Hyprosan

Document: Hyprosan eye-drops, solution ENG PL change

Package leaflet: Information for the user

Hyprosan 3.2 mg/ml eye drops, solution

Hypromellose

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You must talk to a doctor if your symptoms do not get better, or if they get worse.

What is in this leaflet:

1. What Hyprosan is and what it is used for

2. What you need to know before you use Hyprosan

3. How to use Hyprosan

4. Possible side effects

How to store Hyprosan

Contents of the pack and other information

1. What HYPROSAN is and what it is used for

Hyprosan is a substitute for natural tears that moistens and lubricates the eyes. Hyprosan eye drops are used to treat symptoms of dry eyes.

You must talk to a doctor if your symptoms do not get better, or if they get worse.

2. What you need to know before you use HYPROSAN

Do not use Hyprosan

if you are allergic to hypromellose or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

None.

Children and adolescents

Hyprosan has not been tested in children and adolescents. Therefore it must not be used in children or adolescents aged under 18 years.

Other medicines and Hyprosan

If administering other medicinal products into the eye, Hyprosan should always be applied last and no earlier than 5 minutes after the other medicinal products.

Pregnancy, breast-feeding and fertility

Hyprosan can be used during pregnancy and breast feeding.

Driving and using machines

The eye drops may cause short-term blurring of vision. If this happens to you, do not drive or use machines until your vision is fully restored.

Contact Lenses

Hyprosan does not contain any preservative. It can therefore be used together with contact lenses.

3. How to use HYPROSAN

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 1 drop in each eye three times a day, or as needed.

Before instillation of the eye drops:

wash your hands before opening the bottle
when opening the bottle for the very first time, drop one drop to waste
choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror)

Instillation:

Hold the bottle directly below the cap and turn the cap to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.

Tilt your head backwards and hold the bottle above your eye.

Pull the lower eyelid down and look up. Squeeze the bottle gently and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.

B
link a few times so that the drop spreads over the eye. Recap the bottle.

Shake the bottle once downwards to get rid of any remaining solution from the top. Follow the instructions 2. – 4. for dropping Hyprosan also into the other eye.

Before recapping the bottle, shake it once downwards in order to keep the tip surrounding dry.

There might remain a small amount of solution in the bottle at the end. This is accounted for by an overfill of all bottles ensuring that 10 ml solution can always be dispensed.

If administering other medicinal products into the eye, Hyprosan should always be applied lastand no earlier than 5 minutes after the other medicinal products.

Use in children and adolescents

Hyprosan should not be used in children or adolescents aged under 18 years.

If you use more Hyprosan than you should

There are no known reactions of overdosing Hyprosan.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have occurred:

Uncommon (may affect up to 1 in 100 people): local burning, eye pain and blurred vision.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store HYPROSAN

Keep this medicine out of the sight and reach of children.

Store below 25°C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.

After first opening the bottle, the solution can be used for 4 weeks. The bottle must be kept tightly closed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Hyprosan contains

The active substance is hypromellose. 1 ml solution contains 3.2 mg hypromellose.
The other ingredients are disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sorbitol, water for injections.

What Hyprosan looks like and contents of the pack

Hyprosan solution is a clear colourless solution provided in a transparent plastic bottlewith a white Novelia^TMnozzle with white plastic screw cap.

Pack sizes: 1x10 ml, 3x10ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Santen Oy,

Niittyhaankatu 20, 33720 Tampere

Finland

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in 2015-07-02