1. NAME OF THE MEDICINAL PRODUCT

Flurbiprofen sodium Ophthalmic Solution 0.3% w/v Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of solution Contains:
Flurbiprofen sodium Equivalent to
Flurbiprofen (0.3% w/v)………………3mg

For a full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Eye drops, solution

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Flurbiprofen Sodium is indicated for

1) the inhibition of intraoperative miosis. Flurbiprofen Sodium does not have intrinsic mydriatic properties and does not replace mydriatic agents.

2) the management of post-operative and post-laser trabeculoplasty inflammation in the anterior segment of the eye in patients in whom steroid therapy is not recommended.

4.2 Posology and method of administration

Posology:

Adult dosage: For the inhibition of intraoperative miosis, 1 drop is instilled every half hour starting 2 hours before surgery. The final drop should be given not less than 30 minutes before surgery.

To control post-operative and post-laser trabeculoplasty inflammation the dosing regimen above should be followed. Beginning twenty-four hours after surgery, one drop is administered four times daily for at least one week after laser trabeculoplasty or for two to three weeks after other surgery.

Paediatric population:

The safety and efficacy of Flurbiprofen Sodium in children has not been established.

Elderly population:

There is no specific advice for the elderly.

Method of administration:

Flurbiprofen Sodium is administered topically by instillation into the conjunctival sac.

In accordance with standard practice, other topical medication should not be co-administered with Flurbiprofen Sodium. When administering other topical medications, a minimum interval of 5 minutes between instillations is recommended.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Flurbiprofen Sodium is contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis).

The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Flurbiprofen Sodium is contra-indicated in individuals who have previously exhibited sensitivities to these drugs.

With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thromobocyte aggregation. The use of Flurbiprofen Sodium is contra-indicated in patients with known haemostatic defects or who are receiving other medications which may prolong bleeding time. Flurbiprofen Sodium is contra- indicated for intraocular use during surgical procedures.

As with all Non-Steroidal Anti inflammatory drugs, Flurbiprofen Sodium is contraindicated in the third trimester of pregnancy.

4.4 Special warnings and precautions for use

Wound healing may be delayed with the use of Flurbiprofen Sodium.

There have been reports that Flurbiprofen Sodium may cause an increased bleeding tendency of ocular tissues in conjunction with surgery.

Patients with a history of herpes simplex keratitis should be monitored closely.

4.5 Interaction with other medicinal products and other forms of interaction

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in some surgical patients treated with Flurbiprofen Sodium.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Flurbiprofen Sodium should not be given unless clearly necessary.

If Flurbiprofen Sodium is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

– cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

– renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

– possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

– inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, Flurbiprofen Sodium is contraindicated during the third trimester of pregnancy.

Breast-feeding:

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

It is unknown whether flurbiprofen/metabolites are excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Flurbiprofen Sodium therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

4.7 Effects on ability to drive and use machines

Transient blurred vision can result after instillation. If this occurs, the patient should wait until the vision clears before driving or using machinery.

4.8 Undesirable effects

The following adverse reactions were reported during the use of Flurbiprofen Sodium in clinical studies.

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) adverse reactions are presented according to MedDRA System organ class

Eye disorders:

Very common: Eye irritation, eye pain, Hyphema*

Additionally, the following adverse reactions have been identified during post marketing experience;

Eye disorders:

Not known: eye haemorrhage*, mydriasis (prolonged mydriasis), ocular hyperaemia.

* see section 4.4 for further information.

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

Overdose by the topical ophthalmic route will not ordinarily cause acute problems. If accidentally ingested, treatment should be symptomatic.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory agents, non-steroids

Flurbiprofen sodium Ophthalmic Solution 0.3% w/v Taj Pharmais a non steroidal anti inflammatory agent which inhibits prostaglandin synthesis by inhibition of the cyclo-oxygenase enzyme.

Ophthalmic surgery causes prostaglandin release, with the effect that prostaglandin- mediated miosis may occur.

Treatment with Flurbiprofen Sodium prior to surgery has been shown to inhibit intra-operative miosis and it is believed that this is brought about by inhibition of ocular prostaglandin release.

The sympathetic nervous system is not affected by this mechanism and acetylcholine- induced miosis has not been found to be inhibited in clinical trials.

Prostaglandins have also been shown to be mediators of certain kinds of intraocular inflammatory processes. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humour barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.

5.2 Pharmacokinetic properties

Flurbiprofen concentrations of 213 ng/ml in aqueous humour have been reported following half hourly treatment for two hours preceding surgery.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in the Summary of Product Characteristics.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquifilm (polyvinyl alcohol), Potassium chloride, Sodium chloride, Sodium citrate dehydrate, Citric acid monohydrate, Sodium hydroxide or, Hydrochloric acid (for pH-adjustment), Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

The shelf life is 24 months for the unopened vial. The vial should be discarded after a single dose. The remaining vials should be placed back in the original pouch after each use.

6.4 Special precautions for storage

Store at or below 25°C.

6.5 Nature and contents of container

Clear, plastic unit dose vial, each containing 0.4 ml of solution.

6.6 Special precautions for disposal and other handling

Each vial of Flurbiprofen Sodium should be used for a single dose and discarded after use.

  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

FLURBIPROFEN SODIUM OPHTHALMIC SOLUTION
0.3% W/V
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Flurbiprofen Sodium

Read all of this leaflet carefully before you start using this medicine.

  • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

  1. What Flurbiprofen Sodium is and what it is used for
  2. Before you use Flurbiprofen Sodium
  3. How to use Flurbiprofen Sodium
  4. Possible side effects
  5. How to store Flurbiprofen Sodium
  6. Further information1. WHAT FLURBIPROFEN SODIUM IS AND WHAT IT IS USED FOR

Flurbiprofen Sodium is used for two different purposes:

  • Given before and after eye surgery and laser surgery, to control eye inflammation in patients who have been recommended not to use steroids.
  • Given before an operation to help prevent the pupil becoming smaller during surgery.

Flurbiprofen Sodium belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

2. BEFORE YOU USE FLURBIPROFEN SODIUM

Do not use Flurbiprofen Sodium

  • If you are allergic (hypersensitive) to flurbiprofen (or other similar medicines), aspirin, or any of the other ingredients in Ocufen.
  • If you have a viral eye infection
  • If you have a tendency to bleed easily
  • If you are taking medicine that increases the time needed for your blood to clot
  • During surgery
  • If you are in the third trimester of pregnancy

Take special care with Flurbiprofen Sodium

Talk to your doctor before using Flurbiprofen Sodium if you suffer from, or have in the past suffered from:

  • Viral infections of the eye
  • A tendency to bleed

The use of Flurbiprofen Sodium after surgery may slow down healing.

Using other medicines

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

Other eye medicine should not usually be used with Flurbiprofen Sodium. However, if your doctor recommends using Flurbiprofen Sodium with another eye medicine, leave at least 5 minutes between putting in Flurbiprofen Sodium and the other medicine.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor before you start using Flurbiprofen Sodium if you are pregnant or if you are breast-feeding.

Do not use Flurbiprofen Sodium if you are in your third trimester of pregnancy.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

Flurbiprofen Sodium may cause blurred vision following administration, if this occurs wait until your vision clears before driving or using machinery.

  1. HOW TO USE FLURBIPROFEN SODIUM

Always use Flurbiprofen Sodium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

In adults

Dose before surgery

The usual dose is 1 drop in the eye(s) undergoing surgery, every half hour starting 2 hours before the operation or laser surgery (4 drops in total per eye being treated).

The final drop should be given at least 30 minutes before surgery.

Dose after surgery

24 hours after laser surgery the usual dose is 1 drop, 4 times a day for 1 week.

24 hours after eye surgery the usual dose is 1 drop, 4 times a day for 2 to 3 weeks.

Instructions for use

You must not use the vial if the seal on the vial neck is broken before you use it. Apply your eye drops in the following way:

  1. Wash your hands. Twist off the tab to open the vial. Tilt your head back and look at the ceiling.
    2. Gently pull the lower eyelid down until there is a small pocket.
    3. Turn the vial upside down and squeeze it to release one drop into each eye that needs treatment.
    4. Let go of the lower lid and close your eye for 30 seconds.

If a drop misses your eye, try again.

To avoid contamination, do not let the tip of the dropper touch your eye or anything else.

Throw away each vial immediately after use.

After use, the remaining vials should be placed back in the original pouch after each use. Fold ends closed.

The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist.

If you use more Flurbiprofen Sodium than you should

Putting too many drops in your eye(s) is unlikely to lead to unwanted side-effects. If you have placed too many drops in your eye(s), wash your eye(s) with clean water. Apply your next dose at the normal time.

If, by accident, anyone drinks this medicine, contact your doctor straight away.

If you forget to use Flurbiprofen Sodium

If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out the forgotten dose. Then apply your next dose as usual and continue with your normal routine.

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

If you stop using Flurbiprofen Sodium

Flurbiprofen Sodium should be used as advised by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. POSSIBLE SIDE EFFECTS

Like all medicines, Flurbiprofen Sodium can cause side effects, but not everyone gets them.

Tell your doctor if the following side effects prove troublesome or if they are long lasting

  • Irritation of the eye
  • Stinging and/or burning in the eye
  • Bleeding in the eye
  • Blood in the front area of the eye
  • Excessive dilatation of the pupil
  • Redness of the eye.

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:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

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

  1. HOW TO STORE FLURBIPROFEN SODIUM

Keep out of the reach and sight of children.

Discard each vial immediately after use, even if there is some solution remaining.

Do not use Flurbiprofen Sodium after the expiry date which is printed on the vial, the pouch the vial comes in and on the bottom of the carton after EXP. The expiry date refers to the last day of that month.

Store unused vials in the original pouch.

Store at or below 25°C.

The carton can be re-closed after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

  1. FURTHER INFORMATION

What Flurbiprofen Sodium contains

  • The active substance is Flurbiprofen sodium 0.3% w/v
  • The other ingredients are (polyvinyl alcohol), potassium chloride, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (for pH-adjustment) and purified water.

What Flurbiprofen Sodium looks like and contents of the pack

Flurbiprofen Sodium is a sterile eye drop and each clear plastic vial contains 0.4 ml of the medicine.

  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