MIBAC 10 mg/g + 50 mg/g GEL

2. What you need to know before you use 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 applies to you. If you are not sure, consult your doctor or pharmacist before using this medicine.

Warnings and precautions

Consult 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 the nose.
• Do not use the gel on irritated skin areas. For example, if you have cuts, abrasions, sunburn, or broken skin.
• If this medicine accidentally comes into contact with your eyes, mouth, or inside the nose, rinse with plenty of water.
• Do not apply too much of this medicine 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-greasy moisturizer, use this medicine less frequently, or stop using it for a short period to allow your skin to recover and 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.
• Make sure this medicine does not come into contact with colored tissues, such as clothing, towels, bedding, furniture, or carpets. This medicine can bleach these materials.
• This medicine may discolor hair.
• This medicine 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 medicine.

Consult 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 diarrhea that does not improve or is severe, stop using this medicine 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 antibiotics applied to the skin.
• If you have recently used other medicines that contain clindamycin or erythromycin, there is a greater chance that this medicine may not work as well as it should.

Tell your doctor or pharmacist if you have recently used other medicines that contain clindamycin or erythromycin.

Children

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

Other medicines and Mibac

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• any other acne treatment, including antibiotics applied to the skin.
• medicated soaps or cleansers or ‘abrasives’.
• soaps or cosmetics with a strong drying effect.
• products that contain large amounts of alcohol or ‘astringents’.

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

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

• Some acne medicines applied to the skin that contain 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 (e.g., one in the morning and the other 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 must not be used at the same time as medicines that contain 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 will not be permanent.
• One of the components of this medicine may affect the functioning of certain general anesthetics (called “neuromuscular blocking agents”).

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

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before using this medicine.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

It is not known if the components of this medicine can pass into breast milk. One of the components that this medicine contains 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 medicine.

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

3. How to use Mibac

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Method of administration

The medicine is for cutaneous use.

How to apply this medicine

1. Completely remove any remaining makeup.
2. Wash the affected skin area well. Then rinse with warm water and pat dry with a towel.
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 the 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 suffer from a lot of dryness or peeling of the skin, you can use a non-greasy, non-perfumed, and hypoallergenic moisturizer, use this medicine less frequently, or stop treatment for a short period to allow your skin to adapt to treatment. This medicine may not work properly if it is not applied every day.
2. Wash your hands after using the gel.
3. After it has dried, you can use 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 happens, 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 medicine and the amount ingested.

If you accidentally take Mibac

If you accidentally ingest the gel, go to the 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 stop treatment with Mibac

Do not stop using this medicine without consulting.

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

It is important that you continue using the gel as your doctor has prescribed. If you stop too soon, your acne may come back.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using this medicine 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 medicine 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:

• Redness, peeling, dryness.

These side effects are usually mild.

Common side effects(may affect up to 1 in 10 people)

• Headache.

At the application site:

• Burning, pain, sensitivity to light.

Uncommon side effects(may affect up to 1 in 100 people)

At the application site:

• Tingling (paresthesia), worsening of acne, redness, itching of the skin, skin rash (dermatitis, erythematous rash).

Frequency not known(frequency cannot be estimated from the 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 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 which is stated on the tube and carton after “EXP”. The expiry date is the last day of the month shown.

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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 50 mg (5% w/w) of benzoyl peroxide as hydrated benzoyl peroxide.

The other ingredients are:

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

Appearance of the product and pack contents

Mibac 10 mg/g + 50 mg/g gel is a white gel and is supplied in aluminum tubes of 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Clindaderm comp. 10 mg/g + 50 mg/g Gel

Croatia: Acnemine 10 mg/g + 50 mg/g gel

Italy: Aknecutan

Poland: Duocutan

Spain: Mibac 10 mg/g + 50 mg/g gel

Date of last revision of this leaflet: July 2024

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)