SUMMARY CMI

Bimatoprost Sandoz^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Bimatoprost Sandoz?

Bimatoprost Sandoz eye drops contain the active ingredient bimatoprost. Bimatoprost Sandoz is used to lower raised pressure in the eye and to treat glaucoma.

For more information, see Section 1. Why am I using Bimatoprost Sandoz? in the full CMI.

2. What should I know before I use Bimatoprost Sandoz?

Do not use if you have ever had an allergic reaction to bimatoprost or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Bimatoprost Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Bimatoprost Sandoz and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Bimatoprost Sandoz?

• Use one drop in your affected eye(s), according to your doctor's instructions.
• Use the drops each evening.

More instructions can be found in Section 4. How do I use Bimatoprost Sandoz? in the full CMI.

5. What should I know while using Bimatoprost Sandoz?

For more information, see Section 5. What should I know while using Bimatoprost Sandoz? in the full CMI.

6. Are there any side effects?

The most common side effects include red, congested eyes, growth of eyelashes, itching or irritation of the eye. Note that side effects can occur in other parts of the body, including serious allergic reaction (anaphylaxis).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Bimatoprost Sandoz^®

Active ingredient(s): bimatoprost (bim-at-oh-prost)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Bimatoprost Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Bimatoprost Sandoz.

Where to find information in this leaflet:

1. Why am I using Bimatoprost Sandoz?
2. What should I know before I use Bimatoprost Sandoz?
3. What if I am taking other medicines?
4. How do I use Bimatoprost Sandoz?
5. What should I know while using Bimatoprost Sandoz?
6. Are there any side effects?
7. Product details

1. Why am I using Bimatoprost Sandoz?

Bimatoprost Sandoz contains the active ingredient bimatoprost.

Bimatoprost Sandoz is used to lower raised pressure in the eye and to treat glaucoma.

Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure. Glaucoma is usually caused by a build up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye.

There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems, including total blindness. In fact, untreated glaucoma is one of the most common causes of blindness.

Bimatoprost Sandoz eye drops lower the pressure in the eye by helping the flow of fluid out of the eye chamber.

Bimatoprost Sandoz can be used alone or together with other eye drops/medicines to lower raised pressure within your eyes.

Although Bimatoprost Sandoz eye drops help control your condition, they will not cure it.

Your doctor may have prescribed this medication for another reason. Ask your doctor if you have any questions about why Bimatoprost Sandoz has been prescribed for you.

2. What should I know before I use Bimatoprost Sandoz?

Warnings

Do not use Bimatoprost Sandoz if:

• you are allergic to bimatoprost, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• the bottle/packaging shows signs of tampering, or the product does not look quite right.

Check with your doctor if:

• you have or have had inflammation in the eye, such as uveitis
• you have had eye surgery
• your eye does not have a lens
• your eye has an artificial lens, following cataract surgery
• the capsule ("bag") that normally holds the eye's lens in place is torn, or ruptured
• you have had other problems with your eyes, such as inflammation or swelling of the light sensitive part of the eye known as the macula
• you have a diabetes-related eye condition, such as diabetic retinopathy or blockage of a retinal vein
• you have or have had low blood pressure or a slow heartbeat
• you have or have had problems with your lungs or airways
• you have or have had problems with your liver or kidneys
• you take any medicines for any other condition
• you have had an allergy to any medicines or any other substances, such as foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Make sure your doctor is aware that you are pregnant or plan to become pregnant or are breastfeeding or intend to breastfeed.

Cosmetic effects

Before you start using Bimatoprost Sandoz your doctor should tell you that some changes to your eyes may occur which may be permanent.

During treatment, Bimatoprost Sandoz may cause a loss of fat around the eye, which may cause your eyelid crease to deepen, your eye to appear sunken, your upper eyelid to droop, the skin around your eye to tighten and the lower white part of your eye to become more visible. The changes are typically mild, but if pronounced, they can affect your field of vision. The changes may disappear if you stop taking Bimatoprost Sandoz.

Eyelashes may also grow longer and thicker, and eyelashes, the skin around the eye and the coloured part of the eye (iris) may become darker. If only one eye is being treated the cosmetic differences between the eyes may be noticeable. None of these changes affect vision. If you have any concerns, ask your doctor or pharmacist.

Hair may grow where Bimatoprost Sandoz contacts the skin. It is important to use as directed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Bimatoprost Sandoz and affect how it works, while Bimatoprost Sandoz may affect how other medicines work.

Medicines that may reduce the effect of Bimatoprost Sandoz and where Bimatoprost Sandoz may reduce their effect include:

• other eye drops in the same class as Bimatoprost Sandoz, such as latanoprost, tafluprost, and travoprost

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Bimatoprost Sandoz.

4. How do I use Bimatoprost Sandoz?

Follow all directions given to you by your doctor carefully. The directions may differ from the information contained in this leaflet.

How much to use

• Your doctor will tell you how many drops you need to use each day. Use Bimatoprost Sandoz only as prescribed by your doctor.
• The usual dose of Bimatoprost Sandoz is one drop in your affected eye(s), according to your doctor's instructions.

When to use Bimatoprost Sandoz

• Use the drops each evening.
• Use Bimatoprost Sandoz every day, at about the same time each day, unless your doctor tells you otherwise. Using your eye drops at the same time each day will have the best effect on your eye pressure. It will also help you remember when to use the eye drops.
• In some instances, Bimatoprost Sandoz eye drops need to be used with other eye drops. Your doctor will let you know which drops, how to use them, and how long to use them.
• If you are using more than one eye drop product, wait 5 minutes before using the second product. If you are also using an eye ointment, instill the eye ointment last.
• If you are being changed from one eye drop to another, follow your doctor's instructions carefully as to when to stop the old drops and when to start the new drops.

How to use Bimatoprost Sandoz

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses. The preservative in Bimatoprost Sandoz (benzalkonium chloride) may be deposited in soft contact lenses. You can put your soft contact lenses back into your eyes 15 minutes after you have used Bimatoprost Sandoz.

These drops are for use in your eyes only.

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing soft contact lenses, remove them before putting the drops in your eye.

1. Wash your hands well with soap and water.
2. Remove the lid/cap.
3. Hold the bottle upside down in one hand between your thumb and forefinger or index finger.
4. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
5. Tilt your head back and look up.
6. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
7. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
8. Close your eye. Do not blink or rub your eye.
9. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique.
10. Replace the lid/cap, sealing it tightly.
11. Wash your hands again with soap and water to remove any residue.

If a drop misses your eye, try again. Wipe off any excess that runs down the cheek.

Wait 15 minutes before replacing your contact lenses.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.

If you forget to use Bimatoprost Sandoz

It is important that you use Bimatoprost Sandoz at the same time each evening.

If you forget to use Bimatoprost Sandoz and it is almost time for your next dose, use your drops at the usual time the next evening.

If you miss your dose and remember through the night or in the morning, use the drops as soon as you remember and go back to using them at your usual time.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the number of drops to make up for the dose you missed.

If you use too much Bimatoprost Sandoz

If you think that you have used too much Bimatoprost Sandoz, immediately rinse your eyes with warm water.

If Bimatoprost Sandoz is accidentally swallowed, you should immediately:

• phone the Australian Poisons Information Centre
  (by calling 13 11 26), or the New Zealand National Poisons Information Centre (by calling 0800 POISONS or 0800 764 766), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Bimatoprost Sandoz?

Things you should do

• Continue to use Bimatoprost Sandoz every evening unless your doctor tells you to stop. Bimatoprost Sandoz eye drops help to control your condition but does not cure it.
• Use all the medication prescribed to treat your eye condition.
• Keep all your doctor's appointments so that your condition can be monitored, and your eye pressure can be checked.
• Tell your doctor if you think your condition is not improving while using Bimatoprost Sandoz.

Call your doctor straight away if you:

• develop any problems with your eye(s), such as, trauma, change of vision, infection in the eye or eyelid, or have eye surgery.
• become pregnant while using Bimatoprost Sandoz.

Remind any doctor, dentist, pharmacist or optometrist you visit that you are using Bimatoprost Sandoz.

Things you should not do

• Do not touch the dropper tip against your eye, eyelid or anything else, to avoid contaminating the eye drops.
• Do not stop using Bimatoprost Sandoz without checking with your doctor. Your eye pressure can rise again and may cause damage to your eye.

Driving or using machines

Your vision may be blurred after using Bimatoprost Sandoz. Wait until your vision clears before driving or using machines.

Looking after your medicine

• Keep your medicine in a cool dry place where the temperature stays below 25°C.
• Do not leave the top/lid off the bottle for any length of time to avoid contaminating the eye drops.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Discard the bottle 28 days after first opening it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Very serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems or to Medsafe at pophealth.my.site.com/carmreportnz/s/. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Bimatoprost Sandoz contains

Do not take this medicine if you are allergic to any of these ingredients.

What Bimatoprost Sandoz looks like

Bimatoprost Sandoz – Clear, colourless, sterile solution. It is supplied in plastic dropper bottles containing 3 mL of solution (AUST R 234901).

Who distributes Bimatoprost Sandoz

Bimatoprost Sandoz is supplied in Australia by:

Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia

Tel 1800 726 369

Bimatoprost Sandoz is supplied in New Zealand by:

Sandoz New Zealand Limited
12 Madden Street
Auckland 1010
New Zealand

Tel: 0800 726 369

This leaflet was prepared in January 2025.

^® Registered Trade Mark. The trade marks mentioned in this material are the property of their respective owners.

Published by MIMS March 2025

1 Name of Medicine

Bimatoprost.

2 Qualitative and Quantitative Composition

Bimatoprost Sandoz 300 microgram/mL is a sterile ophthalmic solution. Each mL of Bimatoprost Sandoz solution contains active ingredient bimatoprost 0.3 mg.
Bimatoprost is a prostamide with potent ocular hypotensive activity. Bimatoprost is a white or almost white crystalline powder and is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost is a clear, isotonic, colourless, sterile ophthalmic solution with an osmolality of approximately 260 to 330 mOsmol/kg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Bimatoprost Sandoz 300 microgram/mL eye drops sterile solution is packed in plastic dropper bottles with a plastic tamper-proof screw cap. Each bottle has a fill volume of 3 mL.

4 Clinical Particulars

4.1 Therapeutic Indications

Bimatoprost eye drops is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

4.2 Dose and Method of Administration

Monotherapy.

Adjunctive therapy.

4.3 Contraindications

Bimatoprost eye drops are contraindicated in patients with hypersensitivity to bimatoprost or to any component of the medication.

4.4 Special Warnings and Precautions for Use

General.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Other information for patients.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.
No drug-drug interactions are anticipated in humans since systemic concentrations of bimatoprost are extremely low (less than 0.2 nanogram/mL) following ocular dosing. No effects on hepatic drug metabolising enzymes were observed in pre-clinical studies. Therefore, specific interaction studies with other medicinal products have not been performed with bimatoprost.
In clinical studies, bimatoprost was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of drug interactions.
Concomitant use of bimatoprost and anti-glaucoma 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 to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Based on the pharmacodynamic profile, bimatoprost is not expected to affect the ability to drive and use machines. As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

In clinical studies, over 1,700 patients have been treated with bimatoprost eye drops.
In the two pivotal monotherapy trials (715 patients) the most frequently reported treatment-related adverse events were: conjunctival hyperemia in up to 42%, growth of eyelashes in up to 36% and ocular pruritus in up to 14% of patients. The incidence of conjunctival hyperemia at baseline was 25.1% and 17.8% in patients allocated to treatment with bimatoprost once daily and timolol twice daily, respectively. At 6 months, the incidence of patients with a greater than mild increase in conjunctival hyperemia was 6.2% and 0.4% in patients treated with bimatoprost once daily and timolol twice daily, respectively. Less than 7% of patients discontinued due to any adverse event.
The following undesirable effects definitely, probably or possibly related to treatment were reported during clinical trials with bimatoprost. Most were ocular, mild to moderate, and none was serious:

Eye disorders.

Nervous system disorders.

Musculoskeletal and connective tissue disorders.

Respiratory, thoracic and mediastinal disorders.

Skin and subcutaneous tissue disorders.

Post-marketing experiences.

Eye disorders.

Skin and subcutaneous tissue disorders.

Gastrointestinal disorders.

Nervous system disorders.

Immune system disorders.

Vascular disorders.

Respiratory, thoracic and mediastinal disorders.

Investigations.

Adverse reactions reported in phosphate containing eye drops.

Description of selected adverse reactions.

Prostaglandin analogue periorbitopathy (PAP).

Iris hyperpigmentation.

Reporting suspected adverse effects.

4.9 Overdose

In case of overdose treatment should be supportive and symptomatic.

Ophthalmic overdose.

Systemic overdose resulting from accidental ingestion.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Monotherapy.

Adjunctive therapy.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Ocular administration of bimatoprost in monkeys at concentrations of 0.03% or 0.1% once or twice daily for 1 year caused 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. No associated increase in melanocyte number was observed with the pigmentation. It appears that the mechanism of increased iris pigmentation is due to increased stimulation of melanin production in melanocytes and not to an increase in melanocyte number.
Periocular effects were also observed in an intravenous toxicity study at systemic exposures at least 235-fold higher than that observed in humans after ocular administration. No functional or microscopic changes related to the periocular effects were observed. The mechanism of action for the observed periocular changes is unknown.

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzalkonium chloride 0.05 mg (preservative); dibasic sodium phosphate heptahydrate; citric acid monohydrate; sodium chloride; purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

36 months.

6.4 Special Precautions for Storage

Store below 25°C.
To avoid contamination of the solution, keep container tightly closed. Do not touch dropper tip to any surface. Discard contents 4 weeks after opening the bottle. Contents are sterile if seal is intact.

6.5 Nature and Contents of Container

LDPE bottle.
Pack size: 1 x 3 mL bottle.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes