Bendroflumethiazide 2.5mg tablets

Main information

  • Trade name:
  • Bendroflumethiazide 2.5mg tablets
  • Dosage:
  • 2.5mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bendroflumethiazide 2.5mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02020100; GTIN: 5012727903606

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 29831/0022
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

CHANGE CONTROL : Version changes due to change in:

Size/Layout Regulatory Non-Regulatory

Changes in detail:

New regulatory text

Removed pre-printed L.I.No. from front page 1/2

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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,

please 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 Tablets are

and what they are used for

2. What you need to know before you

take Bendroflumethiazide Tablets

3. How to take Bendroflumethiazide

Tablets

4. Possible side effects

5. How to store Bendroflumethiazide

Tablets

6. Contents of the pack and other

information

1. What Bendroflumethiazide Tablets

are and what they are used for

The name of your medicine is

Bendroflumethiazide Tablets. The active

ingredient in your medicine is

bendroflumethiazide.

Bendroflumethiazide Tablets belong to a

group of medicines called diuretics

(water tablets) which increase the

amount of urine you produce.

Bendroflumethiazide Tablets are used to

treat high blood pressure (hypertension)

and fluid retention (oedema) associated

with kidney, liver or heart problems, and

pre-menstrual syndrome.

2. What you need to know before you

take Bendroflumethiazide Tablets

Do not take Bendroflumethiazide

Tablets if you:

are allergic to bendroflumethiazide, or

other sulphonamide-derived medicine

or any of the other ingredients of this

medicine (listed in section 6).

have high levels of calcium in your

blood (hypercalcaemia)

have severe liver or kidney problems,

or you are unable to pass water (urine)

have underactive adrenal glands

(Addison’s disease)

have low levels of sodium in your

blood (refractory hypokalaemia)

have low levels of potassium in your

blood (hyponatraemia)

Warnings and precautions

Take special care with

Bendroflumethiazide Tablets if you

have taken high doses of

Bendroflumethiazide Tablets or have

taken the tablets for a long time, or if

you have severe heart disease or are

taking digitalis preparations (e.g.

digoxin). Your doctor may decide you

need to take potassium supplement

tablets

have problems with your liver or kidneys

are seriously ill

suffer from a condition known as

hyponatraemia (low blood levels of

sodium), particularly if you are elderly

have low blood levels of magnesium

are diabetic or suffer from gout

have a condition known as systemic

lupus erythematosus (an allergic

condition which causes joint pain, skin

rashes and fever)

suffer from alcoholic cirrhosis;

have severe asthma and are taking

medicines called beta-agonists; these

include salbutamol, terbutaline,

formosterol and salmetrol.

have porphyria (a group of disorders

that results from a buildup of natural

chemicals)

suffer from or have a history of a

condition called systemic lupus

erythematosus

suffer from diseases affecting blood

cells or platelets (blood dyscrasias)

suffer from pancreatitis

If you are elderly or have taken

Bendroflumethiazide Tablets for a long

time, your doctor will perform regular

blood tests to check the levels of

electrolytes (salts) in your blood.

Other medicines and

Bendroflumethiazide Tablets

Tell your doctor if you are taking, have

recently taken or might take any other

medicines, including medicines obtained

without a prescription. The following

medicines and products can affect or be

affected by treatment with

Bendroflumethiazide Tablets:

drinking alcohol when being treated

with Bendroflumethiazide Tablets may

cause your blood pressure to drop,

making you feel dizzy or light headed,

especially when standing up

(orthostatic or postural hypotension)

medicines used to treat high blood

pressure including ACE inhibitors,

angiotensin-II antagonists,

alpha-blockers, such as prazosin,

beta-blockers, calcium channel

blockers, hydralazine, diazoxide and

methyldopa

medicines used for treating irregular

heart beats and other heart problems

including amiodarone,

disopyramide,flecainide, lidocaine,

mexiletine, quinidine, sotalol, nitrates

and cardiac glycosides

medicines used to treat Parkinson's

disease, such as levodopa

medicines used to treat epilepsy, such

as carbamazepine

medicines taken for depression and

mental illness including tricyclic

antidepressants, monoamine oxidase

inhibitors (MAOIs), reboxetine,

primozide, sertindole, lithium and

phenothiazines

other diuretics including acetazolamide

and loop diuretics

medicines used for diabetes, such as

chlorpropamide and insulin

medicines used to treat asthma called

beta-agonists, such as theophylline

medicines used in the treatment of

gout, such as allopurinol

medicines, called prostaglandins, such

as alprostadil

medicines used to treat fungal

infections, such as amphotericin

medicines used to treat bacterial

infections, such as trimethoprim

medicines used to treat malaria, such

as halofantrine

medicines used as dietary

supplements, such as calcium salts or

vitamin D

medicines used to treat inflammation,

such as cortisone and hydrocortisone

medicines used to treat stomach

ulcers, such as carbenoxolone

medicines used to treat high blood

cholesterol, such as colestyramine and

colestipol

medicines, called non-steroidal

anti-inflammatory drugs (NSAIDs)

used to treat pain or inflammation,

such as indometacin

medicines, called antihistamines, used

to treat allergies, such as terfenadine

and astemizole

medicines, called muscle relaxants,

such as tizanidine

medicines used in the treatment of

breast cancer, called hormone

antagonists, such as toremifene or

cisplatin

medicines used to treat kidney and

skin cancer (melanoma), such as

aldesleukin

medicines called general anaesthetics,

used to stop pain during surgery

medicines used to suppress the

immune system following organ

transplants, such as ciclosporin.

Other special warnings

Colestipol and colestyramine may

reduce the absorption of thiazide

diuretics and should therefore be given

2 hours prior to, or after the ingestion

of bendroflumethiazide.

Cisplatin can lead to an increased risk

of toxicity in the kidneys

(nephrotoxicity) and ear (ototoxicity)

An increase in low blood pressure

when diuretics given with aldesleukin

Sympathomimetics used for treating

heart problems can cause

hypokalaemia.

Theophylline in combination with

bendroflumethiazide can increase the

risk of hypokalaemia if used

concomitantly.

medicines like pimozide or thioridazine

used to treat psychoses (the term

used to describe a broad range of

conditions affecting a person’s mental

state, often characterised by

symptoms such as delusional

thoughts, hallucinations and agitated

behaviour) may increase the risk of

irregular heart – beats.

the risk of hypercalcaemia is increased

if bendoflumethiazide is given with

Vitamin D.

Tell your doctor if you are having or have

had tests for thyroid problems.

Bendroflumethiazide Tablets with

food, drink and alcohol

Alcohol can affect the way

Bendroflumethiazide Tablets work.

During treatment with

Bendroflumethiazide Tablets, talk to your

doctor before consuming alcoholic

drinks.

Pregnancy, breast-feeding and fertility

If you are pregnant or thinking of

becoming pregnant, check with your

doctor before you use

Bendroflumethiazide Tablets. Your doctor

will decide if you should take them.

Do not breast-feed if you are taking

Bendroflumethiazide Tablets. Ask your

doctor or pharmacist for advice before

taking any medicine.

Driving and using machines

Bendroflumethiazide Tablets may cause

dizziness, drowsiness and mental

confusion. Make sure you are not

affected before driving or operating tools

or machinery.

Bendroflumethiazide Tablets contains

lactose

This medicine contains lactose (a type of

sugar). If you have been told by your

doctor that you cannot tolerate some

sugars, contact your doctor before taking

this medicine.

Package leaflet: Information for the user

Bendroflumethiazide 2.5mg Tablets

Bendroflumethiazide 5mg Tablets

Bendroflumethiazide (Referred to as Bendroflumethiazide

Tablets in the remainder of the leaflet)

pg 1/2

Neutral code not required on the leaflet artworks.

ART WORK CHECK BOX

PRODUCT :

Bendrofluazide 2.5mg & 5mg - 28 Tablets

CUSTOMER :

Wockhardt UK

FP CODE:

FP2145; FP2146; FP3704

PLANT LOCATION :

DIMENSIONS :

(w)128 x (h)420mm

PHARMACODE No. :

2593

SAP CODE No. :

222871

TEXT FONT SIZE :

8 p.t

FILE NAME :

Bendrofluazide_Leaflet_104271-9.ai

SOFTWARE :

Adobe Illustrator CS5

TYPEFACES :

Arial Regular / Bold

ARTWORK (DETAILS)

6th December, 2018

RECEIVED ON :

PROOF REVISION :

R 1st PDF sent on

- 11TH DEC. 2018

R 2nd PDF sent on - 5TH FEB. 2019

Process

Black

3. How to take Bendroflumethiazide

Tablets

Always take Bendroflumethiazide Tablets

exactly as your doctor has told you.

Check with your doctor or pharmacist if

you are not sure.

Fluid retention

Adults: Your starting dose will be

between two and four 2.5mg

Bendroflumethiazide Tablets (or one to

two 5mg Bendroflumethiazide Tablets)

taken in the morning. The dose will then

be kept at one 2.5mg tablet (or one 5mg

tablet) a day on two to three days a

week.

Your doctor will assess your condition

and may decide that a single dose is

enough.

Children: The dose given will depend on

the size of your child. Your doctor will

determine the suitable dose based on

the weight of your child. The usual dose

is 400μg/kg body weight every day to

start with.

Your doctor will assess your child’s

condition and may decide to reduce their

dose to 50μg-100 μg/kg body weight.

High blood pressure

Adults: The usual dose is one 2.5mg

tablet a day taken in the morning.

Pre-menstrual syndrome

Adults: The usual dose is one 2.5mg

tablet a day taken in the morning for

seven days before your period is due.

Older People: You may need to take

less than the usual adult dose. Your

doctor will decide how many tablets you

should take.

If you take more Bendroflumethiazide

Tablets than you should

If you accidentally take too many tablets,

you should contact your doctor or go to

your nearest hospital casualty

department immediately. Take this leaflet

and any unused tablets with you to show

the doctor.

Symptoms of an overdose include thirst,

increase in the frequency and amount of

urination and changes in the levels of

salts and electrolytes in your blood.

Treatment for overdosing involves fluid

and electrolyte replacement.

If you forget to take

Bendroflumethiazide Tablets

If you forget to take your medicine take it

as soon as you remember. If it is almost

time for your next dose do not take the

missed dose at all. NEVER take a

double dose to make up for the one

missed.

If you stop taking

Bendroflumethiazide Tablets

You may experience a skin rash, itchy

skin or your skin may be more sensitive

to sunlight than normal if you stop taking

Bendroflumethiazide Tablets. Speak to

your doctor if you notice these symptoms.

Do not stop taking your medicine unless

your doctor tells you to. If you have any

further questions on the use of this

product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bendroflumethiazide

Tablets can cause side effects, although

not everybody gets them. If you notice

any of these problems talk to your

doctor straight away:

severe allergic reaction (anaphylaxis).

The signs of an allergic reaction may

include rash, itching, difficulty

breathing and/or swelling of your lips,

face, throat or tongue

inflammation of the lungs that can

cause a cough or shortness of breath

fluid in the lungs that can cause you to

cough up blood and make it difficult for

you to breathe

serious skin condition with blistering of

the skin

feeling sick (nausea) or being sick

(vomiting)

loss of appetite

feeling dizzy or light headed,

especially when standing up (low

blood pressure)

feeling weak, tired, drowsy or sleepy

feeling confused

muscle cramp

sudden headache

fits (seizures)

skin rash caused by exposure to light

(photosensitivity)

changes to various types of blood cells

(shown in blood tests). The symptoms

may include infections, paleness of the

skin, weakness, breathlessness,

increased bruising or bleeding

severe stomach pain which may reach

through to your back (pancreatitis)

pale stools, dark urine, yellowing of the

skin or eyes (jaundice).

Other side effects that may be experienced

while taking this medicine are:

tingling or numbness in the hands or

feet

constipation

dry mouth and thirst

inflammation of blood vessels, often

with skin rash (vasculitis)

an increase in uric acid in your blood

(gout)

being unable to achieve an erection

(impotence)

reduced sexual desire

diabetes

changes in the salts and electrolytes in

your blood (shown in blood tests)

an increase in the levels of certain

types of lipids and cholesterol in your

blood (shown in blood tests)

inflammation of the kidney which can

cause you to have a fever or to pass

more or less urine than normal

severe pain in the lower back or sides

(kidney stones)

High level of calcium in the blood

Reporting

of side

effects

If you get

any side

effects,

talk to your

doctor,

pharmacist

or nurse.

This

includes

possible

side effects not listed in this leaflet. You

can also report side effects directly via

the national reporting systems listed

below:

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or

search for MHRA Yellow Card in the

Google Play or Apple App Store

Malta:

ADR Reporting,

Website:

www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help

provide more information on the safety of

this medicine.

5. How to store Bendroflumethiazide

Tablets

Keep this medicine out of the sight and

reach of children.

Do not use Bendroflumethiazide Tablets

after the expiry date which is stated on

the blister and carton.

The expiry date refers to the last day of

that month.

Do not store above 25°C. Store in the

original container.

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

contain

The active ingredient is

bendroflumethiazide.

Each Bendroflumethiazide 2.5mg Tablet

contains 2.5mg of bendroflumethiazide.

Each Bendroflumethiazide 5mg Tablet

contains 5mg of bendroflumethiazide.

The other ingredients are lactose

powder, pregelatinised maize starch,

maize starch, purified talc, magnesium

stearate and water.

What Bendroflumethiazide Tablets

look like and contents of the pack

Bendroflumethiazide 2.5mg Tablets are

white, circular flat faced tablets with

bevelled edges, marked CP on one side

and B 2.5 separated by a breakline on

the other side.

Bendroflumethiazide 5mg Tablets are

white, circular flat faced tablets with

bevelled edges, marked CP on one side

and B 5 separated by a breakline on the

other side.

Bendroflumethiazide 2.5mg Tablets are

available in the following packs:

500 tablets in polypropylene or

polyethylene containers.

Bendroflumethiazide 5mg Tablets are

available in the following packs:

50 tablets in amber glass bottles with a

plastic cap

100, 250, 500 and 1000 and bulk

amount of tablets in polypropylene or

polyethylene containers.

Both strengths of tablets are available in

the following packs:

10, 14, 20, 28, 30, 40, 50, 56, 60, 70,

80, 84, 90, 100 or 112 tablets in blister

packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF, UK

Manufacturer

CP Pharmaceuticals Ltd

Ash Road North

Wrexham

LL13 9UF, UK

Other formats:

To listen to or request a copy of this

leaflet in Braille, large print or audio

please call, free of charge:

0800 198 5000 (UK only).

Please be ready to give the following

information:

Product name

Reference

number

Bendroflumethiazide

2.5mg Tablets

29831/0022

Bendroflumethiazide

5mg Tablets

29831/0023

This is a service provided by the Royal

National Institute of Blind People.

For the Republic of Ireland please call

+44 1978 661261

This leaflet was last revised in 02/2019

104271/9

222871

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