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TIMOLOL 1 MG/G EYE GEL IN SINGLE-DOSE CONTAINER

Active substance(s): TIMOLOL / TIMOLOL

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Tiopex® 1 mg/g,
eye gel in single-dose container

2909
24.08.16[2]

(timolol maleate)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any of the side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet (See
Section 4).
What is in this leaflet:
1. What Tiopex eye gel is and what it is used for
2. What you need to know before you use Tiopex eye gel
3. How to use Tiopex eye gel
4. Possible side effects
5. How to store Tiopex eye gel
6. Contents of the pack and other information

Precautions for wearing contact lenses
- You should not wear contact lenses during treatment because less tears
will be released; this is generally linked with beta-blockers.
Other medicines and Tiopex eye gel
If your doctor has prescribed another kind of eye drops for you, you should
use these eye drops 15 minutes before Tiopex eye gel.
Tiopex eye gel can affect or be affected by other medicines you are using,
including other eye drops for the treatment of glaucoma.
Tell your doctor if you are using or intend to use medicines to lower blood
pressure, heart medicine or medicines to treat diabetes, quinidine (used to
treat heart conditions and some types of malaria) or antidepressants known
as fluoxetine and paroxetine.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
Do not use Tiopex eye gel if you are pregnant unless your doctor considers
it necessary.
Do not use Tiopex eye gel if you are breast-feeding.
Timolol maleate may get into your milk.
Ask your doctor for advice before taking any medicine during breast-feeding.

1. WHAT TIOPEX EYE GEL IS AND WHAT IT IS USED FOR
The full name of your medicine is Tiopex 1 mg/g, eye gel in single-dose
container. It is called Tiopex eye gel in the rest of this leaflet.

Driving and using machines
You may have blurred vision for a short time after using the product. Wait
until your vision is normal before driving or using any machine. Tiopex eye
gel may cause other side effects (dizziness, constant tiredness) likely to
affect your ability to drive or to use machines. If you have any concerns,
please ask your doctor.

This medicine is a beta-blocker administered to the eye.
It is used for the treatment of certain types of eye disease involving high
pressure in the eye (glaucoma and ocular hypertension).

Sport
The active ingredient in this medicine can give a positive result during drug
testing.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE TIOPEX EYE GEL
Do not use Tiopex eye gel
- if you are allergic to timolol maleate, beta-blockers or any of the other
ingredients of this medicine (listed in section 6),
- 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 a slow heart beat, heart failure or disorders of heart rhythm
(irregular heart beats),
- in case of untreated pheochromocytoma (high blood pressure caused by
high levels of a hormone due to a tumour near the kidney),
- in case of corneal dystrophies (alteration of the surface of the eye).

3. HOW TO USE TIOPEX EYE GEL
Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.

Take special care with Tiopex eye gel
If you use Tiopex eye gel, you will have to have regular checks of your eye
and of the pressure inside the eye.
Before you use this medicine, tell your doctor if you have now or have had 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,
- breathing problems, asthma or chronic obstructive pulmonary disease
(lung disease which may cause wheeziness, difficulty in breathing and/or
long standing cough),
- poor blood circulation disease (such as Raynaud’s disease or Raynaud’s
syndrome),
- diabetes as timolol maleate may mask signs and symptoms of low blood
sugar,
- overactivity of the thyroid gland as timolol maleate may mask signs and
symptoms,
- treated pheochromocytoma (high blood pressure due to a tumour near
the kidney which you are taking medicine for),
- psoriasis,
- corneal disease (a disorder of the clear surface of the eye),
- metabolic disease (a disorder that changes the normal process of
metabolism, converting food into energy inside the body).
Tell your doctor before you have an operation that you are using Tiopex eye
gel as timolol maleate may change effects of some medicines used during
anaesthesia.
Do not stop treatment suddenly without your doctor’s advice. Do not
inject, do not swallow.
Children and adolescents
Do not give this medicine to children under the age of 18 years as it is
unlikely to be safe.

Dosage
The recommended dose is
- Adults
The usual dose is one drop in the affected eye(s), once a day, in the
morning.
Each single-dose container contains enough gel to treat both eyes.
- Children and adolescents
There is no experience in children and adolescents. Therefore these
patients should not use this eye gel.
- Elderly patients
The dose is the same as for adults.
Frequency of administration
Apply one drop in the affected eye(s), once a day, in the morning.
Method of administration
This medicine is intended to be administered to the eye (ocular use).
For single use only.
- Wash your hands carefully before using your eye gel.
- Shake the container vigorously, opening downwards, before
applying a drop.
- Do not allow the tip to come into contact with the eye or eyelids.
- Pull the lower lid of the affected eye gently downwards while looking
upwards, and apply the drop into the eye.
- After using Tiopex eye gel press a finger into the corner of your eye, by
the nose for 2 minutes. This helps to stop timolol maleate getting into the
rest of the body.
- Discard the single-dose container after use. Do not keep it to use it again.
If you use more Tiopex eye gel than you should
Among other effects, you may feel as if you have dizziness, or you may
have difficulty in breathing or feel that your pulse rate has slowed down.
Check with your doctor or pharmacist immediately.
If you forget to use Tiopex eye gel
Do not take a double dose to make up for a forgotten dose. Apply the
forgotten dose as soon as possible.
However, if it is nearly time to take the next dose, simply miss out the
forgotten dose.
If you stop using Tiopex eye gel
The pressure inside your eye may increase and damage your vision.
Do not stop treatment suddenly without your Doctor’s advice.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Tiopex eye gel can cause side effects although not
everybody gets them.
You can usually carry on taking the drops, unless the effects are serious. If
you’re worried, talk to your doctor or pharmacist. Do not stop using Tiopex
eye gel without speaking to your doctor.
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:
- Generalised 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, localised and generalised rash, itchiness, severe sudden lifethreatening 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, changes in the way the
eye sees where objects are (refraction, sometimes due to stopping
treatment with miotic drops used for making the pupil of the eye smaller).
- 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,
leg cramps and/ or leg pain when walking (claudication).
- 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, impotence.
- Muscle weakness/tiredness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, nurse or
Optometrist/Optician. This includes any side effects not mentioned in this
leaflet.
You can also report side effects directly on www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety of
this medicine.
5. HOW TO STORE TIOPEX EYE GEL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton,
sachet and single-dose container after EXP. The expiry date refers to the
last day of that month.
Keep the single-dose containers in the sachet and the outer carton in order
to protect from light.
Use the single-dose container immediately after opening and throw it away
after use.
After opening of the sachet, use the single-dose containers within 1 month.
If the eye gel becomes discoloured or shows signs of any deterioration you
should seek the advice of your pharmacist.
Do not throw away any medicines via wastewater. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help
protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tiopex eye gel contains
- The active substance is timolol. 1g of gel contains 1mg of timolol as
timolol maleate.
- The other ingredients are sorbitol, polyvinyl alcohol, carbomer 974P,
sodium acetate trihydrate, lysine monohydrate, water for injections.
What Tiopex eye gel looks like, and the contents of the pack
Tiopex eye gel is an opalescent, colourless to slightly yellow eye gel,
presented in single-dose containers packed in a sachet of 10 units, each
single-dose container holding 0.4 g of product.
A pack size contains 30 (3 x 10) or 90 (9 x 10) single-dose containers.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Tiopex eye gel is manufactured Laboratoire Unither, Zi De La Guerie, 50211
Coutances Cedex, France. Procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2909

Leaflet revision and issue date (Ref) 24.08.16[2]
Tiopex is a trademark of Laboratoires Thea.

Timolol 1 mg/g,
eye gel in single-dose container

2909
24.08.16[2]

(timolol maleate)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any of the side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet (See
Section 4).
What is in this leaflet:
1. What Timolol eye gel is and what it is used for
2. What you need to know before you use Timolol eye gel
3. How to use Timolol eye gel
4. Possible side effects
5. How to store Timolol eye gel
6. Contents of the pack and other information

Precautions for wearing contact lenses
- You should not wear contact lenses during treatment because less tears
will be released; this is generally linked with beta-blockers.
Other medicines and Timolol eye gel
If your doctor has prescribed another kind of eye drops for you, you should
use these eye drops 15 minutes before Timolol eye gel.
Timolol eye gel can affect or be affected by other medicines you are using,
including other eye drops for the treatment of glaucoma.
Tell your doctor if you are using or intend to use medicines to lower blood
pressure, heart medicine or medicines to treat diabetes, quinidine (used to
treat heart conditions and some types of malaria) or antidepressants known
as fluoxetine and paroxetine.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
Do not use Timolol eye gel if you are pregnant unless your doctor considers
it necessary.
Do not use Timolol eye gel if you are breast-feeding.
Timolol maleate may get into your milk.
Ask your doctor for advice before taking any medicine during breast-feeding.

1. WHAT TIMOLOL EYE GEL IS AND WHAT IT IS USED FOR
The full name of your medicine is Timolol 1 mg/g, eye gel in single-dose
container. It is called Timolol eye gel in the rest of this leaflet.

Driving and using machines
You may have blurred vision for a short time after using the product. Wait
until your vision is normal before driving or using any machine. Timolol eye
gel may cause other side effects (dizziness, constant tiredness) likely to
affect your ability to drive or to use machines. If you have any concerns,
please ask your doctor.

This medicine is a beta-blocker administered to the eye.
It is used for the treatment of certain types of eye disease involving high
pressure in the eye (glaucoma and ocular hypertension).

Sport
The active ingredient in this medicine can give a positive result during drug
testing.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE TIMOLOL EYE GEL
Do not use Timolol eye gel
- if you are allergic to timolol maleate, beta-blockers or any of the other
ingredients of this medicine (listed in section 6),
- 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 a slow heart beat, heart failure or disorders of heart rhythm
(irregular heart beats),
- in case of untreated pheochromocytoma (high blood pressure caused by
high levels of a hormone due to a tumour near the kidney),
- in case of corneal dystrophies (alteration of the surface of the eye).

3. HOW TO USE TIMOLOL EYE GEL
Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.

Take special care with Timolol eye gel
If you use Timolol eye gel, you will have to have regular checks of your eye
and of the pressure inside the eye.
Before you use this medicine, tell your doctor if you have now or have had 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,
- breathing problems, asthma or chronic obstructive pulmonary disease
(lung disease which may cause wheeziness, difficulty in breathing and/or
long standing cough),
- poor blood circulation disease (such as Raynaud’s disease or Raynaud’s
syndrome),
- diabetes as timolol maleate may mask signs and symptoms of low blood
sugar,
- overactivity of the thyroid gland as timolol maleate may mask signs and
symptoms,
- treated pheochromocytoma (high blood pressure due to a tumour near
the kidney which you are taking medicine for),
- psoriasis,
- corneal disease (a disorder of the clear surface of the eye),
- metabolic disease (a disorder that changes the normal process of
metabolism, converting food into energy inside the body).
Tell your doctor before you have an operation that you are using Timolol eye
gel as timolol maleate may change effects of some medicines used during
anaesthesia.
Do not stop treatment suddenly without your doctor’s advice. Do not
inject, do not swallow.
Children and adolescents
Do not give this medicine to children under the age of 18 years as it is
unlikely to be safe.

Dosage
The recommended dose is
- Adults
The usual dose is one drop in the affected eye(s), once a day, in the
morning.
Each single-dose container contains enough gel to treat both eyes.
- Children and adolescents
There is no experience in children and adolescents. Therefore these
patients should not use this eye gel.
- Elderly patients
The dose is the same as for adults.
Frequency of administration
Apply one drop in the affected eye(s), once a day, in the morning.
Method of administration
This medicine is intended to be administered to the eye (ocular use).
For single use only.
- Wash your hands carefully before using your eye gel.
- Shake the container vigorously, opening downwards, before
applying a drop.
- Do not allow the tip to come into contact with the eye or eyelids.
- Pull the lower lid of the affected eye gently downwards while looking
upwards, and apply the drop into the eye.
- After using Timolol eye gel press a finger into the corner of your eye, by
the nose for 2 minutes. This helps to stop timolol maleate getting into the
rest of the body.
- Discard the single-dose container after use. Do not keep it to use it again.
If you use more Timolol eye gel than you should
Among other effects, you may feel as if you have dizziness, or you may
have difficulty in breathing or feel that your pulse rate has slowed down.
Check with your doctor or pharmacist immediately.
If you forget to use Timolol eye gel
Do not take a double dose to make up for a forgotten dose. Apply the
forgotten dose as soon as possible.
However, if it is nearly time to take the next dose, simply miss out the
forgotten dose.
If you stop using Timolol eye gel
The pressure inside your eye may increase and damage your vision.
Do not stop treatment suddenly without your Doctor’s advice.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Timolol eye gel can cause side effects although not
everybody gets them.
You can usually carry on taking the drops, unless the effects are serious. If
you’re worried, talk to your doctor or pharmacist. Do not stop using Timolol
eye gel without speaking to your doctor.
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:
- Generalised 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, localised and generalised rash, itchiness, severe sudden lifethreatening 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, changes in the way the
eye sees where objects are (refraction, sometimes due to stopping
treatment with miotic drops used for making the pupil of the eye smaller).
- 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,
leg cramps and/ or leg pain when walking (claudication).
- 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, impotence.
- Muscle weakness/tiredness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, nurse or
Optometrist/Optician. This includes any side effects not mentioned in this
leaflet.
You can also report side effects directly on www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on the safety of
this medicine.
5. HOW TO STORE TIMOLOL EYE GEL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton,
sachet and single-dose container after EXP. The expiry date refers to the
last day of that month.
Keep the single-dose containers in the sachet and the outer carton in order
to protect from light.
Use the single-dose container immediately after opening and throw it away
after use.
After opening of the sachet, use the single-dose containers within 1 month.
If the eye gel becomes discoloured or shows signs of any deterioration you
should seek the advice of your pharmacist.
Do not throw away any medicines via wastewater. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help
protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Timolol eye gel contains
- The active substance is timolol. 1g of gel contains 1mg of timolol as
timolol maleate.
- The other ingredients are sorbitol, polyvinyl alcohol, carbomer 974P,
sodium acetate trihydrate, lysine monohydrate, water for injections.
What Timolol eye gel looks like, and the contents of the pack
Timolol eye gel is an opalescent, colourless to slightly yellow eye gel,
presented in single-dose containers packed in a sachet of 10 units, each
single-dose container holding 0.4 g of product.
A pack size contains 30 (3 x 10) or 90 (9 x 10) single-dose containers.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Timolol eye gel is manufactured Laboratoire Unither, Zi De La Guerie,
50211 Coutances Cedex, France. Procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2909

Leaflet revision and issue date (Ref) 24.08.16[2]

Expand Transcript

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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