Irireact

Patient Information Leaflet

IRIREACT 3 mg/ml + 0.5 mg/ml eye drops, solution

Pheniramine maleate + Tetrahydrozoline hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4 days of treatment.

Contents of this leaflet:

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

1. What IRIREACT is and what it is used for

IRIREACT contains the active substances pheniramine maleate and tetrahydrozoline hydrochloride.
Pheniramine maleate belongs to a group of medicines called "antihistamines" and works by counteracting allergy symptoms.
Tetrahydrozoline hydrochloride belongs to a group of medicines called "decongestants" and works by reducing the dilation of blood vessels.
IRIREACT is used to treat allergies and inflammations of the eye membrane (conjunctiva) associated with light sensitivity (photophobia), tearing, foreign body sensation, and pain.
Consult 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 IRIREACT

Do not use IRIREACT:

• if you are allergic to pheniramine maleate or tetrahydrozoline hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines of the same family as pheniramine maleate and tetrahydrozoline hydrochloride, particularly xylometazoline, oxymetazoline, naphazoline;
• if you have a disease caused by high pressure inside the eye (narrow-angle/closed-angle glaucoma) or if you suffer from other serious eye diseases;
• if it is for a child under 12 years of age;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are currently being treated with medicines used for depression (monoamine oxidase inhibitors, such as tranylcypromine, phenelzine, pargyline) (see "Other medicines and IRIREACT").

Warnings and precautions
Talk to your doctor or pharmacist before using IRIREACT:

• if you have high blood pressure (hypertension);
• if you have overactivity of a gland called the thyroid (hyperthyroidism);
• if you have heart problems;
• if you have high blood sugar levels (hyperglycaemia, diabetes);
• if you have infections or pus in the eye;
• if you have foreign bodies in the eye;
• if you have various eye problems (mechanical, chemical, thermal).

The use, especially prolonged, of locally applied medicines may cause allergies (sensitization phenomena). In such a case, your doctor will ask you to stop treatment and will recommend appropriate therapy.
Do not use this medicine for more than 4 consecutive days unless otherwise prescribed by your doctor, as otherwise undesirable effects may occur. IRIREACT in the multidose bottle contains benzalkonium chloride as a preservative, which may cause allergic reactions.
During treatment, do not wear contact lenses and you may wear them only 15 minutes after using the medicine. If you are allergic to benzalkonium chloride or wear contact lenses, you may use IRIREACT in single-dose containers, which do not contain preservatives.

Children and adolescents
IRIREACT must not be used in children under 12 years of age.

Other medicines and IRIREACT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking medicines belonging to the class of monoamine oxidase inhibitors (used to treat depression). Concomitant use of IRIREACT and these medicines may cause a severe increase in blood pressure; therefore, simultaneous administration is contraindicated.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use IRIREACT only when clearly necessary and under direct medical supervision.

Driving and using machines
No effects on the ability to drive or use machinery are known. However, IRIREACT bottle contains benzalkonium chloride, which may cause allergic reactions; therefore, if your vision becomes blurred immediately after applying IRIREACT, you must not drive or operate machinery until your vision clears.

IRIREACT in the multidose bottle contains benzalkonium chloride
This medicine in the multidose bottle contains 0.012 mg of benzalkonium chloride per maximum recommended daily dose of 6 drops (0.24 ml), equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your 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 outermost layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use IRIREACT

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops applied into the affected eye 2 or 3 times a day.
Do not exceed the recommended doses.
Higher dosages of the product, even if administered locally and for a short period of time, may cause serious adverse effects on the whole organism (see section 4 “Possible side effects”).
Do not use this product for more than 4 consecutive days unless otherwise prescribed by a physician, due to the risk of adverse effects.
If symptoms persist or worsen, consult your doctor.

Instructions for use
To open, press the closure cap and simultaneously unscrew it. After use, close tightly by screwing fully.

Use in children and adolescents
IRIREACT must not be used in children under 12 years of age.

If you use more IRIREACT than you should
In case of accidental ingestion or overdose of IRIREACT, contact your doctor immediately and go to the nearest hospital.
The medicine, if accidentally ingested or used for a prolonged period at excessive doses, may cause toxic effects. Accidental ingestion of the drug, especially in children, may cause depression of the central nervous system, manifesting as marked physical and mental relaxation: severe drowsiness (pronounced sedation), coma.

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

If you stop using IRIREACT
If you have any doubts about using this medicine, consult your doctor or pharmacist. Before stopping treatment, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with IRIREACT, you may experience allergic reactions; in such case, STOP the treatment immediately and contact your doctor, who may prescribe appropriate treatment if necessary.
During treatment with IRIREACT, you may also experience the following side effects:

Effects related to the eye:

• dilation of the pupil;
• increased pressure inside the eye.

Effects related to the whole body:

• increased blood pressure (hypertension);
• heart disorders;
• increased blood sugar levels (hyperglycaemia);
• nausea;
• headache. In children, accidental ingestion may cause drowsiness, even profound (stupor), and reduced activity (hypotonia).

Rarely, hypersensitivity reactions may occur. In such case, discontinue treatment and consult your doctor, who may provide appropriate therapy if necessary.

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 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 IRIREACT

Do not store above 30°C.
After first opening the multidose container, use the medicinal product within 28 days.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product 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 any medicinal product 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 IRIREACT contains

• The active substances are: pheniramine maleate and tetrizoline hydrochloride. 100 ml of solution contain 0.30 g of pheniramine maleate and 0.05 g of tetrizoline hydrochloride.
• The other components are: boric acid, borax, benzalkonium chloride, water for injections.

Description of the appearance of IRIREACT and contents of the pack
IRIREACT is an eye drop solution (to be administered drop by drop directly into the eye).
IRIREACT is available in packs containing 1 dropper bottle in LDPE of 10 ml.
Marketing Authorization Holder
MONTEFARMACO OTC S.p.A. Via IV Novembre, 92 – 20021 Bollate (MI)
Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)

Patient information leaflet

IRIREACT 3 mg/ml + 0.5 mg/ml eye drops, solution in single-dose container

Maleate of pheniramine + hydrochloride of tetryzoline
Generic medicine
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your doctor or pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 4 days of treatment.

Contents of this leaflet:

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

1. What IRIREACT is and what it is used for

IRIREACT contains the active substances pheniramine maleate and tetrazoline hydrochloride.
Pheniramine maleate belongs to a group of medicines called "antihistamines" and works by counteracting allergy symptoms.
Tetrazoline hydrochloride belongs to a group of medicines called "decongestants" and works by reducing the dilation of blood vessels.
IRIREACT is used to treat allergies and inflammation of the eye membrane (conjunctiva) associated with light sensitivity (photophobia), tearing, foreign body sensation, and pain.
If you do not feel better or feel worse after 4 days of treatment, consult your doctor.

2. What you need to know before using IRIREACT

Do not use IRIREACT:

• if you are allergic to pheniramine maleate or tetrazoline hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same family as pheniramine maleate and tetrazoline hydrochloride, particularly xylometazoline, oxymetazoline, naphazoline;
• if you have a disease caused by high pressure inside the eye (narrow-angle/closed-angle glaucoma) or if you suffer from other serious eye diseases;
• if it is for a child under 12 years of age;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are currently being treated with medicines used for depression (monoamine oxidase inhibitors, such as tranylcypromine, phenelzine, pargyline) (see "Other medicines and IRIREACT").

Warnings and precautions
Talk to your doctor or pharmacist before using IRIREACT:

• if you have high blood pressure (hypertension);
• if you have overactivity of a gland called the thyroid (hyperthyroidism);
• if you have heart problems;
• if you have high blood sugar levels (hyperglycaemia, diabetes);
• if you have infections or pus in the eye;
• if you have foreign bodies in the eye;
• if you have various types of eye problems (mechanical, chemical, thermal).

The use, especially prolonged, of locally applied medicines may cause allergic reactions (sensitization phenomena). In such cases, your doctor will ask you to stop treatment and recommend appropriate therapy.
Do not use this medicine for more than 4 consecutive days unless otherwise prescribed by your doctor, as otherwise undesirable effects may occur.
Children and adolescents
IRIREACT must not be used in children under 12 years of age.
Other medicines and IRIREACT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking medicines belonging to the class of monoamine oxidase inhibitors (used to treat depression). Concomitant use of IRIREACT and this type of medicine may cause a severe increase in blood pressure; therefore, simultaneous administration is contraindicated.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use IRIREACT only if clearly needed and under direct medical supervision.
Driving and using machines
No effects on the ability to drive or use machines are known.

3. How to use IRIREACT

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops applied into the affected eye 2 or 3 times a day.
Do not exceed the recommended doses.
Higher doses of the product, even if administered locally and for a short period of time, may cause serious adverse effects on the whole body (See section 4 “Possible side effects”).
Do not use this product for more than 4 consecutive days unless otherwise prescribed by a doctor, due to the risk of adverse effects occurring otherwise.
If symptoms persist or worsen, consult your doctor.

Instructions for use

1. Separate the container from others;
2. Open the container by twisting and pulling off the cap;
3. Use immediately after opening: after use, the container must be discarded even if partially used.

Use in children and adolescents
IRIREACT must not be used in children under 12 years of age.

If you use more IRIREACT than you should
If you ingest or take an excessive dose of IRIREACT, contact your doctor immediately and go to the nearest hospital.
The medicine, if accidentally ingested or used for a prolonged period at excessive doses, may cause toxic effects. Accidental ingestion of the medicine, especially in children, may cause depression of the central nervous system, manifesting as marked physical and mental relaxation: severe drowsiness (marked sedation), coma.

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

If you stop using IRIREACT
If you have any doubts about using this medicine, consult your doctor or pharmacist. Before stopping treatment, speak to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with IRIREACT, you may experience allergic reactions; in this case, STOP treatment immediately and contact your doctor, who, if necessary, can provide appropriate treatment.

During treatment with IRIREACT, you may also experience the following side effects:

Effects related to the eye:

• dilation of the pupil;
• increased pressure inside the eye.

Effects related to the whole body:

• increased blood pressure (hypertension);
• heart disorders;
• increased blood sugar levels (hyperglycaemia);
• nausea;
• headache.

In children, if accidentally ingested, the product may cause drowsiness, even profound (stupor), and reduced activity (hypotonia).

Rarely, hypersensitivity reactions may occur. In such cases, discontinue treatment and consult your doctor, who, if necessary, will provide appropriate therapy.

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 through the national reporting system at the 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 IRIREACT

Do not store above 30°C.
The medicine does not contain preservatives: use the single-dose container immediately after opening
and discard any remaining medicine, even if partially used.
Do not use the medicine more than 28 days after opening the aluminium sachet containing the
single-dose containers.
Keep this medicine out of the sight and reach of children.
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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

7. Package contents and other information

What IRIREACT contains

• The active substances are: pheniramine maleate and tetrizoline hydrochloride. 100 ml of solution contain 0.30 g of pheniramine maleate and 0.05 g of tetrizoline hydrochloride.
• The other components are: boric acid, borax, water for injections.

Description of the appearance of IRIREACT and package contents
IRIREACT is available as eye drops, solution in single-dose containers (to be instilled drop by drop directly into the eye).
IRIREACT is available in packs of 10 single-dose containers made of LDPE, each with a volume of 0.5 ml, packed in sachets of PET/Al/PE. Each sachet contains a strip of 5 single-dose containers.

Marketing Authorization Holder
MONTEFARMACO OTC S.p.A. Via IV Novembre, 92 – 20021 Bollate (MI)
Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)