LUMIGAN 0.1 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

LUMIGAN 0.1mg/ml, eye drops, solution

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.

Contents of the package leaflet:

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

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

LUMIGAN is a medicine for glaucoma. LUMIGAN belongs to a group of medicines called prostamides.

LUMIGAN eye drops are used to reduce high pressure in the eye. LUMIGAN can be used alone or with other eye drops called beta blockers that also reduce pressure.

The eye contains a clear, watery liquid that keeps the inside of the eye healthy. This liquid is constantly drained out of the eye and new liquid is produced to replace it. If the liquid is not drained quickly enough, the pressure inside the eye increases. LUMIGAN works by increasing the drainage of the liquid. This reduces the pressure inside the eye. If this pressure is not reduced, it could lead to a disease called glaucoma and damage your vision.

2. What you need to know before you use LUMIGAN 0.1 mg/ml

Do not use LUMIGAN 0.1 mg/ml:

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to use LUMIGAN 0.1 mg/ml.

• Talk to your doctor if:
• you have any respiratory problems.
• you have liver or kidney problems.
• you have had cataract surgery in the past.
• you have dry eye.
• you have or have had any problems with the cornea (the transparent front part of the eye).
• you wear contact lenses (see "LUMIGAN 0.1 mg/ml contains benzalkonium chloride").
• you have or have had low blood pressure or a slow heart rate.
• you have had a viral infection or inflammation of the eye.

During treatment, LUMIGAN may cause loss of fat around the eye, which can cause deepening of the eyelid fold, sunken eyes (enophthalmos), drooping of the upper eyelid (ptosis), stretching of the skin around the eye (involution of the dermatocalasis), and the white part of the eye becomes more visible (inferior scleral show). The changes are usually mild, but if they worsen, they can affect your field of vision. The changes may disappear if you stop using LUMIGAN. LUMIGAN may also cause darkening and growth of eyelashes, as well as darkening of the skin around the eyelid. The color of the iris may darken. These changes may be permanent and more noticeable if only one eye is being treated.

Children and adolescents

LUMIGAN has not been studied in patients under 18 years of age and should not be used in patients under 18 years of age.

Other medicines and LUMIGAN:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

LUMIGAN may pass into breast milk, so you should not use it if you are breastfeeding.

Driving and using machines:

After instilling LUMIGAN, you may experience blurred vision for a short time. Do not drive or use machines until your vision is clear.

LUMIGAN 0.1 mg/ml contains benzalkonium chloride

This medicine contains 0.6 mg of benzalkonium chloride in every 3 ml of solution, which is equivalent to 0.2 mg/ml.

Do not use the eye drops when wearing contact lenses. The benzalkonium chloride in Lumigan can be absorbed by soft contact lenses and may change the color of the contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use LUMIGAN 0.1 mg/ml

Follow the instructions for administration of the medicine given by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

LUMIGAN should only be used in the eye. The recommended dose is one drop of LUMIGAN in each eye that needs treatment, once a day, in the evening.

If you use LUMIGAN with another eye medicine, wait at least 5 minutes between using LUMIGAN and the other eye medicine.

Do not use the medicine more than once a day, as this may reduce the effectiveness of the treatment.

Instructions for use:

Do not use the container if the protective seal is broken before using it for the first time.

1. Wash your hands. Tilt your head back and look up at the ceiling.
2. Gently pull down the lower eyelid until a small pocket is formed.
3. Turn the container upside down and press it to release one drop into each eye that needs treatment.
4. Release the lower eyelid and keep the eye closed for 30 seconds.

Wipe away any excess that runs down your cheek.

If the drop misses your eye, try again.

To help prevent infections and eye injuries, avoid touching the tip of the container to the eye or any other surface. Replace the cap and close the container immediately after use.

If you use more LUMIGAN 0.1 mg/ml than you should

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

If you forget to use LUMIGAN 0.1 mg/ml

If you forget to apply LUMIGAN, use one drop as soon as you remember, and then go back to your usual routine. Do not apply a double dose to make up for the forgotten dose.

If you stop using LUMIGAN 0.1 mg/ml

LUMIGAN should be used every day to work properly. If you stop using LUMIGAN, the pressure in the eye may increase, so consult your doctor before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects

These may affect 1 or more patients in every 10

Affecting the eye

• Mild redness (up to 29% of patients)
• Loss of fat in the eye area that can cause deepening of the eyelid fold, sunken eyes (enophthalmos), drooping of the upper eyelid (ptosis), stretching of the skin around the eye (involution of the dermatocalasis), and the white part of the eye becomes more visible (inferior scleral show).

Common side effects

These may affect 1 to 9 patients in every 100

Affecting the eye

• Small epithelial erosions in the eye, with or without inflammation
• Irritation
• Itching in the eyes
• Longer eyelashes
• Irritation when instilling the drop in the eye

• Eye pain

Affecting the skin

• Red and itchy eyelids

• Darker skin around the eye.

• Hair growth around the eye.

Uncommon side effects

These may affect 1 to 9 patients in every 1,000

Affecting the eye

• Darker iris color
• Eye strain
• Inflammation of the eye surface
• Blurred vision
• Loss of eyelashes

Affecting the skin

• Dry skin

• Flaking of the eyelid margin
• Swelling of the eyelid
• Itching

Affecting the body

• Headache
• Feeling unwell

Rare side effects

These may affect 1 to 9 patients in every 10,000

Affecting the eye

• Macular edema (inflammation of the retina in the back of the eye that can lead to worsening vision)
• Darker eyelid
• Dryness
• Sticky eyes
• Feeling of a foreign body in the eye
• Eye inflammation
• Increased tearing
• Eye discomfort
• Sensitivity to light

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of chronic obstructive pulmonary disease (COPD)
• Difficulty breathing
• Symptoms of an allergic reaction (inflammation, redness of the eye, and skin rash)
• Dizziness
• High blood pressure
• Discoloration of the skin (around the eye)

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

• Eye burning
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clearly
• Worsening of vision
• Inflammation of the transparent layer that covers the eye
• Tearing
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside the eye
• Cystoid macular edema (inflammation of the retina in the back of the eye that can lead to worsening vision)
• Eyelid twitching
• The eyelid has contracted and separated from the eye surface
• Redness of the skin around the eye
• Weakness
• An increase in blood test results that show liver activity

Other side effects reported with eye drops that contain phosphate

In very rare cases, some patients with severe damage to the transparent layer on the front of the eye (the cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects

If you experience 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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of LUMIGAN 0.1 mg/ml

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

You should throw away the container at the latest 4 weeks after you first opened it, even if there are still some drops left. This will help prevent infections. To remind you, write down the date you opened the container on the space provided on the carton.

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 protect the environment.

6. Contents of the pack and other information

Composition of LUMIGAN 0.1 mg/ml

• The active substance is bimatoprost. One ml of solution contains 0.1 mg of bimatoprost.
• The other ingredients are benzalkonium chloride (preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain the normal level of acidity (pH levels).

Appearance of LUMIGAN 0.1 mg/ml and contents of the container

LUMIGAN is a clear, colorless eye drop solution in a container that contains 1 or 3 plastic bottles, each with a screw cap. The bottle is only filled up to about half, and each bottle contains 3 ml of solution. The contents are sufficient for 4 weeks of treatment. Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu//