CURATODERM 4 MICROGRAMS / G LOTION

Active substance: TACALCITOL MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tacalcitol

11113133

Curatoderm® 4 micrograms/g Lotion

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet
please tell your doctor or pharmacist.
In this leaflet:
1. What Curatoderm Lotion is and what it is used for
2. Before you use Curatoderm Lotion
3. How to use Curatoderm Lotion
4. Possible side effects
5. Storing your Curatoderm Lotion
6. Further information

1. WHAT CURATODERM LOTION IS AND WHAT IT IS USED FOR

Curatoderm Lotion contains tacalcitol which is a drug that belongs to a group of medicines called
antipsoriatics and is a vitamin D derivative.
Curatoderm Lotion is used to treat a condition known as psoriasis vulgaris especially on the scalp.
Psoriasis is a skin disorder in which itchy, red, flaky patches appear on the skin or scalp. Within
affected­ areas of skin, new cells are being produced faster than normal, but old dead cells are
only being shed at the normal rate. As live skin cells accumulate, the skin becomes thickened
and inflamed.­ Curatoderm Lotion works by slowing down cell production and bringing it back to
normal­ and helps to reduce inflammation.

2. BEFORE YOU USE CURATODERM LOTION

11113133

Do not use Curatoderm Lotion
• if you are allergic (hypersensitive) to tacalcitol or any of the other ingredients listed in sec-
tion 6.
• if you have ever had problems with too much calcium in your blood (hypercalcaemia or other
disorders of calcium metabolism).
If this applies to you, do not use this medicine and speak to your doctor.
Take special care with Curatoderm Lotion
When applying Curatoderm Lotion to the face. Do not allow the lotion to come in contact with the
eyes. If it does, rinse thoroughly with water.
Please tell your doctor if:
• you have or have had problems with your kidneys,
• you have a particular type of psoriasis called generalized pustular psoriasis or erythrodermic
exfoliative psoriasis,
• you are taking high doses of vitamin D (more than 500IU).
Your doctor may want to check the level of calcium in your blood if you have any of these conditions.
Using other medicines or therapies
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Especially:
• Multivitamin products or vitamin D
If you are receiving ultraviolet (UV) therapy, this should be given in the morning and Curatoderm
Lotion used at bedtime.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The potential risk to the baby if Curatoderm Lotion is used during pregnancy is unknown.
Therefore if you are pregnant or likely to become pregnant whilst using Curatoderm Lotion, make
sure your doctor knows.
It is not known if Curatoderm Lotion passes into breast milk. Only a small amount of tacalcitol is
absorbed into the body after skin treatment. It is probably not necessary to stop breast-feeding­
during treatment.
If the breast area is affected by psoriasis, it is recommended that the breast area is not treated
with Curatoderm Lotion or breast-feeding should be stopped. Discuss this with your doctor.
Important information about some of the ingredients of Curatoderm Lotion
Due to its propylene glycol content this medicine may cause skin irritation. It may also induce
slight irritation to the skin, eyes and mucous membranes due to its dodecyl gallate content.

3. HOW TO USE CURATODERM LOTION

11113133

Always use Curatoderm Lotion exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Children: Curatoderm Lotion is not recommended for use in children, as there is limited ex­
perience.
Curatoderm Lotion is for use by adults including the elderly.
Curatoderm Lotion can be used on all areas of the body including face, hairline, scalp, armpits,
elbows and knees.
Follow your doctor’s instructions for use exactly. The following are general guidelines:
• Apply Curatoderm Lotion once a day, preferably at bedtime.
• Do not use more than 10ml of lotion (equivalent to 2 teaspoons) each day.
• Spread the lotion over the areas of skin affected by psoriasis and then rub it in.
• To treat the scalp, part your hair and place the nozzle close to the affected area, apply a few
drops, then rub the lotion in gently.
• Avoid transfer of the lotion to other areas of the body not affected by psoriasis.
• Wash your hands as soon as you have finished applying the lotion.
Duration of treatment
• Your doctor will tell you for how long you need to use the lotion.
If you also use Curatoderm Ointment
• Curatoderm is also available as an ointment. If you are also using Curatoderm Ointment, take
into account that the quantity of applied tacalcitol adds up. You should not use more than
280 micrograms of tacalcitol per week. That is for example equivalent to 30ml Curatoderm
Lotion plus 40g Curatoderm Ointment per week.
If you use more Curatoderm Lotion than you should
If you have used too much Curatoderm Lotion, tell your doctor as it may be necessary to check the
amount of calcium in your blood.
If you forget to use Curatoderm Lotion
If you forget to use Curatoderm Lotion at the usual time, use it as soon as you remember, then
carry on as before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Curatoderm Lotion can cause side effects, although not everybody gets them.
Uncommonly (1 in 10 out of 1,000 people treated)
Local skin reactions such as itching, burning or redness may be experienced. These are usually
mild effects and don’t last very long.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE CURATODERM LOTION

Keep out of the reach and sight of children
Keep the bottle in the outer carton in order to protect it from light.
Do not store above 25°C
Do not use Curatoderm Lotion after the expiry date which is stated on the label after “EXP”. The
expiry date refers to the last day of that month.
Do not use for longer than 6 months after first opening the container, write the date of first
opening­ the container bottle on the carton label.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the environ­
ment.

6. FURTHER INFORMATION

11113133

What Curatoderm Lotion contains
The active substance is tacalcitol
The other ingredients are: purified water, light liquid paraffin, medium-chain triglycerides, propylene glycol, octyldodecanol, macrogol (21) stearylether, diisopropyl adipate, phenoxyethanol,
disodium phosphate dodecahydrate, xanthan gum, potassium dihydrogen phosphate, disodium
edetate, dodecyl gallate.
What Curatoderm Lotion looks like and contents of the pack
Curatoderm Lotion is a white, thin emulsion for use on the skin
Your medicinal product comes in either 20 ml, 30 ml or 50 ml HDPE plastic bottle and with HDPE
screw cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3, 21465 Reinbek, Germany
Tel: ++49-40/72704-0
Fax: ++49-40/7229296
info@almirall.de
www.almirall.de
This leaflet was last approved in 01.08.2010

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)