CALCIPOTRIOL/BETAMETHASONE RATIOPHARM 50 micrograms/g + 0.5 mg/g OINTMENT

Introduction

Package Leaflet: Information for theuser

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

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Calcipotriol/Betamethasone ratiopharm and what is it used for

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

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

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

Do not use Calcipotriol/Betamethasone ratiopharm

• If you are allergic 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 ratiopharm contains a potent steroid, DO NOT use it on skin affected by:

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

• Ichthyosis (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/Betamethasone ratiopharm

• If you are using other medicines that contain corticosteroids, as you may suffer from side effects
• If 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' when the steroids are stopped suddenly)
• If you have diabetes mellitus (diabetes), as your blood sugar/glucose level may be affected by the steroid
• If an infection appears on your skin, as it may be necessary 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 dressings or bandages as they increase the absorption of the steroid
• Avoid using it on large areas of damaged skin, on mucous membranes, or in skin folds (e.g., groin, armpits, or under the breasts) as it increases 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, or other light treatments.

Children and adolescents

Calcipotriol/Betamethasone ratiopharm is not recommended for use in children under 18 years of age.

Using Calcipotriol/Betamethasone ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Calcipotriol/Betamethasone ratiopharmcontains butylhydroxytoluene (E321).

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

3. How to use Calcipotriol/Betamethasone ratiopharm

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

How to use Calcipotriol/Betamethasone 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 seal of the tube is not broken
• To break the seal, use the tip that appears on the back of the cap
• Apply the ointment to a clean finger
• Gently rub it into 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 the treated skin area
• Wash your hands well after using Calcipotriol/Betamethasone ratiopharm (unless you are using the ointment to treat your hands). This will prevent accidental contact of the ointment with other parts of your body (especially the face, scalp, mouth, and eyes)
• Do not worry if you accidentally apply a little ointment to the 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 ratiopharm.
• After applying the ointment, avoid contact with tissues that can be easily stained with grease (e.g., silk).

Duration of treatment

• Use the ointment once a day. It may be more convenient to apply the ointment at night
• The initial treatment period is normally 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 in one day.

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

What to expect when using Calcipotriol/Betamethasone ratiopharm

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

If you use more Calcipotriol/Betamethasone ratiopharmthan you should

Consult your doctor if you have used more than 15 grams in one day. Excessive use of Calcipotriol/Betamethasone ratiopharm may cause a problem with the calcium in your blood, which usually normalizes when treatment is stopped.

Your doctor may need to perform blood tests to check that the use of too much ointment 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 (these are located near the kidneys and produce hormones).

Contact the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Calcipotriol/Betamethasone ratiopharm

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

If you stop treatment with Calcipotriol/Betamethasone ratiopharm

The use of Calcipotriol/Betamethasone ratiopharm 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 further questions on 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 for Calcipotriol/Betamethasone ratiopharm:

Uncommon (may affect up to 1 in 100 people)

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

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

• Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet) may occur. If this happens to you, stop using Calcipotriol/Betamethasone and 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 Calcipotriol/Betamethasone ratiopharm. If you experience any of these serious side effects, inform your doctor as soon as possible. These side effects are more likely to occur after long-term use, use in skin folds (e.g., groin, armpits, or under the breasts), use under dressings or bandages, or use on large areas of skin.

Side effects include the following:

• Your adrenal glands may stop working properly. Symptoms are tiredness, depression, and anxiety
• Cataracts (symptoms are cloudy or blurred vision, difficulty seeing at night, and sensitivity to light) or increased pressure inside 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 to you, stop using Calcipotriol/Betamethasone ratiopharm and inform your doctor as soon as possible
• Effect on the metabolic control of diabetes mellitus (if you have diabetes, you may experience changes in blood sugar levels).

Serious side effects known to be caused by Calcipotriol

• Allergic reactions with severe swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and breathing problems may occur. If you experience an allergic reaction, stop using Calcipotriol/Betamethasone ratiopharm, inform your doctor immediately, or go to the emergency department of the nearest hospital.
• Treatment with this ointment may cause an increase in the level of calcium in your blood or urine (usually when too much ointment is used). Symptoms of high calcium in the blood are excessive urination, 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 ointment.

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

• Itching
• Scaling of the skin

Uncommon (may affect up to 1 in 100 people)

• Pain or irritation of the skin
• Redness of the skin due to the dilation of small blood vessels (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
• Purple or red discoloration of the skin (purpura or ecchymosis)

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

• Bacterial or fungal infection of the hair follicle (furuncle)
• Allergic reactions
• Hypercalcemia
• Stretch marks
• Sensitivity of the skin to light leading to a rash
• Acne (pimples)
• Dry skin

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

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

• 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, inform 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)
• Brownish shiny papules (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
• Sensitivity of the skin to light leading to a rash
• Eczema.
• Itching
• Skin irritation
• Burning sensation and itching
• Redness of the skin due to the dilation of small blood vessels (erythema)
• Rash
• Rash with inflammation of the skin (dermatitis)
• Worsening of psoriasis

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines, 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 ratiopharm

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging after the abbreviation EXP. The expiry date is the last day of the month shown.
• Do not store this medicine at a temperature above 25°C
• The tube should be discarded one year after the first opening. Write the date you first open the tube in the space provided on the carton.

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 doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Calcipotriol/Betamethasone ratiopharm

The active substances are: calcipotriol and betamethasone.

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

The other ingredients are:

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

Appearance of the product and pack contents

Calcipotriol/Betamethasone ratiopharm is a white to yellowish ointment that comes in aluminum tubes with a polyethylene cap.

Package sizes: 30, 60, and 120 g.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80.

31-546, Krakow

Poland

or

Pliva Croatia Ltd.

Prilaz baruna, Filipovica 25

10000 Zagreb (Croatia)

Date of last revision of this leaflet: August 2021

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