CALBETA 50 MICROGRAMMI/G + 0,5 MG/G Мазь

Содержание инструкции

1. What is Calbeta and what is it used for
2. What you need to know before using Calcipotriolo and Betametasone Dermapharm
3. How to use Calcipotriol and Betamethasone Dermapharm
4. Possible side effects
5. How to store Calbeta
6. Package Contents and Other Information

Calbeta 50 micrograms/g + 0.5 mg/g ointment
Read this leaflet carefully before taking 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, pharmacist or nurse.
• This medicine has been prescribed for you personally. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
• 1. What Calbetais and what it is used for
• 2. What you need to know before using Calbeta
• 3. How to use Calbeta
• 4. Possible side effects
• 5. How to store Calcipotriol and Betamethasone Dermapharm
• 6. Contents of the pack and other information

1. What is Calbeta and what is it used for

Calbetaunguento is used on the skin to treat plaque psoriasis (common psoriasis)
in adults. Psoriasis is a condition in which skin cells reproduce too
quickly. This causes redness, scaling and thickening of the skin.
Calbetaunguento contains calcipotriol and betamethasone. Calcipotriol normalizes the
growth of skin cells and betamethasone works by reducing inflammation.

2. What you need to know before using Calcipotriolo and Betametasone Dermapharm

Do not useCalcipotriolo e Betametasone Dermapharm
if you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of this medicine (listed in section 6)
if you have problems with calcium levels in your body (consult your doctor)
if you have certain types of psoriasis, such as erythrodermic, exfoliative and pustular psoriasis (consult your doctor)
Since Calbetacontains a potent steroid, do not use it on 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 (TB)
• perioral dermatitis (red rash around the mouth)
• thinning of the skin, easily damaged veins, stretch marks
• ichthyosis (dry skin with scales similar to those of fish)
• acne (pimples)
• rosacea (severe flushing or redness of the facial skin)
• skin ulcers or open wounds.

Warnings and precautions
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Consult your doctor, pharmacist or nurse before using Calbetaif

• you are using other medicines containing corticosteroids, as adverse effects may occur
• you have been using this medicine for a long period and intend to stop treatment (because there is a risk of worsening or “flare-up” of psoriasis when treatment with steroids is stopped suddenly)
• you have diabetes mellitus (diabetes), as blood sugar/glucose levels may be affected by the steroid
• you develop skin infections. Treatment may need to be stopped
• you have certain types of psoriasis called guttate psoriasis.

Special precautions

• avoid applying the product to more than 30% of the body or using more than 15 g per day
• avoid using bandages or clothing that may increase the absorption of the steroid
• avoid applying the medicine to large areas of damaged skin, mucous membranes or at the site of skin sores (groin, armpits, under the breasts) as this increases the absorption of the steroid
• avoid applying the medicine to the face or genitals (sexual organs) as these are areas very sensitive to steroids
• avoid excessive sunbathing, excessive use of solariums or other forms of light treatment
• consult your doctor if you experience blurred vision or other visual disturbances

Children
The use of Calbetais not recommended in children under the age of 18 years.

Other medicines andCalcipotriolo e Betametasone Dermapharm
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility
Do not use Calbetaif you are pregnant (or might be pregnant) or if you are breastfeeding without talking to your doctor first. If your doctor has established that you can breastfeed, make sure not to apply Calbetaointment to the breast area.
Consult your doctor or pharmacist before taking any other medicine.

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

Calbetacontains butylhydroxytoluene (E321)
Butylhydroxytoluene (E321) may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to use Calcipotriol and Betamethasone Dermapharm

Always use Calbetastrictly following your doctor's instructions. If you have any doubts, consult your
doctor or pharmacist.
How to apply Calcipotriol and Betamethasone Dermapharm: for cutaneous use.
Instructions for correct use

• Use the medicine only for psoriasis and not on skin that is not affected by psoriasis

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• Remove the cap and check that the tube seal is not broken before using the ointment
• To break the seal, use the tip on the top of the cap
• Squeeze the ointment onto a clean finger
• Gently rub in until the area affected by psoriasis is covered and most of the ointment has been absorbed by the skin
• Do not bandage, tightly wrap or cover the treated skin area
• Wash your hands thoroughly after applying Calbeta(unless you are using the ointment to treat your hands). This will prevent accidental application of the ointment to other parts of the body (especially the face, scalp, mouth and eyes)
• Do not be alarmed if a small amount of ointment accidentally comes into contact with healthy skin around the psoriasis-affected area, but clean the skin if the medicine spreads too far from the affected area
• It is recommended not to shower or bathe immediately after applying Calbetato obtain an optimal effect
• After applying the ointment, avoid contact with fabrics that could stain (e.g. silk).

Duration of treatment

• use the ointment once a day. It may be more convenient to use the ointment in the evening
• the initial treatment period is 4 weeks, but the doctor may establish a different treatment period
• the doctor may decide to repeat the treatment
• do not use more than 15 g of medicine per day.

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

What to expect with the use ofCalcipotriol and Betamethasone Dermapharm?
Many patients show noticeable results after 2 weeks, even if the psoriasis has not completely
disappeared at that stage.

If you use moreCalbetathan you should
Contact your doctor if you use more than 15 g of medicine in one day. Excessive use of
Calbetacan cause a problem with calcium levels in the blood, which usually normalizes
when treatment is stopped. The doctor may deem it necessary to subject you to some
blood tests to ensure that excessive use of the ointment has not caused
an alteration of calcium levels in the blood. Prolonged excessive use can also cause
improper functioning of the adrenal glands (the adrenal glands are located
near the kidneys and produce hormones).

If you forget to useCalcipotriol and Betamethasone Dermapharm
Do not use a double dose to make up for a missed dose.

If you stop treatment withCalcipotriol and Betamethasone Dermapharm
The use of Calbetashould be discontinued as directed by your doctor. A gradual interruption of treatment may be necessary, especially if you have used the medicine for
a prolonged period.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Contact your doctor/nurse immediately or as soon as possible if any of the following side effects occur.
In this case, you should stop treatment.
The following side effects have been reported with Calcipotriolo and Betametasone
Dermapharm:
Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000)

• Pustular psoriasis may appear (red areas with yellowish pustules, usually on the hands and feet). If you notice this reaction, stop using Calbetae 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 active ingredients of Calcipotriolo and Betametasone Dermapharm. Inform your doctor as soon as possible if a serious side effect occurs. 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 surface. Side effects include:
• The adrenal glands may not function properly. Symptoms are fatigue, depression and anxiety.
• Cataract (symptoms are blurred or cloudy vision, difficulty with night vision and photosensitivity) or an increase in intraocular pressure (symptoms are eye pain, redness of the eyes, reduced or blurred vision).
• Infections (because the immune system, which fights infections, may 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 Calbetae 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 sugar levels).

Some serious side effects are known to be caused by calcipotriol

• Allergic reactions characterized by severe swelling of the face or other parts of the body such as hands or feet. Swelling of the mouth/throat and breathing problems may occur. If you experience an allergic reaction, stop using Calcipotriolo and Betametasone Dermapharm, report it immediately to your doctor or go to the nearest hospital emergency room.
• Treatment with this ointment may cause an increase in calcium levels in the blood or urine (usually when an excessive amount of ointment is used). Signs of an increase in calcium levels in the blood are excessive urination, constipation, muscle weakness, confusion and coma. This can be serious andtherefore you should contact your doctor immediately. However, calcium levels will return to normal once treatment is stopped. Less serious side effects

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The following less serious side effects have been reported with Calcipotriolo and
Betametasone Dermapharm.
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
• Rash with skin inflammation (dermatitis)
• Redness of the skin due to dilation of capillaries (erythema)
• Inflammation or swelling of the hair root (folliculitis)
• Changes in skin color in the area where the ointment has been applied
• 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 1000)

• Infection of hair follicles caused by fungi or bacteria (boils)
• Allergic reactions
• Hypercalcemia
• Stretch marks
• Skin sensitivity to light resulting in a rash
• Acne (boils)
• Dry skin
• Rebound effect: a worsening of symptoms/psoriasis once treatment is finished.

Less serious side effects caused by the use of betamethasone, especially for a long
period of time, include those listed below. You should inform your doctor or nurse as soon as possible if you notice any of the following side effects.

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Alteration of hair growth
• Red rash around the mouth (perioral dermatitis)
• Rash with inflammation or swelling (allergic contact dermatitis)
• Small golden nodules filled with gelatinous substance (milia colloidale)
• Discoloration of the skin (depigmentation)
• Inflammation or swelling at the root of the hair (folliculitis)
• Blurred vision

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

• Dry skin
• Photosensitivity skin with resulting rash
• Eczema
• Itching
• Skin irritation
• Burning and stinging sensation
• Redness of the skin due to dilation of capillaries (erythema)
• Rash

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• Rash with skin inflammation (dermatitis)
• Worsening of psoriasis

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist or nurse. 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 Calbeta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after Scad.
The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Do not refrigerate.
The tube must be discarded 1 year after first opening. Write the date of first opening
of the tube in the designated space on the packaging.
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. Package Contents and Other Information

What the medicine containsCalcipotriol and Betamethasone Dermapharm
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:
Liquid paraffin, polyoxypropylene-stearyl ether, soft white paraffin (contains all-rac-α-
tocopherol), butylhydroxytoluene (E321).

Description of the appearance ofCalbetaand package contents
Calbeta ointment is an ointment of colour from white to yellow contained in tubes in
aluminium/epoxyphenol with a screw cap made of polyethylene.
Pack sizes: 15 g, 30 g, 35 g, 50 g, 60 g, 100 g, 100 g (as a pack of 2 x 50 g), 120 g and 120 g
(as a pack of 2 x 50 g).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
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MIBE PHARMA ITALIA S.R.L.
VIA LEONARDO DA VINCI 20/B, 39100 BOLZANO

Manufacturers responsible for batch release
Mibe GmbH Arzneimittel
Münchener Str. 15
06796 Brehna
Germany
Sun-Farm Sp. z o.o.
Ul. Dolna 21
Mazowieckie
05-092 Lomianki
Poland
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