InfoCons Consumer Protection informs you – Lumigan – Package Leaflet

Before anything else

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This include s any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What LUMIGAN single-dose is and what it is used for

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

LUMIGAN 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 r educes 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.

⚠️ 2. What you need to know before you use LUMIGAN single -dose

Do not use LUMIGAN

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

Warnings and precautions

Talk to you doctor or pharmacist before you use LUMIGAN single -dose if:

• You have any breathing pr oblems
• You have liver or kidney problems
• You have had a 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, 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 pa rt of your eye to 66 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 taking LUMIGAN. LUMIGAN single-dose 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 s may be more noticeable if you are only treating one eye.

Children and adolescents

LUMIGAN single-dose has not been tested in children under the age of 18 and therefore should not be used by patients under 18 years.

Other medicines and LUMIGAN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast -feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

LUMIGAN single-dose may get into breast milk so you should not breast -feed while you are taking this medicine.

Driving and using machines

Your sight may become blurred for a short time just after using LUMIGAN single -dose. You should not drive or use machines until your sight is clear again.

💊 3. How to use LUMIGAN single -dose

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 single -dose should only be applied to the eye .

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

Do not use more than once a day a s 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 use more LUMIGAN than you should

If you use more of this medicine 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.

If you forget to use LUMIGAN

If you forget to use this medicine, use a single drop as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forg otten dose.

If you stop using LUMIGAN

LUMIGAN single-dose should be used every day to work properly. If you stop using LUMIGAN single-dose the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.

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

❗ 4. Possible side effects

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

Very common (may affect more than 1 in 10 people)

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 (may affect up to 1 in 10 people) 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 (may affect up to 1 in 100 people)

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 68 Affecting the body
• Headaches
• Hair growth around the eye

Not known (frequency cannot be estimated from the available data)

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 of 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.

🌡️ 5. How to store LUMIGAN single -dose

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

69 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 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 hou sehold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

📦 6. Contents of the pack and other information

What LUMIGAN single -dose contains

• The active substance is bimatoprost. One ml of solution contains 0.3 mg bimatoprost.
• The other ingredients 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 keep the le vel of acid (pH levels) normal.

What LUMIGAN single -dose looks like and contents of the pack

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

Pack contains 5-single-dose containers in a carton.

Pack contains 3 or 9 aluminium foil pouches, each containing 10 single-dose containers, for a total of 30 or 90 single-dose containers in a carton, respectively .

Not all pack sizes may be marketed.

Marketing Authorisati on Holder AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany

Manufacturer

Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland For any information about this medicine, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien AbbVie SA Tél/Tel: +32 10 477811 Lietuva AbbVie UAB Tel: + 370 5 205 3023 България АбВи ЕООД Тел:+359 2 90 30 430 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien Tél/Tel: +32 10 477811 70 Česká republika AbbVie s.r.o.

Tel.: +420 233 098 111 Magyarország AbbVie Kft.

Tel:+36 1 455 8600 Danmark AbbVie A/S Tlf.: +45 72 30 20 28 Malta Vivian Corporation Ltd.

Tel: +356 27780331 Deutschland AbbVie Deutschland GmbH & Co. KG Tel.: 00800 222843 33 (gebührenfrei) Tel.: +49 (0) 611 / 1720 -0 Nederland AbbVie B.V.

Tel: +31 (0)88 322 2843 Eesti AbbVie OÜ Tel. +372 6231011 Norge AbbVie AS Tlf: +47 67 81 80 00 Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.

Τηλ: +30 214 4165 555 Österreich AbbVie GmbH Tel: +43 1 20589-0 España AbbVie Spain, S.L.U.

Tel: +34 913840910 Polska AbbVie Sp. z o.o.

Tel.: +48 22 372 78 00 France AbbVie Tél: +33 (0) 1 45 60 13 00 Portugal AbbVie, Lda.

Tel.: +351 (0)21 1908400 Hrvatska AbbVie d.o.o.

Tel: + 385 (0)1 5625 501 România AbbVie S.R.L.

Tel: +40 21 529 30 35 Ireland AbbVie Limited Tel: +353 (0)1 4287900 Slovenija AbbVie Biofarmacevtska družba d.o.o.

Tel: +386 (1)32 08 060 Ísland Vistor hf.

Sími: +354 535 7000 Slovenská republika AbbVie s.r.o.

Tel: +421 2 5050 0777 Italia AbbVie S.r.l.

Tel: +39 06 928921 Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200 Κύπρος Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40 Sverige AbbVie AB Tel: +46 (0)8 684 44 600 Latvija AbbVie SIA Tel: +371 67605000

This leaflet was last revised in

71 Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Lumigan (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/02/205).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.