CLARAL 1 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Claral 1mg/g Cream

Diflucortolone valerate

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

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

Contents of the Package Leaflet

1. What is Claral 1 mg/g Cream and what is it used for
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 side effects
5. Storage of Claral 1 mg/g Cream
6. Package Contents and Additional Information

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

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

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

Claral is indicated for the treatment of:

? Acute forms of eczema (skin rash) mild or moderate 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 substances of habitual use, such as soap),
• nummular eczema (coin-shaped eczema),
• dyshidrotic eczema (itchy rash on hands and feet),
• unspecific eczema (vulgar eczema).

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

? Skin rash with inflammation and scaling (seborrheic eczema).

? Scaly red skin condition (psoriasis).

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

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

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

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/pink inflammation of the face and nose), perioral dermatitis (specific inflammation of the skin around the mouth), ulcers, acne vulgaris, or skin thinning (atrophy).
• - In areas of skin with cutaneous reactions caused by vaccination, in the area to be treated.
• - In case of bacterial or fungal skin infections, see section Warnings and Precautions.
• - 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 a bacterial or fungal infection, additional specific treatment is required, as the infection may worsen with the application of the glucocorticoid.
• - Contact your doctor if you experience blurred vision or other visual disturbances.
• - Anti-inflammatory medications (corticosteroids), such as the active ingredient of Claral, can have significant effects on the body.
• - Claral should not be used on large areas of skin or for prolonged periods, especially in children, as this increases the risk of absorption and significantly increases the possibility of systemic side 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 side effects:
• - Use the minimum possible dose, especially in children.
• - Use it only for the time strictly necessary to relieve the skin condition.
• - Claral should not come into contact with the eyes, deep open wounds, or mucous membranes (e.g., mouth or genital area, where absorption is much higher).
• - Inform your doctor if you have previously suffered from glaucoma.
• - It should not be used in skin folds, such as the groin or armpits.
• - It should not be used under impermeable materials (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 was prescribed, you may mask symptoms and make diagnosis and correct treatment more difficult.
• - If you apply Claral 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 protection against sexually transmitted diseases like 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 must make a careful evaluation of benefits and risks before prescribing this medication. In children, it is more likely that the glucocorticoid will pass into the body through the skin and have side effects in other areas of the body than in adults, such as growth retardation, especially in the presence of factors that increase absorption (e.g., under occlusion, such as that produced by diapers).

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

Other Medications and Claral

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

So far, no interactions between Claral and other medications have been reported.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 fetal development.

If you are pregnant, you should avoid applying Claral to large areas, for prolonged periods, or with occlusive dressings/bandages.

It is unknown whether the ingredients of Claral pass into breast milk. A risk to the breastfed child cannot be excluded.

If you are breastfeeding:

• - Do not apply Claral to the breasts.
• - Do not apply Claral to large areas or with occlusive dressings/bandages, or for prolonged periods.

There are no data on the influence of Claral on fertility.

Driving and Using Machines

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

Claral contains stearic alcohol, methylparaben (E-218), and propylparaben (E-216).

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

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218) and propylparaben (E-216).

3. How to Use Claral 1 mg/g Cream

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

The recommended dose is:

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

In general, the duration of treatment can range from 1 week and should not exceed three weeks. Treatment on the face should be as short as possible, up to 1 week.

Topical use.

If you think 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 evaluation before prescribing this medication.

In children, the duration of treatment should be as short as possible.

If You Use More Claral Than You Should

No risk is expected after a single overdose of Claral. Repeated overdoses may cause side effects (see section 4).

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

If You Forget to Use Claral

Do not use a double dose to make up for forgotten doses. If you have forgotten a dose, continue with your usual schedule as instructed by your doctor or as described in this package leaflet.

If You Stop Treatment with Claral

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

Frequency not known (cannot be estimated from available data): blurred vision.

As a result of the application of glucocorticoids, especially on large body surfaces (10% or more) or for prolonged periods (more than 4 weeks), the following side effects may occur: skin atrophy, dryness, dilation of small blood vessels (telangiectasia), folliculitis, stretch marks, acne, excessive hair growth (hypertrichosis), skin color changes, perioral dermatitis, allergic contact dermatitis to one of the components of the medication, skin maceration (softening due to moisture), secondary infection, and systemic effects due to glucocorticoid absorption, such as increased intraocular pressure or glaucoma (optic nerve damage), or a condition affecting the glands near the kidneys and a condition characterized by, among other symptoms, a rounded face and increased intracranial pressure (Cushing's syndrome), increased blood and urine sugar levels (hyperglycemia and glucosuria), hypertension, fluid retention (edema), and hypersensitivity reaction.

To reduce the risk of side effects, see section Warnings and Precautions.

Other Side Effects in Children

The appearance of side effects in newborns whose mothers have been treated on large surfaces or for a prolonged period during pregnancy or breastfeeding cannot be excluded (e.g., decreased adrenal gland function in a baby when applied in the last weeks of pregnancy).

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Claral 1 mg/g Cream

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

Do not store above 30°C.

The shelf life after opening the package is 3 months.

Do not use this medication after the expiration date shown on the package, after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Claral

• - The active ingredient is diflucortolone valerate.
• - Each gram of cream contains 1 mg of diflucortolone valerate (0.1%).

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

Appearance of the Product and Package Contents

Claral is a slightly yellowish and opaque cream.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Manufacturer:

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering, 21

20054 Segrate (Milan) - Italy

Date of the Last Revision of this Package Leaflet: July 2019.

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