Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of suspension contains:
Nepafenac………………………………1mg
(0.1% w/v)

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Eye drops, suspension

Light yellow to light orange uniform suspension, pH 7.4 (approximately).

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma is indicated in adults for:

– Prevention and treatment of postoperative pain and inflammation associated with cataract surgery

– Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients (see section 5.1)

4.2 Posology and method of administration

Posology

Adults, including the elderly

For the prevention and treatment of pain and inflammation, the dose is 1 drop of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period. Treatment can be extended to the first 3 weeks of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery.

For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery.

Special populations

Patients with renal or hepatic impairment

Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma has not been studied in patients with hepatic disease or renal impairment. Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration. No dose adjustment is warranted in these patients.

Paediatric population

The safety and efficacy of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma in children and adolescents have not been established. No data are available. Its use is not recommended in these patients until further data become available.

Geriatric population

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Method of administration

For ocular use.

Patients should be instructed to shake the bottle well before use. After cap is removed, if tamper evident snap collar is loose, remove before using product.

If more than one topical ophthalmic medicinal product is being used, the medicinal product must be administered at least 5 minutes apart. Eye ointments should be administered last.

To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Patients should be instructed to keep the bottle tightly closed when not in use.

If a dose is missed, a single drop should be applied as soon as possible before reverting to regular routine. Do not use a double dose to make up for the 1 missed.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs).

Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.

4.4 Special warnings and precautions for use

The product should not be injected. Patients should be instructed not to swallow Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma .

Patients should be instructed to avoid sunlight during treatment with Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma .

Ocular effects

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation (see section 4.8). These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  and should be monitored closely for corneal health.

Topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Therefore, it is recommended that caution should be exercised if Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  is administered concomitantly with corticosteroids, particularly in patients at high risk for corneal adverse reactions described below.

Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions.

There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery. Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time.

An acute ocular infection may be masked by the topical use of anti-inflammatory medicines. NSAIDs do not have any antimicrobial properties. In case of ocular infection, their use with anti-infectives should be undertaken with care.

Contact lenses

Contact lens wear is not recommended during the postoperative period following cataract surgery. Therefore, patients should be advised not to wear contact lenses unless clearly indicated by their doctor.

Benzalkonium chloride

Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. If contact lenses need to be used during treatment, patients should be advised to remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.

Cross-sensitivity

There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.

4.5 Interaction with other medicinal products and other forms of interaction

In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions (see section 5.2).

Prostaglandin analogues

There are very limited data on the concomitant use of prostaglandin analogues and Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma . Considering their mechanism of action, the concomitant use of these medicinal products is not recommended.

Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Concomitant use of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  with medications that prolong bleeding time may increase the risk of haemorrhage (see section 4.4).

4.6 Fertility, pregnancy and lactation

Women of childbearing potential

Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  should not be used by women of child bearing potential not using contraception.

Pregnancy

There are no adequate data regarding the use of nepafenac in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma , the risk during pregnancy could be considered low. Nevertheless, as inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development. Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  is not recommended during pregnancy.

Breast-feeding

It is unknown whether nepafenac is excreted in human milk. Animal studies have shown excretion of nepafenac in the milk of rats. However, no effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to nepafenac is negligible. Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  can be used during breast-feeding.

Fertility

There are no data on the effect of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  on human fertility.

4.7 Effects on ability to drive and use machines

Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  has no or negligible influence on the ability to drive and use machines.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.

4.8 Undesirable effects

Summary of the safety profile

In clinical studies involving 2314 patients receiving Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.

Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post-marketing reports.

System organ classification Adverse reactions
Immune system disorders Rare: hypersensitivity
Nervous system disorders Rare: dizziness, headache
Eye disorders Uncommon: keratitis, punctate keratitis, corneal epithelium defect, foreign body sensation in eyes, eyelid margin crusting

Rare: iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia

Not known: corneal perforation, impaired healing (cornea), corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision

Vascular disorders Not known: blood pressure increased
Gastrointestinal disorders Rare: nausea

Not known: vomiting

Skin and subcutaneous tissue disorders Rare: cutis laxa (dermatochalasis), allergic dermatitis

Diabetic patients

In the two clinical studies involving 209 patients, diabetic patients were exposed to Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  treatment for 60 days or greater for the prevention of macular oedema post cataract surgery. The most frequently reported adverse reaction was punctate keratitis which occurred in 3% of patients, resulting in a frequency category of common. The other reported adverse reactions were corneal epithelium defect and allergic dermatitis which occurred in 1% and 0.5% of patients, respectively both adverse reactions with a frequency category of uncommon.

Description of selected adverse reactions

Clinical trial experience for the long-term use of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  for the prevention of macular oedema post cataract surgery in diabetic patients is limited. Ocular adverse reactions in diabetic patients may occur at a higher frequency than observed in the general population (see section 4.4).

Patients with evidence of corneal epithelial breakdown including corneal perforation should immediately discontinue use of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  and should be monitored closely for corneal health (see section 4.4).

From post-marketing experience with Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma , cases reporting corneal epithelium defect/disorder have been identified. Severity of these cases vary from non serious effects on the epithelial integrity of the corneal epithelium to more serious events where surgical interventions and/or medical therapy are required to regain clear vision.

Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (eg, dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening. When nepafenac is prescribed to a diabetic patient post cataract surgery to prevent macular oedema, the existence of any additional risk factor should lead to reassessment of the foreseen benefit/risk and to intensified patient monitoring.

Paediatric population

The safety and efficacy of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  in children and adolescents have not been established.

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.

4.9 Overdose

No toxic effects are likely to occur in case of overdose with ocular use, nor in the event of accidental oral ingestion.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Opthalmologicals, Anti-inflammatory agents, non-steroids.

Mechanism of action

Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug. After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Amfenac inhibits the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.

Secondary pharmacology

In rabbits, nepafenac has been shown to inhibit blood-retinal-barrier breakdown, concomitant with suppression of PGE2 synthesis. Ex vivo, a single topical ocular dose of nepafenac was shown to inhibit prostaglandin synthesis in the iris/ciliary body (85%-95%) and the retina/choroid (55%) for up to 6 hours and 4 hours, respectively.

Pharmacodynamic effects

The majority of hydrolytic conversion is in the retina/choroid followed by the iris/ciliary body and cornea, consistent with the degree of vascularised tissue.

Results from clinical studies indicate that Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  eye drops have no significant effect on intraocular pressure.

Clinical efficacy and safety

Prevention and treatment of postoperative pain and inflammation associated with cataract surgery

Three pivotal studies were conducted to assess the efficacy and safety of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  dosed 3 times daily as compared to vehicle and/or ketorolac trometamol in the prevention and treatment of postoperative pain and inflammation in patients undergoing cataract surgery. In these studies, study medication was initiated the day prior to surgery, continued on the day of surgery and for up to 2-4 weeks of the postoperative period. Additionally, nearly all patients received prophylactic treatment with antibiotics, according to clinical practice at each of the clinical trial sites.

In two double-masked, randomised vehicle-controlled studies, patients treated with Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  had significantly less inflammation (aqueous cells and flare) in the early postoperative period through the end of treatment than those treated with its vehicle.

In one double-masked, randomised, vehicle and active-controlled study, patients treated with Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  had significantly less inflammation than those treated with vehicle. Additionally, Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  was non-inferior to ketorolac 5 mg/ml in reducing inflammation and ocular pain, and was slightly more comfortable upon instillation.

A significantly higher percentage of patients in the Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  group reported no ocular pain following cataract surgery compared to those in the vehicle group.

Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients

Four studies (two in diabetic patients and two in non-diabetic patients) were conducted to assess the efficacy and safety of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  for the prevention of postoperative macular oedema associated with cataract surgery. In these studies, study medication was initiated the day prior to surgery, continued on the day of surgery and for up to 90 days of the postoperative period.

In 1 double-masked, randomised vehicle-controlled study, conducted in diabetic retinopathy patients, a significantly greater percentage of patients in the vehicle group developed macular oedema (16.7%) compared to patients treated with Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  (3.2%). A greater percentage of patients treated with vehicle experienced a decrease in BCVA of more than 5 letters from day 7 to day 90 (or early exit) (11.5%) compared with patients treated with nepafenac (5.6%). More patients treated with Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  achieved a 15 letter improvement in BCVA compared to vehicle patients, 56.8% compared to 41.9%. respectively, p=0.019.

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies with Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  in all subsets of the paediatric population in prevention and treatment of post operative pain and inflammation associated with cataract surgery and prevention of post surgical macular oedema (see section 4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

Absorption

Following 3 times daily dosing of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  eye drops in both eyes, low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours post-dose, respectively. The mean steady-state plasma Cmax for nepafenac and for amfenac were 0.310 ± 0.104 ng/ml and 0.422 ± 0.121 ng/ml, respectively, following ocular administration.

Distribution

Amfenac has a high affinity toward serum albumin proteins. In vitro, the percent bound to rat albumin, human albumin and human serum was 98.4%, 95.4% and 99.1%, respectively.

Studies in rats have shown that radioactive labelled active substance-related materials distribute widely in the body following single and multiple oral doses of 14C-nepafenac.

Studies in rabbits demonstrated that the topically administered nepafenac is distributed locally from the front of the eye to the posterior segments of the eye (retina and choroid).

Biotransformation

Nepafenac undergoes relatively rapid bioactivation to amfenac via intraocular hydrolases. Subsequently, amfenac undergoes extensive metabolism to more polar metabolites involving hydroxylation of the aromatic ring leading to glucuronide conjugate formation. Radiochromatographic analyses before and after β-glucuronidase hydrolysis indicated that all metabolites were in the form of glucuronide conjugates, with the exception of amfenac. Amfenac was the major metabolite in plasma, representing approximately 13% of total plasma radioactivity. The second most abundant plasma metabolite was identified as 5-hydroxy nepafenac, representing approximately 9% of total radioactivity at Cmax.

Interactions with other medicinal products: Neither nepafenac nor amfenac inhibit any of the major human cytochrome P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 and 3A4) metabolic activities in vitro at concentrations up to 3000 ng/ml. Therefore, interactions involving CYP-mediated metabolism of concomitantly administered medicinal products are unlikely. Interactions mediated by protein binding are also unlikely.

Elimination

After oral administration of 14C-nepafenac to healthy volunteers, urinary excretion was found to be the major route of radioactive excretions, accounting for approximately 85% while faecal excretion represented approximately 6% of the dose. Nepafenac and amfenac were not quantifiable in the urine.

Following a single dose of Nepafenac Ophthalmic Suspension 0.1% w/v Taj Pharma  in 25 cataract surgery patients, aqueous humour concentrations were measured at 15, 30, 45 and 60 minutes post-dose. The maximum mean aqueous humour concentrations were observed at the 1 hour time-point (nepafenac 177 ng/ml, amfenac 44.8 ng/ml). These findings indicate rapid corneal penetration.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.

Nepafenac has not been evaluated in long-term carcinogenicity studies.

In reproduction studies performed with nepafenac in rats, maternally toxic doses ≥10 mg/kg were associated with dystocia, increased postimplantation loss, reduced foetal weights and growth, and reduced foetal survival. In pregnant rabbits, a maternal dose of 30 mg/kg that produced slight toxicity in the mothers showed a statistically significant increase in the incidence of litter malformations.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Mannitol, Carbomer, Sodium chloride, Tyloxapol, Disodium edetate, Benzalkonium chloride, Sodium hydroxide and/or hydrochloric acid (for pH adjustment), Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

Discard 4 weeks after first opening.

6.4 Special precautions for storage

Do not store above 30˚C.

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

6.5 Nature and contents of container

5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml suspension.

Carton containing 1 bottle.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

  1. 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

NEPAFENAC
OPHTHALMIC SUSPENSION
0.1% W/V
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

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, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

  1. What Nepafenac is and what it is used for
  2. What you need to know before you use Nepafenac
  3. How to use Nepafenac
  4. Possible side effects
  5. How to store Nepafenac
  6. Contents of the pack and other information

    1. WHAT NEPAFENAC IS AND WHAT IT IS USED FOR

Nepafenac contains the active substance nepafenac, and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

Nepafenac is to be used by adults:

  • to prevent and relieve eye pain and inflammation following cataract surgery on the eye
  • to reduce the risk of macular oedema (swelling in the back of the eye) following cataract surgery on the eye in diabetic patients.
  1. WHAT YOU NEED TO KNOW BEFORE YOU USE NEPAFENAC

Do not use Nepafenac

  • if you are allergic to nepafenac or any of the other ingredients of this medicine (listed in section 6),
  • if you are allergic to other nonsteroidal anti-inflammatory drugs (NSAID)
  • if you have experienced asthma, skin allergy, or intense inflammation in your nose when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Nepafenac:

  • if you bruise easily or have bleeding problems or have had them in the past.
  • if you have any other eye disorder (e.g. an eye infection) or if you are using other medicines in the eye (especially topical steroids).
  • if you have diabetes.
  • if you have rheumatoid arthritis
  • if you have had repeated eye surgery within a short period of time. Avoid sunlight during treatment with Nepafenac

Wearing contact lenses is not recommended after cataract surgery. Your doctor will advise you when you can use contact lenses again (see also “Nepafenac contains benzalkonium chloride”)

Children and adolescents

Do not give this medicine to children and adolescents below 18 years old because the safety and efficacy in this population has not been established.

Other medicines and Nepafenac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Nepafenac can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.

Also tell your doctor if you are taking medicines that reduce blood clotting (warfarin) or other NSAIDs. They may increase the risk of bleeding.

Pregnancy and breast-feeding

If you are pregnant, or might get pregnant, talk to your doctor before you use Nepafenac. Women who may become pregnant are advised to use effective contraception during Nepafenac treatment. The use of Nepafenac is not recommended during pregnancy. Do not use Nepafenac unless clearly indicated by your doctor.

If you are breast-feeding, Nepafenac may pass into your milk. However, no effects on suckling children are anticipated. Nepafenac 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

Do not drive or use machines until your vision is clear. You may find that your vision is blurred for a time just after using Nepafenac.

Nepafenac contains benzalkonium chloride

This medicine contains 0.25 mg benzalkonium chloride in each 5 ml which is equivalent to

0.05 mg/ml.

The preservative in Nepafenac, bezalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

  1. HOW TO USE NEPAFENAC

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

Only use Nepafenac for your eyes. Do not swallow or inject.

The recommended dose is

One drop in the affected eye or eyes, three times a day – morning, midday, and evening. Use at the same time each day.

When to take and for how long

Begin 1 day before cataract surgery. Continue on the day of surgery. Then use it for as long as your doctor tells you to. This may be up to 3 weeks (to prevent and relieve eye pain and inflammation) or 60 days (to prevent the development of macular oedema) after your operation.

How to use

Wash your hands before you start.

  • Shake well before use.
  • Twist off the bottle cap.
  • After cap is removed, if tamper evident snap collar is loose, remove before using product.
  • Hold the bottle, pointing down, between your thumb and fingers.
  • Tilt your head back.
  • Pull down your lower eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1).
  • Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
  • Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.
  • Gently press on the base of the bottle to release one drop of Nepafenac at a time.
  • Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2).

If you use drops in both eyes, repeat the steps for your other eye. Close the bottle cap firmly immediately after use.

If a drop misses your eye, try again.

If you are using other eye drops, wait at least five minutes between using Nepafenac and the other drops.

If you use more Nepafenac than you should

Rinse your eye out with warm water. Do not put in any more drops until it is time for your next regular dose.

If you forget to use Nepafenac

Use a single dose as soon as you remember. If it is almost time for the next dose, leave out the missed dose and continue with the next dose of your regular routine. Do not use a double dose to make up for a missed dose. Do not use more than one drop in the affected eye(s) 3 times daily.

If you stop using Nepafenac

Do not stop using Nepafenac without speaking to your doctor first. You can usually carry on using the drops, unless you experience serious side effects. If you are worried talk to your doctor or pharmacist.

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

  1. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects although not everybody gets them. There may be a higher risk of corneal side effects (eye surface problems) if you have:

  • complicated eye surgery
  • repeated eye surgery within a short period of time
  • certain disorders of the surface of the eye, such as inflammation or dry eye
  • certain general disease, such as diabetes or rheumatoid arthritis

Contact your doctor immediately if your eyes become more red or more painful whilst using the drops. This may be a result of inflammation on the eye surface with or without loss or damage of cells or an inflammation of the coloured part of the eye (iritis). These side effects have been observed in up to 1 in 100 people.

The following side effects have also been observed with Nepafenac 1 mg/ml eye drops, suspension or Nepafenac 3 mg/ml eye drops, suspension, or both.

Uncommon side effects

(may affect up to 1 in 100 people)

Effects in the eye: eye surface inflammation with or without loss or damage of cells, foreign body sensation in the eyes, eyelid crusting or drooping.

Rare side effects

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

Effects in the eye: iris inflammation, eye pain, eye discomfort, dry eye, eyelid swelling, eye irritation, itchy eye, eye discharge, allergic conjunctivitis (eye allergy), increased tear production, deposits on the eye surface, fluid or swelling at the back of the eye, eye redness.

General side effects: dizziness, headache, allergic symptoms (eyelid allergic swelling), nausea, skin inflammation, redness and itching.

Side effects with frequency not known (cannot be estimated from the available data)

Effects in the eye: damage on the surface of the eye such as thinning or perforation, impaired healing of the eye, eye surface scar, clouding, reduced vision, eye swelling, blurred vision.

General side effects: vomiting, increased blood pressure.

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.

  1. HOW TO STORE NEPAFENAC

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 bottle and the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Throw away the bottle 4 weeks after first opening, to prevent infections. Write the date of opening on the bottle and carton label in the space provided.

Do not throw away any medicines via waste water 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 NEPAFENAC CONTAINS

Each ml of suspension contains:
Nepafenac………………………………1mg
(0.1% w/v)

The other ingredients are benzalkonium chloride (see section 2), carbomer, disodium edetate, mannitol, purified water, sodium-chloride and tyloxapol.

Tiny amounts of sodium hydroxide and/or hydrochloric acid are added to keep acidity levels (pH levels) normal.

What Nepafenac looks like and the contents of the pack

Nepafenac is a liquid (light yellow to light orange suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap.

  1. 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

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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.