Package Insert: Information for the Patient

Dexamethasone POS 1 mg/ml Eye Drops in Solution

Dexamethasonemetasulfobenzoate sodium

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Dexamethasone POS and how is it used

2. What you need to know before starting to use Dexamethasone POS

3. How to use Dexamethasone POS

4. Possible adverse effects

5. Storage of Dexamethasone POS

6. Contents of the package and additional informationl

Dexametasona POSis a glucocorticoid for local treatment of the eye.

Dexametasona POS is used for the treatment of non-infectious eye inflammations that respond to corticosteroids, such as eye allergies, conjunctival inflammatory disorders, corneal and anterior segment eye inflammations; postoperative irritations.

No useDexametasona POS

• If you are allergic todexametasona metasulfobenzoate or to any of the other ingredients of this medication (listed in section 6),
• In case of acute herpes simplex (dendritic keratitis) and other viral eye infections,
• In case of bacterial and/or fungal eye infections without appropriate antibiotic therapy,
• In case of corneal injuries or ulcers,
• In case of narrow-angle and open-angle glaucoma,
• In case of immunosuppression caused by diseases or medications.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dexametasona POS.

In case of having previously suffered from herpes simplex infection or eye surgery, this medication should only be applied under strict medical supervision.

Your doctor should regularly examine you for intraocular pressure and cornea when using this medication for 10 days or more.

To avoid possible systemic reabsorption, especially in small children, close the tear duct with your finger for 2 to 3 minutes after applying this medication.

Talk to your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after completing a prolonged or intensive treatment with this medication. Talk to your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat.

Contact your doctor if you experience blurry vision or other visual disturbances.

Use of Dexametasona POS with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The concomitant use of this medication with some drugs affecting the nervous system, such as atropine, may produce an additional increase in intraocular pressure.

Inform your doctor if you are taking ritonavir or cobicistat, as this may increase the amount of dexametasona in your blood.

Warning:

In concomitant treatment with other topical ophthalmic medications, there should be a 15-minute interval between the applications of the different products. The ointments should always be administered last.

Pregnancy and breastfeeding

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

There are no validated data on the use of this medication during pregnancy. Since glucocorticoids can cause malformations in animal studies, this medication should only be used during pregnancy if there is a strict indication for it.

It is not known whether topical application of this medication can lead to detectable levels of dexametasona in breast milk through systemic reabsorption. Since systemic glucocorticoids are known to pass detectable amounts into breast milk and may cause growth disturbances in the infant, this medication should only be used during breastfeeding if there is a strict indication for it.

Driving and operating machinery

Do not drive immediately after applying this medication, as it reduces vision for a short period of time and therefore also reduces reaction time while driving.Do not handle electrical tools or machinery temporarily.

Dexametasona POS contains

This medication containsdexametasona metasulfobenzoateas the active ingredient, which may cause allergic reactions. Inform your doctor if you have any allergies.

Remove your contact lenses before applying this medication and wait at least 20 minutes before reinserting them.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

If your doctor does not indicate otherwise, the recommended dose is:

3-5 times a day (in acute cases more frequent), 1 drop in the conjunctival sac.

To ensure therapeutic effect, treatment should not be interrupted before the established time. Your doctor will determine the duration of treatment. If treatment lasts more than 2 weeks, your eyes should be examined regularly by your doctor. In any case, a long-term treatment without medical supervision should be avoided.

How to use Dexametasona POS

Wash your hands.

Step 1:
Take a clean handkerchief and gently clean the tear liquid from the lower part of the eye.

Step 2:
Remove the stopper before each application.
Before the first application of Dexametasona POS, hold the container vertically with the tip down and press the base until the first drop appears in the nozzle. Now the container is ready for use.

Step 3:
Hold the container with the dropper down, so that the thumb presses the shoulder of the container and the rest of the fingers are on the base.

Step 4:
Support the hand holding the container COMOD®over the one that is free, as shown.

Step 5:
Tilt your head slightly back, pull your lower eyelid down gently, and press the base of the container firmly and quickly.This will activate the mechanism for the release of a drop.Thanks to the special technology of the valve in the COMOD®system, the size and speed of the drop are identical, regardless of the pressure applied. During application, avoid contact between the tip of the container and the eye or skin. Close your eyes slowly to allow the liquid to distribute evenly over the surface of the eye.

Step 6:
After applying Dexametasona POS, blink several times to distribute the drop evenly over the entire surface of the eye. Then remove any excess medication.

Step 7:

After application, immediately replace the stopper. Check that the tip of the dropper is dry.

Repeat this procedure in the other eye.

Distribute the applications of Dexametasona POS evenly throughout the day.

If you use moreDexametasona POSthan you should

Up to the present date, no symptoms of intoxication due to overdose in the eye have been known. In case of topical overdose, rinse the eye with water. If an accidental oral ingestion of the medication occurs (e.g., in children), drink water (½glass) to dissolve it. Normallyno additional measures are required. However, in the case of small children, it is advisable to consult a doctor.

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

If you forgot to useDexametasona POS

Do not use a double dose, but apply as soon as possible the same amount and with the same frequency described above or prescribed by your doctor.

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

Like all medicines, thismedicine mayproduce side effects, although not all people will experience them.

The following frequencies of occurrence are defined for the evaluation of side effects:
Very common: more than 1 in 10 patients treated
Common: 1 to 10 in 100 patients treated
Uncommon: 1 to 10 in 1,000 patients treated
Rare: 1 to 10 in 10,000 patients treated
Very rare: less than 1 in 10,000 patients treated
Unknown frequency: cannot be estimated from available data

The frequency of the following side effects is unknown.

Endocrine problems: increased body hair (particularly in women), weakness and muscle wasting, purple striae on the skin, increased blood pressure, irregular or absent periods, changes in protein and calcium levels, growth retardation in children and adolescents, body and facial swelling (called "Cushing's Syndrome") (see section 2).

Ocular disorders
Prolonged treatment may cause an increase in intraocular pressure in patients with a particular predisposition. Therefore, it is advisable to regularly monitor intraocular pressure. Additionally, during prolonged treatment, irreversible opacity of the lens (cataract) may appear.

A pre-existing infection may be masked or worsened. At the same time, the possibility of a secondary infection should be taken into account during prolonged treatment, especially if signs of a chronic infection persist despite treatment. In the case of diseases that cause corneal thinning, treatment may lead to perforations.

There have been cases of allergic reactions such as skin irritation with redness and itching in the eye (contact dermatitis, dermato-conjunctivitis, and eyelid eczema).
Eye drops containing dexamethasone slow down wound healing. If cortisone-containing eye drops are used after cataract surgery, wound healing may be delayed. Prolonged treatment with this medication may also delay wound healing.

After application of eye drops containing glucocorticoids, hypersensitivity reactions may develop with inflammatory symptoms, corneal ulcers, pupillary dilation,accommodation disorders (focusing) andptosis (drooping of the upper eyelid).
Additionally, it may cause temporary burning and itching in the eye, as well as eye irritation, blurred vision, sensation of a foreign body, and allergic reactions.

Reporting of side effects:

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

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 above 25 ° C.

Information on the validity period after opening:

Dexamethasone POS can be used up to 4 weeks after the first opening.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Dexamethasone POS Composition

• The active ingredient isdexamethasone metasulfobenzoate sodium 1.0mg/ml
• The other components arehypromellose, glycerol, and water for injections.

Appearance of the product and contents of the packaging

Dexamethasone POS is presented in a multi-dose container with an airless pump system containing 5 ml eye drops in a clear and colorless solution. Each box contains one container.

The filling of the container is carried out under regular control in such a way that a filling with a lesser amount of solution can be excluded.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BRILL PHARMA, S.L.

C/ Munner, 8

08022, Barcelona

Spain

Responsible for manufacturing

URSAPHARM Arzneimitel GmbH

Industriestraße 35,

66129 Saarbrücken,

Germany

Last review date of this leaflet:October 2019

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.gob.es/