Bimatoprost Sandoz GmbH

Package leaflet: Information for the user

Bimatoprost Sandoz GmbH 0.1 mg/ml eye drops, solution

Generic Medicine (only for packages 044395034, 044395046)
Please 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 any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bimatoprost Sandoz GmbH is and what it is used for
2. What you need to know before using Bimatoprost Sandoz GmbH
3. How to use Bimatoprost Sandoz GmbH
4. Possible side effects
5. How to store Bimatoprost Sandoz GmbH
6. Contents of the pack and other information

1. What Bimatoprost Sandoz GmbH is and what it is used for

Bimatoprost Sandoz GmbH is an antiglaucoma medicine belonging to a class of medicines
called prostamides.
Bimatoprost Sandoz GmbH is used to reduce elevated intraocular pressure. This medicine
can be used alone or in combination with other eye drops known as beta-blockers, which also
help to reduce eye pressure.
The eye contains a clear, watery fluid that nourishes its internal structures. This fluid is constantly drained from the eye, and new fluid is produced to replace the drained fluid. If the fluid is not drained sufficiently quickly, the pressure inside the eye increases. This medicine works by increasing the amount of fluid that is drained out.
This reduces the pressure inside the eye. If elevated intraocular pressure is not reduced, it may lead to a condition called glaucoma and may eventually cause damage to vision.

2. What you should know before using Bimatoprost Sandoz GmbH

Do not use Bimatoprost Sandoz GmbH

• if you are allergic to bimatoprost or to any of the other ingredients of this medicine (listed in section 6).
• if in the past you had to discontinue eye drops due to an adverse reaction caused by the preservative benzalkonium chloride.

Warnings and precautions
Talk to your doctor or pharmacist before using Bimatoprost Sandoz GmbH.
Consult your doctor if:

• you have breathing problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you suffer from dry eye
• you have or have had corneal problems (the transparent front part of the eye)
• you wear contact lenses (see section “Bimatoprost Sandoz GmbH contains benzalkonium chloride”)
• you have or have had low blood pressure or bradycardia
• you have had a viral infection or inflammation of the eyes.

During treatment, Bimatoprost Sandoz GmbH may cause loss of fat around the eye,
which may lead to deepening of the eyelid fold, sunken eye (enophthalmos),
drooping of the upper eyelid (ptosis), tightness of the skin around the eye
(involution of dermatochalasis), and exposure of the lower white part of the eye
(inferior scleral show). These changes are usually mild in degree, but if pronounced,
they may impair the visual field. If you stop using Bimatoprost Sandoz GmbH,
these changes may resolve. Bimatoprost Sandoz GmbH may also cause darkening and
lengthening of the eyelashes, and may darken the skin around the eyelids. The colour of the iris may also darken. These changes may be permanent. These effects are more noticeable if only one eye is treated.

Children and adolescents
Bimatoprost Sandoz GmbH has not been studied in children under 18 years of age and therefore should not be used in patients under 18 years of age.

Other medicines and Bimatoprost Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Bimatoprost Sandoz GmbH may pass into breast milk; therefore, you should not breastfeed during treatment with Bimatoprost Sandoz GmbH.

Driving and using machines
Shortly after administration of Bimatoprost Sandoz GmbH, you may experience transient blurred vision. Do not drive or operate machinery until your vision has cleared.

This medicine contains 0.20 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience an abnormal sensation, burning or pain in the eye after using this medicine, speak with your doctor.

This medicine contains 0.95 mg of phosphates per ml. If you have various damages to the transparent layer at the front of the eye (the cornea), phosphates may, very rarely, cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use Bimatoprost Sandoz GmbH

Use this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Bimatoprost Sandoz GmbH must be applied only in the eyes. The recommended dose is one
drop of Bimatoprost Sandoz GmbH once daily in the evening, in each eye requiring
treatment.
If you are using Bimatoprost Sandoz GmbH with another eye medicine, wait at least 5 minutes between
the application of Bimatoprost Sandoz GmbH and the other eye medicine.
Do not use the medicine more than once a day, as the effectiveness of treatment may be reduced.

Instructions for use:
Do not use the bottle if the tamper-evident seal on the neck of the bottle is broken before
first use.

1. Wash your hands. Tilt your head backward and look upward.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and apply slight pressure to release one drop of eye drops into each eye to be treated.
4. Release the lower eyelid and keep the eye closed for 30 seconds.

Wipe away any excess liquid running down the cheek.
If a drop does not enter the eye, repeat the procedure.
To help prevent infections and avoid eye damage, do not let the tip of the bottle touch the eye or any other surface. Immediately after use, replace the cap and close the bottle tightly.

If you use more Bimatoprost Sandoz GmbH than you should
If you use more Bimatoprost Sandoz GmbH than prescribed, it is unlikely to cause serious
consequences. Take the next dose at your usual time. However, if you are concerned, consult your doctor or pharmacist.

If you forget to use Bimatoprost Sandoz GmbH
If you forget to use Bimatoprost Sandoz GmbH, apply one drop as soon as you remember,
then continue with your regular dosing schedule. Do not use a double dose to make up for
the missed dose.

If you stop using Bimatoprost Sandoz GmbH
To work properly, Bimatoprost Sandoz GmbH must be used every day. If you stop using
Bimatoprost Sandoz GmbH, eye pressure may increase. Therefore, consult your doctor before stopping this treatment.

If you have any questions about how to use this medicine, 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 side effects (may affect more than 1 in 10 people)
Eye area

• Mild redness (up to 29% of people)
• Loss of fat in the eye area which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the eyelid (ptosis), tightening of the skin around the eye (dermatochalasis involution), and exposure of the lower white part of the eye (inferior scleral show).

Common side effects (may affect up to 1 in 10 people)
Eye

• Minor damage on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eyes
• Eyelash elongation
• Irritation when administering the eye drops
• Eye pain

Skin

• Red, itchy eyelids
• Darkening of the skin around the eye
• Growth of hair around the eye

Uncommon side effects (may affect up to 1 in 100 people)
Eye

• Darkening of the iris colour
• Tired eyes
• Swelling of the eye surface
• Blurred vision
• Loss of eyelashes

Skin

• Dry skin
• Crusting at the edge of the eyelid
• Swelling of the eyelid
• Itching

Body as a whole

• Headache
• Feeling unwell

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

• Macular oedema (swelling of the retina at the back of the eye which may lead to worsening of vision)
• Darkening of the eyelids
• Dry eye
• Sticky eyes
• Foreign body sensation in the eye
• Swelling of the eye
• Increased tear production
• Eye discomfort
• Light sensitivity

Body as a whole

• Symptoms of allergic reaction (swelling, redness of the eye and skin rash)
• Asthma
• Worsening of asthma
• Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Dizziness
• Increase in blood pressure values
• Change in skin colour (around the eye)

In addition to the side effects of Bimatoprost Sandoz GmbH, the following side effects have been observed with another medicine containing a higher concentration of bimatoprost (0.3 mg/ml):

• Eye burning
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the transparent layer covering the surface of the eye
• Tearing
• Darker eyelashes
• Bleeding of the retina
• Inflammation inside the eye
• Cystoid macular oedema (swelling of the retina inside the eye leading to worsening of vision)
• Eyelid spasms
• Narrowing of the eyelid, pulling away from the eye surface
• Redness of the skin around the eye
• Weakness
• Increase in liver function test values in blood tests

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed opaque areas on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bimatoprost Sandoz GmbH

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the carton, after Exp. The expiry date refers to the last day of that month.
The vial must be discarded no later than 4 weeks after first opening, even if some drops of the eye drops remain. This will help prevent infections. To help you remember, write the date of first opening in the space provided on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bimatoprost Sandoz GmbH contains

• The active substance is: bimatoprost. One ml of solution contains 0.1 mg of bimatoprost. One drop contains approximately 2.5 micrograms of bimatoprost.
• The other components are: benzalkonium chloride (preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, sodium hydroxide or hydrochloric acid (for pH adjustment), and purified water.

Description of the appearance of Bimatoprost Sandoz GmbH and contents of the pack
Bimatoprost Sandoz GmbH is a clear, colourless solution in a pack containing 1, 3 or 6 plastic bottles, each with a screw cap. Each bottle is filled halfway and contains 2.5 millilitres or 3 millilitres of solution. The content of one bottle is sufficient for 4 weeks of use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH, Biochemiestrasse, 10, 6250 Kundl, Austria
Legal representative in Italy: Sandoz S.p.A., Viale Luigi Sturzo, 43 - 20154, Milan (Italy)

Manufacturers
ROMPHARM COMPANY S.R.L., Eroilor Street, no. 1A, Otopeni 075100, Ilfov, Romania
Salutas Pharma GmbH, Otto-Von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Bimatoprost Sandoz 100 Mikrogramm/ml - Augentropfen
Belgium Bimatoprost Sandoz 0.1 mg/ml oogdruppels, oplossing
Bulgaria Биматопрост Сандоз 0,1 mg/ml капки за очи, разтвор
France BIMATOPROST SANDOZ 0.1 mg/ml, collyre en solution
Germany Bimatoprost HEXAL 0.1 mg/ml Augentropfen
Italy Bimatoprost Sandoz GmbH
Luxembourg Bimatoprost Sandoz 0.1 mg/ml collyre en solution
Netherlands Bimatoprost Sandoz 0.1 mg/ml, oogdruppels, oplossing
Portugal Bimatoprost Sandoz
Romania Bimatoprost Sandoz 0.1 mg/ml picături oftalmice
Slovenia Bimatoprost Sandoz 0.1 mg/ml kapljice za oko, raztopina
Spain Bimatoprost Sandoz 0.1 mg/ml colirio en solución