This leaflet's format was set and its contents inspected and approved by the Ministry of Health

Transcription

1 This leaflet's format was set and its contents inspected and approved by the Ministry of Health Patient leaflet in accordance with the Pharmacists Regulation (Preparations) 1986 The preparation shall be sold only with a doctor's prescription Betoptic S Sterile Ophthalmic Suspension Composition: 1 ml contains: Betaxolol, Betaxolol HCI (as base 0.25%) Excipients appear at the end of the leaflet. Read this leaflet in its entirety before using the medication. This leaflet contains concise information on the medication. If you have additional questions, ask the physician or pharmacist. This medication was prescribed for you. Do not share it with others. It may harm them, even if you think their medical condition is similar. This medication is not for use in children and adolescents under the age of 18 years since the safety and efficiency of the medication has not been evaluated in this population. 1. What is the medication used for? Betoptic S is used to reduce pressure in the eye and treat open-angle glaucoma. Therapeutic group: Beta-blockers, drug to reduce pressure in the eye. 2. Before using the medication Do not use the medication if: Do not use if there is a known sensitivity to one of the medication s ingredients (see section 6). You suffer from slowed heart rate, heart failure, cardiac arrhythmia. If you suffer from or have a history of respiratory impairment such as: severe asthma, chronic obstructive pulmonary disease, severe COPD that might cause wheezing, difficulty breathing and/or chronic cough). Warning: Consult a physician when switching to treatment with this preparation, for dose adjustment. Undergo intraocular pressure tests during treatment with this medication. If you are about to have surgery (including dental), inform the surgeon that you are taking the medication. Special warning concerning use of the medication Before treatment with Betoptic S, inform the physician if: You suffer from or have a history of coronary heart disease (symptoms may include chest pains and/or pressure, shortness of breath or asphyxiation), heart failure or hypotension. You suffer from or have a history of cardiac arrhythmia such as slow heart rate (bradycardia). You suffer from or have a history of respiratory disorders, asthma and/or chronic obstructive pulmonary disease, COPD (that might cause wheezing, difficulty breathing and/or chronic cough). You suffer from or have a history of impaired blood circulation (such as Raynaud s disease or Raynaud s syndrome). You suffer from diabetes, since Betoptic S might hide signs and symptoms of hypoglycemia. You suffer from hyperthyroidism since Betoptic S might hide the signs and symptoms of this condition.

2 You suffer from closed angle glaucoma. You suffer from or have a history of dry eyes (Sicca syndrome). If you are taking, or if you have recently taking other medications including over-the-counter medications and nutritional supplements, inform the physician or pharmacist. In particular, if you are taking or intend to take: Medications for lowering blood pressure Heart medications Diabetes medications Medications for treating emotional, behavioral and/or mental problems (such as anxieties or depression) Any other medication (including over-the-counter medications) Betoptic S might reduce the effect of Adrenalin (indicated to treat acute symptoms of allergic reactions anaphylaxis). Inform the physician or pharmacist of a history of anaphylaxis or allergic reactions. Pregnancy and breastfeeding: Pregnancy: Do not use Betoptic S if you are pregnant without consulting a physician. Breastfeeding: Do not use Betoptic S if you are breastfeeding without consulting a physician. Driving and using machinery: If your vision is blurred after using the medication, do not drive or operate machinery until your vision clears up. Important information on some of the medication s components: Do not use this preparation while wearing soft contact lenses. The preparation contains the preservative Benzlakonium chloride, that change the color of soft contact lenses. Remove the lenses before using this preparation and wear them again no less than 15 minutes after instilling the medication into the eye. 3. How should you use the medication? Always use as instructed by the physician. Check with the physician or pharmacist if you are unsure. Dose and manner of treatment will be determined by the physician only. The standard dose is normally one drop twice a day. Do not exceed the recommended dose. Do not swallow. This medication is for external use only. Thoroughly shake the bottle before use. Medication instructions for use: To prevent contamination of the solution make sure that the bottle s tip does not come into contact with any surface (including the eye itself). Keep the bottle closed tightly. The drop bottle may not be full; this is to allow better control of the rate of instilment. How to use the drops: First, wash your hands. Tilt your head back. With your index finger, pull the lower eyelid down, to create a type of pocket (illustration 1). Instill the medication into the pocket. Close your eyes gently. Do not blink. Keep your eyes closed for 1 to 2 minutes. Do not squeeze the bottle, a gentle press of the bottle s base is enough to release the drop (illustration 2). In addition to the above instructions immediately after instilling the drops into the eye, press the inner corner of the eye with your middle finger. Continue applying pressure for 1 to 2 minutes after instilling into the eye.

3 This action helps preventing the medication from being absorbed into the body, thereby help prevent side effects (illustration 3). Repeat the above actions in the other eye, if the doctor instructed treatment in both eyes. After using the medication, wash your hands to cleanse them from leftover medication. To avoid spreading infection, do not use the same medication container for more than one person. If a drop missed the eye, try again. If you accidentally took a higher dose, wash the eye with warm water. Do not apply another dose until the time of the next dose. If you accidentally took an overdose or if a child accidentally swallowed from the medication, see a physician or go the hospital emergency room immediately and bring the medication package with you. If you forgot to take the medication at the scheduled time, do not take a double dose. Take a dose immediately when you remember, but if you remembered at a time close to the next dose, skip the missed dose and continue to the next dose If you are using other eye drops, wait at least 5 minutes between the administration of this medication and the administration of other eye drops. Use eye ointments last. Use this medication at regular times as instructed by the treating physician. If you forgot to take this medication at the scheduled time, take a dose immediately when you remember; do not take two doses at the same time under any circumstances 4. Side effects As with any medication, use of Betoptic S might cause side effects in some users. Do not be alarmed to read the list of side effects. You may experience none of them. You can continue using this preparation as long as the side effects are not severe. If you are concerned, consult the physician or the pharmacist. Do not stop treatment with Betoptic S without consulting the physician.

4 As with any ophthalmic medication, Betaxolol is absorbed in the blood. This might cause side effects similar to those seen with injectable or oral beta blockers. The frequency of side effects following use of beta blockers for eye diseases is lower than those experienced with medications that are injected or ingested. The side effects listed in this leaflet include reactions caused by taking eye drops that contain Betaxolol or preparations that contain other beta blockers for the treatment of eye diseases. The following side effects were seen in the clinical trials conducted for the preparation Betoptic S Very common side effects (appearing in more than one user in ten): Eye discomfort (including sensation of foreign body in the eye) Common side effects (appearing in 1-10 users in 100): Blurred vision, teary eyes Headaches Uncommon side effects (appearing in 1-10 users in 1000): Eye surface inflammation, conjunctivitis or symptoms of conjunctivitis, impaired vision, sensitivity to light. Pain, dryness and/or tired eye, excessive blinking, tingling, redness and/or swelling in the eyes. Sensation of foreign body in the eye, eye itching, eye secretions, eyelid secretions, red eyes. Irregularly slow or increased heart rate. Asthma, difficulty breathing, nasal congestion Nausea Rare side effects (appearing in 1-10 users in 10000): Cataract, reduced eye sensitivity, blepharitis Anxiety, insomnia, depression Fainting Hypotension Cough Runny nose Taste disorders Skin inflammation, itching or rash, hair loss Reduced libido The following side effects were reported by people who used eye drops containing Betaxolol, whose frequency cannot be determined from available data: Hypersensitivity reactions Dizziness Altered in rhythm or rate of heart beats Loss or absence of strength Additional side effects reported following use of other ophthalmic beta blockers which might appear upon using Betoptic S: Unknown frequency: General allergic reactions, including: swelling under the skin (which might occur in areas such as face and limbs and can obstruct respiratory tracts, resulting in difficulty swallowing or breathing), hives (itchy rash), local and generalized rash, itching, sudden serious life-threatening allergic reaction. Hypoglycemia. Nightmares, memory loss, hallucinations, delusions and confusion.

5 Stroke, impaired blood flow to the brain, increased signs and symptoms of myasthenia gravis (muscle weakness disease), abnormal sensations (such as pins and needles) Detachment of the layer under the retina which might cause vision disorders, cornea abrasion (damage to the front layer of the eyeball), upper eyelid drop (which causes the eye to be half closed), diplopia. Chest pains, palpitations, edema (accumulation of fluids), heart failure (heart disease accompanied by shortness of breath and swelling of legs due to fluid accumulation), cardiac arrhythmia, heart attack. Raynaud s syndrome, cold blue-colored hands and legs, pains in legs (particularly if there is a history of impaired blood flow). Constriction of respiratory tracts in the lungs (primarily in patients with an underlying disease). Dyspepsia, diarrhea, dryness in mouth, abdominal pains, vomiting. Skin rash with a silver-white appearance (psoriasiform rash) or exacerbation of psoriasis. Muscle pains not resulting from physical exercise. Sexual function problems, impotency. Fatigue. Increase in anti-nuclei antibodies was seen in patients using eye medications containing beta blockers. If one of the side effects worsens, or when you experience a side effects not mentioned in the leaflet, consult the physician. Reporting of suspected adverse reactions Suspected adverse events should be reported to the Ministry of Health according to the National Regulation by clicking on the link Adverse Drug Reactions Report on the Ministry of Health s website ( which directs to the online form for reporting adverse events. 5. How to store the medication? Prevent poisoning! This medication and any other medication should be kept in a closed place out of the reach of children and/or infants, preventing poisoning. Do not induce vomiting without explicit instruction from the physician. Do not use the medication after the expiry date (exp. date) imprinted on the carton/label. The expiry date refers to the last day of that month. Storage conditions: Store at a temperature below 30 C Do not use the medication after 28 days have p[assed from the time you first opened the bottle Do not keep different medications in the same package. Store the bottle in the outer carton box to protect from light. 6. Additional information: In addition to the active substance, the medication also contains: Polystyrene divinylbenzene sulfonic acid, carbomer 974P, boric acid, mannitol, disodium edetate, benzalkonium chloride, N-laurylsarcosine, hydrochloric acid, sodium hydroxide, purified water Medication s appearance and package contents: Plastic bottle containing 5 ml of milky/colourless liquid. Registration owner: Lapidot Medical Import and Marketing Ltd., 8 Hashita St., Caesarea Industrial Area, Manufacturer: Alcon Couvrer, Puurs, Belgium This leaflet was reviewed and approved by the Ministry of Health on: Medication s registration no. in the National Medication Register at the Ministry of Health: