Oftalmolosa Cusi gentamicin 3 mg/g ophthalmic ointment

Spain
Brand name Oftalmolosa Cusi gentamicin 3 mg/g ophthalmic ointment
Form ointment, ophthalmic
Active substance / Dosage
GENTAMICIN SULFATE · 5 mg
Prescription type Prescription Only Medicine
ATC code
S01A S01AA S01AA11
Registration number 52662
Manufacturer Ntc S.R.L.
Oftalmolosa Cusi gentamicin 3 mg/g ophthalmic ointment ointment, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OFTALMOLOSA CUSÍ GENTAMICIN 3 mg/g eye ointment

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

  1. What OFTALMOLOSA CUSÍ GENTAMICIN is and what it is used for
  2. What you need to know before using OFTALMOLOSA CUSÍ GENTAMICIN
  3. How to use OFTALMOLOSA CUSÍ GENTAMICIN
  4. Possible side effects
  5. Storage of OFTALMOLOSA CUSÍ GENTAMICIN
  6. Contents of the pack and other information

1. What OFTALMOLOSA CUSÍ GENTAMICIN is and what it is used for

OFTALMOLOSA CUSÍ GENTAMICIN is an ophthalmic ointment containing an antibiotic from the aminoglycoside group, gentamicin, which acts against microorganisms causing infections in the eyes.

Antibiotics are used to treat bacterial infections and are not effective in treating viral infections.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines by flushing them down the sink or drain, or by throwing them in the household waste.

This medicine is used to treat external bacterial infections of the eye caused by germs sensitive to gentamicin, such as conjunctivitis, keratitis (inflammation of the cornea), corneal ulcers, blepharitis (inflammation of the eyelids), and dacryocystitis (inflammation of the tear sac).

2. What you need to know before starting to use OFTALMOLOSA CUSÍ GENTAMICINA

Do not use OFTALMOLOSA CUSÍ GENTAMICINA

  • If you are allergic to gentamicin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use OFTALMOLOSA CUSÍ GENTAMICINA.

  • Use this medicine only in your eye(s).

  • If you develop symptoms of an allergic reaction such as eyelid itching, swelling or redness of the eye, stop treatment immediately and consult your doctor. Allergic reactions may range from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. These allergic reactions may occur with other topical or systemic antibiotics of the same family group (aminoglycosides).

  • If your symptoms worsen or reappear, consult your doctor.

  • If you are simultaneously using another antibiotic treatment, even if taken orally, consult your doctor.

  • If you use this medicine for a long period of time, you may become more susceptible to ocular infections.

  • If you wear contact lenses:

  • Wearing contact lenses (rigid or soft) is not recommended during treatment for an eye infection.

Use of OFTALMOLOSA CUSÍ GENTAMICINA with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess whether or not you should use this medicine.

Driving and using machines

Immediately after applying this medicine, you may notice blurred vision. Do not drive or operate machinery until your vision is clear.

3. How to use OFTALMOLOSA CUSÍ GENTAMICINA

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults (including elderly patients), adolescents, and children:

Generally, apply 1 cm of ointment approximately two or three times a day.

The number of daily applications and the duration of treatment may be adjusted according to medical judgment.

Usage recommendations:

  • Take the tube.
  • Wash your hands and position yourself in front of a mirror.
  • If the application is inside the eye, pull down the eyelid with a clean finger. Apply the ointment into the pouch formed between the eyelid and the eye.
  • If the application is outside the eye, apply the ointment directly to the affected area, first removing any crusts by softening them with warm water.
  • Place the tip of the tube close to the eye. Use the mirror if needed.
  • Avoid touching the eyes, eyelids, surrounding areas, or other surfaces with the tip of the tube.
  • Gently press the tube so that the ointment comes out.
  • Close the eye(s) for a few seconds after applying the ointment.
  • Close the tube tightly after use.

If you are using other eye medications, wait at least 5 minutes between applying this ointment and the other eye medications. Ophthalmic ointments should be administered last.

If you use more OFTALMOLOSA CUSÍ GENTAMICINA than you should, you can remove it by washing your eyes with lukewarm water. Do not apply more ointment until your next scheduled dose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used.

If you forget to use OFTALMOLOSA CUSÍ GENTAMICINA, apply a single dose as soon as you remember, and then continue with your next scheduled dose. However, if it is almost time for your next dose, do not apply the missed dose and continue with your next dose according to your regular schedule. Do not apply a double dose to make up for the missed doses.

If you stop treatment with OFTALMOLOSA CUSÍ GENTAMICINA

It is important that you complete the full course of treatment prescribed by your doctor, even if you start feeling better after a few days. If you stop using this medication too early, the infection may not be completely cured, symptoms may return or even worsen. Additionally, antibiotic resistance (loss of effectiveness) could develop.

If you have any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most frequently observed adverse effects with this medicine were eye itching, eye discomfort, and eye redness.

The following adverse effects have been observed with this medicine:

Frequent adverse effects (may affect up to 1 in 10 people)

  • Eye effects: light sensitivity, eye itching, eye discomfort, eye redness.
  • General effects: allergy (hypersensitivity).

Uncommon adverse effects (may affect up to 1 in 100 people)

  • Eye effects: inflammation of the surface of the eye, blurred vision, dry eye.

In general, you may continue using the ointment unless the effects are severe. If you are concerned, discuss this with your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of OFTALMOLOSA CUSÍ GENTAMICIN

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

To prevent infection, discard the tube 4 weeks after first opening.

Record the date of first opening in the space provided for this purpose on the carton.

Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of OFTALMOLOSA CUSÍ GENTAMICIN

  • The active substance is gentamicin. Each gram of ointment contains 3 mg of gentamicin (as sulfate).
  • The other components are cholesterol, liquid paraffin, and white petrolatum.

Appearance of the product and contents of the container

OFTALMOLOSA CUSÍ GENTAMICIN is an ointment (white) presented in an aluminum tube containing 5 g, with a polyethylene cap.

Marketing Authorization Holder

NTC s.r.l.,

via Luigi Razza 3,

20124 Milan, Italy

Manufacturer

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

NTC Ophthalmics Iberica SL,

Calle Pinar, 5,

28006 Madrid, Spain

Date of the most recent revision of this leaflet: July 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/