PRENAMID 50 micrograms/g + 0.5 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Prenamid 50 micrograms/g + 0.5mg/g ointment

Calcipotriol/Betamethasone

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.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Prenamid and what is it used for
2. What you need to know before you use Prenamid
3. How to use Prenamid
4. Possible side effects
5. Storing Prenamid
6. Contents of the pack and other information

1. What is Prenamid and what is it used for

Prenamid 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.

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

2. What you need to know before you use Prenamid

Do not use Prenamid:

• 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 your calcium levels (consult your doctor),
• if you suffer from certain types of psoriasis: such as erythrodermic, exfoliative and pustular (consult your doctor).

Since Prenamid 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 or ringworm),
• bacterial skin infections,
• parasitic skin infections (e.g. scabies),
• tuberculosis,
• perioral dermatitis (red rash around the mouth),
• thin skin, fragile veins, stretch marks,
• ichthyosis (dry skin with scales),
• acne (pimples),
• rosacea (redness or intense flushing of the skin on the face),
• ulcers or damaged skin.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Prenamidif:

• you are using other medicines that contain corticosteroids, as you may suffer from side effects,
• 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 up' when the steroids are stopped suddenly),
• you have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid,
• a skin infection appears, as it may be necessary to interrupt treatment,
• you suffer from 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 dressings or bandages as this increases 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, under the breasts) as this increases the absorption of the steroid,
• avoid using it on the face or genitals (sex organs) as these are sensitive areas to steroids,
• avoid excessive sunbathing, excessive use of sunlamps and other light treatments.

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

Children

The use of calcipotriol/betamethasone is not recommended in children under 18 years of age.

Using Prenamid with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility

Do not use Prenamid if you are pregnant (or think you may be pregnant) or if you are breast-feeding, unless you have previously agreed this with your doctor. If your doctor agrees that you can breast-feed, be careful and do not apply Prenamid to the area of the breasts.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

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

3. How to use Prenamid

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

How to apply Prenamid: Cutaneous 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 Prenamid (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 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 Prenamid,
• 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 must not exceed 15 grams per day and the treated area must not exceed 30% of the total body surface area.

What to expect when using Prenamid

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

If you use more Prenamid than you should

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

Excessive use of Prenamid can cause a problem with the calcium in your blood, which usually returns to normal when treatment is stopped.

Your doctor may need to perform blood tests to check that using too much ointment has not caused a problem with the calcium in your blood.

Prolonged and excessive use can also cause your adrenal glands to stop working properly (these are located near the 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 medicine and the amount used.

If you forget to use Prenamid

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

If you stop using Prenamid

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

If you have any other questions about 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 suffer from any of the following side effects. You may need to stop your treatment.

The following serious side effects have been reported for calcipotriol/betamethasone:

Uncommon (may affect up to 1 in 100 people)

• worsening of your psoriasis. If your psoriasis worsens, tell your doctor as soon as possible.

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

• psoriasis pustular (a red area with yellowish pustules usually on the hands or feet). If this happens to you, stop using Prenamid and tell 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 Prenamid. If you suffer from any of these serious side effects, tell 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. groin, armpits or under the breasts), when covered or when used 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),
• psoriasis pustular (a red area with yellowish pustules usually on the hands or feet). If this happens to you, stop using Prenamid and tell 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 caused by calcipotriol

• allergic reactions with severe swelling of the face or other parts of the body such as hands or feet. Swelling of the mouth/throat and breathing problems may occur. If you experience an allergic reaction, stop using calcipotriol/betamethasone, tell 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 levels in the blood are excessive production of urine, 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:

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,
• skin rash with inflammation of the skin (dermatitis),
• 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,
• skin rash (rash),
• burning sensation,
• skin infection,
• thinning of the skin,
• appearance of 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 skin rash,
• acne (pimples),
• dry skin,
• rebound effect: Worsening of symptoms/psoriasis after treatment is stopped.

Frequency not known (frequency 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, tell 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),
• golden-colored papules (colloid milium),
• skin discoloration (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 skin rash,
• eczema,
• itching,
• skin irritation,
• burning sensation and itching,
• redness of the skin due to the dilation of small blood vessels (erythema),
• skin rash (rash),
• skin 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. Storing Prenamid

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiry date is the last day of the month stated.

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

The tube should be discarded 1 year after first opening. Write the date of first opening of the tube in the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Prenamid

• The active substances 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 ingredients (excipients) are: all-rac-α-tocopherol (E307), oleic acid, light liquid paraffin and white vaseline.

Appearance of the product and pack contents

Prenamid is a white ointment.

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder, local representative and manufacturer

Marketing authorisation 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

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 authorised in the Member States of the European Economic Area under 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

Date of last revision of this leaflet: 09/2020.

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