Calcipotriol 50 Micrograms/Ml Scalp Solution
Ref: 1446/100714/1/F
Calcipotriol 50 micrograms/ml Scalp Solution
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
^ What Calcipotriol 50 micrograms/ml Scalp Solution is and what it is used for
Before you use Calcipotriol 50 micrograms/ml Scalp Solution How to use Calcipotriol 50 micrograms/ml Scalp Solution ^ Possible side effects
How to store Calcipotriol 50 micrograms/ml Scalp Solution Further information
M 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.
[a Before you take 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:
* if the patient is less than 18 years old. There is no experience with the use of this solution in this age group, therefore it's 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 breast-feeding. 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.
How to take 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.
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.
Patient Information Leaflet (continued)
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.
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.
3 Further information
What this medicine contains:
The active substance is calcipotriol.
One ml contains 50 micrograms of calcipotriol.
The other ingredients are: sodium citrate, hypromellose, propylene glycol, isopropyl alcohol, levomenthol and purified water.
What this medicine looks like and contents of the pack
The cutaneous solution is a clear, colourless solution with an odour of menthol. Each pack contains 2 x 30ml bottles.
Manufacturer and Licence Holder
This medicine is manufactured by Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
IPOM pl 15184/1446 Calcipotriol 50 micrograms/ml Scalp Solution
Revision date: 10/07/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
How to store Calcipotriol 50 micrograms/ml Scalp Solution
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Keep container in the outer carton in order to protect from light.
Do not refrigerate or freeze.
Discard the opened bottle with any remaning solution after 3 months.
Caution flammable - Keep away from fire or flames.
Do not take Calcipotriol 50 micrograms/ml Scalp Solution after the expiry date shown on the bottle label. If your doctor tells you to stop using this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise 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.
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
^ What Calcipotriol 50 micrograms/ml Scalp Solution is and what it is used for
Before you use Calcipotriol 50 micrograms/ml Scalp Solution How to use Calcipotriol 50 micrograms/ml Scalp Solution ^ Possible side effects
How to store Calcipotriol 50 micrograms/ml Scalp Solution Further information
M 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.
[a Before you take 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:
* if the patient is less than 18 years old. There is no experience with the use of this solution in this age group, therefore it's 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 breast-feeding. 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.
How to take 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.
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.
Patient Information Leaflet (continued)
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.
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.
Further information
What this medicine contains:
The active substance is calcipotriol.
One ml contains 50 micrograms of calcipotriol.
The other ingredients are: sodium citrate, hypromellose, propylene glycol, isopropyl alcohol, levomenthol and purified water.
What this medicine looks like and contents of the pack
The cutaneous solution is a clear, colourless solution with an odour of menthol. Each pack contains 2 x 30ml bottles.
Manufacturer and Licence Holder
This medicine is manufactured by Lek Pharmaceuticals d.d., Verovskova 57 1526 Lubiana, Slovenia and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1446 Calcipotriol 50 micrograms/ml Scalp Solution
Revision date: 10/07/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
How to store Calcipotriol 50 micrograms/ml Scalp Solution
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Keep container in the outer carton in order to protect from light.
Do not refrigerate or freeze.
Discard the opened bottle with any remaning solution after 3 months.
Caution flammable - Keep away from fire or flames.
Do not take Calcipotriol 50 micrograms/ml Scalp Solution after the expiry date shown on the bottle label. If your doctor tells you to stop using this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise 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.