BENDROFLUMETHIAZIDE TABLETS BP 5MG

Active substance: BENDROFLUMETHIAZIDE

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Transcript
Index
1 What Bendroflumethiazide
tablets are and what they
are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Bendroflumethiazide tablets are
and what they are used for

Bendroflumethiazide tablets belong to a group of
medicines called thiazide diuretics (water tablets). They
may be used to:
• reduce fluid retention (oedema) particularly in the
heart, kidneys, liver or that caused by medication, by
increasing the flow of urine.
• reduce high blood pressure alone or with other
medication.

2 Before you take

Do not take Bendroflumethiazide tablets and tell
your doctor if you have:
• an allergy (hypersensitivity) to thiazides or any of the
other ingredients in Bendroflumethiazide tablets (see
section 6).
• severely impaired kidney or liver function.
• high blood levels of calcium (hypercalcaemia).
• low blood levels of sodium (hyponatraemia).
• low blood levels of potassium which has not
responded to treatment (refractory hypokalaemia).
• or have had gout (high levels of uric acid in the blood),
causing crystals to deposit in joints of hands or feet
causing pain (hyperuricaemia).
• Addison’s disease (syndrome due to low level of
corticosteroid hormones secretion, symptoms include
weakness, loss of energy, low blood pressure and dark
pigmentation of the skin).

Continued top of next column
50129996

15mm

Check with your doctor or pharmacist before
taking Bendroflumethiazide tablets if you have:

83.6mm

Pharmacode
Position

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.

• mild or moderate impaired kidney or liver function.
• liver disease caused by alcohol (alcoholic cirrhosis).
• or may have diabetes. If you are taking insulin, your
doctor may need to adjust your insulin dosage.
• systemic lupus erythematosus (SLE) (an inflammatory
disease of connective tissue causing large areas of red
scaly patches on the face, hair loss, weight loss, painful
joints and fever).
• an inherited disorder of the red blood pigment
haemoglobin causing skin blisters, abdominal pain and
brain or nervous system disorders (porphyria).

Taking other medicines

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. Especially:
• allopurinol (used in gout)
• colestyramine or colestipol (used to lower cholesterol)
• disopyramide, amiodarone, flecainide, quinidine,
lidocaine or mexiletine (used to control an irregular
heart beat)
• tricyclic antidepressants, reboxetine or monoamineoxidase inhibitors (MAOIs) (used for depression)
• sulfonylureas (used in diabetes to control blood sugar
levels)
• carbamazepine (used in epilepsy)
• amphotericin (used to treat fungal infections)
• prazosin (used in high blood pressure, heart failure,
Raynaud’s syndrome and an enlarged prostate)
• ACE inhibitors (e.g. enalapril) or angiotensin-II
antagonists (e.g. losartan) used to lower blood pressure
• pimozide or thioridazine (antipsychotics)
• calcium salts
• calcium channel blockers e.g. amlodipine or diltiazem
• moxisylyte (used in Raynaud’s syndrome)
• corticosteroids e.g. prednisolone
• cisplatin (used to treat cancer)
• digoxin (used to treat some heart problems)
• aminoglutethamide (used in some cancers and
Cushing’s syndrome)
• toremifene (used in some cancers)
• lithium (used for mental health problems)
• muscle relaxants such as baclofen, tizanidine,
tubocurarine, gallamine, alcuronium or pancuronium
• NSAIDs (non-steroidal anti-inflammatory drugs) such
as indometacin, ketorolac, ibuprofen, piroxicam or
naproxen
• oestrogens and combined oral contraceptives
• sympathomimetics (used as decongestant, asthma or
heart medicine)
• theophylline (used in breathing problems such as
asthma)
• carbenoxolone (an ulcer healing drug)
• vitamin D.

C
L

210mm +/- 0.5mm to centre line of next eye mark

65mm

Bendroflumethiazide 2.5mg
and 5mg tablets

Continued over page

15mm

Pregnancy and breast-feeding

Bendroflumethiazide tablets should not be used in pregnant
or breast-feeding women. Speak to your doctor or pharmacist
before taking any medicine.

Driving and using machines

Bendroflumethiazide tablets can cause dizziness, make sure
you are not affected before driving or operating machinery.

Sugar intolerance

If you have been told you have an intolerance to some sugars,
contact your doctor before taking this medicine, as it contains
a type of sugar called lactose.

Tests

During treatment with Bendroflumethiazide tablets, your
doctor may want to monitor your kidney function. If you are
elderly or on long term treatment with Bendroflumethiazide
tablets, your doctor may want to monitor the level of
chemicals in your body, by carrying out tests.

3 How to take

Always take Bendroflumethiazide tablets exactly as your
doctor has told you. If you are not sure, check with your
doctor or pharmacist.

Swallow the tablets with water in the morning (to avoid
frequent urination at night).
Doses:
Adults and children 12 years and over
Oedema: initially 5-10mg once a day or once every other day.
The maintenance dose is 2.5-10mg two or three times a week.
High blood pressure: 2.5-5mg once a day.
Children under 12 years
A more appropriate formulation may be used.
Initially 400micrograms per kilogram of body weight, a day.
The maintenance dose is 50-100micrograms per kilogram of
body weight, a day.
Elderly
Your doctor may prescribe you a lower dose especially if you
have impaired kidney function.

If you take more than you should

If you forget to take the tablets

5 How to store

Keep out of the reach and sight of children.
Store below 25°C in a dry place.
Do not use Bendroflumethiazide tablets after the expiry date
stated on the label/carton/bottle. 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.

6 Further information

What Bendroflumethiazide tablets contain

• The active substance (the ingredient that makes
the tablets work) is bendroflumethiazide PhEur.
Each tablet contains either 2.5mg or 5mg of the
active substance.
• The other ingredients are lactose, magnesium
stearate, maize starch, pregelatinised maize starch,
stearic acid, water.

What Bendroflumethiazide tablets look
like and contents of the pack

2.5mg tablets are white, circular, biconvex,
uncoated tablets.
5mg tablets are white, circular, flat bevelled-edge,
uncoated tablets.
Pack size is 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in
October 2009

50129996

Actavis, Barnstaple, EX32 8NS, UK

65mm

If you forget to take a dose take it as soon as you remember
it and then take the next dose at the right time. Do not take a
double dose to make up for a forgotten dose.

Like all medicines, Bendroflumethiazide tablets can cause side
effects, although not everybody gets them.
Contact your doctor at once if you experience the following:
• Allergic reaction (hypersensitivity): rashes including skin that
is red, flaky and peeling (exfoliative dermatitis), sensitivity to
sunlight or artificial light (e.g. sun beds), a viral infection of the
lungs (pneumonitis), fluid in the lungs (pulmonary oedema).
• Blood: altered numbers and types of blood cells. If you notice
increased bruising, nosebleeds, sore throats, infections,
excessive tiredness, breathlessness on exertion or abnormal
paleness of the skin, you should tell your doctor who may want
you to have a blood test.
Tell your doctor or pharmacist if you notice any of the
following side effects, they get worse or you notice any not
listed.
• Metabolism: decreased carbohydrate tolerance, worsening of
existing diabetes, increased blood levels of uric acid, worsening
of gout, changes in blood lipid (fat) levels.
• Chemicals within the body: low blood potassium levels
(hypokalaemia) (which may cause an increase in the frequency
and amount of urination, a feeling of general discomfort and
illness, muscle weakness or cramp, dizziness, feeling or being
sick and loss of appetite), low blood magnesium and sodium
levels, high blood levels of calcium (hypercalcaemia), low blood
levels of chloride ions with increased alkalinity in the body
(hypochloraemic alkalosis).
• Stomach and intestines: feeling or being sick, diarrhoea,
constipation, stomach irritation.
• Other: inflammation of the pancreas, blocked bile flow within
the liver, inability to maintain an erection, dizziness on standing
due to low blood pressure (postural hypotension), dizziness.
Tell your doctor or pharmacist if you notice any of the
above side effects, they get worse or if you notice anything
not listed.

Pharmacode
Position

If you (or someone else) swallow a lot of tablets at the same
time, or you think a child may have swallowed any, contact
your nearest hospital casualty department or tell your doctor
immediately. Symptoms of an overdose include feeling or
being sick, diarrhoea, dehydration, dizziness, weakness,
muscle cramps, increase in the frequency and amount of
urination, thirst, decreased volume within blood vessels, low
blood pressure, circulation problems (peripheral circulatory
failure), low blood levels of potassium (hypokalaemia)
and sodium (hyponatraemia), low blood sugar levels
(hypoglycaemia) and central nervous system depression
(drowsiness, tiredness and coma).

4 Possible side effects

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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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