Consumer medicine information

Nyogel [8112]

Timolol

BRAND INFORMATION

Brand name

Nyogel Eye gel

Active ingredient

Timolol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nyogel [8112].

What is in this leaflet

This leaflet answers some common questions about Nyogel.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. You can also download the most up-to-date leaflet from www.novartis.com.au.

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Nyogel against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Nyogel is used for

This medicine is used to lower the pressure in the eye and to prevent loss of vision in glaucoma.

It works by decreasing the formation of fluid which flows through the eye.

The eye is filled with fluid which is constantly being replaced. If excessive amounts of fluid are produced or if it cannot drain away properly, the pressure inside the eye can damage the nerve cells that transmit information from the eye to the brain. This nerve cell damage is called glaucoma.

Glaucoma is often but not always associated with increased pressure in the eye. A reduction of the pressure inside the eye can prevent further nerve cell damage.

There are usually no symptoms of glaucoma. Damage can progress so slowly that you are not aware of a gradual loss of sight. The only way of knowing you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated, it can lead to serious problems. You may have no symptoms but eventually glaucoma can lead to total blindness.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

It is available only with a doctor's prescription.

There is not enough information to recommend the use of this medicine for children under the age of 12 years.

Before you use Nyogel

When you must not use it

Do not use Nyogel if you have an allergy to:

  • any medicine containing timolol
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines used to treat glaucoma or high blood pressure.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not use this medicine if you have or have had:

  • asthma or other lung disease
  • slow heart rate
  • some types of heart disease
  • severe problems with the circulation in your arms and legs
  • a type of angina called Prinzmetal's angina
  • untreated phaeochromocytoma, a rare tumour of the adrenal gland
  • some cases of low blood pressure
  • diseases of the cornea of the eye
  • severe hay fever.

Do not breast-feed if you are using this medicine.

The active ingredient in Nyogel passes into breast milk and there is a possibility that your baby may be affected.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you have or have had any of the following medical conditions:

  • low blood pressure
  • heart disease
  • an overactive thyroid
  • any other type of glaucoma than that for which you have been given this medicine
  • diabetes.

Tell your doctor if you are pregnant or plan to become pregnant.

Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you wear soft contact lenses.

The preservative in Nyogel (benzalkonium chloride) is known to discolour soft contact lenses. You should not wear soft contact lenses while using this medicine. You can put your contact lenses into your eyes 15 minutes after you have used Nyogel.

If you have not told your doctor about any of the above, tell him/her before you start using Nyogel.

Taking other medicines

Tell your doctor or pharmacist if you are taking or using any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Nyogel may interfere with each other. These include:

  • medicines used to treat high blood pressure including a group of medicines called beta-blockers that are also used to treat heart problems and to prevent migraine
  • other medicines used to treat glaucoma
  • medicines used to treat heart disease or abnormal heart beat
  • medicines used to treat depression or schizophrenia
  • anaesthetics
  • cimetidine used to treat stomach ulcers.

These medicines may be affected by Nyogel or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Nyogel

Follow the directions given to you by your doctor or pharmacist carefully.

These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to use

The usual dose is one drop in the affected eye(s) daily.

How to use it

To use this medicine:

  1. First wash your hands and sit or stand comfortably.
  2. With your head tilted back, use your forefinger to gently pull down the lower lid of the eye to be treated.
  3. Hold the container upside down above your eye and place the dropper tip close to your eye but without touching the eye or lid.
  4. Squeeze the bottle gently so that only one drops falls into the pouch between your lower lid and your eye, then release your lower lid.
    To ensure you get the correct dose, keep the bottle vertical while putting in the drops.
  5. Close your eyelid and gently press the inner corner of your eye for one minute.
  6. Treat your other eye in the same way if your doctor has told you to do this.
  7. Put the cap back on the bottle. Discard the bottle and remaining gel four weeks after opening.

If you are using any other eye drops at the same time as Nyogel, leave an interval of at least 5 minutes between each eye drop to stop the drops being washed out of the eye. Use Nyogel last.

When to use it

Use your medicine at about the same time each day, preferably in the morning.

Using it at the same time each day will have the best effect. It will also help you remember when to use it.

How long to use it

Continue using your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it. It is important to keep using your medicine even if you feel well.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.

Otherwise, use it as soon as you remember, and then go back to using your medicine as you would normally.

Do not use a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 764 766 in New Zealand) if you think that you or anyone else may have used too much Nyogel. Do this even if there are no signs of discomfort or poisoning.

You may need medical attention.

While you are using Nyogel

Things you must do

If you wear soft contact lenses, stop wearing them while you are using Nyogel.

If you are going to have surgery, tell the surgeon or anesthetist that you are using this medicine.

You may be advised to gradually stop using Nyogel prior to surgery.

If you have diabetes, you should monitor your blood sugar carefully, particularly when starting Nyogel.

Nyogel may mask the symptoms of low blood sugar.

If you are having an x-ray that requires you to have an injection of dye containing iodine, tell the person doing the x-ray that you are using Nyogel.

Nyogel and x-ray injections that contain iodine may interfere with one another.

If you become pregnant while using this medicine, tell your doctor immediately.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Nyogel.

Tell any other doctors, dentists and pharmacists who treat you that you are using this medicine.

Keep all of your doctor's appointments so that your progress can be checked.

Things you must not do

Do not use Nyogel to treat any other complaints unless your doctor tells you.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop using your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Nyogel affects you.

This medicine may cause visual disturbances and dizziness or fatigue in some people. If you get these symptoms when you use it, do not drive, operate machinery or do anything else that could be dangerous until this effect has worn off.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Nyogel.

This medicine helps most people with increased pressure in the eye, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • Irritation, pain or redness of the eye
  • blurred vision or other vision changes
  • dry eyes or dry mouth
  • dizziness, tiredness or headache
  • nausea, vomiting or diarrhoea.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:

  • conjunctivitis or swollen eyelids
  • fainting
  • palpitations
  • cold hands and feet, or tingling or numbness of the hands and feet
  • chest pain
  • allergic skin reactions including rash, redness, itching, thickened patches of skin, unusual hair loss or thinning
  • shortness of breath, coughing, wheezing or difficulty breathing
  • joint pain
  • muscle weakness and tiredness, especially in the eyes, face, throat, arms and legs, which may cause drooping eyelids and difficulty in speaking and swallowing
  • a butterfly-shaped red rash on face, exposed areas of neck, upper chest and elbows, often with swollen, painful joints
  • a painful erection.

The above list includes serious side effects which may require medical attention. Serious side effects are rare.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using Nyogel

Storage

Keep your eye gel in a cool dry place where the temperature stays below 25°C.

After opening, use the bottle of eye gel for four weeks and then get a new bottle of eye gel, even if there is some left in the old bottle.

Store the dropper bottle upside down in the carton to facilitate instillation of the eye gel.

Do not store Nyogel or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Nyogel is a clear colourless gel in a 5 g bottle.

Ingredients

Nyogel contains 1 mg/g of timolol (as timolol maleate) as the active ingredient. It also contains:

  • benzalkonium chloride
  • carbomer 934 (974 P grade)
  • lysine monohydrate
  • polyvinyl alcohol
  • sodium acetate
  • sorbitol
  • water for injections.

Sponsor

Nyogel is supplied in Australia by:
Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia.

Date of preparation

This leaflet was prepared in May 2014.

® = Registered trademark

AUST R 97737

BRAND INFORMATION

Brand name

Nyogel Eye gel

Active ingredient

Timolol

Schedule

S4

 

Name of the medicine

Timolol maleate.

Excipients.

Benzalkonium chloride, carbomer 934P (974 P grade), lysine monohydrate, polyvinyl alcohol, sodium acetate, sorbitol and water for injections.

Description

Chemical name: (S)-1-(tert-butylamino)-3- [(4-morpholino-1,2,5- thiadiazol-3-yl]- 2-propanol maleate. Molecular formula: C13H24N4O3S.C4H4O4. MW: 432.49. CAS: 26921-17-5.

Pharmacology

Pharmacodynamics.

Timolol is a nonselective β-blocker that does not have any significant cardiac stimulating or direct cardiac depressant or local anaesthetic (membrane stabilising) activity. When applied topically in the eye, it reduces both elevated and normal intraocular pressure. Although not all mechanisms of action of timolol are known yet, it is thought to primarily reduce the production of aqueous humour. It may also have a lesser effect on the outflow of aqueous humour.
Unlike miotics, timolol reduces intraocular pressure with little effect on pupil size or visual acuity. Thus, impairment of vision or night blindness does not occur as with the use of miotics. In cataract patients, the impairment of vision, caused by lenticular opacities when the pupil is constricted, is avoided.
The onset of reduction in intraocular pressure following ocular administration of timolol ophthalmic solution occurs approximately 20 minutes after eye drop administration. The maximum effect is achieved within about one to two hours from administration and significant lowering of intraocular pressure can be maintained for periods as long as 24 hours.

Pharmacokinetics.

Nyogel is an eye drop formulation in gel form which, due to the particular chemical characteristics, maximises the drug absorption in the eye and reduces its absorption into the systemic circulation.
Pharmacokinetic data from studies in 24 healthy volunteers have shown that the mean value of the maximum plasma concentration is 0.18 nanogram/mL when timolol eye gel 1 mg/g is given once daily to both eyes for two weeks, compared to 1.72 nanogram/mL after twice daily dosage of timolol eye drops 5 mg/mL, also given to both eyes for two weeks. This 90% reduction is due to the ten times lower daily timolol maleate dose. In this same study, timolol eye gel 0.1% had a significantly smaller effect on the peak heart rate in an exercise test as compared to timolol 0.5% solution.

Clinical Trials

A total of 1,200 subjects was treated with Nyogel in clinical trials and analysed for efficacy. Results from pivotal studies in patients with primary open angle glaucoma or ocular hypertension are summarised in Table 1. These studies were powered to detect a difference of ± 1.5 mmHg in intraocular pressure between treatments. Patients were followed up for different durations ranging from three weeks up to more than 12 months. All Nyogel treated patients received one drop in both eyes once daily.
These studies demonstrate that the ocular hypotensive effect of Nyogel is equivalent to conventional aqueous formulations of timolol maleate. Long-term data are available from three trials in a total of 116 patients covering periods up to 103 weeks (110 of these patients were followed for periods up to 52 weeks). The IOP lowering effect of long-term Nyogel was similar to that observed in the trials presented in Table 1 above. There are no comparative data beyond six months.

Indications

Nyogel is used to reduce elevated intraocular pressure in the following conditions.
Ocular hypertension.
Chronic open angle glaucoma.

Contraindications

As with all products containing β-receptor blocking agents, Nyogel is contraindicated in patients with the following.
Bronchial asthma.
History of bronchial asthma or severe obstructive pulmonary disease.
Sinus bradycardia.
Sick sinus syndrome (including sino-auricular block).
Atrioventricular (AV) block.
Overt cardiac failure.
Cardiogenic shock.
Severe peripheral circulatory disturbance (Raynaud's disease) and peripheral disorders.
Prinzmetal angina.
Untreated phaeochromocytoma.
Hypotension.
Corneal diseases.
Hypersensitivity to timolol or to any of the excipients and/or other β-blocking agent.
Severe allergic rhinitis and bronchial hyperreactivity.
Nyogel is also contraindicated in case of association with amiodarone (see Interactions with Other Medicines).

Precautions

Like other topically applied ophthalmic drugs, Nyogel is absorbed into the systemic circulation. This may cause similar undesirable side effects as seen with oral β-blocking agents. Therefore it should be used with caution in patients with metabolic acidosis.
During anaesthesia, severe bradycardia and prolonged hypotension have been observed in some patients using β-blockers. The anaesthetist should be informed when the patient is receiving Nyogel. Since some degree of systemic absorption cannot be excluded, a gradual withdrawal of Nyogel is recommended prior to scheduled surgery. As with systemic β-blockers, if discontinuation of ophthalmic Nyogel is needed in patients with coronary heart disease, therapy should be withdrawn gradually. Sudden withdrawal of Nyogel may lead to exacerbation of angina and development of hypertension and arrhythmias; Nyogel should therefore be discontinued at least 24 to 48 hours prior to surgery (see Interactions with Other Medicines).
Nyogel may cause worsening systolic heart failure or new heart failure in patients who depend on high sympathetic drive to maintain cardiac output. Cardiac failure should be adequately controlled before beginning treatment and patients with a history of severe cardiac disease should be monitored for early signs of possible cardiac failure.
β-blocking agents may mask certain symptoms of hyperthyroidism, e.g. tachycardia.
Patients suspected of developing thyrotoxicosis should be watched carefully to avoid abrupt withdrawal of β-blocking agents, which might cause a thyroid storm.
Concomitant use of amisulpride with Nyogel may lead to increased risk of ventricular arrhythmia, particularly torsades de pointes. Therefore, caution is recommended in patients with pre-existing bradycardia (see Interactions with Other Medicines).
Signs and symptoms of hypoglycaemia, especially tachycardia, palpitations and sweating may be masked. Diabetic patients should be advised to reinforce self monitoring of their glycaemia at the beginning of treatment.
Risk of anaphylactic reactions. Patients with a history of atopy or serious anaphylactic reactions to different allergens may be more sensitive to repeated exposure to allergens. The exposure may be accidental, diagnostic or therapeutic. When Nyogel is used in such patients, the normal adrenaline dose used to treat anaphylactic reactions may be insufficient.
Respiratory and cardiac reactions, including death due to bronchospasm in patients with asthma and, rarely, death associated with cardiac failure have been reported.
Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy.
Close monitoring of cardiac function and observation of the patient for bradycardia or heart block is advised when amiodarone and a beta adrenergic blocker are coadministered (see Interactions with Other Medicines).
The concomitant administration of MAO inhibitors should be avoided.
Caution should be exercised if Nyogel is used with systemic β-blockers.
Nyogel should not be used with another topical β-blocker.
Nyogel has little or no effect on the pupil. When this eye gel is used to lower intraocular pressure in patients with angle closure glaucoma, it should be given in combination with a miotic. In these patients, the immediate treatment objective is to open the angle by constriction of the pupil with a miotic agent.
Nyogel contains benzalkonium chloride as a preservative. Benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses. Therefore avoid contact with soft contact lenses. Remove contact lenses prior to drug application and wait at least 15 minutes before reinsertion.
As with any glaucoma treatment, regular examination of the intraocular pressure and cornea is recommended.

Carcinogenicity, mutagenicity, impairment of fertility

No evidence of carcinogenicity was observed with timolol maleate at oral doses up to 100 mg/kg/day in rats and up to 50 mg/kg/day in mice. However, there was a statistically significant increase in the incidence of adrenal phaeochromocytomas in male rats administered 300 mg/kg/day. In female mice, statistically significant increases in the incidence of benign and malignant pulmonary tumours, benign uterine polyps and mammary adenocarcinomas were found at 500 mg/kg/day. The increased occurrence of mammary adenocarcinomas was associated with elevations in serum prolactin which occurred in female mice administered oral timolol at 500 mg/kg, but not at doses of 50 mg/kg/day. An increased incidence of mammary adenocarcinomas in rodents has been associated with administration of several other therapeutic agents that elevate serum prolactin.
Timolol was not mutagenic in assays for gene mutations (Ames test) or chromosomal damage (mouse micronucleus and cytogenic assays). Timolol was also negative in an in vitro neoplastic cell transformation assay.
Reproduction and fertility studies in rats demonstrated no adverse effect on male or female fertility after oral doses of up to 100 mg/kg/day.

Use in pregnancy.

(Category C)
The use of Nyogel during pregnancy has not been studied. Owing to their pharmacological effects, β-adrenergic blocking agents may reduce placental perfusion, which may result in foetal death or premature delivery. In addition, undesirable effects, especially hypoglycaemia and bradycardia, may occur in the foetus or neonate. There is also an increased risk of cardiac and pulmonary complications in a neonate that has been exposed to a β-blocking agent. Nyogel should therefore not be used during pregnancy unless the expected therapeutic benefit clearly outweighs the potential risk to the foetus.
In the event of treatment until delivery, close monitoring of the neonate (heart and glycaemia for the first three or five days of life) is recommended.
Timolol maleate was not teratogenic in mice, rats and rabbits. Embryofoetal development studies with timolol maleate in mice and rabbits showed no evidence of embryofoetal toxicity at oral doses up to 50 mg/kg/day. At higher doses, increases in resorptions and foetal variations (14 ribs and hypoplastic sternebrae) were noted in mice (1000 mg/kg/day) and increased resorption in rabbits (≥ 90 mg/kg/day). In rats, delayed ossification was seen at oral doses ≥ 50 mg/kg/day, and decreased number of caudal vertebral bodies and arches, and an increase in hypoplastic sternebrae were noted at 500 mg/kg/day.

Use in lactation.

The active substance, timolol, is absorbed into the systemic circulation and excreted into the breast milk, having the potential to cause serious undesirable effects in the infant of the breastfeeding mother. Use of the preparation during breastfeeding is therefore not recommended.

Paediatric use

Safety and effectiveness in children have not been established by adequate and well controlled studies.

Effects on ability to drive and use machines

No studies on the effect of this medicinal product on the ability to drive have been conducted. While driving vehicles or operating different machines, it should be taken into account that occasionally visual disturbances may occur, including refractive changes, diplopia, ptosis, frequent episodes of mild and transient blurred vision and occasional episodes of dizziness or fatigue.

Interactions

Although Nyogel has little effect on the size of the pupil, mydriasis has occasionally been reported when timolol has been used with mydriatic agents such as adrenaline.
When Nyogel is administered to patients receiving an oral β-blocking agent, both the reduction in intraocular pressure and the effects of systemic β-blockade may be intensified. The response of such patients should be closely observed.
As timolol maleate is absorbed systemically the following interactions (as those seen with beta-blockers) may occur.
Coadministration of Nyogel with class I antiarrhythmic drugs (e.g. disopyramide, quinidine, propafenone) and amiodarone may have a potentiating effect on atrial conduction and thus induce a negative inotropic effect.
The nature of any cardiovascular adverse effects varies depending on the type of calcium channel blocker used. Dihydropyrine derivatives, such as nifedipine, may lead to hypotension, whereas verapamil or diltiazem tend to cause AV conduction disturbances or left ventricular failure when used with beta-blocker.

Clonidine.

Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
Concomitant use with anaesthetic drugs may attenuate compensatory tachycardia and increase the risk of hypotension. The anaesthetist should be informed when the patient is using Nyogel (see Precautions).

Digitalis glycosides.

The concomitant use of digitalis glycosides and beta-blockers may slow down atrioventricular conduction time.

Catecholamine depleting drugs (rauwolfia alkaloids such as reserpine).

Close observation of the patient is also recommended when a β-blocker is administered to patients receiving catecholamine depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia which may produce vertigo, syncope or postural hypotension.

Parasympathomimetics.

Increased risk of bradycardia.

Amisulpride.

Increased risk of ventricular arrhythmia, particularly torsades de pointes.

CYP2D6 inhibitors (e.g. quinidine, SSRIs).

Potentiated systemic β-blockade (e.g. decreased heart rate, depression) has been reported.

Mefloquine.

Prolongation of QT interval may occur.
Insulin and oral antidiabetic drugs may further lower the glucose concentration in the blood, and β-blockade may mask the signs of hypoglycaemia (tachycardia).

Cimetidine and hydralazine.

May increase the timolol concentration in the plasma.
Concomitant use of Nyogel is not recommended with: lignocaine i.v.; iodine contrast products.

Adverse Effects

Adverse events reported in clinical trials.

Table 2 lists adverse events reported in at least 1% of patients receiving Nyogel regardless of perceived causal relationship to trial medication. The incidence of nonocular adverse events was below 1% in all cases.

Postmarketing surveillance.

Like other topically applied ophthalmic drugs, Nyogel may be absorbed into the systemic circulation. This may cause similar undesirable effects as seen with oral β-blocking agents.

Eye disorders.

Symptoms of ocular irritation include conjunctivitis, blepharitis, keratitis and decreased corneal sensitivity. Blurred vision of short duration may occur in 30 to 50% of patients. Other possible reactions are eye irritation (burning), eye pain (stinging), visual disturbances, including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, eyelid ptosis and choroidal detachment following filtration surgery. Dry eyes have been reported during β-blocker therapy.

Cardiac disorders.

Bradycardia, atrioventricular block (complete or lower degree) or worsening of an existing atrioventricular block, cardiac failure, arrhythmia, palpitation, cardiac arrest and chest pain.

Vascular disorders.

Hypotension, Raynaud's phenomenon and claudication.

Respiratory, thoracic and mediastinal disorders.

Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnoea and cough.

General disorders and administration.

Fatigue, asthenia.

Skin and subcutaneous tissue disorders.

Hypersensitivity reactions including local and generalised rash, erythema, urticaria, alopecia, psoriasiform-like lesions or exacerbation of psoriasis.
The incidence of the symptoms is low, and in most cases the symptoms have cleared after discontinuation of treatment. The use of the medication should be discontinued if any such reaction is not otherwise explicable. Benzalkonium chloride is known to cause allergy in sensitive patients.

Musculoskeletal and connective tissue disorders.

Arthropathy.

Psychiatric disorders.

Depression, insomnia, nightmares, memory loss.

Nervous system disorders.

Syncope, cerebrovascular disorder, cerebral ischaemia, increase in signs and symptoms of myasthenia gravis, dizziness, paraesthesiae, headache.

Gastrointestinal disorders.

Nausea, diarrhoea, vomiting, dyspepsia, dry mouth.

Immune system disorders.

Systemic lupus erythematosus, signs and symptoms of allergic reactions including angioedema.

Metabolism and nutrition disorders.

Hypoglycaemia.

Reproductive system and breast disorders.

Sexual dysfunction, syndrome of Peyronie.

Reactions with unknown causal relationship.

The following undesirable reactions have occurred with the use of systemically administered timolol: aphakic cystoid macular oedema, nasal congestion, anorexia, dyspepsia, CNS effects (confusion, hallucinations, anxiety, disorientation, nervousness, somnolence and other psychiatric disturbances), hypertension and retroperitoneal fibrosis. The side effects seen with oral timolol maleate may occur with topical use of Nyogel.

Dosage and Administration

Adults and children over the age of 12 years.

The recommended dosage is 1 drop of Nyogel in the affected eye(s) daily, preferably in the morning.

Children under the age of 12 years.

Paediatric use is not recommended.

Elderly.

The above dosage can be used for the elderly.

All age groups.

Intraocular pressure should be reassessed 2 to 4 weeks after starting treatment, because response to treatment may take a few weeks to stabilise.
In case of transfer from other topical β-blocking agents: discontinue their use after a full day of therapy and start treatment with Nyogel the next day. Instill 1 drop in each affected eye once a day, preferably in the morning.
In case of transfer from a single antiglaucoma agent other than topical β-blocking agent: continue the agent and add 1 drop of Nyogel in each affected eye once a day. On the following day, discontinue the previous agent completely and continue with Nyogel.

Method of administration.

Nyogel is to be instilled into the conjunctival sac. Glaucoma medication should be continued until otherwise instructed by the physician.
For a correct dosing during application, the eye drop bottle must be held vertically during administration. If Nyogel is used concomitantly with other eye medications, there must be an interval of at least 5 minutes between the two medications, and Nyogel should be the last one to be administered. No controlled clinical studies are available on concomitant use of Nyogel and other antiglaucoma medications.
When using nasolacrimal occlusion or closing the eyelids for 3 minutes, the systemic absorption may be reduced. This may result in a decrease in systemic side effects and an increase in local activity.

Instructions for use and handling.

The dispenser remains sterile until the original closure is broken. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures as this may contaminate the gel.
After opening, Nyogel should be stored upside down in the carton. Nyogel should not be used for more than 4 weeks and any remaining contents should be discarded.

Overdosage

No data specific to this preparation are available. The most common side effects caused by β-blocker overdosage are symptomatic bradycardia, hypotension, bronchospasm and acute cardiac failure.
Contact the Poisons Information Centre on 131 126 for advice on management.

Presentation

Eye gel (sterile), timolol 1 mg/g (as timolol maleate 1.37 mg/g): 5 g (bottle).

Storage

Store below 25°C. Protect from light. Do not freeze.

Poison Schedule

S4.