ECBIRIO 0.3 MG/ML + 5 MG/ML Eye drops, solution

Зміст інструкції

1. What is Bimatoprost and Timolol SIFI and what is it used for
2. What you need to know before using Bimatoprost and Timolol SIFI
3. How to use Bimatoprost and Timolol SIFI
4. Possible side effects
5. How to store Bimatoprost and Timolol SIFI
6. Package Contents and Other Information

Bimatoprost and Timolol SIFI 0.3 mg/ml + 5 mg/ml eye drops, solution
Bimatoprost/Timolol
Generic medicine

Read this leaflet carefully before you start using this medicine as 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Bimatoprost and Timolol SIFI and what is it used for

Bimatoprost and Timolol SIFI contains two different active ingredients (bimatoprost and timolol) which both reduce the pressure inside the eye. Bimatoprost belongs to a group of medicines called prostamides, prostaglandin analogues. Timolol belongs to a group of medicines called beta-blockers.
The eye contains a clear, water-based fluid that nourishes it internally. 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 inside the eye increases and over time can damage vision (a disease called glaucoma). Bimatoprost and Timolol SIFI works by reducing the production of fluid and also increasing the amount of fluid that is drained. In this way it reduces the pressure inside the eye.
The eye drops Bimatoprost and Timolol SIFI are used to treat high intraocular pressure in adults, including the elderly. This high pressure can lead to glaucoma. Your doctor will prescribe Bimatoprost and Timolol SIFI if other eye drops containing beta-blockers or prostaglandin analogues have not worked effectively on their own.
This medicine does not contain preservatives.

2. What you need to know before using Bimatoprost and Timolol SIFI

Do not use Bimatoprost and Timolol SIFI

• if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from or have suffered in the past from respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or persistent cough)
• if you have heart problems, such as slow heart rate, cardiac block or heart failure

Warnings and precautions
Consult your doctor or pharmacist before using Bimatoprost and Timolol SIFI if you have or have had in the
past:

• coronary artery disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure
• heart rate disorders, such as slowed heartbeat
• respiratory problems, asthma or chronic obstructive bronchopneumopathy
• conditions due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• excessive activity of the thyroid gland, as timolol may mask signs and symptoms of a thyroid disease
• diabetes, as timolol may mask signs and symptoms of low blood sugar levels
• severe allergic reactions
• problems with the liver or kidneys
• problems with the surface of the eye
• separation of one of the layers inside the eyeball after surgery to reduce intraocular pressure
• known risk factors for macular edema (swelling of the retina inside the eye that causes worsening of vision), such as cataract surgery

Before surgical anesthesia, inform your doctor that you are using Bimatoprost and Timolol SIFI, as
timolol may alter the effects of some medicines used during anesthesia.
If you have had contact hypersensitivity to silver in the past, do not use this medicine.
Bimatoprost and Timolol SIFI may cause darkening and lengthening of the eyelashes; it may also
darken the skin around the eye. Over time, the color of the iris may also darken. These
changes may be permanent and may be more noticeable if only one
eye is treated. Bimatoprost and Timolol SIFI may cause hair growth if it comes into contact with the
skin surface.

Children and adolescents
Bimatoprost and Timolol SIFI should not be used in children and adolescents under the age of
18 years.

Other medicines and Bimatoprost and Timolol SIFI
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Bimatoprost and Timolol SIFI may influence or be influenced by other medicines you are
taking, including other eye drops for the treatment of glaucoma.
Tell your doctor if you are using or intend to use medicines to lower blood
pressure, medicines for the heart, medicines for the treatment of diabetes, quinidine (used for the
treatment of heart disease and some types of malaria) or medicines for the treatment of
depression known as fluoxetine and paroxetine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Bimatoprost and Timolol SIFI if you are pregnant, unless your doctor has recommended it.
Do not use Bimatoprost and Timolol SIFI if you are breastfeeding with breast milk. Timolol can pass into
breast milk.
Ask your doctor for advice before taking any medicine while breastfeeding.

Driving and using machines
Bimatoprost and Timolol SIFI may cause blurred vision in some patients. Do not drive vehicles and do not
use machines until the symptoms disappear.

Bimatoprost and Timolol SIFIcontains phosphates
This medicine contains approximately 1.4 mg of phosphate buffer in each millilitre. If you have a serious injury
to the outermost transparent layer of the eye (the cornea), phosphates may in very rare cases
cause opaque spots on the cornea due to calcium accumulation during treatment.

3. How to use Bimatoprost and Timolol SIFI

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is one drop once a day, in the morning or evening, in each eye that
needs treatment. Use the medicine every day at the same time.
Bimatoprost and Timolol SIFI is a sterile solution that does not contain preservatives. See section 6.

Description of the appearance of Bimatoprost and Timolol SIFI and contents of the pack.

Before administering the eye drops:

• If you are using the medicine for the first time, practice using the dropper bottle by pressing it slowly to release a drop, away from the eye.
• When you are sure you can deliver one drop at a time, choose the position you find most comfortable for administering the eye drops (sitting, lying down or standing in front of a mirror).

Instructions for use:

Figure 1.Figure 2.Figure 3.Figure 4.

• 1. Wash your hands thoroughly before using this medicine.
• 2. If the package or bottle is damaged, do not use the medicine.
• 3. When using the medicine for the first time, unscrew the cap after making sure that the sealed ring on the cap is not broken. You should feel slight resistance until this tamper-evident ring breaks ( seefigure 1).
• 4. If the tamper-evident ring is loose, remove it as it may fall into the eye.
• 5. Tilt your head back and gently lower the lower eyelid to form a small pocket between your eye and eyelid ( seefigure 2).Avoid having the tip of the bottle come into contact with your eye, eyelids or fingers.
• 6. Gently press the bottle in the middle to release one drop into the eye ( seefigure 3).There may be a delay of a few seconds between pressing the bottle and the drop coming out. Do not press too hard.
• 7. Keeping your eye closed, press a finger against the corner of your closed eye (the point where the eye meets the nose) and hold it for 2 minutes. This ensures that the drop is

absorbed by the eye and helps prevent the medicine from entering the rest of the body.

• 8. Repeat operations 5, 6 and 7 in the other eye if your doctor has prescribed it.
• 9. After use, shake the bottle once downwards, without touching the dropper tip, to remove any residual liquid on the tip. This ensures the dispensing of subsequent drops. Screw the cap back onto the bottle ( seefigure 4).

If a drop does not enter the eye, try again.
If you have any doubts about how to administer the medicine, consult your doctor, pharmacist or nurse.
If you wear contact lenses, remove them before using this medicine. After using the eye drops,
wait 15 minutes before putting the lenses back in.
If you are using Bimatoprost and Timolol SIFI with another medicine for ophthalmic use, wait at least
5 minutes between applying Bimatoprost and Timolol SIFI and applying the other medicine. Ointments
or eye gels should be used last.

If you use more Bimatoprost and Timolol SIFI than you should
If you use more Bimatoprost and Timolol SIFI than you should, it is unlikely to cause serious harm.
Apply the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use Bimatoprost and Timolol SIFI
If you forget to use Bimatoprost and Timolol SIFI, apply one drop as soon as you remember
and then return to your normal dosing schedule. Do not use a double dose to make up for the
missed dose.

If you stop using Bimatoprost and Timolol SIFI
For it to work correctly, Bimatoprost and Timolol SIFI must be used every day.
If you have any further questions about 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.
You can usually continue to apply the eye drops unless the effects are serious. If you are
concerned, consult your doctor or pharmacist. Do not stop using Bimatoprost and Timolol
SIFI without talking to your doctor first.
The following side effects may be observed with Bimatoprost and Timolol SIFI:

Very common side effects
May affect more than 1 in 10 people
Related to the eye
redness.

Common side effects
May affect between 1 in 10 and 1 in 100 people
Related to the eye
burning, itching, stinging pain, irritation of the conjunctiva (clear layer of the eye),
sensitivity to light, eye pain, sticky eyes, dry eyes, feeling of a foreign body
in the eye, small ulcers on the surface of the eye with or without inflammation, difficulty seeing
clearly, redness and itching of the eyelids, growth of eyelashes around the eyes, darkening of the
eyelids, darkening of the skin around the eyes, longer eyelashes, eye irritation, watery eyes, swollen
eyelids, reduced vision.
Related to other parts of the body
runny nose, dizziness, headache.

Uncommon side effects
May affect more than 1 in 1,000 people
Related to the eye
abnormal sensation in the eye, inflammation of the iris, swelling of the conjunctiva (clear
layer of the eye), painful eyelids, tired eyes, growth of eyelashes inwards,
darkening of the color of the iris, sunken eyes, detachment of the eyelid from the surface
of the eye, darkening of the eyelashes.
Related to other parts of the body
shortness of breath.

Side effects with unknown frequency
Frequency cannot be estimated based on available data.
Related to the eye
cystoid macular edema (swelling of the retina inside the eye that causes worsening
of vision), swollen eyes, blurred vision.
Related to other parts of the body
difficulty breathing/wheezing, symptoms of allergic reaction (swelling, redness
of the eye and skin rash), changes in taste, slowing of the heart rate,
difficulty sleeping, nightmares, asthma, hair loss, fatigue.
Further side effects have been observed in patients using eye drops containing timolol or
bimatoprost and it is therefore possible that they may also occur with Bimatoprost and Timolol SIFI. Like
other medicines applied to the eyes, timolol is absorbed into the bloodstream. This can cause side
effects similar to those observed with beta-blockers given intravenously and/or
orally. The possibility of having side effects after using eye drops is lower than when
the medicines are given, for example, by mouth or by injection. The listed side effects
include reactions observed with bimatoprost and timolol used for the treatment of
eye conditions:

• Severe allergic reactions with swelling and difficulty breathing, which could be potentially fatal
• Low blood sugar levels
• Depression; memory loss; dizziness; hallucination
• Fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
• Reduced sensitivity of the surface of the eye; double vision; drooping eyelid; separation of one of the layers inside the eyeball after surgery to reduce pressure in the eye; inflammation of the surface of the eye; bleeding in the back of the eye (retinal bleeding); inflammation inside the eye; increased blinking; sticky eyes; eye discomfort
• Heart failure; irregular or stopped heartbeat; slow or fast heartbeat; accumulation of fluids, mainly water, in the body; chest pain
• Low blood pressure; high blood pressure; hands, feet and extremities swollen or cold due to constriction of blood vessels
• Cough, worsening of asthma, worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• Diarrhea; stomach pain; feeling unwell or malaise; indigestion; dry mouth
• Red, scaly skin patches; skin rash
• Muscle pain
• Reduced sexual desire; sexual dysfunction
• Weakness
• Increased results of blood tests indicating liver function

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Bimatoprost and Timolol SIFI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and the bottle. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
After the first opening of the bottle: store for 90 days at a temperature below 25°C.
Dispose of the bottle 90 days after the first opening.
Do not dispose of any medicine in 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 and Timolol SIFI contains

• The active ingredients are bimatoprost and timolol. Each ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.83 mg of timolol maleate). Each bottle contains 3 ml of solution.
• The other ingredients are disodium phosphate dodecahydrate (see section 2), citric acid monohydrate, sodium chloride, sodium hydroxide or hydrochloric acid, diluted (for pH adjustment), purified water.

Description of the appearance of Bimatoprost and Timolol SIFI and package contents
Bimatoprost and Timolol SIFI is a clear, colorless solution.
This medicine is available in white LDPE (5 ml) bottles, each containing 3 ml of
solution, with an HDPE dropper and an HDPE tamper-evident screw cap.
The dropper has a silicone valve system that prevents contaminated liquid from flowing back into the
bottle and allows filtered air to enter.
Pack size:
Packs of 1 or 3 bottles, each containing 3 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SIFI S.p.A.
Via Ercole Patti 36
95025 Aci Sant'Antonio (CT)
Italy
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A. (Warsaw Pharmaceutical Works Polfa S.A.)
22/24 Karolkowa Street
01-207 Warsaw
Poland

This medicine is authorised in the Member States of the European Economic Area with the
following names: