Prenamid 50 micrograms/g + 0.5 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prenamid 50 micrograms/g + 0.5 mg/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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Prenamid is and what it is used for

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

Prenamid 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 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 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 Prenamid contains a potent steroid, DO NOT use it on skin affected by:

• viral skin infections (e.g., herpes or chickenpox),
• fungal skin infections (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 blood vessels, stretch marks,
• ichthyosis (dry, scaly skin),
• acne,
• rosacea (intense redness or flushing of the facial skin),
• ulcers or damaged skin.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Prenamid if:

• you are using other medicines containing corticosteroids, as you may experience adverse effects,
• 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 stopped suddenly),
• you have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid,
• a skin infection develops, as treatment may need to be interrupted,
• you suffer from a type of psoriasis called guttate psoriasis.

Special precautions

• avoid use on more than 30% of your body surface or more than 15 grams per day,
• avoid using bandages or dressings, as they increase steroid absorption,
• avoid use on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts), as they increase steroid absorption,
• avoid use on the face or genitals (sexual organs), as these areas are highly sensitive to steroids,
• avoid excessive sun exposure, excessive use of artificial tanning, and other forms of light therapy.

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.

Use of Prenamid 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

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

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to use Prenamid

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

How to apply Prenamid: Topical use.

Instructions for proper use

• use it only on areas of psoriasis and do not apply it to skin that is not affected 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 back of the cap,
• apply the ointment to one 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 apply a bandage, or cover or wrap the treated skin area,
• wash your hands thoroughly after using Prenamid (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 be concerned if a small amount of ointment is accidentally applied to healthy skin near your psoriasis, but clean it off if it has spread too far,
• 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 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 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 should I expect when using Prenamid?

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

If you use more Prenamid than you should

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

Excessive use of Prenamid 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 ensure that overuse of the ointment has not caused a problem 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).

If you have used more Prenamid than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the name of the medicine and the amount used.

If you forget to use Prenamid

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

If you stop using Prenamid

The use of Prenamid 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects

Inform 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:

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 happens, stop using Prenamid 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 Prenamid. If you experience any of these serious side effects, inform your doctor as soon as possible. These side effects are more likely to occur with long-term use, when applied to skin folds (e.g. groin, armpits, or under the breasts), when the treated area is covered, or when used over large skin areas.

The side effects include the following:

• your adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety,
• cataracts (symptoms are blurred or cloudy vision, difficulty seeing at night, and light sensitivity) or increased pressure inside the eye (symptoms are eye pain, red eye, blurred vision, or loss of vision),
• 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 happens, stop using Prenamid 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 side effects caused by calcipotriol

• allergic reactions with severe swelling of the face or other body parts 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, 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 high blood calcium include excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and you must contact your doctor immediately. However, calcium levels return to normal once treatment is stopped.

Less serious side effects

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

Frequent side 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,
• appearance of purple or red spots on the skin (purpura or bruising).

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

• infection of the hair follicle caused by bacteria or fungi (boil),
• allergic reactions,
• hypercalcemia,
• stretch marks,
• 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 (frequency cannot be estimated from available data)

• blurred vision.

Less serious side 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,
• changes in hair growth,
• red rash around the mouth (perioral dermatitis),
• skin rash with inflammation or swelling (allergic contact dermatitis),
• golden-yellow papules (colloid milium),
• skin discoloration (depigmentation),
• inflammation or swelling of the hair root (folliculitis).

Less serious side 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,
• skin rash with skin inflammation (dermatitis),
• worsening of psoriasis.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects 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 side effects, you can help provide more information on the safety of this medicine.

5. Storage of Prenamid

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

Do not use this medicine after the expiry date stated on the carton and tube after CAD. The expiry date refers to the last day of the month indicated.

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 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 collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents 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 components (excipients) are: all-rac-α-tocoferol (E307), oleic alcohol, light liquid paraffin, and white vaseline.

Appearance of the product and contents of the pack

Prenamid is a white to off-white ointment.

The ointment is supplied in aluminium/epoxyphenolic tubes with a polyethylene or polypropylene screw cap.

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder, Local Representative and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

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, Süelzetal

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 medicinal product 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 the most recent review of this summary: 09/2020.

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