Package leaflet: Information for the patient

Indocollirio 1 mg/ml eye drops, solution

Indometacin
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Indocollirio is and what it is used for
What you need to know before using Indocollirio
How to use Indocollirio
Possible side effects
How to store Indocollirio
Contents of the pack and other information

1. What Indocollirio is and what it is used for

Indocollirio is an eye drop containing the active substance indometacina, which belongs to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used to relieve symptoms of inflammatory conditions, even those associated with pain, affecting the outer part of the eye (anterior segment), when not caused by infection.
This eye drop is particularly used in cataract surgery.

2. What you need to know before using Indocollirio

Do not use Indocollirio

if you are allergic to the active substance, to other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (aspirin), or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced asthma attacks after taking other NSAIDs or aspirin;
if you suffer from stomach ulcer (active peptic ulcer);
if you have severe liver or kidney disease (severe hepatocellular dysfunction, severe impairment of renal function);
in children under 3 years of age;
during the last trimester of pregnancy or if you are breastfeeding (see section Pregnancy and breastfeeding).

You should avoid wearing contact lenses while using this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using Indocollirio.
Stop using the eye drops immediately and consult your doctor if symptoms of an allergic reaction occur.
Do not use for prolonged treatments.
The use, especially if prolonged, of topically applied products may lead to sensitization (excessive reaction of the body to foreign substances it has come into contact with).
Cross-sensitization reactions with other medicines such as other non-steroidal anti-inflammatory drugs or aspirin are also possible. NSAIDs may delay corneal healing and increase the tendency to bleeding of ocular tissues during surgical procedures.
Consult your doctor if you do not notice improvement after several days of treatment.
You should be cautious and inform your doctor before using this eye drop if:

you have a tendency to bleed or are taking other medicines that may increase the risk of bleeding (see also section “Other medicines and Indocollirio”);
you currently have an eye infection, since this medicine may mask the infection and any possible worsening. Your doctor will assess whether and which treatment should be prescribed alongside the eye drop;
you have previously undergone eye surgery;
you suffer from corneal denervation or other defects of the corneal epithelium or ocular surface (such as dry eye syndrome);
you suffer from diabetes mellitus;
you suffer from rheumatoid arthritis.

If any of the above conditions apply to you, it is important to consult your doctor before taking this medicine to avoid the occurrence of even serious adverse effects, which may pose risks to vision. For the same reason, it is important to inform your doctor if you experience any adverse effects after using the medicine.
Avoid wearing contact lenses during treatment.
If you are using other eye drops, wait 15 minutes between each instillation.
This product is for external use only and must not be ingested.
In case of accidental ingestion, consult a doctor immediately; accidental ingestion may cause toxic effects (see also section “If you use more Indocollirio than you should”).
Indocollirio contains thiomersal.
This medicine contains thiomersal, which may cause allergic reactions.
Children and adolescents
Do not use in children under 3 years of age. The use of this medicine in children is not recommended, as the safety of its use in the pediatric population has not been established.
Other medicines and Indocollirio
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Although only a small amount of indometacin may enter the bloodstream after eye instillation, possible interactions observed with systemically administered NSAIDs (oral, sublingual, rectal, or injectable) should be taken into consideration.
Below is a list of medicines for which you should consult your doctor before using Indocollirio:

oral anticoagulants and heparins due to increased risk of bleeding;
other NSAIDs, including salicylates taken at doses exceeding 3 g/day, due to increased risk of developing stomach and intestinal ulcers and bleeding; in particular, diflunisal, which may cause gastrointestinal bleeding with fatal outcome;
lithium, due to increased levels up to potentially toxic concentrations;
methotrexate, when used at doses of 15 mg/week or more, due to increased levels up to potentially toxic concentrations;
ticlopidine, due to increased risk of bleeding;
diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors), due to reduced antihypertensive effect of these medicines and risk of acute renal failure in dehydrated patients;
pentoxifylline, due to increased risk of bleeding;
antacids, salts, oxides, and hydroxides of magnesium, aluminium, and calcium, as they may reduce indometacin absorption (administration of any antacid should be spaced by more than 2 hours, if possible, from indometacin intake);
zidovudine, due to increased risk of toxicity affecting red blood cells, potentially leading to severe anaemia;
beta-blockers, due to reduced antihypertensive effect of these medicines;
cyclosporine, due to risk of kidney damage, especially in elderly patients;
desmopressin, due to increased anti-diuretic activity of this medicine;
intrauterine devices, due to risk of reduced effectiveness;
thrombolytics, due to increased risk of bleeding.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use of this medicine is contraindicated during the last trimester of pregnancy.
During the third trimester of pregnancy, all NSAIDs may expose the fetus to cardiopulmonary and renal toxicity. Moreover, they may prolong bleeding time in both mother and child towards the end of pregnancy.
You should avoid using the eye drops during breastfeeding.
Driving and use of machines
This eye drop may cause blurred vision or other visual disturbances after instillation.
In such cases, do not drive or operate machinery until your vision has cleared.

3. How to use Indocollirio

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is for ophthalmic use only. Do not drink or inject the medicine.
Your doctor will determine the most appropriate dose and duration of treatment for your condition.
Do not exceed the recommended doses.

Instructions for correct use:
When instilling the drops, avoid touching the eyes with the tip of the bottle or the tip of the single-dose
containers. This will help reduce the risk of infections.
Instill the eye drops into the eye by gently pulling down the lower eyelid.
Do not use this medicine while wearing contact lenses.

5 ml bottle:
Do not use the bottle more than 15 days after first opening.

Single-dose containers:
Single-dose containers must be discarded immediately after use and must not be
kept open for subsequent applications. Any remaining solution should be discarded.

If you use more Indocollirio than you should
At the recommended doses and when used correctly (instillation into the eye), symptoms of overdose are not known.
In case of accidental ingestion, symptoms of toxicity may occur. If you have accidentally ingested
this medicine, inform your doctor or go to the nearest hospital immediately.

If you forget to use Indocollirio
Do not use a double dose to make up for a forgotten dose.

If you stop using Indocollirio
Do not stop using the medicine without first consulting your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects include:

Rare (may affect up to 1 in 1,000 people)

photophobia (discomfort caused by light);
punctate keratitis (inflammation of the cornea).

Not known (frequency cannot be estimated from the available data)

conjunctival hyperemia and ocular hyperemia (redness of the eye);
corneal edema (fluid accumulation in the cornea);
corneal perforation;
eyelid edema (swelling of the eyelids due to fluid accumulation);
keratitis (inflammation of the cornea);
increased lacrimation.

Occasionally, after instillation, a burning sensation, usually mild, or a feeling of warmth may occur, with or without conjunctival hyperemia (eye redness).
In rare cases, these eye drops may induce further inflammation and perforation of the ocular surface membranes, especially in at-risk patients.
Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Indocollirio

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect the medicine from light.
5 ml bottle: the eye drops must not be used more than 15 days after first opening the bottle. Any
remaining solution must be discarded.
Single-dose container: the eye drops must be used immediately after opening the container. The
single-dose container must not be reused once opened, and any remaining solution must be
discarded. After opening the aluminium pouch, the eye drops remain stable for one month.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date
refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Indocollirio contains

The active substance is indometacina. 100 ml of eye drops contain 0.1 g of indometacine.
The other components of the 5 ml bottle are: hydroxypropyl- -cyclodextrin, arginine, hydrochloric acid, thiomersal, purified water.
The other components of the single-dose container are: hydroxypropyl- -cyclodextrin, arginine, hydrochloric acid, purified water.

Description of the appearance of Indocollirio and contents of the pack
Indocollirio is presented as a solution in:

1 bottle of 5 ml with dropper nozzle and screw cap;
single-dose container of 0.35 ml, packaged in aluminum sachets containing 20 single doses.

Marketing Authorization Holder
Bausch & Lomb - IOM S.p.A. – Viale Martesana, 12 – 20090 – Vimodrone (MI), Italy.
Manufacturer
Laboratoire CHAUVIN - Aubenas, France