1 mg / ml + 3 mg / ml eye drops, solution, single dose container
dextran 70 / hypromellos
1. What Bion Tears is and what it is used for
Bion Tears contains the active substances dextran 70 and hypromellose.
Eye drops single-dose containers. Bion Tears belongs to the tear substitutes.
Bion Tears are used to relieve the symptoms of mild to severely dry eyes.
Dextran 70 and hypromellose contained in Bion Tears may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before using Bion Tears
Do not use Bion Tears
- if you are allergic to dextran 70 or hypromellose or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Bion Tears.
If you experience headache, eye pain, vision changes, eye irritation, persistent redness of the eye, or if symptoms worsen or persist for more than 3 days, discontinue use and consult a physician.
Do not use Bion Tears if you notice that the solution has changed color or become cloudy.
Other drugs and Bion Tears
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
Bion Tears can be used during pregnancy and lactation and is not expected to have any effect on fertility.
Driving and using machines
If blurred vision or other visual disturbances occur after using Bion Tears, wait to drive and use machines until vision clears again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Bion Tears
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
Adults and the elderly
1-2 drops are applied to the affected eye 3-4 times a day unless a doctor prescribes otherwise.
The eye drops can be used together with contact lenses.
If you have the impression that the effect of Bion Tears is too strong or too weak, talk to your doctor or pharmacist.
Use only Bion Tears to drip into the eyes.
How to use Bion Tears properly
1.
2.
3.
- Wash your hands and sit in front of a mirror.
- Open the foil bag and remove the strip with 4 containers.
- Hold the strip with the long, flat end at the top and pull off one container by pulling it towards you while holding the others firmly. You must unscrew it from the joint with the others (Fig. 1).
- Keep one container and put the others back in the foil bag.
- Hold the long, flat part of the container between your thumb and forefinger and open it by turning the other end (Fig. 2).
- Tilt your head back. Pull down the lower eyelid with a clean finger, until a “pocket” is formed between the lower eyelid and the eye. This is where the drop should be placed.
- Hold the container between your thumb and forefinger with the open end down.
- Hold the tip of the container close to the eye. Use a mirror if it helps.
- Avoid touching the eye or eyelid, surrounding areas, or anything else with the tip of the container. It can contaminate the eye drops.
- Gently squeeze the container to release one drop of Bion Tears at a time (Figure 3).
- If you are using Bion Tears in both eyes, repeat steps 6-10 for the other eye with the same container.
- Dispose of the container including the remaining solution immediately after use.
If a drop misses the eye, try again.
If you use other eye drops or ointments, wait at least 5 minutes between each preparation. Eye ointments should be used last.
If you forget to use Bion Tears
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been seen with Bion Tears:
Very common (may affect more than 1 user in 10)
Effects in the eye: blurred vision.
Common (may affect up to 1 in 10 people)
Effects in the eye: dry eyes, eyelid disorder, abnormal feeling, or sensation of foreign body in the eye, discomfort in the eyes.
Uncommon (may affect up to 1 in 100 people)
Eye effects: itchy eye, eye irritation, or red-eye.
General side effects: headache.
Has been reported (occurs in an unknown number of users)
Effects in the eye: redness of the eyelid, pain or swelling in the eye, discharge from the eye, crusting of the eyelids, increased tear flow.
General side effects: an allergy (hypersensitivity).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bion Tears
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP:”. The expiration date is the last day of the specified month.
Dispose of the single-dose container immediately after use.
Unused single-dose containers must be discarded 4 days after opening the foil pouch.
No special storage instructions.
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. Contents of the packaging and other information
Content declaration
- The active substances are dextran 70 and hypromellose. 1 ml solution contains 1 mg dextran 70 and 3.0 mg hypromellose.
- Other excipients are sodium chloride, potassium chloride, calcium chloride, magnesium chloride, zinc chloride, sodium bicarbonate, carbon dioxide (for adjustment), and purified water.
What the medicine looks like and the contents of the pack
Bion Tears is a clear, colorless solution supplied in a 0.4 ml single-dose container.
4 single-dose containers are packed in a foil bag.
Pack size: 28 x 0.4 ml.
Marketing Authorisation Holder
Alcon Nordic A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer
SA Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium