IRIDINA 0.5 MG/ML Krople do oczu, roztwór

Treść ulotki

1. Iridina Due 0.5 mg/ml eye drops, solution
   1. What is Iridina Due and what is it used for
   2. What you need to know before you use Iridina Due
   3. How to use Iridina Due
   4. Possible side effects
   5. How to store Iridina Due
   6. Contents of the pack and other information
   7. What is Iridina Due and what is it used for
   8. What you need to know before you use Iridina Due
   9. How to use Iridina Due
   10. Possible side effects
   11. How to store Iridina Due
   12. Contents of the pack and other information

Iridina Due 0.5 mg/ml eye drops, solution

Nafazoline hydrochloride

Read this leaflet carefully before using this medicine as 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 leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after 4 days.

Contents of this leaflet:

• 1. What Iridina Due is and what it is 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. Contents of the pack 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.
See 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 you use Iridina Due

Do not use Iridina Due

• if you are allergic to naphazoline hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from glaucoma (increased internal eye pressure) or other eye diseases;
• in children under ten years of age (see “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using Iridina Due if you suffer from:

• high blood pressure (hypertension),
• hyperthyroidism (excessive thyroid gland function),
• heart disease,
• diabetes (hyperglycemia).

If symptoms should persist or worsen after a short period of treatment, consult your doctor. Do not
use the medicine for more than 4 consecutive days.
If you notice the appearance of undesirable effects within a period of less than 4 days, stop therapy and consult
your doctor.
Iridina Due is not suitable for the treatment of infections, pus, foreign bodies in the eye, mechanical,
chemical and thermal damage. These conditions require medical intervention.

Children
Do not administer this medicine to children under 10 years of age (see “Do not use Iridina Due”).

Other medicines and Iridina Due
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Use Iridina Due with caution if you are being treated with medicines against depression

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
The use of Iridina Due is not contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
Iridina Due eye drops do not interfere with the ability to drive or operate machinery.

3. How to use Iridina Due

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 drops, whenever you feel the sensation of burning.
Squeeze one or two drops of eye drops into the inner corner of each eye, tilting your head back.

Strictly adhere to the recommended doses.A higher dosage of Iridina Due, even for a short
period of time, may lead to serious adverse effects on the body (see “If you use more Iridina Due
than you should”).

Caution: 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 change in its
characteristics.

Instructions for use of the single-dose container:

• 1) Separate the container from the others
• 2) Open the container by rotating and pulling the cap
• 3) Use immediately after opening: after use, discard the container even if partially used.

Use in children
Iridina Due is contraindicated in children under 10 years of age.

If you use more Iridina Due than you should
No cases of overdose following the administration of Iridina Due have been reported so far.
In case of overdose due to accidental ingestion or prolonged use, manifestations
of depression at the central nervous system level may occur with phenomena of bradypnea (reduction in
respiratory rate), feeling of coldness to the skin, drowsiness, tachycardia (acceleration of the heartbeat),
sweating, mental confusion.
In case of accidental ingestion/intake of an excessive dose of Iridina Due eye drops, immediately notify
your doctor 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 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.
Use of the medicine may sometimes determine pupil dilation, general effects on the body such as
high blood pressure (hypertension), heart disorders, excess sugar in the blood (hyperglycemia),
increased pressure inside the eye, nausea, headache.
Rarely, hypersensitivity (allergy) phenomena may occur. In this case, discontinue treatment and
consult your doctor.
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 experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 packaging. The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 30°C.
The product does not contain preservatives: the single-dose container, once opened, must be discarded after
use, even if only partially used.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Iridina Due contains

• The active ingredient is naphazoline hydrochloride. 0.5 ml of eye drops contain 0.25 mg of naphazoline hydrochloride.
• The other ingredients are: sodium chloride, disodium hydrogen phosphate dihydrate, sodium hydroxide, sodium hyaluronate, distilled witch hazel water, distilled chamomile water, water for injections.

Description of the appearance of Iridina Due and contents of the pack
Iridina Due is presented in the form of eye drops, solution.
Packs of 10, 15 or 20 single-dose containers of 0.5 ml.

Marketing Authorisation Holder
MONTEFARMACO OTC S.p.A.- Via IV Novembre, 92 - 20021 Bollate (MI)

Manufacturer
Farmigea S.p.A. Via Giovan Battista Oliva, 8 – 56121 Pisa
Iridina Due 0.5mg/ml eye drops, solution

Naphazoline hydrochloride
Read this leaflet carefully before you start using this medicine as 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 leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if you feel worse after 4 days.

Contents of this leaflet:

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

Do not use Iridina Due

• if you are allergic to naphazoline hydrochloride or other substances closely related from a chemical point of view (in particular xylometazoline, oxymetazoline, tetrizoline) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from glaucoma (increased internal eye pressure) or other eye diseases.
• in children under twelve years of age (see “Children”);
• if you are being treated with medicines against depression (called monoamine oxidase inhibitors) (see “Other medicines and Iridina Due”).

Warnings andprecautions
Talk to your doctor or pharmacist before using Iridina Due if you suffer from:

• high blood pressure (hypertension),
• hyperthyroidism (excessive thyroid gland function),
• heart disease,
• diabetes (hyperglycemia),
• bronchial asthma. If symptoms should 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 thermal damage. These conditions require the intervention of a doctor.
Pay particular attention if you wear contact lenses (see “Iridina Due contains benzalkonium chloride”).

Children
Do not administer this medicine to children under the age of 12 (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 taking, have recently taken or might take any other
medicines.
Do not use Iridina Due if you are being treated with medicines against depression (called MAOIs, monoamine oxidase inhibitors) and for the two weeks following such treatment as severe hypertensive crises (increased blood pressure) may occur (see “Do not use Iridina Due”).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, use Iridina Due only if absolutely necessary and under the direct
control of the doctor.

Driving and using machines
Iridina Due eye drops do not interfere with the ability to drive or use machines.

Iridina Due contains benzalkonium chloride
It may cause eye irritation. Avoid contact with soft contact lenses.
Remove contact lenses before application and wait at least 15 minutes before re-applying them.
The discoloring action on soft contact lenses is known.

3. How to use Iridina Due

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 drops, whenever you feel the sensation of burning.
Squeeze one or two drops of eye drops into the inner corner of each eye, tilting your head back.

Strictly adhere to the recommended doses.A higher dosage of Iridina Due, even for a short period of time, may lead to serious adverse effects on the body (see “If you use more Iridina Due than you should”).
Caution: 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 change in its characteristics.

Use in children
Iridina Due is contraindicated in children under 12 years of age.

If you use more Iridina Due than you should
Cases of overdose following the administration of Iridina Due have not been reported so far.
In case of overdose due to accidental ingestion or prolonged use, manifestations of depression at the central nervous system level may occur with phenomena of bradypnea (reduction of respiratory rate), feeling of coldness to the skin, drowsiness, tachycardia (acceleration of the heartbeat),
sweating, mental confusion and coma.
If this happens, the following will be necessary: gastric lavage, sedation with diazepam and general supportive measures.
In case of accidental ingestion/intake of an excessive dose of Iridina Due eye drops, immediately notify your doctor or go to the nearest hospital.

If you forget to use Iridina Due
Do not use a double dose to make up for the missed dose.
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 everyone will experience them.
The use of the medicine may sometimes determine pupil dilation, general systemic effects on the body such as high blood pressure (hypertension), heart disorders, excess sugar in the blood (hyperglycemia), increased pressure inside the eye, nausea, headache.
Rarely, hypersensitivity (allergy) phenomena may occur. In this case, discontinue treatment and
consult your doctor.
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 experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 packaging. The expiry date refers to
the last day of that month.
The period of validity after first opening of the bottle is 28 days.
Keep the bottle in the original packaging to protect the medicine from light.
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 Iridina Due contains

• The active ingredient is naphazoline hydrochloride. 10 ml of eye drops contain 5 mg of naphazoline hydrochloride.
• The other ingredients are: sodium chloride, disodium hydrogen 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 is presented as eye drops, solution.
The pack contains 1 bottle of 10 ml.

Marketing Authorisation Holder
MONTEFARMACO OTC S.p.A.- Via IV Novembre, 92 - 20021 Bollate (MI)

Manufacturer
Farmigea S.p.A. Via Giovan Battista Oliva, 8 – 56121 Pisa
C.O.C. Farmaceutici S.r.l., Via Modena, 15 – 40019 Sant’Agata Bolognese (BO)