Bendroflumethiazide Tablets
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Patient information leaflet
BENDROFLUMETHIAZIDE 5MG TABLETS
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
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 other questions, or if there is something you do not understand, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to someone else. It may not be the right medicine for 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.
1. What Bendroflumethiazide is and what it is used for
Bendroflumethiazide belongs to a group of medicines called diuretics (water tablets) which increase urine production. Bendroflumethiazide is used in the treatment of high blood pressure and fluid retention (oedema).
2. What you need to know before you take Bendroflumethiazide
Do not take Bendroflumethiazide if you:
• are allergic (hypersensitive) to bendroflumethiazide or other sulphonamide-derived medicine or any of the other ingredients of this medicine (listed in section 6)
• have high blood levels of calcium (hypercalcaemia)
• have low blood levels of sodium (hyponatraemia)
• have low blood levels of potassium which has not responded to treatment (refractory hypokalaemia)
• have or have had severe kidney or liver problems
• are unable to pass urine
• have Addison’s disease (syndrome due to low level of corticosteroid hormones secretion, symptoms include weakness, loss of energy, low blood pressure and dark pigmentation of the skin)
• are taking lithium carbonate
• have gout (high levels of uric acid in the blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia)
Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if you:
• are diabetic and taking insulin
• have systemic lupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• have problems with your liver, including liver disease caused by alcohol (liver cirrhosis) or kidney problems. Patients with alcoholic cirrhosis may be at risk of developing low levels of magnesium in their blood
• are seriously ill
• have severe asthma and are taking medicines called beta-agonists; these include salbutamol, terbutaline, formosterol and salmetrol
Taking this medicine may cause you to develop low levels of potassium in your blood. If necessary, your doctor may recommend that you take a potassium supplement. This is particularly important for patients at risk of heart problems affected by the levels of potassium in the blood, such as those with severe heart disease, taking a medicine containing digitalis, taking high doses of diuretics and those with severe liver disease.
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 to see how your kidneys are working.
Other medicines and Bendroflumethiazide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines and products can affect or be affected by treatment with Bendroflumethiazide Tablets:
• 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 lithium preparation
colestyramine or colestipol (used to lower cholesterol) disopyramide, amiodarone, flecainide, quinidine, lidocaine or mexiletine, quinidine, sotalol, nitrates and cardiac glycosides (used to control an irregular heart beat) alcohol, tricyclic antidepressants or monoamine-oxidase inhibitors (MAOIs), reboxotine, sertindole, phenothiazines (used for depression)
medicines used to treat Parkinson's disease, such as levodopa other diuretics including acetazolamide and loop diuretics medicines used for diabetes, such as chlorpropamide and insulin, sulphonylureas (glimepiride) medicines used in the treatment of gout, such as allopurinol medicines, called prostaglandins, such as alprostadil medicines used to treat bacterial infections, such as trimethoprim
medicines used to treat malaria, such as halofantrine medicines, called antihistamines, used to treat allergies, such as terfenadine and astemizole carbamazepine (used in epilepsy) amphotericin (used to treat fungal infection) prazocin (used in high blood pressure, heart failure, Raynaud’s syndrome and an enlarged prostate) pimozide or thioridazine (antipsychotics) calcium salts, Vitamin D
aminoglutethimide (used in the treatment of Cushing’s syndrome)
barbiturates such as phenobarbital (used as sedatives) beta 2- sympathomimetics such as salbutamol (used in asthma) ACTH (polypeptide hormone used in Addison’s disease) moxisylyte (used in Raynaud’s syndrome) corticosteroids e.g. prednisolone cisplatin, toremifene (used to treat cancers) muscle relaxants such as baclofen, tizanidine, tubocurarine, gallamine, alcuronium or pancuronium non steroidal anti-inflammatory drugs (used to treat pain or inflammation, such as indometacin) oestrogens and combined oral contraceptives theophylline (used in breathing problems such as asthma) carbenoxolone (an ulcer healing drug) medicines used to treat kidney and skin cancer (melanoma), such as aldesleukin
medicines called general anaesthetics, used to cause loss of consciousness during surgery
medicines used to suppress the immune system following organ transplants, such as ciclosporin
Bendroflumethiazide may interfere with some laboratory tests and the patients should inform the relevant healthcare professional that they are taking these tablets if they need any blood tests.
Taking Bendroflumethiazide Tablets with food and drink
Alcohol can affect the way Bendroflumethiazide Tablets work. Drinking alcohol while you are on bendroflumethiazide may make you feel dizzy. Ask for your doctor’s advice about whether you should avoid alcohol.
Pregnancy and breast feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.
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.
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6. Contents of the pack and other information
Bendroflumethiazide contains lactose
These tablets contain lactose. If you have been told by you doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Bendroflumethiazide
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Do not take more than your doctor has recommended.
• The tablets should be swallowed with a drink of water.
The usual starting dosage instructions are given below, your doctor may decide to increase the dose if necessary.
The dosage may be lower for elderly patients and patients with kidney problems.
Keep taking the tablets until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop treatment suddenly your condition may get worse.
Adults: (Oedema)
Initially 5 - 10 mg once daily or on alternative days Maintenance: 5 - 10mg once or thrice weekly Adults: (Hypertension)
2.5 mg once daily. When Bendroflumethiazide is taken with other medicines that lower blood pressure the dose of bendroflumethiazide should be halved.
Children:
Your doctor will determine the suitable dose based on the weight of your child. The usual dose is initially up to 400microgram/kg bodyweight daily.
Maintenance: 50- 100 microgram /kg bodyweight daily.
Elderly:
The dosage of Bendroflumethiazide may need to be reduced in the elderly, particularly those with kidney problems because of the possibility of electrolyte imbalance.
If you are taking the medicine long term or if you are an elderly patient, you will need regular blood tests whilst taking this medicine.
If you take more Bendroflumethiazide than you should
If you take too many tablets tell a doctor or go to a hospital casualty department straight away. Take your medication with you. Overdose of this medicine may be dangerous. Symptoms of overdose include diarrhoea, dehydration, dizziness, weakness, muscle cramps, low blood pressure, low blood levels of potassium (hypokalaemia) and sodium (hyponatraemia), low blood sugar levels (hypoglycaemia).
If you forget to take Bendroflumethiazide
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.
If you see another doctor or go into the hospital, let them or the staff know what medicines you are taking.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Contact your doctor at once if the following serious side
effects occur:
• 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 excessive peeling or blistering of the skin
• muscle weakness, twitching or abnormal heart rhythm (hypokalaemia, hypomagnesaemia)
• tiredness and confusion, muscle twitching, fits or coma due to low sodium and high calcium levels in the blood (hyponatraemia, hypercalcaemia)
• muscles twitch, trembling of hands, numbness in the extremities and facial region due to low levels of chloride in the blood (hypochloraemic alkalosis)
• fever, chills, fatigue, inflammation of a joint, kidney problems due to high levels of uric acid in the blood (hyperuricaemia)
• forgetfulness, mild confusion, change in sleep pattern, shaking of hands or arms, slurred speech which may be signs of hepatic encephalopathy. This is more common in patients with liver cirrhosis
• 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:
• disturbances of acid/base balance, lipids levels (shown in blood tests)
• feeling sick (nausea), being sick (vomiting)
• diarrhoea, constipation, headache, drowsiness, dry mouth, thirst, weakness, dizziness, precipitation of gout
• feeling dizzy or light headed, especially when standing up (postural hypotension)
• loss of appetite or indigestion which may occur occasionally
• sensitivity to sunlight
• inflammation of blood vessels, often with skin rash (vasculitis)
• passage of large volume of urine
• loss of sexual desire, impotence (reversible on withdrawal of treatment)
• changes to various types of blood cells (shown in blood tests)
• decreased level of carbohydrate tolerance, worsening of existing diabetes
• high blood sugar level (increased thirst, dry mouth, frequent urination, tiredness)
• 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)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 use this medicine after the expiry date which is stated on the label after ‘EXP’. The expiry date refers to the last day of that month.
• Store in a cool and dry place, protected from bright light.
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 to protect the environment.
What Bendroflumethiazide tablets contain
• The active substance is Bendroflumethiazide. Each tablet contains 5mg Bendroflumethiazide.
• The other ingredients are: lactose, maize starch, povidone and magnesium stearate.
See end of section 2 for further information on lactose.
What Bendroflumethiazide tablets look like and contents of the pack
Bendroflumethiazide tablets are white, circular biconvex tablets, “PV” on one face “BF” break line “5” on the other.
Pack sizes for Bendroflumethiazide are 500 and 1000 tablets in container packs. Pharmvit Bendroflumethiazide tablets are only available in pharmacies. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:_0208 997 5433_
To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.
PL 04556 / 0012 POM|
Reference: 00120415/02
This leaflet was last revised in April 2015
