3mg/ml + 1 mg/ml eye drops , suspension
tobramycin/dexamethasone
What Toflacort is and what it is used for
Toflacort contains dexamethasone, which has an anti-inflammatory effect. Toflacort also contains tobramycin, an antibiotic that works against several bacteria that can cause infection in the eye.
Toflacort is used to prevent and treat eye inflammation and to prevent bacterial infection in the eye after cataract surgery in adults and children aged 2 years and older.
Tobramycin and dexamethasone found in Toflacort may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Toflacort
Do not use Toflacort
If you are allergic (hypersensitive) to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6).
- If you have or think you have any type of infection in the eye.
- If you have sticky discharge from the eye.
- If you have red eyes that have not been examined by a doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Toflacort.
- If you have a disease that causes thinning of eye tissue, such as rheumatoid arthritis, Fuchs’ dystrophy, or after a corneal transplant, you should inform your doctor. Corticosteroids can lead to further thinning and possible holes in the eyeball.
- If you get allergic reactions, e.g. itching of the eyelids or swollen and red eyes when using Toflacort, stop using the eye drops and consult a doctor. This allergic sensitivity can occur with other local or systemic antibiotics of the aminoglycoside type.
- If your symptoms get worse or come back suddenly, you should consult a doctor. You may become more susceptible to eye infections when using this product.
- If you have diabetes, consult a doctor. The risk of increased pressure in the eye and/or the development of cataracts due to corticosteroids increases in diabetics.
- Contact a doctor if you experience blurred vision or other visual disturbances.
- Talk to your doctor if you develop swelling and weight gain around the trunk and face, as these are usually the first signs of a syndrome called Cushing’s syndrome. The inhibited adrenal function may develop after the end of long-term treatment or intensive treatment with Toflacort. These risks are especially important for children and patients treated with a medicine called ritonavir or cobicistat. Therefore, talk to your doctor before ending the treatment yourself.
- If you have or have ever had a disease such as myasthenia gravis or Parkinson’s disease, consult your doctor. Antibiotics of this type can worsen muscle weakness.
- If you use other antibiotics, including those taken by mouth, at the same time as Toflacort, you should consult a doctor.
- If you use non-steroidal anti-inflammatory ( NSAID ) eye medicines at the same time as Toflacort, you should consult a doctor. Concomitant use of eye medicines containing non-steroidal anti-inflammatory substances ( NSAIDs ) and eye medicines containing steroids can increase the risk of healing problems.
- If you use Toflacort for a long time, you may become more sensitive to eye infections, have increased pressure in the eye(s), or develop cataracts.
- The pressure in the eye ( intraocular pressure) should be checked at regular intervals. This is especially important for children under the age of 6 who are treated with products containing dexamethasone.
- If you wear soft contact lenses, take them out before using this medicine. Then wait at least 15 minutes before inserting them again. This product contains the preservative benzalkonium chloride which can cause eye irritation and discolor soft contact lenses. The use of contact lenses is not recommended during the treatment of an eye infection or eye inflammation.
Children
Do not give Toflacort to children under 2 years of age as efficacy and safety have not been established in this group.
Other medicines and Toflacort
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of ophthalmic drugs containing non-steroidal anti-inflammatory NSAIDs and ophthalmic drugs containing steroids may increase the risk of healing problems.
If you use other eye drops or eye ointments, you must wait at least 5 minutes between the administration of the different medicines. Eye ointments should be used last.
Tell your doctor if you are using ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood.
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. Your doctor will tell you whether you can use Toflacort or not.
Driving ability and use of machinery
If you experience temporary blurred vision after using Toflacort, wait until these symptoms subside before driving or operating machinery.
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 your doctor or pharmacist if you are unsure.
Toflacort contains benzalkonium chloride
This medicine contains 0.1 mg benzalkonium chloride per ml corresponding to 0.5 mg/5 ml volume. Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before putting them back in. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you feel irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
How to use Toflacort
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
One drop in the eye(s) every 4 to 6 hours during the waking part of the day. During the first 48 hours, your doctor may increase the dose by one to one drop every two hours during the waking part of the day.
Do not use it longer than 24 days.
Use for children
Toflacort can be used in children 2 years of age and older at the same dose as for adults.
Always wash your hands before taking the drops.
Take the drops as follows:
- Shake the bottle well.
- Remove the screw cap.
- Tilt your head back and look up at the ceiling.
- Gently pull down the lower eyelid to form a pocket.
- Press the upside-down bottle to release a drop into your eye.
- Keep the affected eye closed while pressing your finger to the corner of the eye (where the eye meets the nose) and hold for 1 minute.
Avoid touching the dropper tip to your eye or anything else.
Screw the cap on the bottle tightly immediately after use.
If you have used too much Toflacort
A local overdose of Toflacort can be rinsed out of the eye(s) with lukewarm tap water.
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 take Toflacort
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, however, you should skip the missed dose entirely and then follow your normal routine.
If you stop taking Toflacort
Your doctor will tell you when to stop taking Toflacort. Tell your doctor if you need to stop treatment.
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.
The following side effects have been seen
Less common side effects are
(may affect up to 1 in 100 users)
Effects in the eye: increased pressure in the eye (s), redness of the eyelid, swollen eyelid, eye irritation, eye pain, eye itching, watery eyes, and eye discomfort.
General side effects: headache, runny nose, the feeling of tightness in the throat.
Rare side effects ar
(may affect up to 1 in 1,000 users)
Effects in the eye: redness, blurred vision, dry eyes, eye allergy, inflammation of the surface of the eye.
General side effects: bad taste in the mouth.
Has been reported
(occurs in an unknown number of users)
Effects in the eye: increased pupil size, redness of the eyelids, increased tear production, inflammation of the surface of the eye.
Hormonal problems: extra hair growth on the body (especially in women), muscle weakness and atrophy, purple stretch marks in the skin, high blood pressure, irregular or no menstruation, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain on the body and in the face (called Cushing’s syndrome, see section 2 “Warnings and precautions”).
General side effects: allergy (hypersensitivity), dizziness, nausea, stomach discomfort, rash, facial swelling, and itching.
Using tobramycin/dexamethasone for more than 24 days may cause you to get an infection and wound healing may also be slower.
How Toflacort should be stored
Keep this medicine out of the sight and reach of children.
Do not use this medicine if the bottle’s safety seal is broken before first use.
Use before the expiry date stated on the label on the bottle and the carton.
Throw away the bottle 28 days after opening, even if there is a solution left.
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 substances are tobramycin and dexamethasone
- 1 ml suspension contains 3 mg tobramycin and 1 mg dexamethasone.
- Other ingredients are the preservative benzalkonium chloride, disodium edetate, hydroxyethyl cellulose, purified water, sodium chloride, sodium sulfate, sulfuric acid and/or sodium hydroxide, and tyloxapol.
Appearance and package sizes of the medicine
A plastic bottle containing 5 ml milky white suspension.
Marketing Authorisation Holder
Blumont Ofta Trading Ltd
103 Stuart Street
Gzira GZR1054,
Malta
Manufacturer
Tubilux Pharma SpA
Via Costarica 20/22
00071 Pomezia (Rome)
Italy
This medicine is approved in the European Economic Area under the names:
Italy
Tobramicina Desametasone Bausch & Lomb 3 mg/ml + 1 mg/ml collirio, sospensione
Sweden
Toflacort
Belgium
DETOBRA 1 mg/ml + 3 mg/ml collyre a suspension
DEBRA 1 mg/ml + 3 mg/ml eye drops, suspension
DETOBRA 1 mg/ml + 3 mg/ml Augentropfen, Suspension
Luxembourg
DETOBRA 1 mg/ml + 3 mg/ml collyre a suspension
DETOBRA 1 mg/ml + 3 mg/ml eye drops, suspension
DETOBRA 1 mg/ml + 3 mg/ml Augentropfen, Suspension