Octilia for allergy and inflammation

Package leaflet: Information for the patient

OCTILIA ALLERGIA E INFIAMMAZIONE 3 mg/ml + 0.5 mg/ml eye drops, solution

Pheniramine maleate + Tetrazoline hydrochloride
Read this leaflet carefully before using 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult 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 OCTILIA ALLERGIA E INFIAMMAZIONE is and what it is used for
2. What you need to know before using OCTILIA ALLERGIA E INFIAMMAZIONE
3. How to use OCTILIA ALLERGIA E INFIAMMAZIONE
4. Possible side effects
5. How to store OCTILIA ALLERGIA E INFIAMMAZIONE
6. Contents of the pack and other information

1. What OCTILIA ALLERGY AND INFLAMMATION is and what it is used for

OCTILIA ALLERGY AND INFLAMMATION 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.
OCTILIA ALLERGY AND INFLAMMATION 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 feel worse after 4 days of treatment.

2. What you should know before using OCTILIA ALLERGY AND INFLAMMATION

Do not use OCTILIA ALLERGY AND INFLAMMATION:

• 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 class 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 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 OCTILIA ALLERGY AND INFLAMMATION").

Warnings and precautions
Talk to your doctor or pharmacist before using OCTILIA ALLERGY AND INFLAMMATION:

• if you have high blood pressure (hypertension);
• if you have overactivity of a gland called the thyroid (hyperthyroidism);
• if you have heart disorders;
• if you have high blood sugar levels (hyperglycemia, diabetes);
• if you have eye 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 use, of locally applied medicines may cause allergic reactions (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 a doctor, as otherwise undesirable effects may occur.
OCTILIA ALLERGY AND INFLAMMATION in the multidose bottle pack contains benzalkonium chloride as a preservative, which may cause allergic reactions. During treatment, you must not wear contact lenses and may wear them only 15 minutes after using the medicine.
If you are allergic to benzalkonium chloride or wear contact lenses, you may use OCTILIA ALLERGY AND INFLAMMATION in the single-dose container pack, which does not contain preservatives.

Children and adolescents
OCTILIA ALLERGY AND INFLAMMATION must not be used in children under 12 years of age.

Other medicines and OCTILIA ALLERGY AND INFLAMMATION
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). The concomitant use of OCTILIA ALLERGY AND INFLAMMATION and these types of medicines may cause severe increases in blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use OCTILIA ALLERGY AND INFLAMMATION only if strictly necessary and under direct medical supervision.

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

OCTILIA ALLERGY AND INFLAMMATION in the multidose bottle pack contains benzalkonium chloride
This medicine in the multidose bottle pack 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 is a preservative that may cause allergic reactions. It can be absorbed by soft contact lenses and may alter their color. During treatment, you must not wear contact lenses; remove them before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use OCTILIA ALLERGIA E INFIAMMAZIONE

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is: 1-2 drops into the affected eye.
Warning: Do not exceed the recommended doses. Higher doses, even if administered locally and for a short period of time, may cause serious adverse effects on the entire organism (See section 4 "Possible side effects").
When and for how long
Use OCTILIA ALLERGIA E INFIAMMAZIONE 2 or 3 times a day.
Do not use this product for longer than 4 consecutive days unless otherwise prescribed by a doctor, due to the risk of adverse effects.
If symptoms persist or worsen, consult your doctor.
How to use
Instill the drops into the affected eye.
Strictly follow the recommended dosage.
Instructions for use of the multidose bottle
To open, press the closure cap and simultaneously unscrew it. After use, close tightly by screwing the cap back on firmly.

Instructions for use of the single-dose container

1. Separate the container from the 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
OCTILIA ALLERGIA E INFIAMMAZIONE must not be used in children under 12 years of age.

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

If you forget to use OCTILIA ALLERGIA E INFIAMMAZIONE
Do not use a double dose to make up for the forgotten dose.

If you stop treatment with OCTILIA ALLERGIA E INFIAMMAZIONE
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 will experience them.
During treatment with OCTILIA ALLERGIA E INFIAMMAZIONE you may experience allergic reactions; if this occurs, STOP treatment immediately and contact your doctor, who may prescribe appropriate therapy if necessary.
During treatment with OCTILIA ALLERGIA E INFIAMMAZIONE 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 profound drowsiness (stupor) and reduced activity (hypotonia).

Hypersensitivity reactions may rarely occur. In such cases, discontinue treatment and consult your doctor, who may prescribe appropriate therapy if necessary.
Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 OCTILIA ALLERGIA E INFIAMMAZIONE

Do not store at temperatures above 25°C.
OCTILIA ALLERGIA E INFIAMMAZIONE multidose bottle
After first opening the multidose bottle, use the medicine within 28 days.
OCTILIA ALLERGIA E INFIAMMAZIONE single-dose container
The medicine does not contain preservatives: use the single-dose container immediately after opening and discard any remaining medicine, even if only partially used.
Do not use the medicine more than 28 days after opening the aluminium pouch 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.
It is important to always keep the medicine information available; therefore, retain both the packaging and the leaflet.

6. Contents of the package and other information

What OCTILIA ALLERGIA E INFIAMMAZIONE contains
Multidose bottle (10 ml bottle):

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

Single-dose container (10 single-dose units of 0.5 ml each):

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

Description of the appearance of OCTILIA ALLERGIA E INFIAMMAZIONE and contents of the pack
OCTILIA ALLERGIA E INFIAMMAZIONE is available as eye drops, solution (to be administered drop by drop directly into the eye).
OCTILIA ALLERGIA E INFIAMMAZIONE is available in packs containing either 1 bottle of 10 ml or 10 single-dose units of 0.5 ml each.
Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900 Lodi
Tel. 03716171 Fax. 0371617244
Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)