PACKAGE LEAFLET: INFORMATION FOR THE USER

BENDROFLUMETHIAZIDE 2.5 mg & 5 mg TABLETS

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

-    Keep this leaflet. You may need to read it again.

-    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.

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

THIS LEAFLET CONTAINS

1.    What Bendroflumethiazide is for

2.    Before you take Bendroflumethiazide

3.    How to take Bendroflumethiazide

4.    Possible side effects

5.    How to store Bendroflumethiazide

6.    Further information

1. WHAT BENDROFLUMETHIAZIDE IS FOR

Bendroflumethiazide belongs to a group of medicines known as the thiazide diuretics. It may be used to treat:

•    a build-up of excess fluid in the body (oedema) by increasing the flow of urine

•    mild to moderate heart failure or high blood pressure (hypertension)

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE BENDROFLUMETHIAZIDE

Do not take Bendroflumethiazide and tell your

doctor if you:

•    are allergic to bendroflumethiazide, any of the other ingredients in the tablets (listed in section 6 of this leaflet) or to other thiazide diuretics

•    have severe liver or kidney problems

•    have low blood levels of potassium or sodium

•    have high blood levels of calcium or uric acid

•    have Addison’s disease (underactive adrenal glands causing tiredness, weight loss and low blood pressure)

•    medicines to treat high blood pressure, heart disease or chest pain such as captopril, enalapril (ACE inhibitors), doxazosin, prazosin (alpha-blockers), candesartan, losartan (angiotensin-II receptor antagonists), propranolol, atenolol (beta-blockers), amlodipine, moxisylyte (calcium-channel blockers), glyceryl trinitrate, isosorbide mononitrate (nitrates) or digoxin

•    medicines used to control an irregular heartbeat such as disopyramide, amiodarone, quinidine, lidocaine, mexiletine or flecainide

•    colestipol or colestyramine to lower cholesterol

•    medicines used in diabetes to lower blood sugar levels, such as sulfonylureas

•    acetazolamide to treat glaucoma (increased eyeball pressure)

•    lithium or medicines for mental health problems such as sertindole, pimozide or thioridazine

•    medicines for depression such as reboxetine, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs)

•    carbamazepine for epilepsy

•    levodopa to treat Parkinson’s disease

•    medicines known as non-steroidal anti-inflammatory drugs, used for pain and swelling such as indometacin, ibuprofen, piroxicam, naproxen or ketorolac

•    allopurinol to treat gout

•    carbenoxolone to treat stomach ulcers

•    muscle relaxants such as baclofen, tizanidine, tubocurarine, gallamine, alcuronium or pancuronium

•    medicines used to treat cancer such as aldesleukin, aminoglutethamide, toremifene or cisplatin

•    theophylline for asthma

•    corticosteroids such as prednisolone to treat inflammation or allergies

•    birth control pills or hormone replace therapy (HRT)

•    alprostadil for problems maintaining an erection

•    amphotericin for fungal infections

•    vitamin D or calcium salts

Alcohol should be avoided when taking this medicine.

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 levels of certain chemicals in your body, by carrying out tests.

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Bendroflumethiazide.

Take special care with Bendroflumethiazide

Tell your doctor before you take this medicine if you:

•    have or have had mild or moderate liver or kidney problems

•    have liver disease caused by alcohol (alcoholic cirrhosis)

•    have diabetes

•    have or have had gout (pain and swelling of the joints)

•    have Systemic Lupus Erythematosus (an inflammatory disease which causes joint pain, skin rashes and fever)

•    have porphyria (an inherited iron disorder)

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Bendroflumethiazide tablets work:

Pregnancy and breast-feeding

Make sure your doctor knows if you are pregnant, planning a pregnancy or breast-feeding and follow his / her advice.

Driving and using machines

Bendroflumethiazide tablets can cause dizziness, you should ensure you are not affected before attempting to drive or operate machinery.

Important information about some of the ingredients of Bendroflumethiazide tablets

This medicine contains lactose. If you know you have an intolerance to lactose or other sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE BENDROFLUMETHIAZIDE

Always take Bendroflumethiazide exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Take these tablets in the morning (to avoid having to pass urine at night), with a glass of water.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition.

Adults and children 12 years and over:

Oedema - Initially the typical dosage is 5 - 10 mg once a day, or once every other day.

This may then be reduced to 5 - 10 mg 1 to 3 times a week.

Hypertension - Typical dosage is 2.5 - 5 mg per day.

Elderly: If you have kidney problems you may require smaller doses. Follow your doctor’s advice.

Children under 12 years: The doctor will decide the dose for your child, as it depends on their bodyweight.

A more appropriate formulation may need to be used.

If you take more Bendroflumethiazide than you should

Contact your doctor or the nearest hospital casualty department immediately. Show them the package.

Symptoms of an overdose can include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, muscle cramps, increased frequency and volume of urination, thirst, decreased volumes within blood vessels, low blood pressure, circulation problems, low blood levels of potassium and sodium, low blood sugar levels and central nervous system depression (drowsiness, tiredness or coma).

If you forget to take Bendroflumethiazide

Don’t worry, just take it as soon as you remember and then take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

•    an increase in blood sugar levels and worsening of diabetes

•    decreased carbohydrate tolerance

•    changes in blood lipid (fat) levels

•    low blood levels of chloride ions with increased alkalinity in the body (hypochloraemic alkalosis)

•    blockage within the liver, which causes itching, yellowing of the skin or whites of the eyes (jaundice), dark urine and pale stools

•    inflammation of the pancreas, which causes severe pain in the abdomen and back

If any of the side effects become serious, or if you

notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

5. HOW TO STORE BENDROFLUMETHIAZIDE

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use these tablets after the expiry date which is stated on the package or container. 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.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

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

If you get any of the following serious side effects, stop taking Bendroflumethiazide and tell your doctor or go to the nearest hospital emergency department immediately:

•    an allergic reaction which may cause skin rashes, itching, sensitivity to sunlight, a viral infection of the lungs (pneumonitis) or fluid in the lungs (pulmonary oedema)

•    blood disorders which may cause you to have unexplained bleeding, bruising and sore throats. Regular blood and urine tests may be needed.

Other side effects may include:

•    nausea, vomiting, diarrhoea, constipation, stomach irritation

•    a fall in blood pressure on standing up, (postural hypotension), which causes dizziness, light-headedness or fainting

•    inability to maintain an erection (reversible once the tablets are stopped)

•    a decrease in blood levels of potassium, which may cause increased frequency and volume of urination, a feeling discomfort or unease, muscle weakness or cramp, dizziness, feeling or being sick and loss of appetite

•    a decrease in blood levels of sodium or magnesium

•    an increase in blood levels of calcium

•    an increase in uric acid and worsening of gout

What Bendroflumethiazide tablets contains

The active ingredient in this medicine is bendroflumethiazide. This is the new name for bendrofluazide. The ingredient itself has not changed. The other ingredients are lactose, maize starch, pregelatinised starch, sodium starch glycollate and magnesium stearate.

What Bendroflumethiazide tablets looks like and contents of the pack

Bendroflumethiazide 2.5 mg tablets are round white tablets with the marking MP18 on one side. Bendroflumethiazide 5 mg are round white tablets with the marking MP19 on one side.

The tablets come in blister packs and containers of 28, 30, 56, 60, 84, 100, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Genethics Europe Limited,

41 - 43 Klimentos, Klimentos Tower,

Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 05/2016

GE0012-0013/O/PIL/GE1