NOTICE
ANSM - Updated on : 08/07/2022
Product name
REFRESH, eye drops in single-dose container
Polyninyl alcohol/Povidone
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is REFRESH eye drops in single-dose containers and what is it used for?
2. What do I need to know before using REFRESH eye drops in single-dose containers?
3. How should REFRESH eye drops be used?
4. What are the possible side effects?
5. How should REFRESH single-dose eye drops be stored?
6. Package contents and other information.
1. WHAT IS REFRESH, eye drops in single-dose containers AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: tear substitutes - ATC code: S01XA20
This medicine is used to relieve signs of irritation linked to dry eyes (when there are insufficient tears).
You should consult your doctor if you do not feel any improvement or if you feel worse.
2. WHAT DO I HAVE TO KNOW BEFORE USING REFRESH, eye drops in single-dose containers?
Never use REFRESH, eye drops in single-dose containers:
- if you are allergic to polyvinyl alcohol and povidone or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Talk to your doctor before using REFRESH.
Stop using REFRESH and consult your doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if dry eye symptoms worsen.
This ophthalmic solution comes in a single-dose, single-use container and contains no preservatives. There is therefore a risk of rapid bacterial contamination. To avoid contamination of the eye drops or possible damage to the eye, do not bring the tip of the single-dose eye drop into contact with the eye or any other surface.
Single-dose eye drops should be discarded immediately after use and not stored for future use.
Do not use if solution changes color or becomes cloudy.
Children
Not applicable.
Other medicinal products and REFRESH, eye drops in single-dose containers
In case of concomitant treatment with another eye drop, wait 15 minutes between instillations and finish with the most viscous product.
REFRESH may delay the penetration of other medications, and should be instilled last if it is the most viscous.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
REFRESH, eye drops in single-dose containers with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving vehicles and operating machinery
Vision may be blurred after instillation, which may impair the ability to drive or operate machinery. In such cases, patients should be advised not to drive or operate machinery until normal vision has been restored.
3. HOW SHOULD I USE REFRESH eye drops in single-dose containers?
Always use this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is 1 drop in the eye(s) to be treated 3 to 4 times a day, and up to 8 times a day if eye dryness persists.
Method of administration
Local use.
OCULAR INSTILLATION.
One single dose treats both eyes.
Use a new single dose for each application during the day.
To ensure proper use of eye drops, certain precautions must be taken:
- Wash hands thoroughly before use.
- Do not touch the eye or any other surface with the dropper tip.
- Do not use the unit-dose if the cap appears broken before use.
To use a single-dose unit, proceed as follows:
1. Detach a single dose from the blister pack
2. Hold the unit-dose vertically (cap upwards). To open the unit-dose, turn the flat part all the way round to break the seal.
3. Gently pull the lower eyelid downwards, looking upwards. Invert the unit-dose and press lightly to drop 1 drop into the eye(s) to be treated. Blink several times.
When the single-dose container has been used, discard immediately. Do not store or reuse.
Frequency of administration
Distribute instillations throughout the day, as needed.
Duration of treatment
If problems persist or worsen, consult an ophthalmologist to adjust your treatment.
If you have used more REFRESH eye drops in single-dose containers than you should have
Consult your doctor or pharmacist immediately.
If you forget to use REFRESH, eye drops in single-dose containers
Do not take a double dose to make up for the single dose you forgot to take, but simply continue your treatment.
If you stop using REFRESH, eye drops in single-dose containers
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
Transient cases of tingling or irritation may occur when REFRESH is administered.
The number of people affected by the following adverse reactions is not known:
Eye reactions :
- Eye irritation,
- Ocular pain,
- Reddening of the conjunctiva (transparent membrane of the eye),
- Blurred vision,
- Ocular itching,
- Sensation of foreign body,
- stuck eye,
- Ocular redness,
- Tearing,
- Hypersensitivity.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE REFRESH, eye drops in single-dose containers?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the bottle after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not keep the unidose after opening.
Do not use this medicine if you notice any damage.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What REFRESH eye drops in single-dose containers contain
- The active ingredients are :
Polyvinyl alcohol..................................................................................................... 5.60 mg
Povidone..................................................................................................................... 2.40 mg
per 0.4 ml single-dose container.
- Other ingredients include: sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment), purified water.
What REFRESH is and what it contains
REFRESH comes in a plastic single-dose container containing 0.4 ml of eye drops.
Each pack contains 5, 10, 30 or 90 single-dose containers.
Not all presentations may be marketed.
Marketing authorization holder
ABBVIE
10 RUE DARCUEIL
94528 RUNGIS CEDEX
Marketing authorization holder
ABBVIE
10 RUE DARCUEIL
94528 RUNGIS CEDEX
Manufacturer
ALLERGAN PHARMACEUTICALS IRELAND
WESTPORT
CO. MAYO
IRELAND
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.