Celluvisc

Package leaflet: Information for the user

CELLUVISC 5 mg/ml eye drops, solution

Sodium carmellose
PLEASE 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.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, 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.

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

1. What CELLUVISC 5 mg/ml is and what it is used for
CELLUVISC 5 mg/ml contains sodium carmellose, a substance belonging to a group of
medicines called artificial tears.
CELLUVISC 5 mg/ml is a moisturizing and lubricating eye preparation.
It is useful in mild ocular irritations or dryness due to alterations in the stability of the tear film.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before using CELLUVISC 5 mg/ml

Do not use CELLUVISC 5 mg/ml
If you are allergic (hypersensitive) to sodium carmellose or to any of the other ingredients of this
medicinal product (listed in section 6).

Warnings and precautions
Since CELLUVISC 5 mg/ml is a sterile preparation, avoid touching the tip of the single-dose container.
Once opened, the product must not be reused.
For external use only; the use, especially prolonged use, of ophthalmic products may lead to sensitization reactions (allergy); in such cases, discontinue treatment and consult your doctor.
You should consult your doctor also if such symptoms have occurred in the past.
If irritation, pain, redness, changes in vision, or worsening of vision occur, stop using the product and consult your doctor.

Children and adolescents
The safety and efficacy of CELLUVISC 5 mg/ml eye drops, solution in children and adolescents have not been established.

Other medicines and CELLUVISC 5 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
No interactions with other medicines have been observed.
CELLUVISC 5 mg/ml eye drops, solution may prolong the contact time of other locally applied ophthalmic medicines commonly used in ophthalmology.
If you are using other eye medications at the same time, wait 5 minutes before applying CELLUVISC 5 mg/ml eye drops, solution.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicinal product.
CELLUVISC 5 mg/ml may be used during pregnancy and breastfeeding.

Driving and using machines
Transient blurred vision may occur immediately after application. Avoid driving vehicles or operating machinery if your vision is not clear.

3. How to use CELLUVISC 5 mg/ml

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Dosage
The recommended dose is 1-2 drops of the product applied directly into the conjunctival sac.
When and for how long
Warning: use only for short-term treatment.
Consult your doctor if the condition recurs or if you notice any recent changes in its characteristics.
How to use

• ensure the bottle is intact before use and that there are no changes in colour or opacity;
• unscrew the cap completely to open the bottle;
• do not reuse. Once opened, discard the bottle.

If you use more CELLUVISC 5 mg/ml than you should
Overdosing is not expected to cause any risk. If you are concerned, contact your doctor or pharmacist.
If you forget to use CELLUVISC 5 mg/ml
Apply the next dose as required or at the usual time as advised by your doctor or pharmacist. Do not use a double dose to make up for a forgotten dose.
If you stop using CELLUVISC 5 mg/ml
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CELLUVISC 5 mg/ml can cause side effects, although not everyone experiences them.
The following side effects may occur with CELLUVISC 5 mg/ml:
Common side effects (occur in 1 to 9 out of 100 patients): eye irritation including burning and discomfort, eye pain, sticky eyes, visual disturbances.
Post-Marketing Data (frequency cannot be estimated from the available data):
The following adverse reactions have been reported since CELLUVISC has been marketed:
allergic reactions (including eye allergy), blurred vision, sticky eyes, increased lacrimation, eye redness, eye surface injury due to the dropper tip touching the eye during use, sensation of having a foreign body in the eyes.
These side effects are generally transient. However, if 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. Side effects can also be reported directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps provide more information on the safety of this medicine.

5. How to store CELLUVISC 5 mg/ml

Keep this medicine out of sight and reach of children.
Expiry date: See the expiry date stated on the packaging.
Do not use this medicine after the expiry date stated on the box following Exp.
The expiry date refers to the product in its original, undamaged packaging and stored
correctly. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use this medicine if the packaging shows any signs of tampering. Do not use this medicine
if the solution changes colour or becomes cloudy.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information What CELLUVISC 5 mg/ml contains

• The active substance is: Carmellose sodium 5 mg/ml
• The other components are: Sodium chloride, Sodium lactate, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Purified water.

Description of the appearance of CELLUVISC 5 mg/ml and contents of the pack
CELLUVISC 5 mg/ml eye drops, solution.
Pack contents: 30 single-dose containers of 0.4 ml each, supplied in 3 pouches,
each containing 2 strips of 5 single-dose containers.
Marketing Authorization Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Manufacturer and Final Controller
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport, County Mayo, Ireland

Instructions for the user: package leaflet

CELLUVISC 10 mg/ml eye drops, solution

Sodium carmellose
PLEASE 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 you experience any side effects, 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.

Contents of this leaflet:
1. What CELLUVISC 10 mg/ml is and what it is used for
2. What you need to know before using CELLUVISC 10 mg/ml
3. How to use CELLUVISC 10 mg/ml
4. Possible side effects
5. How to store CELLUVISC 10 mg/ml
6. Contents of the pack and other information

1. What CELLUVISC 10 mg/ml is and what it is used for
CELLUVISC 10 mg/ml contains sodium carmellose, a substance belonging to a group of
medicines called artificial tears.
CELLUVISC 10 mg/ml is an ocular lubricant and moisturizer.
It is useful in dry eye conditions due to alterations in the stability of the tear film.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using CELLUVISC 10 mg/ml

Do not use CELLUVISC 10 mg/ml
If you are allergic (hypersensitive) to sodium carmellose or to any of the other ingredients of
this medicinal product (listed in section 6).

Warnings and precautions
Since CELLUVISC 10 mg/ml is a sterile preparation, avoid touching the nozzle of the
single-dose container.
Once opened, the product must not be reused.
Before each application, remove contact lenses and reinsert them 15 minutes after application.
For external use only; prolonged use, especially, of ophthalmic products may lead to sensitization reactions (allergy); in such cases, discontinue treatment and consult your doctor.
It is advisable to consult your doctor also if such symptoms have occurred in the past.
If irritation, pain, redness, or changes or worsening of vision occur, stop using the product and consult your doctor.

Children and adolescents
The safety and efficacy of CELLUVISC 10 mg/ml eye drops, solution in children and adolescents have not been established.

Other medicines and CELLUVISC 10 mg/ml
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
No interactions with other medicines have been observed.
CELLUVISC 10 mg/ml eye drops, solution may prolong the contact time of other locally applied ophthalmic medicines commonly used in ophthalmology.
If you are using other eye medications concurrently, wait 5 minutes before applying CELLUVISC 10 mg/ml eye drops, solution.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicinal product.
CELLUVISC 10 mg/ml may be used during pregnancy and breastfeeding.

Driving and using machines
Transient blurred vision may occur immediately after application. Avoid driving or operating machinery if your vision is not clear.

3. How to use CELLUVISC 10 mg/ml

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 of the product applied directly into the conjunctival sac.

When and for how long
Warning: use only for short-term treatment.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.

Instructions for use

• Before use, ensure the dropper bottle is intact and that there are no changes in colour or opacity;
• Open by completely twisting off the top part of the dropper bottle;
• Do not reuse. Discard the dropper bottle after opening.

If you use more CELLUVISC 10 mg/ml than you should
Overdosing is not expected to cause any risk. If you are concerned, contact your doctor or pharmacist.

If you forget to use CELLUVISC 10 mg/ml
Apply the next dose as required or at the usual time, as advised by your doctor or pharmacist. Do not use a double dose to make up for a forgotten dose.

If you stop using CELLUVISC 10 mg/ml
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CELLUVISC 10 mg/ml can cause side effects, although not everybody gets them.
The following side effects may occur with CELLUVISC 10 mg/ml:
Common side effects ( occur in 1 to 9 out of 100 patients ): eye irritation including burning and discomfort.
Post-Marketing Data ( frequency cannot be estimated from the available data )
The following side effects have been reported since CELLUVISC has been marketed:
allergic reactions (including eye or eyelid swelling), sticky eyes, eye pain, eye itching, crusts and/or medicine residue on the eyelid, sensation of having a foreign body in the eyes, eye/eyelid redness, blurred vision and/or worsening of vision, increased eye tearing, eye surface injury due to the dropper tip touching the eye during use.
These side effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps provide more information on the safety of this medicine.

5. How to store CELLUVISC 10 mg/ml

Keep this medicine out of the sight and reach of children.
Expiry date: See the expiry date stated on the packaging.
Do not use this medicine after the expiry date stated on the single-dose vial,
on the pouch and on the carton, after Exp.
The expiry date refers to the product in its original, unopened packaging,
stored correctly. The expiry date refers to the last day of that month.
Keep the single-dose vials in the pouch and store the pouch in the carton to protect the
medicine from light and moisture.
Do not store above 25°C.
Do not use this medicine if the packaging shows any signs of tampering. Do not use this
medicine if the solution changes colour or becomes cloudy.
Do not dispose of any medicine 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 CELLUVISC 10 mg/ml contains

• The active substance is: Carmellose sodium 10 mg/ml
• The other components are: Sodium chloride, Sodium lactate, Potassium chloride, Calcium chloride dihydrate, Purified water

Description of the appearance of CELLUVISC 10 mg/ml and package contents
CELLUVISC 10 mg/ml eye drops, solution.
The package contains 30 single-dose units of 0.4 ml each, supplied in 3 pouches,
each pouch containing 2 strips of 5 single-dose units.
Marketing Authorization Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport, County Mayo, Ireland