Calcipotriol/betamethasone Teva-Ratiopharm 50 micrograms/g + 0.5 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet carefully before you start using this medicine, as 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Do not use Calcipotriol/Betamethasone Teva-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 or pustular psoriasis (consult your doctor).

Since Calcipotriol/Betamethasone Teva-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

• perioral dermatitis (red rash around the mouth)

• thin skin, fragile blood vessels, 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/Betamethasone Teva-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 you develop a skin infection, as treatment may need to be interrupted
• if you suffer from 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 genitals (sex organs), as these areas are highly sensitive to steroids
• Avoid excessive sun exposure, excessive use of artificial tanning or other light-based treatments.

Children and adolescents

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

Using Calcipotriol/Betamethasone Teva-ratiopharm with other medicines

Inform 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 are planning 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/Betamethasone Teva-ratiopharm to the breast area.

Driving and using machines

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

Calcipotriol/Betamethasone Teva-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 Teva-ratiopharm

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

How to use Calcipotriol/Betametasona Teva-ratiopharm: topical use.

Instructions for proper use

• Use it only on areas affected by psoriasis. Do not use it on skin unaffected by 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 underside of the cap.
• Apply the ointment to a clean fingertip.
• Gently rub it onto the affected psoriasis 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 Teva-ratiopharm (unless you are treating your hands). This helps 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 the psoriasis, but wipe it off if it spreads too far.
• To achieve optimal effect, it is recommended not to shower or bathe immediately after applying Calcipotriol/Betametasona Teva-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 medications containing 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 using Calcipotriol/Betametasona Teva-ratiopharm?

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

If you use more Calcipotriol/Betametasona Teva-ratiopharm than you should

Contact your doctor if you have used more than 15 grams in one day. Overuse of Calcipotriol/Betametasona Teva-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 problems with 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 medicine and the amount used.

If you forget to use Calcipotriol/Betametasona Teva-ratiopharm

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

If you stop using Calcipotriol/Betametasona Teva-ratiopharm

Treatment with Calcipotriol/Betametasona Teva-ratiopharm should be discontinued as directed by your doctor. You may need 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/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 for Calcipotriol/Betamethasone Teva-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, stop using Calcipotriol/Betamethasone and inform your doctor as soon as possible.

It is known that some serious adverse effects are caused by betamethasone (a potent steroid), one of the components of Calcipotriol/Betamethasone Teva-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 areas of skin.

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 using Calcipotriol/Betamethasone Teva-ratiopharm and inform your doctor as soon as possible.
• Effect 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/Betamethasone Teva-ratiopharm, 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 must contact your doctor immediately. However, when treatment is stopped, calcium levels return to normal.

Less serious adverse effects

The following less serious adverse effects have been reported for Calcipotriol/Betamethasone 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 inflammation (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling at 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 (furuncle)
• 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 during 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
• Changes in hair growth
• Red rash around the mouth (perioral dermatitis)
• Skin rash with inflammation or swelling (allergic contact dermatitis)
• Shiny brown gel-like papules (colloid milium)
• Skin discoloration (depigmentation)
• Inflammation or swelling at 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 Teva-ratiopharm

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container after the abbreviation CAD. 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Calcipotriol/Betametasona Teva-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
• soft white paraffin
• butylhydroxytoluene (E321).

Appearance of the product and contents of the pack

Calcipotriol/Betametasona Teva-ratiopharm is a white to slightly yellowish ointment supplied in aluminium tubes with a polyethylene cap.

Pack sizes: 30, 60 and 120 g.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 leaflet: August 2021

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78252/P_78252.html

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