Calcipotriol/Betamethasone Sandoz 50/500

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Calcipotriol and betamethasone dipropionate ointment
Consumer Medicine Information

What is in this leaflet?

This leaflet answers some common questions about using the medicine Calcipotriol / Betamethasone Sandoz ointment. 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 using Calcipotriol / Betamethasone Sandoz ointment against the benefits it is expected to have for you.
If you have any concerns about using this medicine, talk to your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.

What Calcipotriol / Betamethasone Sandoz 50/500 ointment is used for

Calcipotriol / Betamethasone Sandoz ointment is an anti-psoriasis medicine. Calcipotriol / Betamethasone Sandoz ointment contains two active ingredients:
Calcipotriol (related to Vitamin D);
Betamethasone dipropionate (a corticosteroid).
Calcipotriol / Betamethasone Sandoz ointment is used only on skin affected by plaque-type psoriasis. Psoriasis is a skin disorder in which skin cells are overactive. The calcipotriol in Calcipotriol / Betamethasone Sandoz ointment treats the overactive skin cells. The betamethasone dipropionate relieves redness, swelling, itching and irritation of the skin.
Calcipotriol / Betamethasone Sandoz ointment is used in the type of psoriasis, where "plaques" form in the skin. Plaques are raised, rough, reddened areas covered with fine, dry silvery scales. Plaques are usually about one to two centimetres across.
Calcipotriol / Betamethasone Sandoz ointment is available only with a doctor's prescription.
This medicine is not expected to affect your ability to drive a car or operate machinery. This medicine is not addictive.

Before you use Calcipotriol / Betamethasone Sandoz 50/500 ointment

When you must not use Calcipotriol / Betamethasone Sandoz ointment

Do not use Calcipotriol / Betamethasone Sandoz ointment if you have an allergy to:
calcipotriol
betamethasone dipropionate
any of the other ingredients listed at the end of this leaflet (see Product description)
any other similar medicine, such as topical corticosteroids.
Some of the symptoms of an allergic reaction include
shortness of breath,
wheezing or difficulty breathing;
swelling of the face,
lips, tongue or other parts of the body;
rash, itching or "hives" on the skin.
Do not use Calcipotriol / Betamethasone Sandoz ointment for
severe widespread psoriasis
generalised pustular psoriasis
erythrodermic exfoliative psoriasis.
Your doctor will identify these conditions for you.
Do not use Calcipotriol / Betamethasone Sandoz ointment if you
have high blood calcium levels;
are taking calcium supplements, drugs to treat calcium deficiency, vitamin D supplements or vitamin D-like medicines, for example calcitriol;
have kidney or liver problems;
have any viral, fungal or bacterial skin infections.
Inform your doctor if you are suffering from any illness before using Calcipotriol / Betamethasone Sandoz ointment.
Do not use Calcipotriol / Betamethasone Sandoz ointment
after the expiry date printed on the pack
if it is 3 months after the tube was first opened
if the packaging is torn, doesn't look quite right or shows signs of tampering.
If any of these apply, return Calcipotriol / Betamethasone Sandoz ointment to your pharmacist for disposal.
Do not breast-feed if you are using Calcipotriol / Betamethasone Sandoz ointment on your breasts.
If you are not sure whether you should start using Calcipotriol / Betamethasone Sandoz ointment, talk to your doctor.

Before you start to use it

Tell your doctor if you have a known allergy to Calcipotriol / Betamethasone Sandoz ointment, calcipotriol, betamethasone dipropionate or any of the ingredients listed at the end of this leaflet.
Tell your doctor if you
are pregnant
are breast-feeding
intend to breast-feed.
Do not use Calcipotriol / Betamethasone Sandoz ointment in children.
Safety and effectiveness of Calcipotriol / Betamethasone Sandoz ointment in those below 18 years of age has not been established.
If you have not told your doctor about any of the above, tell him/her before you start using this medicine.

Other medicines

Tell your doctor or pharmacist if you are using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Your doctor and pharmacist have more information on medicines you should be careful with or avoid whilst using Calcipotriol/Betamethasone Sandoz ointment.

How to use Calcipotriol / Betamethasone Sandoz 50/500 ointment

Follow carefully all directions given to you by your doctor or pharmacist.
They may differ from the information contained in this leaflet.
If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much to use

The area treated should not be more than 30% of the body surface.
Discuss this with your doctor.
Do not use more than 15 g in one day. For example, no more than half (1/2) of a 30 g tube in one day.
Do not use more than 100 g in one week. For example, no more than 3 tubes of 30 g in one week.
NOTE: If you use more than the recommended amount of Calcipotriol / Betamethasone Sandoz ointment, the levels of calcium in your blood may rise. This is known as "hypercalcaemia".
Hypercalcaemia
is measured by a blood test;
may be harmful;
may mean that Calcipotriol / Betamethasone Sandoz ointment or any other product containing calcipotriol (e.g.; Daivonex®) should not be used until the calcium level has become normal again.
Blood calcium levels will quickly normalise when your doctor discontinues treatment.

How to use Calcipotriol / Betamethasone Sandoz ointment

NOTE: unlike certain other skin preparations, which you use very sparingly, use Calcipotriol / Betamethasone Sandoz ointment as follows:
Apply Calcipotriol / Betamethasone Sandoz ointment only to the psoriasis plaques in a thin layer and gently rub in. If you accidentally put some of the ointment on normal skin, wash it off as soon as possible.
Do not use Calcipotriol / Betamethasone Sandoz ointment
on large areas of damaged skin;
in skin folds (eg. groin, underarm);
on the genitalia;
on the scalp;
inside the mouth, nose or in the eyes;
on the face. (An itchy red rash may develop).
under occlusive dressings (such as a bandage).
The treated area does not need to have a special covering. You may wear your usual clothes.
Wash your hands thoroughly after applying Calcipotriol / Betamethasone Sandoz ointment on any part of your body, unless your hands are being treated.
Thoroughly wash your hands prior to handling infants or children.
Take care not to get Calcipotriol / Betamethasone Sandoz ointment in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.
Avoid getting Calcipotriol / Betamethasone Sandoz ointment on your face, scalp, mouth or eyes accidentally (see above). If any skin irritation develops, wash off the Calcipotriol / Betamethasone Sandoz ointment.

When to use Calcipotriol / Betamethasone Sandoz ointment preparations

Apply Calcipotriol / Betamethasone Sandoz ointment once a day (either morning or night), unless otherwise directed by your doctor.

How long to use it

Continue to use Calcipotriol / Betamethasone Sandoz ointment for as long as your doctor tells you. Each treatment course would normally last for up to four weeks.
Your doctor may decide to stop Calcipotriol / Betamethasone Sandoz ointment treatment once your psoriasis has improved, and to recommence it as needed.

If you forget to use it

If you forget to use Calcipotriol/Betamethasone Sandoz ointment, use it as soon as you remember. Then go on as before.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your doctor or pharmacist for some hints.
If you use too much (Overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 764 766 in New Zealand) for advice, or go to the Emergency Department at the nearest hospital if you think that you or anyone else may have used too much or swallowed some of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are using Calcipotriol / Betamethasone Sandoz 50/500 ointment

Things you must do

While you are using Calcipotriol/Betamethasone Sandoz ointment, protect the treated skin areas from sunlight and Ultra Violet (UV) rays, for example, by wearing protective clothing. This is particularly important if your job or lifestyle means you spend time out-of-doors.
If you are going to start any new medicine, tell your doctor and pharmacist that you are using
Calcipotriol / Betamethasone Sandoz ointment.
If you become pregnant while using Calcipotriol / Betamethasone Sandoz ointment, tell your doctor immediately.
Keep all appointments with your doctor so that your progress can be checked.
Your doctor may do blood tests whilst you are using Calcipotriol/Betamethasone Sandoz ointment (or any other product containing calcipotriol). These tests check the levels of calcium in your blood and how well your kidneys are working ("renal function").

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as you.
Do not use more than the recommended daily or weekly dose (see How to use Calcipotriol / Betamethasone Sandoz 50/500 ointment).
Do not use other topical corticosteroids (e.g. Advantan®, Diprosone®, Elocon®) on areas treated with Calcipotriol / Betamethasone Sandoz ointment.

Side effects

As with all medicines, Calcipotriol / Betamethasone Sandoz ointment can cause some side effects.
Do not be alarmed by the following list of side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you have any unpleasant effects while you are using Calcipotriol / Betamethasone Sandoz ointment or if you notice any of the following and they worry you:
skin irritation (including itching, redness or burning, swelling, bruising, rashes or peeling)
rash on your face or body
change in the colour of your skin
your skin is more sensitive to light
headache
back pain
change in control of diabetes mellitus.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.

After using Calcipotriol / Betamethasone Sandoz ointment

Keep Calcipotriol / Betamethasone Sandoz ointment in the box until required.

Storage

Keep your Calcipotriol / Betamethasone Sandoz ointment in a cool dry place where the temperature stays below 25°C.
However, do not keep Calcipotriol / Betamethasone Sandoz ointment in the refrigerator, as the ointment will not spread easily.
Do not store Calcipotriol / Betamethasone Sandoz ointment or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep Calcipotriol / Betamethasone Sandoz ointment where 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
Ask your pharmacist what to do with any Calcipotriol / Betamethasone Sandoz ointment that is left over if:
your doctor tells you to stop using Calcipotriol / Betamethasone Sandoz ointment
the tube has been opened for more than 12 months
the expiry date has passed.

Product description

What it looks like

Calcipotriol / Betamethasone Sandoz ointment is an off-white ointment.

Ingredients

Active ingredients:
calcipotriol (50 microgram/g)
betamethasone dipropionate (500 microgram/g).
Inactive ingredients:
liquid paraffin
oleyl alcohol
alpha-tocopherol
white soft paraffin

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 634 500
This leaflet was prepared in August 2016.
Australian Register Number:
30g tube: AUST R 255532