Vellutan
Italy
Table of Contents
Patient Information Leaflet
VELLUTAN 4 micrograms/g cutaneous emulsion
Tacalcitol
Please 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What VELLUTAN is and what it is used for
- What you need to know before using VELLUTAN
- How to use VELLUTAN
- Possible side effects
- How to store VELLUTAN
- Contents of the pack and other information
1. What VELLUTAN is and what it is used for
VELLUTAN contains the active substance tacalcitol, which belongs to a class of medicines
known as topical antipsoriatics.
VELLUTAN is used in adults for the local treatment of scalp psoriasis vulgaris.
Psoriasis is a chronic, recurring skin inflammation that occurs when skin cells are produced too quickly, leading to scaling and redness. This formulation helps normalize the rate at which skin cells are produced.
2. What you need to know before using VELLUTAN
Do not use VELLUTAN
- If you are allergic to tacalcitol or to any of the other ingredients of this medicine (listed in section 6).
- If you have a disease affecting calcium and phosphorus metabolism.
- If you are pregnant or breastfeeding, unless after careful evaluation by your doctor (see section 2 “Pregnancy and breastfeeding”). Do not give VELLUTAN to children (see section 2 “Children”).
Warnings and precautions
Talk to your doctor or pharmacist before using VELLUTAN.
Exercise particular caution:
- if you are undergoing UV light treatment at the same time as treatment with VELLUTAN. The two treatments should be spaced apart during the day; for example, UV irradiation (lamp) in the morning and application of tacalcitol in the evening at bedtime.
- if you are exposed to sunlight during the day. Perform the tacalcitol treatment in the evening at bedtime.
- if you use peeling agents or astringent and irritating products, as simultaneous use of VELLUTAN on the same areas may increase the risk of local reactions.
Before treatment and subsequently at regular intervals, your doctor may ask you to undergo blood tests to monitor calcium levels and urine tests to monitor calcium and protein levels. If calcium levels in the blood (calcemia) increase, treatment must be discontinued.
Children
This medicine has not been studied in this age group (see “Do not use VELLUTAN”).
Other medicines and VELLUTAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are being treated with medicines that increase calcium levels in the blood, such as thiazide diuretics (medicines used to treat high blood pressure).
There is no experience with the use of Vellutan together with other medicines used to treat psoriasis.
Multivitamin preparations containing vitamin D up to 500 IU can be administered without any special precautions.
Do not use VELLUTAN together with salicylic acid.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This product has not been studied in pregnant or breastfeeding women; therefore, use of VELLUTAN during pregnancy and breastfeeding is not recommended.
Driving and using machines
VELLUTAN does not affect the ability to drive or operate machinery.
VELLUTAN contains propylene glycol
Vellutan cutaneous emulsion contains propylene glycol, which may cause skin irritation.
3. How to use VELLUTAN
Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply VELLUTAN once daily only to the areas of the scalp affected by psoriasis, preferably in the evening before going to bed, unless otherwise prescribed by your doctor.
Do not apply more than 5 grams per day of this medicine, as with higher doses there remains a possibility of increased calcium levels in the blood (hypercalcemia). If you use VELLUTAN cutaneous emulsion together with VELLUTAN ointment, the total daily dose must not exceed 5 grams.
Avoid contact with the eyes. If accidental contact occurs, rinse thoroughly with plenty of water.
The duration of treatment should not exceed 8 weeks of continuous use, but will ultimately be determined by your doctor.
If you use more VELLUTAN than you should
If excessive amounts of the product are applied locally, an increase in calcium levels in the blood (hypercalcemia) may occur.
If this happens, stop using the product and discontinue taking vitamin D or calcium supplements until blood calcium levels return to normal.
In case of accidental ingestion of VELLUTAN, contact your doctor immediately or go to the Emergency Department of the nearest hospital.
If you forget to use VELLUTAN
Do not use a double dose to make up for a forgotten dose.
If you stop using VELLUTAN
If you have any questions about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been reported during treatment with tacalcitol:
- local skin reactions such as, for example, burning, skin irritation with redness (erythema)
- pruritus
- worsening of psoriasis
- contact dermatitis. In general, local skin reactions and pruritus are mild and transient (a few minutes), and treatment usually does not need to be discontinued. However, if severe irritation or contact allergy occurs, treatment with VELLUTAN must be stopped and the patient should consult a physician.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store VELLUTAN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month.
Store below 25°C.
Keep the bottle tightly closed in the original packaging.
Do not use the medicine more than 6 months after first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What VELLUTAN contains
- The active substance contained in 1 g of emulsion is tacalcitol monohydrate 4.173 micrograms (equivalent to 4 micrograms/g of tacalcitol).
- The other components are purified water, light liquid paraffin, propylene glycol (see section 2, “VELLUTAN contains propylene glycol”), medium-chain saturated triglycerides, octyldodecanol, macrogol (21) stearyl ether, diisopropyl adipate, phenoxyethanol, disodium edetate, dodecyl gallate, xanthan gum, potassium dihydrogen phosphate, and sodium phosphate dibasic dodecahydrate.
Description of the appearance of VELLUTAN and contents of the pack
VELLUTAN is presented as an emulsion contained in a plastic bottle with dispenser and screw cap.
It is available in pack sizes of 20 ml, 30 ml, and 50 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto – PISA - Italy
Manufacturer
Pack sizes of 20 ml and 50 ml:
- ALMIRALL HERMAL GmbH Scholtzstraße 3, 21465 Reinbek - Germany
- ABIOGEN PHARMA S.p.A. Via Meucci, 36 - Ospedaletto - Pisa - Italy
Pack size of 30 ml:
- ALMIRALL HERMAL GmbH Scholtzstraße 3, 21465 Reinbek - Germany
Patient Information Leaflet
VELLUTAN 4 micrograms/g ointment
Tacalcitol
Please read this leaflet carefully before using this medicine as it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What VELLUTAN is and what it is used for
- What you need to know before using VELLUTAN
- How to use VELLUTAN
- Possible side effects
- How to store VELLUTAN
- Contents of the pack and other information
1. What VELLUTAN is and what it is used for
VELLUTAN contains the active substance tacalcitol, which belongs to a class of medicines
called topical antipsoriatics.
VELLUTAN is used in adults for the local treatment of vulgar psoriasis, including on the face and scalp.
Psoriasis is a chronic, recurring skin inflammation that occurs when skin cells are produced too quickly,
leading to scaling and redness. This formulation helps normalize the rate at which skin cells are produced.
2. What you need to know before using VELLUTAN
Do not use VELLUTAN
- If you are allergic to tacalcitol or to any of the other ingredients of this medicine (listed in section 6).
- If you suffer from a disorder affecting calcium and phosphorus metabolism.
- If you are pregnant or breastfeeding, unless after careful evaluation by your doctor (see section 2 “Pregnancy and breastfeeding”).
- Do not give VELLUTAN to children (see section 2 “Children”).
Warnings and precautions
Talk to your doctor or pharmacist before using VELLUTAN.
Take particular care:
- If you are undergoing UV light treatment at the same time as treatment with VELLUTAN. The two treatments must be spaced apart during the day; for example, UV irradiation (lamp) in the morning and application of tacalcitol in the evening at bedtime.
- If you are exposed to sunlight during the day. Perform the tacalcitol treatment in the evening at bedtime.
- If you are using peeling agents or astringent and irritating products, because simultaneous use of VELLUTAN on the same areas may increase the risk of local reactions.
Before treatment and subsequently at regular intervals, your doctor may ask you to undergo blood tests to monitor calcium levels and urine tests to monitor calcium and protein levels. If calcium levels in the blood (calcemia) rise, treatment must be discontinued.
Children
This medicine has not been studied in this age group (see “Do not use VELLUTAN”).
Other medicines and VELLUTAN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking medicines that increase calcium levels in the blood, such as thiazide diuretics (medicines used to treat high blood pressure).
Multivitamin preparations containing up to 500 IU of vitamin D can be administered without special precautions.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
This product has not been studied in pregnant or breastfeeding women; therefore, the use of VELLUTAN during pregnancy and breastfeeding is not recommended.
Driving and using machines
VELLUTAN does not affect the ability to drive or operate machinery.
3. How to use VELLUTAN
Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply VELLUTAN once daily only to the areas requiring treatment, preferably in the evening before going to bed, unless otherwise prescribed by your doctor.
You should not apply more than 5 grams per day of this medicine, and the treated area should not exceed 10% of the total body surface area, because with higher doses there remains a risk of increased calcium levels in the blood (hypercalcemia).
Apply a thin layer of VELLUTAN ointment to the affected skin areas. When applying to the face, avoid contact with the eyes; if contact occurs, rinse thoroughly with water. The duration of treatment should not exceed 8 consecutive weeks, but will ultimately be determined by your doctor.
If you use more VELLUTAN than you should
If excessive amounts of the product are applied to the skin, increased calcium levels in the blood (hypercalcemia) may occur.
If this happens, stop applying the product and discontinue taking vitamin D or calcium supplements until blood calcium levels return to normal.
In case of accidental ingestion of VELLUTAN, contact your doctor immediately or go to the nearest hospital emergency department.
If you forget to use VELLUTAN
Do not apply a double dose to make up for the missed dose.
If you stop using VELLUTAN
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not
everyone experiences them.
The following adverse reactions have been observed during treatment with tacalcitol:
- Local skin reactions such as, for example, redness, burning, skin irritation with reddening (erythema). These symptoms may be confused with those of the underlying disease. In general, local skin reactions are mild and transient (lasting a few minutes), and treatment usually does not need to be discontinued.
If severe irritation or contact allergy occurs, treatment with VELLUTAN must
be discontinued and the patient should consult a physician.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this
leaflet, consult your doctor or pharmacist. You may also report adverse
reactions directly via the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse reactions, you can help provide more information
on the safety of this medicine.
5. How to store VELLUTAN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
The expiry date refers to the product in its original, unopened packaging stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What VELLUTAN contains
- The active substance contained in 1 g of ointment is tacalcitol monohydrate 4.173 micrograms (equivalent to 4 micrograms/g of tacalcitol).
- The other components are white vaseline, liquid paraffin, diisopropyl adipate.
Description of the appearance of VELLUTAN and contents of the pack
VELLUTAN is an ointment supplied in a 20 g tube.
Marketing Authorization Holder and Manufacturer
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto - PISA