Label: information for the patient

Bapiri 0.3 mg/ml + 5 mg/ml eye drops in solution

Bimatoprost / Timolol

Read this label carefully before starting to use this medication, because

it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

This medication contains two different active principles (bimatoprost and timolol) that reduce elevated 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 drains continuously from the eye and new liquid is generated to replace it. If the liquid does not drain at a sufficient speed, the pressure inside the eye increases and, in the long term, your vision could be damaged (a disease called glaucoma). This medication acts by reducing the production of liquid and also increasing the amount that drains. This reduces the pressure inside the eye.

This medication is used for the treatment of elevated eye pressure in adults, including elderly people. This elevated 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.

No 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 bronchitis (a serious lung disease that can cause wheezing, difficulty breathing, and/or persistent coughing);
• If you have heart problems such as low heart rate, heart block, or heart failure.

Advertencias y precauciones

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

• coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing, or a feeling of suffocation), heart failure, low blood pressure;
• heart rate irregularities, such as low heart rate;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
• hyperthyroidism, as timolol may mask the signs and symptoms of thyroid diseases;
• diabetes, as timolol may mask the signs and symptoms of hypoglycemia;
• severe allergic reactions;
• liver or kidney problems;
• eye problems;
• separation of one of the layers of the interior of the eyeball after surgery to reduce eye pressure;
• known risk factors for macular edema (inflammation of the retina that causes a worsening of vision), for example, cataract surgery.

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

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

During treatment, Bapiri may cause a loss of fat around the eye that can cause deepening of the eyelid groove, sunken eyes (enophthalmos), drooping of the upper eyelids (ptosis), stretching of the skin around the eye (dermatochalasis) and that the white lower part of the eye becomes more visible (exposure of the inferior sclera). The changes are usually mild, but if they worsen, they may 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. It may also darken the color of the iris. These changes may be permanent and more visible if only one eye is being treated. This medication may cause hair growth in contact with the skin surface.

Niños y adolescentes

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

Otros medicamentos y Bapiri

Inform your doctor or pharmacist if you are using, have used recently, 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 glaucoma treatment.

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

Embarazo y lactancia

If you are pregnant or breastfeeding, 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.

Conducción y uso de máquinas

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 in each milliliter. If you suffer from severe damage to the transparent layer of the front part of the eye (the cornea), treatment with phosphates, in very rare cases, may cause cloudy patches in the cornea due to calcium.

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

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

This medication is a sterile solution that does not contain preservatives. See section 6.Appearance of the product and contents of the package.

Before instilling eye drops:

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

Usage instructions:

image 1image 2image 3image 4

1. Wash your hands carefully before using this medication.
2. Do not use the medication if the container or bottle is damaged.
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 this 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 on the lower eyelid to form a pouch 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 pouch by slowly pressing on 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 the compression and the drop's release. Do not squeeze too hard. If you are unsure how to administer your medication, consult your doctor, pharmacist, or nurse.
7. Compress the tear duct for about 2 minutes (pressing a finger against the corner of the eye near the nose) and close your eyes and keep them closed during 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 to be reduced.
8. Repeat steps 5 and 6 in the other eye if your doctor has instructed you to do so.
9. After use and before replacing the cap, you must shake the bottle once downwards, without touching the tip of the dropper, to eliminate any residual liquid in 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 your eye, try again.

If you are unsure 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 and before putting your contact lenses back in.

If you use this medicationwith another eye medication, leave at least 5 minutes between the application of this medication and the other medication. Use any eye ointment or gel last.

If you use moreBapirithan you should

If you use more of this medication than you should, it is unlikely to cause 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 forgot to useBapiri

If you forgot 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 compensate for the missed dose.

If you interrupt treatment withBapiri

This medicationmust be used every day for it to work properly.

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

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

Generally, you can continue using the drops unless the side effects are severe. If you are concerned, speak with a doctor or pharmacist. Do not stop using this medicationwithout consulting your doctor.

The following side effects may be observed with this medication:

Very common side effects(May affect more than 1 in 10 people)

Affecting the eye:redness.

Affecting the eye:loss of fat in the eye region that may cause deepening of the palpebral sulcus, enophthalmos, ptosis, stretching of the skin around the eye (dermatochalasis involution) and that the lower white part of the eye becomes more visible (exposure of the inferior sclera).

Common side effects(May affect up to 1 in 10 people)

Affecting the eye: burning, itching, stinging, conjunctival irritation (the transparent layer of the eye), light sensitivity, eye pain, sticky eyes, dry eyes, feeling like something is 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:nasal discharge, headache.

Rare side effects(May affect up to 1 in 100 people)

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

Affecting other parts of the body:shortness of breath.

Side effects of unknown frequency

Affecting the eye: macular cystoid edema (inflammation of the retina that causes a worsening of vision), eye inflammation, blurry vision, eye discomfort.

Affecting other parts of the body: difficulty breathing/wheezing (production of sounds while 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, alopecia, skin discoloration (periocular), fatigue.

The following additional side effects have been seen in patients using timolol or bimatoprost eye drops, and may occur with this medication. As other eye medications, timolol is absorbed into the blood. This may cause side effects similar to those observed with intravenous or oral beta-blockers. The likelihood of experiencing side effects with the use of eye drops is lower than when medications are taken, for example, orally or injected. Among the listed side effects are the reactions observed with bimatoprost and timolol when used to treat eye conditions:

• Severe allergic reactions with inflammation and difficulty breathing that may be potentially fatal.
• Hypoglycemia.
• Depression; memory loss; hallucination.
• Loss of consciousness; stroke; decreased cerebral blood flow; worsening of myasthenia gravis (increased muscle weakness); feeling of numbness.
• Decreased sensitivity on the surface of the eye; double vision; ptosis; separation of one of the layers of the eyeball after surgery to reduce eye pressure; inflammation of the surface of the eye, retinal hemorrhage, inflammation inside the eye, increased blinking.
• Heart failure; irregular or interrupted heartbeat; bradycardia or tachycardia, excess fluid, mainly water, that accumulates in the body; chest pain.
• Low blood pressure; swelling or coldness of the hands, feet, and extremities, caused by constriction of blood vessels.
• Cough, worsening of asthma, worsening of known lung disease known as chronic obstructive pulmonary disease (COPD).
• Diarrhea; stomach pain; nausea and vomiting; indigestion; dry mouth.
• Red scaly patches on the skin; skin rash.
• Muscle pain.
• Decreased libido, sexual dysfunction.
• Weakness.
• Increased results in blood tests that indicate how the liver is functioning.

Other side effects reported with eye drops containing phosphates:

If you suffer from severe damage to the transparent layer of the front part of the eye (the cornea), treatment with phosphates, in very rare cases, may cause cloudy patches in the cornea due to calcium.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special conservation conditions.

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

This medicationmust be used within 90 days after opening the bottle. Therefore, discard the bottle 90 days after opening it for the first time, even if there is still some solution left. To remember more easily, write the date you opened it in the space on the box.

Medications should not be thrown away through the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE Pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Bapiri

• The active principle 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 bottle contains 3 ml or 9 ml of solution.

• The other components are sodium dodecahydrate phosphate, citric acid monohydrate, sodium chloride, sodium hydroxide or diluted hydrochloric acid (to adjust the pH), water for injection preparations.

Appearance of the product and contents of the packaging

Bapiri is a transparent and colorless solution.

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

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Responsible for manufacturing

Rafarm S.A.

Thesi Pousi Xatzi Agiou Louka

Paiania, 190 02

Greece

Last review date of this leaflet:December 2023

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)