Label: InformationfortheUser

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

Carmelose sodium

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to 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 not listed in this label. See section 4
• You should consult a doctor if your condition worsens or does not improve after 3 days.

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

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

3. How to use Carmelosa Stada

4. Possible adverse effects

5. Storage of Carmelosa Stada

6. Contents of the package and additional information

Carmelosa Stada belongs to a group of medications known as artificial tears, a tear 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 Stada

If you are allergic to sodium carmellose 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.

Stop using this medication and consult your doctor or pharmacist if irritation, pain, redness, or changes in vision occur, or if you think your condition is worsening.

Use of Carmelosa Stada with other medications

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication can be used during pregnancy and breastfeeding.

Driving and operating machines

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

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

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

Therecommendeddoseisonedropintheeyeoreyesaffectedasmanytimesasnecessaryoraccordingtoyourspecialist.

Make sure the single-use container is intact before use. The solution must be used immediately after opening. To avoidapossiblecontaminationofthedropperandthesolution, 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 asingle-usecontainerfromthestrip.

2.Check thatthesingle-usecontainerisnotdamaged.

3.Holdthesingle-usecontainerbetweentheindexandthumbofonehand.

With the index and thumb of the other hand,performalightleveronthewingedpiecetoopenit.Donotrotatetobreakit.

4.Pullgentlytoremovethewingedpiece.

5.Lowerthecontainerslightlybelowthelowerlidtoformapouchandturnthecontainerdownwardsandpressittoapplyonedropineacheyeandblinkingafewtimes.

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

Ifyouusemorethanonemedicationbyocularroute,theapplicationsofthedifferentmedicamentsmustbespacedatleast5minutesapart.

If you use more Carmelosa Stada than you should

You will not be harmed. 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 Stada

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 the missed doses.

If you have any other doubts about the use of this medication, ask your doctororpharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The adverse reactions or medically relevant adverse effects listed below have been identified in clinical trials:

Frequent Adverse Effects(may affect up to 1 in 10 patients):

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

Post-Marketing Experience

The adverse reactions or medically relevant adverse effects listed below have been reported in post-marketing experience:

Infrequent Adverse Effects(may affect up to 1 in 100 people):

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

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 through the Spanish System of Pharmacovigilance of Medicines 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.

Storethesingle-dosepackagingintheoriginalpackaging.

Disposeofthesingle-dosepackagingafteruse(donotre-usethepackagingonceopenedforsubsequentdoses).

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. Dispose of the packaging and medications you no longer need at the Pharmacy Take-BackPoint. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Carmelosa Stada

• The active principle is sodium carmellose.Eachmlofsolutioncontains5 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.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 package

CarmelosaStadaispresentedinsingle-dosecontainersof0.4mlofsterilesolution.Eachcartoncontainsonealuminumbagwith10or30single-dosecontainers.

Only some package sizes may be commercially available.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for Manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:January 2018

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