Lumigan 0,03 %/0,3 mg Solution

LUMIGAN 0,03 % is prescribed to control glaucoma, which is high pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides. LUMIGAN 0,03 % works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. LUMIGAN 0,03 % may be used on its own or with other drops called beta-blockers which also reduce pressure.

Do not use LUMIGAN 0,03 % • If you are hypersensitive (allergic) to bimatoprost or any of the other ingredients of LUMIGAN 0,03 % (listed in section 6).

Warnings and precautions

Before you use this medicine, tell your doctor:

• If you have any breathing problems;
• If you have or have had low blood pressure or low heart rate;
• If you have liver or kidney problems;
• If you have had cataract surgery in the past;
• If you have or have had any problems with your cornea (front transparent part of the eye);
• If you have had a viral infection, inflammation of the eye or any other eye condition;
• If you are already using a medicine for glaucoma;
• If you wear contact lenses (see ‘LUMIGAN 0,03 % contains benzalkonium chloride’).

During treatment, LUMIGAN 0,03 % may cause a loss of fat around the eye, which may cause your eyelid crease to deepen, your eye to appear sunken (enophthalmos), your upper eyelid to droop (ptosis), the skin around your eye to tighten (involution of dermatochalasis) and the lower white part of your eye to become more visible (inferior scleral show). The changes are typically mild, but if pronounced, they can affect your field of vision. The changes may disappear if you stop using LUMIGAN 0,03 %. LUMIGAN 0,03 % may also cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker. These changes may be permanent. The change may be more noticeable if you are only treating one eye. Hair may grow in areas where LUMIGAN 0,03 % solution has been repeatedly in contact with the skin surface. This is why it is important to apply LUMIGAN 0,03 % as instructed and to avoid it running onto the cheek or other skin areas.

Children and adolescents

LUMIGAN 0,03 % should not be used in people under 18.

Other medicines and LUMIGAN 0,03 %

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before using LUMIGAN 0,03 %. The safety of LUMIGAN 0,03 % in pregnancy has not been established. LUMIGAN 0,03 % should not be used during pregnancy unless your doctor still recommends it. LUMIGAN 0,03 % should not be used if you are breastfeeding because LUMIGAN 0,03 % may get into breast milk.

Driving and using machines

Your sight may become blurred for a short time just after using LUMIGAN 0,03 %. You should not drive or use machines until your sight is clear again.

LUMIGAN 0,03 % contains benzalkonium chloride

LUMIGAN 0,03 % contains 0,15 mg benzalkonium chloride in each 3 ml of solution which is equivalent to 0,05 mg/ml. Do not use the drops when you are wearing your lenses. A preservative in LUMIGAN 0,03 %, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using LUMIGAN 0,03 % and wait 15 minutes after using the drops before you put your lenses back in. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using LUMIGAN 0,03 %, talk to your doctor.

Do not share medicines prescribed for you with any other person. Always use LUMIGAN 0,03 % exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. LUMIGAN 0,03 % should only be applied to the eye.

The usual dose is one drop in each eye that needs treatment, once every day, in the evening, following the instructions for use below. If you use LUMIGAN 0,03 % with another eye medicine, leave at least 5 minutes between using LUMIGAN 0,03 % and the other medicine. Do not use more than once a day as the effectiveness of treatment may be reduced.

Instructions for use

1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.
3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
4. Let go of the lower lid, and close your eye for 30 seconds. If a drop misses your eye, try again. Wipe off any excess that runs down the cheek.

To help prevent infections, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it. Your doctor will tell you how long your treatment with LUMIGAN 0,03 % will last. Do not stop treatment early because the pressure inside your eye may go up. If you have the impression that the effect of LUMIGAN 0,03 % is too strong or too weak, tell your doctor or pharmacist.

If you use more LUMIGAN 0,03 % than you should If you use more LUMIGAN 0,03 % than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to use LUMIGAN 0,03 % Use a single drop as soon as you remember, and then go back to your regular routine. Do not use a double dose to make up for a forgotten individual doses. If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

If you stop using LUMIGAN 0,03 % LUMIGAN 0,03 % should be used every day to work properly.

LUMIGAN 0,03 % can have side effects. Not all side effects reported for LUMIGAN 0,03 % are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using LUMIGAN 0,03 %, please consult your health care provider for advice.

Frequent side effects

Affecting the eye:

• Redness
• Itchiness
• Longer eyelashes
• 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)
• Small breaks in the surface of the eye, with or without inflammation
• Burning
• Irritation
• An allergic reaction in the eye
• Inflamed, red and itchy eyelids
• Worsening of vision
• Tired eyes
• Swelling of the see-through layer which covers the surface of the eye
• A feeling that something is in your eye
• Dryness
• Pain
• Sensitivity to light
• Tears
• Sticky eyes
• Difficulty in seeing clearly or blurred vision
• Darker eye (iris) colour
• Darker eyelashes
• Cataract
• Darker skin colour around the eye
• Darker eyelid colour

Affecting the body:

• Headache
• Increased blood pressure
• Abnormal liver function tests

Less frequent side effects

Affecting the eye:

• Retinal bleeding (bleeding at the back of the eye)
• Inflammation within the eye (uveitis or iritis)
• Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
• Eyelid twitching
• Eyelid shrinking, moving away from surface of the eye
• Skin redness around the eye
• Swollen eyelid

Affecting the body:

• Dizziness
• Nausea
• Excessive hair growth
• Weakness
• Swelling in the arms and/or legs

Side effects where the frequency is not known

Affecting the eye:

• Eye discomfort

Affecting the body:

• Abnormal hair growth
• Skin discolouration around the eyes
• Asthma or 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)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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 of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LUMIGAN 0,03 %. You can also report side effects to AbbVie (Pty) Ltd by sending an e-mail to [email protected]

• Store at or below 25 °C.
• Store all medicines out of reach of children.
• Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you must throw away the bottle 4 weeks (28 days) after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.
• Do not use the eye drops after the expiry date printed on the carton and bottle.
• Keep bottle tightly closed when you are not using it to prevent contamination.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).