Claral 1 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Claral 1mg/g Cream

Diflucortolone valerate

Read this entire 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 must not be given to other people, even if they have the same symptoms as you, since it could 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 Claral 1 mg/g Cream is and what it is used for
2. What you need to know before using Claral 1 mg/g Cream
3. How to use Claral 1 mg/g Cream
4. Possible adverse effects
5. How to store Claral 1 mg/g Cream
6. Contents of the pack and other information

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

Contains as the active substance diflucortolone valerate: it is an anti-inflammatory medicine (a potent corticosteroid) for use on the skin.

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

Claral is indicated for the treatment of:

? Mild to moderate acute forms of eczema (skin rash) 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, for example, soap),
• coin-shaped rash (nummular eczema),
• itchy rash affecting the hands and feet (dyshidrotic eczema),
• non-specific eczema (atopic eczema).

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

? Inflammatory, scaly skin rash (seborrheic eczema).

? Scaly, reddish skin condition (psoriasis).

? Lichen planus (an inflammatory, itchy condition with small, purple papules or elevations).

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

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

Do not use Claral:

• • If you are allergic to diflucortolone valerate or to any of the other ingredients of this medicine (listed in section 6).
• • If you have tuberculosis or syphilis, or viral infections (e.g., herpes or chickenpox).
• • On areas of skin affected by rosacea (red/rosy facial and nasal inflammation), perioral dermatitis (specific skin inflammation around the mouth), ulcers, vulgar acne, or skin diseases associated with skin thinning (atrophy).
• • On areas of skin with vaccination-related skin reactions, in the area to be treated.
• • In cases of bacterial or fungal (fungal) skin infections, see section Warnings and precautions.
• • In the eyes or in deep open wounds.
• • In children under 4 months of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Claral.

• • If your doctor also diagnoses a bacterial or fungal infection, specific additional treatment is required, as otherwise the infection may worsen with application of the glucocorticoid.
• • Contact your doctor if you experience blurred vision or other visual disturbances.
• • Anti-inflammatory drugs (corticosteroids), such as the active ingredient in Claral, cause significant effects in the body.
• • Claral should not be used on extensive skin areas or for prolonged periods, especially in children, as this increases the risk of absorption and significantly increases the possibility of systemic adverse effects (in other parts of the body), including increased intraocular pressure and glaucoma.
• • Extreme caution is required when applying Claral to the face (see section 3. How to use Claral).
• To reduce the risk of adverse effects:
• • Use the lowest possible dose, especially in children.
• • Use it only for the minimum time necessary to relieve the skin condition.
• • Claral must 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 had glaucoma.
• • It should not be used in skin folds, such as the groin or armpits.
• • It should not be used under air- and water-impermeable materials, including non-breathable dressings, bandages, or diapers, except on medical advice in very resistant cases.
• If you are being treated for psoriasis, your doctor should monitor your condition frequently to detect any possible worsening.
• If you use Claral for conditions other than those for which it was prescribed, it may mask symptoms and hinder correct diagnosis and treatment.
• If Claral is applied to the genital or anal area, be aware 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 such as HIV infection may be reduced. Consult your doctor or pharmacist if you need further information.

Children

In children between 4 months and 3 years of age, the doctor must carefully evaluate the benefits and risks before prescribing this medicine. In children, the glucocorticoid is more likely to pass through the skin into the body and cause 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., under occlusion, such as that caused by diapers).

• In children treated with glucocorticoids, disturbances of glands located near the kidneys or a condition characterized, among other symptoms, by a rounded face and increased intracranial pressure may occur.

Other medicines and Claral

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions between Claral and other medicines are currently known.

Pregnancy, breastfeeding, and fertility

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.

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

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

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

If you are breastfeeding:

• Claral must not be applied to the breasts.
• Claral must not be applied to large skin areas or with occlusive dressings/patches 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 machinery.

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

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

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

3. How to use Claral 1 mg/g Cream

Follow exactly the instructions for use of this medicine as given 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 daily or, as needed, up to three times daily. Once symptoms have improved, once daily application is usually sufficient.

In general, treatment duration may range from 1 week and should not exceed three weeks. Treatment on the face should be as short as possible, no longer than 1 week.

For topical use only.

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 of age.

In children between 4 months and 3 years of age, the doctor must carefully assess the risk before prescribing this medicine.

In children, treatment duration should be kept as short as possible.

If you use more Claral than you should

No significant risk is 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, go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 missed a dose, continue with your usual schedule as instructed by your doctor or as described in this leaflet.

If you stop using Claral

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

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

4. Possible adverse effects

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

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

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

As a consequence of glucocorticoid application, especially over large body surface areas (10% or more) or for prolonged periods (more than 4 weeks), the following adverse effects may occur: skin atrophy, dryness, dilation of small blood vessels (telangiectasia), inflammation of hair follicles (folliculitis), stretch marks, acne, excessive hair growth (hypertrichosis), changes in skin pigmentation, perioral dermatitis (skin condition around the mouth), allergic contact dermatitis to one of the components of the medicine, skin maceration (softening due to moisture), secondary infection, and systemic effects (effects in other parts of the body) due to glucocorticoid absorption. These systemic effects may include increased eye pressure or glaucoma (optic nerve damage), a condition affecting the glands near the kidneys, and a disorder characterized by trunk obesity, rounded face, delayed wound healing, etc. (Cushing's syndrome), increased blood and urine sugar levels (hyperglycemia and glycosuria), hypertension, fluid retention (edema), and hypersensitivity reactions.

To reduce the risk of adverse effects, see section Warnings and precautions.

Other adverse effects in children

The occurrence of adverse effects in newborns from mothers who have been treated over large body surface areas or for prolonged periods during pregnancy or breastfeeding cannot be ruled out (e.g., decreased adrenal gland function in a baby following treatment during the last weeks of pregnancy).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Claral 1 mg/g Cream

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

Do not store above 30°C.

The shelf life after first opening the container is 3 months.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This way you will help protect the environment.

6. Contents of the pack and other information

Composition of Claral

• • The active substance is diflucortolone valerate.

• Each g 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 medicinal product and contents of the pack

Claral is a slightly yellowish, opaque cream.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this summary: July 2019.

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