CARMELOSE QUALIGEN 5 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

Introduction

Leaflet: information for theuser

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

Carmelosa sodium

Read the entire leaflet carefully before starting touse thismedication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the leaflet

1. What is Carmelosa Qualigen and what is it 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 package and additional information

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

Carmelosa Qualigen is a tear substitute and contains a lubricant called carmelosa sodium. This medication is used for the symptomatic relief of eye irritation and dryness.

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

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

Do not use Carmelosa Qualigen

If you are allergic to carmelosa sodium 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 think your situation is worsening, stop using this medication and consult your doctor or pharmacist.

Using Carmelosa Qualigen with other medications

Tell 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Carmelosa Qualigen can be used during pregnancy and breastfeeding.

Driving and using machines

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

3. How to use Carmelosa Qualigen

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

Carmelosa Qualigen is used via the ocular route (applied to the eye).

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

Make sure the single-dose container is intact before use. The solution should be used immediately after opening. To avoid 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.

For correct administration, follow these instructions:

1. Remove a unit from the strip of single-dose containers.

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

1. Hold the single-dose container between the index and thumb fingers of one hand.

With the index and thumb fingers of the other hand, gently lever the winged piece to open it. Do not twist to break.

1. Remove the winged piece.

1. Pull the lower eyelid down to form a pocket. Turn the single-dose container upside down and squeeze it to apply one drop to each eye. Blink a few times.

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

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

If you use more Carmelosa Qualigen than you should

It will not harm you. If you are concerned, talk to your doctor or pharmacist.

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

If you forget to use Carmelosa Qualigen

Apply the next dose as needed, or following the usual schedule indicated by your doctor or pharmacist. Do not use a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, Carmelosa Qualigen can cause side effects, although not everyone may experience them.

The following side effects have been reported, but the number of people who may be affected is unknown:

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

Reporting side effects:

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

5. Storage of Carmelosa Qualigen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the container after "CAD". The expiration date is 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 for subsequent doses).

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

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the Sigre Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of Carmelosa Qualigen

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

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

Appearance of the product and contents of the package

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

Only certain package sizes may be marketed.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), Spain

Date of the last revision of this leaflet:July 2013

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es