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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Calcipotriol/Betametasona 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 as 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Calcipotriol/Betametasona ratiopharm is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by an abnormally rapid production of skin cells. This leads to redness, scaling, and thickening of the skin.

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

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

Do not use Calcipotriol/Betametasona 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 have certain types of psoriasis: such as erythrodermic, exfoliative, or pustular psoriasis (consult your doctor).

Since Calcipotriol/Betametasona ratiopharm contains a potent corticosteroid, 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 or 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, scaly skin)

• Acne (spots)

• Rosacea (intense redness or flushing of the facial skin)

• Ulcers or damaged skin

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before and during treatment with Calcipotriol/Betametasona ratiopharm

• If you are using other medicines containing corticosteroids, as you may experience adverse effects
• If you have used this medicine for a long time and plan to stop using it (since there is a risk that your psoriasis may worsen or 'rebound' when steroids are suddenly discontinued)
• If you have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid
• If a skin infection develops, as treatment may need to be interrupted
• If you have a type of psoriasis called guttate psoriasis
• If you experience blurred vision or other visual disturbances.

Special precautions

• Avoid use on more than 30% of your body surface or more than 15 grams per day
• Avoid using dressings or bandages, as they increase steroid absorption
• Avoid use over 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 or genital area (sex organs), as these areas are highly sensitive to steroids
• Avoid excessive sun exposure, excessive use of artificial UV light (sunbeds), and other light-based treatments.

Children and adolescents

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

Using Calcipotriol/Betametasona ratiopharm with other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. If your doctor agrees that you may breastfeed, take care not to apply Calcipotriol/Betametasona ratiopharm to the breast area.

Driving and using machines

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

Calcipotriol/Betametasona ratiopharm contains 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/Betametasona ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

How to use Calcipotriol/Betametasona ratiopharm: cutaneous use.

Instructions for proper use

• Use it only on areas affected by psoriasis; do not apply it to skin without psoriasis
• Before first use of the ointment, remove the cap and check that the seal on the tube is intact
• To break the seal, use the protrusion located on the back of the cap
• Apply the ointment onto a clean fingertip
• Gently rub it into the skin to cover the affected psoriatic area, until most of the ointment has disappeared from the skin
• Do not apply a dressing, or cover or wrap the treated skin area
• Wash your hands thoroughly after using Calcipotriol/Betametasona ratiopharm (unless you are treating your hands with the ointment). This will help prevent accidental contact of the ointment with other parts of your body (especially the face, scalp, mouth, and eyes)
• Do not worry if a small amount of ointment is accidentally applied to healthy skin near your psoriasis, but wipe it off if it spreads excessively
• To achieve optimal effect, it is recommended not to shower or bathe immediately after applying Calcipotriol/Betametasona ratiopharm
• After applying the ointment, avoid contact with fabrics that may be easily stained by grease (e.g., silk)

Duration of treatment

• Use the ointment once daily. It may be more convenient to apply the ointment at night
• The usual initial treatment period is 4 weeks, but your doctor may decide on a different duration
• Your doctor may decide that you should repeat the treatment
• Do not use more than 15 grams in one day

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

What should I expect when using Calcipotriol/Betametasona ratiopharm?

Most patients notice obvious improvement within 2 weeks, even though the psoriasis may not have completely cleared by then.

If you use more Calcipotriol/Betametasona ratiopharm than you should

Contact your doctor if you have used more than 15 grams in one day. Overuse of Calcipotriol/Betametasona ratiopharm may cause a problem with calcium levels in your blood, which usually returns to normal once treatment is stopped.

Your doctor may need to perform blood tests to check whether excessive use has caused any disturbance in your blood calcium levels. Prolonged and excessive use may also cause your adrenal glands to stop functioning properly (these glands are located near the kidneys and produce hormones).

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

If you forget to use Calcipotriol/Betametasona ratiopharm

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

If you stop using Calcipotriol/Betametasona ratiopharm

The use of Calcipotriol/Betametasona ratiopharm should be discontinued as directed 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

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

The following serious adverse effects have been reported with Calcipotriol/Betametasona 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 may occur (a red area with yellowish pustules, usually on the hands or feet). If this occurs, stop applying Calcipotriol/Betametasona and inform your doctor as soon as possible.

It is known that some serious adverse effects are caused by betamethasone (a potent corticosteroid), one of the components of Calcipotriol/Betametasona ratiopharm. If you experience any of these serious adverse effects, inform your doctor as soon as possible. These adverse effects are more likely to occur after long-term use, use in skin folds (e.g., groin, armpits, or under the breasts), use under occlusive dressings or bandages, or use over large skin areas.

The adverse effects include the following:

• Your adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety.
• Cataracts (symptoms include blurred or cloudy vision, difficulty seeing at night, and light sensitivity) or increased pressure inside the eye (symptoms include eye pain, red eye, blurred vision, or vision loss).
• Infections (because your immune system, which fights infections, may be suppressed or weakened).
• Pustular psoriasis (a red area with yellowish pustules, usually on the hands or feet). If this occurs, stop applying Calcipotriol/Betametasona ratiopharm and inform your doctor as soon as possible.
• Effects on metabolic control of diabetes mellitus (if you have diabetes, you may experience changes in blood glucose levels).

Serious adverse 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 difficulties may occur. If you experience an allergic reaction, stop using Calcipotriol/Betametasona ratiopharm immediately, inform your doctor immediately, or go to the nearest hospital emergency department.
• Treatment with this ointment may cause an increase in calcium levels in your blood or urine (usually when too much ointment is used). Symptoms of elevated blood calcium include excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and you should contact your doctor immediately. However, calcium levels return to normal when treatment is stopped.

Less serious adverse effects

The following less serious adverse effects have been reported for Calcipotriol/Betametasona ointment.

Frequent adverse effects (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)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling of the hair root (folliculitis)
• Changes in skin color at the site where the ointment was applied
• Skin rash
• Burning sensation
• Skin infection
• Thinning of the skin
• Red or purple discolored spots on the skin (purpura or bruising)

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

• Bacterial or fungal infection of the hair follicle (boil)
• Allergic reactions
• Hypercalcemia
• Stretch marks (striae)
• Skin sensitivity to light leading to a skin rash
• Acne (spots)
• Dry skin
• Rebound effect: Worsening of symptoms/psoriasis after stopping treatment.

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

• Blurred vision.

Less serious adverse effects caused by the use of betamethasone, especially with prolonged use, include the following. If you notice any of these, inform your doctor or nurse as soon as possible.

• Thinning of the skin
• Appearance of superficial veins or stretch marks (striae)
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rash with inflammation or swelling (allergic contact dermatitis)
• Brown shiny papules with a gelatinous appearance (miliaria colloid)
• Skin discoloration (depigmentation)
• Inflammation or swelling of the hair root (folliculitis)

Less serious adverse effects caused by calcipotriol include:

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.
• Do not store this medicine above 25°C.
• The tube should be discarded one year after first opening. Write the date of first opening in the space provided for this purpose on the carton.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other 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 components are:

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

Appearance of the product and contents of the container

Calcipotriol/Betamethasone ratiopharm is a white to slightly yellowish ointment supplied in aluminium tubes with a polyethylene closure.

Pack 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, 1st floor
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 the most recent revision of this summary: August 2021

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