CELLUVISC 1% W/V EYE DROPS SOLUTION, CARMELLOSE SODIUM 1% W/V EYE DROPS SOLUTION - patient leaflet, side effects, dosage

3. HOW TO USE CELLUVISC

PACKAGE LEAFLET: INFORMATION FOR THE USER

CELLUVISC® 1% w/v EYE DROPS, SOLUTION

(Carmellose Sodium)

Your medicine is known as Celluvisc 1% w/v Eye Drops, Solution but will be referred to as Celluvisc throughout the following leaflet.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

This medicine is available without prescription. Always use this medicine exactly as described in this leaflet or as your pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or

nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

• 1. What Celluvisc is and what it is used for

• 2. What you need to know before you use Celluvisc

• 3. How to use Celluvisc

• 4. Possible side effects

• 5. How to store Celluvisc

• 6. Contents of the pack and other information

1. what celluvisc is and what it is used for

Celluvisc is a tear substitute and contains the lubricant called carmellose sodium. It is used for the treatment of the symptoms of dry eye (such as soreness, burning, irritation or dryness).

You must talk to a doctor if you do not feel better or if you feel worse.

2. what you need to know before you use celluvisc

Do not use Celluvisc

• If you are allergic (hypersensitive) to carmellose sodium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If you wear contact lenses, these should be removed before using Celluvisc. The lenses can be put back again 15 minutes after you have applied your drops.

Other medicines and Celluvisc

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

If you are using other eye drops, leave at least 15 minutes before putting in Celluvisc.

Pregnancy and breast-feeding

Celluvisc can be used during pregnancy and breast-feeding.

Driving and using machines

Celluvisc may cause short-lasting blurring of vision typically lasting

• 1 – 15 minutes. If you do experience temporary blurring, do not drive or use machines until your sight is clear.

Celluvisc is for ocular use (applied on the eye).

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

The recommended dose is 1–2 drops of Celluvisc in the affected eyes as needed.

Make sure that the single-dose container is intact before use.

The solution should be used immediately after opening. To avoid contamination or possible eye injury, do not let the open-end of the single-dose container touch your eye or anything else. Wash your hands before use.

Tear one single-dose container from the strip.

Hold the single-dose container upright (with the cap uppermost) and twist off the cap.

Gently pull down the lower eyelid to form a pocket. Turn the single-dose container upside down and squeeze it to release one drop into each eye. Blink your eyes a few times.

Do not re-use the single-dose container even if there is some solution left. It is most important that you throw it away and do not keep it.

If irritation, pain, redness or changes in vision occur or if you feel your condition is getting worse, stop taking this medicine and consult your doctor or pharmacist.

If you use more Celluvisc than you should

It will not cause you any harm. If you are worried, talk to your doctor or pharmacist.

If you forget to use Celluvisc

Apply your next dose as required or at the normal time as directed by your pharmacist or doctor. Do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

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

The following adverse reactions or medically relevant adverse events were reported during clinical trials:

Common side effects (occurring in between 1 and 10 patients in every 100) are:

Eye irritation (including burning and discomfort), eye pain, itchy eyes, visual disturbance.

Post-Marketing Data

The following adverse reactions or medically relevant adverse events have been reported since the drug has been marketed:

Uncommon side effects (occurring in between 1 and 10 patients in every 1000) are:

Allergic reactions (including eye or eyelid swelling), blurring of vision, increase in tear production (also known as tearing), sticky eye, crusting of the eyelid and/or drug residue, a feeling that something is in your eye, redness of the eye/eyelid, eyesight worsening, eye injury to the surface of the eye due to the tip of the vial touching the eye during use.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store celluvisc

• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Protect from light.
• Do not use this medicine after the expiry date which is stated on the single-dose container tab and the carton after EXP: The expiry date refers to the last day of that month.
• Pouch is required to prevent moisture loss.
• Once the pouch is opened, Keep the single dose containers in the pouch and place the pouch back in the outer carton.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
• Do not use if the packaging shows evidence of tampering. Do not use if solution changes colour or becomes cloudy. You should seek the advice of your pharmacist who will tell you what to do.

What Celluvisc contains

• Each ml contains 10mg of the active ingredient, carmellose sodium.
• Celluvisc also contains the following inactive ingredients: Sodium chloride, sodium lactate, potassium chloride, calcium chloride and purified water.

What Celluvisc looks like and contents of the pack

Celluvisc is a clear, colourless to slightly yellow viscous solution in a small see-through (bubble-like) casing (known as a ‘single-dose container’). The single-dose container has a twist-off cap.

Celluvisc is available as single-dose containers containing 0.4 mls of solution in packs of 30, 60 and 90.

Product Licence holder

Procured from within the EU and repackaged by the PL holder: S&M Medical Ltd, Chemilines, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, Co Mayo, Ireland.

P] PL: 19488/0870

Leaflet revision date: 19 January 2021

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Celluvisc is a registered trade mark of Allergan, Inc, USA.

S0870 LEAFLET Celluvisc 20210119

PACKAGE LEAFLET: INFORMATION FOR THE USER

CARMELLOSE SODIUM 1% w/v EYE DROPS, SOLUTION

Your medicine is known as Carmellose Sodium 1% w/v Eye Drops, Solution but will be referred to as Carmellose Sodium throughout the following leaflet.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

This medicine is available without prescription. Always use this medicine exactly as described in this leaflet or as your pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or

nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

• 1. What Carmellose Sodium is and what it is used for

• 2. What you need to know before you use Carmellose Sodium

• 3. How to use Carmellose Sodium

• 4. Possible side effects

• 5. How to store Carmellose Sodium

• 6. Contents of the pack and other information

1. what carmellose sodium is and what it is used for

Carmellose Sodium is a tear substitute and contains the lubricant called carmellose sodium. It is used for the treatment of the symptoms of dry eye (such as soreness, burning, irritation or dryness).

You must talk to a doctor if you do not feel better or if you feel worse.

Carmellose Sodium is for ocular use (applied on the eye).

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

The recommended dose is 1–2 drops of Carmellose Sodium in the affected eyes as needed.

Make sure that the single-dose container is intact before use.

The solution should be used immediately after opening. To avoid contamination or possible eye injury, do not let the open-end of the single-dose container touch your eye or anything else. Wash your hands before use.

Tear one single-dose container from the strip.

Hold the single-dose container upright (with the cap uppermost) and twist off the cap.

Gently pull down the lower eyelid to form a pocket. Turn the single-dose container upside down and squeeze it to release one drop into each eye. Blink your eyes a few times.

Do not re-use the single-dose container even if there is some solution left. It is most important that you throw it away and do not keep it.

If irritation, pain, redness or changes in vision occur or if you feel your condition is getting worse, stop taking this medicine and consult your doctor or pharmacist.

2. what you need to know before you use carmellose sodium

Do not use Carmellose Sodium

• If you are allergic (hypersensitive) to carmellose sodium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If you wear contact lenses, these should be removed before using Carmellose Sodium. The lenses can be put back again 15 minutes after you have applied your drops.

Other medicines and Carmellose Sodium

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

If you are using other eye drops, leave at least 15 minutes before putting in Carmellose Sodium.

Pregnancy and breast-feeding

Carmellose Sodium can be used during pregnancy and breastfeeding.

Driving and using machines

Carmellose Sodium may cause short-lasting blurring of vision typically lasting 1 – 15 minutes. If you do experience temporary blurring, do not drive or use machines until your sight is clear.

If you use more Carmellose Sodium than you should

It will not cause you any harm. If you are worried, talk to your doctor or pharmacist.

If you forget to use Carmellose Sodium

Apply your next dose as required or at the normal time as directed by your pharmacist or doctor. Do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

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

The following adverse reactions or medically relevant adverse events were reported during clinical trials:

Common side effects (occurring in between 1 and 10 patients in every 100) are:

Eye irritation (including burning and discomfort), eye pain, itchy eyes, visual disturbance.

Post-Marketing Data

The following adverse reactions or medically relevant adverse events have been reported since the drug has been marketed:

Uncommon side effects (occurring in between 1 and 10 patients in every 1000) are:

Allergic reactions (including eye or eyelid swelling), blurring of vision, increase in tear production (also known as tearing), sticky eye, crusting of the eyelid and/or drug residue, a feeling that something is in your eye, redness of the eye/eyelid, eyesight worsening, eye injury to the surface of the eye due to the tip of the vial touching the eye during use.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store carmellose sodium

• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Protect from light.
• Do not use this medicine after the expiry date which is stated on the single-dose container tab and the carton after EXP: The expiry date refers to the last day of that month.
• Pouch is required to prevent moisture loss.
• Once the pouch is opened, Keep the single dose containers in the pouch and place the pouch back in the outer carton.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
• Do not use if the packaging shows evidence of tampering. Do not use if solution changes colour or becomes cloudy. You should seek the advice of your pharmacist who will tell you what to do.

What Carmellose Sodium contains

• Each ml contains 10mg of the active ingredient, carmellose sodium.
• Carmellose Sodium also contains the following inactive ingredients: Sodium chloride, sodium lactate, potassium chloride, calcium chloride and purified water.

What Carmellose Sodium looks like and contents of the pack

Carmellose Sodium is a clear, colourless to slightly yellow viscous solution in a small see-through (bubble-like) casing (known as a ‘single-dose container’). The single-dose container has a twist-off cap.

Carmellose Sodium is available as single-dose containers containing 0.4 mls of solution in packs of 30, 60 and 90.

Product Licence holder

Procured from within the EU and repackaged by the PL holder: S&M Medical Ltd, Chemilines, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, Co Mayo, Ireland.

P] PL: 19488/0870

Leaflet revision date: 19 January 2021

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

S0870 LEAFLET Carmellose Sodium 20210119