BENDROFLUMETHIAZIDE 5 MG TABLETS BP - Patient leaflet, side effects, dosage

1. What Bendroflumethiazide Tablets are and what they are used for

Bendroflumethiazide Tablets contain bendroflumethiazide as the active ingredient. They belong to a group of medicines called thiazide diuretics (water tablets). They may be used to:

• reduce fluid retention (oedema) particularly in the heart, kidneys, liver or that caused by medication, by increasing the flow of urine
• reduce high blood pressure alone or with other medication.
• stop the production of breast milk.

Do NOT take Bendroflumethiazide Tablets if you:

• are allergic to bendroflumethi­azide, thiazides or any of the other ingredients of this medicine (listed in section 6)
• have severe liver or kidney problems, or you are unable to pass water (urine)
• have high level of calcium in your blood (hypercalcaemia)
• have low levels of sodium in your blood (hyponatraemia)
• have low levels of potassium in your blood which has not responded to treatment (refractory hypokalaemia)
• have had gout (high levels of uric acid in blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia)
• have been diagnosed with 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

Warnings and precautions

Talk to your doctor or pharmacist before taking Bendroflumethiazide Tablets if you have:

• experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Bendroflumethiazide Tablets. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.
• if you suffer from gout or suspected gout
• suffer from a condition known as hyponatraemia (low blood levels of sodium), particularly if you are elderly
• have low levels of magnesium in your blood
• mild or moderate impaired kidney or liver function
• liver disease caused by alcohol (alcohol cirrhosis)
• or may have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage.
• an inherited disorder of the red blood pigment haemoglobin causing skin blisters, abdominal pain and brain or nervous system disorders (porphyria)
• systemic lupus erythematosus (SLE) (an inflammatory disease of connective tissue causing large areas of red scaly patches on the face, hair loss, painful joints and fever).
• 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
• are seriously ill
• have severe asthma and are taking medicines called beta-agonists; these include salbutamol, terbutaline, formosterol and salmetrol.

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 or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

• allopurinol (used in gout)
• sulfonylureas (used in diabetes to control blood sugar levels) e.g. chlorpropamide
• sympathomimetics (used as decongestant, asthma or heart medicine) e.g. ephedrine
• theophylline (used in breathing problems such as asthma)
• disopyramide, amiodarone, flecainide, quinidine, lidocaine or mexiletine (used to control irregular heart beat)
• reboxetine, tricyclic antidepressants e.g. amitriptyline or monoamine-oxidase inhibitors (MAOIs) e.g. tranylcypromine (used for depression)
• carbamazepine (used in epilepsy)
• amphotericin (used to treat fungal infections)
• prazosin (used in high blood pressure, heart failure, Raynaud's syndrome and an enlarged prostate)
• antihypertensive agents (used to treat high blood pressure) such as enalapril, losartan and methyldopa
• pimozide, sertindole or thioridazine (used to treat mental illness)
• calcium salts
• calcium channel blockers (used to lower blood pressure) e.g. amlodipine or diltiazem
• moxisylyte (used in Raynaud's syndrome)
• corticosteroids (used to reduce inflammation) e.g. prednisolone
• cisplatin (used to treat cancer)
• digoxin (used to treat heart problems)
• aminoglutethamide (used in some cancers and Cushing's syndrome)
• toremifene (used in some cancers)
• lithium (used for mental health problems)
• baclofen, tizanidine, tubocurarine, gallamine, alcuronium or pancuronium (muscle relaxants)
• NSAIDs (non-steroidal anti-inflammatory drugs) such as indometacin, ketorolac, ibuprofen, piroxicam and naproxen
• oestrogen and combined oral contraceptives
• carbenoxolone, (used to treat stomach ulcers)
• vitamin D preparations
• astemizole and terfenadine (used to treat allergic conditions)
• acetazolamide (used to treat glaucoma, epileptic seizures)
• if you are receiving adrenocorticotropic (ACTH) hormone
• beta-agonists e.g. epinephrine and xanthines e.g. aminophylline (used to treat asthma)
• opioids (strong pain relieving medicine) e.g. morphine
• barbiturates (used to treat either fits or to help you sleep) e.g. phenobarbital
• aldesleukin (used to treat cancer)
• general anaesthetics
• levodopa (treatment of Parkinson's di­sease)
• trimethoprim (antibiotic to treat bacterial infection)
• take any medicines called nitrates
• alprostadil (used to treat erectile dysfunction)
• halofantrine (used to treat malaria)
• immunosuppressive agents such as ciclosporin
• cortisone and hydrocortisone (medicines used to treat inflammation)

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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 machinery.

Pharma Code

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• Always take these tablets exactly as advised by your doctor. Check with your doctor or pharmacist if you are not sure.
• The number of tablets you need will depend on your condition.
• Swallow the tablets with water in the morning (to avoid frequent urination at night).

Doses:

Adults and children 12 years and over:

• High blood pressure: 2.5mg to 5mg once a day.
• Oedema: Initially 5–10mg once a day or once every other day. The maintenance dose is 5–10mg one to three times a week.
• Suppression of breast milk: The usual dose is 5mg taken in the morning and 5mg taken at midday. Treatment usually lasts for approximately five days.

Elderly:

Your doctor may prescribe you a lower dose especially if you have impaired kidney function.

Children under 12 years:

Initially 400micrograms per kilograms of body weight, a day. The maintenance dose is 50–100micrograms per kilogram of body weight, a day.

If you take more Bendroflumethiazide Tablets than you should

If you have accidently taken too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in your original packaging with you in order to enable the doctor to identify your medicine easily. Symptoms of an overdose include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, muscle cramps, increase in the frequency and amount of urination, thirst, decreased volume within blood vessels, low blood pressure, circulation problems (peripheral circulatory failure), low blood levels of potassium (hypokalaemia) and sodium (hyponatraemia), low blood sugar levels (hypoglycaemia) and central nervous system depression (drowsiness, tiredness and coma).

If you forget to take Bendroflumethiazide Tablets

If you forget to take a dose, take it as soon as you remember it and take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Bendroflumethiazide Tablets Do not stop taking Bendroflumethiazide Tablets without seeking medical advice first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Bendroflumethiazide Tablets can cause side effects, although not everybody gets them. The frequency of the following side effects are not known.

Contact your doctor at once if you are experiencing the following:

• Allergic reactions (hypersensitivity): rashes including skin that

is red, flaky and peeling (exfoliative dermatitis), rash with red irregular spots (erythema multiforme), sensitivity to sunlight or artificial light (e.g. sun beds), inflammation of the lungs which causes breathlessness, cough and raised temperature (pneumonitis), fluid in the lungs (pulmonary oedema)

• Blood: altered numbers and types of blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.

Tell your doctor or pharmacist if you notice any of the following side effects, if they get worse, or you notice any not listed.

• Metabolism: decreased carbohydrate tolerance, worsening of existing diabetes, increased blood levels of uric acid, worsening of gout, changes in blood lipid (fat) levels and high blood sugar levels
• Chemicals within the body: low blood potassium levels (hypokalaemia), (which may cause an increase in the frequency and amount of urination, a feeling of general discomfort and illness, muscle weakness or cramp, dizziness, feeling or being sick and loss of appetite), low blood magnesium (hypomagnesaemia) and sodium levels (hyponatraemia), high blood levels of calcium (hypercalcaemia), low blood levels of chloride ions with increased alkalinity in the body (hypochloraemic alkalosis).
• Stomach and intestines: feeling or being sick, diarrhoea, constipation, severe stomach pain which may reach through to your back (pancreatitis)
• Eye disorders: Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Other: inflammation of the pancreas, blocked bile flow within the liver, inability to maintain an erection (impotence), reduced sexual desire, dizziness on

standing due to low blood pressure

• (Postural hypotension), dizziness, headache, pins and needles (paraesthesia), drowsiness, dry mouth, thirst, inflammation of the gallbladder, systemic lupus erythematosus (SLE), decreased urine production (oliguria), high levels of uric acid in blood (hyperuricaemia) with/without gout, feeling confused, fits (seizures), inflammation of blood vessels, often with skin rash (vasculitis), 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), pale stools, dark urine, yellowing of the skin or eyes (jaundice), 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), prolonged bleeding from cuts, sore mouth, fever, sore throat, chills, mouth ulcers. Not known: Frequency cannot be estimated from the available data 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 any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Bendroflumethiazide Tablets should be stored below 25°C and kept in their original package.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Bendroflumethiazide Tablets contain

The active substance is Bendroflumethi­azide.

• each 2.5mg tablet contains 2.5mg of bendroflumethi­azide.
• each 5mg tablet contains 5mg of bendroflumethi­azide.

480 mm