Skinoren Cream

What is Skinoren Cream?

Skinoren Cream is a topical medication containing the active ingredient azelaic acid at a concentration of 20%. Azelaic acid is a naturally occurring dicarboxylic acid found in grains like barley, wheat, and rye. In medicinal form, it's classified as an anti-acne preparation with antibacterial, anti-inflammatory, and comedolytic properties.

Mechanism of Action

Skinoren Cream works through multiple mechanisms to treat acne:

• Antibacterial Action: It attacks Propionibacterium acnes, the primary bacterium involved in acne development, by inhibiting microbial cellular protein synthesis.
• Comedolytic Effect: It normalises keratinisation (the process of skin cell maturation and shedding), preventing the formation of microcomedones (tiny plugs that can develop into blackheads and whiteheads).
• Anti-inflammatory Properties: It reduces inflammation in acne lesions by scavenging free radicals and inhibiting the production of inflammatory cytokines.

Think of Skinoren Cream as a multi-tool for acne treatment: it simultaneously fights bacteria, reduces inflammation, and helps unclog pores - addressing multiple factors that contribute to acne development.

What is Skinoren Cream Used For?

Skinoren Cream is indicated for the topical treatment of acne vulgaris (common acne). It's particularly effective for:

• Inflammatory acne (red, swollen pimples)
• Comedonal acne (blackheads and whiteheads)
• Mild to moderate acne on the face, chest, and back

Approved Patient Groups

It is not recommended for children under 12 years due to insufficient safety and efficacy data in this age group.

Before Using Skinoren Cream

Essential considerations before initiating treatment:

Medical History Assessment

• Asthma (rarely, azelaic acid may worsen asthma symptoms)
• Known hypersensitivity or allergy to azelaic acid or any other ingredients
• Any other skin conditions or disorders
• History of severe skin reactions to topical products

Required Baseline Considerations

1. Assess the type and severity of your acne
2. Evaluate your current skincare routine and other acne treatments
3. Check for any signs of skin conditions that might contraindicate use
4. Review your medical history for potential risk factors

Skinoren Cream Contraindications

Absolute contraindications where Skinoren Cream must not be used:

Absolute Contraindications

• Hypersensitivity to azelaic acid or any excipients in Skinoren Cream
• Children under 12 years of age

Relative Contraindications

Special Population Considerations

Elderly Patients (≥65 years)

• No specific dosage adjustment necessary
• Use with caution in elderly individuals with sensitive skin

Renal or Hepatic Impairment

• Since azelaic acid is minimally absorbed systemically when applied topically, no special precautions are needed
• Always inform your doctor of any pre-existing conditions

Pediatric/Adolescent Restrictions

• Approved for adolescents aged 12-18 years
• Not recommended for children below 12 years

Skinoren Cream and Other Medicines

Formal drug interaction studies have not been conducted with Skinoren Cream. However, consider the following:

High-Risk Combinations

• Other topical acne treatments (e.g., retinoids, benzoyl peroxide, salicylic acid): May increase skin irritation. If combining treatments, apply at different times of day or as directed by your doctor.
• Topical corticosteroids: May alter the effectiveness of either product. Use with caution and under medical supervision.

Application Timing Recommendations

If using other topical products on the same areas:

1. Apply Skinoren Cream first and allow it to absorb fully (approximately 15-20 minutes)
2. Then apply any other prescribed topical medications
3. Apply moisturisers or sunscreens after Skinoren Cream has been absorbed

Always inform your doctor or pharmacist about all medications you're using, including prescription, over-the-counter, and herbal products.

Pregnancy & Breastfeeding

Pregnancy

• Animal studies have not shown direct or indirect harmful effects with respect to reproductive toxicity
• Human data is limited
• If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using Skinoren Cream

Breastfeeding

• It is unknown whether azelaic acid is excreted in human milk
• A risk to newborns/infants cannot be excluded
• Skinoren Cream should be used with caution during breastfeeding
• Infants must not come into contact with treated skin areas on the breast

Driving & Machine Operation

• Skinoren Cream has no known influence on the ability to drive and use machines
• The medication is applied topically and has minimal systemic absorption
• Doesn't affect alertness, coordination, or reaction time

Skinoren Cream Ingredients

Active Substance

• Azelaic acid: 200 mg per gram (20% w/w)

Excipients

Allergen Warning: If you have known allergies to any of these ingredients, do not use Skinoren Cream. Contact your doctor if you experience signs of an allergic reaction.

How to Use Skinoren Cream

Always use Skinoren Cream exactly as prescribed by your doctor. Follow these step-by-step instructions for proper application:

Application Steps

1. Cleanse: Wash the affected area(s) thoroughly with plain water. If your skin is greasy, use a mild skin cleanser. Pat dry with a clean towel.
2. Dry: Ensure the skin is completely dry before application.
3. Measure: Squeeze a small amount of cream (approximately 0.5g for the entire face, adjust accordingly for larger areas).
4. Apply: Apply a thin layer of cream to the affected areas, gently rubbing it in.
5. Wash hands: Wash your hands thoroughly after application to avoid transferring the cream to other areas.
6. Avoid contact: Take care to avoid contact with eyes, mouth, nostrils, and other mucous membranes. If contact occurs, rinse immediately with plenty of cool water.

Skinoren Cream Dosage Guidelines

Standard Dosage Schedule

Dosage Adjustment for Sensitive Skin

If you experience skin irritation, especially at the beginning of treatment:

• Reduce to once daily application (preferably in the evening)
• Use a smaller amount of cream
• If irritation persists, temporarily discontinue use and consult your doctor

Administration Instructions

Step-by-step application guide:

Application Amount Guide

• Face only: Approximately 0.5g (a pea-sized amount) per application
• Face, chest, and back: Adjust amount accordingly; approximately 1.0-1.5g total
• Use just enough to cover affected areas with a thin layer

Treatment Timeline Expectations

1. Weeks 1-2: Some initial irritation may occur. Acne might appear unchanged.
2. Weeks 3-4: Visible improvement typically begins. Redness and inflammation should decrease.
3. Months 2-3: Significant improvement in acne lesions. Skin texture improves.
4. Beyond 3 months: Continued use maintains results. Maximum benefit usually seen after several months of regular use.

Important: Do not use Skinoren Cream for more than 12 months continuously without medical review.

Missed Dose Management

General Principles

• Do NOT apply a double dose to make up for a missed application
• This may increase the risk of skin irritation

Time-Based Guidance

Overdose Information

Symptoms of Excessive Topical Application

• Severe skin irritation, redness, burning, or stinging
• Excessive dryness, scaling, or peeling
• Increased sensitivity to sunlight

If Accidentally Ingested

While systemic absorption through skin is minimal, accidental ingestion of large amounts may cause:

• Gastrointestinal disturbances
• Potential metabolic acidosis (in very large amounts)

Management Protocol

1. Topical overdose: Wash off excess cream with mild soap and water. Apply a soothing moisturiser. If severe irritation persists, seek medical advice.
2. Accidental ingestion: Rinse mouth with water. Do NOT induce vomiting. Seek immediate medical attention or contact a poison control centre.

Skinoren Cream Side Effects

Like all medicines, Skinoren Cream can cause side effects, although not everyone experiences them. Side effects are typically mild and often improve as your skin adjusts to the treatment.

Frequency-Based Side Effect Categorisation

Very Common (may affect more than 1 in 10 people)

• Burning sensation at application site
• Itching (pruritus) at application site
• Abnormal redness of skin (erythema) at application site

Common (may affect up to 1 in 10 people)

• Scaling, pain, or dryness at application site
• Skin discolouration or irritation at application site

Uncommon (may affect up to 1 in 100 people)

• Greasy skin, acne, or loss of skin colour
• Tingling, dermatitis, discomfort, or swelling at application site

Rare (may affect up to 1 in 1,000 people)

• Cracking of the lips, vesicles (small blisters)
• Eczema, ulceration, warmth at application site
• Allergic reaction, rash at application site

Not Known (frequency cannot be estimated from available data)

• Skin swelling, eye swelling, facial swelling (may occur with hypersensitivity)
• Rash, urticaria (hives)
• Worsening of asthma

Managing Common Side Effects

If you experience skin irritation:

1. Reduce the amount of cream applied each time
2. Apply only once daily instead of twice
3. Temporarily stop treatment for a few days, then restart
4. If irritation remains troublesome, consult your doctor

Reporting Side Effects: If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to Store Skinoren Cream

Storage Conditions

• Keep out of reach of children: Store in a secure location where children cannot access it.
• Temperature control: Store below 30°C. Do not freeze.
• Expiry date: Do not use after the expiry date printed on the tube and box after "EXP".
• In-use shelf life: After first opening, use within 6 months.
• Protect from light: Keep the tube in its original packaging to protect from light.

Disposal Protocol

Do not dispose of medicines via wastewater or household waste. Return any unused or expired Skinoren Cream to your pharmacy for proper disposal. These measures help protect the environment.

Skinoren Cream Pack Information

What Skinoren Cream Looks Like

• White, opaque cream
• Available in aluminium tubes with a plastic cap

Available Pack Sizes

• 20g tube
• 30g tube
• 50g tube

Note: Not all pack sizes may be marketed or available at all times.

Marketing Authorisation Holder

LEO Laboratories Limited,
Hurley, Berkshire SL6 6RJ, UK

Manufacturer

LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21, 20054 Segrate (Milan), Italy

Leaflet last revised: February 2022

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