Package Insert: Information for the User

Daivonex 50 micrograms/g Cream

calcipotriol

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Daivonex cream belongs to a group of medicines called topical antipsoriatics.

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

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

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

Do not use Daivonex cream:

• if you are allergic (hypersensitive) to calcipotriol or to any of the other components of this medication (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 to use Daivonex cream.

• Daivonex cream should not be used on the face.
• Wash your hands thoroughly after using Daivonex cream (unless you are using the cream to treat your hands). This will help prevent accidental contact with other parts of your body, especially your 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 sunlight or artificial light.Consult your doctor about any doubts on this.

Other medications and Daivonex cream

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If your doctor agrees that you can breastfeed, be careful and do not apply Daivonexcream to the breast area.

Driving and operating machinery

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

Daivonex cream contains cetearyl alcohol and diazolidinyl urea

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

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

Remember to apply your medication.

Your doctor will indicate the duration of your treatment with Daivonex cream.

Adults

Daivonex cream should be applied to the affected area twice a day. The application of the cream may 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 prescribed you other medications that contain calcipotriol, the total weekly dose of all medications that contain calcipotriol should not exceed 100 grams.

Daivonex cream may be used in combination with topical corticosteroids. In such cases, one will be applied in the morning and the other at night.

Apply the cream to the skin of the affected area, previously cleaned. Perform a gentle 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 more Daivonex cream than prescribed has been applied, it may cause an increase in the level of calcium in your blood. The calcium level in your blood will normalize a few days after stopping treatment. In this case, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Daivonex cream

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

If you interrupt treatment with Daivonex cream

The use of Daivonex cream should be completed as indicated by your doctor. Do not discontinue treatment prematurely, as the expected effects will not be achieved.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Daivonex cream may cause some adverse effects, such as:

Adverse effectsvery frequent(affecting more than 1 in 10 people):

• Skin irritation

Adverse effectscommon(affecting less than 1 in 10 people):

• Worsening of psoriasis
• Dermatitis (skin eruption)
• Skin redness
• Dermatological eruption
• Skin exfoliation
• Burning sensation
• Pruritus (itching)
• Pain at the application site

Adverse effectsinfrequent(affecting less than 1 in 100 people):

• Allergic reactions with facial swelling or other body parts such as hands or feet. It may also cause swelling of the mouth/throat and respiratory problems.
• Increased levels of calcium in your blood or urine, which may cause symptoms. Symptoms include frequent urination, constipation, muscle weakness, and confusion. When treatment is discontinued, calcium levels return to normal.
• Sensitivity of the skin to light resulting in a dermatological eruption
• Skin edema
• Seborrheic dermatitis
• Skin dryness

Adverse effectsrare(affecting less than 1 in 1,000 people):

• Urticaria
• Changes in skin color at the application site

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the tube after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not freeze.

The container must be disposed of 6 months after the first opening.

Medicines should not be thrown away through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Daivonex cream

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

The other components are sodium edetate, dihydrate sodium hydrogen phosphate, liquid paraffin, white vaseline, 85% glycerol, macrogol cetostearyl ether, cetostearyl alcohol,diazolidinyl urea, 2,4-dichlorobenzylic alcohol,all-rac-α-tocopherol, sodium hydroxideand purified water.

Appearance of the productandcontent of the container

Daivonex cream is a white cream.

Container sizes: 30, 100 or 120 grams.

Only some container sizes may be marketed.

Holder of the marketing authorization

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

Responsible for manufacturing

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

Last review date of this leaflet:September 2018

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