Bapiri 0.3 mg + 5 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bapiri 0.3 mg/ml + 5 mg/ml eye drops solution
Bimatoprost / Timolol
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Bapiri is and what it is used for
- What you need to know before using Bapiri
- How to use Bapiri
- Possible adverse effects
- How to store Bapiri
- Contents of the pack and other information
1. What Bapiri is and what it is used for
This medicine contains two different active substances (bimatoprost and timolol) that reduce elevated eye pressure. Bimatoprost belongs to a group of medicines called prostamides, an analogue of prostaglandins. Timolol belongs to a group of medicines called β-blockers.
The eye contains a clear, watery fluid that maintains the interior of the eye. This fluid is continuously drained from the eye, and new fluid is produced to replace it. If the fluid does not drain quickly enough, pressure inside the eye increases, and over time your vision may become damaged (a condition known as glaucoma). This medicine works by reducing the production of fluid and also increasing the amount that is drained. This reduces the pressure inside the eye.
This medicine is used to treat elevated intraocular pressure in adults, including elderly people. This elevated pressure may lead to glaucoma. Your doctor will prescribe this medicine if eye drops containing β-blockers or prostaglandin analogues alone have not been sufficiently effective.
This medicine does not contain preservatives.
2. What you need to know before using Bapiri
Do not use Bapiri
- If you are allergic to bimatoprost, timolol, beta-blockers, or any of the other components of this medicine (listed in section 6);
- If you have or have previously had respiratory 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
Consult your doctor or pharmacist before starting to use this medicine if you have or have previously had:
- Coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or suffocation);
- Heart rate disturbances, such as slow heart rate;
- Respiratory problems, asthma, or chronic obstructive pulmonary disease;
- Circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
- Overactive thyroid gland, as timolol may mask the signs and symptoms of thyroid disorders;
- Diabetes, as timolol may mask the signs and symptoms of hypoglycemia;
- Severe allergic reactions;
- Liver or kidney problems;
- Problems on the surface of the eye;
- Separation of one of the layers inside the eyeball after surgery to reduce eye pressure;
- Known risk factors for macular edema (swelling of the retina causing worsening vision), for example, cataract surgery.
Inform your doctor before undergoing surgical anesthesia that you are using this medicine, as timolol may alter the effects of certain drugs used during anesthesia.
If you have a history of contact hypersensitivity to silver, you should not use this medicine.
During treatment, Bapiri may cause loss of fat around the eye, which can lead to deepening of the eyelid groove, sunken eyes (enophthalmos), drooping of the upper eyelids (ptosis), stretching of the skin around the eye (involution of dermatochalasis), and increased visibility of the lower white part of the eye (inferior scleral show). These changes are usually mild, but if they become more pronounced, they may affect your field of vision. The changes may resolve if you stop using Bapiri.
This medicine 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 noticeable if only one eye is being treated. This medicine may cause increased hair growth on skin surfaces that come into contact with the medication.
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Other medicines and Bapiri
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This medicine may be affected by, or may affect, other medicines you are taking, including other eye drops used to treat glaucoma.
Inform your doctor if you are using or plan to use medicines to lower blood pressure, for heart conditions, for the treatment of diabetes, quinidine (used to treat heart conditions and some types of malaria), or medicines used to treat depression known as fluoxetine and paroxetine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use this medicine if you are pregnant unless recommended by your doctor.
Do not use this medicine if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before using any medicine during breastfeeding.
Driving and using machines
This medicine may cause blurred vision in some patients. Do not drive or operate machinery until symptoms have resolved.
Bapiri contains phosphates
This medicine contains 1.4 mg of phosphates per milliliter. If you have severe damage to the transparent outer layer of the front of the eye (the cornea), treatment with phosphates may, in very rare cases, lead to cloudy patches in the cornea due to calcium deposition.
3. How to use Bapiri
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is one drop administered once daily, either in the morning or in the evening, in each eye requiring treatment. Use this medicine every day at the same time.
This medicine is a sterile solution that contains no preservatives. See section 6. Appearance of the product and contents of the container.
Before instilling the eye drops:
- When using it for the first time, before administering a drop into the eye, you should first practice using the dropper bottle by slowly squeezing it to release one drop into the air, away from the eye.
- Once you are confident that you can administer a drop, choose the position that is most comfortable for instilling the drops (you may sit, lie on your back, or stand in front of a mirror).
Instructions for use:
image 1 image 2 image 3 image 4
- Wash your hands thoroughly before using this medicine.
- Do not use the medicine if the packaging or bottle is damaged.
- When using the medicine for the first time, unscrew the cap after ensuring that the tamper-evident ring on the cap has not been broken. You should feel slight resistance until this tamper-proof ring breaks (see image 1).
- If the tamper-evident ring is loose, discard it, as it could fall into the eye and cause injury.
- Tilt your head backward and gently pull down 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.
- Instill one drop into the pouch by slowly pressing on the bottle (see image 3). Gently squeeze the middle of the bottle to release one drop into your eye. There may be a delay of a few seconds between squeezing and the drop coming out. Do not squeeze too hard. If you are unsure how to administer the medicine, consult your doctor, pharmacist, or nurse.
- Compress the tear duct for about 2 minutes (by pressing a finger against the inner corner of the eye next to the nose) and close your eyes, keeping them closed during this time. This ensures that the drop is absorbed by the eye and likely reduces the amount of medicine draining through the tear duct into the nose.
- Repeat steps 5 and 6 in the other eye if your doctor has instructed you to do so.
- After use and before recapping the bottle, shake it once downward, without touching the dropper tip, to remove any residual liquid from the tip. This is necessary to ensure proper 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 the medicine, ask your doctor, pharmacist, or nurse.
If you wear contact lenses, remove them before using this medicine. Wait 15 minutes after using the drops before reinserting your lenses.
If you use this medicine with another eye medicine, leave at least 5 minutes between applying this medicine and the other medicine. Use any eye ointment or gel last.
If you use more Bapiri than you should
If you use more of this medicine than you should, it is unlikely to cause any serious harm. Apply the next dose at your usual time. If you are concerned, speak to your doctor or pharmacist.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Bapiri
If you forget to apply this medicine, 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 a missed dose.
If you stop using Bapiri
This medicine must be used every day for it to work properly.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You can usually continue using the drops unless the effects are severe. If you are concerned, speak to a doctor or pharmacist. Do not stop using this medicine without consulting your doctor.
The following side effects may occur with this medicine:
Very common adverse effects (May affect more than 1 in 10 people)
Affecting the eye: redness.
Affecting the eye: loss of fat around the eye area, which may cause deepening of the eyelid groove, sunken eyes (enophthalmos), drooping of the eyelids (ptosis), stretching of the skin around the eye (dermatocalasis involution), and increased visibility of the lower white part of the eye (inferior scleral show).
Common adverse effects (May affect up to 1 in 10 people)
Affecting the eye: burning, itching, stinging, conjunctival irritation (irritation of the transparent layer of the eye), light sensitivity, eye pain, sticky eyes, dry eyes, sensation of having something in the eye, minor erosions on the eye surface with or without inflammation, difficulty seeing clearly, redness and itching of the eyelids, increased eyelash growth, darkening of the eyelids, darker skin around the eyes, headache, longer eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.
Affecting other parts of the body: runny nose, headache.
Uncommon adverse 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, inward-growing eyelashes, darkening of the iris color, eyelid pulled away from the eye surface, darkening of eyelashes.
Affecting other parts of the body: shortness of breath.
Adverse effects of unknown frequency
Affecting the eye: cystoid macular edema (retinal swelling causing worsening vision), eye inflammation, blurred vision, eye discomfort.
Affecting other parts of the body: difficulty breathing/wheezing (making sounds when breathing), symptoms of allergic reaction (swelling, eye redness, skin rash), taste disturbances, dizziness, decreased heart rate, elevated blood pressure, sleep disturbances, nightmares, asthma, alopecia, skin discoloration (periocular), fatigue.
The following additional adverse effects have been observed in patients using eye drops containing timolol or bimatoprost, and may therefore also occur with this medicine. As with other eye medications, timolol is absorbed into the bloodstream. This may cause adverse effects similar to those seen with intravenous and/or oral beta-blockers. The likelihood of experiencing adverse effects with eye drops is lower than when medicines are taken orally or by injection. The listed adverse effects include those observed with bimatoprost and timolol when used to treat eye conditions:
- Severe allergic reactions with swelling and breathing difficulties, which may be potentially life-threatening.
- Hypoglycemia.
- Depression; memory loss; hallucinations.
- Fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation.
- Decreased sensitivity on the eye surface; double vision; ptosis; separation of one of the layers of the eyeball following surgery to reduce intraocular pressure; inflammation of the eye surface, bleeding at the back of the eye (retinal hemorrhage), inflammation inside the eye, increased blinking.
- Heart failure; irregular or interrupted heartbeat; bradycardia or tachycardia; fluid retention, mainly water, accumulating in the body; chest pain.
- Low blood pressure; swelling or coldness in the hands, feet, and extremities due to constriction of blood vessels.
- Cough; worsening of asthma; worsening of chronic obstructive pulmonary disease (COPD).
- Diarrhea; stomach pain; nausea and vomiting; indigestion; dry mouth.
- Red, scaly skin patches; skin rash.
- Muscle pain.
- Decreased sexual desire, sexual dysfunction.
- Weakness.
- Increase in certain blood test results indicating how well the liver is functioning.
Other adverse effects reported with eye drops containing phosphates:
If you have severe damage to the transparent front layer of the eye (the cornea), treatment with phosphates, in very rare cases, may cause cloudy patches in the cornea due to calcium deposits.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bapiri
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after "EXP". The expiry date refers to the last day of the month indicated.
This medicine requires no special storage conditions.
After first opening the bottle, store below 25 °C.
This medicine should be used within 90 days of opening the bottle. Therefore, the bottle must be discarded 90 days after first opening, even if some solution remains. To help you remember, write down the date you opened it in the space provided on the carton.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bapiri
- The active substances are 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 hydrogen phosphate dodecahydrate, citric acid monohydrate, sodium chloride, sodium hydroxide or diluted hydrochloric acid (to adjust pH), water for injections.
Appearance of the product and contents of the container
Bapiri is a clear, colourless solution.
This medicine is available in a white 5 ml LDPE bottle containing 3 ml of solution, or in a white 11 ml LDPE bottle containing 9 ml of solution, with a multi-dose HDPE dropper dispenser that prevents contamination of the contents through a silicone valve system, filtered air return to the bottle, and a tamper-evident HDPE screw cap, together with a cardboard box.
Pack sizes: cartons containing 1 bottle of 3 ml solution or 1 bottle of 9 ml solution.
Only some pack 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 most recent revision of this leaflet: December 2023
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)