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

Bimatoprost

LUMIGAN 0.3 mg/mL single-dose is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

LUMIGAN 0.3 mg/mL single-dose eye drops are used to reduce high pressure in the eye. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.

Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

This medicine does not contain a preservative.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one drop once daily, in the evening, once daily in each eye that needs treatment. LUMIGAN 0.3 mg/mL single-dose should only be applied to the eye

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

Do not use more than once a day as the effectiveness of treatment may be reduced.

Wash your hands before use. Make sure that the single-dose container is intact before use. The solution should be used immediately after opening. To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else.

1. Take one single-dose container from the pouch and hold it upright (with the cap pointing upwards) and twist off the cap.
2. Gently pull down the lower eyelid to form a pocket. Turn the single-dose container upside down and squeeze it to release 1 drop into the affected eye(s).
3. Throw away the single-dose container after you have used it, even if there is some solution left.

Wipe off any excess that runs down the cheek.

If you wear contact lenses, take your lenses out before using this medicine. Wait 15 minutes after using the drops, and before you put your lenses back in.

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

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

Very common side effects

These may affect one or more users in 10

Affecting the eye

• Slight redness (up to 24% of people)
• Loss of fat in the eye region which can lead to deepening of your eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightening of the skin around your eye (involution of dermatochalasis), and the lower white part of your eye to become more visible (inferior scleral show)

Common side effects

These may affect 1 to 9 users in 100

Affecting the eye

• Small breaks in the surface of the eye, with or without inflammation
• Irritation
• Itchy eyes
• Pain
• Dryness
• A feeling that something is in your eye
• Longer eyelashes
• Darker skin colour around the eye
• Red eyelids

Uncommon side effects

These may affect 1 to 9 users in 1000

Affecting the eye

• Tired eyes
• Sensitivity to light
• Darker iris colour
• Itchy and swollen eyelids
• Tears
• Swelling of the see-through layer which covers the surface of the eye
• Blurred vision

Affecting the body

• Headaches
• Hair growth around the eye

Side effects where the frequency is not known

Affecting the eye

• Sticky eyes
• Ocular discomfort

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
• Dizziness
• Increased blood pressure
• Skin discoloration (periocular)

In addition to the side effects for LUMIGAN 0.3 mg/mL single-dose, the following side effects have been seen with the preserved multi-dose formulation of LUMIGAN 0.3 mg/mL and may occur in patients taking LUMIGAN 0.3 mg/mL single-dose:

• Burning sensation in the eye
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty in seeing clearly
• Worsening vision
• Darker eyelashes
• Retinal bleeding
• Inflammation within the eye
• Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
• Iris inflammation
• Eyelid twitching
• Eyelid shrinking, moving away from surface of the eye
• Nausea
• Skin redness around the eye
• Weakness
• An increase in blood-test results that show how your liver is working

Other side effects reported with eye drops containing phosphates

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Reporting side effects

If you get any of the 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:

UK

By reporting side effects you can help provide more information on the safety of the medicine.

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 keep any unused solution.

Do not use this medicine after the expiry date which is stated on the single-dose container and the carton after the expiry date (EXP):. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage condition. However, once the pouch is opened use within 30 days.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

For any information about this medicine, please contact the local representative of the marketing authorisation holder.