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Bendroflumethiazide 2.5mg Tablets

Document: label-leaflet MAH GENERIC_PL 04416-0529 change

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For oral administration, as directed by the doctor.


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To not store above 25°C. Keep container tightly closed.



Sandoz Ltd,

Woolmer Way, Bordon, Hants, GU35 9QE.


| POM |

SZ90203LL01A


daily as a single dose or in two divided daily doses, adjusted according to response.

Elderly:

The dosage may need to be reduced, particularly when the patient is suffering from kidney disease.

•    Your doctor will decide the dose that is best for you. The pharmacist’s label will also tell you how many tablets to take and how often. If you are not sure about anything ask your doctor or pharmacist.

•    Do not stop taking this medicine without consulting your doctor.

•    Try to take your medicine at the same time every day. If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES.

   If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the container so that the medicine can be identified.

AFTER TAKING THIS MEDICINE

   Along with the needed effects, this medicine may cause side effects in certain patients. The more common side effects are impotence (difficulty in maintaining an erection); mild loss of appetite and


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indigestion may also occur but these can be reduced by taking the tablets during a meal or immediately after eating. Other side effects include hypersensitivity reactions such as pneumonitis (inflammation of the lungs), skin sensitive to light, joint pain, lower back or side pain, disturbances of electrolyte and acid/base balance, lipids, uric acid levels, nausea, vomiting, diarrhoea, constipation, thirst and excretion of excessive amounts of urine, dark urine, light-coloured stools; difficult, noisy, fast breathing, sometimes with wheezing; blue lips and fingernails, pale skin, increased sweating, dry mouth, increased thirst, irregular heartbeat, mood or mental changes, muscle pain, weak pulse, convulsions, swollen glands, itching, weakness, dizziness, muscle cramps, decreased sexual ability, gout, light-headedness and, in patients with liver disease, hepatic encephalopathy (disorder of the nervous system characterised by tremor and musty odour of breath) may occur. Rare side effects are skin reactions, pancreatitis (inflammation of the pancreas causing abdominal pain, back pain, fever and rapid pulse rate) and changes to blood cells. If you get a bad sore throat or high temperature or become more tired and pale, or you bruise or have nose bleeds more frequently, contact your doctor immediately.

As with all thiazides, Bendroflumethiazide increases the loss of potassium in the urine which can cause a variety of symptoms such as weakness and confusion. This imbalance can be corrected by taking potassium supplements or potassium sparing diuretics. A diet that is rich in potassium (fresh fruit and vegetables) may be helpful.


   You will need to have regular blood tests to check your levels of potassium and other electrolytes while you are taking Bendroflumethiazide.

•    Consult your doctor if any of these symptoms persist or become troublesome.

   Tell your doctor straight away if you get a rash for the first time after taking the medicine as it may be a sign of allergy.

   Tell your doctor or pharmacist if you notice any other unusual or unexpected symptoms.

STORING THIS MEDICINE

•    Do not store above 25°C. Keep container tightly closed.

   KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.

   Unless your doctor tells you to, do not keep any tablets that you no longer need. Return them to the pharmacist.

•    Remember this medicine is for YOU. Do not give it to anyone else, even if their symptoms are the same as yours. This medicine may harm them.

   Do not take the tablets if the expiry date on the label has passed.

Date of revised leaflet: June 2006


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PATIENT INFORMATION LEAFLET

Bendroflumethiazide 2.5mg Tablets

Please read this leaflet carefully before you start taking your tablets. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

WHAT YOU SHOULD KNOW ABOUT THIS MEDICINE

The active ingredient in this medicine is bendroflumethiazide. This is the new name for bendrofluazide. The ingredient has not changed.

•    Bendroflumethiazide Tablets contain 2.5mg of Bendroflumethiazide as the active ingredient. They also contain the following other ingredients: lactose, maize starch and magnesium stearate.

•    This medicine is available in pack sizes of 28, 56, 84, 112 or 500 tablets.

   The product licence holder of this medicine is: Sandoz Ltd, Woolmer Way,

Bordon, Hants, GU35 9QE. The manufacturer of this medicine is: Crescent Pharma Ltd, Units 3 & 4 Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.

   This medicine belongs to a group of drugs known as thiazide diuretics. These are

used for increasing water loss through the kidneys; this makes you pass more water.

   This medicine is used for reducing swelling of any part of the body caused by heart, liver or kidney conditions and is frequently used to treat high blood pressure, either alone or in combination with other drugs which lower blood pressure.

WHAT YOU SHOULD CHECK BEFORE TAKING THIS MEDICINE

   Do not take this medicine if you are allergic to Bendroflumethiazide or any of the ingredients listed above.

•    Do not take this medicine if you have Addison’s disease (underactive adrenal gland), hyponatraemia (low levels of sodium in the blood), refractory hypokalaemia (long-term problems with low levels of potassium in the blood), hypercalcaemia (high levels of calcium in the blood), symptomatic hyperuricaemia (high levels of uric acid in the blood), acute poiphyria (blood metabolism disorder) or if you have long-term kidney or liver problems.

•    Tell your doctor or pharmacist if you are taking any other medicines, including any that you can buy without a prescription. This is particularly important if you are taking medicines known as non-steroidal anti-inflammatory drugs such as indometacin, ketorolac, ibuprofen, diclofenac or mefenamic acid; sulphonylureas e.g. chlorpropamide, glipizide and glibenclamide for diabetes; ulcer healing drugs such as carbenoxolone; pain relieving opiates such as levacetylmethadol; lithium, calcium salts, vitamin D, amphotericin, triamterene, theophylline, carbamazepine, terfenadine, pimozide; alprostadil, barbiturates, cisplatin, aminoglutethimide,

toremifene, moxisylyte; medicines for high blood pressure including prazosin; cardiac glycosides such as digoxin; amiodarone, disopyramide, flecainide, quinidine, lidocaine and mexiletine; tricyclic antidepressants such as amitriptyline and reboxetine; beta-blockers such as sotalol; medicines known as calcium-channel blockers such as verapamil; corticosteroids such as prednisolone; baclofen, tizanidine and non-depolarising neuromuscular blocking drugs such as pancuronium and atracurium; oestrogens and combined oral contraceptives; acetazolamide and loop diuretics such as furosemide; beta2 agonists such as bambuterol, fenoterol, formoterol, reproterol, ritodrine, salmeterol, tulobuterol, and salbutamol or terbutaline.

   Consult your doctor before taking this medicine if you have diabetes, gout, porphyria (blood metabolism disorder), pancreatitis (inflammation of the pancreas), hypercalcaemia (excessive calcium in the blood), systemic lupus erythematosus (a destructive skin condition), enlarged prostate, hyperlipidaemia (excessive fat in the blood), alcohol related liver problems, other liver problems, kidney problems or if you have severe asthma and are also taking beta2 agonist medicines such as salbutamol or terbutaline, or if you are pregnant or are breast feeding.

•    If you are going for an operation you should tell the doctor or dentist that you are taking this medicine.

   Alcohol consumption should be kept low as Bendroflumethiazide increases the

likelihood of dehydration and hangover after consumption of alcohol.

•    If you are taking the anion-exchange resin medicine colestyramine or colestipol, do not take at the same time as your Bendroflumethiazide medicine. Instead, take them 2 hours apart.

•    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

HOW TO TAKE THIS MEDICINE

•    Swallow the tablets with water.

DOSE:

Adults:

Diuretic (for swelling of any part of the body): initially 5mg to 10mg in the morning daily or on alternate days. Maintenance: 2.5 to 5mg two or three times a week. Antihypertensive (for lowering blood pressure): 2.5mg in the morning, alone or in conjunction with other blood pressure lowering agents.

Children:

Diuretic (for swelling of any part of the body): dosage in children may be up to 0.4mg per kg of bodyweight daily initially, reducing to 0.05 to 0.1mg per kg of bodyweight for maintenance.

Antihypertensive (for lowering blood pressure): 0.05 to 0.4mg per kg of bodyweight

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mini


For oral administration, as directed by the doctor.


Bendroflu-

methiazide

2.5mg Tablets

Each tablet contains: Bendroflumethiazide 2.5mg.

Also contains lactose.

500 tablets


For further information, see Patient Information Leaflet.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Do not store above 25°C. Keep container tightly closed.

PL 04416/0529



Sandoz Ltd, WoolmerWay, Bordon, Hants, GU35 9QE.


|POM|


SZ90203LL01A