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TIMOLOL NOVARTIS 0.5% EYE DROPS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Timolol Novartis 0,5% eye drops, solution
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.
2.
3.
4.
5.
6.

What Timolol Novartis is and what it is used for
Before you use Timolol Novartis
How to use Timolol Novartis
Possible side effects
How to store Timolol Novartis
Further information

1.

WHAT TIMOLOL NOVARTIS IS AND WHAT IT IS USED FOR

Timolol N ovartis c ontains the active su bstance t imolol. Timolol belongs t o a group of medicines
called “beta-blockers” which help to reduce pressure inside the eye.
Timolol Novartis is used to treat conditions where there is an increased pressure in the eye.
2.

BEFORE YOU USE TIMOLOL NOVARTIS

Do not use Timolol Novartis eye drops solution
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if you are allergic to timolol maleate, beta-blockers or any of the other ingredients.
if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats).
if yo u have now or have had in 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 runny nose, sneezing, itching of the nose, eyes, throat or roof of
the mouth.
if you have a corneal disease.

Take special care with Timolol Novartis
Before you use this medicine, tell your doctor if you have now or have had in the past:
coronary heart disease (symptoms can i nclude ch est p ain o r t ightness, b reathlessness o r
choking), heart failure, low blood pressure.
disturbances of heart rate such as slow heart beat.
breathing problems, asthma or chronic obstructive pulmonary disease
poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)
untreated phaeochromocytoma (high blood pressure due to a tumour near the kidneys)
excessive a cidity of t he bl ood (a di sorder called m etabolic aci dosis causing rapid br eathing,
confusion and tiredness)
overactivity of the thyroid gland as timolol maleate may mask signs and symptoms
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diabetes as timolol maleate may mask signs and symptoms of low blood sugar
severe kidney problem and are on dialysis
If you h ave an y al lergies, you may b e more l ikely t o h ave an al lergic reaction while using Timolol
Novartis.
Tell your doctor before you have an operation that you are using Timolol Novartis as timolol maleate
may change effects of some medicines used during anaesthesia.
Your doctor will regularly examine your eye pressure and eye.
Children
Timolol Novartis is not recommended for use in premature or new-born babies.
Using other medicines
Timolol Novartis can affect or be affected by other medicines you are using, including other eye drops
for the treatment of glaucoma.
If you need to apply other medicinal products to your eyes at the same time as Timolol Novartis, wait
at least 5 minutes between applying each product.
Follow y our doc tor’s i nstructions carefully when changing treatment f rom a nother pr oduct us ed t o
decrease eye pressure.
Please t ell y our d octor o r pharmacist if y ou ar e t aking o r have r ecently 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. fluoxetine, paroxetine)
medicines used for widening the pupil
medicines used to treat glaucoma (by reducing pressure of the eye)
medicines used to treat heart problems (e.g. amiodarone, disopyramide, quinidine, propafenone)
medicines used t o t reat high blood pr essure (e.g. verapamil, diltiazem, clonidine, hydralazine,
nifedipine)
medicines used to treat diabetes (e.g. insulin)
local or general anaesthetics
medicines used to treat ulcers in your stomach or intestine (e.g. cimetidine)
medicines used to treat malaria (e.g. mefloquine)
contrast liquids which are used for radiological examination
Using Timolol Novartis with food and drink
Alcohol may lead t o a higher level of Timolol Novartis in the blood. As a r esult you may get more
side effects.
Pregnancy
Tell your doctor if you are pregnant or planning to become pregnant. Do not use Timolol Novartis if
you are pregnant unless your doctor considers it necessary.
Breast-feeding
Do not use Timolol Novartis if you are breast-feeding. Timolol maleate may get into your milk.
Ask your doctor or pharmacist for advice before taking any medicine during breast-feeding.
Driving and using machines
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Timolol Novartis may cause blurred vision, 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 Timolol Novartis
This medicine contains benzalkonium chloride, which may discolour soft contact lenses and cause eye
irritation. Remove your contact lenses before using Timolol Novartis. Wait at least 15 minutes after
using Timolol Novartis before reinserting your contact lenses.
3.

HOW TO USE TIMOLOL NOVARTIS

Always use T imolol N ovartis eye dr ops s olution exactly a s y our doc tor ha s t old y ou. Y ou s hould
check with your doctor or pharmacist if you are not sure. Do not stop using Timolol Novartis without
asking your doctor, as your symptoms may get worse.
Timolol Novartis is for use in the eyes (ocular use) only. Do not swallow.
The usual dose is one drop of Timolol Novartis in the affected eye(s) twice a day.
Your doctor may change the dose according to the progress of your disease.
Follow your doctor’s instructions carefully. Do not exceed the recommended dose.
Instructions for proper use of Timolol Novartis
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 Timolol Novartis, 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

Fig.3

If you use more Timolol Novartis than you should
If you us e too m any eye drops or accidentally swallow T imolol N ovartis, contact a doc tor
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 Timolol Novartis

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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 al l m edicines, T imolol N ovartis, e ye dr ops solution can cau se si de ef fects al though not
everybody gets them.
You can usually carry on taking the drops, unless the effects are serious. If you're worried, talk to a
doctor or pharmacist. Do not stop using Timolol Novartis without speaking to your doctor.
Like o ther medicines ap plied i nto eyes, timolol maleate is absorbed i nto t he bl ood. T his may cause
similar side effects as seen with i ntraveneous an d/or o ral as ap plicable b eta-blocking a gents.
Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for
example, t aken b y m outh o r i njected. L isted si de ef fects i nclude r eactions seen w ithin t he cl ass o f
beta-blockers when used for treating eye conditions:
Lupus e rythematosus ( a c ondition w hich c auses s welling a nd r eddening of t he s kin w ith f ever a nd
joint pain), generalized allergic reactions including swelling beneath the skin that can occur in areas
such as t he f ace an d l imbs, an d can o bstruct t he ai rway w hich may cau se d ifficulty sw allowing o r
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, i ncreases i n 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 co ntains b lood v essels f ollowing f iltration su rgery w hich m ay cau se visual disturbances,
decreased co rneal sensitivity, d ry ey es, co rneal er osion ( damage t o t he f ront l ayer o f t he eyeball),
drooping of the upper eyelid (making the eye stay half closed), double vision, ringing in the ears.
Slow heart rate, chest pain, palpitations, oedema (fluid buildup), 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 t o f luid buildup), a type of heart r hythm disorder, he art attack, he art failure, leg pa in a nd
weakness brought on by walking.
Low blood pressure, Raynaud's phenomenon, cold hands and feet.
Constriction of t he a irways i n t he l ungs ( predominantly i n pa tients w ith pr e-existing d isease),
difficulty breathing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair l oss, sk in r ash w ith w hite si lvery co loured ap pearance (psoriasiform rash) or worsening of
psoriasis, skin rash.
Muscle pain not caused by exercise.
Sexual dysfunction, decreased libido, painful erection of the penis.
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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 TIMOLOL NOVARTIS

Keep out of the reach and sight of children.
Do not use Timolol Novartis after the expiry date which is stated on the pack. The expiry date refers
to the last day of that month.
Close the bottle immediately after use.
Keep the bottle in the outer carton.
Do not use Timolol Novartis for longer than 4 weeks after opening the bottle.
Do not use Timolol Novartis if you notice that the pack is damaged or if the safety ring of the cap has
been tampered with.
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 Timolol Novartis contains
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The active substance is timolol. One ml contains 6.8 mg timolol maleate, corresponding to 5 mg
timolol (0.5%).
The ot her i ngredients a re be nzalkonium c hloride, di sodium phos phate d odecahydrate, s odium
dihydrogen phosphate dihydrate and water for injections.

What Timolol Novartis looks like and contents of the pack
Timolol Novartis is a clear solution, available as a bottle of 5 ml.
Timolol Novartis is also available as 0.25% eye drops solution. Not all strengths may be marketed.
Marketing Authorisation Holder
Alcon Laboratories (UK) Limited, Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire
HP2 7UD, UK
Manufacturer
Alcon-Couvreur, Rijksweg 14, Puurs, Antwerpen, B-2870, Belgium
This medicinal product is authorised in the Member States of the EEA under the following
names:
Italy:
Timololo Alcon
United Kingdom: Timolol Novartis
This leaflet was last approved in June 2013

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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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