ViSKERN 5 mg/ml eye drops in single-dose container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Viskern 5 mg/ml eye drops solution in single-dose container
Sodium carmellose
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine provided in this leaflet or those indicated 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days.
Contents of the leaflet:
- What Viskern is and what it is used for
- What you need to know before using Viskern
- How to use Viskern
- Possible adverse effects
- Storage of Viskern
- Contents of the pack and other information
1. What Viskern is and what it is used for
Viskern is a tear substitute and contains a lubricant called Natrium carmellose. This medicine is used for the symptomatic relief of eye irritation and dryness.
You should consult a doctor if your condition worsens or does not improve after 3 days.
2. What you need to know before using Viskern
Do not use Viskern
If you are allergic to carmellose sodium or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If irritation, pain, redness or changes in vision occur, or if you feel your condition worsens, stop using this medicine and consult your doctor or pharmacist.
Use of Viskern with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Viskern may be used during pregnancy and breastfeeding.
Driving and using machines
Viskern may cause short-term blurred vision, usually lasting from 1 to 15 minutes. If you experience temporary blurred vision, do not drive or operate machinery until your vision is clear.
3. How to use Viskern
Follow exactly the instructions for administering the medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Viskern is administered by the ophthalmic route (applied into the eye).
The recommended dose is one drop into 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 should be used immediately after opening. To avoid possible contamination of the dropper tip and the solution, the dropper must not come into contact with the eye or any other surface.
Wash your hands before use.
For correct administration, follow the instructions below:
- Remove a single-dose container from the strip.
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Check that the single-dose container is not damaged.
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Hold the single-dose container between the thumb and index finger of one hand.
With the thumb and index finger of the other hand, turn the winged piece at the end of the single-dose container two full turns.
- Gently pull off the winged piece.
- Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and squeeze it to apply one drop into each eye. Blink a few times.
Do not reuse the single-dose container, even if some solution remains.
If more than one ophthalmic medicine is being used, administration of the different medicines should be spaced at least 5 minutes apart.
If you use more Viskern than you should
This will not cause you any harm. If you are concerned, speak to your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered or ingested.
If you forget to use Viskern
Apply the next dose as needed, or according to the schedule prescribed by your doctor or pharmacist. Do not use a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Viskern may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported, but the number of affected individuals is unknown:
- Eye irritation, burning or stinging sensation,
- Blurred vision,
- Increased tear production (also known as watery eyes).
Reporting of adverse effects:
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Viskern
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
Store the single-dose containers in the original packaging.
Discard the opened single-dose container after use (do not reuse the container once opened for subsequent doses).
Do not use this medicine if you notice that the solution changes colour or becomes cloudy.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Viskern
- The active substance is sodium carmellose. Each ml of solution contains 5 mg of sodium carmellose.
- The other components are sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid and water for injections.
The components of Viskern have been designed to simulate the natural composition of your tear fluid.
Appearance of the product and contents of the pack
Viskern is supplied as single-dose containers containing 0.4 ml of sterile solution. Each cardboard box contains an aluminium pouch with 10 or 30 single-dose containers.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí (Barcelona)
Spain
Date of the most recent review of this leaflet: July 2014
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es