at least oneand-a-half metres above the ground.
If your doctor asks you to stop taking NOVATRETIN, or the capsules have passed their expiry date, you should return any remaining capsules at the end of your treatment to your dermatologist.
What it looks like:
NOVATRETIN hard-gelatin capsules can be described as follows:
10 mg Capsules: Hard gelatin capsule containing a yellow powder with a white to off-white body and a brown cap printed in black with “A10” on the capsule body.
25 mg Capsules: Hard gelatin capsule containing a yellow powder with a yellow to light yellow body and a brown cap printed in black with “A25” on the capsule body.
Active ingredient – acitretin
Each 10 mg capsule contains 10 mg acitretin
Each 25 mg capsule contains 25 mg acitretin
maltodextrin, sodium ascorbate, microcrystalline cellulose, gelatin, sodium lauryl sulfate, purified water, black printing ink and the colourants iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172) and titanium dioxide.
NOVATRETIN Capsules are available in packs of 100 capsules.
Douglas Pharmaceuticals Ltd
P O Box 45 027
Phone: (09) 835 0660
Fax: (09) 835 0665
Date of preparation of this information was July 2011.
We would like to acknowledge The New Zealand Dermatological Society Inc. in preparation of this booklet and the provision of photographs from Waikato District Health Board and the NZ DermNet website.