CELLUVISC 10 mg /Ml Krople Do Oczu, Roztwór

Treść ulotki

1. CELLUVISC 5 mg/ml eye drops, solution
   1. What you need to know before using CELLUVISC 5 mg/ml
   2. How to use CELLUVISC 5 mg/ml
   3. Possible side effects
   4. How to store CELLUVISC 5 mg/ml
   5. Package contents and other information What contains CELLUVISC 5
2. CELLUVISC 10 mg/ml eye drops, solution
   1. What you need to know before using CELLUVISC 10 mg/ml
   2. How to use CELLUVISC 10 mg/ml
   3. Possible side effects
   4. How to store CELLUVISC 10 mg/ml
   5. Contents of the pack and other information

CELLUVISC 5 mg/ml eye drops, solution

Sodium carmellose

READ THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE
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.
• Talk to your doctor if you do not feel better or if you feel worse.

Contents of this leaflet:

1. What CELLUVISC 5 mg/ml is and what it is used for

2. What you need to know before you use 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 wetting and lubricating agent for ophthalmic use.
It is useful in mild eye irritation or dryness due to alterations in the stability of the tear film.
See 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 carboxymethylcellulose or to any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Since CELLUVISC 5 mg/ml is a sterile preparation, avoid touching the nozzle of the single-dose vial.
The product, once opened, must not be reused.
For external use only; the use, especially prolonged, of ophthalmic products may give rise to
sensitization phenomena (allergy), in which case discontinue treatment and consult your doctor.
It is advisable to consult your doctor even in cases where such disorders have manifested in the past.
If irritation, pain, redness, changes or worsening of vision occur,
stop use and consult your doctor.

Children and adolescents
The safety and efficacy of CELLUVISC 5 mg/ml eye drops, solution in children and adolescents
has 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 medicines for local use commonly used in
ophthalmology.
If undergoing concomitant treatment with other eye medications, you should wait 5 minutes before
applying CELLUVISC 5 mg/ml eye drops, solution.

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.
CELLUVISC 5 mg/ml can be used during pregnancy and breastfeeding.

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

3. How to use CELLUVISC 5 mg/ml

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. How much
The recommended dose is 1-2 drops of product applied directly into the conjunctival sac.

When and for how long
Caution: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

How

• make sure that the bottle is intact before use and does not present any changes in colour or opacity;
• open by rotating the top part of the bottle completely; - do not reuse. Once opened, discard the bottle.

If you use more CELLUVISC 5 mg/ml than you should
Any overdoses do not entail any risk. If you are concerned, consult your doctor or pharmacist.

If you forget to use CELLUVISC 5 mg/ml
Apply the next dose as needed or at the usual time as recommended by your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

If you stop treatment with CELLUVISC 5 mg/ml
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, CELLUVISC 5 mg/ml can cause side effects, although not everybody gets them.
The following side effects may occur with CELLUVISC 5 mg/ml:

Common side effects(occur in 1-9 patients out of 100):eye irritation including burning
and discomfort, eye pain, sticky eyes, visual disturbances.

Post-Marketing Data( frequency cannot be estimated based on available data) The
following side effects have been reported since CELLUVISC was marketed:
allergic reactions (including eye allergy), blurred vision, sticky eyes, increased
tearing of the eyes, redness of the eyes, injury to the surface of the eye due to the
tip of the bottle touching the eye during use, sensation of having a foreign body in the
eyes.
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 get any side effects, talk to 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 . Reporting side
effects helps to provide more information on the safety of this medicine.

5. How to store CELLUVISC 5 mg/ml

Keep this medicine out of the sight and reach of children.

Expiry date: See the expiry date printed on the packaging.
Do not use this medicine after the expiry date stated on the box after Expiry.
The expiry date refers to the product in intact packaging, correctly
stored. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not use this medicine if the packaging shows signs of tampering. Do not use this medicine
if the solution changes color or becomes cloudy.

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. Package contents and other information What contains CELLUVISC 5

mg/ml

• The active ingredient is: Sodium carboxymethylcellulose 5 mg/ml
• The other ingredients 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 package contents
CELLUVISC
5 mg/ml eye drops, solution.
The package contains 30 single-dose vials of 0.4 ml each supplied in 3
sachets,
each containing 2 strips of 5 single-dose containers.

Marketing Authorisation Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy

Manufacturer and final control
Allergan Pharmaceuticals Ireland Castlebar
Road
Westport, County Mayo, Ireland

CELLUVISC 10 mg/ml eye drops, solution

Sodium carmellose

READ THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE
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.

Contents of this leaflet:

1. What CELLUVISC 10 mg/ml is and what it is used for

2. What you need to know before you use 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 a wetting and lubricating agent for ophthalmic use.
It is useful for dry eyes due to alterations in the stability of the tear film.
See 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 carboxymethylcellulose or to any of the other ingredients of
this medicine (listed in section 6).

Warnings and precautions
Since CELLUVISC 10 mg/ml is a sterile preparation, avoid touching the nozzle of the
single-dose vial.
The product, once opened, must not be reused.
Before each application, remove contact lenses and reapply them after 15 minutes.
For external use only; the use, especially prolonged, of ophthalmic products may give rise to
sensitization phenomena (allergy), in which case discontinue treatment and consult your
doctor.
It is advisable to consult your doctor even in cases where such disorders have occurred in the past.
If irritation, pain, redness, changes or worsening of vision occur,
stop using it and consult your doctor.

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

Other medicines and CELLUVISC 10 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine, 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 medicines for local use commonly used in
ophthalmology.
If undergoing concomitant treatment with other eye medications, wait 5 minutes before
applying CELLUVISC 10 mg/ml eye drops, solution.

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.
CELLUVISC 10 mg/ml can be used during pregnancy and breastfeeding.

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

3. How to use CELLUVISC 10 mg/ml

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.

How much
The recommended dose is 1-2 drops of product applied directly into the conjunctival sac.

When and for how long
Caution: use only for short periods of treatment
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

How

• make sure that the bottle is intact before use and does not present changes in color or opacity;
• open by rotating the top of the bottle completely;
• do not reuse. Once opened, discard the bottle.

If you use more CELLUVISC 10 mg/ml than you should
Any overdose will not cause any risk. If you are concerned, consult your doctor or pharmacist.

If you forget to use CELLUVISC 10 mg/ml
Apply the next dose as needed or at the normal time as recommended by your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

If you stop using CELLUVISC 10 mg/ml
If you have any doubts about using 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 1-9 patients out of 100): eye irritation including
burning and discomfort.

Post-Marketing Data( frequency cannot be estimated based on available data)
The following side effects have been reported since CELLUVISC was marketed:
allergic reactions (including swelling of the eye or eyelid), sticky eyes, eye pain, eye itching,
crusts and/or medicine residue on the eyelid, feeling of having something foreign
in the eyes, redness of the eye/eyelid, blurred vision and/or worsening
of vision, increased tearing of the eye, injury to the surface of the eye due to
the tip of the bottle touching the eye during use.
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 get any side effects, talk to 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 . Reporting side effects
helps to 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 printed on the packaging.
Do not use this medicine after the expiry date that is reported on the single-dose vial, on the sachet and on the carton, after Exp.
The expiry date refers to the product in intact packaging, correctly
stored. The expiry date refers to the last day of that month.
Keep the single-dose vials in the sachet and store the sachet in the carton to protect the
medicine from light and moisture.
Do not store at a temperature above 25°C.
Do not use this medicine if the packaging shows signs of tampering. Do not use this
medicine if the solution changes color or becomes cloudy.

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 CELLUVISC 10 mg/ml contains

• The active ingredient is: Sodium carboxymethylcellulose 10 mg/ml
• The other ingredients are: Sodium chloride, Sodium lactate, Potassium chloride, Calcium chloride dihydrate, Purified water

Description of the appearance of CELLUVISC 10 mg/ml and contents of the pack
CELLUVISC 10 mg/ml eye drops, solution.
The pack contains 30 single-dose vials of 0.4 ml each supplied in 3 pouches,
each containing 2 strips of 5 single-dose vials.

Marketing Authorisation 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