Bimatoprost Mylan

Package leaflet: Information for the user

Bimatoprost Mylan 0.1 mg/ml, eye drops, solution

Bimatoprost
Generic Medicine
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bimatoprost Mylan 0.1 mg/ml is and what it is used for
2. What you need to know before using Bimatoprost Mylan 0.1 mg/ml
3. How to use Bimatoprost Mylan 0.1 mg/ml
4. Possible side effects
5. How to store Bimatoprost Mylan 0.1 mg/ml
6. Contents of the pack and other information

1. What Bimatoprost Mylan 0.1 mg/ml is and what it is used for

Bimatoprost Mylan is an antiglaucoma medicine. It belongs to a group of
medicines called prostamides.
Bimatoprost Mylan is used to reduce elevated intraocular pressure. This medicine can be used alone or in combination with other eye drops called beta-blockers, which also help reduce pressure in the eye.
The eye contains a clear, watery fluid that nourishes its interior. This fluid is constantly drained out of the eye, and new fluid is produced to replace it. If the fluid is not drained quickly enough, the pressure inside the eye increases. This medicine works by increasing the amount of fluid that is drained, thereby reducing the pressure inside the eye. Elevated intraocular pressure, if left untreated, can lead to a condition called glaucoma and may eventually cause damage to vision.

2. What you need to know before using Bimatoprost Mylan 0.1 mg/ml

Do not use Bimatoprost Mylan 0.1 mg/ml

• if you are allergic to bimatoprost or to any of the other ingredients of this medicine (listed in section 6).
• if in the past you had to stop using eye drops due to an adverse reaction caused by the preservative benzalkonium chloride.

Warnings and precautions
Talk to your doctor or pharmacist before using Bimatoprost Mylan 0.1 mg/ml.
Consult your doctor if:

• you suffer from breathing problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you suffer from dry eye
• you have or have had corneal problems (the transparent front part of the eye)
• you wear contact lenses (see “Bimatoprost Mylan 0.1 mg/ml contains benzalkonium chloride”)
• you suffer or have suffered from low blood pressure or reduced heart rate
• you have had a viral infection or inflammation of the eyes.

Bimatoprost Mylan may cause darkening and growth of eyelashes, and may also darken the skin around the eyelids. Over time, the colour of the iris may also darken. These changes may be permanent and are more noticeable if only one eye is treated.

Children and adolescents
Bimatoprost Mylan has not been tested in children and adolescents under 18 years of age.
Therefore, it must not be used in patients under 18 years of age.

Other medicines and Bimatoprost Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Bimatoprost Mylan may pass into breast milk; therefore, breastfeeding is not recommended during treatment with Bimatoprost Mylan.

Driving and using machines
After administration of Bimatoprost Mylan, you may experience mild, temporary blurred vision. In this case, do not drive or operate machinery until your vision has cleared.

Bimatoprost Mylan 0.1 mg/ml contains phosphates and benzalkonium chloride
This medicine contains 0.95 milligrams of phosphate in each millilitre.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak to your doctor.

3. How to use Bimatoprost Mylan 0.1 mg/ml

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Bimatoprost Mylan must be applied only in the eyes. The recommended dose is one drop of
Bimatoprost Mylan once daily, in the evening, in each eye to be treated.
If you are using Bimatoprost Mylan with another eye medicine, apply Bimatoprost Mylan first and
wait 5 minutes before applying the second eye medicine.
Do not use it more than once a day, as the effectiveness of treatment may be reduced.
Instructions for use:
Do not use the bottle if the tamper-evident seal on the cap is not intact before use.

1. Wash your hands. Tilt your head back and look upwards.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and gently squeeze to release one drop of eye drops into each eye to be treated.
4. Release the lower eyelid and close the eye for 30 seconds.

Wipe away any excess liquid running down the cheek.
If the drop did not enter the eye, repeat the procedure.
To avoid eye infections and injury, the tip of the bottle must not touch the eye or come into contact
with any other surfaces. After using the bottle, close it tightly by screwing the cap back on.
If you use more Bimatoprost Mylan 0.1 mg/ml than you should
If you use more Bimatoprost Mylan than recommended, it is unlikely to cause serious
consequences. Take the next dose at your usual time. If you are concerned, consult your
doctor or pharmacist.
If you forget to use Bimatoprost Mylan 0.1 mg/ml
If you forget to use Bimatoprost Mylan, as soon as you remember, apply one drop and then
resume your regular dosing schedule. Do not use a double dose to make up for the missed dose.
If you stop using Bimatoprost Mylan 0.1 mg/ml
To work properly, Bimatoprost Mylan must be used every day. If you stop using Bimatoprost Mylan,
intraocular pressure may increase; therefore, you should speak with your doctor before stopping this
treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Very common side effects (may affect more than 1 in 10 people)
Eye effects

• Mild redness (up to 29% of people)

Common side effects (may affect up to 1 in 10 people)
Eye effects

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eyes
• Eyelash elongation
• Irritation when administering the drops into the eyes
• Eye pain

Skin effects

• Red, itchy eyelids
• Darkening of the skin around the eye
• Growth of hair around the eye

Uncommon side effects (may affect up to 1 in 100 people)
Eye effects

• Darkening of the iris colour
• Tired eyes
• Swelling of the surface of the eye
• Blurred vision
• Loss of eyelashes

Skin effects

• Dry skin
• Crusting at the edge of the eyelid
• Swelling of the eyelid
• Itching

General effects

• Headache
• Feeling unwell

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

• Macular edema (swelling of the retina at the back of the eye which may lead to worsening of vision)
• Darkening of the eyelids
• Sunken eyes
• Dry eye
• Sticky eyes
• Foreign body sensation in the eye
• Eye swelling
• Increased tearing
• Eye disorder
• Light sensitivity

General effects

• Asthma
• Worsening of asthma
• Worsening of the lung condition known as chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, and skin rash)
• Dizziness
• Increase in blood pressure
• Skin discoloration (periorbital)

In addition to the side effects of Bimatoprost Mylan 0.1 mg/ml, the following side effects have been observed with another medicine containing a higher concentration of bimatoprost (0.3 mg/ml):

• Eye burning
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the transparent layer covering the surface of the eye
• Tearing
• Darkening of eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision)
• Eyelid spasms
• Eyelid tightening, pulling away from the eye surface
• Redness of the skin around the eye
• Weakness
• Increased liver function test values in blood tests

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed opaque areas on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bimatoprost Mylan 0.1 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the carton after Exp. The expiry date refers to the last day of that month.
The bottle must be discarded no later than 4 weeks after first opening, even if there are still eye drops remaining. This will prevent the risk of infection. To help you remember, write down the date of first opening in the space provided on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bimatoprost Mylan 0.1 mg/ml contains

• The active substance is bimatoprost. One ml of solution contains 0.1 mg of bimatoprost. One drop contains approximately 2.5 micrograms of bimatoprost.
• The other ingredients are benzalkonium chloride (preservative), disodium phosphate heptahydrate (see section 2 “Bimatoprost Mylan 0.1 mg/ml contains phosphates and benzalkonium chloride”), sodium chloride, citric acid monohydrate, sodium hydroxide or hydrochloric acid (for pH adjustment), and purified water.

Description of the appearance of Bimatoprost Mylan 0.1 mg/ml and package contents
Bimatoprost Mylan is a clear, colourless eye drop solution supplied in a pack containing 1 plastic bottle or 3 plastic bottles, each with a screw cap. Each bottle is filled halfway and contains 2.5 millilitres or 3 millilitres of solution, sufficient for 4 weeks of use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturer
S.C. Rompharm Company S.r.l., Eroilor Street n° 1A, Otopeni Ilfov 075100, Romania