BANEOCIN ung 20g
Leaflet: user information
Baneocin 250 IU/ 5,000 IU / g ointment
Baneocin 250 IU / 5000 IU / g ointment
Bacitracin zinc/neomycin sulfate
( B acitracin zinc/neomycin sulphate )
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your doctor or pharmacist.
- If drug reactions inform your doctor or pharmacist, this includes all possible ones
- If you do not feel better within 7 days or your condition worsens, you should seek medical attention.
What this leaflet contains :
- What Baneocin is and what it is used for
- What you need to know before you use Baneocin
- How to use Baneocin
- Possible side effects
- How to store Baneocin
- Package contents and additional information
1. What Baneocin is and what it is used for
Baneocin ointment is an antibiotic medicinal product for topical application. It contains two antibiotic active substances, bacitracin and neomycin, which are active against a large number of bacteria that cause infections.
Baneocin ointment is used
- to treat skin infections that affect the surface layers of the skin
- to treat and prevent infection of superficial wounds, burns or lacerations that occur during or after treatment of another pre-existing infection
- to prevent infection after skin surgery
2. What you need to know before you use Baneocin
Do not use Baneocin
- if you are hypersensitive to bacitracin and/or neomycin, as well as to other aminoglycoside antibiotics or to any of the other ingredients of this medicine (listed in section 6).
- on extensive and severe skin wounds, because the passage of the drug into the blood can cause adverse reactions on the part of the auditory system, which can lead to hearing loss.
- if you suffer from a severe impairment of excretory function as a result of heart or kidney disease or have vestibular impairment and/or inner ear impairment, as there is a possibility of uncontrolled resorption upon administration.
- in the external ear canal if the tympanic membrane is damaged/perforated.
- do not apply to the eyes.
Warnings and precautions
Talk to your doctor or pharmacist before using Baneocin.
Talk to your doctor at the first sign of side effects.
It is necessary to inform your doctor if pregnancy occurs during treatment with Baneocin.
If you have used more Baneocin Ointment than the recommended doses, monitor closely for signs of renal impairment (loss of appetite, excessive thirst, decreased urine output, traces of blood in the urine) or hearing impairment (high-frequency hearing loss, "ringing of ears", noise and tension in the ears), especially in the treatment of abscesses that are difficult to heal due to the possible penetration of the dissolved active substances into the blood stream. This risk is higher in patients with impaired liver and/or kidney function, therefore close monitoring by urine and blood testing and/or hearing is recommended before and during intensive treatment of such patients.
Combined topical and systemic administration of aminoglycosides should be avoided due to the risk of cumulative toxicity.
With high doses and long-term treatment with Baneocin, there is a risk of muscle weakness or its worsening if it is already present (eg myasthenia gravis or a similar disease).
With long-term use of antibiotics, the possibility of developing resistant microorganisms should be taken into account.
If allergies or superinfections occur, the use of this drug should be discontinued.
Exposure to sunlight or UV radiation may cause photosensitivity or phototoxicity reactions.
Please pay attention to signs of infection (burning, redness, swelling and pain) or symptoms of fungal infection at the treated site. See a doctor if you notice these or other unusual changes.
Other medicines and Baneocin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If the active substances of Baneocin are resorbed when applied to a large body area, with impaired skin integrity, this may increase the damage to the kidneys caused by other drugs (such as cephalosporins or other aminoglycoside antibiotics).
Simultaneous use of Baneocin ointment with diuretics such as ethacrynic acid or furosemide can increase the symptoms of kidney and hearing damage caused by them.
Baneocin ointment can increase muscle weakness if used together with anesthetics during surgery.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
When applied to extensive, open wounds or similar injuries, the active substances can act not only at the site of inflammation; they can also pass into the mother's body. In such cases, Baneocin ointment should be used only according to a doctor's prescription.
3. How to use Baneocin
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
This medicine is for external use only.
Adults and children
Baneocin ointment is applied in a thin layer to the treatment site, 2 to 3 times a day.
Do not exceed the dose of 200 g of Baneocin ointment for 7 days.
For repeated therapy, the maximum dose should be halved.
If you have used more than the required dose of Baneocin
If doses exceed strongly recommended, attention should be paid to symptoms of nephrotoxicity and/or ototoxicity due to possible resorption of the active substances (see Warnings and precautions ).
Please inform your doctor or pharmacist if large amounts of Baneocin have been administered.
If you forget to use Baneocin
Do not use a double dose to make up for a missed dose.
If you have stopped using Baneocin ointment
Even when the symptoms of your condition improve or disappear, continue to apply Baneocin ointment for the entire necessary treatment period, if one has been recommended to you by a doctor, to be sure that all disease-causing agents are destroyed and to avoid re-infection.
If you have any further questions related to 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.
Rare (may affect up to 1 in 1,000 people)
- Allergic reactions (symptoms may include: redness, dryness and peeling of the skin, skin rash, itching, lack of improvement in the condition or its worsening).
If you experience such symptoms, stop using this medicine and consult your doctor or pharmacist immediately.
During use on large areas of damaged skin, the passage of the active substances into the body may cause adverse drug reactions.
The following side effects have been reported for Baneocin ointment
Rare (may affect up to 1 in 1,000 people)
- If you are allergic to neomycin, in 50% of cases there will also be a cross-allergy to other aminoglycoside antibiotics.
Not known (frequency cannot be estimated from the available data)
- Compared to intact skin, sensitivity to many different substances, including neomycin, is increased, primarily when used in chronic dermatoses (eg, congestive dermatitis or chronic otitis media). Under certain conditions, the allergy can manifest itself even simply, as not affecting the condition.
- Vestibular nerve disorder, neuromuscular blockade
- Impaired hearing
- Allergic reactions such as redness, dry, scaly skin, skin rash and itching may occur with prolonged use.
- Spread of lesions or failure to respond to treatment
- Photosensitivity or phototoxicity reactions, when exposed to the sun or ultraviolet light
- Kidney disorder.
Reporting adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system to the Executive Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, phone: +35928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Baneocin
To be stored at a temperature below 25 ºС.
To be stored in the original packaging.
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Baneocin contains
- The active substances are bacitracin and neomycin. 1 g of ointment contains 250 IU of bacitracin zinc and 5000 IU of neomycin sulfate.
- The other substances are lanolin and white soft paraffin.
What Baneocin looks like and contents of the pack
Lubricant Tube of 5 g, 15 g or 20 g.
Not all types of packaging can be put on sale.
Marketing Authorization Holder :
Sandoz GmbH,
6250 Kundl,
Austria
Manufacturers:
Sandoz GmbH,
6250 Kundl,
Austria
and
Lek dd, Verovškova 57,
1526 Ljubljana,
Slovenia
Salutas Pharma GmbH,
Lange Goehren 3,
D-39171 Osterweddingen
Germany
Date of last revision of the leaflet:
MM/YYYY
