INDOCOLLIRIO 0.1% Eye drops, solution

Зміст інструкції

1. Indocollirio 1 mg/ml eye drops, solution
   1. What is Indocollirio and what is it used for
   2. What you need to know before using Indocollirio
   3. How to use Indocollirio
   4. Possible side effects
   5. How to store Indocollirio
   6. Contents of the pack and other information

Indocollirio 1 mg/ml eye drops, solution

Indometacin

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Indocollirio is and what it is used for
• 2. What you need to know before you use Indocollirio
• 3. How to use Indocollirio
• 4. Possible side effects
• 5. How to store Indocollirio
• 6. Contents of the pack and other information

1. What is Indocollirio and what is it used for

Indocollirio is an eye drop containing the active substance indometacin, which belongs to the group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used to relieve the symptoms of inflammatory, even painful, conditions not caused
by infection, affecting the outer part of the eye (anterior segment).
This eye drop is used in particular for cataract surgery.

2. What you need to know before using Indocollirio

Do not use Indocollirio

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

You should avoid wearing contact lenses during the use of the medicine.

Warnings and precautions
Consult your doctor or pharmacist before using Indocollirio.
Stop using the eye drops immediately and consult your doctor if you experience symptoms of
an allergic reaction.
Do not use for prolonged treatments.
The use, especially if prolonged, of products for local (topical) use can give rise to phenomena of
sensitization (excessive reaction of the body to foreign substances with which it has come into contact).
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 cause
an increased tendency to bleeding of ocular tissues during surgery.
Consult your doctor if you do not notice any improvement after a few days of treatment.
You should be careful and inform your doctor before using this eye drops, if:

• you have a predisposition to bleeding or if you are taking other medicines that may promote a tendency to bleeding (see also section “Other medicines and Indocollirio”);
• you have an eye infection, as this medicine may mask the infection and any possible worsening. The doctor will assess whether and which treatment to prescribe together with the use of the eye drops;
• you have undergone eye surgery in the past;
• you suffer from corneal denervation or other defects of the corneal epithelium or the surface of the eye (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 onset of even serious side effects, which may
entail risks to vision. For the same reason, it is important to inform your doctor, even if
you experience side effects following the use of the medicine.
Avoid the use of contact lenses during treatment.
If you have to use other eye drops, wait 15 minutes between instillations.
The product is for external use only and therefore must not be ingested.
In case of accidental ingestion, consult a doctor immediately; accidental ingestion may
determine toxic phenomena (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 use of this medicine 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 may take
any other medicine.
Although only a small amount of indometacin may pass into the bloodstream after
instillation into the eyes, it is advisable to consider the possible interactions observed with
NSAIDs taken systemically (orally, sublingually, rectally or by injection).
The following is a list of drugs for which it is advisable to consult your doctor before using
Indocollirio:

• oral anticoagulantsand heparinsfor increased risk of bleeding;
• other NSAIDs, including salicylatestaken at doses greater than 3 g/day, for increased risk of developing stomach and intestinal ulcers and bleeding; in particular Diflunisal, which can cause gastrointestinal bleeding with fatal outcome;
• lithium, for increased levels of the same, up to concentrations that may be toxic;
• methotrexate, used at doses of 15 mg/week or more, for increased levels of the same up to concentrations that may be toxic;
• ticlopidine, for increased risk of bleeding;
• diureticsand angiotensin converting enzyme inhibitors(ACE inhibitors), for reduced antihypertensive effect of these medicines and for the risk of acute renal failure, in dehydrated patients;
• pentoxifylline, for increased risk of bleeding;
• antacids, salts, oxides and hydroxides of magnesium, aluminum and calcium, because they can reduce the absorption of indometacin (the administration of any antacid should be spaced, if possible, more than 2 hours from the administration of indometacin);
• zidovudine, for increased risk of toxicity to red blood cells, with possible onset of severe anemia;
• beta-blockers, for reduced antihypertensive effect of these medicines;
• cyclosporine, for the risk of kidney damage, especially in the elderly;
• desmopressin, for increased diuretic activity of this medicine;
• intrauterine devices, for the risk of reduced efficacy of the same;
• thrombolytics, for increased risk of bleeding.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
The use of the medicine is contraindicated in the last trimester of pregnancy.
During the third trimester of pregnancy, all NSAIDs can expose the fetus to cardio–
pulmonary and renal toxicity. Furthermore, they can prolong bleeding time in the mother and child
in the final stage of pregnancy.
The use of eye drops during breastfeeding should be avoided.

Driving and operating machinery
The use of this eye drops may cause blurred vision or other visual problems after instillation.
In these cases, do not drive and do not use machinery until your vision returns to normal.

3. How to use Indocollirio

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
This medicine is for exclusive ophthalmic use. Do not drink or inject the medicine.
The doctor will establish the dose and duration of therapy most suitable for your case.
Do not exceed the recommended doses.
Information for correct use:
During instillation, avoid touching your eyes with the tip of the bottle or with the tip of the single-dose containers. This will help reduce the risk of infection.
Instill the eye drops into the eye, gently pulling down the lower eyelid.
Do not use this medicine while wearing contact lenses.

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

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

If you use more Indocollirio than you should
At the recommended doses and in case of correct use (instillation into the eye), no symptoms of
overdose are known.
In case of accidental ingestion, symptoms of toxicity may occur. If you have accidentally ingested
this medicine notify your doctor or go to the nearest hospital.

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

If you stop using Indocollirio
Do not stop taking the medicine before asking your doctor for advice.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may 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 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 tearing.

Occasionally, after instillation, burning may be felt, generally mild in intensity, or a
sensation of warmth, accompanied or not by hyperemia (redness) of the conjunctiva.
In rare cases, these eye drops may induce further inflammation and perforation of the membranes of the
ocular surface, especially in at-risk patients.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature above 25°C.
Store in the original packaging to protect the medicine from light.

5 ml bottle: the eye drops must not be used 15 days after the first opening of the bottle. The
excess solution must be discarded.

Single-dose container: the eye drops must be used only immediately after opening the
container. The single-dose container must not be reused once opened and the excess
solution must be discarded. After opening the aluminum pouch, the eye drops are stable for one
month.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Indocollirio contains

• The active substance is indometacin. 100 ml of eye drops contain 0.1 g of indometacin.
• 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 a dropper nozzle and screw cap;
• single-dose container of 0.35 ml, packaged in aluminum pouches, containing 20 single doses.

Marketing Authorisation Holder
Bausch & Lomb - IOM S.p.A. – Viale Martesana, 12 – 20090 – Vimodrone (MI), Italy.

Manufacturer
Laboratoire CHAUVIN - Aubenas, France