1. NAME OF THE MEDICINAL PRODUCT

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of solution contains:
Bimatoprost…………………………0.3mg

Excipients with known effect

One ml of solution contains 0.05 mg benzalkonium chloride.

One ml of solution contains 0.95 mg phosphates.

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Eye drops, solution.

Clear, colourless solution, free from visible particles.

pH: 6.8-7.8

Osmolality: 290 mOsm/kg

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).

4.2 Posology and method of administration

Posology

The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect.

Paediatric population

The safety and efficacy of bimatoprost in children aged 0 to 18 years have not yet been established.

Patients with hepatic and renal impairment

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients. In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost 0.3 mg/ml eye drops, solution had no adverse reaction on liver function over 24 months.

Method of administration

If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

4.3 Contraindications

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

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire 0.3 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium chloride that has led to discontinuation.

4.4 Special warnings and precautions for use

Ocular

Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation, since these have been observed during treatment with bimatoprost. Some of these changes may be permanent and may lead to differences in appearance between the eyes when only one eye is treated. Increased iris pigmentation is likely to be permanent. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long-term effects of increased iris pigmentation are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts become more brownish. Neither naevi nor freckles of the iris appears to be affected by the treatment. At 12 months, the incidence of iris pigmentation with bimatoprost 0.3mg/ml was 1.5% (see section 4.8) and did not increase following 3 years treatment. Periorbital tissue pigmentation has been reported to be reversible in some patients.

Cystoid macular oedema has been uncommonly reported (≥1/1,000 to <1/100) following treatment with bimatoprost 0.3 mg/ml eye drops. Therefore, bimatoprost should be used with caution in patients with known risk factors for macular oedema (e.g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).

There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/ml eye drops, solution. Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma should be used with caution in patients with a prior history of significant ocular viral infections (e.g. herpes simplex) or uveitis/iritis.

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.

Skin

There is a potential for hair growth to occur in areas where Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire solution comes repeatedly in contact with the skin surface. Thus, it is important to apply Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire as instructed and avoid it running onto the cheek or other skin areas.

Respiratory

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma has not been studied in patients with compromised respiratory function. While there is limited information available on patients with a history of asthma or COPD, there have been reports of exacerbation of asthma, dyspnoea and COPD, as well as reports of asthma, in post-marketing experience. The frequency of these symptoms is not known. Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution.

Cardiovascular

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure. There have been a limited number of spontaneous reports of bradycardia or hypotension with bimatoprost 0.3 mg/ml eye drops, solution. Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire should be used with caution in patients predisposed to low heart rate or low blood pressure.

Other information

In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP-lowering effect (see section 4.5). Patients using bimatoprost with other prostaglandin analogues should be monitored for changes to their intraocular pressure.

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire 0.3 mg/ml eye drops, solution contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses and discolour soft contact lenses. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.

Patients should be monitored in case of prolonged use.

There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent ocular disease. Patients with a disruption of the ocular epithelial surface are at greater risk of developing bacterial keratitis.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures, to avoid eye injury and contamination of the solution.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/ml) following ocular dosing with bimatoprost 0.3 mg/ml eye drops, solution. Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma is biotransformed by any of multiple enzymes and pathways and no effects on hepatic metabolic enzymes of medicinal products were observed in preclinical studies.

In clinical studies, bimatoprost was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.

Concomitant use of bimatoprost and antiglaucomatous agents other than topical beta-blockers has not been evaluated during adjunctive glaucoma therapy.

There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire) to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues (see section 4.4).

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire should not be used during pregnancy unless clearly necessary.

Breast-feeding

It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown excretion of bimatoprost in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue from Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effects of bimatoprost on human fertility.

4.7 Effects on ability to drive and use machines

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma Aspire has negligible influence on the ability to drive and use machines. As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.

4.8 Undesirable effects

In clinical studies, over 1,800 patients have been treated with bimatoprost 0.3 mg/ml eye drops, solution. On combining the data from phase III monotherapy and adjunctive bimatoprost 0.3 mg/ml eye drops, solution usage, the most frequently reported treatment-related adverse events were: growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 years and 2% at 3 years, conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in up to 44% in the first year with the incidence of new reports decreasing to 13% at 2 years and 12% at 3 years and ocular pruritus in up to 14% of patients in the first year with the incidence of new reports decreasing to 3% at 2 years and 0% at 3 years. Less than 9% of patients discontinued due to any adverse event in the first year with the incidence of additional patient discontinuations being 3% at both 2 and 3 years.

The following adverse reactions were reported during clinical trials with bimatoprost 0.3 mg/ml eye drops, solution or in the post-marketing period. Most were ocular, mild to moderate and none was serious:

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) and not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1

System Organ Class Frequency Adverse reaction
Immune system disorders not known hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis
Nervous system disorders common headache
uncommon dizziness
Eye disorders very common conjunctival hyperaemia, ocular pruritus, growth of eyelashes
common superficial punctate keratitis, corneal erosion, ocular burning, ocular irritation, allergic conjunctivitis, blepharitis, worsening of visual acuity, asthenopia, conjunctival oedema, foreign body sensation, ocular dryness, eye pain, photophobia, tearing, eye discharge, visual disturbance/blurred vision, increased iris pigmentation, eyelash darkening, eyelid erythema, eyelid pruritus
uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction, periorbital erythema, eyelid oedema
not known periorbital and lid changes including deepening of the eyelid sulcus, ocular discomfort
Vascular disorders common hypertension
Respiratory, thoracic and mediastinal disorders not known asthma, asthma exacerbation, COPD exacerbation and dyspnoea
Gastrointestinal disorders uncommon nausea
Skin and subcutaneous tissue disorders common pigmentation of periocular skin
uncommon hirsutism
not known skin discoloration (periocular)
General disorders and administration site conditions uncommon asthenia
Investigations common liver function test abnormal

Adverse reactions reported in phosphate containing eye drops:

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.

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 case of overdose has been reported and is unlikely to occur after ocular administration.

If overdose occurs, treatment should be symptomatic and supportive. If bimatoprost is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m2 is at least 70 times higher than the accidental dose of one bottle of bimatoprost 0.3 mg/ml eye drops, solution in a 10 kg child.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues

Mechanism of action

The mechanism of action by which bimatoprost reduces intraocular pressure in humans is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow. Reduction of the intraocular pressure starts approximately 4 hours after the first administration and maximum effect is reached within approximately 8 to 12 hours. The duration of effect is maintained for at least 24 hours.

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to prostaglandin F (PGF) that does not act through any known prostaglandin receptors. Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma selectively mimics the effects of newly discovered biosynthesised substances called prostamides. The prostamide receptor, however, has not yet been structurally identified.

During 12 months monotherapy treatment with bimatoprost 0.3 mg/ml in adults, versus timolol, mean change from baseline in morning (08:00) intraocular pressure ranged from -7.9 to -8.8 mmHg. At any visit, the mean diurnal IOP values measured over the 12-month study period differed by no more than 1.3 mmHg throughout the day and were never greater than 18.0 mmHg.

In a 6-month clinical study with bimatoprost 0.3 mg/ml, versus latanoprost, a statistically superior reduction in morning mean IOP (ranging from -7.6 to -8.2 mmHg for bimatoprost versus –6.0 to -7.2 mmHg for latanoprost) was observed at all visits throughout the study. Conjunctival hyperaemia, growth of eyelashes, and eye pruritus were statistically significantly higher with bimatoprost than with latanoprost, however, the discontinuation rates due to adverse events were low with no statistically significant difference.

Compared to treatment with beta-blocker alone, adjunctive therapy with beta-blocker and bimatoprost 0.3 mg/ml lowered mean morning (08:00) intraocular pressure by -6.5 to -8.1 mmHg.

Limited experience is available in patients with open-angle glaucoma with pseudoexfoliative and pigmentary glaucoma, and chronic angle-closure glaucoma with patent iridotomy.

No clinically relevant effects on heart rate and blood pressure have been observed in clinical trials.

Paediatric population

The safety and efficacy of bimatoprost in children aged 0 to less than 18 years have not been established.

5.2 Pharmacokinetic properties

Absorption

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma penetrates the human cornea and sclera well in vitro. After ocular administration in adults, the systemic exposure of bimatoprost is very low with no accumulation over time. After once daily ocular administration of one drop of bimatoprost 0.3 mg/ml to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ml) within 1.5 hours after dosing. Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 at approximately 0.08ng/ml and 0.09ng hr/ml respectively, indicating that a steady bimatoprost concentration was reached during the first week of ocular dosing.

Distribution

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 l/kg. In human blood, bimatoprost resides mainly in the plasma. The plasma protein binding of bimatoprost is approximately 88%.

Biotransformation

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing. Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.

Elimination

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy adult volunteers was excreted in the urine, 25% of the dose was excreted via the faeces. The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 l/hr/kg.

Characteristics in elderly patients

After twice daily dosing of bimatoprost 0.3 mg/ml, the mean AUC0-24hr value of 0.0634 nghr/ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 nghr/ml in young healthy adults. However, this finding is not clinically relevant as systemic exposure for both elderly and young subjects remained very low from ocular dosing. There was no accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and young patients.

5.3 Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Monkeys administered ocular bimatoprost concentrations of ≥ 0.3 mg/ml daily for 1 year had an increase in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper and/or lower sulcus and widening of the palpebral fissure. The increased iris pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and not by an increase in melanocyte number. No functional or microscopic changes related to the periocular effects have been observed, and the mechanism of action for the periocular changes is unknown.

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma was not mutagenic or carcinogenic in a series of in vitro and in vivo studies.

Bimatoprost Ophthalmic Solution 0.3mg/ml Taj Pharma did not impair fertility in rats up to doses of 0.6 mg/kg/day (at least 103 times the intended human exposure). In embryo/foetal developmental studies abortion, but no developmental effects were seen in mice and rats at doses that were at least 860 times or 1,700 times higher than the dose in humans, respectively. These doses resulted in systemic exposures of at least 33 or 97 times higher, respectively, than the intended human exposure. In rat peri/postnatal studies, maternal toxicity caused reduced gestation time, foetal death, and decreased pup body weights at ≥ 0.3 mg/kg/day (at least 41 times the intended human exposure). Neurobehavioural functions of offspring were not affected.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium chloride, Sodium chloride, Sodium phosphate dibasic heptahydrate, Citric acid monohydrate, Hydrochloric acid or sodium hydroxide concentrated (for pH adjustment), Water for injection

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months.

4 weeks after first opening.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

White opaque low density polyethylene vial for eye drops containing 3 ml of the ophthalmic solution sealed with a white opaque LDPE plug applicator and a white HDPE/LDPE cap with a tamper proof seal.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution.

Not all pack sizes may be marketed.

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

BIMATOPROST
OPHTHALMIC SOLUTION
0.3MG/ML
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bimatoprost

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

    1. WHAT BIMATOPROST IS AND WHAT IT IS USED FOR

Bimatoprost is an anti-glaucoma preparation. It belongs to a group of medicines called prostamides.

Bimatoprost eye drops are used to reduce high pressure in the eye. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.

Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

  1. WHAT YOU NEED TO KNOW BEFORE YOU USE BIMATOPROST

Do not use Bimatoprost:

  • if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6);
  • if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride.

Warnings and precautions

Talk to your doctor or pharmacist before using Bimatoprost.

Talk to your doctor:

  • if you have any breathing problems;
  • if you have liver or kidney problems;
  • if you have had a cataract surgery in the past;
  • if you have dry eye;
  • if you have or have had any problems with your cornea (front transparent part of the eye);
  • if you wear contact lenses (see ‘Bimatoprost contains benzalkonium chloride’);
  • if you have or have had low blood pressure or low heart rate;
  • if you have had a viral infection or inflammation of the eye.

Bimatoprost may cause your eyelashes to darken and grow and cause the skin around the eyelid to darken too. The colour of your iris may also go darker over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye.

Children and adolescents

This medicine has not been tested in children under the age of 18 and therefore Bimatoprost should not be used by patients under 18 years.

Other medicines and Bimatoprost

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

Pregnancy and 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.

You should not breast-feed while using Bimatoprost as this medicine may get into breast milk.

Driving and using machines

Your sight may become blurred for a short time just after using this medicine. You should not drive or use machines until your sight is clear again.

Bimatoprost contains benzalkonium chloride

This medicine contains 0.05mg benzalkonium chloride in each ml of solution. Benzalkonium 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.

Bimatoprost contains phosphate buffer

This medicine contains 0.95mg phosphates in each ml of solution. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

  1. HOW TO USE BIMATOPROST

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

This medicine should only be applied to the eye. The recommended dose is one drop of Bimatoprost in the evening, once daily in each eye that needs treatment.

If you use Bimatoprost with another eye medicine, wait at least five minutes between using Bimatoprost and the other eye medicine.

Do not use more than once a day as the effectiveness of treatment may be reduced.

Instructions for use:

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

  • Take the bottle (picture 1)out of the carton box.
  • Wash your hands. Tilt your head back and look at the ceiling (picture 2).
  • Gently pull down the lower eyelid until there is a small pocket (picture 3).
  • Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment (picture 4).
  • Let go of the lower lid and close your eye for 30 seconds (picture 5).

Wipe off any excess that runs down the cheek.

If a drop misses your eye, try again.

To help prevent infections and avoid eye injury, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it.

If you use more Bimatoprost than you should

If you use more Bimatoprost than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.

If you forget to use Bimatoprost

If you forget to use Bimatoprost, use a single drop as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose.

If you stop using Bimatoprost

Bimatoprost should be used every day to work properly. If you stop using Bimatoprost the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.

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.

Very common: may affect more than 1 in 10 people

Affecting the eye

  • Longer eyelashes (up to 45% of people)
  • Slight redness (up to 44% of people)
  • Itchiness (up to 14% of people)

Common: may affect up to 1 in 10 people

Affecting the eye

  • An allergic reaction in the eye
  • Tired eyes
  • Sensitivity to light
  • Darker skin colour around the eye
  • Darker eyelashes
  • Pain
  • A feeling that something is in your eye
  • Sticky eyes
  • Darker iris colour
  • Difficulty in seeing clearly
  • Irritation
  • Burning
  • Inflamed, red and itchy eyelids
  • Tears
  • Dryness
  • Worsening of vision
  • Blurred vision
  • Swelling of the see-through layer which covers the surface of the eye
  • Small breaks in the surface of the eye, with or without inflammation

Affecting the body

  • Headaches
  • An increase in blood-test results that show how your liver is working
  • Increased blood pressure

Uncommon: may affect up to 1 in 100 people

Affecting the eye

  • Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
  • Inflammation within the eye
  • Retinal bleeding
  • Swollen eyelids
  • Eyelid twitching
  • Eyelid shrinking, moving away from the surface of the eye
  • Skin redness around the eye

Affecting the body

  • Nausea
  • Dizziness
  • Weakness
  • Hair growth around the eye

Not known: frequency cannot be estimated from the available data

Affecting the eye

  • Eyes appear sunken
  • Ocular discomfort

Affecting the body

  • Asthma
  • Worsening of asthma
  • Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
  • Shortness of breath
  • Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
  • Skin discolouration (periocular)

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 BIMATOPROST

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

This medicine does not require any special storage conditions.

After first opening of the container, the product may be stored for 4 weeks. You must throw away the bottle at the latest four weeks after you first opened it, even if there are still some drops left. This will prevent infections. To help you remember, write down the date you opened it in the space on the box and bottle.

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 Bimatoprost contains

Each ml of solution contains:
Bimatoprost…………………………0.3mg

The other ingredients are benzalkonium chloride (preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the level of acid (pH levels) normal.

What Bimatoprost looks like and contents of the pack

Bimatoprost is a clear, colourless solution, free from visible particles in a white opaque low density polyethylene vial for eye drops containing 3ml of the ophthalmic solution sealed with a white opaque LDPE plug applicator and a white HDPE/LDPE cap with a tamper-proof seal.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3ml solution.

Not all pack sizes may be marketed.

  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