Aspire Puradex 1mg/ml Eye Drops User manual

Brand: Aspire

Model: Puradex 1mg/ml Eye Drops

Type: User manual

Puradex mg/ml eye drops, solution

Dexamethasone phosphate

Read all of this leaet carefully before you start using this medicine because it contains

important information for you.

- Keep this leaet. You may need to read it again.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaet. See section .

What is in this leaet

 What Puradex mg/ml eye drops, solution is and what it is used for

 What you need to know before you use Puradex mg/ml eye drops, solution

 How to use Puradex mg/ml eye drops, solution

 Possible side effects

 How to store Puradex mg/ml eye drops, solution

 Contents of the pack and other information

 What Puradex mg/ml eye drops, solution is and what it is used for

Puradex mg/ml eye drops, solution contains a substance called dexamethasone. This substance is

a corticosteroid which relieves inammatory symptoms.

This medicine is used for treatment of the inammation of your eye(s).

The eye should not be infected (red eye, secretions, tearing); otherwise a specic treatment of your

infection should be combined (see section ).

 What you need to know before you use Puradex mg/ml eye drops, solution

Do not use this medicine if you:

• are suffering from an eye infection that you are not using a medicine for

• are suffering from an untreated ocular infection which could be caused by bacteria (acute

purulent infection), fungi, virus (herpetic virus, vaccine virus, varicella zona virus) or

amoeba (a single-celled parasite)

• have damage on the surface of the eye (perforation, ulcerations or injury associated with

incomplete healing)

• have increased ocular pressure known to be caused by corticosteroids

• are allergic to dexamethasone sodium phosphate or any of the other ingredients of this

medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

DO NOT INJECT, DO NOT SWALLOW.

Talk to your doctor if you experience swelling and weight gain around the trunk and in the face as

these are usually the rst manifestations of a syndrome called Cushing’s syndrome. Suppression

of the adrenal gland function may develop after stopping a long-term or intensive treatment with

this medicine. Talk to your doctor before stopping the treatment by yourself. These risks are

especially important in children and patients treated with a drug called ritonavir

or cobicistat.

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

Avoid contact between the dispenser tip and the eye or eyelids.

• Close ophthalmic monitoring is required during the use of this medicine in any case and in

particular:

- for children and the elderly. More frequent ophthalmic monitoring is recommended

- if you have an ocular infection. Only use this medicine if the infection is being treated

with an anti-infective treatment

- if you are suffering from a corneal ulcer. Do not use a local dexamethasone treatment

or this medicine, unless inammation is the main cause of delayed healing

- if you suffer from increased intraocular pressure. If you have already experienced

side effects to local corticosteroid treatment, resulting in increased ocular pressure,

you are at risk of developing increased ocular pressure if treated by this medicine

- if you have an eye disease called glaucoma.

• Children: you should avoid continual, long-term treatment.

• Severe allergic conjunctivitis: if you have severe allergic conjunctivitis that fails to

respond to standard treatment, only use this medicine over a short period of time.

• Diabetic: if you are diabetic, inform your ophthalmologist.

• Red eye: if you have a red eye that has not been diagnosed, do not use this medicine.

• Contact lenses: you should avoid wearing contact lenses during treatment with

this medicine.

Other medicines and Puradex mg/ml eye drops, solution

If you are using any other medicine to be applied in the eye, you should wait  minutes between

each application.

Precipitation of calcium phosphate on the surface of the cornea has been observed during the local

concomitant use of corticosteroids and beta-blockers (a group of medicines used for glaucoma).

Tell your doctor or pharmacist if you are using, have recently used or might use any

other medicines.

Tell your doctor if you are using ritonavir or cobicistat, as this may increase the amount of

dexamethasone in the blood.

Pregnancy and breast-feeding

• There is insufcient information on the use of this medicine during pregnancy to evaluate

the potential harmful effects on pregnancy. Therefore the use of this medicine during

pregnancy is not recommended.

• It is not known whether this medicine is excreted in breast milk. However the total dose of

dexamethasone in this medicine is low. Therefore this medicine can be used during

breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

As with all eye drops, temporary blurred vision, or other eyesight disturbance may affect the ability

to drive or use machines. Do not drive or use machines until normal vision has returned.

 How to use Puradex mg/ml eye drops, solution

Dose

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

The recommended dose is  drop,  to 6 times a day in the affected eye. In severe cases, treatment

can be started with  drop every hour and then reduced to  drop every  hours once a favourable

response has been observed. Gradual dose reduction is recommended in order to avoid relapse.

- In elderly people: there is no need to adjust the dose.

- In children: continual, long-term treatment should be avoided.

Method of administration

Ocular use: this medicine is intended to be administered into the eye.

DO NOT INJECT, DO NOT SWALLOW.

. Wash your hands carefully prior to instillation.

. Look upwards and pull the lower eyelid down with your nger. Put one drop into the eye to

be treated.

. Immediately after you have put the eye drop in, press lightly with your nger on the inside

corner of your eye, nearest your nose for few minutes. This helps to stop the eye drops

spreading into the rest of your body.

. Avoid contact between the tip of the dispenser and the eye or eyelids.

Frequency of administration

 to 6 times a day.

Duration of treatment

The duration of treatment usually varies from a few days to a maximum of  days.

If you use more Puradex mg/ml eye drops, solution than you should

Rinse the eye with sterile water if you have applied too much of the medicine into your eye and

there is prolonged irritation.

Immediately contact your doctor or your pharmacist.

If you forget to use Puradex mg/ml eye drops, solution

Do not use a double dose to make up for a forgotten dose.

If you stop using Puradex mg/ml eye drops, solution

Do not stop using this medicine abruptly. Always consult your doctor if you are considering

stopping the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following side effects after using this medicine, stop using this medicine and

seek medical advice:

• weakened function of the adrenal gland. If used often, the kidneys may not produce enough

hormones (suppression of cortico-adrenal function). This could be shown by low blood

sugar, dehydration, weight loss and feeling confused about where you are

• high pressure in the eye after  weeks of using the drops (generally picked up during a

routine eye test, however symptoms may include eye pain and blurred vision)

• allergic and hypersensitivity reactions (symptoms can include redness, itching or swelling

of the eye)

• eye infections that may not normally happen (opportunistic infections, i.e., infectious

diseases caused by pathogens that usually do not cause disease in people with healthy

immune systems, but infection may occur in people whose immune systems have been

weakened). Symptoms can include redness, pain, swelling around the eye or sensitivity to

bright light

• cloudy patches on the cornea due to calcium build-up during treatment (corneal

calcications)

• corneal ulceration, or perforation which may cause pain, tears, squinting and visual loss

• small holes on the surface of the eye (perforation of the cornea).

Other possible side effects are listed below according to their frequency:

Common (may affect up to  in  people)

• eye discomfort, irritation, burning, stinging, itching and blurred vision after use. These are

usually mild and do not last long

Uncommon (may affect up to  in  people)

• delayed eye wound healing

• clouding of the lens in the eye (posterior capsular cataract)

• eye disease caused by the increased pressure in your eye (glaucoma)

• weakened function of adrenal gland if used often, the kidneys may not produce enough

hormones (suppression of cortico-adrenal function). This could be shown by low blood

sugar, dehydration, weight loss and feeling confused about where you are

Package leaet: Information for the user

Rare (may affect up to  in , people)

• blurred vision

Very rare (may affect up to  in , people)

• inammation of the outermost layer of the eye (conjunctivitis)

• dilation of the pupil (mydriasis)

• swelling of the face

• drooping eyelids (ptosis)

• inammation inside your eye (uveitis)

• inammation of the cornea (crystalline keratopathy)

• changes in the thickness of the front of the eye (cornea)

• swelling of the cornea

• corneal ulceration, or perforation which may cause pain, tears, squinting and visual loss

• small holes on the surface of the eye (perforation of the cornea)

Not known (frequency cannot be estimated from the available data)

Hormone problems: growth of extra body hair (particularly in women), muscle weakness and

wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods,

changes in the levels of protein and calcium in your body, stunted growth in children and teenagers

and swelling and weight gain of the body and face (called ‘Cushing’s syndrome’) (see section ,

“Warnings and precautions”).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaet. You can also report side effects directly via the Yellow Card

Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play

or Apple App Store. By reporting side effects you can help provide more information on the safety of

this medicine.

 How to store Puradex mg/ml eye drops, solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container after EXP. The expiry

date refers to the last day of that month. Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw away medicines you no longer use. These

measures will help protect the environment.

6 Contents of the pack and other information

What Puradex mg/ml eye drops, solution contains

- The active substance is dexamethasone sodium phosphate.

- The other excipients are disodium edetate, sodium chloride, disodium hydrogen phosphate

anhydrous, water for injection.

What Puradex mg/ml eye drops, solution looks like and contents of the pack

ml solution in a white opaque ml LDPE bottle with white Novelia nozzle (HDPE and silicone)

and a white HDPE cap, clear colourless solution, with no visible particles.

Marketing Authorisation Holder

Rafarm UK Limited

6th Floor

 Kingdom Street

W 6BD

London

United Kingdom

Manufacturer

Rafarm S.A.

Thesi Pousi –Xatzi

Agiou Louka

, Paiania Attiki

Greece

Distributor

Aspire Pharma Limited

 Rotherbrook Court

Bedford Road

Peterseld

Hampshire

GU QG

United Kingdom

This leaet was last revised in /

 - P.

Aspire Puradex 1mg/ml Eye Drops User manual

Aspire Puradex 1mg/ml Eye Drops User manual

Aspire Puradex 1mg/ml Eye Drops User manual

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