Zoripot

Package leaflet: Information for the user

Zoripot 50 micrograms/g + 0.5 mg/g ointment

calcipotriol/betamethasone
Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 using 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 Zoripot is and what it is used for

Zoripot ointment is applied to the skin to treat plaque psoriasis (psoriasis vulgaris) in adults.
Psoriasis is caused by the excessively rapid production of skin cells. This leads to
redness, scaling, and thickening of the skin.
Zoripot ointment contains calcipotriol and betamethasone.
Calcipotriol helps normalize the rate of skin cell growth, while betamethasone reduces inflammation.

2. What you need to know before using Zoripot

Do not use Zoripot

• 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 specific types of psoriasis: erythrodermic psoriasis, exfoliative psoriasis, or pustular psoriasis (ask your doctor)

Zoripot contains a potent steroid; therefore, it must not be applied to skin affected by:

• skin infections caused by viruses (e.g., cold sores or chickenpox)
• skin infections caused by fungi (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, fragile veins, stretch marks
• ichthyosis (dry, fish-scale-like skin)
• acne (pimples)
• rosacea (intense 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 containing corticosteroids, as adverse effects may occur
• you have been using this medicine for a long time and wish to stop treatment (because there is a risk that psoriasis may worsen or reappear when steroid treatment is abruptly stopped)
• you have diabetes mellitus (diabetes), as your blood glucose level (blood sugar concentration) may be affected by the steroid
• you develop a skin infection, as it may be necessary to discontinue treatment
• you suffer from a particular type of psoriasis called guttate psoriasis

Special precautions

• Avoid applying the ointment to more than 30% of your body surface or using more than 15 grams of ointment per day.
• Avoid covering the treated areas with bandages or occlusive dressings, as these increase steroid absorption.
• Avoid using the ointment on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breast) because this increases steroid absorption.
• Avoid using the ointment on the face and genitals (sexual organs) because these areas are highly sensitive to steroids.
• Avoid excessive exposure to sunlight and excessive use of sunbeds or other types of phototherapy.

Talk to your doctor if you experience blurred vision or other visual disturbances.
Children
Zoripot is not recommended for use in children under 18 years of age.
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 discussed this with your doctor beforehand. If your doctor approves breastfeeding, take care to avoid applying Zoripot to the breast area.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
This medicine is unlikely to affect your ability to drive or operate machinery.

3. How to use Zoripot

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to apply Zoripot: for topical use.
Instructions for correct use

• Apply the ointment only to areas affected by psoriasis, avoiding healthy skin.
• Remove the cap and check that the tube seal is intact before first use of the ointment.
• Use the pointed end of the cap to pierce the seal.
• Squeeze the ointment onto a clean finger.
• Gently spread the ointment over the affected skin, covering the psoriatic area until most of the ointment has been absorbed.
• Do not apply plasters, dressings, or cover the treated area with tight bandages.
• Wash your hands thoroughly after using Zoripot (unless you are applying the ointment to your hands). This will help prevent accidentally spreading the ointment to other parts of the body (especially the face, scalp, mouth, and eyes).
• Do not worry if a small amount of ointment accidentally reaches healthy skin around the affected area, but remove any excess ointment.
• For 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 daily. It may be more convenient to apply it in the evening.
• The usual initial treatment period is 4 weeks, but your doctor may determine a different duration 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 calcipotriol-containing medicines 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 show noticeable improvement after 2 weeks, although psoriasis may not be completely resolved by then.
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 may cause problems related to calcium levels in the blood, which usually resolve once treatment is stopped.
Your doctor may need to perform blood tests to check whether excessive use of the ointment has caused any disturbances in blood calcium levels. Prolonged use of excessive amounts of ointment may also cause impaired function 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 forgotten doses.
If you stop using Zoripot
Treatment with Zoripot should be discontinued according to your doctor's instructions. You may need to stop treatment gradually, especially if it has been used for a long time.
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 everyone gets them.

Serious side effects

Contact your doctor or nurse immediately or as soon as possible if you experience any of the following events. You may need 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. Inform your doctor as soon as possible if your psoriasis worsens.

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

• Pustular psoriasis may occur (red areas with yellowish pustules, usually on the hands or feet). In this case, stop using Zoripot and inform 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. Inform your doctor as soon as possible if you experience any serious side effect.
These side effects occur more frequently after prolonged use, use in skin folds (e.g. groin, armpits, or under the breasts), use under occlusive dressing, or application over a large skin surface area.

Side effects include:

• Adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety.
• Cataract (symptoms include blurred or hazy vision, difficulty seeing at night, and light sensitivity) or increased intraocular pressure (symptoms include eye pain, red eyes, reduced vision, or hazy vision).
• Infections (because the immune system, which fights infections, may be suppressed or weakened).
• Pustular psoriasis (a red area with yellowish pustules, usually appearing on the hands or feet). If you notice this, stop using Zoripot and inform your doctor as soon as possible.
• Interference with metabolic control of diabetes mellitus (if you are diabetic, you may experience fluctuations in blood glucose levels).

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 also occur. If you have an allergic reaction, stop using Zoripot and contact your doctor immediately or go to the nearest hospital emergency department.
• Treatment with this ointment may increase calcium levels in your blood or urine (usually when excessive amounts of ointment are used). Symptoms of increased calcium levels in the blood include: excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and therefore you must contact your doctor immediately. However, calcium levels will return to normal once 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 peeling

Uncommon (may affect up to 1 in 100 people)

• Skin pain or irritation
• Skin rash with skin inflammation (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling at the base of hair follicles (folliculitis)
• Changes in skin color in the area where the ointment was applied
• Rash
• Burning sensation
• Skin infection
• Thinning of the skin
• Appearance of red or purple discolored spots on the skin (purpura or bruising)
• Acne (pimples)
• Dry skin
• Rebound effect: worsening of psoriasis symptoms after stopping treatment

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

• Infection of hair follicles caused by fungi or bacteria (boils)
• Allergic reactions
• Hypercalcemia
• Skin striae (stretch marks)
• Skin sensitivity to light, leading to rash
• Acne (pimples)
• Dry skin

Frequency not known (frequency cannot be estimated from the available data)

• Blurred vision

Less serious side effects due to the use of betamethasone, especially with prolonged use, include the following. If any of these occur, inform 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)
• Skin rashes with inflammation or swelling (allergic contact dermatitis)
• Small golden-colored cysts (colloid milium)
• Skin discoloration (depigmentation)
• Inflammation or swelling at the base of hair follicles (folliculitis)

Less serious side effects known to be caused by calcipotriol include:

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

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: 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 stated on the carton and on the tube after
"Exp". The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not refrigerate or freeze.
The tube should be discarded 1 year after first opening.
Write the date of opening of the tube in the space provided on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Zoripot contains
The active substances 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 components are: all-rac-α-tocopherol (E307), oleyl alcohol, light liquid paraffin,
white soft paraffin.

Description of the appearance of Zoripot and the contents of the pack
Zoripot is a pale white ointment. The ointment is packaged in an aluminum/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 Authorization 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 authorized in the European Economic Area (EEA) Member States under the following names:
Belgium Calcipotriol/Betamethasone Sandoz 50 microgram/ 0.5 mg/g salve
Bulgaria Потрибет 50 микрограма/g + 0.5 mg/g маз
Denmark Calcipotriol/Betamethasone Sandoz 50 mikrogram/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 microgram + 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 Betamethasone + 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