DAIVONEX 50 micrograms/g CREAM

Introduction

Package Leaflet: Information for the User

Daivonex 50 micrograms/g cream

calcipotriol

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.
• 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 and other information

1. What is Daivonex cream and what is it used for
2. What you need to know before you use Daivonex cream
3. How to use Daivonex cream
4. Possible side effects
5. Storage of Daivonex cream

Contents of the pack and further information

1. What is Daivonex cream and what is it used for

Daivonex cream belongs to a group of medicines called topical psoriasis treatments.

Daivonex cream is a medicine used for the topical treatment of plaque psoriasis (psoriasis vulgaris).

The cause of psoriasis is the excessively rapid production of your skin cells. This causes redness, scaling, and thickening of your skin.

Daivonex cream contains calcipotriol. Calcipotriol helps to normalize the rate of growth of your skin cells.

2. What you need to know before you use Daivonex cream

Do not use Daivonex cream:

• if you are allergic (hypersensitive) to calcipotriol or any of the other ingredients of this medicine (listed in section 6).
• if you have problems with calcium levels in your blood (consult your doctor).

Warnings and precautions:

Consult your doctor or pharmacist before starting treatment with Daivonex cream.

• Daivonex cream should not be used on the face.
• Wash your hands well after using Daivonex cream (unless you are using the cream to treat your hands). This will prevent accidental contact with other parts of your body, especially the face and eyes.
• Do not exceed the maximum recommended dose (see section 3) to minimize the risk of increased calcium in the blood.

During treatment with Daivonex cream, you should limit or avoid excessive exposure to natural or artificial sunlight. Consult your doctor if you have any doubts about this.

Other medicines and Daivonex cream

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

Pregnancy and breastfeeding

If you are pregnant or 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 can breastfeed, be careful and do not apply Daivonex cream to the breast area.

Driving and using machines

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

Daivonex cream contains cetyl alcohol and diazolidinyl urea

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and diazolidinyl urea, which releases formaldehyde.

3. How to use Daivonex cream

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist.

Remember to apply your medicine.

Your doctor will tell you how long to use Daivonex cream.

Adults

Daivonex cream should be applied to the affected area twice a day. The application of the cream can be reduced to once a day when the severity of the lesions has improved.

Do not use more than 100 grams of cream per week. If your doctor has also prescribed other medicines containing calcipotriol, the total weekly dose of all medicines containing calcipotriol should not exceed 100 grams.

Daivonex cream can be used in combination with topical corticosteroids. In such cases, one should be applied in the morning and the other in the evening.

Apply the cream to the affected skin area, previously cleaned. Gently massage until the cream is fully absorbed. Wash your hands after applying the cream.

Use in children

Daivonex cream is not recommended for use in children.

If you use more Daivonex cream than you should

If you have applied more Daivonex cream than you should, it may cause an increase in calcium levels in your blood. The calcium level in your blood will return to normal a few days after stopping treatment. In this case, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Daivonex cream

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

If you stop using Daivonex cream

The use of Daivonex cream should be stopped as indicated by your doctor. Do not stop treatment before, as the expected effects will not be achieved.

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 everybody gets them.

Daivonex cream can cause some side effects, such as:

Very commonside effects (affecting more than 1 in 10 people):

• Skin irritation

Commonside effects (affecting less than 1 in 10 people):

• Worsening of your psoriasis
• Skin rash (dermatitis)
• Redness of the skin
• Skin eruption
• Peeling of the skin
• Burning sensation
• Itching (pruritus)
• Pain at the application site

Uncommonside effects (affecting less than 1 in 100 people):

• Allergic reactions with swelling of the face or other parts of the body, such as hands or feet. Swelling of the mouth/throat and respiratory problems may also occur.
• Calcium levels in your blood or urine may increase, causing symptoms such as frequent urination, constipation, muscle weakness, and confusion. When treatment is stopped, calcium levels return to normal.
• Skin sensitivity to light leading to a skin eruption
• Swelling of the skin
• Seborrheic dermatitis
• Dryness of the skin

Rareside effects (affecting less than 1 in 1,000 people):

• Hives
• Changes in skin color at the application site

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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Daivonex cream

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 shown.

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

The container should be discarded 6 months after first opening.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Daivonex cream

• The active substance is calcipotriol (as hydrate).
• One gram of cream contains 50 micrograms of calcipotriol (as hydrate).

The other ingredients are disodium edetate, disodium hydrogen phosphate dihydrate, liquid paraffin, white petrolatum, glycerol 85%, cetylstearyl alcohol, cetyl alcohol, diazolidinyl urea, 2,4-dichlorobenzyl alcohol, all-rac-α-tocopherol, sodium hydroxide, and purified water.

Appearance and pack size

Daivonex cream is a white cream.

Available pack sizes: 30, 100, or 120 grams.

Not all pack sizes may be marketed.

Marketing authorisation holder

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup (Denmark).

Manufacturer

LEO Laboratories Limited, Cashel Road, Dublin 12 (Ireland).

Date of last revision of this leaflet:September 2018

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