Dexamethason Vzf 0,1%

Package Leaflet: Information for the Patient

DEXAMETHASONE WZF 0.1%, 1 mg/ml, eye drops, suspension
Dexamethasone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dexamethasone WZF 0.1% and what is it used for
• 2. Important information before using Dexamethasone WZF 0.1%
• 3. How to use Dexamethasone WZF 0.1%
• 4. Possible side effects
• 5. How to store Dexamethasone WZF 0.1%
• 6. Contents of the pack and other information

1. What is Dexamethasone WZF 0.1% and what is it used for

The medicine contains dexamethasone, which has anti-inflammatory, anti-allergic, and anti-itching effects.
The medicine is indicated for the treatment of inflammatory conditions of the conjunctiva, cornea, and anterior segment of the eye that respond to steroid therapy, such as: anterior uveitis, iritis, scleritis, allergic and vernal conjunctivitis, phlyctenular keratitis, superficial punctate keratitis, and non-specific superficial keratitis.
It is also indicated for the treatment of corneal injuries caused by chemical, radiation, or thermal burns, as well as after foreign body injury.
It is indicated for use after surgical procedures to reduce the severity of inflammatory reactions and prevent graft rejection.

2. Important information before using Dexamethasone WZF 0.1%

When not to use Dexamethasone WZF 0.1%

• if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has cowpox, chickenpox, or other viral diseases of the cornea and conjunctiva (except for phlyctenular keratitis);
• if the patient has herpetic keratitis;
• if the patient has fungal eye infections;
• if the patient has eye infections caused by Mycobacteriae;
• if the patient has untreated acute purulent bacterial eye infections.

Warnings and precautions

Before starting treatment with Dexamethasone WZF 0.1%, the patient should discuss it with their doctor or pharmacist.

• In patients with bacterial, viral, or fungal eye infections, the medicine may mask the symptoms of the infection. In such cases, the doctor may recommend the use of an antibiotic.
• After using the medicine in people who have had diseases that cause thinning of the cornea or sclera (eye structures), there is a very rare risk of perforation (puncture) of these eye structures.
• Prolonged (much longer than recommended) use of the medicine increases the risk of secondary infections caused by fungi, bacteria, and viruses. It may also lead to the development or acceleration of cataract (clouding of the lens), increased intraocular pressure in predisposed individuals, and in some cases, even glaucoma.
• During long-term treatment with dexamethasone, the doctor may recommend ophthalmological examinations (lens, cornea, and intraocular pressure measurements).
• It is not recommended to wear contact lenses during eye inflammation treatment.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
If the patient experiences swelling and weight gain, particularly on the trunk and face, they should consult their doctor, as these are usually the first symptoms of a condition called Cushing's syndrome. Adrenal insufficiency may occur as a result of discontinuing long-term or intensive treatment with Dexamethasone WZF 0.1%. The patient should consult their doctor before stopping treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.
Topically administered corticosteroids should not be used for more than one week without ophthalmological supervision and regular intraocular pressure monitoring.

Children

There is no data on the safety of use in children under 2 years of age.

Dexamethasone WZF 0.1% and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use of topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs) may enhance potential corneal healing disorders.
The patient should tell their doctor about taking ritonavir or cobicistat, as these medicines may increase the levels of dexamethasone in the blood.
If the patient is using other eye drops, they should wait for 5 minutes between administering the medicines. Eye ointments should always be applied last.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Dexamethasone WZF 0.1% is not recommended for use during pregnancy, unless the patient's clinical condition requires the use of dexamethasone.
The decision to use the medicine during breastfeeding will be made by the doctor.

Driving and using machines

As with other eye drops, temporary blurred vision or other vision disturbances may affect the ability to drive or operate machinery. If blurred vision occurs, the patient should wait until their vision returns to normal before driving or operating machinery.

Dexamethasone WZF 0.1% contains benzalkonium chloride and phosphates

The medicine contains 0.1 mg of benzalkonium chloride per 1 ml of suspension. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before administering the eye drops and wait at least 15 minutes before putting them back. Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.
The medicine contains 1.58 mg of phosphates per 1 ml of suspension. In patients with severely damaged cornea, phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use Dexamethasone WZF 0.1%

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Adults, adolescents, and children (aged 2 and over)
The doctor will recommend a dose depending on the severity of the condition.
In acute inflammatory conditions, the patient should administer 1-2 drops into the conjunctival sac every 30-60 minutes until improvement occurs. Once improvement occurs, the dose should be reduced to 1 drop every 4 hours.

Method of administration

The medicine is for external use only - topical application to the conjunctival sac.
The patient should not touch the tip of the dropper, as this may contaminate the contents of the bottle.

• 1. Before administering the eye drops, the patient should wash their hands thoroughly.

2. Shake the bottle before use.

• 3. Remove the cap from the bottle.
• 4. Tilt the head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 5. Invert the bottle and gently press the thumb or index finger on the wall until one drop of the medicine is released into the eye. The patient should not touch the dropper tip to the eye or eyelids. If the drop does not get into the eye, the patient should administer another drop.
• 6. Immediately after administering the eye drops, the patient should gently press the inner corner of the eye for about 1 minute. This will help reduce the risk of systemic side effects.
• 7. If the doctor has recommended administering the medicine to the other eye, the patient should repeat the steps from points 4, 5, and 6.
• 8. The dropper is designed to accurately measure the drops, so the patient should not enlarge the opening of the dropper.
• 9. After administering the eye drops, the patient should replace the cap on the bottle. However, they should not tighten it too much.

Regular administration of the medicine is recommended throughout the entire treatment period prescribed by the doctor.

Using a higher dose of Dexamethasone WZF 0.1% than recommended

In case of accidental overdose during administration to the eye, excess medicine can be rinsed out of the eye with warm water.

Missing a dose of Dexamethasone WZF 0.1%

If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and administer the next dose according to the established dosing schedule. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexamethasone WZF 0.1% can cause side effects, although not everybody gets them.
Frequent(less than 1 in 10 people):

• eye discomfort.

Infrequent(less than 1 in 100 people):

• taste disturbances;
• corneal inflammation, conjunctivitis, dry eye syndrome, corneal discoloration, photophobia, blurred vision, eye itching, foreign body sensation in the eye, increased tearing, abnormal sensations in the eyes, eyelid margin crusts, eye irritation, eye redness.

Frequency not known(cannot be estimated from the available data):

• hypersensitivity;
• dizziness, headache;
• increased intraocular pressure, corneal ulceration, eyelid ptosis, eye pain, pupil dilation, blurred vision;
• hormonal disorders: excessive hair growth on the body (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and weight gain and swelling, particularly on the trunk and face (Cushing's syndrome) (see section 2 "Warnings and precautions").

Prolonged use of topical corticosteroids may cause increased intraocular pressure with damage to the optic nerve, decreased visual acuity, visual field disturbances, and the development of posterior subcapsular cataract.
Due to the corticosteroid content, in cases of diseases that cause thinning of the cornea or sclera, there is a higher risk of perforation, especially after long-term treatment.
Corticosteroids may decrease resistance to infections and promote their occurrence.
In patients with severely damaged cornea, very rare cases of corneal clouding due to calcium deposition during treatment have been observed.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Dexamethasone WZF 0.1%

Store the bottle tightly closed in the outer packaging to protect it from light, at a temperature below 25°C.
The medicine should be kept out of the sight and reach of children.

Shake before use.

Do not use this medicine after the expiry date stated on the carton and bottle.
The expiry date stated on the packaging is the last day of the specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
After opening the bottle, the medicine should not be used for more than 4 weeks.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What does Dexamethasone WZF 0.1% contain

• The active substance of the medicine is dexamethasone. 1 ml of suspension contains 1 mg of dexamethasone.
• The other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate, benzalkonium chloride solution, polysorbate 80, ethanol 96%, sodium hydroxide 10%, purified water.

What Dexamethasone WZF 0.1% looks like and contents of the pack

Dexamethasone WZF 0.1% is a sterile, white suspension for topical application to the eyes. The medicine is available in polyethylene bottles containing 5 ml of suspension, packaged in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Rompharm Company SRL
1A Eroilor Street, 075100 Otopeni, Ilfov
Romania

Date of last revision of the leaflet: