Tobramycin/Dexamethasone Tubilux Pharma

Package Leaflet: Information for the patient

Tobramycin/DexamethasoneTubilux Pharma 3 mg/ml + 1 mg/ml eye drops, suspension
Tobramycin/Dexamethasone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Tobramycin/Dexamethasone Tubilux Pharma is and what it is used for

What you need to know before you use Tobramycin/Dexamethasone Tubilux Pharma

How to use Tobramycin/Dexamethasone Tubilux Pharma

Possible side effects

How to store Tobramycin/Dexamethasone Tubilux Pharma

Contents of the pack and other information

1. What Tobramycin/Dexamethasone Tubilux Pharma is and what it is used for

Tobramycin/Dexamethasone Tubilux Pharma contains dexamethasone, which has an anti-inflammatory effect. Tobramycin/Dexamethasone Tubilux Pharma also contains tobramycin, which is an antibiotic effective against several bacteria that may cause eye infections.

Tobramycin/Dexamethasone Tubilux Pharma is used to prevent and treat eye inflammations and prevent bacterial infections after cataract surgery in adults and children aged 2 years and older.

2. What you need to know before you use Tobramycin/Dexamethasone Tubilux Pharma

Do not use Tobramycin/Dexamethasone Tubilux Pharma:

If you are allergic (hypersensitive) to tobramycin, dexamethasone or any of the other ingredients of the eye drops (listed in section 6).
If you have or think you might have an infection of the eye
If you have a sticky discharge from you eye
If you have a red eye that has not been seen by a doctor

Warnings and precautions

Talk to your doctor or pharmacist before using Tobramycin/Dexamethasone Tubilux Pharma.

If you have a disease that might cause thinning of eye tissue, such as rheumatoid arthritis, Fuch’s dystrophy or after transplantation of the cornea, you should inform your doctor. Corticosteroids may cause further thinning and possible perforation

If you experience allergic reactions such as eyelid itching, swelling or, redness of the eye with Tobramycin/Dexamethasone Tubilux Pharma, discontinue use and consult your doctor. This allergic sensitivity may occur with other topical or systemic antibiotic of aminoglycoside type.

If your symptoms get worse or suddenly return, please consult your doctor. You may become more susceptible to eye infections with the use of this product.

If you are diabetic please consult your doctor. The risk of corticosteroid-induced increase intraocular pressure and/or cataract formation is increased in diabetic patients

If you are using other antibiotic treatment, including oral, with Tobramycin/Dexamethasone Tubilux Pharma, ask your doctor for advice.

If you are using nonsteroidal anti-inflammatory (NSAIDs) eye preparations with Tobramycin/Dexamethasone Tubilux Pharma, ask your doctor for advice. Concomitant use of eye preparations that contain nonsteroidal anti-inflammatory (NSAIDs) and eye preparations that contain steroids may increase the potential for healing problems.

If you use Tobramycin/Dexamethasone Tubilux Pharma for a long period of time you may become more susceptible to eye infections, have increased pressure in your eye(s) or develop cataracts.

Intraocular pressure should be checked frequently, this is especially important in children below 6 years of age receiving dexamethasone-containing products.

If you wear soft contact lenses, remove them before using this medicine and wait at least 15 minutes before reinsertion. This product contains benzalkonium chloride as preservative which may cause eye irritation and discolour soft contact lenses.

Contact lens wear is not recommended during treatment of an ocular infection or inflammation.

Children

Do not give Tobramycin/Dexamethasone Tubilux Pharma to children below 2 years old because the safety and efficacy in this population has not been established.

Other medicines and Tobramycin/Dexamethasone Tubilux Pharma

Tell your doctor or pharmacist if you areusing, have recently used or might use any other medicines.

Concomitant use of eye preparations that contain nonsteroidal anti-inflammatory (NSAIDs) and eye preparations that contain steroids may increase the potential for healing problems.

If you are using other eye drops or eye ointments, wait at least 5 minutes between using each one. Eye ointments should be administered last.

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 for advice before taking this medicine. Your doctor will tell you whether you can use Tobramycin/Dexamethasone Tubiluxor not.

Driving and using machines

If you experience temporary blurred vision after using Tobramycin/Dexamethasone Tubilux Pharma you should wait until these symptoms are cleared before driving and using machines.

Tobramycin/Dexamethasone Tubilux Pharma contains benzalkonium chloride

This product contains benzalkonium chloride as preservative which may cause eye irritation. Avoid contact with soft contact lenses, as they may be discolored. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

3. How to use Tobramycin/Dexamethasone Tubilux Pharma

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

The recommended dose is:

One drop in the eye(s) every 4 to 6 hours, while you are awake. During the first 48 hours, your doctor may increase the dose to one drop every two hours, while you are awake.

Do not use more than 24 days.

Use in children and adolescents

Tobramycin/Dexamethasone Tubilux Pharmamay be used in children 2 years of age and older at the same dose as in adults.

Always wash your hands before applying eye drops.

Apply your eye drops in the following way:

Shake the bottle well.

Remove protective cap.

Tilt your head back and look at the ceiling.

Gently pull the lower eyelid down until there is a small pocket.

Squeeze the upturned dropper bottle to release a drop into your eye.

Whilst keeping the affected eye closed, press your finger against the corner of the closed eye (the side where the eye meets the nose) and hold for 1 minute.

Avoid touching the dropper tip against your eye or anything else.

Replace and tighten the cap straight after use.

If you take more Tobramycin/Dexamethasone Tubilux Pharma than you should

A topical overdose of Tobramycin/Dexamethasone Tubilux Pharmamay be flushed from the eye(s) with lukewarm tap water.

If you forget to use Tobramycin/Dexamethasone Tubilux Pharma

If you forget to take a dose, apply it as soon as you remember. If, however, it is almost time for your next dose, you should omit the missed dose altogether and then follow your normal routine.

If you stop using Tobramycin/Dexamethasone Tubilux Pharma

Your doctor will tell you when to stop using Tobramycin/Dexamethasone Tubilux Pharma.

Inform your doctor if you need to interrupt the treatment.

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

4. Possible side effects

Like all medicines, Tobramycin/Dexamethasone Tubilux Pharma can cause side effects, although not everybody gets them.

The following side effects have been seen

Uncommon side effects

(may affect up to 1 in 100 people)

Effects in the eye: increased pressure in your eye(s), eyelid redness, eyelid swelling, eye irritation, eye pain, eye itching, watery eyes, eye discomfort.

General side effects: headache, runny nose, tightness of the throat.

Rare side effects

(may affect up to 1 in 1000 people)

Effects in the eye:redness, blurred vision, dry eye, eye allergy, eye surface inflammation.

General side effects: bad taste

Not known

(frequency cannot be estimated from available data)

Effects in the eye: increase in pupil size, eyelid redness, increased tear production, eye surface inflammation.

General side effects: allergy (hypersensitivity), dizziness, nausea, abdominal discomfort, rash, swelling of the face, itching.

If Tobramycin/Dexamethasone Tubilux Pharmais used for more than 24 days, it may cause you to get an infection and the healing of your wound may also be delayed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tobramycin/Dexamethasone Tubilux Pharma

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

Do not use the bottle if the tamper-proof seal on the bottle is broken before first use.

Do not use this medicine after the expiry date which is stated on the bottle label and on the carton. Discard the bottle 28 days after opening, even if there is solution remaining.

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.

6. Contents of the pack and other information

What Tobramycin/Dexamethasone Tubilux Pharmacontains

The active substances are tobramycin and dexamethasone
1 ml solution contains 3 mg tobramycin and 1 mg dexamethasone.
The other ingredients are benzalkonium chloride as a preservative, disodium edetate, hydroxyethylcellulose, purified water, sodium chloride, sodium sulphate, sulphuric acid and/or sodium hydroxide, tyloxapol.

What Tobramycin/Dexamethasone Tubilux Pharma looks like and contents of the pack

A plastic bottle containing 5 ml of a milky white suspension.

Marketing Authorisation Holder

[to be completed nationally]

Manufacturer

Tubilux Pharma S.p.A.

Via Costarica 20/22

00071 Pomezia (RM)

Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

Italy

Tobramicina DesametasoneBausch & Lomb 3 mg/ml + 1 mg/ml collirio, sospensione

Sweden

Tobramycin/Dexamethasone Tubilux Pharma, 3 mg/ml + 1 mg/ml ögondroppar, suspension

Belgium

DETOBRA 3 mg/ml + 1 mg/ml collyre en suspension

DETOBRA 3 mg/ml + 1 mg/ml oogdruppels, suspensie

DETOBRA 3 mg/ml + 1 mg/ml Augentropfen, Suspension

Luxemburg

DETOBRA 3 mg/ml + 1 mg/ml collyre en suspension

DETOBRA 3 mg/ml + 1 mg/ml oogdruppels, suspensie

DETOBRA 3 mg/ml + 1 mg/ml Augentropfen, Suspension

This leaflet was last revised in 2016-07-06