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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 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
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, difficulty
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 Raynaud’s disease or Raynaud’s 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 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:
• medicines used for psychiatric illness (amisulpride, MAO inhibitors e.g. moclobemide
fluoxetine, 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. mefloquine, 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 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 (Fig.1).
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 (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 finger 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

Fig. 2
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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 you’re 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
• 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)
• severe allergic reaction, including breathing difficulties 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 difficulty
swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness,
severe sudden life-threatening allergic reaction.
• Low blood glucose levels.
• Difficulty 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),
inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of
the layer below the retina that contains blood vessels following filtration 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 (fluid 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 fluid build up), a type of heart rhythm disorder, heart
attack, heart failure.
• Low blood pressure, Raynaud’s phenomenon, cold hands and feet.
• Constriction of the airways in the lungs (predominantly in patients with pre-existing
disease), difficulty 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 leaflet,
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 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.
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 Lombardière, 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 leaflet 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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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