Iridina Due* Eye Drops 10ml 0.5mg/ml - Montefarmaco

Iridina Due 0.5mg/ml eye drops, Naphazoline hydrochloride solution
Read this leaflet carefully before you use this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this sheet. You may need to read it again. If you would like more information or advice, please ask your pharmacist. If you get any side effects, talk to your doctor or pharmacist, including effects not listed in this leaflet. See section 4. Talk to your doctor if you do not feel better or if you feel worse after 4 days.
Contents of this sheet:
1. What is Iridina Due and what is it used for
2. What you need to know before using Iridina Due
3. How to use Iridina Due
4. Possible side effects
5. How to store Iridina Due
6. Package contents and other information
1. What is Iridina Due and what is it used for
Iridina Due contains the active ingredient naphazoline hydrochloride which belongs to a group of medicines called decongestants. Iridina Due eye drops are used for the treatment of irritation, burning, redness of the eye, with excessive tearing and sensitivity to light. Talk to your doctor if you do not feel better or if you feel worse after 4 days of treatment.
2. What you need to know before using Iridina Due
Do not use Iridina Due if you are allergic to naphazoline hydrochloride or other closely chemically related substances (in particular xylometazoline, oxymetazoline, tetrizoline) or to any of the other components of this medicine (listed in section 6); if you suffer from glaucoma (increased pressure inside the eye) or other eye diseases, in children under the age of twelve (see Children); if you are being treated with medicines for depression (called monoamine oxidase inhibitors) (see Other medicines and Iridine Due).
Warnings and precautions
Talk to your doctor or pharmacist before using Iridina Due if you suffer from: high blood pressure (hypertension), hyperthyroidism (excessive function of the thyroid gland), heart disease, diabetes (hyperglycemia), bronchial asthma. If symptoms persist or worsen after a short period of treatment, consult your doctor. Do not use the medicine for more than 4 consecutive days. Iridina Due is not suitable for the treatment of infections, pus, foreign bodies in the eye, mechanical, chemical and heat damage. These conditions require medical intervention. Be especially careful if you wear contact lenses (see Iridina Due contains benzalkonium chloride).
Children
Do not give this medicine to children under 12 years of age (see Do not use Iridina Due). Keep the medicine out of the reach and sight of children as accidental ingestion can cause serious side effects. In these cases, immediate medical intervention is always necessary (see also If you use more Iridina Due than you should).
Other medicines and Iridina Due
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Do not use Iridina Due if you are being treated with medicines against depression (called MAOIs, monoamine oxidase inhibitors) and in the two weeks following such treatment as severe hypertensive crises (increased blood pressure) may appear (see Do not use Iridina Due).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to have a baby, or are breast-feeding, ask your doctor or pharmacist for advice before using this medicine. During pregnancy and breastfeeding, use Iridina Due only if clearly necessary and under the direct supervision of your doctor.
Driving vehicles and using machinery
Iridina Due eye drops do not interfere with the ability to drive or use machines.
Iridina Due contains benzalkonium chloride
May cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reapplying them. The bleaching action on soft contact lenses is known.
3. How to use Iridina Due
Always use this medicine exactly as stated in this leaflet or as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist. The recommended dose is 1 or 2 drops, whenever you feel the burning sensation. Squeeze a drop or two of eye drops into the inside corner of each eye, tilting your head back.
Carefully follow the recommended doses. A higher dosage of Iridina Due, even for a short period of time, can cause serious side effects on the body (see If you use more Iridina Due than you should).
Warning: use the medicine only for short periods of treatment and do not exceed 4 consecutive days. Consult your doctor if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
Use in children
Iridina Due is contraindicated in children under 12 years of age.
If you use more Iridin Two than you should
To date, no overdose phenomena have been reported following the administration of Iridina Due. In case of overdose due to accidental ingestion or prolonged use, there may be manifestations of depression at the level of the central nervous system with phenomena of bradypnea (reduction in respiratory rate), sensation of cold skin, drowsiness, tachycardia (acceleration of the heartbeat) , sweating, mental confusion and coma. If this happens, gastric lavage, sedation with diazepam and general supportive measures will be necessary. In case of accidental ingestion/administration of an excessive dose of Iridina Due eye drops, contact your doctor immediately or go to the nearest hospital.
If you forget to use Iridina Due
Do not use a double dose to make up for a missed dose. If you have any further questions on 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. The use of the medicine can sometimes cause dilation of the pupils, general systemic effects on the body such as high blood pressure (hypertension), heart problems, excess sugar in the blood (hyperglycaemia), increased pressure inside the eye, nausea, headache. Rarely, hypersensitivity (allergy) phenomena may occur. In this case, stop treatment and consult your doctor. Compliance with the instructions contained in the leaflet reduces the risk of side effects. These side effects are generally transient. However, when they occur it is advisable to consult your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, including any not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Iridina Due
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 package. The expiry date refers to the last day of that month. The shelf life after first opening the bottle is 28 days. Keep the bottle in the original package to protect the medicine from light. Do not throw away any 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 Iridina Due contains
- The active ingredient is naphazoline hydrochloride. 10 ml of eye drops contain 5 mg of naphazoline hydrochloride.
- The other components are: sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide, sodium hyaluronate, benzalkonium chloride, distilled witch hazel water, distilled chamomile water, purified water. Description of the appearance of Iridina Due and contents of the pack Iridina Due comes in the form of eye drops, solution. The package contents are 1 bottle of 10 ml.
Marketing authorization holder MONTEFARMACO OTC SpA- Via IV Novembre, 92 - 20021 Bollate (MI) Manufacturer Farmigea SpA Via Giovan Battista Oliva, 8-56121 Pisa COC Farmaceutici Srl, Via Modena, 15 - 40019 Sant'Agata Bolognese (BO)