Baneocin Ointment is a combination of two antibiotics for external use only. It contains two locally highly effective substances which kill germs: neomycin and bacitracin.

Their scopes of action complement each other and enhance the overall effect, as a result of which Baneocin Ointment is effective against a wide range of pathogens (broad-spectrum effect). Neither neomycin nor bacitracin are absorbed by the body in significant quantities if applied correctly, and therefore have a rapid and intense effect at the inflammation site.

In general, both antibiotics are well tolerated and are not rendered ineffective by wound secretions, pus, blood or tissue parts. Therefore, Baneocin Ointment can be used locally on skin, mucous membranes and wounds.

It is effective against infections caused by neomycin-sensitive and/or bacitracin-sensitive germs.

The effect is enhanced by a dressing.

·                Focal bacterial skin infections, e.g.

Following surgical treatment of pus cavities (furuncles, carbuncles) or following drainage of soft tissue abscesses, hair follicle inflammation (razor bumps, deep folliculitis), painful inflammation of the skin with formation of abscesses and fistulas (acne inversa), sweat gland abscesses (periporitis), nail bed inflammation (paronychia)

·                Small-scale bacterial infections, e.g.

Impetigo (non-bullous impetigo), infected varicose ulcers (ulcus cruris), secondarily infected eczema, secondarily infected contused lacerations and cuts, following cosmetic surgery and skin grafts (also for prevention and for preparation of ointment dressings).

          For local infection prevention following burns and scalds.

·                Following major and minor surgical procedures

Baneocin Ointment can be used as adjunctive therapy in follow-up treatment (e.g. aftercare of a perineal tear or episiotomy, following paranasal sinus surgery or temporal bone surgery).

In the event of infected body cavities or wound cavities, use of Baneocin Ointment is recommended for targeted local treatment (e.g. in the event of inflammation of the external auditory canal [otitis externa] and for wounds or surgical scars at risk of infection or not healing well).

Do not use Baneocin Ointment:

-    if you are allergic to bacitracin and/or neomycin, or other aminoglycoside antibiotics, or any of the other ingredients of this medicine (listed in section 6);

-    avoid using Baneocin Ointment on severe, large skin wounds, since absorption via the bloodstream can cause side effects which damage hearing with hearing loss.

-    in the event of severe excretion disorders of cardiac or renal origin and pre-existing defects of the balance system and/or inner ear, if there is a possibility of uncontrolled absorption.

-    do not use in the external auditory canal if the eardrum is damaged.

-    Baneocin Ointment should not be used on the eye.

Warnings and precautions

Talk to your doctor or pharmacist before using Baneocin Ointment.

-    The first signs of side effects must be reported to the doctor.

-    When using doses that are much higher than the recommended doses (especially in the event of poorly healing ulcers) and because of the possible absorption of dissolved active substances in the bloodstream, it is important to watch out for signs of illness indicating kidney damage (loss of appetite, excessive thirst, decreased output of urine, traces of blood in urine) or hearing impairment (higher frequency hearing loss, ringing in the ears, roaring and feeling of pressure in the ears). This risk is increased in people with liver and/or kidney impairment, and in such cases urine and blood tests or hearing tests are therefore recommended prior to and during intensive therapy.

-    Baneocin Ointment should not be used in the ear area if the eardrum is damaged.

-    If elevated levels of Baneocin Ointment get into the body, muscle weakness can occur, or, if already present (e.g. myasthenia gravis or similar), can be aggravated.

-    Prolonged use of antibiotics can encourage the development of resistant germs.

-    Please keep an eye out for the occurrence of signs of inflammation (heat, redness, swelling, pain) or signs of fungal infestation at the treated sites. Tell your doctor about these or other abnormal changes.

-    Tell your doctor if you become pregnant.

-    Baneocin Ointment must not be used in the mouth – especially in children.

-    In the event of exposure to sunlight or UV radiation, the development of skin reactions cannot be excluded, and therefore caution should be exercised during treatment with Baneocin Ointment.

Other medicines and Baneocin Ointment

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

If Baneocin Ointment's active substances get into the body through use on large, open areas of skin, they can increase the kidney-damaging effect of other medicines (e.g. cephalosporins or other aminoglycoside antibiotics).

They can enhance both the hearing and kidney-damaging effect of diuretics such as ethacrynic acid or furosemide.

Muscle weakness can also be increased through the use of anaesthetics during surgery. If you are suffering from a muscle condition, you should therefore let the doctor know about this before surgery.

Pregnancy and breast-feeding

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

Only in the event of large open wounds, for instance, is it possible that the active substances will not only affect the inflammation site but also enter the mother’s body. In this case pregnant and breast-feeding women should only use Baneocin Ointment under close medical supervision.

With small-scale infections and short-term treatment at low doses, there is generally no risk for use in pregnancy and while breast-feeding.

Driving and using machines

Baneocin Ointment does not affect the ability to drive and use machines.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Unless instructed otherwise, stick strictly to the dosage.

In general, Baneocin Ointment is applied twice to three times daily in adults and children.

No more than 1% of the body surface (corresponding to the size of a palm of a hand) should be treated.

Method of administration

For cutaneous application.

Apply a thin layer of the ointment to the affected area. A dressing may be used.

Treatment duration should be limited to 7 days.

If you use more Baneocin Ointment than you should

When using doses that are much higher than the recommended doses, changes that damage the kidneys or hearing must be considered, because of possible absorption of the active substances. See “Warnings and precautions for use” section

If you forget to use Baneocin Ointment

Do not use double the quantity to make up for forgetting to use Baneocin Powder.

If you stop using Baneocin Ointment

Even if your symptoms improve or disappear, continue to use Baneocin Ointment for the entire duration of treatment specified by your doctor, to eliminate all germs and to prevent relapse.

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

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

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

Common         (may affect up to 1 in 10 people)

Uncommon     (may affect up to 1 in 100 people)

Rare                (may affect up to 1 in 1000 people)

Very rare         (may affect up to 1 in 10,000 people)

Not known       (frequency cannot be estimated from available data)

Baneocin Ointment is generally well tolerated following external application to the skin, mucous membranes and wound area.

Rare side effects (may affect up to 1 in 1000 people):

·                In approximately 50% of cases of neomycin allergy, there is also a cross-allergy to other aminoglycoside antibiotics.

·                Allergies, mainly appearing as skin rash (contact eczema).

Not known (frequency cannot be estimated from available data)

·                Sensitisation: Compared to healthy skin, use for chronic skin conditions generally promotes sensitisation to many different substances including the active substance in this medicine, neomycin. Under certain circumstances the allergy can simply appear to be a failure to heal.

·                With long-term use, allergic hypersensitivity reactions can develop, such as skin rash with redness, swelling, drying and flaking, rash and itching. Spread of the sensitisation or failure to heal may be allergy-related.

Therefore, if such a rash appears for the first time, you should tell your doctor, so that he/she can decide whether you should continue using this medicine. If an allergy is detected, you should report this before using other aminoglycoside antibiotics.

·                If used repeatedly on large, open areas of the skin, the active substances that find their way into the body can cause balance problems, muscle weakness, hearing impairment and kidney damage.

·                In the event of exposure to sunlight or UV radiation, the development of skin reactions cannot be excluded, and therefore caution should be exercised during treatment with Baneocin Ointment.

Store below 25 °C.

Store in the original package in order to protect from light.

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 carton, tube or tub after “EXP.”. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.