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

Active substance(s): TIMOLOL MALEATE

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Package leaflet: Information for the patient

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

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

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.

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.

Sport

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

3. How to use Tiopex eye gel
1. What Tiopex eye gel is and what
it is used for

Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.

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 Dosage
rest of this leaflet.
The recommended dose is
• Adults
This medicine is a beta-blocker administered to the eye. The usual dose is one drop in the affected eye(s),
It is used for the treatment of certain types of eye
once a day, in the morning.
disease involving high pressure in the eye (glaucoma
Each single-dose container contains enough gel to
and ocular hypertension).
treat both eyes.
• Children and adolescents
There is no experience in children and adolescents.
Therefore these patients should not use this eye gel.
2. What you need to know before
• Elderly patients
you use Tiopex eye gel
The dose is the same as for adults.

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 longstanding 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).

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
Take special care with Tiopex eye gel
corner of your eye, by the nose for 2 minutes. This
If you use Tiopex eye gel, you will have to have regular
helps to stop timolol maleate getting into the rest of
checks of your eye and of the pressure inside the eye.
the body.
Before you use this medicine, tell your doctor if you have - Discard the single-dose container after use. Do not
now or have had in the past
keep it to use it again.
• coronary heart disease (symptoms can include chest
pain or tightness, breathlessness or choking), heart
If you use more Tiopex eye gel than you
failure, low blood pressure,
should
• disturbances of heart rate such as slow heart beat,
Among other effects, you may feel as if you have
• breathing problems, asthma or chronic obstructive
dizziness, or you may have difficulty in breathing or feel
pulmonary disease (lung disease which may cause
that your pulse rate has slowed down.
wheeziness, difficulty in breathing and/or long
Check with your doctor or pharmacist immediately.
standing cough),
• poor blood circulation disease (such as Raynaud’s
If you forget to use Tiopex eye gel
disease or Raynaud’s syndrome),
Do not take a double dose to make up for a forgotten
• diabetes as timolol maleate may mask signs and
dose. Apply the forgotten dose as soon as possible.
symptoms of low blood sugar,
However, if it is nearly time to take the next dose, simply
• overactivity of the thyroid gland as timolol maleate
miss out the forgotten dose.
may mask signs and symptoms,
• treated pheochromocytoma (high blood pressure
due to a tumour near the kidney which you are
If you stop using Tiopex eye gel
taking medicine for),
The pressure inside your eye may increase and damage
• psoriasis,
your vision.
• corneal disease (a disorder of the clear surface of
Do not stop treatment suddenly without your
the eye),
Doctor’s advice.
• metabolic disease (a disorder that changes the
normal process of metabolism, converting food into If you have any further questions on the use of this
energy inside the body).
medicine, ask your doctor or pharmacist.
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.
4. Possible side effects
Do not stop treatment suddenly without your
doctor’s advice. Do not inject, do not swallow.
Like all medicines Tiopex eye gel can cause side effects
although not everybody gets them.
Children and adolescents
You can usually carry on taking the drops, unless the
Do not give this medicine to children under the age of
effects are serious. If you’re worried, talk to a doctor or
18 years as it is unlikely to be safe.
pharmacist. Do not stop using Tiopex eye gel without
speaking to your doctor.
Precautions for wearing contact lenses
- You should not wear contact lenses during treatment Like other medicines applied into eyes, timolol maleate
because less tears will be released; this is generally is absorbed into the blood. This may cause similar
side effects as seen with ‘intraveneous’ and/or ‘oral’ as
linked with beta-blockers.
applicable beta-blocking agents. Incidence of side effects
after topical ophthalmic administration is lower than
Other medicines and Tiopex eye gel
when medicines are, for example, taken by mouth or
If your doctor has prescribed another kind of eye drops
injected. Listed side effects include reactions seen within
for you, you should use these eye drops 15 minutes
the class of beta-blockers when used for treating eye
before Tiopex eye gel.
conditions:
Tiopex eye gel can affect or be affected by other
• Generalised allergic reactions including swelling
medicines you are using, including other eye drops for
beneath the skin (that can occur in areas such as
the treatment of glaucoma.
the face and limbs, and can obstruct the airway
Tell your doctor if you are using or intend to use
which may cause difficulty swallowing or breathing),
medicines to lower blood pressure, heart medicine
hives or itchy rash, localised and generalised rash,
or medicines to treat diabetes, quinidine (used to
itchiness, severe sudden life-threatening allergic
treat heart conditions and some types of malaria) or
reaction.
antidepressants known as fluoxetine and paroxetine.
• Low blood glucose levels.
• Difficulty sleeping (insomnia), depression,
Please tell your doctor or pharmacist if you are taking
nightmares, memory loss.
or have recently taken any other medicines, including
medicines obtained without a prescription.















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.
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. 1 g of gel contains
1 mg of timolol in the form of 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 a milky, 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) singledose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Laboratoires THEA
12, Rue Louis Bleriot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer
Laboratoire UNITHER
Rue Andre Durouchez
80084 Amiens Cedex 2
France
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Germany, Italy,
The Netherlands, Portugal, Spain:...............................Timogel
Belgium, Bulgaria, Greece,
Luxembourg, Romania:..................................................... Geltim
Denmark, Iceland:..............................................Timosan Depot
Finland:.................................................................................Timosan
France:............................................................................... Geltim LP
Ireland:................................................................................ Timofluid
United Kingdom:...................................................................Tiopex
This leaflet was last revised in 11/2014.
PL 20162/0010

N1030U30L04/0613
XXXXXXXXXX

Package leaflet: Information for the patient

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

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

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.

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.

Sport

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

3. How to use Tiopex eye gel
1. What Tiopex eye gel is and what
it is used for

Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.

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 Dosage
rest of this leaflet.
The recommended dose is
• Adults
This medicine is a beta-blocker administered to the eye. The usual dose is one drop in the affected eye(s),
It is used for the treatment of certain types of eye
once a day, in the morning.
disease involving high pressure in the eye (glaucoma
Each single-dose container contains enough gel to
and ocular hypertension).
treat both eyes.
• Children and adolescents
There is no experience in children and adolescents.
Therefore these patients should not use this eye gel.
2. What you need to know before
• Elderly patients
you use Tiopex eye gel
The dose is the same as for adults.

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 longstanding 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).

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
Take special care with Tiopex eye gel
corner of your eye, by the nose for 2 minutes. This
If you use Tiopex eye gel, you will have to have regular
helps to stop timolol maleate getting into the rest of
checks of your eye and of the pressure inside the eye.
the body.
Before you use this medicine, tell your doctor if you have - Discard the single-dose container after use. Do not
now or have had in the past
keep it to use it again.
• coronary heart disease (symptoms can include chest
pain or tightness, breathlessness or choking), heart
If you use more Tiopex eye gel than you
failure, low blood pressure,
should
• disturbances of heart rate such as slow heart beat,
Among other effects, you may feel as if you have
• breathing problems, asthma or chronic obstructive
dizziness, or you may have difficulty in breathing or feel
pulmonary disease (lung disease which may cause
that your pulse rate has slowed down.
wheeziness, difficulty in breathing and/or long
Check with your doctor or pharmacist immediately.
standing cough),
• poor blood circulation disease (such as Raynaud’s
If you forget to use Tiopex eye gel
disease or Raynaud’s syndrome),
Do not take a double dose to make up for a forgotten
• diabetes as timolol maleate may mask signs and
dose. Apply the forgotten dose as soon as possible.
symptoms of low blood sugar,
However, if it is nearly time to take the next dose, simply
• overactivity of the thyroid gland as timolol maleate
miss out the forgotten dose.
may mask signs and symptoms,
• treated pheochromocytoma (high blood pressure
due to a tumour near the kidney which you are
If you stop using Tiopex eye gel
taking medicine for),
The pressure inside your eye may increase and damage
• psoriasis,
your vision.
• corneal disease (a disorder of the clear surface of
Do not stop treatment suddenly without your
the eye),
Doctor’s advice.
• metabolic disease (a disorder that changes the
normal process of metabolism, converting food into If you have any further questions on the use of this
energy inside the body).
medicine, ask your doctor or pharmacist.
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.
4. Possible side effects
Do not stop treatment suddenly without your
doctor’s advice. Do not inject, do not swallow.
Like all medicines Tiopex eye gel can cause side effects
although not everybody gets them.
Children and adolescents
You can usually carry on taking the drops, unless the
Do not give this medicine to children under the age of
effects are serious. If you’re worried, talk to a doctor or
18 years as it is unlikely to be safe.
pharmacist. Do not stop using Tiopex eye gel without
speaking to your doctor.
Precautions for wearing contact lenses
- You should not wear contact lenses during treatment Like other medicines applied into eyes, timolol maleate
because less tears will be released; this is generally is absorbed into the blood. This may cause similar
side effects as seen with ‘intraveneous’ and/or ‘oral’ as
linked with beta-blockers.
applicable beta-blocking agents. Incidence of side effects
after topical ophthalmic administration is lower than
Other medicines and Tiopex eye gel
when medicines are, for example, taken by mouth or
If your doctor has prescribed another kind of eye drops
injected. Listed side effects include reactions seen within
for you, you should use these eye drops 15 minutes
the class of beta-blockers when used for treating eye
before Tiopex eye gel.
conditions:
Tiopex eye gel can affect or be affected by other
• Generalised allergic reactions including swelling
medicines you are using, including other eye drops for
beneath the skin (that can occur in areas such as
the treatment of glaucoma.
the face and limbs, and can obstruct the airway
Tell your doctor if you are using or intend to use
which may cause difficulty swallowing or breathing),
medicines to lower blood pressure, heart medicine
hives or itchy rash, localised and generalised rash,
or medicines to treat diabetes, quinidine (used to
itchiness, severe sudden life-threatening allergic
treat heart conditions and some types of malaria) or
reaction.
antidepressants known as fluoxetine and paroxetine.
• Low blood glucose levels.
• Difficulty sleeping (insomnia), depression,
Please tell your doctor or pharmacist if you are taking
nightmares, memory loss.
or have recently taken any other medicines, including
medicines obtained without a prescription.















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.
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. 1 g of gel contains
1 mg of timolol in the form of 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 a milky, 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) singledose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Laboratoires THEA
12, Rue Louis Bleriot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer
Laboratoire UNITHER
Zi De La Guérie
50211 Coutances Cedex
France
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Germany, Italy,
The Netherlands, Portugal, Spain:...............................Timogel
Belgium, Bulgaria, Greece,
Luxembourg, Romania:..................................................... Geltim
Denmark, Iceland:..............................................Timosan Depot
Finland:.................................................................................Timosan
France:............................................................................... Geltim LP
Ireland:................................................................................ Timofluid
United Kingdom:...................................................................Tiopex
This leaflet was last revised in 11/2014.
PL 20162/0010

N1030U30L04/X0613
XXXXXXXXXX

Expand view ⇕

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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