3 mg/ml eye drops, solution
tobramycin
What Tobrex Depot is and what it is used for
Tobrex Depot contains the active substance tobramycin and is an antibiotic.
Tobrex Depot is used to treat superficial bacterial infections of the eye in adults and children over 1 year of age.
Tobramycin contained in Tobrex Depot may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tobrex Depot
Do not use Tobrex Depot
- if you are allergic to tobramycin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Tobrex Depot.
- If you experience allergic reactions such as itchy eyelids, or swollen or red eyes while using Tobrex Depot, stop using the eye drops and consult your doctor. This allergic sensitivity can occur with other aminoglycoside antibiotics that are used topically or taken by mouth.
- If you are using another antibiotic treatment at the same time as Tobrex Depot, you should ask your doctor for advice.
- If you have or have ever had a disease that affects the muscles such as myasthenia gravis (a disease that causes muscle weakness) or Parkinson’s disease, consult your doctor. Antibiotics of this type can worsen muscle weakness.
- If your symptoms get worse or come back suddenly, consult your doctor. If you use Tobrex Depot for a long time, you may become more susceptible to eye infections.
- If you wear contact lenses: You should not use contact lenses (hard or soft) during the treatment of an eye infection.
Children
- Children under 1 year should not use Tobrex Depot.
Other medicines and Tobrex Depot
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Tobrex Depot can be used during pregnancy and breastfeeding.
Driving ability and use of machinery
If you experience temporary blurred vision or other visual disturbances after using Tobrex Depot, you should not drive or operate machinery until your vision has cleared.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Tobrex Depot contains benzododecinium bromide
If you wear contact lenses:
Take out your contact lenses (hard or soft) before using Tobrex Depot and wait at least 15 minutes before putting them back in.
Tobrex Depot contains a preservative (benzododecinium bromide) which can irritate the eyes and has been found to discolor soft contact lenses. Avoid contact with soft contact lenses.
However, you should not use contact lenses (hard or soft) during the treatment of an eye infection.
How to use Tobrex Depot
Always use this medicine as directed by your doctor or pharmacist.
Ask your doctor or pharmacist if you are unsure.
The recommended dose is
Adults including the elderly
The usual dosage is 1 drop in the infected eye(s) 2 times daily – morning and evening. Do not use Tobrex Depot in both eyes unless your doctor has prescribed it.
Use Tobrex Depot only as eye drops.
How to use Tobrex Depot correctly:
Remove the loose collar from the cap when opening the bottle for the first time. Keep the bottle tightly closed when not in use.
- Take out the bottle of Tobrex Depot.
- Wash your hands and sit in front of a mirror.
- Twist off the bottle cap.
- Hold the bottle with the tip down between your thumb and middle finger (picture 1).
- Tilt your head back. Pull down the lower eyelid with a clean finger until a “pocket” is formed between the lower eyelid and the eye. This is where the drop should be placed.
- Bring the dropper tip of the bottle to the eye. Use a mirror if it helps.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the dropper tip. It can contaminate the eye drops in the bottle.
- Do not squeeze the bottle: it is designed so that light pressure on the bottom is sufficient (picture 2).
- Gently press the bottom of the bottle to release one drop of Tobrex Depot at a time (picture 3).
- After using Tobrex Depot, close the eye and gently press with a finger in the corner of the eye near the nose for 2 minutes (picture 4).
- If you are using Tobrex Depot in both eyes, repeat steps 5-9 for the other eye.
- Screw the bottle cap tightly immediately after use.
- Use only one bottle at a time.
If a drop misses the eye, try again.
If you use other eye medicines in the form of drops or ointments, you must wait at least 5 minutes between each medicine. Eye ointments should be used last.
Children
Tobrex Depot can be used for children 1 year and older.
If you have used too much Tobrex Depot
Rinse the eye with lukewarm water. Do not take any more drops until it is time for your next dose.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Tobrex Depot
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
If you stop using Tobrex Depot
Do not stop using this medicine prematurely, even if your symptoms have disappeared. If you stop using this medicine too soon, the symptoms may come back.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affects up to 1 in 10 users):
Effects in the eyes: eye discomfort, itchy eyes, red eyes, increased tear production.
Uncommon (may affect up to 1 in 100 users):
Effects on the eyes: inflammation of the surface of the eye, damage to the cornea, visual impairment, blurred vision, red eyelids, swollen eyes and eyelids, eye pain, dry eyes, watery eyes, and eye allergy.
General side effects: allergy (hypersensitivity), headache, hives, skin inflammation, reduced growth or fewer number of eyelash hairs, loss of skin pigment, itching, and dry skin.
Frequency not known (cannot be estimated from available data):
Effects in the eyes: eye irritation, itchy eyelids.
General side effects: skin rash.
How Tobrex Depot should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after “EXP”. The expiration date is the last day of the specified month.
Discard the bottle 4 weeks after opening.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tobramycin. One ml of solution contains 3 mg tobramycin.
- Other ingredients are xanthan gum, benzododecinium bromide, mannitol, trometamol, boric acid, polysorbate 80, sulfuric acid, and/or sodium hydroxide, and purified water.
Appearance and package sizes of the medicine
Tobrex Depot is a clear and colorless solution supplied in a 5 ml plastic bottle (DROPTAINER) with a screw cap.
Marketing Authorisation Holder:
Manufacturer
Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
Siegfried El Masnou, SA
Camille Fabra 58
El Masnou 08320
Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain