PATIENT INFORMATION LEAFLET

BENDROFLUMETHIAZIDE

Tablets 2.5mg & 5mg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others; it may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

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

2.    Before you take Bendroflumethiazide Tablets

3.    How to take Bendroflumethiazide Tablets

4.    Possible side effects

5.    How to store Bendroflumethiazide Tablets

6.    Further information

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

This medicine belongs to a group of drugs known as diuretics (water tablets). This medicine is used to reduce fluid retention (oedema) caused by heart, liver or kidney conditions by increasing the flow of urine. It is also used to treat high blood pressure, either alone or in combination with other drugs which lower blood pressure.

2.    Before you take Bendroflumethiazide Tablets

Do not take these tablets if you have:

• an allergy to bendroflumethiazide or to any of the other ingredients (see section 6)

• Addison’s disease (a disorder where the adrenal glands do not produce enough steroid hormones)

•    low blood levels of sodium (hyponatraemia) or of potassium (hypokalaemia)

•    high levels of calcium in the blood (hypercalcaemia)

•    high levels of uric acid in the blood (hyperuricaemia) causing symptoms of gout ie. pain in the joints

•    acute porphyria

•    severe kidney or liver function problems.

Check with your doctor before taking these tablets if you have:

•    diabetes

•    porphyria

•    gout

•    systemic lupus erythematosus (SLE) which is a destructive skin condition

•    liver disease (cirrhosis), including that caused by alcohol

•    kidney or liver function problems

•    inflammation of the pancreas (pancreatitis)

•    prostate problems

•    severe asthma and you are taking beta agonist (sympathomimetic) medicines (see below)

•    high blood lipid levels.

Taking other medicines:

Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking:

•    any medicines for treatment of asthma including sympathomimetics (bambuterol, fenoterol, formoterol, reproterol, ritodrine, salbutamol, salmeterol, terbutaline, tulobuterol) or theophylline

•    non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation eg. ibuprofen, indometacin or ketorolac

•    medicines containing opiates, used for the relief of pain eg. codeine, morphine

•    any other medicines used to treat high blood pressure, including ACE inhibitors eg. enalapril, angiotensin II antagonists eg. losartan, alpha blockers eg. prazosin, and calcium channel blockers eg. amlodipine, diltiazem

• medicines for heart problems including beta blockers (especially sotalol) and cardiac glycosides eg. digoxin

• medicines to control irregular heart beat especially amiodarone, disopyramide, flecainide, lidocaine, mexiletine and quinidine

•    medicines to treat depression such as lithium, tricyclic antidepressants or reboxetine

•    any other diuretic medicines especially acetazolamide

•    medicines taken by mouth for diabetes especially chlorpropamide

•    corticosteroids eg. prednisolone

•    oestrogens or progesterones (as present in oral contraceptives or HRT)

•    allopurinol (used to treat gout)

•    alprostadil (for impotence)

•    aminoglutethimide (used in some cancers and Cushing's syndrome)

•    amphotericin (used to treat fungal infections)

•    calcium salts or Vitamin D

•    carbamazepine or barbiturates (used in epilepsy)

•    carbenoxolone (used for stomach ulcers)

•    cisplatin (used to treat cancer) or toremifene (for breast cancer)

•    colestyramine and colestipol (used to lower blood cholesterol)

•    pimozide (used to treat mental illness)

•    moxisylyte (for Raynaud’s syndrome)

• terfenadine (used in allergies)

• baclofen or tizanidine (muscle relaxants)

Pregnancy and breast-feeding

Bendroflumethiazide is not recommended for use in pregnant or breast-feeding women. Check with your doctor or pharmacist before taking this medicine.

Taking bendroflumethiazide with alcohol

Alcohol consumption should be kept to a minimum as this medicine increases the likelihood of dehydration after drinking alcohol.

Effects on driving or operating machinery

This medicine may cause dizziness. Do not drive or operate machinery if it has this effect on you.

Important information about an ingredient of this medicine

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

Tests

Your doctor may want to carry out regular blood tests during your treatment with this medicine, to check your kidney function and to monitor the levels of potassium and other salts, as this medicine may lead to an imbalance of salts/chemicals in your blood (see Section 4 “Possible Side Effects” for symptoms of this disorder).

3.    How to take Bendroflumethiazide Tablets

The tablets should be taken with a drink of water. The usual doses are given below but your doctor will decide the dose that is best for you. The pharmacist's label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

Adults

For fluid retention: Initially 5 mg to 10 mg once a day in the morning or on alternate days.

The maintenance dose is 2.5 mg to 5 mg two or three times a week.

For high blood pressure: 2.5 mg once a day in the morning.

Children

The dose will depend on the body weight of the child and the condition being treated, and may be given using a more appropriate formulation (i.e. a liquid).

Elderly

Your doctor may have prescribed you a lower dose than the usual adult dose, particularly if you have problems with your kidney function.

If you have taken too many tablets:

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 pack so that the medicine can be identified.

If you forget to take a dose:

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 DOSE.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and contact your doctor IMMEDIATELY as these are serious effects:

•    allergic reactions affecting the skin such as rashes, severe itching, peeling or blistering, sensitivity to light

•    allergic reactions affecting the lungs causing inflammation of the lung tissue or fluid on the lungs; signs include cough, difficulty breathing, tiredness, fever, sweating

•    yellowing of your skin or whites of your eyes, pale stools, dark urine, loss of appetite; these may be signs of liver problems caused by blocked bile flow. Damage to the brain may also occur in those who already have existing liver disease such as cirrhosis (signs include changes in personality or behaviour, abnormal movements or shaking)

•    you experience any unusual bruising, nose bleeds, feel unusually tired, have a sore throat; these may be signs of a blood disorder.

Tell your doctor or pharmacist if you suffer from any of the following other effects:

•    changes to the salts/chemicals in your blood especially of potassium, chloride, sodium and magnesium. Symptoms include mild loss of appetite, thirst, nausea, vomiting, constipation, muscle weakness, twitching, cramps, dizziness, abnormal heart rhythm, confusion, tiredness, fits

•    inability to get an erection or lack of sex drive

•    worsening of gout

•    diarrhoea and occasionally indigestion

•    feeling faint on standing up

•    increase in amount and frequency of urination

•    inflammation of the pancreas (rarely).

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 the tablets in the pack provided. Do not store above 25°C.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    Further information

Ingredients:

Bendroflumethiazide tablets are available in two strengths and contain either 2.5mg or 5mg of bendroflumethiazide as the active ingredient. They also contain the following other ingredients: lactose, maize starch, pregelatinised maize starch and magnesium stearate.

What the medicine looks like:

Bendroflumethiazide Tablets 2.5mg are white, round tablets engraved with the company logo on one side and “A268” on the other. Bendroflumethiazide Tablets 5mg are white, round tablets engraved with the company logo on one side and “C218” with a breakline on the other side.

The tablets are available in packs of 28, 30, 42, 56, 60, 84, 90,112 or 500. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.

Date leaflet revised: June 2016

If you would like this leaflet in a different format please contact the licence holder at the above address.