VELLUTAN 4 MICROGRAMMI/G Ointment

Зміст інструкції

1. VELLUTAN 4 micrograms/g cutaneous emulsion
   1. What is VELLUTAN and what is it used for
   2. What you need to know before using VELLUTAN
2. Vellutan cutaneous emulsion contains propylene glycol which may cause irritation of the
   1. How to use VELLUTAN
   2. Possible side effects
   3. How to store VELLUTAN
   4. Contents of the pack and other information
3. VELLUTAN is presented in the form of an emulsion contained in a plastic bottle
4. VELLUTAN 4 micrograms/g ointment
   1. What is VELLUTAN and what is it used for
   2. What you need to know before using VELLUTAN
   3. How to use VELLUTAN
   4. Possible side effects
   5. How to store VELLUTAN
   6. Contents of the pack and other information

VELLUTAN 4 micrograms/g cutaneous emulsion

Tacalcitol

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What VELLUTAN is and what it is used for
• 2. What you need to know before you use VELLUTAN
• 3. How to use VELLUTAN
• 4. Possible side effects
• 5. How to store VELLUTAN
• 6. Contents of the pack and other information

1. What is VELLUTAN and what is it used for

VELLUTAN contains the active ingredient tacalcitol, which belongs to the topical antipsoriatic medicinal products.
VELLUTAN is used in adultsfor the local treatment of plaque psoriasis of the scalp.
Psoriasis is a chronic and relapsing skin inflammation, which manifests
when skin cells are produced too quickly, a phenomenon that
causes scaling and redness. This formulation helps to restore to normal values 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 any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a calcium and phosphorus metabolism disorder.
• 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.
Pay particular attention:

• if, while undergoing treatment with VELLUTAN, you are also undergoing treatment with UV rays. The two treatments must be spaced out during the day, for example, irradiation with UV rays (lamp) in the morning, and the 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 peels or astringent and irritating products, because the simultaneous use of VELLUTAN in 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. In case of increased calcium levels in
the blood (calcemia), the treatment must be interrupted.

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, tell your doctor if you are being treated with
medicines that increase calcium levels in the blood, such as thiazide diuretics
(medicines to treat high blood pressure).
There is no experience with the use of Vellutan together with other medicines used for
treating psoriasis.
Multivitamin preparations containing up to 500 IU of vitamin D can be
administered without any particular precautions.
Do not use VELLUTAN together with salicylic acid.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.
The product has not been studied in pregnant women and during breastfeeding, therefore
the use of VELLUTAN during pregnancy and breastfeeding is not recommended.

Driving and using machines
VELLUTAN does not impair the ability to drive vehicles or operate machinery.

VELLUTAN contains propylene glycol

Vellutan cutaneous emulsion contains propylene glycol which may cause irritation of the

skin.

3. How to use VELLUTAN

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Apply VELLUTAN once a day only to the areas of the scalp affected by
psoriasis, 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 because with
higher dosages, an increase in blood calcium levels (hypercalcemia) cannot be completely ruled out. If you use VELLUTAN cutaneous emulsion together with VELLUTAN
ointment, the total dose should still not exceed 5 grams per day.
Avoid contact with eyes. If this should happen accidentally, rinse
thoroughly with water.
The duration of treatment should not exceed 8 weeks of continuous treatment,
but will still be established by the doctor.

If you use more VELLUTAN than you should
In case of local application of an excessive amount of product, it is possible that
an increase in blood calcium levels (hypercalcemia) may occur.
If this occurs, stop applying the product and taking vitamin D or
calcium supplements, until blood calcium levels return to
normal.
In case of accidental ingestion of VELLUTAN, immediately inform your doctor or
go to the Emergency Room of the nearest hospital.

If you forget to use VELLUTAN
Do not use a double dose to make up for a missed dose.

If you stop treatment with VELLUTAN
If you have any doubts about 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 everyone will experience them.
During treatment with tacalcitol, the following side effects have been reported:

• local skin reactions such as, for example, burning, skin irritation that becomes red (erythema)
• itching
• worsening of psoriasis
• contact dermatitis. In general, local skin reactions and itching are mild and transient (a few minutes) and usually do not require discontinuation of treatment. In case of severe irritation or contact allergy, treatment with VELLUTAN must be discontinued and the patient should consult a doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
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 which is stated on the pack after
EXP.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Keep the bottle tightly closed in its original packaging.
Do not use the medicine after 6 months from the first opening of the bottle.
Do not dispose of any medicine in 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 ingredient 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 phosphate dodecahydrate, xanthan gum, monobasic potassium phosphate, disodium edetate, dodecyl gallate.

Description of the appearance of VELLUTAN and contents of the pack

VELLUTAN is presented in the form of an emulsion contained in a plastic bottle

with a dispenser and screw cap.
It is available in pack sizes of 20 ml, 30 ml, 50 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto – PISA-Italy

Manufacturer
20 ml and 50 ml packs:

• ALMIRALL HERMAL GmbH Scholtzstraβe 3, 21465 Reinbek - Germany
• ABIOGEN PHARMA S.p.A. Via Meucci, 36 - Ospedaletto - Pisa- Italy 30ml pack:
• ALMIRALL HERMAL GmbH Scholtzstraβe 3, 21465 Reinbek - Germany

VELLUTAN 4 micrograms/g ointment

Tacalcitol

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What VELLUTAN is and what it is used for
• 2. What you need to know before you use VELLUTAN
• 3. How to use VELLUTAN
• 4. Possible side effects
• 5. How to store VELLUTAN
• 6. Contents of the pack and other information

1. What is VELLUTAN and what is it used for

VELLUTAN contains the active ingredient tacalcitol, which belongs to the topical antipsoriatic medicines.
VELLUTAN is used in adultsfor the local treatment of plaque psoriasis
including the face and scalp.
Psoriasis is a chronic and relapsing inflammatory skin condition that manifests
when skin cells are produced too quickly, a phenomenon that
causes scaling and redness. This formulation helps to restore to normal values 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 any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a calcium and phosphorus metabolism disorder.
• 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 special care:

• if, while undergoing treatment with VELLUTAN, you are also undergoing UV radiation treatment. The two treatments must be spaced throughout the day, for example, UV radiation (lamp) in the morning, and the 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 peels or astringent and irritating products, because the simultaneous use of VELLUTAN in 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. In case of increased calcium levels in
the blood (calcemia), treatment should 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, tell your doctor if you are being treated with
medicines that increase calcium levels in the blood, such as thiazide diuretics,
(medicines to treat high blood pressure).
Multivitamin preparations containing up to 500 IU of vitamin D may be
administered without any particular precautions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you
are breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.
The product has not been studied in pregnant women and during breastfeeding, therefore
the use of VELLUTAN during pregnancy and breastfeeding is not recommended.

Driving and operating machinery
VELLUTAN does not impair the ability to drive vehicles or operate machinery.

3. How to use VELLUTAN

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Apply VELLUTAN once a day only to the areas to be treated, preferably in the evening before going to bed, unless otherwise prescribed by your doctor.
You should not apply more than 5 grams of this medicine per day, and the area to which you apply the product should not exceed 10% of the total body surface, because
with higher doses, an increase in blood calcium levels (hypercalcemia) cannot be completely ruled out.
Apply VELLUTAN ointment in a thin layer to the affected skin areas; in
case of application to the face, avoid contact with the eyes and if this should happen, rinse them
thoroughly with water. The duration of treatment should not exceed
8 consecutive weeks, but will still be established by the doctor.

If you use more VELLUTAN than you should
In case of applying an excessive amount of product to the skin, it is possible
that an increase in blood calcium levels (hypercalcemia) may occur.
If this occurs, stop applying the product and taking vitamin D or
calcium supplements, until blood calcium levels return to
normal.
In case of accidental ingestion of VELLUTAN, immediately inform your doctor or
go to the Emergency Room of the nearest hospital.

If you forget to use VELLUTAN
Do not use a double dose to make up for a missed dose.

If you stop using VELLUTAN
If you have any doubts about the use of this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
During treatment with tacalcitol, the following side effects have been reported:

• local skin reactions such as, for example, redness, burning, skin irritation that becomes red (erythema). These symptoms can be confused with those of the disease itself. In general, local skin reactions are mild and transient (a few minutes) and usually do not require discontinuation of treatment.

In case of severe irritation or contact allergy, treatment with VELLUTAN must
be stopped and the patient should consult a doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side
effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information
about 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 which is stated on the pack after
EXP.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly
stored.
Do not dispose of any medicine in 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 petrolatum, liquid paraffin, diisopropyl adipate.

Description of the appearance of VELLUTAN and contents of the pack
VELLUTAN is presented as an ointment contained in a 20 g tube.
Marketing authorisation holder and manufacturer
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto - PISA