NUMARK MANAGEMENT LIMITED BENDROFLUMETHIAZIDE 2.5 MG TABLETS

Active substance: BENDROFLUMETHIAZIDE

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BENDROFLUMETHIAZIDE
2.5 mg AND 5 mg TABLETS

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Top of page cut-off to middle of registration mark: 21mm. Registration Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)

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• Adults
• High Blood Pressure:
2.5 mg daily in the morning. Your
doctor may occasionally prescribe
a higher dose depending on your
response to treatment.
• Water Retention (oedema):
5 – 10 mg daily in the morning or
on alternate days. The maintenance
dose is 5 – 10 mg one to three
times a week.
• To Inhibit Breast Milk:
5 mg in the morning and 5 mg at
noon, for five days.
• Elderly
Initially your doctor will start you on
a lower dose.
• Children
The dosage will depend upon the
weight of the child. Usually
400 micrograms per kilogram of
bodyweight initially. This may be
reduced to a maintenance dose of
50 – 100 micrograms per kilogram of
bodyweight daily.
• Taking Bendroflumethiazide in
combination with colestipol or
colestyramine:
If you are also taking colestipol or
colestyramine, you should take
these either 2 hours before or 2 hours
after taking Bendroflumethiazide.
If you take more Bendroflumethiazide
than you should
If you (or someone else) swallow a lot
of the tablets all together, or if you
think a child has swallowed any of the
tablets, contact your nearest hospital
casualty department or your doctor
immediately.
An overdose is likely to cause nausea,
vomiting, loss of appetite, increased
urination, diarrhoea, dehydration,
dizziness, hypotension (low blood
pressure), weakness, muscle cramps,
twitching, numbness and tingling,
gastric bleeding, low blood levels of
sodium and potassium, effects on
blood sugar levels, a change in the
acid base balance of the body.
Please take this leaflet, any remaining
tablets, and the container with you to
the hospital or doctor so that they
know which tablets were consumed.
If you forget to take
Bendroflumethiazide
DO NOT take a double dose to make
up for a forgotten tablet
If you stop taking
Bendroflumethiazide
You should continue to take these
tablets for as long as your doctor tells
you to.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

• problems with the liver
• salt imbalance caused by a lowering
of the levels of potassium or sodium
in the blood. Signs of salt imbalance
include dry mouth, thirst, weakness,
lethargy, drowsiness, restlessness
and anxiety, muscle pain and
cramps, seizures, changes in heart
rate and blood pressure, and
gastro-intestinal disturbances
• dizziness or faintness on standing
which may be due to a lowering of
your blood pressure
• there may be a rise in the level of
uric acid in the blood which can
result in swelling of the joints (gout)
• impotence has been reported
occasionally, although this is
reversible once your treatment with
Bendroflumethiazide Tablets is over
or stopped
• reduced carbohydrate tolerance if
you are a diabetic
• stomach problems.
If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor
or pharmacist.

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HOW TO STORE
BENDROFLUMETHIAZIDE

Keep out of the reach and sight of
children.
Do not use Bendroflumethiazide after
the expiry date that is stated on the
outer packaging. The expiry date refers
to the last day of that month.
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.

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FURTHER INFORMATION

(Main)

Pharma code 210

What Bendroflumethiazide Tablets
contain:
• The active ingredient is
bendroflumethiazide.
• The other ingredients are lactose
monohydrate, maize starch,
povidone, sodium starch glycolate,
magnesium stearate, and colloidal
silicon dioxide.
What Bendroflumethiazide Tablets
look like and contents of the pack:
• The 2.5 mg tablets are white, round,
flat, bevel edged tablets engraved
BERK 1G5 on one side and plain on
the reverse, or 1G5 on one side and
plain on the reverse.
• The 5 mg tablets are white, biconvex
tablets engraved BERK 2G5 on one
side with a break line on the
reverse, or 2G5 on one side with a
break line on the reverse.
• Bendroflumethiazide Tablets are
available in pack sizes of 7, 10, 14,
POSSIBLE SIDE EFFECTS
21, 28, 30, 56, 60, 84, 90, 100, 110,
112, 120, 150, 160, 168, 1000 and
Like all medicines, Bendroflumethiazide
10000 tablets. The 2.5 mg tablets are
can cause side effects, although not
also available in packs of 500
everybody gets them.
tablets, and the 5 mg tablets are
Stop taking the tablets and tell your
also available in packs of 25 tablets.
doctor immediately or go to the
Not all pack sizes may be marketed.
casualty department at your nearest
Marketing Authorisation Holder and
hospital if the following happens,:
Manufacturer
• an allergic reaction (swelling of the Marketing Authorisation holder and
lips, face or neck leading to severe
company responsible for manufacture:
difficulty in breathing; skin rash or
TEVA UK Limited, Eastbourne,
nettle rash).
BN22 9AG.
This is a very serious but rare side
This leaflet was last revised:
effect. You may need urgent medical
March 2008
attention or hospitalisation.
PL 00289/0172-0173
Tell your doctor if you experience any
of the following whilst taking
Bendroflumethiazide Tablets:
• skin rashes
• sensitivity to light
• blood disorders of various types
including anaemia reduction of red
blood cells and altered level of fat in
your blood
• problems with the pancreas
52734-V

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(Backup)

Talk to your doctor if you are taking
any of the following:
• colestipol or colestyramine
(medicines to reduce the level of
PACKAGE LEAFLET: INFORMATION
fats in the blood); read section 3
FOR THE USER
“How to take Bendroflumethiazide”
Read all of this leaflet carefully before • non-steroidal anti-inflammatory
you start taking this medicine.
drugs (NSAID) e.g. indometacin
• Keep this leaflet. You may need to
• any medicines used to treat asthma
read it again.
• carbamazepine, an antiepileptic
• If you have any further questions,
• amphotericin (for infections)
ask your doctor or pharmacist.
• calcium salts
• This medicine has been prescribed
• vitamin D preparations
for you. Do not pass it on to others. • cisplatin, toremifene or
It may harm them, even if their
aminoglutethimide (used to treat
symptoms are the same as yours.
cancer)
• If any of the side effects get serious, • disopyramide, amiodarone,
or if you notice any side effects not
flecainide, quinidine, mexiletine,
listed in this leaflet, please tell your
sotalol or digoxin or
doctor or pharmacist.
calcium-channel blockers, e.g.
nicardipine (used to treat heart
IN THIS LEAFLET:
problems)
1. What Bendroflumethiazide is and
• corticosteroids (used to reduce
what it is used for
inflammation) e.g. prednisolone
2. Before you take Bendroflumethiazide • moxisylyte, used to treat Raynaud’s
3. How to take Bendroflumethiazide
syndrome
4. Possible side effects
• any medicines used to treat
5. How to store Bendroflumethiazide
depression e.g. amitriptyline,
6. Further information
phenelzine or reboxetine
• muscle relaxants, e.g. baclofen or
WHAT BENDROFLUMETHIAZIDE
tizanidine
IS AND WHAT IT IS USED FOR • oral contraceptives
• any medicines used to treat mental
• Bendroflumethiazide is a type of
illness e.g. lithium, pimozide or
medicine called a thiazide diuretic,
thioridazine
which increases the amount of water
• terfenadine, used to treat allergies
(urine) passed.
• any pain-killers which contain
• Bendroflumethiazide is used :
opioids such as codeine,
• to treat high blood pressure
diamorphine or pentazocine
• to treat oedema (water retention)
• barbiturates e.g. amobarbital or
• to suppress the production of
phenobarbital
breast milk.
• ACTH (corticotropin), acetazolamide
(used to treat glaucoma)
BEFORE YOU TAKE
• MAOIs (Monoamine Oxidase
BENDROFLUMETHIAZIDE
Inhibitors) which are a group of
DO NOT take Bendroflumethiazide if
drugs used for depression.
you:
If you are due to undergo surgery or
• are allergic (hypersensitive) to
dental treatment which may require
bendroflumethiazide or any of the
the use of a muscle relaxant e.g.
other ingredients of this medicine
tubocurarine, or lidocaine (a local
• are allergic (hypersensitive) to any
anaesthetic), consult your doctor.
diuretics belonging to the thiazide
Please tell your doctor or pharmacist if
group, such as chlortalidone,
you are taking or have recently taken
metolazone or cyclopenthiazide
any other medicines, including
• have severe liver or kidney
medicines obtained without a
problems
prescription.
• suffer from hypercalcaemia (high
level of calcium in the blood)
Important information about some of
• suffer from an imbalance of water
the ingredients of Bendroflumethiazide
and salts in the body
• Patients who are intolerant to
• suffer from Addison’s disease
lactose should note that
• suffer from gout.
Bendroflumethiazide tablets contain
a small amount of lactose. If your
Take special care with
doctor has told you that you have an
Bendroflumethiazide
intolerance to some sugars, contact
Tell your doctor before you start to
your doctor before taking this
take this medicine if you:
medicine.
• are pregnant or breast-feeding
• have ever suffered from gout
Taking Bendroflumethiazide with food
• have mild to moderate liver or
and drink
kidney problems
• You should avoid alcohol while
• suffer from, or have a history of
taking these tablets, as it may
systemic lupus erythematosus
increase any feeling of dizziness you
(autoimmune disorder)
may experience.
• suffer from alcoholic liver disease
Pregnancy and breast-feeding
• are diabetic (your blood glucose
• Bendroflumethiazide is not
levels may be affected, please see
recommended if you are pregnant,
“Taking other medicines”).
planning to become pregnant or are
Your doctor may carry out blood tests
breast-feeding. Ask your doctor for
especially if you are elderly or taking
advice before taking this medicine.
this medicine long term.
Driving and using machines
Taking other medicines
• Bendroflumethiazide is not known to
If you are taking Bendroflumethiazide
affect your ability to drive or operate
in combination with the following
machinery.
medicines, your doctor may adjust the
HOW TO TAKE
dose of the other medicine whilst you
BENDROFLUMETHIAZIDE
are taking these tablets:
• medicines used to treat high blood
Always take Bendroflumethiazide
pressure e.g. prazosin
exactly as your doctor has told you.
• insulin (you may need to have your
You should check with your doctor or
dose of insulin adjusted as your
pharmacist if you are not sure.
body’s ability to deal with the insulin
Bendroflumethiazide may be taken
may be affected if you are taking
with or without food. The tablets
Bendroflumethiazide at the same
should be swallowed preferably with a
time).
glass of water. The usual dose is:

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Pharma code 210

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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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