NYOGEL 0.1% EYE GEL
Active substance: TIMOLOL MALEATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
NYOGEL 0.1% w/w, eye gel
Timolol Read all of this leaet carefully before you start using this medicine. Keep this leaet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Nyogel is and what it is used for 2. Before you use Nyogel 3. How to use Nyogel 4. Possible side effects 5. How to store Nyogel 6. Further information 1. WHAT NYOGEL IS AND WHAT IT IS USED FOR Nyogel contains the active substance timolol. Timolol belongs to a group of medicines called beta-blockers which help to reduce pressure inside the eye. Nyogel is used to treat conditions where there is an increased pressure in the eye. 2. BEFORE YOU USE NYOGEL Do not use Nyogel eye gel if you are allergic (hypersensitive) to timolol maleate, to any other beta-blocker medicine or any of the other ingredients of Nyogel. If you think you may be allergic, do not use this medicine and talk to your doctor. if you have any heart problems such as severe heart failure, irregular pulse or slow pulse. if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difculty in breathing and/or long standing cough). if you have symptoms such as a runny nose, sneezing, itching of the nose, eyes throat or roof of the mouth. if you have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidneys). if you have a persistent slow heartbeat causing weakness and tiredness. Take special care with Nyogel Before you use this medicine, tell your doctor if you have now or have in the past: coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure disturbances of heart rate such as slow heart beat. excessive acidity of the blood (a disorder called metabolic acidosis causing rapid breathing, confusion and tiredness) overactivity of the thyroid gland as timolol maleate may mask signs and symptoms diabetes as timolol maleate may mask signs and symptoms of low blood sugar breathing problems, asthma or chronic obstructive pulmonary disease poor blood circulation disease (such as Raynauds disease or Raynauds syndrome) if you have any allergies, you may be more likely to have an allergic reaction while using Nyogel. Your doctor will regularly examine your eye pressure and eye. Tell your doctor before you have an operation that you are using Nyogel as timolol maleate may change effects of some medicines used during anaesthesia. Children Nyogel is not recommended for use in children below 12 years. Elderly patients No dosage adjustment is necessary. Using other medicines If you need to apply other medicinal products to your eyes at the same time as Nyogel, wait at least 5 minutes between applying each product and always apply Nyogel last. Nyogel can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Follow your doctors instructions carefully when changing treatment from another product used to decrease eye pressure. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking: medicines used for psychiatric illness (amisulpride, MAO inhibitors e.g. moclobemide uoxetine, paroxetine) medicines used for widening the pupil (e.g. epinephrine) medicines used to treat heart problems (e.g. amiodarone, propafenone, hydralazine, disopyramide, quinidine, lidocaine i.v.) medicines used to treat malaria (e.g. meoquine, quinidine) medicines used to treat high blood pressure (e.g. nifedipine, verapamil, diltiazem) medicines used to treat diabetes (e.g. insulin) anaesthetics medicines used to treat ulcers in your stomach or intestine (e.g. cimetidine) contrast liquids which are used for radiological examination Pregnancy Tell your doctor if you are pregnant or planning to become pregnant. Do not use Nyogel if you are pregnant, unless your doctor considers it necessary. Breast-feeding Do not use Nyogel if you are breast-feeding. Timolol maleate may get into your milk. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Nyogel may cause disturbances of vision including blurred and double vision, drooping eyelids as well as dizziness or tiredness. If this happens to you, do not drive or use any tools or machines. Important information about some of the ingredients of Nyogel This medicine contains benzalkonium chloride, which may discolour soft contact lenses and cause eye irritation. If you wear contact lenses remove contact lenses before using Nyogel and wait at least 15 minutes before reinserting your contact lenses into your eyes. 3. HOW TO USE NYOGEL Always use Nyogel eye gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not stop using Nyogel without asking your doctor, as your symptoms may get worse. Nyogel is for use in the eyes (ocular use) only. Do not swallow. The usual dose is one drop of Nyogel in the affected eye(s) once a day, preferably in the morning. Follow your doctors instructions carefully. Do not exceed the recommended dose. Instructions for proper use of Nyogel 1. Wash your hands. 2. Tilt your head back (Fig.1). 3. Pull the lower eyelid down with a nger. With the other hand hold the bottle with the dropper pointing downwards. 4. Gently squeeze the bottle so that one drop falls into the eye (Fig 2). To avoid contamination, do not allow the eye or anything else to touch the tip of the dropper. 5. After using Nyogel, press a nger into the corner of your eye, by the nose (Fig 3) for 2 minutes. This helps to stop timolol maleate getting into the rest of the body. 6. If necessary repeat steps 2 to 5 with your other eye. 7. Close the bottle after use. Do not wipe or rinse off dropper.
Fig. 1
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Fig. 2
Fig. 3
If you use more Nyogel than you should If you use too many drops or accidentally swallow Nyogel, contact your doctor immediately as you may need medical attention. If you need to see a doctor or go to the hospital, take the pack with you. If you forget to use Nyogel Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nyogel eye gel can cause side effects, although not everybody gets them. Although Nyogel is a local eye treatment, you may experience side effects in other parts of your body. You can usually carry on taking the medicine, unless the effects are serious. If youre worried, talk to a doctor or pharmacist. Do not stop using Nyogel without speaking to your doctor. Some effects could be serious: eye pain and abnormal sensitivity of the eye slow or irregular heart beat; low blood pressure; heart disorder which can cause breathlessness or swelling of the ankles; fainting; stroke; heart attack; chest pain difculty breathing with wheezing or coughing depression; worsening of signs and symptoms of myasthenia gravis (a neurological disorder causing muscle weakness) lupus erythematosus (a condition which causes swelling and reddening of the skin with fever) severe allergic reaction, including breathing difculties and swelling mainly of the face and throat low blood sugar joint diseases (arthropathy) If you experience any of these, tell your doctor straight away. Like other medicines applied into eyes, timolol maleate is absorbed into the blood. This may cause similar side effects as seen with intraveneous and/or oral as applicable beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions: Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airway which may cause difculty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction. Low blood glucose levels. Difculty sleeping (insomnia), depression, nightmares, memory loss. Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations like pins and needles, and headache. Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inammation of the eyelid, inammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following ltration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision. Slow heart rate, chest pain, palpitations, oedema (uid build up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to uid build up), a type of heart rhythm disorder, heart attack, heart failure. Low blood pressure, Raynauds phenomenon, cold hands and feet. Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difculty breathing, cough. Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting. Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash. Muscle pain not caused by exercise. Sexual dysfunction, decreased libido. Muscle weakness/tiredness. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE NYOGEL Keep out of the reach and sight of children. Do not use Nyogel after the expiry date which is stated on the carton and the bottle. The expiry date refers to the last day of that month. Keep the bottle in the outer carton in order to protect from light. After rst opening store bottle upside down in the outer carton. Do not use Nyogel for longer than 4 weeks after opening the bottle. Do not store above 25C. Do not freeze. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Nyogel contains The active substance is timolol. 1 g of Nyogel contains 1.37 mg timolol maleate, corresponding to 1 mg timolol (0.1%). The other ingredients are benzalkonium chloride, sorbitol, polyvinyl alcohol, carbomer 974 P, sodium acetate trihydrate, lysine monohydrate, water for injection. What Nyogel looks like and contents of the pack Nyogel is a colourless, odourless gel, free of visible particulate matter. Nyogel is available in bottles containing 5 g. The following pack sizes are available: cartons containing 1 or 3 bottles of 5 g. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder Novartis Pharmaceuticals UK Ltd., Frimley Business Park, Frimley, Surrey GU16 7SR, UK Manufacturer EXCELVISION , Rue de la Lombardire, 07104 Annonay, Cedex, France This medicinal product is authorised in the Member States of the EEA under the following names: Belgium: Nyogel Denmark: Timosan Depot Finland: Timosan France: Nyogel Greece: Nyogel Iceland: Timosan Depot Ireland: Nyogel Italy: Nyogel Netherlands: Nyogel Portugal: Nyogel Spain: Timogel United Kingdom: Nyogel This leaet was last approved in April 2012.
R92 397477
NYOGEL 0.1% w/w, eye gel
Timolol Read all of this leaet carefully before you start using this medicine. Keep this leaet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Nyogel is and what it is used for 2. Before you use Nyogel 3. How to use Nyogel 4. Possible side effects 5. How to store Nyogel 6. Further information 1. WHAT NYOGEL IS AND WHAT IT IS USED FOR Nyogel contains the active substance timolol. Timolol belongs to a group of medicines called beta-blockers which help to reduce pressure inside the eye. Nyogel is used to treat conditions where there is an increased pressure in the eye. 2. BEFORE YOU USE NYOGEL Do not use Nyogel eye gel if you are allergic (hypersensitive) to timolol maleate, to any other beta-blocker medicine or any of the other ingredients of Nyogel. If you think you may be allergic, do not use this medicine and talk to your doctor. if you have any heart problems such as severe heart failure, irregular pulse or slow pulse. if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difculty in breathing and/or long standing cough). if you have symptoms such as a runny nose, sneezing, itching of the nose, eyes throat or roof of the mouth. if you have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidneys). if you have a persistent slow heartbeat causing weakness and tiredness. Take special care with Nyogel Before you use this medicine, tell your doctor if you have now or have in the past: coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure disturbances of heart rate such as slow heart beat. excessive acidity of the blood (a disorder called metabolic acidosis causing rapid breathing, confusion and tiredness) overactivity of the thyroid gland as timolol maleate may mask signs and symptoms diabetes as timolol maleate may mask signs and symptoms of low blood sugar breathing problems, asthma or chronic obstructive pulmonary disease poor blood circulation disease (such as Raynauds disease or Raynauds syndrome) if you have any allergies, you may be more likely to have an allergic reaction while using Nyogel. Your doctor will regularly examine your eye pressure and eye. Tell your doctor before you have an operation that you are using Nyogel as timolol maleate may change effects of some medicines used during anaesthesia. Children Nyogel is not recommended for use in children below 12 years. Elderly patients No dosage adjustment is necessary. Using other medicines If you need to apply other medicinal products to your eyes at the same time as Nyogel, wait at least 5 minutes between applying each product and always apply Nyogel last. Nyogel can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Follow your doctors instructions carefully when changing treatment from another product used to decrease eye pressure. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking: medicines used for psychiatric illness (amisulpride, MAO inhibitors e.g. moclobemide uoxetine, paroxetine) medicines used for widening the pupil (e.g. epinephrine) medicines used to treat heart problems (e.g. amiodarone, propafenone, hydralazine, disopyramide, quinidine, lidocaine i.v.) medicines used to treat malaria (e.g. meoquine, quinidine) medicines used to treat high blood pressure (e.g. nifedipine, verapamil, diltiazem) medicines used to treat diabetes (e.g. insulin) anaesthetics medicines used to treat ulcers in your stomach or intestine (e.g. cimetidine) contrast liquids which are used for radiological examination Pregnancy Tell your doctor if you are pregnant or planning to become pregnant. Do not use Nyogel if you are pregnant, unless your doctor considers it necessary. Breast-feeding Do not use Nyogel if you are breast-feeding. Timolol maleate may get into your milk. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Nyogel may cause disturbances of vision including blurred and double vision, drooping eyelids as well as dizziness or tiredness. If this happens to you, do not drive or use any tools or machines. Important information about some of the ingredients of Nyogel This medicine contains benzalkonium chloride, which may discolour soft contact lenses and cause eye irritation. If you wear contact lenses remove contact lenses before using Nyogel and wait at least 15 minutes before reinserting your contact lenses into your eyes. 3. HOW TO USE NYOGEL Always use Nyogel eye gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not stop using Nyogel without asking your doctor, as your symptoms may get worse. Nyogel is for use in the eyes (ocular use) only. Do not swallow. The usual dose is one drop of Nyogel in the affected eye(s) once a day, preferably in the morning. Follow your doctors instructions carefully. Do not exceed the recommended dose. Instructions for proper use of Nyogel 1. Wash your hands. 2. Tilt your head back (Fig.1). 3. Pull the lower eyelid down with a nger. With the other hand hold the bottle with the dropper pointing downwards. 4. Gently squeeze the bottle so that one drop falls into the eye (Fig 2). To avoid contamination, do not allow the eye or anything else to touch the tip of the dropper. 5. After using Nyogel, press a nger into the corner of your eye, by the nose (Fig 3) for 2 minutes. This helps to stop timolol maleate getting into the rest of the body. 6. If necessary repeat steps 2 to 5 with your other eye. 7. Close the bottle after use. Do not wipe or rinse off dropper.
Fig. 1
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Fig. 2
Fig. 3
If you use more Nyogel than you should If you use too many drops or accidentally swallow Nyogel, contact your doctor immediately as you may need medical attention. If you need to see a doctor or go to the hospital, take the pack with you. If you forget to use Nyogel Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Nyogel eye gel can cause side effects, although not everybody gets them. Although Nyogel is a local eye treatment, you may experience side effects in other parts of your body. You can usually carry on taking the medicine, unless the effects are serious. If youre worried, talk to a doctor or pharmacist. Do not stop using Nyogel without speaking to your doctor. Some effects could be serious: eye pain and abnormal sensitivity of the eye slow or irregular heart beat; low blood pressure; heart disorder which can cause breathlessness or swelling of the ankles; fainting; stroke; heart attack; chest pain difculty breathing with wheezing or coughing depression; worsening of signs and symptoms of myasthenia gravis (a neurological disorder causing muscle weakness) lupus erythematosus (a condition which causes swelling and reddening of the skin with fever) severe allergic reaction, including breathing difculties and swelling mainly of the face and throat low blood sugar joint diseases (arthropathy) If you experience any of these, tell your doctor straight away. Like other medicines applied into eyes, timolol maleate is absorbed into the blood. This may cause similar side effects as seen with intraveneous and/or oral as applicable beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions: Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airway which may cause difculty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction. Low blood glucose levels. Difculty sleeping (insomnia), depression, nightmares, memory loss. Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations like pins and needles, and headache. Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inammation of the eyelid, inammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following ltration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision. Slow heart rate, chest pain, palpitations, oedema (uid build up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to uid build up), a type of heart rhythm disorder, heart attack, heart failure. Low blood pressure, Raynauds phenomenon, cold hands and feet. Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difculty breathing, cough. Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting. Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash. Muscle pain not caused by exercise. Sexual dysfunction, decreased libido. Muscle weakness/tiredness. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE NYOGEL Keep out of the reach and sight of children. Do not use Nyogel after the expiry date which is stated on the carton and the bottle. The expiry date refers to the last day of that month. Keep the bottle in the outer carton in order to protect from light. After rst opening store bottle upside down in the outer carton. Do not use Nyogel for longer than 4 weeks after opening the bottle. Do not store above 25C. Do not freeze. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Nyogel contains The active substance is timolol. 1 g of Nyogel contains 1.37 mg timolol maleate, corresponding to 1 mg timolol (0.1%). The other ingredients are benzalkonium chloride, sorbitol, polyvinyl alcohol, carbomer 974 P, sodium acetate trihydrate, lysine monohydrate, water for injection. What Nyogel looks like and contents of the pack Nyogel is a colourless, odourless gel, free of visible particulate matter. Nyogel is available in bottles containing 5 g. The following pack sizes are available: cartons containing 1 or 3 bottles of 5 g. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder Novartis Pharmaceuticals UK Ltd., Frimley Business Park, Frimley, Surrey GU16 7SR, UK Manufacturer EXCELVISION , Rue de la Lombardire, 07104 Annonay, Cedex, France This medicinal product is authorised in the Member States of the EEA under the following names: Belgium: Nyogel Denmark: Timosan Depot Finland: Timosan France: Nyogel Greece: Nyogel Iceland: Timosan Depot Ireland: Nyogel Italy: Nyogel Netherlands: Nyogel Portugal: Nyogel Spain: Timogel United Kingdom: Nyogel This leaet was last approved in April 2012.
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
