BAPIRI 0.3 mg + 5 mg/mL EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Bapiri 0.3 mg/ml + 5 mg/ml Eye Drops Solution

Bimatoprost / Timolol

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Keep this package leaflet, as you may need to read it again.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bapiri and what is it used for
2. What you need to know before starting to use Bapiri
3. How to use Bapiri
4. Possible side effects
5. Storage of Bapiri
6. Package Contents and Additional Information

1. What is Bapiri and what is it used for

This medication contains two different active substances (bimatoprost and timolol) that reduce high eye pressure. Bimatoprost belongs to a group of medications called prostamides, a prostaglandin analogue. Timolol belongs to a group of medications called beta-blockers.

The eye contains a clear, watery liquid that maintains the interior of the eye. This liquid is continuously drained from the eye and new liquid is generated to replace it. If the liquid does not drain quickly enough, the pressure inside the eye increases, and in the long run, your vision could be damaged (a disease called glaucoma). This medication works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye.

This medication is used to treat high eye pressure in adults, including elderly people. This high pressure can cause glaucoma. Your doctor will prescribe this medication if other eye drops containing beta-blockers or prostaglandin analogues have not had a sufficient effect on their own.

This medication does not contain preservatives.

2. What you need to know before starting to use Bapiri

Do not use Bapiri

• If you are allergic to bimatoprost, timolol, beta-blockers, or any of the other components of this medication (listed in section 6);
• If you have or have had respiratory problems, such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or persistent cough);
• If you have heart problems such as low heart rate, heart block, or heart failure.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication if you have or have had:

• coronary heart disease (symptoms may include chest pain, difficulty breathing, or feeling of suffocation), heart failure, low blood pressure;
• changes in heart rate, such as low heart rate;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• poor blood circulation disorders (such as Raynaud's disease or Raynaud's syndrome);
• overactive thyroid gland, as timolol may mask the signs and symptoms of thyroid disease;
• diabetes, as timolol may mask the signs and symptoms of hypoglycemia;
• severe allergic reactions;
• liver or kidney problems;
• surface eye problems;
• separation of one of the layers of the inside of the eyeball after surgery to reduce eye pressure;
• known risk factors for macular edema (retinal inflammation that causes vision impairment), such as cataract surgery.

Inform your doctor before surgical anesthesia that you are using this medication, as timolol may alter the effects of some medications used during anesthesia.

If you have a history of contact hypersensitivity to silver, you should not use this medication.

During treatment, Bapiri may cause fat loss around the eye, which can cause deepening of the palpebral sulcus, sunken eyes (enoftalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involvement of dermatocalasis), and the white part of the eye becomes more visible (inferior scleral exposure). The changes are usually mild, but if they worsen, they can affect your field of vision. The changes may disappear if you stop using Bapiri.

This medication may also cause darkening and growth of eyelashes, as well as darkening of the skin around the eye. The color of the iris may also darken. These changes may be permanent and more visible if only one eye is being treated. This medication may cause hair growth on contact with the skin surface.

Children and Adolescents

This medication should not be used in children and adolescents under 18 years of age.

Other Medications and Bapiri

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

This medication may affect or be affected by other medications you are using, including other eye drops for the treatment of glaucoma.

Inform your doctor if you are using or plan to use medications to lower blood pressure, for the heart, for the treatment of diabetes, quinidine (used to treat heart conditions and some types of malaria), or for the treatment of depression, known as fluoxetine and paroxetine.

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 medication.

Do not use this medication if you are pregnant unless your doctor recommends it.

Do not use this medication if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before using any medication during breastfeeding.

Driving and Using Machines

This medication may cause blurred vision in some patients. Do not drive or use machines until the symptoms have disappeared.

Bapiri Contains Phosphates

This medication contains 1.4 mg of phosphates per milliliter. If you have severe damage to the clear layer of the front of the eye (the cornea), treatment with phosphates, in very rare cases, can cause cloudy patches on the cornea due to calcium.

3. How to Use Bapiri

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one drop administered once a day, either in the morning or at night, in each eye that needs treatment. Use this medication every day at the same time.

This medication is a sterile solution that does not contain preservatives. See section 6, Product Appearance and Package Contents.

Before Instilling the Eye Drops:

• When using it for the first time, before administering a drop in the eye, you should first practice using the dropper bottle by slowly squeezing it to release a drop in the air, away from the eye.
• When you are sure you can administer a drop, you should choose the position that is most comfortable for you to instill the drops (you can sit, lie on your back, or stand in front of a mirror).

Instructions for Use:

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1. Wash your hands carefully before using this medication.
2. If the package or bottle is damaged, do not use the medication.
3. When using the medication for the first time, unscrew the cap after making sure the tamper-evident ring on the cap has not been broken. You should feel a slight resistance until the tamper-evident ring breaks (see image 1).
4. If the tamper-evident ring is loose, discard it because it could fall into the eye and cause injury.
5. Tilt your head back and gently pull down the lower eyelid to form a pocket between the eye and the eyelid (see image 2). Avoid contact between the tip of the bottle and your eye, eyelids, or fingers.
6. Instill one drop into the pocket by slowly pressing the bottle (see image 3). Squeeze the bottle gently in the middle and let one drop fall into your eye. There may be a delay of a few seconds between compression and the drop coming out. Do not squeeze too hard. If you are not sure how to administer your medication, consult your doctor, pharmacist, or nurse.
7. Compress the tear duct for about 2 minutes (by pressing a finger against the corner of the eye next to the nose) and close your eyes, keeping them closed for this time. This ensures that the drop is absorbed by the eye and that the amount of medication that drains through the tear duct into the nose is likely reduced.
8. Repeat steps 5 and 6 in the other eye if your doctor has indicated that you should do so.
9. After use and before closing the bottle, you should shake it once downward, without touching the tip of the dropper, to remove any residual liquid from the tip. This is necessary to ensure the delivery of subsequent drops. After instillation, screw the cap back onto the bottle (see image 4).

If a drop does not reach the eye, try again.

If you are not sure how to administer your medication, ask your doctor, pharmacist, or nurse.

If you wear contact lenses, remove them before using this medication. Wait 15 minutes after using the drops before putting your lenses back in.

If you use this medication with another eye medication, wait at least 5 minutes between applying this medication and the other medication. Use any eye ointment or gel last.

If You Use More Bapiri Than You Should

If you use more of this medication than you should, it is unlikely to cause you any serious harm. Apply the next dose at the usual time. If you are concerned, talk to your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Bapiri

If you forget to apply this medication, use one drop as soon as you remember and then return to your usual routine. Do not apply a double dose to make up for the missed dose.

If You Stop Using Bapiri

This medication should be used every day for it to work well.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Usually, you can continue using the drops, unless the effects are severe. If you are concerned, talk to a doctor or pharmacist. Do not stop using this medication without consulting your doctor.

The following side effects may occur with this medication:

Very Common Side Effects(May affect more than 1 in 10 people)

Affecting the eye: redness.

Affecting the eye: fat loss in the eye area that can cause deepening of the palpebral sulcus, sunken eyes (enoftalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involvement of dermatocalasis), and the white part of the eye becomes more visible (inferior scleral exposure).

Common Side Effects(May affect up to 1 in 10 people)

Affecting the eye: burning, itching, stinging, conjunctival irritation (the clear layer of the eye), sensitivity to light, eye pain, sticky eyes, dryness of the eyes, feeling of having something in the eye, small erosions on the surface of the eye with or without inflammation, difficulty seeing clearly, redness and itching of the eyelids, hair growth around the eye, darkening of the eyelids, darker color around the eyes, headache, longer eyelashes, eye irritation, watery eyes, inflamed eyelids, reduced vision.

Affecting other parts of the body: runny nose, headache.

Uncommon Side Effects(May affect up to 1 in 100 people)

Affecting the eye: abnormal sensation in the eye, iris inflammation, conjunctivitis (inflammation of the clear layer of the eye), painful eyelids, tired eyes, eyelashes growing inward, darkening of the iris color, eyelid separated from the eye surface, darkening of the eyelashes.

Affecting other parts of the body: shortness of breath.

Side Effects of Unknown Frequency

Affecting the eye: cystoid macular edema (retinal inflammation that causes vision impairment), eye inflammation, blurred vision, eye discomfort.

Affecting other parts of the body: difficulty breathing/wheezing (production of sounds when breathing), symptoms of allergic reaction (swelling, redness of the eye, and skin rash), changes in taste, dizziness, decreased heart rate, high blood pressure, sleep disturbances, nightmares, asthma, hair loss, skin discoloration (around the eye), fatigue.

Other side effects reported with phosphate-containing eye drops:

If you have severe damage to the clear layer of the front of the eye (the cornea), treatment with phosphates, in very rare cases, can cause cloudy patches on the cornea due to calcium.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bapiri

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the bottle after "EXP". The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

After opening the bottle for the first time, store below 25 °C.

This medication should be used within 90 days of opening the bottle. Therefore, you should discard the bottle 90 days after first opening it, even if some solution remains. To remember more easily, write the date you opened it in the space on the box.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Collection Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Bapiri Composition

• The active ingredient is bimatoprost and timolol.
• Each ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.8 mg of timolol maleate).

Each vial contains 3 ml or 9 ml of solution.

• The other components are sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, sodium chloride, sodium hydroxide or diluted hydrochloric acid (for pH adjustment), water for injectable preparations.

Product Appearance and Packaging Content

Bapiri is a clear and colorless solution.

This medication is available in a 5 ml white LDPE vial, which contains 3 ml of solution, or in an 11 ml white LDPE vial, which contains 9 ml of solution, with a multidose dropper applicator made of HDPE that prevents contamination of the contents due to a silicone valve system, filtered air return to the vial, and a tamper-evident HDPE screw cap, and a cardboard box.

Packaging sizes: boxes containing 1 vial of 3 ml of solution or 1 vial of 9 ml of solution.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Manufacturer

Rafarm S.A.

Thesi Pousi Xatzi Agiou Louka

Paiania, 190 02

Greece

Date of the Last Revision of this Leaflet:December 2023

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)