NOTICE
ANSM - Updated on : 17/01/2019
Product name
DACRYUM, ophthalmic solution in single-dose container
Borax / Boric acid
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided 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 DACRYUM ophthalmic solution in single-dose containers and what is it used for?
2. What do I need to know before using DACRYUM, ophthalmic solution in a single-dose container?
3. How do I use DACRYUM, ophthalmic solution in a single-dose container?
4. What are the possible side effects?
5. How should DACRYUM ophthalmic solution be stored?
6. Package contents and other information.
1. WHAT IS DACRYUM, ophthalmic solution in a single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic class OTHER ANTI-INFECTING agents - ATC code: S01AX.
Eyewash in case of irritation.
2. WHAT DO I HAVE TO KNOW BEFORE USING DACRYUM, eyewash solution in single-dose container?
Never use DACRYUM, ophthalmic solution in a single-dose container:
- if you are allergic to boric acid, borax or any of the other ingredients listed in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Talk to your doctor or pharmacist before using DACRYUM, solution for ophthalmic lavage in single-dose containers.
Do not inject or swallow.
If eye irritation persists without improvement or worsens after 2 days of treatment, or if new symptoms appear, discontinue use and consult a doctor.
This treatment is not intended for contact lens irritation.
If you wear contact lenses, you may use this product, but you must remove them before washing your eye.
An opened single-dose vial should never be reused for subsequent administrations, as this product does not contain a preservative, and there is a risk of rapid bacterial contamination.
Discard the single-dose container immediately after use.
Medical advice should be sought in the event of eye disorders, unusual eye symptoms, reduced visual acuity or eye pain.
If symptoms persist or worsen, or if new symptoms appear, discontinue treatment and consult a doctor.
Children and adolescents
Not applicable.
Other drugs and DACRYUM, ophthalmic solution in single-dose container
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DACRYUM, ophthalmic solution in a single-dose container with food and drink
Not applicable.
Pregnancy and breast-feeding
This medicine should be used with caution during pregnancy and while 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
Use with caution when driving a vehicle or operating machinery, as your vision may be blurred immediately after use. In this case, it is advisable not to drive or operate machinery until vision returns to normal.
3. HOW DO I USE DACRYUM, ophthalmic solution 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 to 3 eye washes per day.
Washes are made directly by jet by turning the single-dose bottle upside down and pressing lightly on it, taking care not to bring the single-dose bottle into contact with the surface of the eye, and wiping off any excess with a compress or absorbent cotton.
Local use.
EYE ROUTE.
Wash hands thoroughly.
Avoid touching the eye or eyelids with the tip of the unit-dose container.
The same container can be used to treat both eyes.
Use immediately after opening and discard after use.
Do not reuse a previously opened container.
In the event of concomitant treatment with eye drops, wait 15 minutes before instilling.
Treatment is limited to 2 days without medical advice.
If you have used more DACRYUM, ophthalmic solution in a single-dose container than you should have and you experience any undesirable effects, rinse with sterile saline solution and inform your doctor or pharmacist immediately. If swallowed, seek medical advice or contact a Poison Control Centre immediately.
If you forget to use DACRYUM, ophthalmic solution in single-dose container
Not applicable.
If you stop using DACRYUM, solution for ophthalmic lavage in a single-dose container
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.
Rare adverse reactions (occurring in 1 to 10 people out of 10,000) :
- Eye irritation
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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE DACRYUM, ophthalmic solution in single-dose container?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the bottle. The expiration date refers to the last day of that month.
Before opening : No special storage precautions.
After opening : Discard single-dose container after use.
Do not reuse opened single-dose containers.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DACRYUM ophthalmic solution in single-dose container contains
- The active ingredients are :
Borax................................................................................................................................ 1.2 g
Boric acid.................................................................................................................... 1.8 g
Per 100 ml solution
- Other ingredients are : Sodium chloride, distilled rose water, purified water.
What DACRYUM ophthalmic solution in single-dose container is and what it contains
This medicine is presented in the form of an ophthalmic solution.
Single-dose container of 5 ml.
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN
Manufacturer
LABORATOIRE UNITHER
ESPACE INDUSTRIEL NORD
151 RUE ANDRE DUROUCHEZ
CS 28028
80084 AMIENS CEDEX 2
or
UNITHER
Z.I. DE LA GUERIE
50211 COUTANCES CEDEX
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].
Other
Detailed information on this drug is available on the ANSM(France) website.
Advice / Health education :
Eye irritation is a common, benign condition.
Eyewash is a therapeutic gesture that can be sufficient to relieve superficial irritation of the eye.
In fact, eyewashing facilitates the removal of foreign bodies that irritate the eye, such as sand, gnats, dust and make-up debris, and helps reduce the sensation of discomfort.
Other factors may cause irritation and not respond to eyewash. In such cases, you should consult your doctor.