Indocollire 0,1%

Leaflet attached to the packaging: information for the user

Indocollyre 0.1%

1 mg/ml, eye drops, solution

Indometacin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
See section 4.
Table of contents of the leaflet:

• 1. What is Indocollyre 0.1% and what is it used for
• 2. Important information before using Indocollyre 0.1%
• 3. How to use Indocollyre 0.1%
• 4. Possible side effects
• 5. How to store Indocollyre 0.1%
• 6. Contents of the packaging and other information

1. What is Indocollyre 0.1% and what is it used for

This medicine is called Indocollyre 0.1% and contains the active substance indomethacin, a substance from the group of non-steroidal anti-inflammatory drugs. The medicine has strong local anti-inflammatory and analgesic effects.
The medicine is intended for use during surgical procedures and post-operatively to:

• prevent miosis (constriction of the pupil),
• as an anti-inflammatory agent after cataract surgery and surgery on the anterior segment of the eye,
• to treat pain after photorefractive keratectomy in the first days after surgery.

2. Important information before using Indocollyre 0.1%

When not to use Indocollyre 0.1%:

If the patient is allergic to indomethacin or any of the other ingredients of this medicine (listed in section 6).
If the patient is allergic to non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (aspirin).
If the patient has had an asthma attack caused by taking aspirin or other non-steroidal anti-inflammatory drugs in the past.
If the patient has active gastric or duodenal ulcer disease.
If the patient has severe liver or kidney function disorders.
Do not use from the sixth month of pregnancy.
Do not use at the same time as:

• oral anticoagulant medicines
• other non-steroidal anti-inflammatory drugs (including salicylates in a dose equal to or greater than 3 g per day)
• diflunisal
• heparin
• lithium
• methotrexate in high doses
• ticlopidine

For additional information, see the section: Indocollyre 0.1% and other medicines

Warnings and precautions

Before starting to use Indocollyre 0.1%, you should discuss it with your doctor, pharmacist, or nurse.

• If the patient is allergic to the medicine. In such a case, the use of Indocollyre 0.1% should be discontinued. The doctor will then order diagnostic tests for the eye; The medicine may cause cross-sensitivity reactions to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• The medicine may mask the typical symptoms of eye infection. If there is a risk of eye infection, the doctor will use appropriate treatment;
• Non-steroidal anti-inflammatory drugs may delay the healing of the cornea;
• If the patient has or has had a tendency to bleed or is taking medicines that reduce blood clotting, NSAIDs may increase the risk of bleeding from eye tissues during surgical procedures in these patients;
• If the patient is using local corticosteroids (e.g., hydrocortisone), as they may cause side effects;
• If the patient has eye problems (e.g., dry eye syndrome, corneal disorders);
• If the patient has diabetes;
• If the patient has rheumatoid arthritis;
• If the patient has undergone repeated eye surgeries in a short period;
• If the patient wears contact lenses. It is not recommended to use contact lenses during treatment with this medicine;
• In the case of treatment with other eye medicines, a 15-minute interval should be maintained between the administration of individual medicines.
• The tip of the dropper bottle should not be allowed to touch the eye.

You should consult a doctor, even if the above warnings concern situations that occurred in the past.

Children and adolescents

The use of the medicine in children is not recommended, as its safety and efficacy in this age group have not been studied.

Indocollyre 0.1% and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In the case of administration of the medicine to the eye, the amount of indomethacin penetrating into the general circulation is small, but nevertheless, interactions with non-steroidal anti-inflammatory drugs administered systemically may occur.
Particular caution should be exercised when using eye drops containing indomethacin with corticosteroids.
It is not recommended to use Indocollyre 0.1% eye drops with the following medicines:

• oral anticoagulant medicines (medicines used to reduce blood clotting)
• other non-steroidal anti-inflammatory drugs (including aspirin, starting from a dose of 3 g per day in adults)
• diflunisal (a medicine used to treat arthritis)
• heparin (a medicine that reduces blood clotting)
• lithium (a medicine used to treat certain types of depression)
• methotrexate (in a dose of 15 mg per week or more) (a medicine used to treat rheumatoid arthritis and psoriasis)
• ticlopidine (a medicine that reduces blood clotting)

Caution should be exercised in patients taking:

• diuretics
• angiotensin-converting enzyme inhibitors (medicines used to treat high blood pressure)
• methotrexate (in a dose less than 15 mg per week) (a medicine used to treat rheumatoid arthritis and psoriasis)
• pentoxifylline (a medicine used to treat certain circulation disorders)
• zidovudine (a medicine used to treat HIV infection)
• antacids (salts, oxides, hydroxides of magnesium, aluminum, and calcium)
• cyclosporin (a medicine used to prevent transplant rejection)
• desmopressin (a medicine used to treat nocturnal enuresis)
• beta-blockers (medicines used to treat high blood pressure, heart disease, hyperthyroidism, migraine, or high eye pressure)

Non-steroidal anti-inflammatory drugs may reduce the effectiveness of intrauterine contraceptives.
When used with thrombolytics (medicines used to dissolve blood clots), there is an increased risk of bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
The medicine can be used in women from 1 to 5 months of pregnancy, only if the doctor considers it absolutely necessary.
Do not use from the sixth month of pregnancy.
There are no data on the penetration of indomethacin into breast milk after administration to the eye. Indomethacin administered systemically penetrates into breast milk. The medicine should not be used in breastfeeding women. The doctor will decide whether the patient should stop breastfeeding or stop using this product, considering the benefits of treatment for the mother and the risk to the child.
NSAIDs may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment. The effect of indomethacin in the form of eye drops on fertility has not been studied.

Driving and using machines

There is a risk of transient vision disturbances immediately after administration of the medicine, so you should wait until the disturbances have completely disappeared before driving or operating machines.

Indocollyre 0.1% contains thiomersal

The medicine may cause allergic reactions. In case of an allergic reaction, you should immediately stop using Indocollyre 0.1%.

3. How to use Indocollyre 0.1%

This medicine should always be used as directed by your doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist.
Recommended dose:
To prevent miosis during surgical procedures: 4 drops on the day before the procedure, 4 drops within 3 hours before the procedure.
Prevention of inflammation caused by cataract surgery and surgery on the anterior segment of the eye: 1 drop 4 to 6 times a day, until the inflammation symptoms have completely disappeared.
Administration of the medicine should be started 24 hours before the surgical procedure.
Treatment of eye pain as a result of photorefractive keratectomy in the first days after surgery:
1 drop 4 times a day in the first days after surgery.
Instructions for administration of the medicine:

• 1. Wash your hands thoroughly.
• 2. Unscrew the protective cap from the bottle.
• 3. Hold the bottle upside down with your thumb and index finger.
• 4. Tilt your head back.
• 5. Gently pull down the lower eyelid with your index finger to create a "pocket" between the eye and the eyelid, into which the medicine will be instilled.
• 6. Bring the tip of the bottle close to the eye without touching the dropper to the eye, eyelid, or surrounding areas.
• 7. To release a single drop of the medicine, gently squeeze the bottle walls.
• 8. Looking up, insert 1 drop of the medicine into the eye. If this is not successful, repeat the action.
• 9. Close your eye and press the inner corner of your eye at the base of your nose for 1 minute. This will help minimize the risk of the medicine entering the entire body.
• 10. If drops are to be administered to both eyes, repeat the above steps for the second eye.
• 11. Immediately after use, replace the protective cap and carefully close the bottle.

Having someone else help you with the instillation or using a mirror may make it easier to administer the medicine.
Indocollyre 0.1% eye drops are sterile. To avoid contamination, do not touch the tip of the dropper with your fingers or touch it to the surface of the eye or any other surface.
Using contaminated drops may lead to serious eye damage, including vision loss.
If you feel that the effect of Indocollyre 0.1% is too strong or too weak, you should consult a doctor.

Using a higher dose of Indocollyre 0.1% than recommended

In case of using a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Indocollyre 0.1%

You should not take a double dose to make up for a missed dose. In case of missing a dose, you should wait until the next dose is due.

Stopping the use of Indocollyre 0.1%

In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare(may affect up to 1 in 1000 people): allergic reactions.
Unknown(frequency cannot be estimated from the available data):

• inflammation, ulceration, or perforation of the membrane on the surface of the eye (cornea), especially in patients with its damage
• transient burning of the eye, stinging in the eye
• vision disturbances
• increased sensitivity to light
• damage to the corneal epithelium (e.g., corneal abrasion, punctate keratitis)
• increased intraocular pressure
• eye discomfort
• eyelid edema
• corneal edema (the outer, transparent part of the eye)
• eye edema
• eye pain
• eye irritation
• redness of the eye
• conjunctival redness
• conjunctivitis
• increased tearing
• thrombocytopenia (decreased platelet count)
• asthma
• redness and itching of the skin
• edema.

In some patients, during the use of Indocollyre 0.1%, other side effects may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Indocollyre 0.1%

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the specified month.
After the first opening of the bottle, the medicine remains stable for 15 days.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Indocollyre 0.1% contain

The active substance of the medicine is indomethacin. 1 ml of the solution contains 1 mg of indomethacin.
The other ingredients are: thiomersal, arginine, hydroxypropyl-beta-cyclodextrin, hydrochloric acid 1 M, purified water, nitrogen.

What Indocollyre 0.1% looks like and what the pack contains

A bottle containing 5 ml of eye drops, with a dropper, closed with a cap, in a cardboard box.

Marketing authorization holder

BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
customerservice.pharma.poland@bausch.com

Manufacturer:

Laboratoire Chauvin
Z.I. Ripotier Haut
07200 Aubenas
France
Dr. Gerhard Mann
chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin, Germany

Date of last revision of the leaflet: