OCTILIA 0.5 MG/ML Krople do oczu, roztwór

Treść ulotki

1. WHAT IS OCTILIA AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE USING OCTILIA
3. HOW TO USE OCTILIA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE OCTILIA
6. PACKAGE CONTENTS AND OTHER INFORMATION
7. WHAT IS OCTILIA AND WHAT IS IT USED FOR
8. WHAT YOU NEED TO KNOW BEFORE USING OCTILIA
9. HOW TO USE OCTILIA
10. POSSIBLE SIDE EFFECTS
11. HOW TO STORE OCTILIA
12. PACKAGE CONTENTS AND OTHER INFORMATION

OCTILIA 0.5 mg/mleye drops, solution in single-dose container, 10 single-dose containers of 0.5
ml

Tetrizoline hydrochloride

Read this leaflet carefully before using this medicine as 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. Do not give it to other people even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.
• See your doctor if you do not feel better or if your symptoms worsen after a short period of time.

Contents of this leaflet:

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

1. WHAT IS OCTILIA AND WHAT IT IS USED FOR

OCTILIA is a decongestant for ophthalmic use.
OCTILIA is indicated in the symptomatic treatment of eye irritations due to smoke, wind, salt water,
prolonged exposure to light, allergic conjunctivitis and other irritating agents.

2. WHAT YOU NEED TO KNOW BEFORE USING OCTILIA

Do not use OCTILIA

• if you are hypersensitive to Tetrizoline or any of the excipients
• if you have narrow-angle glaucoma (elevated intraocular pressure)
• if you have serious eye diseases
• if you have heart problems or suffer from high blood pressure (hypertension)
• if you suffer from a tumor of the adrenal gland (pheochromocytoma)
• if you suffer from hyperthyroidism
• if you suffer from diabetes treated with insulin
• if you are taking monoamine oxidase inhibitors (so-called MAOIs) or other medicines that can cause an increase in blood pressure
• if you suffer from dry rhinitis
• if you suffer from inflammation of the cornea and ocular conjunctiva (keratoconjunctivitis)
• in children under three years of age, while the use of the product in children over 3 years of age is left to the doctor's judgment.
• if the aluminum blister or containers are visibly damaged.

Warnings and precautions
Consult your doctor or pharmacist before taking OCTILIA.
In particular:

• if you are over 65 years of age
• if you have infections, pus, foreign bodies in the eye, mechanical, chemical, thermal damage
• if you have eye pain, headache, sudden changes in the visual field, appearance of visual spots, intense redness of the eye, light intolerance or diplopia
• if you suffer from hypertension, hyperthyroidism, severe cardiovascular diseases and hyperglycemia due to diabetes mellitus.
• if you have temporary mydriasis (pupil dilation)
• if you have swelling and itching around the eye (hyperemia and rebound hyperemia)

Attention for those who play sports: the product contains substances prohibited for doping. It is forbidden
to take it in a manner different from the prescribed dosage regimen and route of administration.

Other medicines and OCTILIA
Do not use OCTILIA if you are being treated with monoamine oxidase inhibitors
(a particular class of antidepressant drugs) or being treated with tricyclic antidepressants as
severe hypertensive crises may occur.
Do not use OCTILIA if you are taking medicines that can cause an increase in blood pressure
In any case, inform your doctor if you are taking or have recently taken any other
medicines, including those available without a prescription.

Children and adolescents
OCTILIA is contraindicated in children under three years of age, while the use of the product in children
over three years of age is left to the doctor's judgment.

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 taking this medicine.

Driving and operating machinery
OCTILIA has no influence on the ability to drive vehicles or operate machinery. In
rare cases, the ability to drive vehicles and operate machinery may be altered due to slight and
temporary blurred vision.

3. HOW TO USE OCTILIA

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
This medicine is to be administered via ophthalmic route.

How much
The recommended dose is 1 or 2 drops of OCTILIA in each eye 2-3 times a day.
Do not exceed the indicated doses.
Use this medicine only for short periods of treatment.
Consult your doctor if the disorder recurs or if you notice any recent change in its characteristics.

How
After opening the protective sachet, separate a single-dose container from the others. Open
by twisting and pulling the cap; administer one or two drops of OCTILIA into the eye,
applying slight pressure on the body of the container. To avoid contamination of the
product, avoid contact of the dropper tip with any surface.
The product must be used exclusively for minor eye irritations. If you do not obtain
relief within 48 hours or if redness increases or persists, discontinue use and consult a doctor.
Discontinue treatment as soon as symptoms disappear. Therapy should not last for a period
longer than one week.

If you use more OCTILIA than you should
Accidental ingestion or the use of OCTILIA for a long period at excessive doses may
cause toxic effects. Ingestion of Tetrizoline ophthalmic solution may be
associated with cardiovascular instability, CNS depression including drowsiness and coma, respiratory
depression including apnea.
Symptoms associated with an overdose of the product are: pupil dilation, bluish discoloration of the skin and mucous membranes, nausea, fever, cramps, altered heart rhythm, cardiac arrest, hypertension, pulmonary edema, respiratory and mental alterations.
The product should be kept out of reach of children because accidental ingestion may
cause severe sedation.
In case of ingestion/accidental intake of an excessive dose of OCTILIA, immediately inform
your doctor or go to the nearest hospital.

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

If you stop using OCTILIA
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, OCTILIA can cause side effects, although not everybody gets them.

Uncommon(affects 1 to 10 users out of 1000): redness of the eye mucosa, dry eye, hyperemia, palpitations, headache, tremor, weakness, sweating and increased blood
pressure.

Rare(affects 1 to 10 users out of 10000): blurred vision, conjunctival irritations and
pupil dilation (mydriasis).
Prolonged and frequent use can produce dry eye syndrome.
Only with very high doses can hypertension, heart disorders or hyperglycemia occur.

Reporting of side effects
If you experience any side effects, 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 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

Keep this medicine out of the sight and reach of children.
Store this medicine below 30°C.
Do not use the product after the expiry date which is reported on the packaging (“Exp.”). The expiry
date refers to the last day of the month in intact packaging, correctly
stored.
Do not use this medicine if you notice signs of deterioration of the solution.
Do not dispose of this medicine in drains or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

Shelf life after opening
Use immediately after opening and discard any remaining solution.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What OCTILIA contains
The active ingredient is Tetrizoline hydrochloride.
The excipients are :Sodium chloride, Boric acid, Borax, Sodium Hydroxide or Hydrochloric Acid (for the
pH adjustment), Water for injections.

Description of the appearance of OCTILIA and contents of the pack
Pack containing 10 single-dose containers of 0.5 ml, divided into 2 strips of 5 units, individually packaged
in aluminum pouches.

Marketing authorization holder and manufacturer:
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900 Lodi
Tel. 03716171 Fax. 0371617244
Manufacturer
Farmigea S.p.A., Via G.B. Oliva, 8 – 56121 Pisa
Tel: 05031211; Fax: 050-3121255; e-mail: [email protected]

OCTILIA 0.5 mg/mleye drops, solution, 10 ml bottle

tetrizoline 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 you experience any side effects, 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 worsen after a short period of time.

Contents of this leaflet:

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

1. WHAT IS OCTILIA AND WHAT IS IT USED FOR

OCTILIA is a decongestant for ophthalmic use.
OCTILIA is indicated in the symptomatic treatment of eye irritations due to smoke, wind, salt water,
prolonged exposure to light, allergic and other irritative conjunctivitis.

2. WHAT YOU NEED TO KNOW BEFORE USING OCTILIA

Do not use OCTILIA

• if you are hypersensitive to tetrizoline or any of the excipients
• if you have narrow-angle glaucoma (elevated intraocular pressure)
• if you have severe eye diseases.
• if you have heart problems or suffer from high blood pressure (hypertension)
• if you suffer from a tumor of the adrenal gland (pheochromocytoma)
• if you suffer from hyperthyroidism
• if you suffer from diabetes treated with insulin
• if you are taking monoamine oxidase inhibitors (so-called MAOIs) or other medicines that can cause an increase in blood pressure
• if you suffer from dry rhinitis
• if you suffer from inflammation of the cornea and ocular conjunctiva (keratoconjunctivitis)
• in children under three years of age, while the use of the product in children over 3 years of age is left to the doctor's judgment.
• if the container appears visibly damaged.

Warnings and precautions
Consult your doctor or pharmacist before taking OCTILIA.
In particular:

• if you are over 65 years of age
• if you have infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage
• if you have eye pain, headache, sudden changes in the field of vision, appearance of visual spots, intense redness of the eye, light intolerance or diplopia
• if you suffer from hypertension, hyperthyroidism, severe cardiovascular diseases and hyperglycemia due to diabetes mellitus.
• if you have temporary mydriasis (pupil dilation)
• if you have swelling and itching around the eye (hyperemia and rebound hyperemia)
• if you use soft contact lenses (for more information see paragraph “OCTILIA contains benzalkonium chloride”).

Attention for those who play sports: the product contains substances prohibited for doping. It is forbidden
to take a dose different from that reported, both in terms of dosage and route of administration.

Other medicines and OCTILIA
Do not use OCTILIA if you are being treated with monoamine oxidase inhibitors
(a particular class of antidepressant drugs) or being treated with tricyclic antidepressants as
severe hypertensive crises may occur.
Do not use OCTILIA if you are taking medicines that can cause an increase in blood pressure
In any case, inform your doctor if you are taking or have recently taken any other
medicines, including those available over the counter.

Children and adolescents
OCTILIA is contraindicated in children under three years of age, while the use of the product in children
over three years of age is left to the doctor's judgment.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
OCTILIA has no influence on the ability to drive vehicles or operate machinery. In
rare cases, the ability to drive vehicles and operate machinery may be altered due to slight and
temporary blurred vision.

OCTILIA contains benzalkonium chloride
This medicine contains 0.01 mg of benzalkonium chloride per dose (maximum 2 drops) equivalent to
0.1 mg/ml. Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
a change in their color. Remove contact lenses before using this medicine and wait 15
minutes before re-applying them. Benzalkonium chloride can also cause irritation to the eyes
especially if you have dry eyes or corneal disorders (the most superficial transparent layer
of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this
medicine, talk to your doctor.

3. HOW TO USE OCTILIA

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.
This medicine is to be administered via ophthalmic route.

How much
The recommended dose is 1 or 2 drops of OCTILIA in each eye 2-3 times a day.
Do not exceed the indicated doses.
Use this medicine only for short periods of treatment.
Consult your doctor if the disorder recurs or if you notice any recent change in its characteristics.

How
Administer one or two drops of OCTILIA, applying gentle pressure to the body of the bottle.
To avoid contamination of the product, avoid contact of the dropper tip with any surface.
The product should be used exclusively for minor eye irritations. If you do not experience relief within 48 hours or if redness increases or persists, discontinue use and consult a doctor.
Stop treatment as soon as symptoms disappear. Therapy should not last for a period longer than one week.

If you use more OCTILIA than you should
Accidental ingestion or use of OCTILIA for a prolonged period at excessive doses may cause toxic effects. Ingestion of tetrizoline ophthalmic solution may be associated with cardiovascular instability, CNS depression including drowsiness and coma, respiratory depression including apnea.
Symptoms associated with an overdose of the product are: pupil dilation, bluish discoloration of the skin and mucous membranes, nausea, fever, cramps, altered heart rhythm, cardiac arrest, hypertension, pulmonary edema, respiratory and mental alterations.
The product should be kept out of the reach of children because accidental ingestion can cause severe sedation.
In case of ingestion/accidental intake of an excessive dose of OCTILIA, immediately inform your doctor or go to the nearest hospital.

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

If you stop using OCTILIA
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, OCTILIA can cause side effects, although not everybody gets them.

Uncommon(affects 1 to 10 users out of 1000): redness of the ocular mucosa, dry
eye, hyperemia, palpitations, headache, tremor, weakness, sweating and increased blood
pressure.

Rare(affects 1 to 10 users out of 10000): blurred vision, conjunctival irritations and
pupil dilation (mydriasis).
Prolonged and frequent use can produce dry eye syndrome.
Only with very high doses can hypertension, cardiac disorders or hyperglycemia occur.

Reporting of side effects
If you experience any side effects, 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 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

Keep this medicine out of the sight and reach of children.
Do not store the medicine above 25°C.
Do not use the product after the expiry date which is reported on the packaging (“Exp.”). The expiry date
refers to the last day of the month in intact packaging, correctly stored.
Do not use this medicine if you notice signs of deterioration of the solution.
Do not dispose of this medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines that you no longer use. This will help protect the environment.

Shelf life after opening
Use within 4 weeks from the date of opening the bottle.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What OCTILIA contains
The active ingredient is tetrizoline hydrochloride.
The excipients are :sodium chloride, boric acid, borax, benzalkonium chloride sol., disodium edetate,
sodium hydroxide or hydrochloric acid (for pH adjustment), water for injectable preparations.

Description of the appearance of OCTILIA and contents of the pack
10 ml bottle, equipped with a special dropper.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900 Lodi
Tel. 03716171 Fax. 0371617244 e-mail: [email protected]
Manufacturer:
Farmigea S.p.A., Via G.B. Oliva 8, 56121 Pisa (PI), Italy