Package Insert: Information for the User

Hipromelosa STADA 3.2 mg/ml Eye Drops in Single-Dose Container

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

• Follow exactly the administration instructions contained in this package insert or those provided by your doctor or pharmacist.
• Keep this package insert, as you may need to refer to it again.
• For advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after3days.

Hipromelosa STADA is a medication that belongs to the group of artificial tearsandis indicated for symptomatic relief of eye irritation and dryness.

You should consult a doctor if it worsens or does not improve after3days.

Do not use Hipromelosa STADA

If you are allergic to hypromellose or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hipromelosa STADA.

If irritation, pain, redness, or changes in vision occur, or if you consider your condition to worsen, stop using this medicine and consult your doctor or pharmacist.

Use of Hipromelosa STADA with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or might have to use any other medicine.

In intraocular application, no interactions with other medicines have been described to date.

Pregnancy and breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you might be pregnant, consult your doctor or pharmacist before using this medicine.

No experience is available regarding the safety of this product during pregnancy or breastfeeding.

Driving and operating machines

No effects on the ability to drive or operate machinery have been described due to the use of Hipromelosa STADA.

Hipromelosa STADA contains sodium dodecahydrate hydrogen phosphate and dihydrogen sodium phosphate dihydrate

This medicine contains 0.95 mg of phosphates in each single-dose container, equivalent to 1.9 mg/ml.

If you suffer from severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in very rare cases, may cause blurred vision due to calcium accumulation.

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

Hipromelosa STADA is used by ocular route, as eye drops.

The recommended dose is one drop in the affected eye(s) 3 to 5 times a day or, if necessary, more frequently or as indicated by your specialist.

Ensure the single-use container is intact before use. The solution must be used immediately after opening. To avoid possible contamination of the dropper and solution, the dropper should not come into contact with the eye or any other surface.

Wash your hands before use.

For correct administration, follow the following instructions:

1. Remove a single-use container from the strip.

1. Check that the single-use container is not damaged.
2. Hold the single-use container between the index and thumb of one hand.

With the index and thumb of the other hand, perform a light lever action on the winged piece to open it. Do not turn to break.

1. Gently pull to remove the winged piece.

1. Gently pull downwards from the lower eyelid to form a pouch. Turn the single-use container downwards and squeeze it to apply one drop to each eye. Blink a couple of times.

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

The treatment of dry eye syndrome requires an individualized dosing regimen.

If you are using more than one eye drop medication, the applications of the different medications should be spaced at least 5 minutes apart.

If you use more Hipromelosa STADA than you should

If you have used more Hipromelosa STADA than you should, consult your doctor or pharmacist immediately.

No ocular overdoses are known and no ocular overdose effects are anticipated with the ocular administration route.

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

If you forgot to use Hipromelosa STADA

Do not use a double dose to compensate for the missed doses.

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

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

You may experience the following adverse effects:

Rare(may affect between 1 and 10 out of every 1,000 patients): burning sensation, blurred vision, and sticky eyelids.

Reporting Adverse Effects

If you experience any type of adverse effect,consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them 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.

Do not store at a temperature above 30°C.

Store single-dose containers in the original packaging.

Dispose of the opened single-dose container after use (do not reuse 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 you no longer need at the Pharmacy Take-Back Pointof your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hipromelosa STADA

• The active ingredient is hypromellose. Each milliliter of solution contains 3.20 mg of hypromellose.
• The other components aremonohydrate sodium phosphate dodecahydrate, dihydrate sodium dihydrogen phosphate, sorbitol(E420)and water forinjectable preparations.

Appearance of the product and contents of the packaging

Hypromellose STADA eye drops in solution are presented in single-dose containers of 0.5 ml of sterile solution. Each cardboard box containsa foil pouch with30single-dose containers.

Marketing Authorization Holder

STADA Laboratory, 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:May 2022

The 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