Indom

Package leaflet: Information for the user

Indom 5 mg/ml eye drops, suspension

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 other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Indom is and what it is used for

This medicinal product contains the active substance indometacin, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving the symptoms of inflammation.
Indom is an eye drop solution used to treat inflammatory conditions, even those associated with pain, affecting the front part of the eye (anterior segment), when not caused by infection. It is particularly used in cataract surgery.

2. What you need to know before using Indom

Do not use Indom

• if you are allergic to indometacin or to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced breathing difficulties due to bronchial constriction (bronchospasm) after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). Avoid using this medicine if you wear contact lenses.

Warnings and precautions
Talk to your doctor or pharmacist before using Indom.
The use, especially if prolonged, of topically applied medicines may cause allergic reactions (sensitization reactions). In such cases, discontinue treatment and consult your doctor.
The use of topical non-steroidal anti-inflammatory drugs (NSAIDs) may cause corneal inflammation (keratitis).
In at-risk patients, continued use of topical NSAIDs may lead to defects in the tissue covering the corneal surface, corneal thinning, corneal damage, corneal ulcers, or corneal perforation. These effects may pose a risk to vision.
If you have peptic ulcer, a condition characterized by lesions in the stomach and intestine, use this medicine with particular caution.
If you have a tendency to bleeding or are taking other medicines that may increase the risk of bleeding (see also section “Other medicines and Indom”), take care and inform your doctor before using this eye drop.
After opening the multidose bottle, avoid contact between the dropper tip and fingers, the eye surface, or other surfaces.
The single-dose container does not contain preservatives; therefore, after use, discard the container even if there is residual medicine left.

Children
The safety of this medicine in children has not been established.

Other medicines and Indom
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
This medicine may alter the ocular effect of epinephrine, a substance that contributes to lowering intraocular pressure. Therefore, if you are also using epinephrine-containing eye drops, intraocular pressure should be monitored to ensure desired levels are maintained.
Although only a small amount of indometacin may pass into the bloodstream after ocular instillation, possible interactions observed with systemically administered NSAIDs (oral, sublingual, rectal, or injectable) should be taken into consideration.
The following are some medicines for which you should consult your doctor before using Indom:

• oral anticoagulants, due to increased risk of bleeding;
• other NSAIDs, including salicylates taken at doses exceeding 3 g/day, due to increased risk of developing gastric and intestinal ulcers and bleeding.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if clearly needed and under direct medical supervision.

Driving and using machines
This medicine may cause dizziness, vertigo, and headache (cephalalgia), which may impair your ability to drive or operate machinery.

Indom in 7 ml bottle contains benzalkonium chloride
This medicine, in the “7 ml bottle” pack, contains 0.1 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.

Indom contains phosphates
This medicine contains 5.7 mg of phosphate buffer per 1 ml. If you have severe damage to the outer transparent layer of the eye (the cornea), phosphates may very rarely cause corneal opacities due to calcium deposits during treatment.

3. How to use Indom

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose to use and the duration of treatment with this medicine.
Shake the bottle well before using this medicine.
If you wear contact lenses, remove them before applying the eye drops from the 7 ml bottle; you may reinsert them after 15 minutes.
If you use more Indom than you should
The amount of active substance contained in each bottle is not toxic. However, in case of accidental ingestion/overdose of Indom, inform your doctor immediately or go to the nearest hospital.
If you forget to use Indom
Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The use of this medicine may cause the following side effects:
Frequency not known (frequency cannot be estimated from the available data):

• redness and burning of the tissue covering the front of the eye and the inner surface of the eyelids (conjunctiva);
• changes in the corneal tissue (corneal epithelium);
• increased intraocular pressure;
• swelling of the eyelid or cornea due to fluid accumulation (eyelid or corneal edema);
• inflammation of the cornea (striate keratitis);
• itching.

In rare cases, this eye drop may induce further inflammation and perforation of the membranes on the ocular surface, especially in at-risk patients.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Indom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Keep the container tightly closed to protect the medicine from light.
7 ml bottle: once the multidose bottle has been opened, use the medicine within 28 days from opening.
0.5 ml single-dose container: discard the single-dose container after use, even if there is residual medicine left.
Do not dispose of any medicine 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 Indom contains
Indom 5 mg/ml eye drops, suspension - 7 ml bottle

• The active substance is indometacin. 100 ml of eye drops contain 500 mg of indometacin.
• The other components are: hydroxyethylcellulose; sodium dihydrogen phosphate dihydrate; disodium hydrogen phosphate dodecahydrate; sodium chloride; disodium edetate; tyloxapol; benzalkonium chloride; purified water.

Indom 5 mg/ml eye drops, suspension - 0.5 ml single-dose containers

• The active substance is indometacin. 100 ml of eye drops contain 500 mg of indometacin.
• The other components are: hypromellose; sodium dihydrogen phosphate dihydrate; disodium hydrogen phosphate dodecahydrate; sodium chloride; disodium edetate; purified water.

Description of the appearance of Indom and contents of the pack
Pack containing 30 single-dose containers made of polyethylene, each with a volume of 0.5 ml.
Pack containing 1 multidose 7 ml bottle made of polyethylene, with dropper and cap equipped with a tamper-evident seal.

Marketing Authorisation Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera, 26
80026 Casoria (NA)
Italy
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