Bendroflumethiazide Tablets

Document: leaflet MAH GENERIC_PL 00289-0173 change

PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 210

(Main)

BENDROFLUMETHIAZIDE 2.5 mg AND 5 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking this medicine.

i* Keep this leaflet. You may need to read it again.

i» If you have any further questions, 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, i* If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1. What Bendroflumethiazide is and what it is used for

2. Before you take Bendroflumethiazide

3. How to take Bendroflumethiazide

4. Possible side effects

5. How to store Bendroflumethiazide

6. Further information

OWHAT BENDROFLUMETHIAZIDE IS AND WHAT IT IS USED FOR

i» Bendroflumethiazide is a type of medicine called a thiazide diuretic, which increases the amount of water (urine) passed.

i» Bendroflumethiazide is used :

• to treat high blood pressure • to treat oedema (water retention)

• to suppress the production of breast milk.

©BEFORE YOU TAKE

BENDROFLUMETHIAZIDE

DO NOT take Bendroflumethiazide if you:

!» are allergic (hypersensitive) to bendroflumethiazide or any of the other ingredients of this medicine i» are allergic (hypersensitive) to any diuretics belonging to the thiazide group, such as chlortalidone, metolazone or cyclopenthiazide • have severe liver or kidney problems

l» suffer from hypercalcaemia (high level of calcium in the blood) i» suffer from an imbalance of water and salts in the body ^ suffer from Addison's disease suffer from gout.

Take special care with

Bendroflumethiazide

Tell your doctor before you start to

fake this medicine if you:

f are pregnant or breast-feeding • have ever suffered from gout !» have mild to moderate liver or kidney problems

r suffer from, or have a history of systemic lupus erythematosus (autoimmune disorder)

^ suffer from alcoholic liver disease f are diabetic (your blood glucose levels may be affected, please see "Taking other medicines").

Your doctor may carry out blood tests 'especially if you are elderly or taking fhis medicine long term.

Taking other medicines

ilf you are taking Bendroflumethiazide in combination with the following 'medicines, your doctor may adjust the 'dose of the other medicine whilst you are taking these tablets: p medicines used to treat high blood pressure e.g. prazosin p insulin (you may need to have your dose of insulin adjusted as your body's ability to deal with the insulin may be affected if you are taking Bendroflumethiazide at the same time).

Talk to your doctor Tf you are taking any of the following:

• colestipol or colestyramine (medicines to reduce the level of fats in the blood); read section 3 "How to take Bendroflumethiazide"

• non-steroidal anti-inflammatory drugs (NSAID) e.g. indometacin

• any medicines used to treat asthma

• carbamazepine, an antiepileptic

• amphotericin (for infections)

• calcium salts

• vitamin D preparations

• cisplatin, toremifene or aminoglutethimide (used to treat cancer)

• disopyramide, amiodarone, flecainide, quinidine, mexiletine, sotalol or digoxin or calcium-channel blockers, e.g. nicardipine (used to treat heart problems)

• corticosteroids (used to reduce inflammation) e.g. prednisolone

• moxisylyte, used to treat Raynaud's syndrome

• any medicines used to treat depression e.g. amitriptyline, phenelzine or reboxetine

• muscle relaxants, e.g. baclofen or tizanidine

• oral contraceptives

• any medicines used to treat mental illness e.g. lithium, pimozide or thioridazine

• terfenadine, used to treat allergies

• any pain-killers which contain opioids such as codeine, diamorphine or pentazocine

• barbiturates e.g. amobarbital or phenobarbital

• ACTH (corticotropin), acetazolamide (used to treat glaucoma)

• MAOIs (Monoamine Oxidase Inhibitors) which are a group of drugs used for depression.

If you are due to undergo surgery or dental treatment which may require the use of a muscle relaxant e.g. tubocurarine, or lidocaine (a local anaesthetic), consult your doctor.

Please tell your doctor or pharmacist if, you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information about some of the ingredients of Bendroflumethiazide

• Patients who are intolerant to lactose should note that Bendroflumethiazide tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Taking Bendroflumethiazide with food and drink

• You should avoid alcohol while taking these tablets, as it may increase any feeling of dizziness you may experience.

Pregnancy and breast-feeding

• Bendroflumethiazide is not recommended if you are pregnant, planning to become pregnant or are breast-feeding. Ask your doctor for advice before taking this medicine.

Driving and using machines

• Bendroflumethiazide is not known to, affect your ability to drive or operatei machinery.

©HOWTOTAKE

BENDROFLUMETHIAZIDE

Always take Bendroflumethiazide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Bendroflumethiazide may be taken with or without food.The tablets should be swallowed preferably with a _glass of water.Xhejjsua] dosejs:___i

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• Adults

• High Blood Pressure:

2.5 mg daily in the morning. Your doctor may occasionally prescribe a higher dose depending on your response to treatment.

• Water Retention (oedema):

5-10 mg daily in the morning or on alternate days.The maintenance dose is 5 - 10 mg one to three times a week.

• To Inhibit Breast Milk:

5 mg in the morning and 5 mg at noon, for five days.

• Elderly

Initially your doctor will start you on a lower dose.

• Children

The dosage will depend upon the weight of the child. Usually 400 micrograms per kilogram of bodyweight initiaIly.This may be reduced to a maintenance dose of 50 - 100 micrograms per kilogram of bodyweight daily.

• Taking Bendroflumethiazide in combination with colestipol or colestyramine:

If you are also taking colestipol or colestyramine, you should take these either 2 hours before or 2 hours after taking Bendroflumethiazide.

If you take more Bendroflumethiazide than you should

If you (or someone else) swallow a lot pf the tablets all together, or if you ithink a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor Immediately.

An overdose is likely to cause nausea, vomiting, loss of appetite, increased urination, diarrhoea, dehydration, idizziness, hypotension (low blood pressure), weakness, muscle cramps, twitching, numbness and tingling, igastric bleeding, low blood levels of 'sodium and potassium, effects on blood sugar levels, a change in the acid base balance of the body.

Please take this leaflet, any remaining itablets, and the container with you to ithe hospital or doctor so that they know which tablets were consumed.

If you forget to take Bendroflumethiazide

DO NOT take a double dose to make up for a forgotten tablet

If you stop taking Bendroflumethiazide

You should continue to take these itablets for as long as your doctor tells you to.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Bendroflumethiazide pan cause side effects, although not leverybody gets them.

Stop taking the tablets and tell your doctor immediately or go to the

casualty department at your nearest hospital if the following happens,: i» an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or nettle rash).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor if you experience any 'of the following whilst taking Bendroflumethiazide Tablets:

• skin rashes

• sensitivity to light

i» blood disorders of various types including anaemia reduction of red blood cells and altered level of fat in your blood

'• problems with die pancreas__

• "problem's withlhe fiver

• salt imbalance caused by a lowering of the levels of potassium or sodium in the blood. Signs of salt imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, restlessness and anxiety, muscle pain and cramps, seizures, changes in heart rate and blood pressure, and gastro-intestinal disturbances

• dizziness or faintness on standing which may be due to a lowering of your blood pressure

• there may be a rise in the level of uric acid in the blood which can result in swelling of the joints (gout)

• impotence has been reported occasionally, although this is reversible once your treatment with BendroflumethiazideTablets is over or stopped

• reduced carbohydrate tolerance if you are a diabetic

• stomach problems.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOWTO STORE BENDROFLUMETHIAZIDE

Keep out of the reach and sight of children.

Do not use Bendroflumethiazide after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These' measures will help to protect the environment.

FURTHER INFORMATION

What BendroflumethiazideTablets contain:

• The active ingredient is bendroflumethiazide.

• The other ingredients are lactose monohydrate, maize starch, povidone, sodium starch glycolate, magnesium stearate, and colloidal silicon dioxide.

What BendroflumethiazideTablets look like and contents of the pack:

• The 2.5 mg tablets are white, round, flat, bevel edged tablets engraved BERK 1G5 on one side and plain on the reverse, or 1G5 on one side and plain on the reverse.

• The 5 mg tablets are white, biconvex tablets engraved BERK 2G5 on one side with a break line on the reverse, or 2G5 on one side with a break line on the reverse.

• BendroflumethiazideTablets are available in pack sizes of 7, 10, 14,

21,28, 30, 56, 60, 84, 90, 100, 110,

112, 120, 150, 160, 168, 1000 and 10000 tablets.The 2.5 mg tablets are also available in packs of 500 tablets, and the 5 mg tablets are also available in packs of 25 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne,

BN229AG.

This leaflet was last revised:

March 2008

PL 00289/0172-0173

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XEVA UK LIMITED_