MIBAC 10 MG/G + 30 MG/G GEL

Introduction

Package Leaflet: Information for the Patient

Mibac 10 mg/g + 30 mg/g Gel

clindamycin + benzoyl peroxide

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 doubts, 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Mibac is and what it is used for
2. What you need to know before using Mibac
3. How to use Mibac
4. Possible side effects
5. Storage of Mibac
6. Package Contents and Additional Information

1. What Mibac is and what it is used for

This medication contains two active ingredients: clindamycin and benzoyl peroxide. This medication belongs to a group of medications known as "anti-acne preparations".

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential to follow the dosage, administration interval, and treatment duration instructions indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash.

This medication is indicated for the treatment of mild to moderate acne of the skin.

• Clindamycin is an antibiotic that prevents the reproduction of bacteria involved in acne.
• Benzoyl peroxide reduces blackheads and whiteheads. It also kills bacteria involved in acne.

Used together in this medication, they:

• combat bacteria that can cause acne,
• treat blackheads, whiteheads, and pimples,
• reduce the number of red and inflamed acne pimples.

This medication is indicated for adults and adolescents 12 years of age or older.

2. What you need to know before using Mibac

Do not use Mibac

• if you are allergic to clindamycin, lincomycin, benzoyl peroxide, or any of the other components of this medication (listed in section 6).

Do not use this medication if any of the above circumstances apply to you. If you are unsure, consult your doctor or pharmacist before starting to use this medication.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

• Use this medication only on the skin. Keep it away from areas such as the eyes, lips, mouth, or inside the nose.
• Do not use the gel on irritated skin areas. For example, if you have cuts, scrapes, sunburns, or cracked skin.
• If this medication accidentally comes into contact with your eyes, mouth, or inside your nose, rinse with plenty of water.
• Do not apply too much of this medication to sensitive skin areas.
• Most patients will experience some redness and peeling of the skin during the first few weeks of treatment. If your skin becomes irritated, you may need to use a non-comedogenic moisturizer, use this medication less frequently, or stop using it for a short period to allow your skin to recover and then restart treatment.
• Interrupt treatment and consult your doctor if skin irritation is severe (intense redness, dryness, itching, stinging, or burning) or does not improve.
• Make sure this medication does not come into contact with colored tissues, such as clothing, towels, bedding, furniture, or carpets. This medication can bleach these materials.
• This medication can discolor hair.
• This medication can make your skin more sensitive to the harmful effects of the sun. Avoid using sunbeds/lamps and minimize the time you spend in the sun. When you cannot avoid exposure to intense sunlight, use a sunscreen and wear protective clothing while using this medication.

Consult your doctor or pharmacist before using this medication if:

• You have ever had any of the following intestinal problems: "regional enteritis", "ulcerative colitis", or "antibiotic-associated colitis".
• If you develop stomach cramps or diarrhea that does not improve or is severe, stop using this medication and contact your doctor immediately. Antibiotics can cause a condition that leads to severe diarrhea and stomach cramps, although it is unlikely to occur with topical antibiotics.
• If you have recently used other medications containing clindamycin or erythromycin, there is a higher likelihood that this medication may not work as well as it should.

Inform your doctor or pharmacist if you have recently used other medications containing clindamycin or erythromycin.

Children

Do not give this medication to children under 12 years of age. It is not known if it works or is safe for them.

Other Medications and Mibac

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

Inform your doctor or pharmacist if you are using any of the following:

• any other acne treatment, including topical antibiotics.
• medicated soaps or cleansers or 'abrasives'.
• soaps or cosmetics with a strong drying effect.
• products containing large amounts of alcohol or 'astringents'.

This is because when used with this medication, they can irritate your skin over time.

This medication can make some acne medications less effective when used at the same time. This includes:

• Some topical acne medications that contain tretinoin, isotretinoin, or tazarotene.

Inform your doctor or pharmacist if you are also using any of these medications. You may need to use the two products at different times of the day (e.g., one in the morning and the other at night).

Using other acne medications at the same time as this medication can increase the risk of skin irritation.

Interrupt treatment and consult your doctor if skin irritation becomes severe (intense redness, dryness, itching, stinging, or burning).

• This medication should not be used at the same time as medications containing erythromycin.
• Applying this medication at the same time as medications like dapsone and sulfacetamide may cause a temporary change in skin or facial hair color (yellow/orange). This will not be permanent.
• One of the components of this medication may affect the functioning of certain general anesthetics (called "neuromuscular blocking agents").

Inform your doctor or pharmacist if you are going to undergo surgery.

If you are unsure about any of the above, consult your doctor or pharmacist before using this medication.

Pregnancy and Breastfeeding

Only limited information is available on the safety of this medication in pregnant women.

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.

Your doctor will consider the benefit to you and the risk to your baby of using this medication while pregnant.

It is not known if the components of this medication can pass into breast milk. One of the components contained in this medication is clindamycin. It has been reported that clindamycin passes into breast milk when taken orally or by injection.

If you are breastfeeding, consult your doctor before using this medication.

Do not use this medication on the breast if you are breastfeeding.

3. How to Use Mibac

Follow your doctor's or pharmacist's instructions for using this medication exactly. If you are unsure, consult your doctor or pharmacist again.

• Use this medication once a day at night.
• It may take 2 to 5 weeks before you notice the effect of this medication.
• Do not use it for more than 12 weeks in a row. Your doctor will indicate the duration of treatment.

Method of Administration

The medication is for topical use.

How to Apply this Medication

1. Completely remove any remaining makeup.
2. Wash the affected skin area well. Then, rinse with warm water and dry with gentle patting.
3. Apply a thin layer of gel to the entire affected skin area, using your fingertips.
4. Apply it to all areas of the skin with acne, not just individual pimples. If the gel does not penetrate easily into the skin, you are using too much.

• For the face only, use an amount of gel from the tube that reaches from the tip of your finger to the first joint (the first fold of the finger). This is the "finger tip".
• For the face and back, use two and a half "finger tips" in total.

1. If you experience significant dryness or peeling of the skin, you can use a non-comedogenic, fragrance-free, and hypoallergenic moisturizer, use this medication less frequently, or interrupt treatment for a short period to allow your skin to adapt to treatment. This medication may not work correctly if it is not applied every day.
2. Wash your hands after using the gel.
3. After it has dried, you can use a non-greasy makeup.

If you use more Mibac than you should

Be careful not to apply too much. Applying too much gel or applying it more frequently will not help acne improve more quickly and may cause skin irritation. If this occurs, use the gel less frequently or stop using it for a few days and then restart.

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

If you accidentally take Mibac

If you accidentally ingest the gel, consult your doctor. You may experience symptoms similar to those that occur when antibiotics are taken orally (stomach upset).

If you forget to use Mibac

• Do not apply a double dose to make up for forgotten doses.
• Apply the next dose at the usual time.

If you interrupt treatment with Mibac

Do not stop using this medication without consulting.

Do not use the gel for more than 12 weeks in a row without consulting your doctor. Use this medication for the time recommended by your doctor. Do not stop using it unless your doctor advises you to.

It is essential to continue using the gel as prescribed by your doctor. If you stop too soon, your acne may return.

If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

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

Stop using this medication and consult your doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

• signs of an allergic reaction (such as swelling of the face, eyes, lips, or tongue, hives, difficulty breathing, collapse)
• severe or prolonged diarrhea, or stomach cramps
• severe burning, peeling, or itching of the skin

Other possible side effects:

If you notice any of these side effects, try using this medication less frequently, or stop using it for one or two days and then restart.

Very Common Side Effects(may affect more than 1 in 10 people) At the application site:

• Burning sensation on the skin, peeling, itching, dry skin.
• Redness of the skin, especially during the first few weeks of use.

These side effects are usually mild.

Common Side Effects(may affect up to 1 in 10 people)

• Headache

At the application site:

• Sensitivity to sunlight, skin pain
• Redness and itching of the skin, skin rash (dermatitis)

Uncommon Side Effects(may affect up to 1 in 100 people)

At the application site:

• Numbness or tingling (paresthesia), worsening of acne

Frequency Not Known(frequency cannot be estimated from available data)

• Allergic reactions
• Inflammation of the intestine, diarrhea, even with blood, stomach pain

At the application site:

• Skin reactions, skin discoloration
• Raised skin rash with itching (urticaria)

Reporting Side Effects

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

5. Storage of Mibac

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

Do not use this medication after the expiration date stated on the tube and carton after "EXP". The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

After the first opening, this medication can be used for 2 months if stored below 25 °C.

Medications should not be disposed of down the drain or in the trash. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mibac

The active ingredients are:

clindamycin and benzoyl peroxide. 1 g of gel contains 10 mg (1% w/w) of clindamycin as clindamycin phosphate and 30 mg (3% w/w) of benzoyl peroxide as hydrated benzoyl peroxide.

The other ingredients are:

carbomer, dimethicone 100, disodium lauryl sulfosuccinate, disodium edetate, glycerol 85% (E 422), hydrated colloidal silica, poloxamer 182, purified water, and sodium hydroxide (E 524).

Appearance of the Product and Package Contents

Mibac 10 mg/g + 30 mg/g gel is a white gel and is supplied in aluminum tubes with 30 g, 50 g, and 60 g of gel.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4ª planta, letra B,

28045, Madrid

Spain

Manufacturer

Mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

Or

Sun-Farm Sp. z o.o.

Ul. Dolna 21,

05-092 Lomianki, Mazowieckie

Poland

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Clindaderm comp. 10 mg/g + 30 mg/g Gel

Poland: Duocutan

Spain: Mibac 10 mg/g + 30 mg/g gel

Date of the last revision of this package leaflet: June 2024

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