CALCIPOTRIOL/BETAMETHASONE ARISTO 50 micrograms/g + 0.5 mg/g GEL

Introduction

Package Leaflet: Information for the User

Calcipotriol/betamethasone Aristo 50 micrograms/g + 0.5 mg/g gel

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Calcipotriol/betamethasone Aristo is and what it is used for
2. What you need to know before you use Calcipotriol/betamethasone Aristo
3. How to use Calcipotriol/betamethasone Aristo
4. Possible side effects
5. Storage of Calcipotriol/betamethasone Aristo
6. Contents of the pack and other information

1. What Calcipotriol/betamethasone Aristo is and what it is used for

Calcipotriol/betamethasone contains the active substances calcipotriol and betamethasone. Calcipotriol helps to normalize the rate of skin cell growth and betamethasone reduces inflammation.

Calcipotriol/betamethasone is used as a topical treatment for scalp psoriasis in adults and to treat plaque psoriasis (psoriasis vulgaris) of mild to moderate severity on other areas of the body in adults.

The cause of psoriasis is the excessively rapid production of skin cells. This leads to redness, scaling, and thickening of the skin.

2. What you need to know before you use Calcipotriol/betamethasone Aristo

Do not usecalcipotriol/betamethasone:

• 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 suffer from certain types of psoriasis: such as erythrodermic, exfoliative and pustular (consult your doctor).

Since calcipotriol/betamethasone contains a potent steroid, do not useit on skin affected by:

• skin infections caused by viruses (e.g. herpes or chickenpox)
• skin infections caused by fungi (e.g. athlete's foot or ringworm)
• bacterial skin infections
• skin infections caused by parasites (e.g. scabies)
• tuberculosis
• perioral dermatitis (red rash around the mouth)
• thin skin, fragile veins, stretch marks
• ichthyosis (dry skin with scales)
• acne (pimples)
• rosacea (severe redness or flushing of the skin on the face)
• ulcers or damaged skin.

Warnings and precautions

Consult your doctor, pharmacist or nurse before and during the use of calcipotriol/betamethasone if:

• you are using other medicines that contain corticosteroids, as you may suffer from side effects
• you have used this medicine for a long time and plan to stop using it (as there is a risk that your psoriasis may worsen or 'flare up' when the steroids are stopped suddenly)
• you have diabetes mellitus (diabetes), as your blood sugar/glucose level may be affected by the steroid
• a skin infection appears, as it may be necessary to interrupt treatment
• you suffer from a type of psoriasis called guttate psoriasis.
• if you experience blurred vision or other visual disturbances.

Special precautions

• Avoid using it on more than 30% of your body or more than 15 grams per day
• Avoid using occlusive dressings, bandages or gauzes as they increase the absorption of the steroid
• Avoid using it on large areas of damaged skin, mucous membranes or skin folds (e.g. groin, armpits, under the breasts) as they increase the absorption of the steroid
• Avoid using it on the face or genitals (sex organs) as they are highly sensitive to steroids
• Avoid excessive sunbathing, excessive use of sunlamps and other light treatments.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age.

Calcipotriol/betamethasone and other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. If your doctor agrees that you can breastfeed, be careful and do not apply calcipotriol/betamethasone to the breast area.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Calcipotriol/betamethasone Aristo contains butylhydroxytoluene (E321) and castor oil.

This medicine may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene.

This medicine may cause skin reactions because it contains castor oil.

3. How to use Calcipotriol/betamethasone Aristo

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to use calcipotriol/betamethasone:

Topical use.

Instructions for proper use

• Use it only on your psoriasis and do not use it on skin that does not have psoriasis
• Shake the bottle before use and remove the cap
• Apply the gel to a clean finger or directly to the area with psoriasis
• Apply calcipotriol/betamethasone with your fingertips to the affected area and massage carefully until the area affected by psoriasis is covered by a thin layerof gel
• Do not put a bandage, cover or wrap the treated skin area
• Wash your hands well after using calcipotriol/betamethasone. This will prevent accidental contact of the gel with other parts of your body (especially the face, mouth and eyes)
• Do not worry if you accidentally apply a little gel to healthy skin near your psoriasis, but clean it if it has spread too much
• In order to achieve an optimal effect, it is recommended not to shower or bathe immediately after applying calcipotriol/betamethasone gel
• After applying the gel, avoid contact with tissues that may be easily stained with grease (e.g. silk).

If you have psoriasis on the scalp

• Before applying calcipotriol/betamethasone to the scalp, brush your hair to remove loose scales. Tilt your head to avoid calcipotriol/betamethasone spreading to your face. It may be helpful to separate the hair from the area to be treated before using calcipotriol/betamethasone. Apply calcipotriol/betamethasone with your fingertips to the affected area and massage carefully.

It is not necessary to wash your hair before applying calcipotriol/betamethasone.

In order to achieve an optimal effect, it is recommended not to wash your hair immediately after applyingcalcipotriol/betamethasone. Leavecalcipotriol/betamethasoneon the scalp overnight or during the day. When you wash your hair after application, the following instructions may be helpful:

If necessary, repeat steps 4 to 6 one or two times.

Treatment duration

• Use the gel once a day. It may be more convenient to apply the gel at night
• The initial treatment period is normally 4 weeks for scalp areas and 8 weeks for other areas
• Your doctor may decide on a different treatment period
• Your doctor may decide to repeat the treatment
• Do not use more than 15 grams in one day.

If you are using other medicines that contain calcipotriol, the total amount of calcipotriol-containing medicines should not exceed 15 grams per day, and the treated area should not exceed 30% of the total body surface area.

What should I expect when usingcalcipotriol/betamethasone?

Most patients see noticeable results after 2 weeks, even if the psoriasis has not completely cleared at that time.

If you use morecalcipotriol/betamethasone than you should

Consult your doctor if you have used more than 15 grams in one day.

Excessive use of calcipotriol/betamethasone may cause a problem with the calcium in your blood, which usually returns to normal when treatment is stopped.

Your doctor may need to perform blood tests to check that using too much gel has not caused a problem with the calcium in your blood.

Prolonged and excessive use may also cause your adrenal glands to stop working properly (the adrenal glands are located near the kidneys and produce hormones).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use calcipotriol/betamethasone

Do not apply a double dose to make up for the forgotten dose.

If you stop using calcipotriol/betamethasone

The use of calcipotriol/betamethasone should be stopped as indicated by your doctor. It may be necessary to stop using this medicine gradually, especially if you have been using it for a long time.

If you have any other questions about the use of this medicine, ask 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 following side effects. You may need to stop your treatment.

The following serious side effects have been reported: Uncommon (may affect up to 1 in 100 people):

• Worsening of your psoriasis. If your psoriasis worsens, 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 calcipotriol/betamethasone. If you experience any of these serious side effects, tell your doctor as soon as possible. These side effects are more likely to occur after long-term use, when used in skin folds (e.g. groin, armpits or under the breasts), when covered or when used on large areas of skin.

Side effects include the following:

• Your adrenal glands may stop working properly. Symptoms are fatigue, depression and anxiety
• Cataracts (symptoms are cloudy or blurred vision, decreased night vision and sensitivity to light) or increased pressure in the eye (symptoms are eye pain, red eye, blurred vision or decreased vision)
• Infections (because your immune system, which fights infections, may be weakened or suppressed)
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens to you, stop using calcipotriol/betamethasone and tell your doctor as soon as possible
• Effect on the metabolic control of diabetes mellitus (if you have diabetes, you may experience changes in blood glucose levels).

Serious side effects caused by calcipotriol

• Allergic reactions with 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/betamethasone, tell your doctor immediately or go to the emergency department of the nearest hospital
• Treatment with this gel may cause an increase in the level of calcium in your blood or urine (usually when too much gel is used). Symptoms of high calcium in the blood are excessive urine production, constipation, muscle weakness, confusion and coma. This can be serious and you should contact your doctor immediately.However, when treatment is stopped, levels return to normal.

Less serious side effects

The following less serious side effects have been reported for calcipotriol/betamethasone.

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

• Itching.

Uncommon (may affect up to 1 in 100 people)

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

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

• Allergic reactions
• Stretch marks
• Exfoliation of the skin
• Rebound effect: Worsening of symptoms/psoriasis after stopping treatment.

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

• When used on the scalp, white or gray hair may temporarily change to a yellowish color at the application site
• Blurred vision.

Less serious side effects caused by the use of betamethasone, especially during prolonged use, include the following. If you notice any of them, tell your doctor or nurse as soon as possible

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rash with inflammation or swelling (allergic contact dermatitis)
• Papules with golden gel (colloid milium)
• Discoloration of the skin (depigmentation)
• Inflammation or swelling of the hair root (folliculitis).

Less serious side effects caused by calcipotriol include

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use https://www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calcipotriol/betamethasone Aristo

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 outer packaging and on the tube after “EXP”. The expiry date is the last day of the month stated.

Do not refrigerate.

Discard the tube with the remaining gel 6 months after the first opening.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the packaging and any unused medicine, ask your pharmacist. This will help protect the environment.

6. Container contents and additional information

Composition of Calcipotriol/betamethasone Aristo

The active ingredients are Calcipotriol and betamethasone.

One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

The other components are:

• liquid paraffin
• polyoxypropylene stearyl ether
• hydrogenated castor oil
• butylhydroxytoluene (E321)

Appearance of the product and container contents

Calcipotriol/betamethasone is a nearly transparent gel, colorless to slightly whitish, presented in a white HDPE cylindrical tube with a white PP screw cap.

The tube is included in a cardboard box.

Package sizes:

1 tube of 30 g

1 tube of 60 g.

Multiple packages with 60 g (2 tubes of 30 g), and 120 g (2 tubes of 60 g).

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Or

C.P.M. Contract Pharma GmbH

Frühlingsstr. 7

83620 Feldkirchen-Westerham

Germany

Or

esparma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized inthe member states of the European Economic Area under the following names:

Germany Calcipotriol comp. Aristo 50 micrograms/g + 0.5 mg/g Gel

Austria Calcipotriol comp. Aristo 50 micrograms/g + 0.5 mg/g Gel

Czech Republic Talizon 50 micrograms/g + 0.5 mg/g gel

Denmark Calcipotriol/Betamethasone Aristo

Spain Calcipotriol/betamethasone Aristo 50 micrograms/g + 0.5 mg/g gel

Ireland Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g gel

Italy Aribec

Netherlands Calcipotriol/Betamethasone Aristo

Norway Calcipotriol/Betamethasone Aristo

Poland BETACAL

Portugal Calcipotriol + Betamethasone Aristo

Sweden Calcipotriol/Betamethasone Aristo

United Kingdom

(Northern Ireland) Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g, gel

Date of the last revision of this prospectus:April 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/