ECBIRIO

Package leaflet: Information for the patient

Bimatoprost and Timolol SIFI 0.3 mg/ml + 5 mg/ml eye drops, solution
Bimatoprost/Timolol
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bimatoprost and Timololo SIFI contains two different active substances (bimatoprost and timolol), both of which reduce the pressure inside the eye. Bimatoprost belongs to a group of medicines called prostamides, which are prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers.

The eye contains a clear, watery fluid that nourishes its internal structures. This fluid is continuously drained from the eye, and new fluid is produced to replace it. If the fluid does not drain quickly enough, the pressure inside the eye increases and, over time, may damage vision (a condition known as glaucoma). Bimatoprost and Timololo SIFI works by reducing the production of this fluid and also by increasing the amount of fluid that is drained. In this way, it reduces the intraocular pressure.

Bimatoprost and Timololo SIFI eye drops are used to treat elevated intraocular pressure in adults, including the elderly. This increased pressure may lead to glaucoma. Your doctor will prescribe Bimatoprost and Timololo SIFI if other eye drops containing beta-blockers or prostaglandin analogues alone have not been effective.
This medicine does not contain preservatives.

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

Do not use Bimatoprost and Timololo 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 have or have previously had breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or persistent cough)
• if you have heart problems such as slow heart rate, heart block, or heart failure

Warnings and precautions
Talk to your doctor or pharmacist before using Bimatoprost and Timololo SIFI if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure
• heart rhythm disorders, such as slow heartbeat
• breathing problems, asthma, or chronic obstructive pulmonary disease
• conditions due to poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
• overactivity of the thyroid gland, as timolol may mask signs and symptoms of thyroid disease
• diabetes, as timolol may mask signs and symptoms of low blood sugar levels
• severe allergic reactions
• liver or kidney problems
• eye surface problems
• 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 causing worsening of vision), for example cataract surgery

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

Children and adolescents
Bimatoprost and Timololo SIFI must not be used in children and adolescents under 18 years of age.

Other medicines and Bimatoprost and Timololo SIFI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Bimatoprost and Timololo SIFI may affect or be affected by other medicines you are taking, including other eye drops used to treat glaucoma.
Inform your doctor if you are using or intend to use medicines to lower blood pressure, medicines for the heart, medicines to treat diabetes, quinidine (used to treat heart conditions and certain types of malaria), or medicines for depression known as fluoxetine and paroxetine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Bimatoprost and Timololo SIFI if you are pregnant, unless specifically recommended by your doctor.
Do not use Bimatoprost and Timololo SIFI if you are breastfeeding. Timolol may pass into breast milk.
Consult your doctor before taking any medicine during breastfeeding.

Driving and using machines
Bimatoprost and Timololo SIFI may cause blurred vision in some patients. Do not drive or operate machinery until symptoms have resolved.

Bimatoprost and Timololo SIFI contains phosphates
This medicine contains approximately 1.4 mg of phosphate buffer per millilitre. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to cloudy spots on the cornea during treatment.

3. How to use Bimatoprost and Timolol SIFI

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one drop once daily, in the morning or evening, in each eye requiring
treatment. Use the medicine at the same time every day.
Bimatoprost and Timololo SIFI is a sterile solution that contains no preservatives. See section 6.
Description of the appearance of Bimatoprost and Timololo 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 gently squeezing it to release one drop, away from the eye.
• Once you are confident that you can dispense 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. Do not use the medicine if the packaging or bottle is damaged.
3. When using the medicine for the first time, unscrew the cap after ensuring that the tamper-evident seal on the cap is intact. You should feel slight resistance until this tamper-evident ring breaks ( see Figure 1).
4. If the tamper-evident ring is loose, remove it, as it could fall into the eye.
5. Tilt your head backward and gently pull down the lower eyelid to form a small pocket between the eye and the eyelid ( see Figure 2). Avoid letting the tip of the bottle touch the eye, eyelids, or fingers.
6. Gently press the center of the bottle to release one drop into the eye ( see Figure 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. With the eye closed, press a finger against the corner of the closed eye (where the eye meets the nose) and hold 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 steps 5, 6, and 7 in the other eye if prescribed by your doctor.
9. After use, tap the bottle once downward without touching the dropper tip, to remove any residual liquid from the tip. This ensures proper delivery of subsequent drops. Screw the cap back onto the bottle ( see Figure 4).

If a drop fails to 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. Wait 15 minutes after using the eye drops before reinserting your contact lenses.
If you use Bimatoprost and Timololo SIFI together with another ophthalmic medicine, wait at least
5 minutes between applying Bimatoprost and Timololo SIFI and the other medicine. Ocular ointments
or gels should be used last.
If you use more Bimatoprost and Timololo SIFI than you should
Using more Bimatoprost and Timololo SIFI than prescribed is unlikely to cause serious harm.
Apply the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.
If you forget to use Bimatoprost and Timololo SIFI
If you forget to use Bimatoprost and Timololo SIFI, apply one drop as soon as you remember,
and then return to your regular dosing schedule. Do not use a double dose to make up for
a missed dose.
If you stop using Bimatoprost and Timololo SIFI
To work properly, Bimatoprost and Timololo SIFI must be used every day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
You can usually continue using the eye drops unless the side effects are severe. If you have any concerns, consult your doctor or pharmacist. Do not stop using Bimatoprost and Timololo SIFI without first talking to your doctor.

The following side effects may occur with Bimatoprost and Timololo SIFI:

Very common side effects
May affect more than 1 in 10 people
Eye-related

• Redness of the eye.

Common side effects
May affect between 1 in 10 and 1 in 100 people
Eye-related

• Burning, itching, stinging pain, conjunctival irritation (the transparent layer of the eye), sensitivity to light, eye pain, sticky eyes, dry eyes, sensation of a foreign body in the eye, small ulcers on the surface of the eye with or without inflammation, blurred vision, redness and itching of the eyelids, increased eyelash growth, darkening of the eyelids, darkening of the skin around the eyes, longer eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.
  Other body parts
• Runny nose, dizziness, headache.

Uncommon side effects
May affect more than 1 in 1,000 people
Eye-related

• Abnormal sensation in the eye, iris inflammation, conjunctival swelling (the transparent layer of the eye), painful eyelids, tired eyes, inward-growing eyelashes, darkening of the iris colour, sunken eyes, eyelid retraction (eyelid pulling away from the eye surface), darkening of eyelashes.
  Other body parts
• Shortness of breath.

Side effects with unknown frequency
Frequency cannot be determined from available data.
Eye-related

• Cystoid macular edema (swelling in the retina inside the eye causing worsening of vision), eye swelling, blurred vision.
  Other body parts
• Difficulty breathing/wheezing, symptoms of allergic reaction (swelling, eye redness, skin rash), taste disturbances, slowed heart rate, difficulty sleeping, nightmares, asthma, hair loss, fatigue.

Additional side effects have been observed in patients using eye drops containing timolol or bimatoprost, and therefore these may also occur with Bimatoprost and Timololo SIFI. Like other eye drops, timolol may be absorbed into the bloodstream. This can cause side effects similar to those seen with intravenously and/or orally administered beta-blockers. The likelihood of experiencing side effects with eye drops is lower than when medicines are taken orally or by injection. The listed side effects include reactions observed with bimatoprost and timololo used for treating eye disorders:

• Severe allergic reactions with swelling and difficulty breathing, which could potentially be life-threatening
• Low blood sugar levels
• Depression; memory loss; dizziness; hallucinations
• Fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
• Reduced sensitivity of the eye surface; double vision; drooping eyelid; detachment of one of the layers inside the eyeball after eye surgery to reduce intraocular pressure; inflammation of the eye surface; bleeding at the back of the eye (retinal haemorrhage); intraocular inflammation; increased eyelid twitching; sticky eyes; eye discomfort
• Heart failure; irregularities or arrest of heartbeat; slow or fast heartbeat; fluid retention, mainly water, in the body; chest pain
• Low blood pressure; high blood pressure; swollen or cold hands, feet, and extremities due to constriction of blood vessels
• Cough, worsening of asthma, worsening of chronic obstructive pulmonary disease (COPD)
• Diarrhoea; stomach ache; feeling unwell; indigestion; dry mouth
• Red, scaly skin patches; skin rash
• Muscle pain
• Reduced sexual desire; sexual dysfunction
• Weakness
• Increased liver function blood test results

Other side effects reported with phosphate-containing eye drops
In very rare cases, some patients with severe damage to the transparent layer of the front part of the eye (the cornea) have developed cloudy corneal deposits due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via 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 Timololo SIFI

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

• The active substances 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 components 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 Timololo SIFI and package contents
Bimatoprost and Timololo SIFI is a clear, colourless solution.
This medicinal product is available in white LDPE bottles (5 ml), each containing 3 ml of solution, with an HDPE dropper and a tamper-evident HDPE screw cap.
The dropper has a silicone valve system that prevents reflux of contaminated liquid into the bottle and allows filtered air to enter.
Pack sizes:
Packages containing 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 medicinal product is authorised in the European Economic Area Member States under the following names: