Package Insert: Information for the User

LUMIGAN 0.1mg/ml, eye drops solution

bimatoprost

Read this package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3.How to use LUMIGAN 0.1 mg/ml

4.Possible adverse effects

5.Storage of LUMIGAN 0.1 mg/ml

6.Contents of the package and additional information

LUMIGAN is a medication for glaucoma. LUMIGAN belongs to a group of medications called prostamides.

LUMIGAN eye drops are used to reduce high eye pressure. 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. This liquid drains continuously out of the eye and new liquid is generated to replace it. If the liquid does not drain quickly enough, the pressure inside the eye increases. LUMIGAN acts by increasing the drainage of the liquid. This reduces the pressure inside the eye. If this pressure is not reduced, it could cause a disease called glaucoma and damage your vision.

Do not use LUMIGAN 0.1 mg/ml:

• if you are allergic to bimatoprost or any of the other components of this medication (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 corneal (front transparent part of the eye) problems
• you wear contact lenses (see “LUMIGAN 0.1 mg/ml contains benzalkonium chloride”)
• you have or have had low blood pressure or low heart rate
• you have had a viral infection or eye inflammation

During treatment, LUMIGAN may cause aloss of fat around the eye that can cause deepening of the eyelid crease, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (dermatochalasis involution) and that the white lower part of the eye becomes more visible (inferior scleral exposure). The changes are usually mild, but if they worsen, they may 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. It may darken the color of the iris. 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 medications and LUMIGAN:

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery:

After instilling LUMIGAN, you may experience blurred vision for a short period of time. Do not drive or operate machinery until your vision clears.

LUMIGAN 0.1 mg/ml contains benzalkonium chloride

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

Do not use the eye drops when wearing contact lenses. Benzalkonium chloride, the preservative in Lumigan, can be absorbed by soft contact lenses and may alter the color of the lenses. Remove your contact lenses before using this medication and wait 15 minutes before reinserting them. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal (front transparent part of the eye) diseases. Consult your doctor if you feel a strange sensation, burning or pain in the eye after using this medication.

Follow exactly the medication administration instructions indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

If you use LUMIGAN with another eye medication, wait at least five minutes between the use of LUMIGAN and the other eye medication.

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

Usage Instructions:

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 towards the ceiling.
2. Gently pull your lower eyelid down until a small space is created.
3. Invert the container and press it to release one drop into each eye that requires treatment.
4. Release your lower eyelid and keep your eye closed for 30 seconds.

Wipe away any excess that may run down your cheek.

If the drop falls outside the eye, try again.

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

If you use moreLUMIGAN 0.1 mg/mlthan you should

If you use more LUMIGAN than you should, it is unlikely to cause 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 useLUMIGAN 0.1 mg/ml

If you forget to apply LUMIGAN, use one drop as soon as you remember and return to your regular routine. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with LUMIGAN 0.1 mg/ml

LUMIGAN should be used daily for it to work properly. If you stop using LUMIGAN, the pressure inside the eye may increase, so consult your doctor before stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Frequent side effects

These may affect 1 or more patients in every 10

That affect the eye

• Mild redness (up to 29% of people)
• Loss of fat in the eye area that can cause deepening of the palpebral groove, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (dermatochalasis involution) and that the lower white part of the eye becomes more visible (exposure of the inferior sclera).

Frequent side effects

These may affect between 1 and 9 patients in every 100

That affect 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

• Dry eye

That affect the skin

• Red and itchy eyelids

• Darker skin around the eye.

• Increased hair growth around the eye.

Rare side effects

These may affect between 1 and 9 patients in every 1000

That affect the eye

• Darkening of the iris color
• Eye fatigue
• Surface inflammation of the eye
• Blurred vision
• Loss of eyelashes

That affect the skin

• Dry skin

• Peeling of the eyelid margin
• Swelling of the eyelid
• Itching

That affect the body

• Headache
• Feeling unwell

Side effects of unknown frequency

That affect the eye

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

That affect the body

• Asthma
• Worsening of asthma
• Worsening of chronic obstructive pulmonary disease (COPD)
• Difficulty breathing
• Allergic reaction symptoms (inflammation, redness of the eye and skin rash)
• Dizziness
• High blood pressure
• Skin discoloration (periocular)

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

• Eye burning
• Allergic reaction in the eye
• Swollen eyelids
• Difficulty seeing clearly
• Worsening of vision
• Inflammation of the transparent layer covering the eye
• Tearing
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside the eye
• Macular cystoid edema (inflammation of the retina inside the eye that leads to a worsening of vision)
• Fasciculations of the eyelid
• The eyelid has contracted and separated from the surface of the eye
• Redness of the skin around the eye
• Weakness
• Increased results of blood tests showing liver activity

Other side effects reported with eye drops containing phosphate

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet. You can also report them directly throughthe national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the container and on the box after EXP. The expiration date is the last day of the month indicated.

You should discard the container, at the latest, four weeks after having opened it for the first time, even if there are still some drops left. This will help prevent infections. To remember, write the date you opened the container in the space provided on the box.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of LUMIGAN 0.1 mg/ml

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

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

LUMIGAN is a colorless, transparent eye drop solution in a container that contains 1 or 3 plastic bottles, each with a screw cap. The contents of the bottle only reach approximately half and each bottle contains 3 ml of solution. The contents are sufficient for 4 weeks of treatment. Some container sizes may only be marketed.

Marketing authorization holder and manufacturer:

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder.

Last update of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu//