Bimatoprost indoco

Package leaflet: Information for the user

Bimatoprost Indoco, 0.3 mg/ml, eye drops, solution
Bimatoprostum
Please read this leaflet carefully before using the medicine, because it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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 0.3 mg/ml is and what it is used for
2. Important information before using Bimatoprost Indoco 0.3 mg/ml
3. How to use 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 Bimatoprost Indoco 0.3 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-blockers, 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 with new fluid. If the fluid does not drain sufficiently quickly, intraocular pressure increases. This medicine works by increasing the outflow of fluid, thereby reducing the pressure inside the eye. Untreated elevated pressure may lead to a disease called glaucoma and ultimately to vision damage.

2. Important information before using Bimatoprost Indoco 0.3 mg/ml

When not to use Bimatoprost Indoco 0.3 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 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 0.3 mg/ml, discuss with your 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 some of the ingredients of Bimatoprost Indoco 0.3 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 within the eye.

During treatment, the medicinal product Bimatoprost Indoco may cause loss of periorbital fat tissue, which may lead to deepening of the eyelid sulcus, enophthalmos (sunken eyes), upper eyelid ptosis (drooping), 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 treatment with Bimatoprost Indoco. Bimatoprost Indoco may also cause darkening and excessive growth of eyelashes, darkening of the skin around the eyelid, and may darken the iris colour. These changes may be permanent. Changes may be more noticeable when 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 your 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Bimatoprost Indoco may pass into human breast milk; therefore, breastfeeding should not be undertaken during treatment with Bimatoprost Indoco.

Driving and operating machinery
After instilling Bimatoprost Indoco, vision may become temporarily blurred. Do not drive or operate machinery until vision has cleared.

Bimatoprost Indoco 0.3 mg/ml contains benzalkonium chloride
If using contact lenses, do not use the drops while wearing lenses. Wait 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 0.3 mg/ml

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Bimatoprost Indoco is for ophthalmic use only. The recommended dose is one drop of Bimatoprost Indoco in each affected eye once daily in the evening.

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 the effectiveness of treatment.

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 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 affected eye.
4. Release the lower eyelid and close the eye for 30 seconds.

Wipe away any excess medicine that runs off the eye onto the cheek. If the drop misses the eye, try again.

To prevent contamination and eye injury, do not let the tip of the bottle touch the eye or any other surface. Immediately after use, replace and tighten the cap on the bottle.

Accidental overdose of Bimatoprost Indoco 0.3 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 0.3 mg/ml

If you miss a dose of Bimatoprost Indoco, 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 a missed dose.

Stopping treatment with Bimatoprost Indoco 0.3 mg/ml

To remain effective, Bimatoprost Indoco must be used every day. If you stop using Bimatoprost Indoco, intraocular pressure may increase. Therefore, talk to your doctor before stopping 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 not everyone will experience them.

Very common adverse reactions (may occur in at least 1 in 10 patients)
Eye-related symptoms:

• 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 part of the sclera);

• Longer eyelashes (in up to 45% of patients);
• Mild redness (in up to 44% of patients);
• Itching (in up to 14% of patients).

Common adverse reactions (may occur in 1 in 10 patients)
Eye-related symptoms:

• Allergic reaction in the eye;
• Eye fatigue;
• Light sensitivity;
• Darkening of the skin around the eye;
• Darkening of eyelashes;
• Pain;
• Foreign body sensation in the eye;
• Eye stickiness;
• Darkening of the iris;
• Difficulty with clear vision;
• Irritation;
• Burning sensation;
• Inflammation, redness, and itching of the eyelids;
• Tearing;
• Dryness;
• Worsening of vision;
• Blurred vision;
• Swelling of the transparent layer lining the surface of the eye;
• Minor damage to the surface of the eye, with or without inflammation.

General systemic symptoms:

• Headache;
• In blood tests, elevated liver function parameters;
• Increased blood pressure.

Uncommon adverse reactions (may occur in 1 in 100 patients)
Eye-related symptoms:

• Cystoid macular edema (swelling of the retina in the eye leading to worsening of vision);
• Inflammatory condition of the eye;
• Retinal hemorrhage;
• Eyelid swelling;
• Eyelid twitching;
• Eyelid contraction and retraction from the eye surface;
• Redness of the skin around the eye.

General systemic symptoms:

• Nausea;
• Dizziness;
• Weakness;
• Increased hair growth around the eye.

Frequency unknown (Frequency cannot be estimated from available data)
General systemic symptoms:

• Symptoms of allergic reaction (swelling, eye redness, and skin rash);
• Asthma;
• Worsening of asthma;
• Exacerbation of a lung disease known as chronic obstructive pulmonary disease (COPD);
• Shortness of breath.

Other adverse reactions reported with use of 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:
Department of Monitoring of Adverse Drug Reactions
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 responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bimatoprost Indoco 0.3 mg/ml

Keep the 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 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 you no longer use. 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 adjust the pH.

What Bimatoprost Indoco 0.3 mg/ml looks like and contents of the pack
Bimatoprost Indoco 0.3 mg/ml is a colourless, clear solution free from visible particles, used as eye drops, supplied in a cardboard box containing 1 plastic bottle with a screw cap. Each bottle is approximately half-filled and contains 3 millilitres of solution (approximately 115 drops). This is sufficient for 4 weeks of treatment.
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 for sale in the European Economic Area under the following names:
Czech Republic Bimatoprost Indoco
Poland Bimatoprost Indoco