Liquivisc Tm 2.5mg/G Eye Gel
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Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use LIQUIVISC carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- 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.
OThea LIQUIVISC™
Package leaflet : 2-5 mg/g eye gel
information for the user Carbomer 974p
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Turn over
In this leaflet:
1. What LIQUIVISC is and what it is used for
2. Before you use LIQUIVISC
3. How to use LIQUIVISC
4. possible side effects
5. How to store LIQUIVISC
6. Further information
1.WHAT LIQUIVISC IS AND WHAT IT IS USED FOR
LIQUIVISC is a substitute for tears and contains a lubricant called Carbomer 974P.
It is an eye gel used for the relief of the symptoms of dry eye (such as soreness, burning, irritation or dryness) caused by your
eyes not producing enough
tears.
2.BEFORE YOU USE LIQUIVISC
Do NOT use LIQUIVISC:
• if you are allergic
(hypersensitive) to Carbomer or any of the other ingredients of LIQUIVISC listed in Section 6, “What LIQUIVISC contains”.
Take special care with
LIQUIVISC:
• if you wear soft contact lenses: you must remove them before using LIQUIVISC eye gel. After using LIQUIVISC, wait at least 30 minutes before putting your lenses back in. See also in Section 2, “Important information about some of the ingredients of LIQUIVISC”.
• if your condition worsens or has not improved after having started treatment with LIQUIVISC: Contact your doctor.
• DO NOT INJECT, DO NOT SWALLOW.
Children and adolescents aged to 18 years:
The safety and efficacy of LIQUIVISC in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you have to use any other eye medicine during treatment with LIQUIVISC: first use the other eye medicine, wait 15 minutes, then use LIQUIVISC.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, contact your doctor for advice before you start using LIQUIVISC.
He/she will decide if you can use LIQUIVISC.
Driving and using machines
Your sight may become blurred for a short time just after using LIQUIVISC. You should not drive or use machines until your sight is clear again.
Important information about some of the ingredients of LIQUIVISC
If you wear soft contact lenses you must remove them before using LIQUIVISC eye gel. After using LIQUIVISC, you have m
to wait at least 30 minutes before putting your lenses back in.
This is important because one of the ingredients of LIQUIVISC, called benzalkonium chloride, may cause eye irritation and can change the colour of soft contact lenses.
3.HOW TO USE LIQUIVISC
If LIQUIVISC has been recommended for you then use it exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose of
LIQUIVISC is 1 drop
in each eye that needs treatment, up to 4 times a day.
Children and adolescents aged to 18 years:
The safety and efficacy of LIQUIVISC in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.
Instructions for use
Do not use the bottle if the seal around the cap is broken before you first open it.
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1. |
Gently pull down the lower eyelid |
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of the eye | |
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w |
that needs treatment until there is a small |
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“pocket”. | |
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2. |
Turn the bottle upside down. |
|
Squeeze it to release 1 drop into the “pocket”. | |
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3. |
Let go of the lower lid, and |
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blink your eyes a few times. |
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4. |
Repeat the steps 1 to 3 for the other eye, if it also needs treatment. |
00.0000
Wash your hands before opening the bottle.
Tilt your head back and look at the ceiling.
To help prevent infection, do not let the tip of the bottle touch your eye, the surrounding tissue or anything else.
Put the screw cap back on to close the bottle, straight after you have used it.
Store the bottle in an upside down position as this helps drops to form the next time you use LIQUIVISC.
Once you have opened the bottle, you must not use it longer than 28 days;
please see also Section 5, “How to store LIQUIVISC”.
If you use more LIQUIVISC than you should
Using more drops of LIQUIVISC than you should will not cause you any harm.
If you forget to use LIQUIVISC
If you have missed a dose of LIQUIVISC continue with your next dose as normal.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.POSSIBLE SIDE EFFECTS
Like all medicines, LIQUIVISC can cause side effects, although not everybody gets them.
Contact your doctor if:
• your condition worsens or has not improved after having started treatment with LIQUIVISC.
If you experience any of the following side effects just after putting in the eye gel, talk to your doctor if they worry you:
• short-lived blurring of vision
• mild short-lived stinging
or feeling of burning in the eye.
The above mentioned side effects are known to occur, but the number of people likely to be affected can vary.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
UK
The Yellow Card Scheme. Website: www.mhra.gov. uk/yellowcard
Ireland
HPRA Pharmacovigilance Earlsfort Terrace IRL-Dublin 2 Tel: +353 1 676 4971 Fax: +353 1 676 2517 Website: www.hpra.ie e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
5.HOW TO STORE LIQUIVISC
Keep out of the reach and sight of children.
Do not use LIQUIVISC after the expiry date which is stated on the bottle label and the carton after ‘EXP.’. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light. Store the bottle in an upside down position as this helps drops to form the next time you use LIQUIVISC.
You must throw away the bottle 28 days after you first opened it, even if there are still some drops left.
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.
6.FURTHER INFORMATION
What LIQUIVISC contains
• The active ingredient is Carbomer974P 2.5 mg/g.
• The other ingredients are benzalkonium chloride, sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol, water for injections.
What LIQUIVISC looks like and contents of the pack
LIQUIVISC is a slightly yellow opalescent gel in a plastic bottle with a screw-cap.
Each bottle contains 10 g of eye gel.
Each pack contains 1 bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratoires Thea 12 rue Louis Bleriot 63017 Clermont-Ferrand Cedex 2 FRANCE Manufacturer: URSAPHARM, Arzneimittel GmbH
Industriestrasse 66129 Saarbriicken Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
France, Spain, Italy, Portugal, The Netherlands
and Greece:.....SICCAFLUID
United Kingdom and
Ireland:...............LIQUIVISC
Iceland and Norway:..........
.............................OFTAGEL
This leaflet was last approved in 03/2015.
PL 20162/0009 PA 1107/2/1
N830G1OAS P-2-Bis