ASPIRE Puradex 1mg/ml Eye Drops User Manual

Puradex 1mg/ml Eye Drops

Product Information: Puradex 1mg/ml Eye Drops, Solution

Puradex 1mg/ml eye drops, solution contains dexamethasone phosphate, which is a corticosteroid that reduces inflammation. This medicine is used to treat inflammation in the eyes, but it should not be used if the eye is infected. If the eye is infected, a specific treatment for the infection should be used in combination with Puradex 1mg/ml eye drops, solution.

What You Need to Know Before Using Puradex 1mg/ml Eye Drops, Solution

Do not use this medicine if you have an allergic reaction to dexamethasone phosphate or any of the other ingredients in the medicine. It should also not be used if you have an eye infection caused by bacteria, fungi, or viruses. If your infection does not respond to standard treatment, only use this medicine over a short period of time.

If you are using any other medicine to be applied in the eye, you should wait 15 minutes between each application. If you are using ritonavir or cobicistat, inform your doctor or pharmacist as this may increase the amount of dexamethasone in your blood. Temporary blurred vision or other eyesight disturbance may affect your ability to drive or use machines. Do not drive or use machines until normal vision has returned.

How to Use Puradex 1mg/ml Eye Drops, Solution

1. Wash your hands carefully prior to instillation.
2. Look upwards and pull the lower eyelid down with your finger.
3. Put one drop into the eye to be treated.
4. Immediately after you have put the eye drop in, press lightly with your finger 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.
5. Avoid contact between the tip of the dispenser and the eye or eyelids.

The frequency of administration is 4 to 6 times a day, and the duration of treatment usually varies from a few days to a maximum of 14 days. If you experience any side effects, talk to your doctor or pharmacist immediately.

Package leaflet: Information for the user

Puradex 1mg/ml eye drops, solution
Dexamethasone phosphate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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 leaflet. See section 4.

What is in this leaflet

1. What Puradex 1mg/ml eye drops, solution is and what it is used for
2. What you need to know before you use Puradex 1mg/ml eye drops, solution
3. How to use Puradex 1mg/ml eye drops, solution
4. Possible side effects
5. How to store Puradex 1mg/ml eye drops, solution
6. Contents of the pack and other information

What Puradex 1mg/ml eye drops, solution is and what it is used for
Puradex 1mg/ml eye drops, solution contains a substance called dexamethasone. This substance is a corticosteroid which relieves inflammatory symptoms.
This medicine is used for treatment of the inflammation of your eye(s).
The eye should not be infected (red eye, secretions, tearing); otherwise a specific treatment of your infection should be combined (see section 2).

What you need to know before you use Puradex 1mg/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 first 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 inflammation 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 1mg/ml eye drops, solution
If you are using any other medicine to be applied in the eye, you should wait 15 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 insufficient 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 1mg/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 1 drop, 4 to 6 times a day in the affected eye. In severe cases, treatment can be started with 1 drop every hour and then reduced to 1 drop every 4 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.

1. Wash your hands carefully prior to instillation.
2. Look upwards and pull the lower eyelid down with your finger. Put one drop into the eye to be treated.
3. Immediately after you have put the eye drop in, press lightly with your finger 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.
4. Avoid contact between the tip of the dispenser and the eye or eyelids.

• Frequency of administration
  4 to 6 times a day.

• Duration of treatment
  The duration of treatment usually varies from a few days to a maximum of 14 days.

• If you use more Puradex 1mg/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 1mg/ml eye drops, solution
  Do not use a double dose to make up for a forgotten dose.

• If you stop using Puradex 1mg/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 2 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 calcifications)
• 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 1 in 10 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 1 in 100 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

Rare (may affect up to 1 in 1,000 people)

• blurred vision

Very rare (may affect up to 1 in 10,000 people)

• inflammation of the outermost layer of the eye (conjunctivitis)
• dilation of the pupil (mydriasis)
• swelling of the face
• drooping eyelids (ptosis)
• inflammation inside your eye (uveitis)
• inflammation 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 2, “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 leaflet. 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 1mg/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.

Contents of the pack and other information
What Puradex 1mg/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 1mg/ml eye drops, solution looks like and contents of the pack
6ml solution in a white opaque 11ml 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
2 Kingdom Street
W2 6BD
London
United Kingdom

Manufacturer
Rafarm S.A.
Thesi Pousi –Xatzi
Agiou Louka
19002, Paiania Attiki
Greece

Distributor
Aspire Pharma Limited
4 Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom

This leaflet was last revised in 10/2022
1010570 – P2.4

References

• Yellow Card | Making medicines and medical devices safer

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