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CALCIPOTRIOL 50 MICROGRAMS/ML SCALP SOLUTION

Active substance(s): CALCIPOTRIOL / CALCIPOTRIOL HYDRATE

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Calcipotriol 50 micrograms/ml Scalp Solution
(calcipotriol)
Patient Information Leaflet
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 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 Calcipotriol 50 micrograms/ml Scalp Solution is and what it is used
for
2) Before you use Calcipotriol 50 micrograms/ml Scalp Solution
3) How to use Calcipotriol 50 micrograms/ml Scalp Solution
4) Possible side effects
5) How to store Calcipotriol 50 micrograms/ml Scalp Solution
6) Further information

1) What Calcipotriol 50 micrograms/ml Scalp Solution is and
what it is used for
Calcipotriol 50 micrograms/ml Scalp Solution is used for the local treatment of
mild to moderate scalp psoriasis.
Psoriasis is when your skin cells are being produced too quickly. This causes
scaling and redness. This solution helps bring the rate at which your skin
cells are produced back to normal.

2) Before you use Calcipotriol 50 micrograms/ml Scalp Solution
Do not use Calcipotriol 50 micrograms/ml Scalp Solution:
 if you are allergic (hypersensitive) to calcipotriol or to any of the other
ingredients (please see section 6 for other ingredients).
 if you have severe liver or kidney impairment.
 if you have a problem with your calcium metabolism or if the level of
calcium in your body is too high. This solution can increase calcium levels
in the blood.
 if you use this treatment with other medicinal products which increase
your calcium level.
Take special care with Calcipotriol 50 micrograms/ml Scalp Solution:
Check with your doctor or pharmacist before using your medicine if:
 if the patient is less than 18 years old. There is no experience with the
use of this solution in this age group, therefore its use is not
recommended.
 the solution may cause irritation of the skin. If the scalp solution
accidentally gets on your face, wash it off immediately. If it gets in your
eye, bathe the eye with water. Wash your hands after you have applied
the solution.
 if you use more than 60 ml of Calcipotriol solution in a week, you may
develop high blood calcium levels (please see also Section 3).



if you are exposed to sunlight when using this solution. Any use of it with
artificial UV light therapy (including sunbeds) should be discussed with
your doctor first.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Avoid use in pregnancy since there is no information available. It is not known
if calcipotriol is excreted in breast milk, so also avoid use during breastfeeding. Tell your doctor if you are pregnant or breast-feeding or if you
become pregnant while you are using this solution.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No effect on the ability to drive and use machines is to be expected.
Important information about some of the ingredients of Calcipotriol 50
micrograms/ml Scalp Solution
This solution contains propylene glycol, which may cause skin irritation.

3) How to use Calcipotriol 50 micrograms/ml Scalp Solution
Dosage:
Always apply this solution exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Adults
You should not apply more than 60 ml of this solution in one week.
If you apply it together with cream or ointment containing calcipotriol, the total
weekly amount of calcipotriol should not be more than 5 mg.
Method and route of administration:
Calcipotriol 50 micrograms/ml Scalp Solution is intended for use on the skin
(cutaneous use). It should be used on parts of scalp that are affected by
psoriasis.
When you use the solution, tilt your head to make sure the solution does not
run onto your face. It may help to part your hair before you use the solution.
Remove the cap and place the nozzle through the hair onto an affected area
of the scalp. Squeeze the bottle gently and apply a few drops. Rub in gently.
One or two drops should cover an area about the size of a postage stamp.
If you accidentally get the solution on your face, wash it off straight away. If
you get the solution in your eyes rinse it out immediately with water. If you
have any sterile saline solution, you could use it to bathe your eye afterwards.
If your eye is sore, you should see your doctor.
Wash your hands after you have applied this solution.
Children and adolescents (under 18 years)
Calcipotriol 50 micrograms/ml Scalp Solution is not recommended for
children and adolescents (under 18 years), because there is not enough
experience with the use of this solution in these patients.

Frequency of administration
For the best results you should apply this solution twice a day, once in the
morning and once in the evening.
Duration of treatment
Duration of treatment will be decided by your physician, but should not
normally be longer than 22 weeks.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5) How to store Calcipotriol 50 micrograms/ml Scalp Solution
If you use more Calcipotriol 50 micrograms/ml Scalp Solution than you
should:
If you have applied more solution than you should (more than 60 ml in a
week), you should consult your doctor. Such usage may lead to high blood
calcium levels, which may cause the following: nausea, loss of appetite,
constipation, vomiting, muscle weakness, lack of energy, tiredness,
depression, impaired thinking or memory, loss of consciousness, kidney
dysfunction.
If you forget to use Calcipotriol 50 micrograms/ml Scalp Solution:
If you forget to use this solution at the right time, apply it as soon as you
remember. Then go on as before. Do not apply more solution than usual to
make up for a forgotten dose.
If you want to stop using Calcipotriol 50 micrograms/ml Scalp Solution:
Always consult your doctor if you are thinking about stopping the treatment. If
you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4) Possible side effects
Like all medicines, Calcipotriol 50 micrograms/ml Scalp Solution can cause
side effects, although not everybody gets them.
Side effects occur in approximately 25% of patients. The most frequently
reported are various transient skin reactions.
Very common side effects (affects more than 1 user in 10) are: burning and
stinging sensation.
Common side effects (affects 1 to 10 users in 100) are: itching, skin irritation,
dry skin, redness and rash.
Uncommon side effects (affects 1 to 10 users in 1,000) are: contact
dermatitis, eczema and aggravated psoriasis.
Rare side effects (affects 1 to 10 users in 10,000) are: irritation around your
mouth.
Very rare side effects (affects less than 1 user in 10,000) are: high level of
calcium in blood and urine.
Side effects with unknown frequency: allergic reactions including hives,
swelling of the face, eyelids, hands, feet or throat, transient changes in skin
colour, transient increased sensitivity of the skin to light.
If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.

 Keep all medicines out of the sight and reach of children.
 Do not use Calcipotriol 50 micrograms/ml Scalp Solution after the expiry
date which is stated on the bottle and carton after EXP. The expiry date
refers to the last day of that month.
 Do not store above 25°C. Keep the bottle in the outer carton. Protect from
light. Do not refrigerate or freeze. Keep the cutaneous solution away from
fire or flames (the alcohol base is inflammable).
 Discard the opened bottle with any remaining solution after 3 months.
 If the solution becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6) Further information
What Calcipotriol 50 micrograms/ml Scalp Solution contains:
The active substance is calcipotriol. Each ml of cutaneous solution contains
50 micrograms of calcipotriol.
The other ingredients are: sodium citrate, hypromellose, propylene glycol,
isopropyl alcohol, levomenthol and purified water.
What Calcipotriol 50 micrograms/ml Scalp Solution looks like and
contents of the pack
The cutaneous solution is a clear, colourless solution with an odour of
menthol. The cutaneous solution comes in a white polyethylene bottle fitted
with a white polyethylene nozzle and closed with a white polypropylene screw
cap. Each bottle contains 30ml of cutaneous solution
Calcipotriol 50 micrograms/ml Scalp Solution is available in packs containing
1, 2, and 4 bottles.
PL 10383/2061

POM

Who makes and repackages your medicine
Your medicine is manufactured by Lek Pharmaceuticals d.d., Verovśkova 57,
1526 Ljubljana, Slovenia or Salutas Pharma GmbH, Otto-von-Guericke, Allee
1, 39179 Barleben, Germany. Procured from within the EU and repackaged
by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 06.01.2014

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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.

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