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BENDROFLUMETHIAZIDE 5MG TABLETS

Active substance(s): BENDROFLUAZIDE / BENDROFLUMETHIAZIDE

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Package Leaflet: Information for the User
Bendroflumethiazide 2.5mg & 5mg Tablets
Bendroflumethiazide is the new name for Bendrofluazide.
If you have been taking Bendrofluazide tablets, do not worry, as this is the same medicine
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.
2.
3.
4.
5.
6.

What Bendroflumethiazide Tablets are and what they are used for
What you need to know before you take Bendroflumethiazide Tablets
How to take Bendroflumethiazide Tablets
Possible side effects
How to store Bendroflumethiazide Tablets
Contents of the pack and other information

1. What Bendroflumethiazide Tablets are and what they are used for
The active ingredient in this medicine is bendroflumethiazide. Bendroflumethiazide belongs to a group of medicines called
thiazide diuretics (‘water tablets’). They are used to increase the flow of urine to help reduce high blood pressure and reduce the
build-up of fluid in tissue below the skin (oedema). They are also used to stop the production of breast milk.

2. What you need to know before you take Bendroflumethiazide Tablets
Do not take Bendroflumethiazide Tablets if you:
 are allergic to Bendroflumethiazide, other thiazide diuretics or





to any of the other ingredients in the tablets (see Section 6);
have severe liver or kidney disease;
have gout or an increase in uric acid in the blood;
are taking lithium (for some mental disorders);
are pregnant, planning to become pregnant or are
breast-feeding;





have high levels of calcium in the blood
( hypercalcaemia);
have low levels of blood potassium
(hypokalaemia) or low blood sodium
(hyponatraemia);
have Addison’s disease (when the adrenal
glands above the kidneys do not work properly,
resulting in a lack of adrenal hormones).

Warnings and precautions:
Talk to your doctor or pharmacist before taking Bendroflumethiazide Tablets if you:
 are over 60, as older adults are more sensitive to the effects
 have an inflammatory disease called systemic
of thiazide diuretics;
lupus erythematosus, as Bendroflumethiazide
may make this condition worse;
 have diabetes, as Bendroflumethiazide can make diabetes worse
and can reduce the effect of some drugs to control diabetes;
 have a blood disorder known as porphyria;
 have kidney problems including kidney stones or gallstones;
 liver disease caused by alcohol (alcoholic cirrhosis).

Other medicines and Bendroflumethiazide Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:
 other diuretics (water tablets);
 digoxin (for heart conditions);
 other medicines to lower blood pressure;
 barbiturates or opioid drugs such as codeine;
 non steroidal anti-inflammatory drugs such as aspirin,
 corticosteroids such as prednisolone;
ibuprofen and indomethacin (used to treat pain
 carbenoxolone (to treat stomach ulcers);
and inflammation);
 pimozide or thioridazine (antipsychotics);
 amphotericin (used to treat fungal infections);
 colestyramine or colestipol (used to lower cholesterol);
 carbamazepine (used in epilepsy);
 prazosin (used in high blood pressure, heart failure,
 terfenadine (antihistamine for treating allergies);
Raynaud’s syndrome and an enlarged prostate);
 calcium salts or Vitamin D preparations;
 muscle relaxants (such as baclofen, tizanidine,
 cisplatin (used to treat cancer);
tubocurarine, gallamine, alcuronium or pancuronium);
 calcium channel blockers (such as amlodipine,  disopyramide, amiodarone, flecainide, quinidine,
diltiazem);
lidocaine or mexiletine (used to control an irregular
heartbeat);
 tricyclic antidepressants, reboxetine or monoamine
oxidase inhibitors (MAOIs) (used for depression);
 aminoglutethimide (used in some cancers and Cushing’s
syndrome);
 moxisylyte (used in Raynaud’s syndrome);
 toremifene (used in some cancers);
 oestrogens and combined oral contraceptives;
 sulfonylureas (used in diabetics to control blood sugar
 allopurinol (used in gout);
levels).
If you are going to have an anaesthetic, tell your doctor or surgeon that you are taking Bendroflumethiazide tablets.

Bendroflumethiazide tablets with food, drink and alcohol
It is recommended not to take alcohol with Bendroflumethiazide Tablets as it may aggravate dizziness on standing due to low
blood pressure.

Pregnancy, breast-feeding and fertility
Bendroflumethiazide tablets should not be taken during pregnancy. Expectant mothers who take Bendroflumethiazide may be
at an increased risk of pancreatic bleeding and the newborn infant may suffer from a blood condition (thrombocytopenia) that
can result in serious bleeding. Bendroflumethiazide can also pass into breast milk, therefore it should not be used during breastfeeding. If you become pregnant whilst taking these tablets, tell your doctor straight away.

Driving and using machines
Bendroflumethiazide should not normally affect your ability to drive or operate machinery. If you find that you do get drowsy, do
not drive or operate machinery.

Blood tests
Diuretics can cause salt imbalances in the blood to occur. If you are over 60 years of age, taking high doses or are taking this
medicine for a long time, your doctor should carry out regular blood tests to check for such imbalances.

Bendroflumethiazide Tablets contain lactose
This medicine contains lactose. If you have been previously told by your doctor that you have an intolerance to some sugars
(such as lactose), contact your doctor before taking this medicine.

3. How to take Bendroflumethiazide Tablets
You will be prescribed the lowest dose needed to control your symptoms. Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets with a glass of water.

Usual doses
Adults

Adults over 60 years: Dosage may need to be

High blood pressure: 2.5mg a day in the morning.

reduced, particularly when kidney function is impaired.
Children: The dose in children depends on how
much they weigh. The starting dose is 400
micrograms per kilo of bodyweight and should be
reduced to 50 to 100 micrograms per kilo of
bodyweight.. Your doctor will tell you how many
tablets your child will have to take.

Oedema: 5mg a day in the morning. If required, this dose can be
increased to 10mg. Many patients will respond to a lower dose of 2.5mg
or 5mg on 2 or 3 days per week. In some cases, a single dose once a
week may be sufficient.
Suppression of breast milk: The usual dose is
5 mg taken in the morning and 5 mg taken at
midday. Treatment usually lasts for approximately
five days.

If you take more than you should
If you accidentally take more tablets than you should, or somebody else takes any tablets, contact a doctor or go to your nearest
hospital casualty department at once. Take any remaining tablets and the container or packaging with you so they can be
identified.

If you forget to take the tablets
If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a
forgotten dose.

If you stop taking Bendroflumethiazide Tablets
It is important that you keep taking these tablets until your doctor tells you to stop. Do not stop just because you feel better. If
you stop taking the tablets too soon your condition may get worse.

4. Possible side effects
Like all medicines Bendroflumethiazide can cause side effects although not everybody gets them.
Contact your doctor at once if you experience the following:
 allergic reaction (hypersensitivity): including severe skin reactions, which include swelling of the face, lips, tongue and/or
throat which may be accompanied by difficulty in swallowing or breathing; inflammation of the lungs (pneumonitis) or
fluid retention on the lungs (pulmonary oedema);
 if you feel very tired, experience unexpected bruising or bleeding or more infections (e.g. cold and sore throats) than usual,
please tell your doctor immediately. Your doctor may decide to conduct tests on your blood periodically as a result of these
symptoms.
Other side effects may include:
 skin rashes, sensitivity to light, blood disorders of various types
including anaemia;
 a rise in the levels of uric acid in the blood and urine which can
result in swelling of the joints (gout) may occur;
 problems with the pancreas and liver have been reported;
 dizziness or faintness on standing which may be due to a lowering
of your blood pressure;
 impotence has been reported occasionally,
although this is reversible once your treatment
is over or stopped;





dry mouth, thirst, weakness, lethargy, drowsiness,
restlessness and anxiety, muscle pain and
cramps, seizures, changes in heart rate and
blood pressure, diarrhoea and gastrointestinal
problems may be signs and symptoms of salt
imbalance. This is caused by a lowering of the
potassium or sodium in the blood;
if you are an insulin-dependent diabetic patient,
you may need to have your dose of insulin
adjusted as your body’s ability to deal with
the insulin may be affected if
you are taking Bendroflumethiazide Tablets at the
same time.

Reporting of 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, website: 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 Tablets
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in a dry place, protect from light.
Keep the container tightly closed. Do not use this medicine after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month. Do not throw away any medicine 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 the tablets contain
The active ingredient (which makes the tablets work) is bendroflumethiazide. The 2.5mg tablets contain 2.5mg of
bendroflumethiazide. The 5mg tablets contain 5mg of bendroflumethiazide. The tablets also contain lactose, maize starch,
pregelatinised starch, sodium starch glycollate and magnesium stearate.

What the tablets look like and contents of pack
The tablets are round, white tablets. Both 2.5mg and 5mg strengths are available in pack sizes of 28, 30, 50, 56, 60, 84, 100, 250,
500 and 1000.
Marketing authorisation holder and manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK.
Leaflet revised January 2014 © Dr Reddy’s Laboratories (UK) Ltd

Bendroflumethiazide 2.5mg Tablets: PL 08553/0066
Bendroflumethiazide 5mg Tablets: PL 08553/0067

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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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