Bimixin

Package leaflet: Information for the patient

BIMIXIN 25,000 IU + 2,500 IU tablets

neomycin sulfate + bacitracin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BIMIXIN is and what it is used for
2. What you need to know before taking BIMIXIN
3. How to take BIMIXIN
4. Possible side effects
5. How to store BIMIXIN
6. Contents of the pack and other information

1. What BIMIXIN is and what it is used for

BIMIXIN contains two antibiotic active substances, neomycin sulfate and bacitracin, used to fight bacteria.
This medicinal product is indicated for the treatment of bacterial intestinal infections.

2. What you need to know before taking BIMIXIN

Do not use BIMIXIN

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have kidney disease (renal insufficiency);
• if you suffer from muscle weakness (myasthenic syndromes);
• if you have problems absorbing food (malabsorption);
• if you have intestinal disorders (intestinal obstruction, even partial);
• if you are taking certain medicines that may be harmful to the kidneys, such as antibiotics: kanamycin, streptomycin, gentamicin, polymyxin, viomycin, colistin and cephalosporins (see section “Other medicines and BIMIXIN”);
• in children under two years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BIMIXIN:

• if you have liver problems (hepatic lesions, even mild ones), as this may cause accumulation of the medicine;
• if you have ototoxicity or a family history of ototoxicity (harmful effects on the ear), with signs and symptoms including ringing in the ears, imbalance (associated with dizziness, nausea and blurred vision), decreased hearing, or hearing loss;
• if you know (or suspect) that you have a mitochondrial disease (mutations in parts of your cells that help produce energy). These diseases may increase your risk of hearing loss when taking this product.

During treatment with this medicine, your doctor may wish to monitor your kidney function and hearing to promptly detect any signs of toxicity.
Children
This medicine is contraindicated in children under two years of age.
Other medicines and BIMIXIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor or pharmacist if you are taking or have recently taken any of the following medicines:

• medicines that may be harmful to the ear (ototoxic medicines);
• anticoagulant medicines (used to reduce blood clotting);
• medicines used to relax muscles (neuromuscular blocking agents);
• medicines for nausea and vomiting (antiemetics) or for motion sickness (anti-vertigo medicines), as these may mask signs of ear toxicity;
• medicines that may be toxic to the kidneys, such as the following antibiotics: kanamycin, streptomycin, gentamicin, polymyxin, viomycin, colistin and cephalosporins. Concomitant use with BIMIXIN must be avoided: see section “Do not use BIMIXIN”;
• highly active diuretics (medicines used to increase urine production); combining these with BIMIXIN may increase harmful effects on the kidneys or hearing (effects on the auditory nerve), therefore this combination must be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
In such cases, the medicine should only be used if strictly necessary and under medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
BIMIXIN contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take BIMIXIN

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose best suited for treating your condition.

Adults
1-2 tablets every 6-8 hours.

Use in children
In children over two years of age: 1 tablet every 6-8 hours.

Duration of treatment
Treatment should not be prolonged beyond 3-5 days.
The breakline on the tablet is not intended for splitting the tablet.

If you take more BIMIXIN than you should
If you take a dose of this medicine higher than prescribed, contact your doctor immediately or go to the nearest hospital. Take this leaflet with you.
Very high doses of this medicine can cause kidney and ear damage (see section “Possible side effects”).

If you forget to take BIMIXIN
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most common side effects are:

• nausea, vomiting and constipation.

Side effects that may occur with prolonged or repeated use of this medicine are:

• malabsorption problems (malabsorption) with diarrhoea, pale and strongly odorous stools due to high fat content (steatorrhoea);
• kidney toxicity problems: or altered urine test results such as decreased urine output (oliguria), increased albumin (albuminuria), presence of cylindrical formations (cylindruria), presence of blood (haematuria), or increased blood urea levels (hyperazotemia);
• ear toxicity problems (dizziness, ringing in the ears, hearing loss).

Side effects reported in rare cases:

• allergic reactions with various types and locations of skin changes.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BIMIXIN

Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BIMIXIN contains
BIMIXIN 25,000 I.U. + 2,500 I.U. tablets

• The active substances are neomycin sulfate and bacitracin. Each tablet contains 25,000 I.U. of neomycin sulfate and 2,500 I.U. of bacitracin.
• The other components are lactose, maize starch, potato starch, hydrated colloidal silica, talc, stearic acid.

Description of the appearance of BIMIXIN and contents of the pack
BIMIXIN 25,000 I.U. + 2,500 I.U. tablets are presented in a cardboard box containing a
glass bottle with 16 tablets.
Marketing Authorization Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
Sanofi Aventis S.A.
Ctra. C35 La Batlloria a Hostalric, km 63.09
17404 Riells I Viabrea, Girona - Spain