MAXITROL

Poland

The information provided does not contain an indication for the use of the drug; it only specifies that it is an ophthalmic ointment.

Brand name MAXITROL

Dosage form ointment, for eyes

Active substance / Dosage

dexamethasone · 1 mg/g

neomycin · 3500 j.m./g

polymyxin b · 6000 j.m./g

Prescription type Prescription only

ATC code

S01CA01

Registration number 100472330

Manufacturer Novartis Pharma NV

Frequently asked questions

How to use Maxitrol?

The medicine should be administered directly into the eye.

How long can the ointment be used after opening the package?

The product must be discarded 4 weeks after the first opening of the tube.

Under what conditions should the medicine be stored?

The package should be stored tightly closed at a temperature not exceeding 25°C. Do not store the medicine in a refrigerator.

Where is the best place to keep the medicine to ensure it is safe?

It should be stored in a place that is out of sight and out of reach of children.

Instructions for use

Table of contents

2. COMPOSITION OF ACTIVE SUBSTANCE
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGE
5. METHOD AND ROUTE OF ADMINISTRATION
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
9. STORAGE INSTRUCTIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
12. MARKETING AUTHORISATION NUMBERS
13. LOT NUMBER
14. GENERAL CATEGORY OF AVAILABILITY
17. UNIQUE IDENTIFIER – 2D CODE
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
19. OTHER INFORMATION

INFORMATION DISPLAYED ON OUTER PACKAGING
LABEL FOR THE CARDBOARD BOX

1. NAME OF THE MEDICINAL PRODUCT

Maxitrol, (1 mg + 3500 i.u. + 6000 i.u.)/g, ophthalmic ointment
Dexamethasone + Neomycin sulfate + Polymyxin B sulfate

2. COMPOSITION OF ACTIVE SUBSTANCE

1 g of ointment contains 1 mg of dexamethasone, 3500 i.u. of neomycin sulfate and 6000 i.u. of polymyxin B sulfate.

3. LIST OF EXCIPIENTS

Excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), anhydrous liquid lanolin, white vaseline.

4. PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGE

Sterile ophthalmic ointment
3.5 g GTIN number: 5909991493998

5. METHOD AND ROUTE OF ADMINISTRATION

Ophthalmic administration.
Read the instruction leaflet before using the medicine.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

8. EXPIRY DATE

Expiry date - EXP
Discard 4 weeks after first opening the tube.

9. STORAGE INSTRUCTIONS

Do not store above 25°C. Do not store in the refrigerator.
Keep the container tightly closed.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVING FROM IT, IF
APPLICABLE

11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY

Responsible entity in Belgium, country of export:
Novartis Pharma NV
Medialaan 40, B-1800 Vilvoorde, Belgium

12. MARKETING AUTHORISATION NUMBERS

Marketing authorisation number in Belgium, country of export: BE092145
Parallel import authorisation number: 311/22

13. LOT NUMBER

Lot number - Lot

14. GENERAL CATEGORY OF AVAILABILITY

Rp - Medicinal product subject to medical prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE
Maxitrol ointment

17. UNIQUE IDENTIFIER – 2D CODE

Includes a 2D code serving as the carrier of the unique identifier.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

PC: 05909991493998
SN:
NN:

19. OTHER INFORMATION

Manufacturer:
Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
SA ALCON-COUVREUR NV, Rijksweg 14, B-2870 Puurs, Belgium
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Approved: 17.09.2025

Similar drugs

Brand name	Dosage form	Active substance / Dosage	Manufacturer
DEXAMYTREX	ointment, for eyes	gentamicin sulfate · 5 mg dexamethasone · 0.3 mg	Bausch+Lomb Ireland Ltd.
DEXAMYTREX	ointment, for eyes	gentamicin sulfate · 5 mg/g dexamethasone · 0.3 mg/g	Bausch Health Ireland Limited
MAXITROL	ointment, for eyes	dexamethasone · 1 mg/g neomycin · 3500 j.m./g polymyxin b · 6000 j.m./g	Novartis Pharma S.A.S.
MAXITROL	ointment, for eyes	dexamethasone · 1 mg/g neomycin · 3500 j.m./g polymyxin b · 6000 j.m./g	Novartis Pharma S.A.S.
MAXITROL	ointment, for eyes	dexamethasone · 1 mg/g neomycin · 3500 j.m./g polymyxin b · 6000 j.m./g	Novartis s.r.o.
MAXITROL	ointment, for eyes	dexamethasone · 1 mg/g neomycin · 3500 j.m./g polymyxin b · 6000 j.m./g	Novartis Pharma S.A.S.
MAXITROL	ointment, for eyes	dexamethasone · 1 mg neomycin · 3500 j.m. polymyxin b · 6000 j.m.	Novartis Pharma NV
MAXITROL	ointment, for eyes	dexamethasone · 1 mg/g neomycin · 3500 j.m./g polymyxin b · 6000 j.m./g	Novartis Croatia d.o.o.
MAXITROL	ointment, for eyes	dexamethasone · 1 mg/g neomycin · 3500 j.m./g polymyxin b · 6000 j.m./g	Novartis Pharma S.A.S.
MAXITROL	ointment, for eyes	dexamethasone · 1 mg/g neomycin · 3500 j.m./g polymyxin b · 6000 j.m./g	Novartis Pharma S.A.S.
MAXITROL	ointment, for eyes	dexamethasone · 1 mg/g neomycin · 3500 j.m./g polymyxin b · 6000 j.m./g	Novartis Croatia d.o.o.

The original data is available in the language of the country of manufacture.

Data source: Register of Medicinal Products of Poland (URPL)

Data last verified: September 01, 2026