Patient leaflet - TOBRAMYCIN 3 MG / ML + DEXAMETHASONE 1 MG / ML EYE DROPS SUSPENSION
1. what this product is and what it is used for
This product contains dexamethasone, which has an anti-inflammatory effect. this product also contains tobramycin, which is an antibiotic effective against several bacteria that may cause eye infections.
This product 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 THIS PRODUCT
Do not use this product:
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 your 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 this product.
- 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 this product, discontinue use and consult your doctor. This allergic sensitivity may occur with other topical or systemic antibiotics 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
- Contact your doctor if you experience blurred vision or other visual disturbances.
- Talk to your doctor if you experience swelling and weight gain around the trunk and in the face as these are usually the first manifestations of a syndrome called Cushing’s syndrome. Suppression of the adrenal gland function may develop after stopping a long-term or intensive treatment with this product. Talk to your doctor before stopping the treatment by yourself. These risks are especially important in children and patients treated with a drug called ritonavir or cobicistat.
- Talk to your doctor if you have a neuromuscular disorder such as myasthenia gravis or Parkinson’s disease. This medicine may aggravate muscle weakness.
- If you are using other antibiotic treatments, including oral treatments, with this product, ask your doctor for advice.
- If you are using nonsteroidal anti-inflammatory (NSAIDs) eye preparations with this product, 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 this product 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 this product to children below 2 years old because the safety and efficacy in this population has not been established.
Other medicines and this product
Tell your doctor or pharmacist if you are using, 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.
Tell your doctor if you are using ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood.
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 this product or not.
Driving and using machines
If you experience temporary blurred vision after using this product you should wait until these symptoms are cleared before driving and using machines.
This product contains benzalkonium chloride
This medicine contains 0.1mg benzalkonium chloride in each ml which is equivalent to 0.5mg/5ml bottle. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
3. how to use this product
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
This product may 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:
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1. Shake the bottle well.
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2. Remove protective cap.
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3. Tilt your head back and look at the ceiling.
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4. Gently pull the lower eyelid down until there is a small pocket.
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5. Squeeze the upturned dropper bottle to release a drop into your eye.
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6. 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 this product than you should
A topical overdose of this product may be flushed from the eye(s) with lukewarm tap water.
If you forget to use this product
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 this product
Your doctor will tell you when to stop using this product.
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, this product 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.
Hormone problems: growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in your body, stunted growth in children and teenagers and swelling and weight gain of the body and face (called ‘Cushing’s syndrome') (see section 2, “Warnings and precautions”).
General side effects: allergy (hypersensitivity), dizziness, nausea, abdominal discomfort, rash, swelling of the face, itching.
If this product is 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store this product
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 this product contains
- 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 this product looks like and contents of the pack
A plastic bottle containing 5 ml of a milky white suspension.
Marketing Authorisation Holder
Blumont Pharma Ltd
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23 Moortown Close