Label: information for the user

LUMIGAN 0.3mg/ml, eye drop solution in single-dose container

bimatoprost

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

• Keep this label, 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 label. See section 4.

1.What is LUMIGAN 0.3 mg/ml single-dose and for what it is used

2.What you need to know before using LUMIGAN 0.3 mg/ml single-dose

3.How to use LUMIGAN 0.3 mg/ml single-dose

4.Possible adverse effects

5.Storage of LUMIGAN 0.3 mg/ml single-dose

6.Contents of the container and additional information

LUMIGAN 0.3 mg/ml single-dose is a medication for glaucoma. LUMIGAN belongs to a group of medications called prostamides.

LUMIGAN 0.3 mg/ml single-dose eye drops are used to reduce high eye pressure. This medication can be used alone or with other eye drops called beta-blockers that also reduce pressure.

The eye contains a clear, watery liquid that maintains the inner part of the eye. This liquid continuously drains out of the eye and new liquid is generated to replace it. If the liquid does not drain at a sufficient speed, the pressure inside the eye increases. This medication 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.

This medication does not contain preservatives.

You should not use this medicine:

• If you are allergic to bimatoprost or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Consult your doctor or pharmacist before starting to use LUMIGAN 0.3 mg/mL single-dose.

Talk to your doctor or pharmacist if:

• You have any respiratory problems.
• You have liver or kidney problems.
• You have had cataract surgery in the past.
• You have or have had low blood pressure or low heart rate.
• You have had a viral infection or inflammation of the eye.

During treatment, LUMIGAN may cause a loss of fat around the eye that can cause deepening of the eyelid crease, sinking of the eyes (enophthalmos), drooping of the upper 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). The changes are usually mild, but if they become more pronounced, they may affect your field of vision. The changes may disappear if you stop using LUMIGAN. LUMIGAN 0.3 mg/mL single-dose 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 0.3 mg/mL single-dose 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 0.3 mg/mL single-dose:

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

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

LUMIGAN 0.3 mg/mL single-dose may pass into breast milk, so you should not use it if you are breastfeeding.

Driving and operating machinery:

After instillation of LUMIGAN 0.3 mg/mL single-dose, you may experience blurred vision for a short period of time. Do not drive or operate machinery until your vision clears.

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

The recommended dose is one drop in each eye that requires treatment, once a day, in the late afternoon. LUMIGAN 0.3 mg/ml single-dose should be used only in the eye.

If you use LUMIGAN 0.3 mg/ml single-dose with another eye medication, wait at least 5 minutes between the use of LUMIGAN 0.3 mg/ml single-dose and the other eye medication.

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

Wash your hands before using it.AMake sure the single-dose vial is intact before using this medication. The solution must be used immediately after opening the vial. To avoid contamination, do not let the tip of the single-dose vial touch the eye or any other surface.

1.Take a single-dose vial from the bag and hold it in a vertical position (with the cap facing up) and turn the cap until it comes loose.

2.Gently pull the lower eyelid down to form a pouch. Invert the single-dose vial and press until a drop falls into the affected eye or eyes.

3.Dispose of the single-dose vial after use, even if there is solution left inside.

Wipe away any excess that runs down your cheek.

If you wear contact lenses, you must remove them before using this medication. Wait 15 minutes after using the drops to put your lenses back in.

If you use moreLUMIGAN 0.3 mg/ml single-dosethan you should

If you use more of this medication 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 forgot to useLUMIGAN 0.3 mg/ml single-dose

If you forgot to apply this medication, use one drop as soon as you remember and go back to your regular routine. Do not apply a double dose to make up for the missed dose.

If you interrupt treatment with LUMIGAN 0.3 mg/ml single-dose

LUMIGAN 0.3 mg/ml single-dose should be used every day for it to work properly. If you stop using LUMIGAN 0.3 mg/ml single-dose, the pressure inside the eye may increase, so consult your doctor before stopping treatment.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Very common side effects

These may affect 1 or more users in every 10

That affect the eye

• Mild redness (affecting up to 24% of people)Loss of fat in the eye area that can cause deepening of the eyelid groove, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (dermatochalasis) and making the white lower part of the eye more visible (exposure of the inferior sclera)

Common side effects

These may affect between 1 and 9 users in every 100

That affect the eye

• Small erosions on the surface of the eye, with or without inflammation

• Irritation

• Itching in the eyes
• Pain

• Dryness

• Sensation of having something in the eye
• Longer eyelashes
• Darker skin around the eye

• Red eyelids

Uncommon side effects

These may affect between 1 and 9 users in every 1000

That affect the eye

• Eye fatigue
• Light sensitivity
• Darker iris
• Swollen and itchy eyelids
• Excessive tearing
• Inflammation of the transparent layer covering the eye surface
• Blurred vision

That affect the body

• Headaches

• Excessive hair growth around the eye

Side effects of unknown frequency

That affect the eye

• Sticky eyes
• Ocular discomfort

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
• Decoloration of the skin (periocular)

In addition to the side effects of LUMIGAN 0.3 mg/ml single-dose, the following side effects have been observed with the multidose formulation with preservative of LUMIGAN 0.3 mg/ml and may occur in patients using LUMIGAN 0.3 mg/ml single-dose:

• Burning sensation in the eye
• Allergic reaction in the eye
• Swollen eyelid
• Difficulty seeing clearly
• Worsening of vision
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside the eye
• Macular edema (inflammation of the retina inside the eye that leads to worsening of vision)
• Inflammation of the iris
• Fasciculations of the eyelid
• The eyelid has contracted and separated from the surface of the eye
• Nausea
• Redness of the skin around the eye
• Weakness
• Increased levels of some blood tests that indicate how the liver is functioning

Other side effects reported with eye drops containing 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 in the cornea due to calcium accumulation 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 prospectus. 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 about the safety of this medication.

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

This medication is for single use and does not contain preservatives. Do not conserve unused solution.

Do not use this medication after the expiration date that appears on the single-dose packaging and on the box after the expiration date (EXP). The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. However, once the bag is opened, use it within 30 days.

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

LUMIGAN 0.3 mg/ml Single-Dose

• The active ingredient is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The other components are 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 pH levels.

Appearance of the product and contents of the pack

LUMIGAN 0.3 mg/ml Single-Dose is a colourless and transparent solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.

The box contains 5 single-dose containers in a box.

The box contains 3 or 9 aluminium foil bags, each containing 10 single-dose containers, with a total of 30 or 90 single-dose containers in the box respectively.

Only some container sizes may be marketed.

Marketing Authorisation Holder and Responsible Person for Manufacturing:

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder.

Date of the last revision of this leaflet:<{MM/AAAA}>

The detailed information on this medicinal product is available on the website of the European Medicines Agency,http://www.ema.europa.eu.

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.