Package leaflet: Information for the user Bendroflumethiazide 2.5 mg Tablets BP Bendroflumethiazide 5 mg Tablets BP

bendroflumethiazide

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

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.

2. What you need to know before you take Bendroflumethiazide Tablets

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 severely impaired kidney or liver function

•    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).

Warnings and precautions

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

•    if you suffer from gout or suspected gout

•    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).

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)

•    colestipol & colestyramine (used to lower cholesterol)

•    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)

•    amphoterecin (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

•    pimozide 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

•    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

Bendroflumethiazide tablets with food, drink and alcohol

It is recommended not to consume alcohol with Bendroflumethiazide tablets as it may aggravate dizziness on standing due to low blood pressure.

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.

Bendroflumethiazide passes into breast milk, so breast-feeding should be avoided whilst taking this medicine. Driving and using machines

Bendroflumethiazide tablets can cause dizziness. Make sure you are not affected before driving or operating machinery.

Tests

During treatment with Bendroflumethiazide tablets, your doctor may want to monitor your kidney function. If you are elderly or on long term treatment with Bendroflumethiazide tablets, your doctor may want to monitor the level of chemicals in your body by carrying out tests.

Bendroflumethiazide may interfere with a number of laboratory tests including estimation of serum protein-bound iodine and tests of parathyroid function.

Bendroflumethiazide Tablets contain Lactose

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

3. How to take Bendroflumethiazide Tablets

•    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 50-10mg one to

three times a week.

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.

4. Possible side effects

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), 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 and sodium levels, 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, stomach irritation.

•    Other: inflammation of the pancreas, blocked bile flow within the liver, inability to maintain an erection, dizziness on standing due to low blood pressure (Postural hypotension), dizziness.

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 Tablets

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.

6. Contents of the pack and other information

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.

The other ingredients are: lactose, pregelatinised maize starch, maize starch, purified talc and magnesium Stearate. (See Section 2 ‘Bendroflumethiazide Tablets contain Lactose’).

What Bendroflumethiazide Tablets look like and the contents of the pack

Bendroflumethiazide tablets are white, circular and flat faced with bevelled edges, having ‘B 2.5’ (for 2.5mg) and ‘B 5’ (for 5mg) separated by a break line on one face and is plain on the reverse. Bendroflumethiazide tablets come in blister packs containing 14, 28, 56, 84 and 112 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Milpharm Limited,

Ares Block, Odyssey Business Park West End Road,

Ruislip, HA4 6QD United Kingdom

This leaflet was last revised in July 2016