ZORIPOT 50 MICROGRAMMI/G + 0,5 MG/G Ointment

Зміст інструкції

1. Zoripot 50 micrograms/g + 0.5 mg/g ointment
   1. What is Zoripot and what is it used for
   2. What you need to know before using Zoripot
   3. How to use Zoripot
   4. Possible side effects
   5. How to store Zoripot
   6. Contents of the pack and other information

Zoripot 50 micrograms/g + 0.5 mg/g ointment

calcipotriol/betamethasone
Equivalent medicinal product

Read this leaflet carefully before you start to use 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 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 Zoripot is and what it is used for
• 2. What you need to know before you use Zoripot
• 3. How to use Zoripot
• 4. Possible side effects
• 5. How to store Zoripot
• 6. Contents of the pack and other information

1. What is Zoripot and what is it used for

Zoripot ointment is applied to the skin to treat plaque psoriasis (common psoriasis) in adults.
Psoriasis is caused by the overproduction of skin cells. This causes
redness, scaling and thickening of the skin.
Zoripot ointment contains calcipotriol and betamethasone.
Calcipotriol helps to restore the rate of skin cell growth to a normal level,
while betamethasone reduces inflammation.

2. What you need to know before using Zoripot

Do not useZoripot

• if you are allergic to calcipotriol, betamethasone or any of the other ingredients of this medicine (listed in section 6)
• if you have problems related to calcium levels in the body (ask your doctor)
• if you suffer from certain types of psoriasis: erythrodermic psoriasis, exfoliative psoriasis or pustular psoriasis (ask your doctor)

Zoripot contains a strong steroid, therefore it must notbe applied to skin affected by:

• skin infections caused by viruses (e.g., herpes labialis or chickenpox)
• skin infections caused by a fungus (e.g., athlete's foot or ringworm)
• skin infections caused by bacteria
• skin infections caused by parasites (e.g., scabies)
• tuberculosis
• perioral dermatitis (skin rash with redness around the mouth)
• thin skin, weak veins, stretch marks
• ichthyosis (dry skin with scales similar to those of fish)
• acne (pimples)
• rosacea (severe redness or flushing of the facial skin)
• ulcers or damaged skin

Warnings and precautions
Talk to your doctor or pharmacist before using Zoripot if:

• you are using other medicines that contain corticosteroids because adverse effects may occur
• you have been using this medicine for a long time and want to stop treatment (because there is a risk that the psoriasis will worsen or reappear when treatment with steroids is stopped abruptly)
• you suffer from diabetes mellitus (diabetes) because your blood sugar level, i.e. the concentration of sugar in the blood, may be altered by the steroid
• you develop a skin infection because it may be necessary to stop treatment
• you suffer from a particular type of psoriasis called guttate psoriasis

Special precautions

• Avoid applying the ointment to more than 30% of the body or using more than 15 grams of ointment per day.
• Avoid applying bandages or plasters to the areas where you have used the ointment because these increase the absorption of the steroid.
• Avoid using the ointment on large areas of damaged skin, on mucous membranes or in skin folds (groin, armpits, under the breast) because this increases the absorption of the steroid.
• Avoid using the ointment on the face and genitals (sexual organs) because they are very sensitive to steroids.
• Avoid excessive exposure to sunlight and excessive use of sunbeds and other types of phototherapy.

See your doctor if you experience blurred vision or other visual disturbances.

Children
Zoripot is not recommended for use in children under the age of 18 years.

Other medicines and Zoripot
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those obtained without a prescription.

Pregnancy, breastfeeding and fertility
Do not use Zoripot if you are pregnant (or might be pregnant) or if you are breastfeeding, unless
you have agreed this with your doctor. If your doctor agrees with breastfeeding,
be careful to avoid applying Zoripot to the breast area.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding with milk
ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
This medicine should not affect your ability to drive or use machines.

3. How to use Zoripot

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
How to apply Zoripot: for cutaneous use.
Instructions for correct use

• Apply the ointment only to the areas affected by psoriasis, avoiding healthy skin.
• Remove the cap and check that the tube seal is not broken before the first use of the ointment.
• Use the pointed back of the cap to break the seal.
• Squeeze the ointment onto a clean finger.
• Gently spread the ointment on the skin, covering the area affected by psoriasis until most of the ointment has penetrated the skin.
• Do not apply plasters, cover or wrap the treated skin area with tight bandages.
• Wash your hands thoroughly after using Zoripot (unless you need to apply the ointment to your hands). This will prevent you from accidentally spreading the ointment to other parts of the body (especially the face, scalp, mouth and eyes).
• Do not worry if a little ointment accidentally reaches healthy skin around the area affected by psoriasis, but remove the ointment if it has spread excessively.
• To obtain an optimal effect, it is recommended not to bathe or shower immediately after applying Zoripot ointment.
• After applying the ointment, avoid contact with fabrics that are easily damaged by greasy substances (e.g., silk).

Duration of treatment

• Use the ointment once a day. It may be more convenient to apply it in the evening.
• The normal initial treatment period is 4 weeks, but your doctor may establish a different treatment period for you.
• Your doctor may decide to repeat the treatment.
• Do not use more than 15 grams of ointment per day.

If you are using other medicines containing calcipotriol, the total amount of medicines based on calcipotriol
must not exceed 15 grams per day and the treated area must not exceed 30% of the total
body surface area.

What should I expect from using Zoripot?
Most patients obtain noticeable results after 2 weeks, even if the psoriasis does not
resolve completely by that date.

If you use more Zoripot than you should
Contact your doctor if you have used more than 15 grams of ointment per day.
Using excessive amounts of Zoripot can cause a problem related to calcium in the blood,
which usually resolves by stopping the treatment.
Your doctor may need to perform some blood tests to verify that using an
excessive amount of ointment has not caused a problem related to calcium in the blood. Prolonged
use of excessive amounts of ointment can also cause malfunction of the adrenal glands (glands located near the kidneys that produce hormones).

If you forget to use Zoripot
Do not take a double dose to make up for missed doses.

If you stop using Zoripot
The use of Zoripot must be discontinued as directed by your doctor. It may be necessary
to discontinue treatment gradually, especially if it has been used for a long time.
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 everybody gets them.
Serious side effects
Tell your doctor/nurse immediately or as soon as possible if you experience any of the events listed below. It may be necessary to stop treatment.
The following serious side effects have been reported with Zoripot:
Uncommon (may affect up to 1 in 100 people)

• Worsening of psoriasis. Tell your doctor as soon as possible if your psoriasis gets worse.

Rare (may affect up to 1 in 1,000)

• Pustular psoriasis (red areas with yellowish pustules usually on the hands or feet) may occur. In this case, stop using Zoripot and tell your doctor as soon as possible.

Some serious side effects are known to be caused by betamethasone (a potent steroid), one
of the components of Zoripot. Tell your doctor as soon as possible if you experience a serious side effect.
These side effects are more frequent after prolonged use, use in skin folds
(e.g. groin, armpits or under the breasts), use with occlusive dressing or use on a large
skin area.
Side effects include:

• The adrenal glands may stop functioning properly. Symptoms are fatigue, depression and anxiety.
• Cataract (symptoms are blurred or misty vision, difficulty seeing at night and sensitivity to light) or increased pressure inside the eyes (symptoms are eye pain, red eyes, decreased vision or blurred vision).
• Infections (because the immune system, which fights infections, can be suppressed or weakened).
• Pustular psoriasis (a red area with yellowish pustules that usually appears on the hands or feet). If you notice this, stop using Zoripot and tell your doctor as soon as possible.
• Interference with metabolic control of diabetes mellitus (if you are diabetic you may experience fluctuations in blood sugar).

Serious side effects known to be caused by calcipotriol:

• Allergic reactions with severe swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and difficulty breathing may occur. If you have an allergic reaction, stop using Zoripot, tell your doctor immediately or go to thenearest hospital emergency room.
• Treatment with this ointment may increase the levels of calcium in your blood or urine (usually when using excessive amounts of ointment). Symptoms of increased calcium levels in the blood are: excessive urination, constipation, muscle weakness, confusion and coma. This can be serious and therefore you must contactyour doctor immediately.However, levels will return to normal when treatment is stopped.

Less serious side effects
The following less serious side effects have been reported with Zoripot.
Common (may affect up to 1 in 10 people)
Itching
Skin flaking
Uncommon (may affect up to 1 in 100 people)
Skin pain or irritation
Rash with inflammation of the skin (dermatitis)
Redness of the skin due to dilation of small blood vessels (erythema)
Inflammation or swelling of the hair roots (folliculitis)
Changes in skin color in the area where the ointment has been used
Rash
Burning sensation
Skin infection
Thinning of the skin
Appearance of red or purple discoloration on the skin (purpura or ecchymosis)
Rare (may affect up to 1 in 1,000)
Infection of hair follicles caused by fungi or bacteria (boils)
Allergic reactions
Hypercalcemia
Skin striae
Skin sensitization to light and resulting rash
Acne (pimples)
Dry skin
Rebound effect: a worsening of psoriasis symptoms after treatment is finished
Frequency not known (frequency cannot be estimated based on available data)
Blurred vision
Less serious side effects, due to the use of betamethasone, especially for a
prolonged time, include those listed below; if any of these effects occur, you should
tell your doctor or nurse as soon as possible.
Thinning of the skin
Appearance of superficial blood vessels or stretch marks
Changes in hair growth
Red rashes around the mouth (perioral dermatitis)
Rashes, with inflammation or swelling (allergic contact dermatitis)
Small golden cysts (milia colloidale)
Discoloration of the skin (depigmentation)
Inflammation or swelling at the root of the hair (folliculitis)
Less serious side effects known to be caused by calcipotriol include the following:

• Dry skin
• Skin sensitivity to light, with resulting rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Redness of the skin due to dilation of small blood vessels (erythema)
• Rash
• Rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Zoripot

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 and the tube after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Do not refrigerate or freeze.
The tube must be discarded 1 year after first opening.
Write the date of opening the tube in the designated space on the pack
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 Zoripot contains
The active ingredients are: calcipotriol and betamethasone.
One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of
betamethasone (as dipropionate).
The other ingredients are: Allrac-α-tocopherol (E307), oleyl alcohol, light liquid paraffin,
soft white paraffin.

Description of the appearance of Zoripot and contents of the pack
Zoripot is a pale white coloured ointment. The ointment is packaged in an aluminium/epoxyphenol tube with a
screw cap made of polyethylene or polypropylene.
Pack sizes: tubes containing 15 g, 30 g, 60 g and 120 g of ointment
Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57,
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Lange Göhren 3,
39171 Sülzetal, Osterweddingen,
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium Calcipotriol/Betamethasone Sandoz 50 micrograms/ 0.5 mg/g ointment
Bulgaria Потрибет 50 микрограма/g + 0,5 mg/g маз
Denmark Calcipotriol/Betamethasone Sandoz 50 micrograms/g + 0.5 mg/g salve
Estonia Cabemet
France CALCIPOTRIOL/ BETAMETHASONE SANDOZ 50 microgrammes/0,5
mg/g, pommade
Germany Calcipotriol comp HEXAL
Italy Zoripot
Ireland Calcipotriol/Betamethasone Rowex 50 micrograms + 0.5 mg/g Ointment
Latvia Cabemet 50 mikrogrami/0,5 mg/g ziede
Lithuania Cabemet 50 mikrogramų/0,5 mg/g tepalas
Luxembourg Calcipotriol/Betamethasone Sandoz 50 microgrammes/ 0.5 mg/g pommade
Netherlands Calcipotriol/Betamethason Sandoz 50 microgram/g + 0.5 mg/g, zalf
Portugal Betametasona + Calcipotriol Sandoz
United Kingdom Calcipotriol/Betamethasone Sandoz 50 micrograms per g / 500
micrograms per g ointment
Czech Republic Kalcipotriol/betamethason Sandoz 50 mikrogramů/g + 0,5 mg/g
Slovenia SOREL COMBO 50 mikrogramov/500 mikrogramov v 1 g mazilo
Spain Prenamid 50 microgramos/g + 0,5 mg/g pomada
Sweden Calcipotriol/Betamethasone Sandoz 50 mikrogram/g + 0.5 mg/g salva