Leaflet: information for theuser

Carmelosa Qualigen 5 mg/ml eye drops in single-dose container

Sodium Carmelose

Read this leaflet carefully before you start using thismedicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by yourdoctor 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 you get worse or do not improve after 3 days.

1.What is Carmelosa Qualigen and what it is used for

2.What you need to know before starting to use Carmelosa Qualigen

3.How to use Carmelosa Qualigen

4.Possible side effects

5.Storage of Carmelosa Qualigen

6.Contents of the container and additional information

Carmelosa Qualigen is an eye drop substitute and contains a lubricant called sodium carmelose. 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 Carmelosa Qualigen

If you are allergic to sodium carmellose or any of the other components of this medication (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 Carmelosa Qualigen 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, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Carmelosa Qualigen may be used during pregnancy and breastfeeding.

Driving and operating machinery

Carmelosa Qualigen may cause temporary 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.

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

Carmelosa Qualigen is used by ocular route (applied in the eye).

The recommended dose is one drop in the affected eye or eyes as many times as necessary or as indicated by your specialist.

Ensure that the single-dose container is intact before use. The solution must be used immediately after opening. To avoid a possible contamination of the dropper and the 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.Release one unit from the strip of single-dose containers.

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, perform a gentle lever action on the winged piece to open it. Do not turn to break.

4.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 Carmelosa Qualigen than you should

No harm will be caused. 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, Teléfono 91 562 04 20, indicating the medication and the amount administered or ingested.

If you forgot to use Carmelosa Qualigen

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, Carmelosa Qualigen 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.

Storethe single-dose containers in the original packaging.

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

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

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

Composition of Carmelosa Qualigen

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

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

Appearance of the product and contents of the packaging

Carmelosa Qualigen is presented in single-dose vials of 0.4 ml sterile solution. Each cardboard box contains a foil pouch with 10 or 30 single-dose vials.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for Manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), Spain

Last review date of this leaflet: July 2013

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