Prospect: information for the user

Claral 1mg/g Cream

Diflucortolone valerate

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

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only to you and should not be given to other people, even if they 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 prospect. See section 4.

1.What is Claral 1 mg/g Cream and for what it is used

2.What you need to know before starting to use Claral 1 mg/g Cream

3.How to use Claral 1 mg/g Cream

4.Possible adverse effects

5.Storage of Claral 1 mg/g Cream

6.Contents of the package and additional information

It contains diflucortolone valerate as the active ingredient: a potent anti-inflammatory (corticosteroid) medication for use on the skin.

Claral reduces skin inflammation and allergic reactions. It reduces redness, fluid accumulation (edema), and exudate from inflamed skin, and relieves discomfort such as itching, burning sensation, and pain.

Claral is indicated for the treatment of:

?Mild to moderate acute eczema (skin eruption) related to an external cause, such as:

• Allergic contact dermatitis (allergy to a substance that has come into contact with the skin),
• Irritant contact dermatitis (reaction to commonly used substances such as soap),
• Money spot eczema (nummular eczema),
• Eczema with itching that appears on hands and feet (dishidrotic eczema),
• Non-specific eczema (vulgar eczema).

?Eczema due to patient factors (endogenous eczema), such as atopic dermatitis (not due to a local agent) or neurodermatitis.

?Eczema with inflammation and scaling (seborrheic eczema) on the skin.

?Red scaly skin condition (psoriasis).

?Lichen planus (inflammatory condition with itching and papules or small, purple elevations).

Claral is particularly indicated for exudative (wet) skin conditions and seborrheic skin, as the cream has a low fat content, and is also suitable for hairy body areas.

Do not use Claral:

• - If you are allergic to diflucortolone valerate or any of the other components of this medication (listed in section 6).
• - If you have tuberculosis or syphilitic processes, or viral infections (e.g. herpes or chickenpox).
• - In areas of skin affected by rosacea (red/inflamed face and nose), perioral dermatitis (specific skin inflammation around the mouth), ulcers, common acne, skin diseases with skin thinning (atrophy).
• - In areas of skin with skin reactions caused by vaccination, in the treated area.
• - In case of bacterial or fungal skin infections, see Warnings and Precautions section..
• - In the eyes or in deep open wounds.
• - In children under 4 months.

Warnings and Precautions:

Consult your doctor or pharmacist before starting to use Claral.

• - If your doctor diagnoses an additional bacterial or fungal infection, requires specific additional treatment because, if not, the infection may worsen with the application of the glucocorticoid.
• - Contact your doctor if you experience blurred vision or other visual disturbances.
• - Corticosteroid medications, like the active ingredient in Claral, cause significant effects on the body.
• - Claral should not be used in extensive skin areas or for prolonged periods, especially in children, as this increases the risk of absorption and significantly increases the likelihood of systemic adverse effects (in other parts of the body), including increased intraocular pressure and glaucoma.
• - Caution is required when applying Claral to the face (See Section 3. How to use Claral).
• To reduce the risk of adverse effects:
• - Use it in the smallest possible doses, especially in children.
• - Use it only for the strictly necessary time to relieve skin symptoms.
• - Claral should not come into contact with the eyes, deep open wounds, or mucous membranes (e.g. the mouth or genital area, where absorption is much higher).
• - Inform your doctor if you have had previous cases of glaucoma.
• - It should not be used in skin folds, such as the groin or armpits.
• - It should not be used under impermeable materials to air and water, including bandages, dressings, or diapers, unless indicated by your doctor in very resistant cases.
• If you are being treated for psoriasis, your doctor should frequently monitor your condition to observe any possible worsening.
• If you use Claral for conditions other than those for which it has been prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.
• If Claral is applied to the genital or anal area, note that some of its excipients may damage latex products, such as condoms. Therefore, the effectiveness of these latex products as contraceptives or as a means of protection against sexually transmitted diseases such as HIV may be reduced. Consult your doctor or pharmacist if you need more information.

Children:

In children between 4 months and 3 years, the doctor should carefully evaluate the benefits and risks before prescribing this medication. In children, it is more likely that the glucocorticoid will pass through the skin and have adverse effects in other parts of the body than in adults, such as growth retardation, especially in the presence of factors that increase absorption (e.g. occlusion, such as that produced by diapers).

• In children treated with glucocorticoids, there may be an alteration of glands located near the kidneys or a characteristic alteration, among other symptoms, by rounded face, and increased intracranial pressure.

Other medications and Claral:

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

At present, there are no known interactions between Claral and other medications.

Pregnancy, breastfeeding, and fertility:

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

Glucocorticoids should not be applied during the first three months of pregnancy to avoid risks to the fetus.

If you are pregnant, avoid applying Claral to extensive areas, prolonged periods, or with occlusive dressings/pads.

The ingredients of Claral are unknown to pass into breast milk. A risk to the infant cannot be ruled out.

If you are breastfeeding:

- Do not apply Claral to the breasts

- Do not apply Claral to extensive areas or with occlusive dressings/pads, or for prolonged periods.

No data are available on the influence of Claral on fertility.

Driving and operating machinery:

Claral does not affect your ability to drive or operate machinery.

Claral contains alcohol stearate, methyl parahydroxybenzoate (E-218), and propyl parahydroxybenzoate (E-216).

This medication may cause local skin reactions (such as contact dermatitis) because it contains alcohol stearate.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

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

The recommended dose is:

At the beginning of treatment, a thin layer of Claral is applied twice a day or, as needed, up to three times a day. Once symptoms have improved, it is usually sufficient to apply once a day.

Generally, the treatment duration can be from 1 week and should not exceed three weeks. Treatment on the face should be as short as possible, a maximum of 1 week.

Cutaneous use.

If you consider that the effect of Claral is too strong or too weak, consult your doctor or pharmacist.

Use in children

Claral is contraindicated in children under 4 months.

In children between 4 months and 3 years, the doctor must make a careful assessment before prescribing this medication.

In children, the treatment duration should be the minimum possible.

If you use more Claral than you should

No adverse effects are expected after a single overdose of Claral. Repeated overdoses may cause adverse effects (see section 4)

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately or go to a medical center, or callthe Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Claral

Do not use a double dose to compensate for the missed dose. If you have forgotten a dose, continue with your regular schedule as instructed by your doctor or as described in this leaflet.

If you interrupt treatment with Claral

The original symptoms of your skin problem may reappear. Please contact your doctor before interrupting treatment.

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

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

Frequent (may affect up to 1 in 10 people): itching, burning, and erythema (redness) at the application site.

Unknown frequency (cannot be estimated from available data): blurred vision.

As a consequence of the application of glucocorticoids, especially over large body surfaces (10% or more) or for prolonged periods of time (more than 4 weeks), the following side effects may occur: skin atrophy, dryness,small blood vessel dilation (telangiectasia),inflammation of hair follicles (folliculitis), stretch marks, acne,excessive hair growth (hypertrichosis), skin color changes,oral area involvement (perioral dermatitis),allergic contact dermatitisto one of the components of the medication, skin maceration (softening due to moisture), secondary infectionand systemic effects in other parts of the body due to glucocorticoid absorption,such as increased eye pressure or glaucoma (optic nerve damage), or a condition affecting glands located near the kidneys and a condition characterized bytruncal obesity, rounded face, delayed wound healing, etc. (Cushing's syndrome), increased blood sugar levels and urine (hyperglycemia and glucosuria), hypertension, fluid retention (edema), and hypersensitivity reaction.

To reduce the risk of side effects, see theWarnings and precautionssection.

Other side effects in children

The appearance of side effects in newborns of mothers who have been treated over large areas or for a prolonged period during pregnancy or lactation cannot be ruled out (for example, decreased adrenal gland function in a baby when applied in the last weeks of pregnancy).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30º C.

The period of validity after the first opening of the container is 3 months.

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

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Claral

• - The active principle is diflucortolone valerate.
• Cada g of cream contains 1 mg of diflucortolone valerate (0.1%).

- The other components (excipients) are: white soft paraffin, liquid paraffin, stearic alcohol, macrogol stearate, carbomers, sodium hydroxide, disodium edetate dihydrate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and purified water.

Appearance of the product and content of the container

Claral is a slightly yellowish and opaque cream.

It is presented in 30 and 60 g tubes with a screw cap.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Responsible for manufacturing:

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

Last review date of this leaflet: July 2019.

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