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

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

Do not use Carmelosa Stada

If you are allergic to carmelosa sodium or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Carmelosa Stada.

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

Using Carmelosa Stada with other medications

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

Pregnancyand 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.

This medication can be used during pregnancy and breastfeeding.

Driving and using machines

This medication 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 Stada

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

Carmelosa Stada 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 indicated 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 single-dose container from the strip.

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, perform a slight lever on the winged piece to open it. Do not twist to break.

1. Gently pull to remove the winged piece.

1. Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and squeeze 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 Stada than you should

It will not cause you any harm. 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, Telephone 91 562 04 20, indicating the medication and the amount administered or ingested.

If you forget to use Carmelosa Stada

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, this medication can cause side effects, although not everyone will experience them.

The adverse reactions or side effects that are medically relevant and mentioned below have been identified in clinical trials:

Common side effects(may affect up to 1 in 10 patients):

Ocular irritation (including burning and discomfort), eye pain, ocular itching, visual disturbances.

Post-marketing experience

The adverse reactions or side effects that are medically relevant and mentioned below have been reported in post-marketing experience:

Uncommon side effects(may affect up to 1 in 100 people):

Allergic reaction (including ocular or eyelid inflammation), blurred vision, increased tear production (also known as lacrimation), sticky eye, crust on the eyelid and/or medication residue, ocular or eyelid redness, worsening of vision, injury to the eye surface due to the dropper coming into contact with the eye during administration of the eye drops.

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 package leaflet. You can also report them 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 Stada

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the container after "EXP". 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 once opened 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 Collection 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 container and additional information

Composition of Carmelosa Stada

• 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 Stada have been designed to simulate the natural composition of your tear.

Appearance of the product and contents of the container

Carmelosa Stada 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 some container sizes may be marketed.

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the last revision of this package leaflet:January 2018

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.gob.es