1. Name of the medicinal product

Prednisolone Sodium Phosphate Ophthalmic Solution USP 0.5%w/v
Prednisolone Sodium Phosphate Ophthalmic Solution USP 1%w/v

  1. Qualitative and quantitative composition

a) Prednisolone Sodium Phosphate Ophthalmic Solution USP 0.5%w/v
Each ml contains:
Prednisolone Sodium Phosphate USP 5mg (0.5%w/v)
Excipients: Q.S.

b) Prednisolone Sodium Phosphate Eye and Ear Drops Solution USP 1%w/v
Each ml contains:
Prednisolone Sodium Phosphate USP 10mg (1%w/v)
Excipients: Q.S.

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

Eye and ear drops/Ophthalmic Solution, solution sterilized clear and colourless aqueous solution

  1. Clinical particulars
  • Therapeutic indications

Prednisolone Taj Pharma Sodium Phosphate Drops is indicated for short term treatment of steroid responsive inflammatory conditions of the eye after clinical exclusion of bacterial, viral and fungal infections and Non-infected inflammatory conditions of the ear.

  • Posology and method of administration

Adults and Children (including the Elderly)

Eyes

1 or 2 drops instilled into the eyes every one or two hours until control is achieved, when the frequency may be reduced.

Ears

2 or 3 drops instilled into the ear every two or three hours until control is achieved, when the frequency can be reduced.

Frequency of dosing depends on clinical response. If there is no clinical response within 7 days treatment, the drops should be discontinued. Treatment should be the lowest effective dose for the shortest possible time. After more prolonged treatment (over 6-8 weeks), the drops should be withdrawn slowly to avoid relapse.

  • Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Bacterial, viral, fungal tuberculous or purulent conditions of the eye. Use is contraindicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to the extension of the ulcer and marked visual deterioration.

In the ear, topical corticosteroids are contraindicated in patients with fungal diseases of the auricular structure, and in those with a perforated tympanic membrane.

  • Special warnings and precautions for use

Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.

Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.

The use of corticosteroids may reduce resistance to or mask the signs of infection. Appropriate anti-infective agents should be used if infection is present.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders and anxiety.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Paediatric population

Prolonged use may lead to the risk of adrenal suppression in infants. Potential systemic effects may include growth retardation in children and adolescents and more rarely a range of psychological or behavioural effects including depression or aggression (particularly in children).

  • Interaction with other medicinal products and other forms of interaction

Prednisolone Taj Pharma Sodium Phosphate Drops contain benzalkonium chloride as a preservative and, therefore, should not be given to treat patients who wear soft contact lenses.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

  • Fertility, pregnancy and lactation

Pregnancy

Safety for use in pregnancy and lactation has not been established. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may be a very small risk of such effects in the human foetus.

Breastfeeding

There is insufficient information on the excretion of Prednisolone Taj Pharma sodium phosphate / metabolites in human milk. A risk to the newborns / infants cannot be excluded.

Fertility

No fertility data is available.

  • Effects on ability to drive and use machines

Prednisolone Taj Pharma Sodium Phosphate Drops has moderate influence on the ability to drive and use machines.

It may cause transient blurring of vision on instillation, warn patients not to drive or operate hazardous machinery until vision is clear.

  • Undesirable effects

Very rare (<1/10,000)

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

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

Not known: Immune system disorders

Hypersensitivity reactions usually of the delayed type may occur leading to irritation, burning, stinging and itching.

Not known: Skin and subcutaneous tissue disorders

Dermatitis

Not known: Eye disorders

Topical corticosteroid use may result in increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects. Other side effects include Chorioretinopathy, mydriasis, ptosis, epithelial punctate keratitis and possible corneal or scleral malacia. Within a few days after discontinuing topical ophthalmic corticosteroid therapy and occasionally during therapy, acute anterior uveitis has occurred in patients (mainly blacks) without pre-existing ocular inflammation or infection.

Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts.

In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation.

Vision, blurred (see also section 4.4)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

  • Overdose

Long term intensive topical use may lead to systemic effects. Oral ingestion of the contents of one bottle (up to 10ml) is unlikely to lead to any serious adverse effects.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic group – Ophthalmological and Otological preparations

  • Pharmacokinetic properties

Not available

  • Preclinical safety data

Not available

  1. Pharmaceutical particulars
  • List of excipients

Benzalkonium chloride solution, Sodium chloride, Sodium acid phosphate, Disodium edetate, Sodium hydroxide, Phosphoric acid, Purified water

  • Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

  • Shelf life

18 months unopened.

4 weeks after first opening.

  • Special precautions for storage

Store below 25°C. Do not freeze. Store in the original package in order to protect from light.

Sterility of the drops is assured until cap seal is broken.

For storage conditions after first opening of the medicinal product, see section 6.3.

  • Nature and contents of container

Single 5ml or 10ml bottle with nozzle insert moulded in natural low density polyethylene closed with a tamper evident high density polyethylene cap.

Not all pack sizes are marketed.

  • Special precautions for disposal and other handling

No special requirement for disposal.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825) Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Prednisolone Sodium Phosphate Eye and Ear Drops Solution USP 1%w/v Taj Pharma

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 Prednisolone Taj Pharma Sodium Phosphate Drops is and what it is used for
  2. What you need to know before you use Prednisolone Taj Pharma Sodium Phosphate Drops
  3. How to use Prednisolone Taj Pharma Sodium Phosphate Drops
  4. Possible side effects
  5. How to store Prednisolone Taj Pharma Sodium Phosphate Drops
  6. Contents of the pack and other information

1.What Prednisolone Taj Pharma Sodium Phosphate Drops is and what it is used for

Prednisolone Taj Pharma Sodium Phosphate 0.5%w/v Eye and Ear Drops, Solution (referred to as Prednisolone Taj Pharma Sodium Phosphate drops in this leaflet) contains 0.5%w/v of Prednisolone Taj Pharma Sodium Phosphate. It belongs to a group of medicines called corticosteroids (‘steroids’ for short).

Prednisolone Taj Pharma Sodium Phosphate Drops work by reducing inflammation (redness, itching and soreness).
Prednisolone Taj Pharma Sodium Phosphate Drops is used to treat inflammation of the eye or ear where there is no infection.

  1. What you need to know before you use Prednisolone Taj Pharma Sodium Phosphate Drops

Do not use Prednisolone Taj Pharma Sodium Phosphate Drops:

  • if you are allergic to Prednisolone Taj Pharma Sodium
  • Phosphate or any of the other ingredients of this medicine (listed in section 6)
  • if you have an infection in the eye, or it is producing pus and is sticky
  • if you have glaucoma (increased pressure in the eye)
  • if you have ulcers in your eye (shingles)
  • if you have a fungal disease in your ear
  • if you have a perforated ear drum.

Warnings and precautions

Important: Never use this medicine in your eye without first checking with your doctor.

If it is used for the wrong condition, it could lead to blindness.

Talk to your doctor or pharmacist before using Prednisolone Taj Pharma Sodium Phosphate Drops

  • if you have been treated with Prednisolone Taj Pharma
  • Sodium Phosphate or similar corticosteroid drops recently. Do not have repeated or prolonged treatment without regular checkups from your doctor
  • if you have tuberculosis (TB)
  • if you wear soft contact lenses (see other medicines and Prednisolone Taj Pharma Sodium Phosphate Drops below)
  • Systemic effects of nasal corticosteroids:
  • Prolonged use at high doses may cause:
  • Cushing’s syndrome (a hormonal disorder caused by high levels of cortisol), Cushingoid features such as facial roundness or puffiness, adrenal suppression, cataract and glaucoma.
  • Rarely, a range of psychological effects including psychomotor hyperactivity (a feeling of restlessness, muscle spasms, twitches), sleep disorders, anxiety.

Children

  • prolonged use may lead to the risk of adrenal suppression in infants
  • growth retardation in children and adolescents
  • depression or aggression (particularly in children)

Other medicines and Prednisolone Taj Pharma Sodium Phosphate Drops

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

This medicine contains benzalkonium chloride as a preservative which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.

Some medicines may increase the effects of Prednisolone Taj Pharma Sodium Phosphate Drops and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)

Pregnancy, breast-feeding and fertility

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.

There is a small risk of cleft palate or retarded growth in the foetus.

Driving and using machines

Prednisolone Taj Pharma Sodium Phosphate Drops may cause temporary blurred vision. If this happens to you, do not drive or use machinery until your sight returns to normal.

Warnings about visual problems when using Prednisolone Taj Pharma Sodium Phosphate Drops

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

  1. How to use Prednisolone Taj Pharma Sodium Phosphate Drops

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it is not, or you are not sure, ask your doctor or pharmacist.

Remember:

  • Always use Prednisolone Taj Pharma Sodium Phosphate exactly as your doctor has told you
  • How often you use the drops will depend on how your body responds to the treatment.
  • Use as few drops as possible for the shortest possible time.
  • If there is no improvement in your symptoms after 7 days, stop using the drops and see your doctor again.

Check that the seal on the bottle is not broken before using Prednisolone Taj Pharma Sodium

Phosphate Drops for the first time. Wash and dry your hands. Do not breathe on or touch the dropper nozzle.

Eyes

  • The recommended dose is 1 or 2 drops put into the eye every one or two hours

Prednisolone Taj Pharma Sodium Phosphate 0.5%w/v and 1%w/v Eye and Ear Drops, Solution

Prednisolone Taj Pharma Sodium Phosphate

  • Once the redness, itching and soreness starts to feel better, apply the drops less often.
  1. Tilt your head back
  2. Gently pull your lower eyelid downwards and outwards
  3. Place drops in the gap between the eyelid and eye (squeeze bottle very gently if necessary)
  4. Blink a few times to spread out the drops
  5. Repeat for the other eye if needed.

Ears

  • The recommended dose is 2 or 3 drops put into the ear every two or three hours
  • Once the redness, itching and soreness starts to feel better, apply the drops less often.
  1. Tilt your head to one side
  2. Place drops in the ear canal (squeeze bottle gently if necessary)
  3. Keep head tilted for a minute or two to let the drops soak in
  4. Repeat for other ear if needed.

Medical check-ups

If you are using this medicine for your eyes and you use it for a number of weeks, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you. Your doctor will check your eyes for:

  • An increase in pressure
  • Cataracts

If you use more Prednisolone Taj Pharma Sodium Phosphate Drops than you should

If you accidentally use too much Prednisolone Taj Pharma Sodium Phosphate Drops it is unlikely to lead to any serious side effects. However, if you are concerned, contact your doctor or the nearest hospital casualty department.

It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should use only as much as your doctor recommends; using more or less may make your symptoms worse.

If you forget to use Prednisolone Taj Pharma Sodium Phosphate Drops

Do not use a double dose to make up for a forgotten dose. Simply use the next dose as planned.

If you stop using Prednisolone Taj Pharma Sodium Phosphate Drops

Do not stop using Prednisolone Taj Pharma Sodium Phosphate Drops without first talking to your doctor.

If you have been using Prednisolone Taj Pharma Sodium Phosphate Drops for a long period of time (around 6 to 8 weeks), then you should stop using it gradually, to avoid the inflammation coming back.

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

  1. Possible side effects

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

Effects on your eyes

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

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

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

  • Ulcers on the surface of the eye (cornea). Tell your doctor if your eye becomes painful and if you have blurred vision which does not improve after a few minutes
  • Increased pressure in the eye (glaucoma) which can lead to problems with your sight
  • A hole in the eyeball (if you have a disease which causes thinning of the surface of the eye)
  • Cataracts (clouding of the lens of the eye)
  • Enlarged pupils
  • Drooping of the eyelid
  • Swelling and redness of the outer surface of the eye
  • Blurred vision and other alterations to your sight.

Effects on the skin around your eyes

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

These may not appear until some time after you have started to use the medicine.

  • Irritation
  • Burning
  • Stinging
  • Itching

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.
By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Prednisolone Taj Pharma Sodium Phosphate Drops

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 label. Do not use for longer than 28 days after the seal on the bottle has been broken.

Store below 25°C. Do not Freeze. Store in the original package in order to protect from light.

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.

  1. Contents of the pack and other information

What Prednisolone Taj Pharma Sodium Phosphate Drops contains

  • The active substance is Prednisolone Taj Pharma sodium phosphate (0.5 %w/v) and (1%w/v)
  • The other ingredients are benzalkonium chloride solution, sodium chloride, sodium acid phosphate, disodium edetate, sodium hydroxide, phosphoric acid, purified water.

What Prednisolone Taj Pharma Sodium Phosphate Drops looks like and contents of the pack

Prednisolone Taj Pharma Sodium Phosphate Drops is clear, colourless solution. It comes in 5 ml or 10 ml plastic bottles with a built in nozzle and a tamper evident plastic cap.

Not all pack size may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825) Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com