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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
because it contains important information for you.
• 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1) What Calcipotriol 50 micrograms/ml Scalp Solution is and what it is used
for
2) What you need to know 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) Contents of the pack and other 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) What you need to know before you use Calcipotriol 50
micrograms/ml Scalp Solution
Do not use Calcipotriol 50 micrograms/ml Scalp Solution:
• if you are allergic to calcipotriol or to any of the other ingredients of this
medicine (listed in section 6).
• 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 concomitantly use treatment with other medicinal products which
increase your calcium level.
Warnings and precautions
Talk to your doctor or pharmacist before using Calcipotriol 50
micrograms/ml Scalp Solution:
• if the patient is less than 18 years old. There is no experience with the
use of this solution in children and adolescents.
• 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 Scalp Solution in a week, you
may develop high blood calcium levels. This may cause e.g. weakness,
nausea, loss of appetite, and constipation (please see also Section 4).
• 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.
• if you know you have a type of psoriasis called generalised pustular
psoriasis or erythrodermic exfoliative psoriasis. Ask your doctor if you are
unsure.
Do not apply it on your face.
Do not cover the treated area with waterproof wrap.
You should avoid excessive exposure to sunlight when using this solution.

Other medicines and Calcipotriol 50 micrograms/ml Scalp Solution
Tell your doctor or pharmacist if you are using, have recently used or might
use any other medicines.
If you are using this cutaneous solution with other treatments for psoriasis,
your doctor will tell you when to use it.
Do not apply a cream or ointment containing salicylic acid to the skin where
this cutaneous solution has to be applied, as it breaks down the active
substance in this cutaneous solution.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
using this medicine.
Calcipotriol 50 micrograms/ml Scalp Solution should not be used during
pregnancy unless clearly necessary. It is not known if calcipotriol is excreted
in breast-milk. Your doctor will decide whether you can be given Calcipotriol
50 micrograms/ml Scalp Solution during pregnancy and breast-feeding.
Short-term use on small surfaces is not expected to lead to effects on the
breastfed child. In all other cases, breastfeeding is not recommended during
treatment with calcipotriol.
Driving and using machines
No effect on the ability to drive and use machines is to be expected.
Calcipotriol 50 micrograms/ml Scalp Solution contains propylene
glycol, which may cause skin irritation.

3) How to use Calcipotriol 50 micrograms/ml Scalp Solution
Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Dosage:
Adults
You should not apply more than 60 ml of this cutaneous 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 (for example 40
ml scalp solution plus 60 g of cream or ointment).
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.
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 e.g. 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 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, this medicine can cause side effects, although not
everybody gets them.
Like all medicines, this solution can cause allergic reaction in some patients
(less than 1 in 10,000 people). Signs of allergy include hives, swelling of the
face, eyelids, hands, feet or throat, If you get any of these symptoms after
using this cutaneous solution, you should stop using the cutaneous solution
and contact your doctor immediately.
Side effects could occur in approximately 25% of patients treated with
Calcipotriol 50 micrograms/ml Scalp Solution. These reactions are usually
mild. The most frequently reported are various transient skin reactions.
Very common side effects (may affect more than 1 in 10 people):
• skin irritation.
Common side effects (may affect up to 1 in 10 people):
• itching
• burning and stinging sensation
• dry skin
• redness
• rash.
Uncommon side effects (may affect up to 1 in 100 people):
• contact dermatitis
• eczema
• aggravated psoriasis.
Very rare side effects (may affect up to 1 in 10,000 people):
• hypersensitivity reactions
• hypercalcaemia, hypercalciuria
• itchy raised rash (hives)
• temporary changes in your skin colour
• temporary increased sensitivity to sunlight
• facial and perioral dermatitis.
If you accidentally get the cutaneous solution on your face, it can cause
redness or irritation on your face or around your mouth.

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
• 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) Contents of the pack and other 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: 20.02.2017

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Further information

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