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TIMOLOL MALEATE / BENDROFLUMETHIAZIDE 10 MG / 2.5 MG TABLETS

Active substance(s): BENDROFLUMETHIAZIDE / TIMOLOL MALEATE

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Patient Information Leaflet

Timolol maleate/Bendroflumethiazide
10 mg/2.5 mg tablets
10 mg timolol maleate
2.5 mg bendroflumethiazide
Read all of this leaflet carefully before you start
taking 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 you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
In this leaflet:
1. What Timolol maleate/Bendroflumethiazide is
and what it is used for
2. What you need to know before you take Timolol
maleate/Bendroflumethiazide 10 mg/2.5 mg tablets
3. How to take Timolol maleate/Bendroflumethiazide
10 mg/2.5 mg tablets
4. Possible side effects
5. How to store Timolol maleate/Bendroflumethiazide
10 mg/2.5 mg tablets
6. Contents of the pack and other information
1. WHAT TIMOLOL MALEATE/
BENDRO­FLUMETHIAZIDE IS AND
WHAT IT IS USED FOR
Timolol maleate/Bendroflumethiazide 10 mg/2.5 mg
tablets are a combination of two medicines; one slows
your heart rate and the other increases water
removal from your body.
Timolol maleate/Bendroflumethiazide 10 mg/2.5 mg
tablets are used to treat raised blood pressure. Your
doctor has prescribed these tablets for you because
your blood pressure is too high.
2. W
 HAT YOU NEED TO KNOW
BEFORE YOU TAKE TIMOLOL MALEATE/
BENDROFLUMETHIAZIDE 10 MG/
2.5 MG TABLETS
Do not take Timolol maleate/Bendroflumethiazide
10 mg/2.5 mg tablets if you:
• Are allergic (hypersensitive) to timolol maleate,
bendroflumethiazide, any of the other ingredients
of Timolol maleate/Bendroflumethiazide (these
are listed in section 6, “Contents of the pack and
other information”), or any medicine known as a
thiazide diuretic.
• Have bronchial asthma or a chronic lung disease.
• Have a history of wheezing or asthma.
• Have serious kidney or liver problems.
• Have difficulty urinating.
• Have lower than normal potassium or sodium
levels in your blood or higher than normal
calcium levels in your blood even with treatment.
• Have high uric acid levels in your blood which
may cause gout.
• Have chronic adrenal insufficiency (Addison’s
disease).
• Have uncontrolled heart failure, a very slow
heart rate, other heart problems or a certain
type of angina called Prinzmetal’s angina.
• Have low blood pressure or problems with your
blood circulation.
• Have a condition affecting your adrenal glands
called phaeochromocytoma.
• Have a condition that causes acidity of the blood
called metabolic acidosis.
• Are taking medicines used for relieving depression
such as lithium, monoamine oxidase inhibitors
(e.g. selegiline, moclobedine) and tricyclic
antidepressants (e.g. amitriptyline, lofepramine).
• Are pregnant, or think that you might be pregnant.
Warnings and Precautions
Tell your doctor before you start treatment if you have
or have had in the past one of the following problems
or if you develop any of these during treatment:
• Suffer from diabetes, low blood sugar levels
(hypoglycaemia), heart, liver or kidney problems.
• Have portal hypertension (high blood pressure in
the blood vessel to your liver).

0514_GI_Timolol-Bendro_56UK16052014-00R.indd 1

 ave higher than normal
• H
potassium or sodium levels in
your blood or lower than normal
calcium levels in your blood even
with treatment.
• Have swelling in your ankles,
hands or eye area.
• Have non-serious kidney problems
(see “Do not take Timolol
maleate/Bendroflumethiazide”
section above if you have
serious kidney problems).
• Have a hormone condition
called ‘hyperaldosteronism’.
• Are malnourished.
• Have muscle weakness
(myasthenia gravis).
• Suffer from an overactive thyroid gland.
• Suffer from gout or systemic lupus erythematosus
(an allergic condition which can cause joint pain,
skin rashes and fever).
• Psoriasis (this is a skin disease with thickened
patches of red skin, often with silvery scales).
Children
Timolol maleate/Bendroflumethiazide 10 mg/
2.5 mg tablets are not suitable for children.
Other medicines and Timolol maleate/
Bendroflumethiazide 10 mg/2.5 mg tablets
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
This is extremely important, as using more than
one medicine at the same time can strengthen or
weaken the effect of the medicines. In particular, tell
your doctor if you are taking any of the following:
• Any other medicines for high blood pressure or
heart problems such as: lignocaine, verapamil,
disopyramide, tocainide, diltiazem, quinidine,
amiodarone, clonidine, digitalis glycosides,
hydralazine, dihydropyridine derivatives
(e.g. nifedipine) and any of the medicines known
as class I antiarrhythmic agents.
• Any medicines which increase the QT interval of
the heart such as astemizole, terfenadine,
halofantrine, pimozide and sotalol.
Medicines used for treating depression (e.g.
• 
lithium, tricyclic antidepressants and monoamine
oxidase inhibitors) or other mental problems
(e.g. phenothiazines).
• Medicines known as barbiturates, used to treat
sleeping disorders.
• An anti-ulcer medicine called cimetidine.
• An antibiotic called rifampicin and also
tetracyclines.
• Medicines known as prostaglandin synthetase
inhibitors (e.g. ibuprofen, aspirin).
• Any steroid medicines.
• Theophylline.
• Medicines known as sympathomimetic agents used
for asthma (e.g. salbutamol), to stimulate your
heart (e.g. isoprenaline) and in some cough and
cold preparations.
• Medicines for treating diabetes (e.g. insulin or
oral anti-diabetic medicines).
If you are going to have surgery
If you are going to have an operation in hospital or
going to the dentist, tell the doctor at the hospital
or the dentist that you are taking Timolol maleate/
Bendroflumethiazide 10 mg/2.5 mg tablets.
Certain anaesthetics should not be used with these
tablets (e.g. ether, cyclopropane, trichloroethylene).
You should not be given a local anaesthetic combined
with adrenaline while you are taking Timolol
maleate/Bendroflumethiazide 10 mg/2.5 mg tablets.
Taking Timolol maleate/Bendroflumethiazide
10 mg/ 2.5 mg tablets with food and drink
You should avoid excessive alcohol consumption
while taking Timolol maleate/Bendroflumethiazide.
Pregnancy and breast-feeding
Tell your doctor before you take any tablets if you
are pregnant or breast-feeding. Also, tell your
doctor if you become pregnant during treatment.
Do not take Timolol maleate/Bendroflumethiazide
10 mg/2.5 mg tablets if you are pregnant.
Your doctor will decide if you should take Timolol
maleate/Bendroflumethiazide while you are
breast-feeding.

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Driving and using machines
This medicine may cause tiredness or dizziness as a
side effect.
Therefore you should be careful if you are going to
drive or operate machinery.
3. H
 OW TO TAKE TIMOLOL MALEATE/
BENDROFLUMETHIAZIDE 10 MG/
2.5 MG TABLETS
Always take Timolol maleate/Bendroflumethiazide
exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
The usual dose can vary from 1 to 4 tablets. You can
take the tablets as a single dose in the morning or in
two doses, one in the morning and the other in the
evening. Timolol maleate/Bendroflumethiazide
10 mg/2.5 mg tablets should be swallowed whole
with water.
If you take more Timolol maleate/
Bendro­flumethiazide 10 mg/2.5 mg tablets
than you should
If you or anyone else accidentally take more than
the recommended dose of these tablets, call your
doctor straight away or go to your nearest hospital
casualty department.
If you forget to take Timolol maleate/
Bendroflumethiazide
If you forget to take your tablet(s), take the next
dose as normal.
Do not take a double dose to make up for forgotten
tablet(s).
If you stop taking Timolol maleate/
Bendroflumethiazide
Keep taking the Timolol maleate/Bendroflumethiazide
10 mg/2.5 mg tablets for as long as your doctor tells
you to. Do not stop taking them without consulting
your doctor first. If it is right for you to stop taking
Timolol maleate/Bendroflumethiazide then your
doctor will probably reduce the dose gradually since
it is important not to stop suddenly.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Timolol maleate/
Bendroflumethiazide can cause side effects,
although not everybody gets them.
Tell your doctor immediately if you
experience severe abdominal pain and vomiting or
you notice inflammation of your blood vessels
(e.g. veins) ­accompanied by small red or purple,
solid, and raised skin lesions on your legs, hands, or
other parts of the body, and/or bluefingers or toes.
Tell your doctor if you notice a skin rash, visual
disturbances, or dry eyes. Your doctor may decide
to change your treatment. If you have a skin rash,
this may be associated with an increased sensitivity
to sunlight.
Tell your doctor if you have any of the side effects
mentioned below and you are concerned:
• Upset stomach, dizziness, tiredness, depression,
weakness, sleeplessness, breathing difficulties, a
slow heart beat or other heart problems.
• 
You may also experience tired or painful muscles,
feel thirsty and pass less urine than normal.
• If you are short sighted this may get worse.
• 
Poor blood circulation which makes your toes
and fingers numb and pale, low blood pressure,
“pins and needles”, tingling in the hands or feet, a
­worsening of any problems with blood circulation
in your legs or impotence (male erection problems).
• Painful joints.
• Nausea (feeling sick), vomiting (being sick),
­diarrhoea or abdominal pain.
• Vertigo or feeling faint, headaches, trouble with
sleeping or nightmares.
• Depression, hallucinations, drowsiness,
disorientation, confusion or other mental problems.

effects not listed in this leaflet.
You can also report side effects
directly via the Yellow Card
Scheme at: 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 MALEATE/
BENDRO­FLUMETHIAZIDE
10 MG/2.5 MG TABLETS
Keep out of the sight and reach of
children.
Store Timolol maleate/
Bendro­flumethiazide 10 mg/2.5 mg
tablets below 25 °C.
Do not use Timolol maleate/Bendroflumethiazide
after the expiry date which is stated on the bottle
label and outer carton after the text “EXP”. The
expiry date refers to the last day of that month.
Medicines must 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. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Timolol maleate/Bendroflumethiazide
contains
Active substance: Timolol maleate and bendro­flumethiazide.

Each tablet contains 10 mg

of timolol maleate and 2.5 mg

of bendroflumethiazide.
Other ingredients: Microcrystalline cellulose,
pregelatinised starch and
magnesium stearate.
What Timolol maleate/Bendroflumethiazide
looks like and contents of the pack.
Timolol maleate/Bendroflumethiazide 10 mg/2.5 mg
V
tablets are white, flat and oval with “ PRE
” imprinted
on one side and a break-mark on the other.
The tablets are supplied in glass bottles of 30, 100 or
500 tablets.
Not all packs sizes may be marketed
Marketing Authorisation Holder
Beechmere Pharmaceuticals,
Merlin Place, Milton Road,
Cambridge CB4 0DP, UK
Manufacturer
Labiana Pharmaceuticals S.L.U., Casanova 27 – 31,
08757 – Corbera de Llobregat (Barcelona), Spain.
For any information about this medicine, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in August 2014.

If this leaflet is difficult to see or
read, or you would like it in a
­different format, please contact
Beechmere Pharmaceuticals,
Merlin Place, Milton Road,
­Cambridge CB4 0DP, UK

Some side effects will not normally be noticed.
These include an increase in blood sugar and sugar
in the urine (particularly in people who are
diabetic), changes in levels of some substances in
the blood, such as a decrease in potassium or an
increase in urea, and changed blood cells. Your
doctor may therefore need to do some tests.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side

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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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