Mibac 10 mg/g + 30 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mibac 10 mg/g + 30 mg/g gel

clindamycin + benzoyl peroxide

Read the 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Mibac
6. Contents of the pack and other information

1. What Mibac is and what it is used for

This medicine contains two active substances: clindamycin and benzoyl peroxide. This medicine belongs to a group of medicines known as "anti-acne preparations".

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

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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

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

Used together in this medicine, they act by:

• fighting the bacteria that can cause acne,
• treating blackheads, whiteheads, and pimples,
• reducing the number of red, inflamed acne pimples.

This medicine is indicated for adults and adolescents aged 12 years and 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 ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

• Use this medicine only on the skin. Keep it away from areas such as the eyes, lips, mouth, or inside of the nose.
• Do not use the gel on irritated areas of skin. For example, if you have cuts, scrapes, sunburn, or broken skin.
• If this medicine accidentally comes into contact with your eyes, mouth, or inside of the nose, rinse thoroughly with plenty of water.
• Do not over-apply this medicine to sensitive areas of skin.
• 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 an oil-free moisturizer, use this medicine less frequently, or stop using it temporarily to allow your skin to recover, then restart treatment.
• Stop treatment and consult your doctor if skin irritation is severe (intense redness, dryness, itching, stinging, or burning) or does not improve.
• Take care to avoid contact of this medicine with colored fabrics such as clothing, towels, bed linens, furniture, or carpets. This medicine may bleach these materials.
• This medicine may bleach hair.
• This medicine may make your skin more sensitive to the harmful effects of sunlight. Avoid using sunbeds or sunlamps, and minimize your time in the sun. When exposure to strong sunlight cannot be avoided, use sunscreen and wear protective clothing while using this medicine.

Talk to your doctor or pharmacist before using this medicine 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 diarrhoea that does not improve or is severe, stop using this medicine and contact your doctor immediately. Antibiotics can cause a condition leading to severe diarrhoea and stomach cramps, although this is unlikely with antibiotics applied to the skin.
• If you have recently used other medicines containing clindamycin or erythromycin, there is an increased chance that this medicine may not work as well as expected.

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

Children

Do not give this medicine to children under 12 years of age. It is not known whether it is effective or safe for them.

Other medicines and Mibac

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

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

• any other acne treatments, including topical antibiotics.
• medicated or abrasive soaps and cleansers.
• soaps or cosmetics with a strong drying effect.
• products containing high amounts of alcohol or astringents.

This is because when used together with this medicine, they may irritate your skin over time.

This medicine may make some acne treatments less effective when used at the same time. This includes:

• Some topical acne medicines containing tretinoin, isotretinoin, or tazarotene.

Tell your doctor or pharmacist if you are also using any of these medicines. You may need to use the two products at different times of the day (for example, one in the morning and one at night).

Using other acne medicines at the same time as this medicine may increase the risk of skin irritation.

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

• This medicine should not be used at the same time as medicines containing erythromycin.
• Applying this medicine at the same time as medicines such as dapsone and sulfacetamide may cause a temporary change in skin or facial hair color (yellow/orange). This is not permanent.
• One of the components of this medicine may affect the action of certain general anaesthetic medicines (called “neuromuscular blocking agents”).

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

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using this medicine.

Pregnancy and breast-feeding

There is limited information available on the safety of this medicine in pregnant women.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will consider the benefit to you and the risk to your baby of using this medicine during pregnancy.

It is unknown whether the components of this medicine pass into breast milk. One of the components of this medicine is clindamycin. It has been reported that clindamycin passes into breast milk when taken orally or by injection.

If you are breast-feeding, you should consult your doctor before using this medicine.

Do not use this medicine on the breasts if you are breast-feeding.

3. How to use Mibac

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Use this medicine once daily at night.
• It may take 2 to 5 weeks before you notice the effect of this medicine.
• Do not use it for longer than 12 consecutive weeks. Your doctor will advise you on the duration of treatment.

Method of administration

This medicine is for cutaneous use only.

How to apply this medicine

1. Completely remove any traces of makeup.
2. Wash the affected area of skin thoroughly. Then rinse with lukewarm water and pat dry gently.
3. Apply a thin layer of gel over the entire affected area of skin, using your fingertips.
4. Apply it to all areas of skin affected by acne, not only on individual pimples. If the gel does not absorb easily into the skin, you are using too much.

• For the face only, use an amount of gel from the tip of your finger up to the first joint (the first crease of the finger). This is referred to as a "fingertip unit".
• For the face and back combined, use a total of two and a half fingertip units.

1. If you experience significant dryness or peeling of the skin, you may use an oil-free, fragrance-free, hypoallergenic moisturizer, use this medicine less frequently, or interrupt treatment briefly to allow your skin to adapt. This medicine may not work properly if not applied daily.
2. Wash your hands after applying the gel.
3. Once the gel has dried, you may apply non-comedogenic 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 make acne improve faster and may cause skin irritation. If this occurs, use the gel less frequently or stop using it for a few days and then restart treatment.

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

If you accidentally ingest Mibac

If you accidentally ingest the gel, seek medical advice. You may experience symptoms similar to those that occur when taking oral antibiotics (such as stomach upset).

If you forget to use Mibac

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

If you stop treatment with Mibac

Do not stop using this medicine without consulting your doctor.

Do not use the gel for longer than 12 consecutive weeks without consulting your doctor. Use this medicine for the length of time recommended by your doctor. Do not stop using it unless advised by your doctor.

It is important that you continue using the gel as prescribed by your doctor. If you stop treatment too early, your acne may return.

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 experiences them.

Stop using this medicine and consult your doctor immediately if you notice any of the following serious adverse effects – you may require urgent medical treatment:

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

Other possible adverse effects:

If you notice any of these adverse effects, try using this medicine less frequently, or stop using it for one or two days and then start again.

Very common adverse effects (may affect more than 1 in 10 people)
At the application site:

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

These adverse effects are usually mild.

Common adverse 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 adverse effects (may affect up to 1 in 100 people)

At the application site:

• Tingling (paresthesia), worsening of acne

Frequency not known (frequency cannot be estimated from the available data)

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

At the application site:

• Skin reactions, skin discoloration
• Raised itchy skin rash (urticaria)

Reporting of adverse effects

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

5. Storage of Mibac

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

Do not use this medicine after the expiry date stated on the tube and the carton after “EXP”. The expiry date refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mibac

The active substances 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 components are:

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

Appearance of the product and pack contents

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter 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 medicinal product is authorized in the European Economic Area member states 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 most recent review of this leaflet: June 2024

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