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Medrolgin eye drops 0.5%. 5 ml.

Product Code: Medrolgin eye drops 0.5%. 5 ml.
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What Medrolgin is and what it is used for
The name of your medicine is Medrolgin 0.5% eye drops, which is intended for use in the eye. As an active substance, it contains 5 mg / ml ketorolac trometamol, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used in adults to prevent and reduce inflammation and related symptoms after eye surgery.

2. What you need to know before you use Medrolgin
Do not use Medrolgin:
if you are allergic (hypersensitive) to ketorolac trometamol or any of the other ingredients of Medrolgin (listed in section 6);
if you are allergic to aspirin or other similar medicines.
Warnings and precautions
Talk to your doctor or pharmacist before using Medrolgin.

Medrolgin should be used with caution and after consulting a doctor if you have or have had a history of:

viral or bacterial eye infections;
tendency to bleed (eg anemia) or stomach ulcers;
rheumatoid arthritis;
dry eye syndrome; asthma after using NSAIDs;
recent eye surgery.
Medrolgin should not be prescribed to children.

Other medicines and Medrolgin
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you use other ophthalmic medicines with Medrolgin, the interval between administrations should be at least 5 minutes.

Pregnancy, lactation and fertility
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.

Medrolgin should not be used during pregnancy and breast-feeding unless your doctor tells you to.

Driving and using machines
Medrolgin may cause temporary blurred vision soon after administration. Do not drive or use machines until symptoms have resolved.

Medrolgin contains benzalkonium chloride
Benzalkonium chloride may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before use and wait at least 15 minutes before putting them back on. Benzalkonium chloride is known to discolor soft contact lenses.

3. How to use Medrolgin
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose is 1 drop in the affected eye (s) 3 times a day, starting 24 hours before surgery and lasting up to 3 weeks after eye surgery.
It is important to observe good hygiene when applying the drops. Do not allow the tip of the bottle to touch the eye, eyelids and surrounding surfaces, as it can become contaminated and this can lead to the development of an eye infection with serious consequences for the eye, even loss of vision. Always wash your hands before using the bottle!

Instructions for use
Medrolgin is instilled in each eye as follows:

1. Wash your hands before using the medicine. Tilt your head back and look at the ceiling.
2. Pull your lower eyelid down to form a small "pocket" between your eyelid and your eye.
3. Turn the bottle upside down and squeeze until one drop falls into the affected eye (s).
4. Relax your lower eyelid and close your eye (s) for 30 seconds.

If you do not hit your eye, try again. If you have dripped out of the eye, wipe with a clean cloth.
Close the bottle tightly immediately after use.
Use this bottle only for your eyes!

If you use more Medrolgin than you should
The use of higher doses is unlikely to lead to unwanted side effects. Rinse eye (s) with lukewarm water and consult your doctor.
In case of accidental ingestion of the contents of the bottle, drink more fluids and seek advice from your doctor or pharmacist.

If you forget to use Medrolgin
If you miss a dose, apply the drops as soon as you remember, unless it is time for the next dose, then continue to use them as before. Do not take a double dose to make up for a forgotten dose.

If you stop using Medrolgin
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

You should use Medrolgin for as long as your doctor prescribes it.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The likelihood of corneal (eye surface) side effects increases if Medrolgin is used for more than two weeks or if other topical steroid drops are used at the same time. You should consult your doctor immediately if you experience eye pain, irritation or changes in vision.

The following side effects have been reported with Medrolgin.

Very common side effects (may affect more than 1 in 10 people)
Irritation, stinging, burning sensation and eye pain.

Common side effects (may affect 1 to 10 in every 100 people)
Allergic reaction, swelling / puffiness of the eyes and / or eyelids, itching, redness, infection or inflammation of the eye, retinal haemorrhage, swelling of the central part of the retina (photosensitive area of ​​the eye), headache, accidental injury caused by the dropper tip eye contact, increased intraocular pressure, blurred and / or reduced vision.

Uncommon side effects (may affect 1 to 10 in every 1,000 patients)
Inflammation or damage to the anterior transparent layer of the eye, dry eyes and / or watery eyes.

Adverse reactions of unknown frequency (cannot be estimated from the available data)
Damage to the surface of the eye such as thinning, erosion, damage to the surface layer of the cornea, difficulty breathing or wheezing, worsening asthma.
5. How to store Medrolgin
Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle label. The expiry date refers to the last day of that month.

Shelf life after first opening the bottle: 4 weeks.
Store below 25 ° C.

When not using Medrolgin, keep the bottle in the outer carton in order to protect from light.
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 Medrolgin contains
The active substance in 1 ml solution is 5 mg ketorolactrometamol.
Excipients: octoxynol 40, edetate disodium, sodium chloride, benzalkonium chloride, sodium hydroxide or concentrated hydrochloric acid (for pH adjustment), water for injections.
What Medrolgin looks like and contents of the pack
Medrolgin eye drops is a clear, colorless to pale yellow liquid, free of visible particles.

It is packed in a white opaque 5 ml LDPE bottle with an LDPE dropper applicator. The bottle is closed with a white HDPE screw cap with a protective ring. The bottle is placed in a cardboard box.


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