Package Insert: Information for the Patient

Mibac 10 mg/g + 30 mg/g Gel

Clindamycin + Benzoyl Peroxide

Read the entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medication contains two active principles: clindamicina and peróxido de benzoílo. This medication belongs to a group of medications known as “anti-acne preparations”.

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

• Clindamicina is an antibiotic that prevents the reproduction of bacteria involved in acne.
• Peróxido de benzoílo reduces blackheads and whiteheads. It also kills bacteria involved in acne.

Used together in this medication, they act:

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

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

No use Mibac

- if you are allergic to clindamicina, lincomicina, peróxido de benzoílo or any of the other components of this medication (listed in section 6).

Do not use this medication if you have any of the above circumstances. 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 the inside of the nose.
• Do not use the gel on irritated skin areas. For example, if you have cuts, scrapes, sunburn or torn skin.
• If this medication accidentally enters your eyes, mouth or the inside of your nose, rinse with plenty of water.
• Do not apply too much of this medication on sensitive skin areas.
• Most patients will experience some redness and skin peeling during the first weeks of treatment. If your skin becomes irritated, you may need to use a non-oil moisturizing cream, use this medication 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 medication does not come into contact with colored fabrics, such as clothing, towels, bedding, furniture or carpets. This medication may bleach these materials.
• This medication may discolor hair.
• This medication may make your skin more sensitive to the harmful effects of the sun. Avoid the use of sunbeds/solar lamps and minimize the time you spend in the sun. When you cannot avoid exposure to intense sunlight, you must 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 this is unlikely to occur with antibiotics applied to the skin.
• If you have recently used other medications that contain clindamicina or eritromicina, there is a higher probability that this medication will not work as well as it should.

Inform your doctor or pharmacist if you have recently used other medications that contain clindamicina or eritromicina.

Children

Do not administer this medication to children under twelve years old. 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 antibiotics applied to the skin.
• medicinal soaps and cleaners 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 may irritate your skin over time.

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

• Some skin-applied acne medications that contain tretinoína, isotretinoína or tazaroteno.

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 (for example, one in the morning and the other at night).

The use of other acne medications at the same time as this medication 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 medication should not be used at the same time as medications that contain eritromicina.
• The application of this medication at the same time as medications such as dapsona and sulfacetamida may cause a temporary change in skin or facial hair color (yellow/orange color). 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 to undergo surgery.

If you are unsure about anything mentioned 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, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

The components of this medication are unknown to pass into breast milk. One of the components of this medication is clindamicina. It has been reported that clindamicina passes into breast milk when taken orally or by injection.

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, 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 consecutive weeks. Your doctor will indicate the duration of treatment.

Administration Form

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 pats.
3. Apply a thin layer of gel over the entire affected skin area, using the fingertips.
4. Apply it to all acne-affected skin areas, not just individual pimples. If the gel does not penetrate easily into the skin, you are using too much.

• For the face, use a gel amount from the tip of the finger to the first joint (the first finger crease). This is the "fingertip pad".
• For the face and back, use two and a half "fingertip pads" in total.

1. If you experience excessive dryness or skin peeling, you may use a fragrance-free, oil-free, and hypoallergenic moisturizing cream, use this medication less frequently or interrupt treatment for a short period to allow your skin to adapt to the treatment. This medication 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 may 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 using it more frequently will not help your 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 start again.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological 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, see a doctor. You may experience symptoms similar to those that occur when taking oral antibiotics (stomach upset).

If you forget to use Mibac

• Do not apply a double dose to compensate for the missed 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 consecutive weeks 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 using it too soon, your acne may reappear.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop using this medicine and consult a doctor immediately if you notice any of the following severe side effects - you may need urgent medical treatment:

• Signs of an allergic reaction (such as swelling of the face, eyes, lips, or tongue, nettle rash, or difficulty breathing, collapse)
• Severe or prolonged diarrhea, or abdominal cramps
• Intense 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 start again.

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

• Burning sensation in the skin, peeling, itching, dry skin.
• Redness of the skin, especially during the first 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:

• Tickling (paresthesia), worsening of acne

Unknown frequency(the frequency cannot be estimated from the available data)

• Allergic reactions
• Intestinal inflammation, diarrhea, even with blood, stomach pain

At the application site:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the tube and on the box after “EXP.” The expiration date is the last day of the month indicated.

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

After the first opening, this medication may be used for 2 months if stored at less than 25 °C.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Mibac

The active principles are:

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

The other components are:

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

Appearance of the product and content of the container

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.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Responsible for manufacturing

Mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

O

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 with the following names:

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

Poland: Duocutan

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

Last review date of this leaflet: June 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es )