Leaflet: information for the user

Viskern 5 mg/ml eye drops in single-dose solution

Sodium carmelose

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

1. What Viskern is and what it is used for

2. What you need to know before using Viskern

3. How to use Viskern

4. Possible side effects

5. Storage of Viskern

6. Contents of the pack and additional information

Viskern is an eye drop substitute and contains a lubricant called sodium carboxymethylcellulose. This medication is used for symptomatic relief of eye irritation and dryness.

You should consult a doctor if it worsens or does not improve after 3 days.

Do not use Viskern

Si you are allergic to sodium caramel or any of the other components of this medication (including those listed in section 6).

Warnings and precautions

If irritation, pain, redness, or changes in vision occur, or if you consider your condition to worsen, stop using this medication and consult your doctor or pharmacist.

Use of Viskern with other medications

Inform your doctor or pharmacist if you are using, have used, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Viskern may be used during pregnancy and breastfeeding.

Driving and operating machines

Viskern may cause temporary blurred vision, usually lasting from 1 to 15 minutes. If you experience temporary blurred vision, do not drive or use machines until your vision is clear.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Viskern is used by ocular route (applied to the eye).

The recommended dose is one drop in the affected eye(s) as often as necessary or as directed by your specialist.

Ensure the single-dose container is intact before use. The solution must be used immediately after opening. To avoid possible contamination of the dropper tip and solution, the dropper should not come into contact with the eye or any other surface.

Wash your hands before use.

To ensure correct administration, follow the following instructions:

1.Remove a single-dose container from the strip.

2.Check that the single-dose container is not damaged.

3.Hold the single-dose container between the index and middle fingers of one hand.

With the index and middle fingers of the other hand, turn two full turns the winged piece located at the end of the monodose.

4.Gently pull to remove the winged piece.

5.Gently pull the lower eyelid down to form a pouch. Turn the single-dose container downwards and press it to apply one drop to each eye. Blink a couple of times.

Do not use the single-dose container again even if there is solution remaining.

If more than one medication is used by ocular route, the applications of the different medications should be spaced at least 5 minutes apart.

If you use more Viskern than you should

No harm will be done. If you are concerned, speak with your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount administered or ingested.

If you forgot to use Viskern

Apply the next dose as needed, or following the normal schedule indicated by your doctor or pharmacist. Do not use a double dose to compensate for missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Viskern may cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported, but the number of people affected is unknown:

• Eye irritation, burning sensation, or stinging,
• Blurred vision,
• Increased tear production (also known as tearing).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store single-dose containers in the original packaging.

Dispose of the opened single-dose container after use (do not reuse the container once opened for subsequent doses).

Do not use this medication if you observe that the solution changes color or becomes cloudy.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the Sigre Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Viskern

• The active principle is sodium carboxymethylcellulose. Each ml of solution contains 5 mg of sodium carboxymethylcellulose.
• The other components are sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, and water for injection preparations.

The components of Viskern have been designed to simulate the natural composition of your tear.

Appearance of the product and contents of the packaging

Viskern is presented in single-dose containers of 0.4 ml sterile solution. Each cardboard box contains an aluminum bag with 10 or 30 single-dose containers.

Only some sizes of containers may be commercially marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:July2014

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es