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

•    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

•    If you have severe liver or kidney problems

•    If you have low blood levels of potassium or sodium

•    If you have high blood levels of calcium or uric acid

•    If you are being treated with Lithium

•    If you have Addison's disease (underactive adrenal glands causing tiredness, weight loss and low blood pressure).

Take special care with BENDROFLUMETHIAZIDE

Tell your doctor before you take this medicine if

you

have or have had liver or kidney problems

•    have low blood levels of magnesium

•    are taking Pimozide or Thioridazine for mental health problems

•    have diabetes or 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:

•    Medicines to treat high blood pressure, heart disease or irregular heartbeat such as Disopyramide or Flecainide

•    Colestipol or Colestyramine to lower cholesterol

•    Antidiabetics to lower blood sugar levels

•    Acetazolamide to treat glaucoma (increased eyeball pressure)

•    Lithium or phenothiazines for mental health problems

•    Medicines for anxiety or depression such as Reboxetine

•    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 or Ketorolac; or Allopurinol to treat gout

•    General anaesthetics to treat pain during surgery

•    Carbenoxolone to treat stomach ulcers

•    Muscle relaxants such as Baclofen or Tizanidine

•    Toremifene or Cisplatin to treat cancer

•    Theophylline for asthma

•    Steroids to treat inflammation or allergies

•    Birth control pills or Alprostadil for problems maintaining an erection

•    Amphotericin for fungal infections

•    Vitamin D or calcium salts.

Alcohol should be avoided when taking this medicine.

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

Pregnancy and breast-feeding

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

Driving and using machines

BENDROFLUMETHIAZIDE tablets should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of BENDROFLUMETHIAZIDE

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.

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:

Oedema - Initially the typical dosage is 5-10 mg per day then reduced to 5-10 mg 1 to 3 times a week. Hypertension - Typical dosage is 2.5 mg per day.

Elderly: If you have kidney problems you may require smaller doses. Follow your doctor's advice. Children: The doctor will decide the dose for your child, as it depends on their bodyweight.

If you take more BENDROFLUMETHIAZIDE than you should

Contact your doctor or pharmacist immediately. Show them the package.

If you forget to take BENDROFLUMETHIAZIDE

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

•    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

•    inflammation of the lungs, which causes breathlessness, cough and raised temperature

•    an increase of fluid in the lungs, which causes shortness of breath, coughing up blood, excessive sweating and anxiety.

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.

These may include:

•    mild loss of appetite (anorexia), nausea, vomiting, diarrhoea, constipation, aches and pains in the stomach area, worsening gout

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

•    temporary inability to maintain an erection until the tablets are stopped

•    a decrease in blood levels of potassium, sodium or magnesium

•    an increase in blood levels of calcium or uric acid

•    an increase in blood sugar levels

•    changes in blood lipid (fat) levels.

Other less common side effects include:

•    muscle cramps

•    itching, rashes, sensitivity to sunlight, severe skin reactions

•    blood disorders. Tell your doctor immediately if you have unexplained bleeding, bruising and sore throats. Regular blood and urine tests may be needed

What BENDROFLUMETHIAZIDE 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 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 approved in 05/2016

GE0012-0013/O/PIL/G1