1. What TOBREX eye drops are and what
TOBREX eye drops are used for is a group of medicines called anti-inflammatory drugs. The anti-inflammatory group includes antibiotics (tobramycin in this case), which are effective against a wide range of microorganisms that can infect the eye (s).
TOBREX eye drops is intended for the treatment of external bacterial infections of the eye (s) and its structures caused by bacteria sensitive to tobramycin in adults and children over 1 year.
2. What you need to know before using TOBREX eye drops
Do not use TOBREX eye drops:
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 eye drops.
• If you get allergic reactions when using TOBREX eye drops, stop using and consult your doctor. Allergic reactions can range from localized itching or redness of the skin to severe allergic reactions (anaphylactic reaction) or severe skin reactions. Such allergic reactions may also occur with the use of other topical or systemic antibiotics of the same group (aminoglycosides).
• Talk to your doctor if you are taking another antibiotic treatment at the same time as TOBREX eye drops.
• Talk to your doctor if you have or have had conditions such as myasthenia gravis or Parkinson's disease. Antibiotics of this type can aggravate muscle weakness.
• If your symptoms worsen or suddenly return, please consult your doctor. If you use TOBREX eye drops for a long time, you may become more susceptible to eye infections.
Other medicines and TOBREX eye drops
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 or pharmacist for advice before taking this medicine. During pregnancy TOBREX eye drops should be used only if really necessary. TOBREX eye drops are not recommended during breastfeeding.
Driving and using machines
Short-term blurred vision may occur immediately after applying TOBREX eye drops. Do not drive or use machines until your vision is clear.
TOBREX eye drops contain benzalkonium chloride
Wearing contact lenses is not recommended during the treatment of an eye infection.
This medicine contains 0.1 mg benzalkonium chloride in each ml.
Benzalkonium chloride can be absorbed by soft contact lenses and may change the color of the lenses. You must remove contact lenses before using this medicine and wait at least 15 minutes before putting them back on.
Benzalkonium chloride can also cause eye irritation, especially if you have a 'dry eye' or a corneal disorder (the clear layer in the front of the eye). If you have an unusual feeling in your eye, such as burning or pain in your eye after taking this medicine, talk to your doctor.
3. How to use TOBREX eye drops
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
After removing the bottle cap, if the protective ring is loose, remove it before using the product.
Use TOBREX eye drops only for your eyes.
The recommended dose (for adults and children over 1 year of age) is:
In mild to moderate conditions, the usual dose is one or two drops in the affected eye (s) every four hours.
In severe disease, the usual dose is one or two drops in the affected eye (s) every hour until improvement is seen; reduce the frequency of administration before stopping treatment.
The usual duration of treatment is 7-10 days. The duration of treatment is at the discretion of your doctor.
3. How to use TOBREX eye drops
1. Take the bottle of TOBREX eye drops and mirror.
2. Wash your hands.
3. Unscrew the cap.
4. Hold the bottle facing down between your thumb and middle finger (Figure 1).
5. Tilt your head back. Dissolve the eyelid, with the finger already cleaned, so that a 'pocket' forms between it and the eye. The drop should fall exactly in this place (figure 2).
6. Move the dropper applicator closer to the bottle. Use the mirror if this makes it easier for you.
7. Do not touch the eye, eyelid, surrounding area or other surfaces with the tip of the dropper applicator. There is a risk of contamination of the drops.
8. Gently press the base of the upside-down bottle with your index finger to release one drop of TOBREX (Figure 3),
9. After applying TOBREX eye drops, release the lower eyelid, close the eye and gently press with your finger in the corner of the eye, near the nose (Figure 4). This will prevent TOBREX eye drops from moving to other parts of the body.
10. If you need to use the drops for both eyes, repeat the steps for the other eye.
11. Replace the cap and close the bottle tightly immediately after use.
12. Use only the same bottle.
If you are using other eye medicines (drops or ointment), wait 5 minutes between applying them. Eye ointment should be applied last.
If the drop does not get into the eye, try again.
If you apply more TOBREX eye drops than necessary , rinse the entire eye / eyes with lukewarm water. No side effects are expected. Do not put more drops until it is time for your next regular dose.
If you forget to apply TOBREX eye drops, continue with the next dose as planned. However, if it is time for your next dose, skip the missed dose and return to your usual dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been seen with the use of TOBREX eye drops:
Common side effects (may affect 1 to 10 users in 100):
• Eye-related effects: eye discomfort, redness of the eye
Uncommon side effects (may affect 1 to 10 users in 1,000):
* Eye-related effects: inflammation of the eye surface, corneal damage, visual disturbances, blurred vision, redness of the eyelid, swelling of the eye and eyelid, pain in the eye, dry eye, eye discharge, eye itching, increased tearing
• Effects related to the whole body: allergy (hypersensitivity), headache, urticaria, skin inflammation, reduced growth or number of eyelashes, loss of skin pigmentation, itching , dry skin
Uncommon reactions (cannot be estimated from the available data):
• Eye effects: eye allergy, eye irritation, eyelid itching
• Body effects: rash, severe allergic reaction, severe skin reaction ( Stevens-Johnson syndrome, erythema multiforme)
5. How to store TOBREX eye drops
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
The bottle should be discarded 4 weeks after first opening to avoid possible infections.
Store below 25 ° C.
Store in a tightly closed container.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and additional information
What TOBREX eye drops contain
The active substance is: tobramycin. One ml of solution contains 3 mg tobramycin.
The other ingredients are: boric acid (E284), anhydrous sodium sulphate (E514), sodium chloride, tyloxapol, benzalkonium chloride and purified water. Small amounts of sodium hydroxide and / or sulfuric acid are added to maintain normal acid levels (pH levels).
What TOBREX eye drops look like and contents of the pack
TOBREX is a liquid (clear, colorless to pale yellow or pale brown solution) and is supplied in a pack containing a 5 ml plastic bottle with a screw cap with a protective ring.