Nyogel 0.1% eye gel
Timolol
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. 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 leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 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
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.
Before You Use Nyogel
Do not use Nyogel
- if you are allergic (hypersensitive) to timolol, 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 or have had asthma or any other breathing disorder.
- if you have symptoms such as runny nose, sneezing, itching of the nose, eyes, throat or roof of the mouth.
- if you have an eye disorder known as corneal dystrophy.
- if you have numb or cold toes and fingers (Raynaud’s syndrome).
- if you have angina (pain and tightness around the chest).
- if you have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidneys).
- if you have low blood pressure.
- if you are taking a medicine containing floctafenine or sultopride.
Floctafenine is used to treat pain and swelling. Sultopride is used to treat mental problems.
Take special care with Nyogel
Tell your doctor before using Nyogel if you have:
- cardiac failure (a heart disorder)
- sick sinus syndrome (a persistent slow heartbeat causing weakness and tiredness)
- excessive acidity of the blood (a disorder called metabolic acidosis causing rapid breathing, confusion and tiredness)
- an overactive thyroid gland
- a low level of sugar in the blood. If you have diabetes, you should check your blood sugar level more frequently at the beginning of treatment.
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.
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.
Follow your doctor’s 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:
- MAO inhibitors, which are used to treat depression (e.g. moclobemide)
- medicines used for widening the pupil (e.g. epinephrine)
- medicines used to treat heart problems (e.g. amiodarone, disopyramide, quinidine, lidocain i.v.)
- 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 during pregnancy, unless your doctor considers it necessary.
Breast-feeding
Breast-feeding is not recommended while you are using Nyogel.
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. Do not use Nyogel if you wear contact lenses.
How To Use Nyogel
Always use Nyogel 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 doctor’s instructions carefully. Do not exceed the recommended dose.
Instructions for proper use of Nyogel
- 1. Wash your hands.
- 2. Tilt your head back.
- 3. Pull the lower eyelid down with a finger. 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. To avoid contamination, do not allow the eye or anything else to touch the tip of the dropper.
- 5. After applying the drop, close your eyelid and press the inside corner of your eye for 3 minutes with your fingertip. This prevents the drop running into your throat through the tear duct and more Nyogel will remain in the eye.
- 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.
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.
Possible Side Effects
Like all medicines, Nyogel 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.
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
- difficulty 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 and joint pain)
- severe allergic reaction, including breathing difficulties and swelling mainly of the face and throat
- low blood sugar
If you experience any of these, tell your doctor straight away.
Further side effects which have been reported include:
- irritation of the eye such as itching, red and swollen eyes or eyelids; disturbance of vision including blurred and double vision; drooping eyelids; dry eyes
- palpitations; cold hands and feet; leg pain and weakness brought on by walking
- tiredness; headache; weakness
- allergic reactions which may cause local or widespread skin reddening including itchy rash, hair loss and worsening of existing psoriasis
- dizziness; difficulty sleeping; nightmares; memory loss; tingling or numbness
- nausea; vomiting; diarrhoea; indigestion; stomach pain; dry mouth
- decreased sexual desire; impotence; painful erection of the penis
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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. After first 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 25°C.
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.
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.
Marketing Authorisation Holder
Manufacturer
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 leaflet was last approved in 11/2008
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