Calbeta

Italy
Brand name Calbeta
Form ointment
Active substance / Dosage
BETAMETHASONE
Prescription type Prescription only
ATC code
D05AX52
Registration number 047840
Manufacturer MIBE PHARMA ITALIA S.R.L.

Table of Contents

Patient Information Leaflet

Calbeta 50 micrograms/g + 0.5 mg/g ointment
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, pharmacist, or nurse.
  • This medicine has been prescribed for you personally. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4. Contents of this leaflet:
    1. What Calbeta is 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 Calbeta is and what it is used for

Calbeta ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is a condition in which skin cells reproduce too quickly. This causes redness, scaling, and thickening of the skin. Calbeta ointment 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 Calcipotriol and Betamethasone Dermapharm

Do not use Calcipotriol and Betamethasone Dermapharm
if you are allergic (hypersensitive) to calcipotriol, betamethasone, or to 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, or pustular psoriasis (consult your doctor)
Since Calbeta contains a potent steroid, do not use it on skin affected by:

  • viral skin infections (e.g., cold sores or chickenpox)
  • fungal skin infections (e.g., athlete’s foot or ringworm)
  • bacterial skin infections
  • parasitic skin infections (e.g., scabies)
  • tuberculosis (TB)
  • perioral dermatitis (red rash around the mouth)
  • thinning of the skin, fragile blood vessels, stretch marks
  • ichthyosis (dry, fish-scale-like skin)
  • acne (pimples)
  • rosacea (flushing or redness of the facial skin)
  • skin ulcers or open wounds.

Warnings and precautions
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Talk to your doctor, pharmacist, or nurse before using Calbeta if:

  • you are using other medicines containing corticosteroids, as side effects may occur
  • you have used this medicine for a long time and intend to stop treatment (because there is a risk of worsening or "rebound" flare-up of psoriasis when steroid treatment is stopped abruptly)
  • you have diabetes mellitus (diabetes), as blood sugar/glucose levels may be affected by the steroid
  • you develop skin infections. It may be necessary to discontinue treatment
  • you have a certain type of psoriasis called guttate psoriasis.

Special precautions

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

Children
The use of Calbeta is not recommended in children under 18 years of age.
Other medicines and Calcipotriol and Betamethasone Dermapharm
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Pregnancy, breastfeeding, and fertility
Do not use Calbeta if you are pregnant (or suspect you may be pregnant) or if you are breastfeeding, without first talking to your doctor. If your doctor determines that you may breastfeed, make sure not to apply Calbeta ointment to the breast area.
Consult your doctor or pharmacist before taking any other medicine.
Driving and operating machinery
This medicine is unlikely to affect your ability to drive or operate machinery.
Calbeta contains 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 Calbeta exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
How to apply Calcipotriol and Betamethasone Dermapharm: for topical use.
Instructions for correct use

  • Use the medicine only for psoriasis and not on skin unaffected by psoriasis

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  • Remove the cap and check that the tube seal is intact before using the ointment
  • To break the seal, use the protruding tip on the top of the cap
  • Squeeze the ointment onto a clean finger
  • Gently spread it until the psoriatic area is covered and most of the ointment has been absorbed into the skin
  • Do not bandage, tightly wrap, or cover the treated skin area
  • Wash your hands thoroughly after applying Calbeta (unless you are treating the hands with the ointment). This will help 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 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 Calbeta to achieve optimal effect
  • After applying the ointment, avoid contact with fabrics that may become stained (e.g. silk).

Duration of treatment

  • Use the ointment once daily. It may be more convenient to apply the ointment in the evening
  • The initial treatment period is 4 weeks, but your doctor may prescribe a different duration
  • Your doctor may decide to repeat the treatment
  • Do not use more than 15 g of the medicine per day.

If you are using 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 30% of the total body surface area.
What to expect when using Calcipotriol and Betamethasone Dermapharm?
Many patients show noticeable improvement after 2 weeks, although psoriasis may not be completely cleared at that stage.
If you use more Calbeta than you should
Contact your doctor if you use more than 15 g of the medicine in one day. Excessive use of Calbeta may cause disturbances in blood calcium levels, which usually return to normal once treatment is stopped. Your doctor may consider it necessary to perform blood tests to ensure that excessive use of the ointment has not caused changes in blood calcium levels. Prolonged excessive use may also cause impaired adrenal gland function (the adrenal glands are located near the kidneys and produce hormones).
If you forget to use Calcipotriol and Betamethasone Dermapharm
Do not use a double dose to make up for the missed dose.
If you stop using Calcipotriol and Betamethasone Dermapharm
Treatment with Calbeta should be discontinued as directed by your doctor. Gradual discontinuation may be necessary, especially if you have used the medicine for a prolonged period.
If you have any questions 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 everybody gets them.
Serious side effects
Contact your doctor or nurse immediately or as soon as possible if any of the following side
effects occur.
In such a case, you must stop treatment.
The following side effects have been reported with Calcipotriol and Betamethasone
Dermapharm:
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 appear (reddened areas with yellowish pustules, usually on the hands and feet). If you notice this reaction, stop using Calbeta 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 substances in Calcipotriol and Betamethasone Dermapharm. Inform your doctor as soon as possible if a serious side effect occurs. 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:

  • The adrenal glands may not function properly. Symptoms include fatigue, depression, and anxiety.

  • Cataract (symptoms are blurred or hazy vision, difficulty seeing at night, and photosensitivity) or increased 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, usually appearing on the hands or feet). If you notice this, stop using Calbeta 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).

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 Calcipotriol and Betamethasone Dermapharm, report it immediately to your doctor or go to the emergency department of the nearest hospital.
  • Treatment with this ointment may cause increased levels of calcium in the blood or urine (usually when excessive amounts of ointment are used). Signs of elevated 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 discontinued.
    Less serious side effects

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The following less serious side effects have been reported with Calcipotriol and
Betamethasone 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
  • Skin rash with skin inflammation (dermatitis)
  • Skin redness due to capillary dilation (erythema)
  • Inflammation or swelling at the hair root (folliculitis)
  • Changes in skin color at the site of ointment application
  • Rash
  • Burning sensation
  • Skin infection
  • Skin thinning
  • Appearance of red or purple discoloration on the skin (purpura or bruising)

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 resulting in a rash
  • Acne (boils)
  • Dry skin
  • Rebound effect: worsening of symptoms/psoriasis after treatment is stopped.

Less serious side effects caused by long-term use of betamethasone include the following. You
should inform your doctor or nurse as soon as possible if you notice any of these side effects.

  • Skin thinning
  • Appearance of superficial veins or stretch marks
  • Changes in hair growth
  • Red rash around the mouth (perioral dermatitis)
  • Rash with skin inflammation or swelling (allergic contact dermatitis)
  • Small golden-colored nodules filled with gelatinous material (colloid milium)
  • Skin discoloration (depigmentation)
  • Inflammation or swelling at the hair root (folliculitis)
  • Blurred vision

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

  • Dry skin
  • Skin photosensitivity resulting in a rash
  • Eczema
  • Itching
  • Skin irritation
  • Burning and stinging sensation
  • Skin redness due to capillary dilation (erythema)
  • Rash
  • Skin rash with skin inflammation (dermatitis)
  • Worsening of psoriasis

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Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor,
pharmacist, or nurse. You can also report side effects directly via 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 stated on the label after Exp.
The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not refrigerate.
The tube should 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 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 Calcipotriol and Betamethasone Dermapharm 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).
Other components are:
Liquid paraffin, polyoxystearil ether, white soft paraffin (contains all-rac-α-tocopherol), butylated hydroxytoluene (E321).

Description of the appearance of Calbeta and package contents
Calbeta ointment is a white to yellowish ointment contained in aluminum/epoxy-phenolic tubes with a polyethylene screw cap.
Pack sizes: 15 g, 30 g, 35 g, 50 g, 60 g, 100 g, 100 g (as pack of 2 x 50 g), 120 g and 120 g (as pack of 2 x 50 g).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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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