Label: information for theuser

Calcipotriol/Betametasona ratiopharm 50 micrograms/g + 0.5 mg/g ointment

Read this label carefully before starting touse this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other peoplealthough they may have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor,pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What is Calcipotriol/Betametasona ratiopharm and how is it used

2.What you need to know before starting to use Calcipotriol/Betametasona ratiopharm

3.How touse Calcipotriol/Betametasona ratiopharm

4.Possible side effects

5.Storage of Calcipotriol/Betametasona ratiopharm

6.Contents of the package and additional information

Calcipotriol/Betametasona ratiopharm is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. The cause of psoriasis is the excessively rapid production of skin cells. This causes redness, scaling, and thickening of the skin.

Calcipotriol/Betametasona ratiopharmcontains calcipotriol and betametasona. Calcipotriol helps to normalize the rate of skin cell growth and betametasona reduces inflammation.

Do not use Calcipotriol/Betametasona ratiopharm

• If you are allergic to calcipotriol, betametasona or any of the other components of this medication (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: erythrodermic, exfoliative and pustular (consult your doctor).

Since Calcipotriol/Betametasona ratiopharmcontains a potent steroid, DO NOT use it on the skin affected by:

• Skin infections caused by viruses (for example, herpes or chickenpox)
• Skin infections caused by fungi (for example, athlete's foot and ringworm)
• Skin infections caused by bacteria
• Skin infections caused by parasites (for example, scabies)
• Tuberculosis (TB)
• Perioral dermatitis (red rash around the mouth)
• Fine skin, fragile veins, stretch marks

• Ictiosis (dry skin with scales)
• Acne (pimples)
• Rosacea (intense 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/Betametasona ratiopharm

• If you are using other medications that contain corticosteroids, as you may experience adverse effects
• If you have used this medication for a long time and plan to stop using it (as there is a risk that your psoriasis may worsen or 'flare up' when steroids are suddenly stopped)
• If you have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid
• If a skin infection appears, as you may need to interrupt treatment
• If 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 bandages or gauze as it increases the absorption of the steroid
• Avoid using it on large areas of damaged skin, mucous membranes or skin folds (groins, armpits, under the breasts) as it increases the absorption of the steroid
• Avoid using it on the face or genitals (sexual organs) as these areas are highly sensitive to steroids
• Avoid excessive sun exposure, excessive use of artificial sun and other forms of light treatment.

Children and adolescents

Calcipotriol/Betametasonaratiopharmis not recommended for use in children under 18 years old.

Use of Calcipotriol/Betametasona ratiopharmwith other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. If your doctor agrees that you can breastfeed, be careful and do not apply Calcipotriol/Betametasona ratiopharmto the breast area.

Driving and operating machinery

This medication does not affect your ability to drive or operate machinery.

Calcipotriol/Betametasona ratiopharmcontains butylhydroxytoluene (E321).

It may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

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

How to use Calcipotriol/Betametasona ratiopharm: topical use.

Instructions for proper use

• Use it only on your psoriasis and do not use it on skin that does not have psoriasis
• Before the first use of the ointment, remove the cap and check that the tube seal is not broken
• To break the seal, use the point that appears on the back of the cap
• Apply the ointment to a clean finger
• Gently rub it onto your skin to cover the affected psoriasis area, until most of the ointment has disappeared from the skin
• Do not put a bandage, or cover or wrap the treated skin area
• Wash your hands thoroughly after using Calcipotriol/Betametasona ratiopharm(unless you are using the ointment to treat your hands). This will prevent accidental contact with other parts of your body (especially your face, scalp, mouth, and eyes)
• Do not worry if you accidentally apply a little ointment to the surrounding healthy skin, but clean it up if it has spread too much
• To achieve optimal results, it is recommended not to shower or bathe immediately after applying Calcipotriol/Betametasona ratiopharm.
• After applying the ointment, avoid contact with fabrics that can easily stain with grease (for example, silk).

Treatment duration

• Use the ointment once a day. It may be more convenient to apply the ointment at night
• The initial treatment period is usually 4 weeks, but your doctor may decide on a different treatment period
• Your doctor may decide to repeat the treatment
• Do not use more than 15 grams per day.

If you use other medications containing calcipotriol, the total amount of calcipotriol-containing medications 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 using Calcipotriol/Betametasona ratiopharm?

Most patients observe noticeable results within 2 weeks, even if the psoriasis has not yet faded at that time.

Using more Calcipotriol/Betametasona ratiopharmthan you should

Consult your doctor if you have used more than 15 grams per day. Excessive use of Calcipotriol/Betametasona ratiopharmmay cause a problem with your blood calcium levels, which usually normalize when treatment is stopped.

Your doctor may need to perform blood tests to evaluate whether excessive use has caused a problem with your blood calcium levels. Prolonged and excessive use may also cause your adrenal glands to malfunction (located near the kidneys and produce hormones).

Contact the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Calcipotriol/Betametasona ratiopharm

Do not apply a double dose to compensate for the missed doses.

Stopping treatment with Calcipotriol/Betametasona ratiopharm

Calcipotriol/Betametasona ratiopharm use should be discontinued as indicated by your doctor. It may be necessary to discontinue use gradually, especially if you have been using it for a long time.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctor/nurse immediately or as soon as possible if you experience any of the following severe side effects. You may need to stop treatment.

The following severe side effects have been reported for Calcipotriol/Betametasona ratiopharm:

Rare (may affect up to 1 in 100 people)

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

Very rare (may affect up to 1 in 1,000 people)

• It may cause pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens, stop applying Calcipotriol/Betametasona and inform your doctor as soon as possible.

We know that some severe side effects are caused by betametasona (a powerful steroid), one of the components of Calcipotriol/Betametasona ratiopharm. If you experience any of the severe side effects, inform your doctor as soon as possible. It is more likely to occur after long-term use, use in skin folds (e.g. armpits, groin or under the breasts), use under dressings or bandages, or use on large areas of skin.

The side effects include the following:

• Your adrenal glands may not function properly. Symptoms are fatigue, depression, and anxiety
• Cataracts (symptoms are blurred vision, difficulty seeing at night, 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 depressed or weakened)
• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If this happens, stop applying Calcipotriol/Betametasona and inform your doctor as soon as possible
• Effect on blood sugar control in diabetes mellitus (if you have diabetes, you may experience changes in blood glucose levels)

Severe side effects known to be caused by Calcipotriol

• Allergic reactions with intense swelling of the face or other parts of the body such as the hands or feet. It may cause swelling of the mouth/throat and breathing problems. If you experience an allergic reaction, stop applying Calcipotriol/Betametasona, inform your doctor immediately or go to the nearest hospital emergency department.
• Treatment with this cream may cause an increase in calcium levels in your blood or urine (usually when too much cream is used). Symptoms of high calcium levels 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.

Mild side effects

The following mild side effects have been reported for Calcipotriol/Betametasona cream.

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

• Itching
• Skin exfoliation

Rare (may affect up to 1 in 100 people)

• Skin pain or irritation
• Skin rash with inflammation of the skin (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling of the hair follicle (folliculitis)
• Changes in skin color in the area where the cream has been applied.

• Skin rash

• Burning sensation
• Skin infection
• Thinning of the skin
• Appearance of red or purple discoloration on the skin (purpura or ecchymosis)

Very rare (may affect up to 1 in 1,000 people)

• Folliculitis caused by bacterial or fungal infection
• Allergic reactions
• Hypercalcemia
• Striae
• Sensitivity of the skin to light resulting in a skin rash
• Acne (pimples)
• Dry skin

• Rebound effect: Worsening of symptoms/psoriasis after treatment is stopped.

Frequency not known (cannot be estimated from available data):

• Blurred vision.

Mild side effects caused by the use of betametasona, especially during prolonged use, include the following. If you notice any of them, inform your doctor or nurse as soon as possible.

• Thinning of the skin
• Appearance of superficial veins or striae
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Red rash with inflammation or swelling of the skin (allergic contact dermatitis)
• Brownish-yellow papules with shiny gel (miliar colloid)
• Decoloration of the skin (depigmentation)

• Inflammation or swelling of the hair follicle (folliculitis).

Mild side effects caused by calcipotriol include

• Dry skin
• Sensitivity of the skin to light resulting in 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use, https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep out of sight and reach of children.
• Do not use this medicationafter the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.
• Do not store this medication at a temperature above 25°C
• The tube must be discarded one year after the first opening. Write the date when you first open the tube in the space provided for this on the box.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Calcipotriol/Betametasona ratiopharm

The active ingredient is: calcipotriol and betametasona.

One gram of ointment contains 50 micrograms of calcipotriol and 0.5 mg of betametasona (as 0.643 mg of betametasona dipropionate).

The other components are:

• liquid paraffin
• polyoxypropylene-15 stearate ether
• white soft paraffin
• butylhydroxytoluene (E321)

Appearance of the product and content of the container

Calcipotriol/Betametasona ratiopharm is a whitish to yellowish ointment that is presented in aluminum tubes with a polyethylene closure.

Container sizes: 30, 60, and 120 g.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108Alcobendas, Madrid

Spain

Responsible for manufacturing

Teva Operations PolandSp. z.o.o

ul.Mogilska 80.

31-546, Krakow

Poland

or

Pliva Croatia Ltd.

Prilaz baruna, Filipovica 25

10000 Zagreb (Croatia)

Last review date of this leaflet: August 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/