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Bendroflumethiazide 5mg Tablets

Document: leaflet MAH GENERIC_PL 08553-0067 change

Package Leaflet: Information for the User Bendroflumethiazide 2.5mg & 5mg Tablets

Bendroflumethiazide is the new name for Bendrofluazide.

If you have been taking Bendrofluazide tablets, do not worry, as this is the same medicine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you:

-    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 only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

The active ingredient in this medicine is bendroflumethiazide. Bendroflumethiazide belongs to a group of medicines called thiazide diuretics (‘water tablets’). They are used to increase the flow of urine to help reduce high blood pressure and reduce the build-up of fluid in tissue below the skin (oedema). They are also used to stop the production of breast milk.

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

Do not take Bendroflumethiazide Tablets if you:

have high levels of calcium in the blood ( hypercalcaemia);

have low levels of blood potassium

(hypokalaemia) or low blood sodium

(hyponatraemia);

have Addison’s disease (when the adrenal glands above the kidneys do not work properly, resulting in a lack of adrenal hormones).

if you:

have an inflammatory disease called systemic

lupus erythematosus, as Bendroflumethiazide

may make this condition worse;

have a blood disorder known as porphyria;

liver disease caused by alcohol (alcoholic cirrhosis).


•    are allergic to Bendroflumethiazide, other thiazide diuretics or    •

to any of the other ingredients in the tablets (see Section 6);

•    have severe liver or kidney disease;    

•    have gout or an increase in uric acid in the blood;

•    are taking lithium (for some mental disorders);

•    are pregnant, planning to become pregnant or are    

breast-feeding;

Warnings and precautions:

Talk to your doctor or pharmacist before taking Bendroflumethiazide Tablets

•    are over 60, as older adults are more sensitive to the effects    •

of thiazide diuretics;

•    have diabetes, as Bendroflumethiazide can make diabetes worse

and can reduce the effect of some drugs to control diabetes;    •

•    have kidney problems including kidney stones or gallstones;    •

Other medicines and Bendroflumethiazide Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:

levels).

If you are going to have an anaesthetic, tell your doctor or surgeon that you are taking Bendroflumethiazide tablets.


other diuretics (water tablets);

other medicines to lower blood pressure;

non steroidal anti-inflammatory drugs such as aspirin,

ibuprofen and indomethacin (used to treat pain

and inflammation);

amphotericin (used to treat fungal infections); carbamazepine (used in epilepsy); terfenadine (antihistamine for treating allergies); calcium salts or Vitamin D preparations; cisplatin (used to treat cancer);

calcium channel blockers (such as amlodipine, diltiazem);

tricyclic antidepressants, reboxetine or monoamine oxidase inhibitors (MAOIs) (used for depression); moxisylyte (used in Raynaud’s syndrome); oestrogens and combined oral contraceptives; allopurinol (used in gout);


digoxin (for heart conditions); barbiturates or opioid drugs such as codeine; corticosteroids such as prednisolone; carbenoxolone (to treat stomach ulcers); pimozide or thioridazine (antipsychotics); colestyramine or colestipol (used to lower cholesterol); prazosin (used in high blood pressure, heart failure, Raynaud’s syndrome and an enlarged prostate); muscle relaxants (such as baclofen, tizanidine, tubocurarine, gallamine, alcuronium or pancuronium);

disopyramide, amiodarone, flecainide, quinidine, lidocaine or mexiletine (used to control an irregular heartbeat);

aminoglutethimide (used in some cancers and Cushing’s syndrome);

toremifene (used in some cancers);

sulfonylureas (used in diabetics to control blood sugar


Bendroflumethiazide tablets with food, drink and alcohol

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

Pregnancy, breast-feeding and fertility

Bendroflumethiazide tablets should not be taken during pregnancy. Expectant mothers who take Bendroflumethiazide may be at an increased risk of pancreatic bleeding and the newborn infant may suffer from a blood condition (thrombocytopenia) that can result in serious bleeding. Bendroflumethiazide can also pass into breast milk, therefore it should not be used during breastfeeding. If you become pregnant whilst taking these tablets, tell your doctor straight away.

Driving and using machines

Bendroflumethiazide should not normally affect your ability to drive or operate machinery. If you find that you do get drowsy, do not drive or operate machinery.

Blood tests

Diuretics can cause salt imbalances in the blood to occur. If you are over 60 years of age, taking high doses or are taking this medicine for a long time, your doctor should carry out regular blood tests to check for such imbalances.

Bendroflumethiazide Tablets contain lactose

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

3. How to take Bendroflumethiazide Tablets

You will be prescribed the lowest dose needed to control your symptoms. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets with a glass of water.

Adults over 60years: Dosage may need to be reduced, particularly when kidney function is impaired.

Children: The dose in children depends on how much they weigh. The starting dose is 400 micrograms per kilo of bodyweight and should be reduced to 50 to 100 micrograms per kilo of bodyweight.. Your doctor will tell you how many tablets your child will have to take.


Usual doses

Adults

High blood pressure: 2.5mg a day in the morning.

Oedema: 5mg a day in the morning. If required, this dose can be increased to 10mg. Many patients will respond to a lower dose of 2.5mg or 5mg on 2 or 3 days per week. In some cases, a single dose once a week may be sufficient.

Suppression of breast milk: The usual dose is 5 mg taken in the morning and 5 mg taken at midday. Treatment usually lasts for approximately five days.

If you take more than you should

If you accidentally take more tablets than you should, or somebody else takes any tablets, contact a doctor or go to your nearest hospital casualty department at once. Take any remaining tablets and the container or packaging with you so they can be identified.

If you forget to take the tablets

If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Bendroflumethiazide Tablets

It is important that you keep taking these tablets until your doctor tells you to stop. Do not stop just because you feel better. If you stop taking the tablets too soon your condition may get worse.

4. Possible side effects

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

Contact your doctor at once if you experience the following:

•    allergic reaction (hypersensitivity): including severe skin reactions, which include swelling of the face, lips, tongue and/or throat which may be accompanied by difficulty in swallowing or breathing; inflammation of the lungs (pneumonitis) or fluid retention on the lungs (pulmonary oedema);

•    if you feel very tired, experience unexpected bruising or bleeding or more infections (e.g. cold and sore throats) than usual, please tell your doctor immediately. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.

Other side effects may include:

dry mouth, thirst, weakness, lethargy, drowsiness, restlessness and anxiety, muscle pain and cramps, seizures, changes in heart rate and blood pressure, diarrhoea and gastrointestinal problems may be signs and symptoms of salt imbalance. This is caused by a lowering of the potassium or sodium in the blood; if you are an insulin-dependent diabetic patient, 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 Tablets at the same time.


•    skin rashes, sensitivity to light, blood disorders of various types • including anaemia;

•    a rise in the levels of uric acid in the blood and urine which can result in swelling of the joints (gout) may occur;

•    problems with the pancreas and liver have been reported;

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

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: 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. Do not store above 25°C. Store in a dry place, protect from light. Keep the container tightly closed. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicine via wastewater or household waste. 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 the tablets contain

The active ingredient (which makes the tablets work) is bendroflumethiazide. The 2.5mg tablets contain 2.5mg of bendroflumethiazide. The 5mg tablets contain 5mg of bendroflumethiazide. The tablets also contain lactose, maize starch, pregelatinised starch, sodium starch glycollate and magnesium stearate.

What the tablets look like and contents of pack

The tablets are round, white tablets. Both 2.5mg and 5mg strengths are available in pack sizes of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000.

Bendroflumethiazide 2.5mg Tablets: PL 08553/0066 Bendroflumethiazide 5mg Tablets: PL 08553/0067


Marketing authorisation holder and manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 OLD, UK. Leaflet revised January 2014 © Dr Reddy’s Laboratories (UK) Ltd