Prospect: information for the user

Prenamid 50 micrograms/g + 0.5mg/g ointment

Calcipotriol/Betamethasone

Read this prospect carefully before starting to use this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.
• This medication has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects,consult your doctor or pharmacist,evenifthey do not appear in this prospect. See section 4.

1. What is Prenamid and for what it is used

2. What you need to know before starting to use Prenamid

3. How to use Prenamid

4. Possible adverse effects

5. Storage of Prenamid

6. Contents of the package and additional information

Prenamidis 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.

Prenamid contains calcipotriol and betamethasone.Calcipotriol helps to normalize the growth rate of skin cells and betamethasone reduces inflammation.

Do not use Prenamid:

• if you are allergic to calcipotriol, betamethasone, 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 have certain types of psoriasis: erythrodermic, exfoliative, and pustular (consult your doctor).

SincePrenamidcontains 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 or ringworm),
• skin infections caused by bacteria,
• skin infections caused by parasites (for example, scabies),
• tuberculosis,
• perioral dermatitis (red rash around the mouth),
• thin skin, fragile veins, striae,
• 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 or pharmacist before starting tousePrenamidif:

• you are using other medications that contain corticosteroids, as you may experience adverse effects,
• 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),
• you have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid,
• you notice a skin infection, as you may need to interrupt treatment,
• you have a type of psoriasis called guttate psoriasis.

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, in mucous membranes, or in skin folds (groins, armpits, under the breasts) as it increases the absorption of the steroid,
• avoid using it on the face or genitals (sex organs) as these areas are highly sensitive to steroids,
• avoid excessive sun exposure, excessive use of artificial sunlight, and other forms of light treatment.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children

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

Use of Prenamid with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication.

Pregnancy,breastfeedingand fertility

Do not use Prenamid if you are pregnant (or think you may be) or breastfeeding, unless your doctor has previously agreed. If your doctor agrees that you can breastfeed, be careful and do not apply Prenamid to the breast area.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consultyour doctor or pharmacist before using this medication.

Driving and operating machinery

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

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

How to apply Prenamid: 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 area of psoriasis, until most of the ointment has disappeared from the skin,
• Do not apply a bandage, or cover or wrap the treated skin area,
• Wash your hands thoroughly after using Prenamid (unless you are using the ointment to treat your hands). This will help prevent accidental contact with other parts of your body (especially your face, scalp, mouth, and eyes),
• Do not worry if some ointment accidentally gets applied to healthy skin near your psoriasis, but clean it up if it spreads too much,
• To achieve optimal effect, it is recommended not to shower or bathe immediately after applying Prenamid,
• After applying the ointment, avoid contact with fabrics that may easily stain with grease (e.g., 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 your total body surface area.

What to expect when using Prenamid?

Most patients notice obvious results within 2 weeks, even if their psoriasis has not yet cleared at that time.

If you use more Prenamid than you should

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

Excessive use of Prenamid may 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 of the ointment has caused a problem with your blood calcium levels.

Prolonged and excessive use may also cause your adrenal glands to malfunction (located near your kidneys and produce hormones).

If you have used more Prenamid than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to use Prenamid

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

If you interrupt treatment with Prenamid

Treatment with Prenamid should be stopped as indicated by your doctor. It may be necessary to gradually discontinue use of this medication, especially if you have been using it for a long time.

If you have any other questions about the use of 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:

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)

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

It is known that some severe side effects are caused by betametasona (a potent steroid), one of the components of Prenamid. If you experience any of the severe side effects, inform 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. elbows, armpits or under the breasts), when the area is covered or when used 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 Prenamid and inform your doctor as soon as possible,
• Effect on blood glucose control in diabetes mellitus (if you have diabetes you may experience changes in blood glucose levels).

Severe side effects caused by calcipotriol

• Allergic reactions with intense swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and respiratory problems may occur. If you experience an allergic reaction, stop applying calcipotriol/betametasona,inform your doctor immediately or go to the nearest hospital emergency department,
• The 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 increased 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:

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

• Itching,
• Skin peeling.

Uncommon (may affect up to 1 in 100 people)

• Skin pain or irritation,
• Dermatitis (skin inflammation or redness),
• 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,
• Rash,
• Burning sensation,
• Skin infection,
• Skin thinning,
• Purple or red discoloration of the skin (purpura or ecchymosis).

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

• Folliculitis caused by bacteria or fungi,
• Allergic reactions,
• Hypercalcemia,
• Striae,
• Sensitivity of the skin to light leading to a rash,
• Acne (pimples),
• Dry skin,
• Rebound effect: Worsening of symptoms/psoriasis after treatment is stopped.

Frequency unknown (frequency 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.

• Skin thinning,
• Appearance of superficial veins or striae,
• Changes in hair growth,
• Erythema around the mouth (perioral dermatitis),
• Dermatitis (skin inflammation or redness),
• Yellowish papules (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 leading to a rash,
• Eczema,
• Itching,
• Skin irritation,
• Burning sensation and itching,
• Redness of the skin due to dilation of small blood vessels (erythema),
• Rash,
• Rash with skin inflammation (dermatitis),
• Worsening of psoriasis.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and the tubeafter CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C. Do not refrigerate or freeze.

The tube must be discarded after 1 year after its first opening. Write the date of the first tube opening in the space indicated for this on the box.

Medications should not be thrown away through drains or in the trash. Deposit containers and medications that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications that you do not need. In this way, you will help protect the environment.

Composition of Prenamid

• The active principles are calcipotriol and betamethasone. One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

• The other components (excipients) are: all-rac-α-tocopherol (E307), oleic alcohol, light liquid paraffin, and white vaseline.

Appearance of the product and contents of the package

Prenamid is a whitish-colored ointment.

The ointment is presented in aluminum/epoxyphenol tubes with a polyethylene or polypropylene screw cap.

Package sizes: tubes containing 15 g, 30 g, 60 g, or 120 g of ointment.

Only some package sizes may be commercially available.

Marketing Authorization Holder, Local Representative, and Responsible Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Local Representative

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander

Spain

Responsible Manufacturer

Lek Pharmaceuticals d.d.

Verovskova ulica, 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Lange Goehren 3

D-39171, Suelzetal

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

EURODEP PHARMA

10 rue Antoine de Saint Exupéry

ZAC du Parc de Compans

77290 MITRY MORY

France

This medicine is authorized in the Member States of the European Economic Area with the following names:

Germany: Calcipotriol comp HEXAL

Belgium: Calcipotriol/Betamethasone Sandoz 50 microgram/ 0.5 mg/g zalf

Bulgaria: ???????? 50 ??????????/g + 0.5 mg/g ???

Denmark: Calcipotriol/Betamethasone Sandoz

Slovenia: SOREL COMBO 50 mikrogramov/500 mikrogramov v 1 g mazilo

Spain: Prenamid 50 microgramos/g + 0.5 mg/g pomada

Estonia: Cabemet

France: CALCIPOTRIOL/ BETAMETHASONE SANDOZ 50 microgrammes/0.5 mg/g, pommade

Ireland: Calcipotriol/Betamethasone Rowex 50 microgram + 0.5 mg/g Ointment

Lithuania: Cabemet 50 mikrogramu/0.5 mg/g tepalas

Luxembourg: Calcipotriol/Betamethasone Sandoz 50 microgrammes/ 0.5 mg/g pommade

Latvia: Cabemet 50 mikrogrami/0.5 mg/g ziede

Netherlands: Calcipotriol/Betamethason Sandoz 50 microgram/g + 0.5 mg/g, zalf

Portugal: Dilabion 50 microgramas/g + 0.5 mg/g pomada

United Kingdom: Calcipotriol/Betamethasone Sandoz 50 micrograms per g / 500 micrograms per g ointment

Sweden: Calcipotriol/Betamethasone Sandoz 50 mikrogram/g + 0.5 mg/g salva

Last review date of thisleaflet: 09/2020.

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