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BENDROFLUMETHIAZIDE 5 MG TABLETS

Active substance(s): BENDROFLUMETHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

BENDROFLUMETHIAZIDE
2.5 mg & 5 mg TABLETS
Bendroflumethiazide

Read all of this leaflet carefully before you start
taking 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 or
pharmacist.
- 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 side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1. What Bendroflumethiazide is and what
it is used for
2. What you need to know before you
take Bendroflumethiazide
3. How to take Bendroflumethiazide
4. Possible side effects
5. How to store Bendroflumethiazide
6. Contents of the pack and other
information

1. WHAT BENDROFLUMETHIAZIDE IS AND
WHAT IT IS USED FOR
Bendroflumethiazide tablets contain the active substance
bendroflumethiazide. Bendroflumethiazide belongs to a
group of medicines known as the thiazide diuretics (water
tablets). It may be used to reduce:
 a build-up of excess fluid in the body (oedema)
particularly caused by heart, kidney, liver disease or
that caused by medication, by increasing the flow of
urine
 high blood pressure (hypertension), alone or with other
medication.
You must talk to your doctor if you do not feel better or if
you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE BENDROFLUMETHIAZIDE
Do not take Bendroflumethiazide and tell your doctor
if you:
 are allergic to bendroflumethiazide, or any of the other
ingredients of this medicine (listed in section 6) or to
other thiazide diuretics
 have severe liver or kidney problems
 have low blood levels of potassium or sodium
 have high blood levels of calcium or uric acid
 have Addison’s disease (underactive adrenal glands
causing tiredness, weight loss and low blood pressure
and dark pigmentation of the skin)
Warnings and precautions
Talk to your doctor or pharmacist before you take this
medicine if you:
 have or have had mild or moderate liver or kidney
problems
 have liver disease caused by alcohol (alcoholic
cirrhosis)
 have diabetes
 have or have had gout (pain and swelling of the joints)
 have Systemic Lupus Erythematosus (an inflammatory
disease which causes joint pain, skin rashes and fever)
 have porphyria (an inherited iron disorder)
 are receiving digoxin (digitalis treatment)
 are taking pimozide or thioridazine

 have an intolerance to some sugars, including lactose
Other medicines and Bendroflumethiazide Tablets
Tell your doctor or pharmacist if you are taking or have
recently taken, any other medicines, even medicines
bought without a prescription.
In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may affect
how Bendroflumethiazide tablets work:
 medicines to treat high blood pressure, heart disease or
chest pain such as captopril, enalapril (ACE inhibitors),
doxazosin, prazosin (alpha-blockers), candesartan,
losartan (angiotensin-II receptor antagonists),
propranolol, atenolol (beta-blockers), amlodipine,
moxisylyte (calcium-channel blockers), glyceryl
trinitrate, isosorbide mononitrate (nitrates) or digoxin
 medicines used to control an irregular heartbeat such
as disopyramide, amiodarone, quinidine, lidocaine,
mexiletine or flecainide
 colestipol or colestyramine to lower cholesterol
 medicines used in diabetes to lower blood sugar
levels, such as sulfonylureas
 acetazolamide to treat glaucoma (increased eyeball
pressure)
 lithium or medicines for mental health problems such
as sertindole, pimozide or thioridazine
 medicines for depression such as reboxetine, tricyclic
antidepressants or monoamine oxidase inhibitors
(MAOIs)
 carbamazepine for epilepsy
 levodopa to treat Parkinson’s disease
 medicines known as non-steroidal anti-inflammatory
drugs, used for pain and swelling such as indometacin,
ibuprofen, piroxicam, naproxen or ketorolac
 allopurinol to treat gout
 carbenoxolone to treat stomach ulcers
 muscle relaxants such as baclofen, tizanidine,
tubocurarine, gallamine, alcuronium or pancuronium
 medicines used to treat cancer such as aldesleukin,
aminoglutethamide, toremifene or cisplatin
 theophylline and sympathomimetics (for asthma)
 corticosteroids such as prednisolone to treat
inflammation or allergies and ACTH
(Adrenocorticotropic hormone)
 Oestrogens and progestogens in birth control pills or
hormone replace therapy (HRT)
 alprostadil for problems maintaining an erection
 amphotericin for fungal infections
 vitamin D or calcium salts
Bendroflumethiazide with food, drink and Alcohol
Alcohol should be avoided when taking this
medicine.
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 levels of certain chemicals in your body, by
carrying out tests.
If you go into hospital or have treatment for other
conditions, tell the doctor that you are taking
Bendroflumethiazide.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine
Bendroflumethiazide should be avoided during
pregnancy, as there is no sufficient evidence of its safety.
Because Bendroflumethiazide passes into the breast milk
it should be avoided in mothers who wish to breast-feed.
New born infants whose mothers have taken
bendroflumethiazide during pregnancy may suffer from a
blood condition known as thrombocytopenia.
Driving and using machines
Bendroflumethiazide tablets can cause dizziness, you
should ensure you are not affected before attempting to
drive or operate machinery.

Bendroflumethiazide tablets contains lactose
This medicine contains lactose. If you know you have an
intolerance to lactose or other sugars, contact your doctor
before taking this medicine.

3. How to take Bendroflumethiazide
Always take Bendroflumethiazide exactly as your doctor
has told you. check with your doctor or pharmacist If you
are not sure.
Take these tablets in the morning (to avoid having to pass
urine at night), with a glass of water.
Dosage
Your doctor will decide your dose and length of treatment,
as it depends on your condition.
Adults and children 12 years and over:
Oedema - Initially the recommended dose is 5 - 10 mg
once a day, or once every other day.
This may then be reduced to 2.5 - 10 mg 2 to 3 times a
week.
Hypertension - The recommended dose is 2.5 - 5 mg per
day.
Elderly: If you have kidney problems you may require
smaller doses. Follow your doctor’s advice.
Children under 12 years: Initially 400 micrograms per
kilogram of body weight, a day. The maintenance dose is
50-100 micrograms per kilogram of body weight a day.
The doctor will decide the dose for your child, as it
depends on their bodyweight.
A more appropriate formulation may need to be used.
If you take more Bendroflumethiazide than you
should
Contact your doctor or the nearest hospital casualty
department immediately. Show them the package.
Symptoms of an overdose can include feeling or being
sick, diarrhoea, dehydration, dizziness, weakness,
muscle cramps, increased frequency and volume of
urination, thirst, decreased volumes within blood vessels,
low blood pressure, circulation problems, low blood levels
of potassium and sodium, low blood sugar levels and
central nervous system depression (drowsiness,
tiredness or coma).
If you forget to take Bendroflumethiazide
Don’t worry, just take it as soon as you remember and
then take your next scheduled dose at the correct time.
Do not take a double dose to make up for a forgotten
dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Bendroflumethiazide can cause side
effects, although not everybody gets them.
If you get any of the following serious side effects,
stop taking Bendroflumethiazide and tell your doctor
or go to the nearest hospital emergency department
immediately:
 an allergic reaction which may cause skin rashes,
itching, sensitivity to sunlight, a viral infection of the
lungs (pneumonitis) or fluid in the lungs (pulmonary
oedema)
 blood disorders which may cause you to have
unexplained bleeding, bruising and sore throats.
Regular blood and urine tests may be needed.
Other side effects may include:
 nausea, vomiting, diarrhoea, constipation, stomach
irritation
 a fall in blood pressure on standing up, (postural
hypotension), which causes dizziness,
light-headedness or fainting
 inability to maintain an erection (reversible once the
tablets are stopped)
 a decrease in blood levels of potassium, which may
cause increased frequency and volume of urination, a

feeling discomfort or unease, muscle weakness or
cramp, dizziness, feeling or being sick and loss of
appetite
 a decrease in blood levels of sodium or magnesium
 an increase in blood levels of calcium
 an increase in uric acid levels in the blood and
worsening of gout
 an increase in blood sugar levels and worsening of
diabetes
 decreased carbohydrate tolerance
 changes in blood lipid (fat) levels
 low blood levels of chloride ions with increased
alkalinity in the body (hypochloraemic alkalosis)
 blockage within the liver, which causes itching,
yellowing of the skin or whites of the eyes (jaundice),
dark urine and pale stools
 inflammation of the pancreas, which causes severe
pain in the abdomen and back
Reporting side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 BENDROFLUMETHIAZIDE
Keep this medicine out of the sight and reach of
children.
Do not store above 25°C. Store in the original package or
container and keep the container tightly closed.
Do not use these tablets after the expiry date which is
stated on the package or container after EXP. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. 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 Bendroflumethiazide tablets contains
The active substance is bendroflumethiazide. This is the
new name for bendrofluazide. The ingredient itself has
not changed.
The other ingredients are lactose, maize starch,
pregelatinised starch, sodium starch glycollate and
magnesium stearate.
What Bendroflumethiazide tablets looks like and
contents of the pack
Bendroflumethiazide 2.5 mg tablets are round white
tablets of 5.5mm diameter with the marking MP18 on one
side.
Bendroflumethiazide 5 mg tablets are round white tablets
of 6.5 mm diameter with the marking MP19 on one side.
The tablets come in blister packs and containers of 28,
30, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all
pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41 - 43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
84 Pembroke Road, London, W8 6NX, UK
For more information about this product, please contact
the Marketing Authorisation Holder.
This leaflet was last revised in 10/2017

GE0012-0013/O/PIL/GE3

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