Bimatoprost Indoco

Package Leaflet: Information for the User

Bimatoprost Indoco, 0.1 mg/ml, eye drops, solution
Bimatoprost

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

• Keep this package leaflet, you may need to read it again.
• If you have any 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Bimatoprost Indoco 0.1 mg/ml and what is it used for
• 2. Important information before taking Bimatoprost Indoco 0.1 mg/ml
• 3. How to take Bimatoprost Indoco 0.1 mg/ml
• 4. Possible side effects
• 5. How to store Bimatoprost Indoco 0.1 mg/ml
• 6. Contents of the pack and other information

1. What is Bimatoprost Indoco 0.1 mg/ml and what is it used for

Bimatoprost Indoco is a medicine used in glaucoma. It belongs to a group of medicines called prostamides.
The eye drops Bimatoprost Indoco are used 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 the pressure in the eye.
The eye contains a clear, watery fluid that feeds the inside of the eye. This fluid is constantly drained from the eye, and new fluid is produced to replace it. If the fluid is not drained quickly enough, the pressure in the eye increases. The action of this medicine is to increase the amount of fluid drained, which reduces the pressure in the eye. If left untreated, high pressure can lead to a disease called glaucoma and eventually damage vision.

2. Important information before taking Bimatoprost Indoco

When not to use Bimatoprost Indoco 0.1 mg/ml:

Warnings and precautions

Before starting treatment with Bimatoprost Indoco 0.1 mg/ml, tell your doctor or pharmacist if you:

• have breathing difficulties;
• have kidney or liver problems;
• have had cataract surgery;
• have dry eye syndrome;
• have or have had problems with the cornea (the transparent layer on the front of the eye)
• wear contact lenses (see "Important information about some ingredients of Bimatoprost Indoco 0.1 mg/ml");
• have or have had low blood pressure or a slow heart rate;
• have had a viral infection or inflammation in the eye.

During treatment with Bimatoprost Indoco, the medicine may cause loss of fat tissue around the eye, which can lead to deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tension around the eye (involutional entropion), and increased visibility of the 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 stopping treatment with Bimatoprost Indoco. Bimatoprost Indoco may also cause darkening and excessive growth of eyelashes, and may also cause darkening of the skin around the eyelid. It may also darken the color of the iris. These changes may be permanent. The changes may be more noticeable if only one eye is treated.

Children and adolescents

Bimatoprost Indoco should not be used in children under 18 years of age due to a lack of studies in this age group.

Bimatoprost Indoco 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Bimatoprost Indoco may pass into breast milk, so you should not breastfeed during treatment with Bimatoprost Indoco.

Driving and using machines

After using Bimatoprost Indoco, vision may be blurred for a short time. Do not drive or operate machinery until your vision is clear.

Bimatoprost Indoco 0.1 mg/ml contains benzalkonium chloride

If you wear contact lenses, do not use the drops while wearing your lenses. Wait 15 minutes after using the drops before putting your lenses back in. The preservative in Bimatoprost Indoco (benzalkonium chloride) may cause eye irritation and may discolor soft contact lenses.

3. How to take Bimatoprost Indoco 0.1 mg/ml

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Bimatoprost Indoco is for use in the eye only. The recommended dose is one drop of Bimatoprost Indoco in the evening, once a day, in each eye that needs treatment.
If you are using Bimatoprost Indoco with another eye medicine, wait at least 5 minutes between using Bimatoprost Indoco and the other medicine.
Do not use this medicine more than once a day, as it may reduce the effectiveness of the treatment.

How to administer the medicine:

Do not use the bottle if the seal on the bottle neck is broken before first use.

• 1. Wash your hands. Tilt your head back and look up at the ceiling.
• 2. Gently pull down the lower eyelid to form a small pocket.
• 3. Turn the bottle upside down and press it to release one drop into each eye that needs treatment.
• 4. Release the lower eyelid and close your eye for 30 seconds.

Wipe away any excess medicine that runs onto your cheek. If a drop misses your eye, try again.
To avoid contamination and eye injury, do not touch the tip of the bottle to your eye or any other surface. Replace the cap immediately after use.

Using more Bimatoprost Indoco 0.1 mg/ml than recommended

Using more than the recommended dose of Bimatoprost Indoco is unlikely to cause serious harm. Take the next dose at the usual time. If you are concerned, talk to your doctor or pharmacist.

Missing a dose of Bimatoprost Indoco 0.1 mg/ml

If you miss a dose of Bimatoprost Indoco, use one drop as soon as you remember, and then continue with your regular schedule. Do not use a double dose to make up for a missed dose.

Stopping treatment with Bimatoprost Indoco 0.1 mg/ml

To be effective, Bimatoprost Indoco must be used every day. If you stop using Bimatoprost Indoco, it may cause the pressure in the eye to increase (intraocular pressure). Therefore, before stopping treatment, talk to your doctor. If you have any further questions on the use of 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 commonside effects (may affect up to 1 in 10 people)
Eye symptoms
loss of fat tissue around the eye, which can lead to deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tension around the eye (involutional entropion), and increased visibility of the white part of the eye (visibility of the lower part of the sclera);

• mild redness (up to 29% of patients).

Commonside effects (may affect up to 1 in 10 people)
Eye symptoms

• minor damage to the surface of the eye, with or without inflammation;
• irritation;
• itching of the eyes;
• lengthening of eyelashes;
• irritation after using eye drops;
• eye pain.

Skin disorders

• redness and itching of the eyelids;
• darkening of the skin around the eye;
• increased growth of eyebrows and eyelashes.

Uncommonside effects (may affect up to 1 in 100 people)
Eye symptoms

• darkening of the iris;
• eye fatigue;
• swelling of the front part of the eye;
• blurred vision;
• loss of eyelashes.

Skin disorders

• dry skin;
• scaly patches on the edges of the eyelids;
• swelling of the eyelids;
• itching.

General disorders

• headache;
• feeling unwell.

Frequency not known(frequency cannot be estimated from the available data)
Eyes:

• swelling of the macula (swelling of the retina in the back of the eye, which can lead to vision problems);
• darkening of the skin around the eyes;
• dryness;
• feeling of sticky eyelids;
• feeling of a foreign body in the eye;
• eye swelling;
• increased tear production.

General disorders

• symptoms of an allergic reaction (swelling, redness of the eye, and skin rash);
• asthma;
• worsening of asthma;
• worsening of chronic obstructive pulmonary disease (COPD);
• shortness of breath.

The above list includes side effects of Bimatoprost Indoco 0.1 mg/ml. After using a higher concentration of bimatoprost (0.3 mg/ml), the following side effects have also been observed:

• dizziness;
• burning sensation in the eye;
• eye allergic reaction;
• blepharitis;
• blurred vision;
• vision problems;
• swelling of the clear layer covering the eye;
• increased sensitivity to light;
• tearing;
• darkening of the eyelashes;
• retinal bleeding;
• inflammatory changes in the eye;
• macular edema (swelling of the retina that can impair vision);
• eyelid twitching;
• eyelid contraction and its deviation from the eye surface;
• sunken appearance of the eyes;
• redness of the skin around the eye;
• increased blood pressure;
• weakness;
• abnormal liver function test results.

Other side effects reported with phosphates eye drops

In very rare cases, in some patients with severe damage to the outer, transparent layer of the eye (cornea) during treatment, white, cloudy patches appeared on the cornea due to calcium deposits.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the
Department of Drug Safety Monitoring
National Institute of Medicines
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.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 Bimatoprost Indoco 0.1 mg/ml

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of that month.
Discard the bottle no later than 4 weeks after first opening, even if there are still drops left in it. This will help prevent infection. To remember the date you opened the bottle, note it on the packaging.
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 Bimatoprost Indoco 0.1 mg/ml contains

• The active substance is bimatoprost. 1 ml of solution contains 0.1 mg of bimatoprost.
• The other ingredients are benzalkonium chloride (preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain the appropriate acidity (pH).

What Bimatoprost Indoco 0.1 mg/ml looks like and contents of the pack

Bimatoprost Indoco 0.1 mg/ml is a colorless, clear solution, without visible particles, for use as eye drops, available in a cardboard box containing 1 plastic bottle with a screw cap. Each bottle is filled approximately to the middle and contains 3 milliliters of solution (about 123 drops). This is enough for 4 weeks of treatment.
Not all pack sizes may be marketed.

Marketing authorization holder

Indoco Remedies Czech s.r.o.
Třtinová 260/1, Čakovice
196 00 Prague 9
Czech Republic

Importer

IMUNA PHARM, a.s.
Jarková 269/17
082 22 Šarišské Michaľany
Slovakia

Date of last revision of the leaflet: March 2022

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

Czech Republic
Bimatoprost Indoco
Poland
Bimatoprost Indoco