Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lumigan

Document Subject

Generated Narrative: MedicinalProductDefinition mp6ff79951b10cf21bd6fd953fc17e7cc0

identifier: http://ema.europa.eu/identifier/EU/1/02/205/003-004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: LUMIGAN 0.1 mg/ml eye drops, solution

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6ff79951b10cf21bd6fd953fc17e7cc0

identifier: http://ema.europa.eu/identifier/EU/1/02/205/003-004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - lumigan

Attesters

What is in this leaflet:

1. What LUMIGAN 0.1 mg/ml is and what it is used for
2. What you need to know before you use LUMIGAN 0.1 mg/ml
3. How to use LUMIGAN 0.1 mg/ml
4. Possible side effects
5. How to store LUMIGAN 0.1 mg/ml
6. Contents of the pack and other information

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

Do not use LUMIGAN 0.1 mg/ml:

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

if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride. Warnings and precautions: Talk to your doctor or pharmacist before you use LUMIGAN 0.1 mg/ml Talk to your doctor, if:

You have any breathing problems

You have liver or kidney problems

You have had a cataract surgery in the past

You have dry eye

You have or have had any problems with your cornea (front transparent part of the eye)

You wear contact lenses (see LUMIGAN 0.1 mg/ml contains benzalkonium chloride )

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 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 taking LUMIGAN. LUMIGAN 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 changes may be more noticeable if you are only treating one eye. Children and adolescents LUMIGAN 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 and breast-feeding 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 any medicine. LUMIGAN may get into breast milk so you should not breast-feed while you are taking LUMIGAN. Driving and using machines Your sight may become blurred for a short time just after using LUMIGAN. You should not drive or use machines until your sight is clear again. LUMIGAN 0.1 mg/ml contains benzalkonium chloride This medicine contains 0.6 mg benzalkonium chloride in each 3 ml of solution which is equivalent to 0.2 mg/ml. Do not use the drops when you are wearing your lenses. A preservative in LUMIGAN, 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 this medicine 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 this medicine, talk to your doctor.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. LUMIGAN should only be applied to the eye. The recommended dose is one drop of LUMIGAN in the evening, once daily in each eye that needs treatment. If you use LUMIGAN with another eye medicine, wait at least five minutes between using LUMIGAN and the other eye medicine. Do not use more than once a day as the effectiveness of treatment may be reduced. Instructions for use: You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

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. Wipe off any excess that runs down the cheek. If a drop misses your eye, try again. To help prevent infections and avoid eye injury, 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. If you use more LUMIGAN 0.1 mg/ml than you should If you use more LUMIGAN 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 0.1 mg/ml If you forget to use LUMIGAN, 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 forgotten dose. If you stop using LUMIGAN 0.1 mg/ml LUMIGAN should be used every day to work properly. If you stop using LUMIGAN 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 medicine, 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 Affecting the eye

Slight redness (up to 29 % 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 Affecting the eye

Small breaks in the surface of the eye, with or without inflammation

Irritation

Itchy eyes

Longer eyelashes

Irritation, when drop is put in the eye

Eye pain Affecting the skin

Red and itchy eyelids

Darker skin colour around the eye

Hair growth around the eye Uncommon side effects These may affect 1 to 9 users in 1Affecting the eye

Darker Iris colour

Tired eye

Swelling of the surface of the eye

Blurred vision

Loss of eye lashes Affecting the skin

Dry skin

Crusting on the edge of the eyelid

Swelling of the eyelid

Itching Affecting the body

Headache

Feeling of sickness Side effects where the frequency is not known Affecting the eye

Macular oedema (swelling of the retina at the back of the eye which may lead to worsening vision)

Darker eyelid colour

Dryness

Sticky eyes

A feeling that something is in your eye

Swelling of the eye

Increasing tears

Ocular discomfort

Sensitivity to light 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 0.1 mg/ml, the following side effects have been seen with another medicine containing a higher strength of bimatoprost (0.3 mg/ml):

Ocular burning

An allergic reaction in the eye

Inflamed eyelids

Difficulty in seeing clearly

Worsening of vision

Swelling of the see-through layer that covers the eye

Tears

Darker eyelashes

Retinal bleeding

Inflammation within the eye

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

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 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 national reporting system listed in Appendix V. 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. Do not use this medicine after the expiry date which is stated on the bottle label and the carton after EXP. The expiry date refers to the last day of that month. You must throw away the bottle at the latest four weeks after you first opened it, even if there are still some drops left. This will prevent infections. To help you remember, write down the date you opened it in the space on the box. 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.

What LUMIGAN 0.1 mg/ml contains

The active substance is bimatoprost. One ml of solution contains 0.1 mg bimatoprost.

The other ingredients are benzalkonium chloride (preservative), 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 level of acid (pH levels) normal. What LUMIGAN 0.1 mg/ml looks like and contents of the pack LUMIGAN is a colourless clear eye drop solution in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap. Each bottle is approximately half full and contains 3 millilitres of solution. This is enough for 4 weeks usage. Not all pack sizes may be marketed. Marketing Authorisation Holder AbbVie Deutschland GmbH & Co. KG Knollstra e 67061 Ludwigshafen Deutschland 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. Belgi /Belgique/Belgien AbbVie SA T l/Tel: +32 10 477Lietuva AbbVie UAB Tel: + 370 5 205 3

:+359 2 90 30 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien T l/Tel: +32 10 477 esk republika AbbVie s.r.o. Tel.: +420 233 098 Magyarorsz g AbbVie Kft. Tel:+36 1 455 8Danmark AbbVie A/S Tlf: +45 72 30 20 Malta Vivian Corporation Ltd. Tel: +356 27780Deutschland AbbVie Deutschland GmbH & Co. KG Tel.: 00800 222843 33 (geb hrenfrei) Tel.: +49 (0) 611 / 1720-0 Nederland AbbVie B.V. Tel: +31 (0)88 322 2Eesti AbbVie O Tel. +372 6231Norge AbbVie AS Tlf: +47 67 81 80
AbbVie . . : +30 214 4165 sterreich AbbVie GmbH
Tel: +43 1 20589-0 Espa a AbbVie Spain, S.L.U. Tel: +34 913840Polska AbbVie Sp. z o.o. Tel.: +48 22 372 78 France AbbVie T l: +33 (0) 1 45 60 13 Portugal AbbVie, Lda. Tel.: +351 (0)21 1908Hrvatska AbbVie d.o.o. Tel: + 385 (0)1 5625 Rom nia AbbVie S.R.L. Tel: +40 21 529 30 Ireland AbbVie Limited Tel: +353 (0)1 4287Slovenija AbbVie Biofarmacevtska dru ba d.o.o. Tel: +386 (1)32 08 sland Vistor hf. S mi: +354 535 7Slovensk republika AbbVie s.r.o. Tel: +421 2 5050 0Italia AbbVie S.r.l. Tel: +39 06 928Suomi/Finland AbbVie Oy
Puh/Tel: +358 (0)10 2411
Lifepharma (Z.A.M.) Ltd : +357 22 34 74 Sverige AbbVie AB Tel: +46 (0)8 684 44 Latvija AbbVie SIA Tel: +371 67605United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561This leaflet was last revised in Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu. Package leaflet: Information for the user LUMIGAN 0.3 mg/ml, eye drops, solution Bimatoprost 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 includes any possible side effects not listed in this leaflet. See section 4.