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BENDROFLUMETHIAZIDE 2.5 MG TABLETS

Active substance(s): BENDROFLUMETHIAZIDE / BENDROFLUMETHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

BENDROFLUMETHIAZIDE
2.5 mg & 5 mg TABLETS
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 any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Bendroflumethiazide is for
2. Before you take Bendroflumethiazide
3. How to take Bendroflumethiazide
4. Possible side effects
5. How to store Bendroflumethiazide
6. Further information

1. WHAT BENDROFLUMETHIAZIDE IS FOR
Bendroflumethiazide belongs to a group of medicines
known as the thiazide diuretics. It may be used to treat:
 a build-up of excess fluid in the body (oedema) by
increasing the flow of urine
 mild to moderate heart failure or high blood pressure
(hypertension)
If you are not sure why you have been prescribed these
tablets then please ask your doctor.

2. BEFORE YOU TAKE BENDROFLUMETHIAZIDE
Do not take Bendroflumethiazide and tell your
doctor if you:
 are allergic to bendroflumethiazide, any of the other
ingredients in the tablets (listed in section 6 of this
leaflet) 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)
Take special care with Bendroflumethiazide
Tell your doctor 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)
Taking other medicines
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 for asthma
 corticosteroids such as prednisolone to treat
inflammation or allergies
 birth control pills or hormone replace therapy (HRT)
 alprostadil for problems maintaining an erection
 amphotericin for fungal infections
 vitamin D or calcium salts
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 and breast-feeding
Make sure your doctor knows if you are pregnant,
planning a pregnancy or breast-feeding and follow his /
her advice.
Driving and using machines
Bendroflumethiazide tablets can cause dizziness, you
should ensure you are not affected before attempting to
drive or operate machinery.
Important information about some of the ingredients
of Bendroflumethiazide tablets
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. If you are not sure, check with
your doctor or pharmacist.

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 typical dosage is 5 - 10 mg once a
day, or once every other day.
This may then be reduced to 5 - 10 mg 1 to 3 times a
week.
Hypertension - Typical dosage 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: 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 the one you
have missed.

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 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
If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE BENDROFLUMETHIAZIDE
Keep out of the reach and sight 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. 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 contains
The active ingredient in this medicine 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 with the marking MP18 on one side.
Bendroflumethiazide 5 mg are round white tablets 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,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please contact
the Marketing Authorisation Holder.
This leaflet was last revised in 06/2016
GE0012-0013/O/PIL/GE1

Product:

Bendroflumethiazide
Tablets 2.5 & 5 mg

MA Holder:

Genethics Europe

PL No.:

42976/0012 & 0013

Pack Size:

All

Printing Colours:

Non-Printing Colours:
Final Preparation Date For Submission: 22/06/2016

Packing Site Technical Approval:

Livery:
Manufacturer:
Market:
Component:

Genethics Europe/Genesis
UK
PIL

00/00/0000
Dimensions:

150 x 254 mm

Created By:

APatel

Artwork Code:

GE0012-0013/O/PIL/GE1

Bar Code:

5000000000000

Font Type:
Font Size:

Bliss Regular
8.7 pt

Authority Approval Date:
00/00/0000
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000

Expand Transcript

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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