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PRESTIM TABLETS

Active substance(s): BENDROFLUMETHIAZIDE / TIMOLOL MALEATE

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Patient Information Leaflet

Prestim 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 Prestim is and what it is used for
2. What you need to know before you take
Prestim Tablets
3. How to take Prestim Tablets
4. Possible side effects
5. How to store Prestim Tablets
6. Contents of the pack and other information
1. WHAT PRESTIM IS AND WHAT IT IS
USED FOR
Prestim Tablets are a combination of two medicines, one slows your heart rate and the other
increases water removal from your body.
Prestim tablets are used to treat raised blood
pressure. Your doctor has prescribed these
tablets for you because your blood pressure is
too high.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE PRESTIM TABLETS
Do not take Prestim Tablets if you:
• Are allergic (hypersensitive) to timolol maleate,
bendroflumethiazide, any of the other ingredients of Prestim (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).

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• 
Have higher than normal
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
Prestim” 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
Prestim Tablets are not suitable for children.
Other medicines and Prestim 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
Prestim Tablets.
Certain anaesthetics should not be used with
these tablets (e.g. ether, cyclopropane, trichlo
roethylene). You should not be given a local
anaesthetic combined with adrenaline while you
are taking Prestim Tablets.
Taking Prestim Tablets with food and drink
You should avoid excessive alcohol consumption while taking Prestim.
Pregnancy and breast-feeding
Tell your doctor before you take any tablets if
you are pregnant or breast-feeding. Also, tell

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your doctor if you become pregnant during
treatment.
Do not take Prestim tablets if you are pregnant.
Your doctor will decide if you should take Prestim
while you are breast-feeding.
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. HOW TO TAKE PRESTIM TABLETS
Always take Prestim 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.
Prestim Tablets should be swallowed whole
with water.
If you take more Prestim 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 Prestim
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 Prestim
Keep taking the Prestim 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 Prestim 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, Prestim 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 blue fingers
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.

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• Depression, hallucinations,
drowsiness, disorientation,
confusion or other mental
problems.
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 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 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 PRESTIM TABLETS
Keep out of the sight and reach of children.
Store Prestim Tablets below 25 °C.
Do not use Prestim 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 Prestim 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 Prestim looks like and contents of the pack
Prestim Tablets are white, flat and oval with
V
“ 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
Meda Pharmaceuticals Ltd.
Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, United Kingdom.
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 03/2014.

If this leaflet is difficult to see or read,
or you would like it in a different
format, please contact Meda Pharmaceuticals Ltd. Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford,
CM22 6PU, UK
34842E0EU-G00
56UK2023131-03

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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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