Betacal

Patient Information Leaflet

Betacal, (50 micrograms + 0.5 mg)/g, gel
Calcipotriol + Betamethasone
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Betacal is and what it is used for
2. Important information before using Betacal
3. How to use Betacal
4. Possible side effects
5. How to store Betacal
6. Contents of the pack and other information

1. What Betacal is and what it is used for

Betacal contains the active substances: calcipotriol and betamethasone. Calcipotriol helps restore the normal rate of skin cell growth, and betamethasone has an anti-inflammatory effect.
Betacal is used for the topical treatment of scalp psoriasis in adult patients and for the treatment of mild to moderate plaque-type psoriasis (psoriasis vulgaris) in adult patients affecting skin other than the scalp.
Psoriasis is caused by excessive skin cell growth. This leads to redness, scaling, and thickening of the skin.

2. Important information before using Betacal

When not to use Betacal

• if the patient is allergic to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has disorders of calcium blood levels (consult a doctor),
• if the patient has been diagnosed with other types of psoriasis, such as erythrodermic psoriasis, pustular psoriasis, or palmoplantar pustulosis (consult a doctor).

Betacal contains a potent corticosteroid medicine; therefore, DO NOT use this medicine
in case of the following skin conditions:

• viral skin infections (e.g. herpes simplex or chickenpox)
• fungal skin infections (e.g. athlete's foot or dermatophytosis)
• bacterial skin infections
• parasitic skin infections (e.g. scabies)
• tuberculosis
• perioral dermatitis (red rash around the mouth)
• thin skin, fragile blood vessels, skin striae (stretch marks)
• ichthyosis (dry skin with scaling resembling fish scales)
• acne
• rosacea (severe redness or flushing of the facial skin)
• skin ulcers or skin damage.

Warnings and precautions
Before starting and during treatment with Betacal, discuss with your doctor
or pharmacist if:

• the patient is using other medicines containing corticosteroids, as adverse effects may occur,
• the patient has used this medicine for a long time and plans to stop treatment (because there is a risk of worsening or "rebound" of psoriasis after abrupt discontinuation of steroids),
• the patient has diabetes, as steroid-containing medicines may affect blood sugar/glucose levels,
• a skin infection has occurred, as treatment may need to be discontinued,
• the patient has a certain type of psoriasis called guttate psoriasis,
• the patient experiences blurred vision or other visual disturbances.

Precautions

• Avoid using the medicine on more than 30% of the body surface and using more than 15 g per day.
• Avoid using the medicine under occlusive swim caps, bandages, or dressings, as this increases steroid absorption.
• Avoid using the medicine on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts), as this increases steroid absorption.
• Avoid use on the face and genital organs (genitalia), as these areas are particularly sensitive to steroids.
• Avoid excessive sun exposure, use of sunbeds, or other forms of phototherapy.

Children and adolescents
Betacal is not recommended for use in children and adolescents under 18 years of age.
Betacal and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using
or has recently used, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to
become pregnant, she should consult a doctor before using this medicine.
If the doctor has approved breastfeeding, the patient should exercise caution and avoid applying
Betacal on the breast area.
Driving and operating machinery
This medicine is unlikely to affect the ability to drive or operate machinery.
Betacal contains butylated hydroxytoluene (E 321)
Betacal contains butylated hydroxytoluene (E 321), which may cause local skin reactions
(e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Betacal contains hydrogenated castor oil
Betacal contains hydrogenated castor oil, which may cause skin reactions.

3. How to use Betacal

This medicine should always be used exactly as directed by your doctor. In case of doubt, consult your doctor or pharmacist.

How to apply Betacal:

For topical use only.

Instructions for correct use:

• Apply only to skin affected by psoriasis. Do not apply to unaffected skin.
• Shake the tube well before use and remove the cap.
• Squeeze the gel onto a clean finger or directly onto the psoriatic skin area.
• Using fingertips, apply Betacal gel to the affected areas and gently spread until the psoriatic skin is covered with a thin layer of gel.
• Do not cover treated areas with bandages, occlusive dressings, or wraps.
• Wash hands thoroughly after using Betacal. This helps prevent accidental transfer of the gel to other parts of the body (especially face, mouth, and eyes).
• Do not be concerned if a small amount of gel accidentally spreads to healthy skin near the affected area, but wipe it off if it spreads too far.
• To achieve optimal effect, avoid showering or bathing immediately after applying Betacal gel.
• After applying the gel, avoid contact with textiles that are easily stained by oily substances (e.g. silk).

If the patient has psoriasis on the scalp:

Before applying Betacal to the scalp, comb through the hair to remove any loose, flaking skin. Tilt the head to ensure that Betacal does not run down the face. Parting the hair before application may be helpful. Apply Betacal with fingertips directly to the affected area and gently massage into the skin.

It is not necessary to wash the hair before applying Betacal.

Shake the tube before use. Apply a drop of Betacal. Apply directly
onto fingertip. onto the hairy scalp
at the site where
psoriatic scaling may
be present, and rub Betacal
gel into the skin.
Depending on the size of
the affected area, 1–4 g
(up to 1 teaspoon) of gel is
usually sufficient.
To achieve optimal effect, avoid washing the hair immediately after using Betacal. Leave the medicine on the skin overnight or during the day. When washing the hair after application, the following instructions may be helpful:

Apply a gentle shampoo to Leave the shampoo on the Wash hair as usual.
dry hair, especially on scalp for several
areas where the gel was applied. minutes before washing.
If necessary, repeat steps 4–6 once or twice.

Duration of treatment:

• The gel should be used once daily. Evening application may be more convenient.
• The initial treatment period is usually 4 weeks for areas of the scalp and 8 weeks for other skin areas.
• Your doctor may decide on a different treatment duration.
• Your doctor may decide to repeat the treatment.
• Do not use more than 15 grams of medicine per day.

When using other medicines containing calcipotriol, the total daily amount of calcipotriol-containing medicines must not exceed 15 grams, and the treated skin area should not exceed 30% of the total body surface area.

What results to expect when using Betacal

Most patients will see clear improvement within 2 weeks, even if psoriasis symptoms have not yet completely resolved at the treated site.

Using more than the recommended dose of Betacal

If more than 15 g per day is used, contact your doctor.
Excessive use of Betacal at high doses may lead to disturbances in blood calcium levels, which usually resolve after stopping treatment.
Your doctor may order blood tests to check whether using more than the recommended dose of gel has caused disturbances in blood calcium levels.
Prolonged, excessive use of Betacal may also lead to adrenal gland dysfunction (adrenal glands are located above the kidneys and produce hormones).

Missing a dose of Betacal

Do not use a double dose to make up for a missed dose.

Stopping Betacal

Stop using Betacal only after consulting your doctor. Gradual discontinuation may be necessary, especially if the medicine has been used for a prolonged period.

If you have any further doubts about using 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

If any of the following symptoms occur, inform your doctor or nurse immediately or as soon as possible. It may be necessary to stop treatment.

The following serious side effects have been reported with this medicine:

Uncommon side effects (may affect up to 1 in 100 patients)

• Worsening of psoriasis. If psoriasis worsens, inform your doctor as soon as possible.

It is known that some serious side effects are caused by betamethasone (a potent steroid), one of the components of Betacal. Inform your doctor as soon as possible if any of the serious side effects occur. These are more likely to occur after long-term use, use in skin folds (such as groin, underarms, under breasts), use under occlusive dressings, or use over large areas of skin.

Side effects include:

• Adrenal glands may stop functioning properly. Symptoms include: fatigue, depression, and anxiety.
• Cataracts (symptoms include: blurred or cloudy vision, difficulty seeing at night, and sensitivity to light) or increased pressure in the eye (symptoms include: eye pain, redness of the eye, worsened or blurred vision).
• Infections (due to suppression or weakening of the immune system fighting infections).
• Pustular psoriasis (a red area with yellowish pustules, usually on the hands or feet). If such symptoms are observed, discontinue use of Betacal and contact your doctor immediately.
• Effect on metabolic control of diabetes (in patients with diabetes, fluctuations in blood glucose levels may occur).

Serious side effects caused by calcipotriol

• Allergic reactions with severe swelling of the face or other body parts, such as hands or feet. Swelling of the lips or throat and difficulty breathing may occur. If an allergic reaction occurs, discontinue use of Betacal and seek immediate medical attention by contacting your doctor or going to the nearest hospital emergency department.
• Treatment with this gel may cause increased calcium levels in the blood or urine (usually after excessive application of the gel). Signs of increased calcium levels in the blood include: excessive urination, constipation, muscle weakness, confusion, and coma. This condition can be serious and you should contact your doctor immediately. However, calcium levels usually return to normal after stopping treatment.

Less serious side effects

The following less serious side effects have been reported with Betacal.

Common side effects (may affect up to 1 in 10 patients)

• Itching.

Uncommon side effects (may affect up to 1 in 100 patients)

• Eye irritation.
• Burning sensation of the skin.
• Skin pain or irritation.
• Inflammation or swelling of the hair root (folliculitis).
• Skin rash with inflammation (dermatitis).
• Redness of the skin due to dilation of small blood vessels (erythema).
• Acne (pimples).
• Dry skin.
• Rash.
• Pustular psoriasis.
• Skin infections.

Rare side effects (may affect up to 1 in 1,000 patients)

• Allergic reactions.
• Stretch marks.
• Skin peeling.
• Rebound effect: worsening of psoriasis symptoms after stopping treatment.

Frequency not known (cannot be estimated from available data)

• White or grey hairs may temporarily turn yellowish at the site of gel application when the medicine is applied to hairy scalp.
• Blurred vision.

Less serious side effects are usually caused by betamethasone, especially when used for a prolonged period. Inform your doctor or nurse as soon as possible if you notice any of the following symptoms:

• Thinning of the skin.
• Appearance of surface veins or stretch marks.
• Change in the rate of hair growth.
• Red rash around the mouth (perioral dermatitis).
• Skin rash with accompanying inflammation or swelling (allergic contact dermatitis).
• Yellowish, gel-filled bumps (colloid milia).
• Lightening of skin color (depigmentation).
• Inflammation or swelling of hair follicles (folliculitis).

Other less serious known side effects caused by calcipotriol include:

• Dry skin.
• Skin sensitivity to light, manifesting as a rash.
• Eruption.
• Itching.
• Skin irritation.
• Burning or stinging sensation.
• Redness of the skin due to dilation of small blood vessels (erythema).
• Rash.
• Inflammatory skin rash (dermatitis).
• Worsening of psoriasis.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Betacal

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the tube and the cardboard box following EXP. The expiry date refers to the last day of the stated month.
• Do not store in the refrigerator.
• Discard the tube and any remaining gel 6 months after first opening.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Betacal contains
The active substances are: calcipotriol and betamethasone.
One gram of gel contains 50 micrograms of calcipotriol (as calcipotriol monohydrate)
and 0.5 mg of betamethasone (as betamethasone dipropionate).
Other ingredients are:

• liquid paraffin
• polyoxypropylene stearyl ether
• hydrogenated castor oil
• butylated hydroxytoluene (E 321)

What Betacal looks like and contents of the pack
Betacal is an almost transparent, colourless to slightly cream-coloured gel packed in a white tube made of HDPE, with a white PP cap.
The tube is placed in a cardboard box.
Pack sizes:
1 tube of 30 g
1 tube of 60 g
Multipacks containing 60 g (2 tubes of 30 g) and 120 g (2 tubes of 60 g)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
Poland

Manufacturer
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
Esparma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
C.P.M Contract Pharma GmbH
Fruehlingstrasse 7
83620 Feldkirchen-Westerham
Germany

This medicinal product is authorised in the European Economic Area under the following names:
Austria Calcipotriol comp. Aristo 50 Mikrogramm/g + 0,5 mg/g Gel
Czech Republic Talizon 50 Mikrogramů/g + 0,5 mg/g gel
Denmark Calcipotriol/Betamethasone Aristo
Spain CALCIPOTRIOL/BETAMETASONA ARISTO 50 MICROGRAMOS/G+0,5 MG/G GEL
Netherlands Calcipotriol/Betamethason Aristo 50 microgram/g + 0,5 mg/g, gel
Ireland Calcipotriol/Betamethasone 50 microgram/g + 0,5 mg/g gel
Germany Calcipotriol comp. Aristo 50 Mikrogramm/g + 0,5 mg/g Gel
Norway Calcipotriol/Betamethasone Aristo
Poland BETACAL
Portugal Katriomet 0,5 mg/g + 50 microgramas/g gel
Sweden Calcipotriol/Betamethasone Aristo
United Kingdom Calcipotriol/Betamethasone 50 micrograms / g + 0,5 mg / g, gel
(Northern Ireland)
Italy Aribec