Bimatoprost Indoco

Package Leaflet: Information for the User

Bimatoprost Indoco, 0.3 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Bimatoprost Indoco 0.3 mg/ml and what is it used for
• 2. Important information before taking Bimatoprost Indoco 0.3 mg/ml
• 3. How to take Bimatoprost Indoco 0.3 mg/ml
• 4. Possible side effects
• 5. How to store Bimatoprost Indoco 0.3 mg/ml
• 6. Contents of the pack and other information

1. What is Bimatoprost Indoco 0.3 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 blocking agents, which also lower the pressure inside 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 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, which in turn lowers 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 taking Bimatoprost Indoco 0.3 mg/ml

When not to use Bimatoprost Indoco 0.3 mg/ml:

• if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).
• if you have previously had to stop using eye drops because of allergic reactions to the preservative benzalkonium chloride.

Warnings and precautions

Before starting treatment with Bimatoprost Indoco 0.3 mg/ml, discuss with your doctor or pharmacist if:

• you have breathing difficulties;
• you have kidney or liver problems;
• you have had cataract surgery;
• you have dry eye syndrome;
• you have or have had problems with the cornea (the transparent layer on the front of the eye)
• you wear contact lenses (see section "Important information about some of the ingredients of Bimatoprost Indoco 0.3 mg/ml");
• you have or have had slow heart rate or low blood pressure;
• you 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 tightening around the eye (involutional entropy), and increased visibility of the white part of the eye (visibility of the lower part of the sclera). These changes are usually mild but can affect vision if they are pronounced. The changes may disappear after discontinuation of 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 now or have taken recently, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Bimatoprost Indoco may pass into breast milk, so you should not breastfeed during treatment with Bimatoprost Indoco.

Driving and using machines

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

Bimatoprost Indoco 0.3 mg/ml contains benzalkonium chloride

If you wear contact lenses, do not use the drops while wearing the lenses. Wait 15 minutes after administering the drops before putting the 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 0.3 mg/ml

Always use this medicine exactly as your doctor has told you. If you are unsure, 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 daily, in each eye that needs treatment.
If you are using Bimatoprost Indoco with another eye medicine, wait at least 5 minutes between administering Bimatoprost Indoco and the other medicine.
Do not use this medicine more than once a day, as it may reduce the effectiveness of treatment.

Method of administration:

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 prevent infections and avoid eye injury, do not touch the tip of the bottle to your eye or anything else. Immediately after use, replace the cap and tighten the bottle.

Using a higher dose of Bimatoprost Indoco 0.3 mg/ml than recommended

If you use more Bimatoprost Indoco than you should, it is unlikely to cause serious harm. Take the next dose at the usual time. If you are unsure, consult your doctor or pharmacist.

Missing a dose of Bimatoprost Indoco 0.3 mg/ml

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

Stopping treatment with Bimatoprost Indoco 0.3 mg/ml

To be effective, Bimatoprost Indoco must be used every day. If you stop using Bimatoprost Indoco, it may cause an increase in pressure inside the eye (intraocular pressure). Therefore, before planning to stop treatment, discuss it with your doctor.
If you have any further questions about using 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)
Eyelid changes

• loss of fat tissue around the eye, which can lead to deepening of the eyelid fold, sunken eyes, drooping eyelids (ptosis), skin tightening around the eye (involutional entropy), and increased visibility of the white part of the eye (visibility of the lower part of the sclera);
• longer eyelashes (up to 45% of patients);
• mild redness (up to 44% of patients);
• itching (up to 14% of patients).

Commonside effects (may affect up to 1 in 10 people)
Eyelid changes

• allergic reaction in the eye;
• eye fatigue;
• sensitivity to light;
• darkening of the skin around the eye;
• darkening of the eyelashes;
• pain;
• feeling of a foreign body in the eye;
• stickiness of the eyes;
• darkening of the iris;
• blurred vision;
• irritation;
• burning sensation;
• inflammation, redness, and itching of the eyelids;
• tearing;
• dryness;
• worsening of vision;
• blurred vision;
• swelling of the clear layer that lines the surface of the eye;
• small injuries on the surface of the eye, with or without inflammation.

General changes:

• headaches;
• abnormal liver function test results;
• increased blood pressure.

Uncommonside effects (may affect up to 1 in 100 people)
Eyelid changes

• cystoid macular edema (swelling of the retina in the eye leading to impaired vision);
• inflammation of the eye;
• bleeding into the retina;
• swelling of the eyelids;
• twitching of the eyelids;
• contraction of the eyelids and their deviation from the surface of the eye;
• redness of the skin around the eye.

General changes:

• nausea;
• dizziness;
• weakness;
• excessive hair growth around the eye.

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

• 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.

Other side effects reported with the use of eye drops containing phosphates.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
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 0.3 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.
The bottle should be discarded 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 the bottle was first opened, 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 0.3 mg/ml contains

• The active substance is bimatoprost. 1 ml of solution contains 0.3 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 0.3 mg/ml looks like and contents of the pack

Bimatoprost Indoco 0.3 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 half and contains 3 milliliters of solution (about 115 drops). This is sufficient 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