NOTICE
ANSM - Updated on : 21/09/2023
Product name
NUTRIVISC 5 PER CENT, eye drops solution
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 any advice or information you may need.
- 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 after a few days of treatment.
What does this leaflet contain?
1. What is NUTRIVISC 5 PER CENT, eye drops solution and what is it used for?
2. What do I need to know before using NUTRIVISC 5 PER CENT, eye drops solution?
3. How should NUTRIVISC 5 PER CENT Eyedrops solution be used?
4. What are the possible side effects?
5. How do I keep NUTRIVISC 5 PER CENT, eye drops solution?
6. Package contents and other information.
1. WHAT IS NUTRIVISC 5 PER CENT, eye drops solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Other ophthalmological drugs - ATC code: S01XA20.
NUTRIVISC 5 PER CENT, eye drops solution contains povidone. This component replaces and plays the same role as tears.
This medicine is used to treat dry eye (symptomatic treatment of dry eye syndrome).
You should contact your doctor if you do not feel any improvement or if you feel worse after a few days of treatment.
2. WHAT DO I HAVE TO KNOW BEFORE USING NUTRIVISC 5 PER CENT, eye drops solution?
Never use NUTRIVISC 5 PER CENT, eye drops solution:
- if you are allergic to povidone or any of the other ingredients listed in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before using NUTRIVISC 5 PER CENT, eye drops solution.
Take special care with NUTRIVISC 5 PER CENT, eye drops solution:
- Do not swallow or inject this product.
- Wash your hands thoroughly before use.
- Avoid touching your eyelids with the tip of the bottle, to avoid the risk of contaminating the eye drops and injuring your eye.
- Close the bottle carefully after use.
- If symptoms persist or worsen, consult your doctor.
- If you need to use another eye drop, wait 15 minutes between applications. NUTRIVISC 5 PER CENT, eye drops solution should always be applied last.
If you experience headache, eye pain, blurred vision, eye irritation, persistent redness, or if symptoms persist or worsen, stop using NUTRIVISC 5 PER CENT, eye drops immediately and consult your doctor.
Benzalkonium chloride
This medicine contains 0.0018 mg benzalkonium chloride per dose, equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you suffer from dry eye syndrome or corneal disorders (clear coating on the front of the eye). In the event of abnormal sensation, tingling or pain in the eyes after using this medicine, contact your doctor.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Other medicines and NUTRIVISC 5 PER CENT, eye drops solution
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
NUTRIVISC 5 PER CENT, eye drops solution with food and drink
Not applicable.
Pregnancy and breast-feeding
Pregnancy
NUTRIVISC 5 PER CENT, eye drops solution may be used during pregnancy, if necessary.
Lactation
NUTRIVISC 5 PER CENT, ophthalmic solution may be used during lactation, if necessary.
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
Blurred vision may affect your ability to drive and operate machinery. In this case, wait until normal vision is restored before driving a vehicle or operating machinery.
NUTRIVISC 5 PER CENT, eye drops contains benzalkonium chloride.
3. HOW DO I USE NUTRIVISC 5 PER CENT, eye drops solution?
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.
Dosage and frequency of administration
Adults (including the elderly)
Apply 1 drop of eye drops, 4 times a day or as prescribed, depending on the severity of symptoms.
Apply 1 drop of eye drops when eye problems (dryness, burning, itching) are felt.
Use in children
The use of this eye drop is not recommended for children.
Method of administration
Local route (ophthalmic route).
FOR OCULAR INSTILLATION ONLY.
When using this eye drop, please observe the following steps:
1. Wash your hands thoroughly before handling the eye drops.
2. After removing the cap, if the safety ring is too loose, remove it before using the product.
3. Avoid contact between the tip of the bottle and the eye or eyelids to avoid contamination of the eye drops and injury to the eye.
4. Gently pull the lower eyelid downwards while looking upwards.
5. Place a drop of eye drops in the space formed.
6. Carefully recap the bottle after use.
If the drop falls next to your eye, try again.
If you are using other eye drops or ointments, wait at least 15 minutes between instillations. Ophthalmic ointments should be applied last.
If you have used more NUTRIVISC 5 PER CENT, eye drops solution than you should have
No adverse effects are expected.
If you forget to use NUTRIVISC 5 PER CENT, eye drops solution
Not applicable.
If you stop using NUTRIVISC 5 PER CENT, eye drops solution
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
The following adverse reactions, for which the frequency is unknown (cannot be estimated on the basis of available data), have been reported following use of NUTRIVISC 5 PER CENT, eye drops in solution:
Eye disorders
Undetermined frequency: blurred vision, ocular pain, ocular itching, ocular irritation, abnormal sensation in the eye, redness in the eye (ocular hyperemia), transient sensation of burning or stuck eyelids.
Immune system disorders
Undetermined frequency: irritation reactions, allergic reactions to the drug (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: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE NUTRIVISC 5 PER CENT, eye drops solution?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the bottle. The expiration date refers to the last day of that month.
Store at temperatures not exceeding +25°C.
After first opening, do not use for more than 4 weeks.
Do not use if you notice any visible signs of deterioration.
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 NUTRIVISC 5 PER CENT, eye drops solution contains
- The active substance is :
Povidone............................................................................................................................. 5 g
For 100 ml of eye drops.
- The other components are :
Boric acid, sodium chloride, sodium lactate, potassium chloride, calcium chloride, magnesium chloride, sodium hydroxide, benzalkonium chloride (see section 2), water for injection.
What NUTRIVISC 5 PER CENT is and what it contains
This medicine is available as an eye drop.
10 ml bottle.
Marketing authorization holder
LABORATOIRES ALCON
20 RUE DES DEUX GARES
92500 RUEIL-MALMAISON
Marketing authorization holder
LABORATOIRES ALCON
20 RUE DES DEUX GARES
92500 RUEIL-MALMAISON
Manufacturer
ALCON LABORATORIES BELGIUM
LICHTERVELD 3
2870 PUURS-SINT-AMANDS
BELGIUM
Product 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].
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.