Bimatoprost indoco

Package leaflet: Information for the user

Bimatoprost Indoco, 0.1 mg/ml, eye drops, solution
Bimatoprostum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Bimatoprost Indoco 0.1 mg/ml is and what it is used for
2. Important information before using Bimatoprost Indoco 0.1 mg/ml
3. How to use 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 Bimatoprost Indoco 0.1 mg/ml is and what it is used for

Bimatoprost Indoco is a medicine used in glaucoma. It belongs to a group of medicines called prostamides.
Bimatoprost Indoco eye drops are used to reduce elevated intraocular pressure. This medicine may be used alone or in combination with other eye drops known as beta-adrenolytic agents, which also reduce intraocular pressure.
The eye contains a clear, watery fluid that nourishes the inside of the eye. This fluid is continuously drained from the eye and replaced by newly produced fluid. If it is not drained sufficiently quickly, pressure inside the eyeball increases. This medicine works by increasing the outflow of fluid, thereby reducing intraocular pressure. Untreated elevated pressure may lead to a condition called glaucoma and ultimately to damage of vision.

2. Important information before using Bimatoprost Indoco

When not to use Bimatoprost Indoco 0.1 mg/ml:

• if the patient is allergic to bimatoprost or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously had to discontinue use of eye drops due to adverse reactions to the preservative benzalkonium chloride.

Warnings and precautions
Before starting treatment with Bimatoprost Indoco 0.1 mg/ml, discuss with a doctor or pharmacist if:

• the patient has breathing difficulties;
• the patient has kidney or liver problems;
• the patient has undergone cataract surgery;
• the patient has dry eye syndrome;
• the patient has or has had corneal problems (the transparent layer at the front of the eye);
• the patient wears contact lenses (see section “Important information about certain ingredients of Bimatoprost Indoco 0.1 mg/ml”);
• the patient has or has had slow heart rate or low blood pressure;
• the patient has had or currently has a viral infection or inflammation in the eye.

During treatment, Bimatoprost Indoco may cause loss of periorbital fat tissue, which may lead to deepening of the eyelid sulcus, sunken eyes, drooping of the upper eyelid (ptosis), skin tightness around the eye (dermatochalasis-induced involution), and increased visibility of the lower white part of the eye (exposure of the lower sclera). These changes are usually mild, but if pronounced, they may affect the visual field. These changes may resolve after discontinuation of Bimatoprost Indoco. Bimatoprost Indoco may also cause darkening and excessive growth of eyelashes, may darken the skin around the eyelid, and may darken the colour of the iris. These changes may be permanent. 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 lack of data in this age group.

Bimatoprost Indoco with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
Bimatoprost Indoco may pass into breast milk; therefore, breastfeeding is not recommended during treatment with Bimatoprost Indoco.

Driving and operating machinery
After instillation of Bimatoprost Indoco, vision may become temporarily blurred. The patient should not drive or operate machinery until vision is restored.

Bimatoprost Indoco 0.1 mg/ml contains benzalkonium chloride
If using contact lenses, do not use the drops while wearing them. Wait at least 15 minutes after instillation of the medicine before reinserting contact lenses.
The preservative in Bimatoprost Indoco (benzalkonium chloride) may cause eye irritation and may stain soft contact lenses.

3. How to use Bimatoprost Indoco 0.1 mg/ml

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Bimatoprost Indoco is for ocular use only. The recommended dose is one drop of Bimatoprost
Indoco in the evening, once daily, into each eye requiring treatment.
If you are using Bimatoprost Indoco together with another eye medicine, wait at least 5 minutes
between applying Bimatoprost Indoco and the other medicine.
Do not use this medicine more than once a day, as this may reduce its effectiveness.
Instructions for administration:
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 at the ceiling.
2. Gently pull down the lower eyelid to form a small pocket.
3. Turn the bottle upside down and squeeze it to instill one drop into each eye requiring treatment.
4. Release the lower eyelid and close the eye for 30 seconds.

Wipe away any excess medicine that runs onto the cheek. If the drop misses the eye, try again.
To prevent infections and avoid eye injury, do not let the tip of the bottle touch the eye or any other
surface. Immediately after use, replace the cap and screw the bottle closed.
Overdose of Bimatoprost Indoco 0.1 mg/ml
If more than the recommended dose of Bimatoprost Indoco is used, it is unlikely to cause any serious
harm. Take the next dose at the usual time. If in doubt, consult your doctor or pharmacist.
Missed dose of Bimatoprost Indoco 0.1 mg/ml
If you miss a dose of Bimatoprost Indoco, apply one drop as soon as you remember, then continue
with the regular dosing schedule. Do not use a double dose to make up for a missed dose.
Stopping treatment with Bimatoprost Indoco 0.1 mg/ml
To ensure effectiveness, Bimatoprost Indoco must be used every day. If treatment with Bimatoprost
Indoco is stopped, it may lead to an increase in intraocular pressure. Therefore, talk to your doctor
before planning to discontinue treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Very common adverse reactions (may occur in at least 1 in 10 patients)
Eye disorders

• Loss of fat tissue around the eye, which may lead to deepening of the eyelid groove,
  sunken eyes, drooping eyelids (ptosis), tightness of the skin around the eye (dermatochalasis-induced involution), and increased visibility of the lower white part of the eye (exposure of the lower sclera);

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

Common adverse reactions (may occur in 1 in 10 patients)
Eye disorders

• minor damage to the surface of the eye, with or without inflammation;
• irritation;
• itching of the eyes;
• eyelash elongation;
• stinging after instillation of 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.

Uncommon adverse reactions (may occur in 1 in 100 patients)
Eye disorders

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

Skin disorders

• dry skin;
• crusted thickening at the eyelid margins;
• eyelid swelling;
• itching.

General disorders

• headache;
• malaise.

Frequency unknown (frequency cannot be estimated from available data)
Eye-related:

• macular edema (swelling of the retina at the back of the eye, which may lead to worsening of vision);
• darkening of the skin around the eyes;
• dryness;
• sensation of sticky eyelids;
• sensation of a foreign body in the eye;
• eye swelling;
• increased tear production.

General disorders

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

The above list includes adverse reactions of the medicinal product Bimatoprost Indoco 0.1 mg/ml.
The following adverse reactions have also been observed after administration of a medicine containing a higher concentration of bimatoprost (0.3 mg/ml):

• dizziness;
• burning sensation in the eye;
• eye allergic reaction;
• blepharitis (inflammation of the eyelids);
• blurred vision;
• worsening of vision;
• swelling of the clear membrane covering the eye (corneal edema);
• photophobia (light sensitivity);
• tearing;
• darkening of eyelashes;
• retinal haemorrhage;
• inflammatory changes in the eye;
• cystoid macular edema (retinal swelling in the eye worsening vision);
• eyelid twitching;
• eyelid retraction and pulling away 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 adverse reactions reported with eye drops containing phosphates.
In very rare cases, in some patients with severe damage to the outer transparent layer of the eyeball (cornea), hazy spots caused by calcium deposits have appeared on the cornea during treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the
Department of Monitoring Adverse Reactions of Medicinal Products
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, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bimatoprost Indoco 0.1 mg/ml

Keep this medicine out of 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 the stated month.
The bottle should be discarded no later than four weeks after first opening, even if there are still drops remaining. This is to prevent contamination. To help remember the date of opening, write it down on the container.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 (a 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 level).

What Bimatoprost Indoco 0.1 mg/ml looks like and contents of the pack
Bimatoprost Indoco 0.1 mg/ml is a colourless, clear solution free from visible particles, used as eye drops, available in a cardboard box containing 1 plastic bottle with a cap. Each bottle is approximately half-filled and contains 3 millilitres of solution (approximately 123 drops). This is sufficient for 4 weeks of use.
Not all pack sizes may be marketed.

Marketing Authorisation 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

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic Bimatoprost Indoco
Poland Bimatoprost Indoco