Lumigan 0.3 mg/ml eye drops solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

bimatoprost

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What LUMIGAN 0.3 mg/ml single-dose is and what it is used for
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 side effects
5. How to store LUMIGAN 0.3 mg/ml single-dose
6. Contents of the pack and other information

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

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

LUMIGAN 0.3 mg/ml eye drops, single-dose, is used to reduce elevated eye pressure. This medicine may be used alone or in combination with other eye drops called beta-blockers, which also reduce pressure.

The eye contains a clear, watery fluid that maintains the inner part of the eye. This fluid continuously drains out of the eye, and new fluid is produced to replace it. If the fluid does not drain quickly enough, pressure inside the eye increases. This medicine works by increasing the drainage of fluid, thereby reducing pressure within the eye. If this pressure is not reduced, it may lead to a condition called glaucoma and cause damage to your vision.

This medicine does not contain preservatives.

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

Do not use this medicine:

• If you are allergic to bimatoprost or to any of the other components 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 previously undergone cataract surgery.
• you currently 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 lead to deepening of the eyelid sulcus, sunken eyes (enophthalmos), drooping of the upper eyelids (ptosis), stretching of the skin around the eye (dermatocalasis involution), and increased visibility of the lower white part of the eye (inferior scleral show). These changes are usually mild, but if they become more pronounced, they may affect your field of vision. The changes may resolve 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 individuals under 18 years of age and should therefore 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 taking, have recently taken, or might need to take any other medicines.

Pregnancy, breast-feeding and fertility

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

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

Driving and using machines

After instillation of LUMIGAN 0.3 mg/ml single-dose, blurred vision may occur for a short period of time. Do not drive or operate machinery until your vision is clear.

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

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is one drop in each eye requiring treatment, once daily, in the late afternoon. LUMIGAN 0.3 mg/ml single-dose must be used only in the eye.

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

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

Wash your hands before use. A Make sure the single-dose container is intact before using this medicine. The solution should be used immediately after opening the container. To avoid contamination, do not let the tip of the single-dose container touch the eye or any other surface.

1. Take a single-dose container from the pouch and hold it upright (with the cap facing upwards) and twist the cap until it comes off.
2. Gently pull down the lower eyelid to form a pouch. Invert the single-dose container and squeeze until one drop falls into the affected eye or eyes.
3. Discard the single-dose container after use, even if there is some solution left inside.

Wipe away any excess that runs down your cheek.

If you wear contact lenses, you must remove them before using this medicine. Wait 15 minutes after using the drops before reinserting your lenses.

If you use more LUMIGAN 0.3 mg/ml single-dose than you should

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

If you forget to use LUMIGAN 0.3 mg/ml single-dose

If you forget to apply this medicine, use one drop as soon as you remember, and then continue with your usual routine. Do not apply a double dose to make up for the missed dose.

If you stop using LUMIGAN 0.3 mg/ml single-dose

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

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

4. Possible adverse effects

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

Very common adverse effects

These may affect 1 or more users in 10

Eye-related

• Mild redness (up to 24% of people)
  Loss of fat in the eye region, which may cause deepening of the eyelid groove, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (dermatocalasis involution), and increased visibility of the lower white part of the eye (inferior scleral show).

Common adverse effects

These may affect between 1 and 9 users in 100

Eye-related

• Minor erosions on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eyes
• Pain
• Dryness
• Sensation of having something in the eye
• Longer eyelashes
• Darker skin around the eye
• Red eyelids

Uncommon adverse effects

These may affect between 1 and 9 users in 1000

Eye-related

• Tired eyes
• Light sensitivity
• Darker iris
• Swollen and itchy eyelids
• Tearing
• Inflammation of the transparent layer covering the surface of the eye
• Blurred vision

Body-related

• Headaches
• Growth of hair around the eye

Adverse effects with unknown frequency

Eye-related

• Sticky eyes
• Eye discomfort

Body-related

• Asthma
• Worsening of asthma
• Worsening of the lung disease known as chronic obstructive pulmonary disease (COPD)
• Difficulty breathing
• Symptoms of allergic reaction (swelling, eye redness, and skin rash)
• Dizziness
• High blood pressure
• Skin discoloration (periocular)

In addition to the adverse effects of LUMIGAN 0.3 mg/ml single-dose, the following adverse 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
• Eyelid inflammation
• Difficulty seeing clearly
• Worsening of vision
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside the eye
• Cystoid macular edema (retinal inflammation within the eye leading to worsening vision)
• Inflammation of the iris
• Eyelid fasciculations
• Eyelid contraction and separation from the eye surface
• Nausea
• Redness of the skin around the eye
• Weakness
• Increase in certain blood test values indicating liver function

Other adverse effects reported with eye drops containing phosphate:

Very rarely, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed cloudy spots in the cornea due to calcium accumulation during treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

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

This medicine is for single use only and does not contain preservatives. Do not store any unused solution.

Do not use this medicine after the expiry date stated on the single-dose packaging and on the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. However, once the pouch is opened, the container should be used within 30 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer in use. This will help protect the environment.

6. Contents of the pack and other information

Composition of LUMIGAN 0.3 mg/ml single-dose unit

• The active substance 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 a normal acidity level (pH levels).

Appearance of the product and contents of the pack

LUMIGAN 0.3 mg/ml single-dose unit is a clear, colourless solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.

The pack contains 5 single-dose units in a box.

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

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer:

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder.

Date of latest review of this leaflet: <{MM/YYYY}>

Detailed information on this medicine 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 European Medicines Agency website.