Elimbus

Leaflet accompanying the packaging: patient information

Elymbus, 0.1 mg/g, eye gel in a single-dose container

Bimatoprost

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Elymbus and what is it used for
• 2. Important information before using Elymbus
• 3. How to use Elymbus
• 4. Possible side effects
• 5. How to store Elymbus
• 6. Contents of the pack and other information

1. What is Elymbus and what is it used for

Elymbus is a medicine used in glaucoma. It belongs to a group of medicines called prostamides.
The eye gel Elymbus is used in adults to lower high pressure in the eye. This medicine
can be used alone or with other eye drops called beta-adrenergic blockers, which also lower eye pressure.
The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid is constantly drained
from the eye, and new fluid is produced to replace it. If it is not drained quickly enough,
the pressure in the eye increases. The action of this medicine is to increase the amount of fluid drained.
This reduces the pressure inside the eye. If left untreated, high pressure can lead to a disease called glaucoma and eventually damage vision.

2. Important information before using Elymbus

When not to use Elymbus

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

Warnings and precautions

Before starting treatment with Elymbus, discuss it with your doctor or pharmacist.
Tell your doctor if:

• you have breathing difficulties
• you have kidney or liver problems
• you have had cataract surgery in the past
• you have low blood pressure or a slow heart rate
• you have had a viral infection or inflammation in the eye.

During treatment with Elymbus, you may experience loss of fat tissue around the eye, which can
cause deepening of the eyelid fold, sunken eyes (enophthalmus), drooping eyelids (ptosis), skin tension around the eye (dermatochalasis-induced involution) and increased visibility of the lower white part of the eye (visibility of the lower part of the sclera). These changes are usually mild, but if they are pronounced, they can affect the field of vision. The changes may disappear after discontinuation of Elymbus. Elymbus may also cause darkening and excessive growth of eyelashes
and darkening of the skin around the eyelid. The color of the iris may also become darker. These changes
may be permanent. Such a change may be more noticeable when treating only one eye.

Children and adolescents

Elymbus has not been studied in children under 18 years of age and should not be used in patients under 18 years of age.

Elymbus and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Elymbus may pass into breast milk, so you should not breastfeed while taking Elymbus.

Driving and using machines

Immediately after using Elymbus, your vision may be blurred for a short time. Do not drive or operate machinery until your vision is clear again.

3. How to use Elymbus

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Elymbus is for use in the eye only. The recommended dose is one drop of Elymbus in the evening, once a day, in each eye that needs treatment.
If you are using Elymbus with another eye medicine, use it at least 15 minutes before Elymbus. Elymbus should be used last.
Do not use more than once a day, as this may reduce the effectiveness of the treatment.

People wearing contact lenses

If you wear contact lenses, remove them before using Elymbus. After using Elymbus, wait 15 minutes before putting your contact lenses back in.

Method and route of administration

This medicine is intended for administration in the eye.
To apply the drops, follow these instructions:

• 1. Wash your hands and sit or stand in a comfortable position.
• 2. Open the sachet containing 10 single-dose containers.

• 3. Break off one single-dose container from the strip.

• 4. Unscrew the top of the single-dose container, as shown in the picture. Do not touch the tip of the container after opening.

• 5. Gently pull down the lower eyelid of the affected eye.
• 6. Tilt your head back and look up at the ceiling.
• 7. Place the tip of the single-dose container close to the eye, without touching the eye.
• 8. Gently squeeze the single-dose container to release one drop into the eye, then release the lower eyelid.

• 9. Repeat the steps for the second eye, if advised by your doctor. Each single-dose container contains enough gel to treat both eyes.
• 10. Release the lower eyelid and close your eye(s) for a moment.
• 11. Wipe away any excess medicine that runs down your cheek. If a drop misses your eye, try again.
• 12. Discard the single-dose container after use. Do not store it for reuse. Since the sterility of the medicine cannot be maintained after opening a single-dose container (the eye gel does not contain preservatives), a new container should be opened before each use.
• 13. Wipe away any excess liquid with a clean tissue.

• 14. Place the unopened single-dose containers back in the sachet. Unopened single-dose containers are suitable for use for 1 month after opening the sachet.

Using more Elymbus than prescribed

If you use more Elymbus than prescribed, it is unlikely to cause serious effects. Take the next dose at the usual time. If you are concerned, talk to your doctor or pharmacist.

Missing a dose of Elymbus

If you forget to use Elymbus, use one drop as soon as you remember, and then return to your usual dosing schedule. Do not use a double dose to make up for a missed dose.

Stopping treatment with Elymbus

To work properly, Elymbus should be used every day. If you stop using Elymbus, the pressure in your eye may increase, so before stopping treatment, talk to your doctor.
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.
The following side effects have been observed during treatment with Elymbus:

Common side effects

May affect up to 1 in 10 people

Related to the eye:

• mild redness
• eye pain
• eye irritation
• redness and discomfort in the eye
• feeling of a foreign body in the eye
• dry eye
• itchy eyes
• temporary blurred vision

Uncommon side effects

May affect up to 1 in 100 people

Related to the eye:

• minor damage to the surface of the eye, with or without inflammation
• feelings such as numbness, tingling, or stinging in the eye
• blepharitis
• loss of eyelashes
• lengthening of eyelashes
• sensitivity to light
• increased tearing
• darker eyelashes
• darker skin pigmentation around the eye
• eyelid swelling
• itchy, red, and dry skin of the eyelids

Related to the whole body:

• dizziness

The following side effects have been observed during treatment with eye drops containing bimatoprost (0.1 mg/ml, with preservative):

Very common side effects

May affect more than 1 in 10 people

Related to the eye:

• mild redness (in up to 29% of people)
• loss of fat tissue around the eye, which may lead to deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tension around the eye (dermatochalasis-induced involution), and increased visibility of the lower white part of the eye (visibility of the lower part of the sclera)

Common side effects

May affect up to 1 in 10 patients

Related to the eye:

• minor damage to the surface of the eye, with or without inflammation
• irritation
• itchy eyes
• lengthening of eyelashes
• irritation after administration of eye drops
• eye pain

Skin disorders:

• redness and itching of the eyelids
• darker skin pigmentation around the eye
• hair growth around the eyes

Uncommon side effects

May affect up to 1 in 100 patients

Eye symptoms:

• darker iris color
• eye fatigue
• swelling of the front part of the eye
• blurred vision
• loss of eyelashes

Skin disorders:

• dry skin
• meibomian gland dysfunction
• eyelid swelling
• itching

Related to the whole body:

• headache
• malaise

Side effects with unknown frequency

Related to the eye:

• macular edema (swelling of the retina in the back of the eye, which can lead to impaired vision)
• darker skin pigmentation around the eyes
• dryness
• feeling of sticky eyelids
• feeling of a foreign body in the eye
• eye swelling
• increased tearing
• eye discomfort
• increased sensitivity to light

Related to the whole body:

• asthma
• worsening of asthma
• worsening of chronic obstructive pulmonary disease (COPD)
• shortness of breath (dyspnea)
• symptoms of allergic reactions (swelling, redness of the eye, and skin rash)
• dizziness
• increased blood pressure
• skin discoloration (around the eye)

In addition to the above side effects, the following side effects have been observed during treatment with another medicine containing bimatoprost in the form of eye drops with a higher strength (0.3 mg/ml, with preservative):

• feeling of burning in the eye
• allergic reaction in the eye
• blepharitis
• blurred vision
• impaired vision
• swelling of the clear membrane covering the eye
• tearing
• darker eyelash color
• retinal hemorrhage
• inflammatory changes in the eye
• cystoid macular edema (swelling of the retina that can impair vision)
• eyelid twitching
• eyelid contraction and its detachment from the eye surface
• redness of the skin around the eye
• weakness
• abnormal liver function test results

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Elymbus

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 carton, sachet, and single-dose container after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening the sachet: use within 1 month.
To help you remember, write down the date you first opened the sachet.
Keep the unopened single-dose containers in the sachet to protect them from light.
After first opening the single-dose container: use immediately and discard the container after use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Elymbus contains

• The active substance is bimatoprost. 1 g of gel contains 0.1 mg of bimatoprost.
• The other ingredients are: sorbitol, carbomer, sodium acetate trihydrate, macrogol, sodium hydroxide (to adjust pH), water for injections.

What Elymbus looks like and contents of the pack

Elymbus is a colorless, opalescent eye gel in a single-dose container. It is available in single-dose containers, packaged in sachets of 10, in a cardboard box.
Each single-dose container contains 0.3 g of the product.
The pack contains 30 (3 x 10) or 90 (9 x 10) single-dose containers.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Laboratoires THEA
12 rue Louis Blériot
63100 Clermont-Ferrand
France
Manufacturer:
LABORATOIRE UNITHER
1 rue de l’Arquerie
50200 Coutances
France
Laboratoires THEA
12 rue Louis Blériot
63100 Clermont-Ferrand
France

For more information, contact the marketing authorization holder:

THEA Polska Sp. z o.o.
ul. Cicha 7
00-353 Warsaw
Tel.: +48 22 642 87 77

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark, Czech Republic, Estonia, Greece, Netherlands, Finland, Iceland, Luxembourg, Norway, Poland, Portugal, Slovakia, Sweden, Italy ................................................................................... Elymbus
Austria, Germany ................................................ Elymbus 0,1 mg/g Augengel im Einzeldosisbehältnis
Belgium ........................................................... Elymbus 0,1 mg/g gel ophtalmique en récipient unidose
Bulgaria ........................................................ .......................................................... Elymbus / Елимбус
Croatia ..................................................... Elymbus 0.1 mg/g gel za oko u jednodoznom spremniku
Cyprus …………………………………… Elymbus 0,1 mg/g Οφθαλμική γέλη σε περιέκτη μίας χρήσης
Hungary ...................................................................... Elymbus 0.1 mg/g szemgél egyadagos tartályban
Spain ............................................................ Elymbus 0.1 mg/g gel oftálmico en envase unidosis
France ........................................................... Elumibus 0,1 mg/g gel ophtalmique en récipient unidose
Ireland ................................................................... Elymbus 0.1 mg/g eye gel in single dose container
Lithuania ................................................................ Elymbus 0,1mg/g akių gelis vienadozėje talpyklėje
Latvia .................................................................... Elymbus 0,1 mg/g acu gels vienas devas iepakojumā
Romania ............................................................... Elymbus 0,1 mg/g gel oftalmic în recipient unidoză
Slovenia…………………………………….. Elymbus 0,1 mg/g gel za oko v enoodmernem vsebniku

Date of last revision of the leaflet:

Detailed information on this medicinal product is available on the website www.urpl.gov.pl