5 mm

30 mm

8 mm

PATIENT LEAFLET: INFORMATION FOR THE USER BENDROFLUMETHI­AZIDE 2.5 MG or 5 MG TABLETS

Bendroflumethi­azide

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 queries, 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 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 name of your medicine is Bendroflumethiazide 2.5 mg tablets or

Bendroflumethiazide 5mg tablets. The active ingredient is Bendroflumethi­azide.

Bendroflumethiazide tablets belong to a group of medicines called thiazide diuretics (water tablets). They may be used to:

• reduce fluid retention (oedema) particularly in the heart, kidneys, liver or that caused by medication, by increasing the flow of urine.
• reduce high blood pressure alone or with other medication.

2. what you need to know before you take bendroflumethiazide tablets

Do not take Bendroflumethiazide tablets and tell your doctor if you:

• are allergic to thiazides or any of the other ingredients in Bendroflumethiazide tablets (see section 6).
• have high levels of calcium in your blood (hypercalcaemia)
• have severe liver or kidney problems, or you are unable to pass water

(urine)

• have underactive adrenal glands (Addison’s disease- syndrome due to low level of corticosteroid hormones secretion, symptoms include weakness, loss of energy, low blood pressure and dark pigmentation of the skin).
• low blood levels of sodium (hyponatraemia).
• low blood levels of potassium which has not responded to treatment (refractory hypokalaemia).
• or have had gout (high levels of uric acid in the blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia).

Warnings and Precautions

Check with your doctor, nurse or pharmacist before taking Bendroflumethiazide tablets if you:

• have taken high doses of Bendroflumethiazide Tablets or have taken the tablets for a long time, or if you have severe heart disease or are taking digitalis preparations (e.g. digoxin). Your doctor may decide you need to take potassium supplement tablets
• have problems with your liver or kidneys
• have photosensitive skin (risk of developing sunburn)
• suffer from a condition known as hyponatraemia (low blood levels of sodium), particularly if you are elderly
• have low blood levels of magnesium
• have low blood levels of potassium (hypokalaemia)
• have low blood levels of calcium (hypocalcaemia)
• have high blood cholesterol level (hyperlipidaemia)
• suffer from pancreatitis
• are diabetic or suffer from gout
• have a condition known as systemiclupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• Have liver disease caused by alcohol (alcoholic cirrhosis).
• Have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking this medicine. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

If you are elderly or have taken Bendroflumethiazide Tablets for a long time, your doctor will perform regular blood tests to check the levels of electrolytes (salts) in your blood.

Other medicines and Bendroflumethiazide Tablets

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

Especially:

• medicines used to treat high blood pressure including ACE inhibitors, (e.g. Enalapril) angiotensin-II antagonists (e.g. Losartan), alpha-blockers, such as prazosin, beta-blockers, calcium channel blockers (e.g. amlodipine and diltiazem), hydralazine, diazoxide and methyldopa
• medicines used for heart problems including amiodarone, disopyramide, flecainide, lidocaine, mexiletine, quinidine, sotalol, nitrates and cardiac glycosides (e.g. digoxin)
• medicines used to treat Parkinson’s di­sease, such as levodopa
• medicines used to treat epilepsy, such as carbamazepine
• medicines taken for depression and mental illness including tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), reboxetine, pimozide, sertindole, lithium and phenothiazines
• other diuretics including acetazolamide and loop diuretics
• medicines used for diabetes, such as chlorpropamide and insulin
• medicines used to treat asthma called beta-agonists
• medicines used in the treatment of gout, such as allopurinol
• medicines, called prostaglandins, such as alprostadil
• medicines used to treat fungal infections, such as amphotericin
• medicines used to treat bacterial infections, such as trimethoprim
• medicines used to treat malaria, such as halofantrine
• medicines used as dietary supplements, such as calcium salts or vitamin D
• medicines used to treat inflammation, such as prednisolone, cortisone and hydrocortisone
• medicines used to treat stomach ulcers, such as carbenoxolone
• medicines used to treat high blood cholesterol, such as cholestyramine and colestipol
• medicines, called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain or inflammation, such as indomethacin, ketorolac, ibuprofen, piroxicam or naproxen
• medicines, called antihistamines, used to treat allergies, such as terfenadine and astemizole
• medicines, called muscle relaxants, such as tizanidine, baclofen, tubocurarine, gallamine, alcuronium or pancuronium
• medicines used in the treatment of breast cancer, called hormone

antagonists, such as toremifene

• medicines used to treat kidney and skin cancer (melanoma), such as aldesleukin
• medicines called general anaesthetics used to stop pain during surgery
• medicines used to suppress the immune system following organ transplants, such as ciclosporin.
• Thioridazine (antipsychotics)
• Medicines called sulfonylureas which are used in diabetes to control blood sugar levels
• moxisylyte (used in Raynaud’s syndrome)
• cisplatin (used to treat cancer)
• aminoglutethamide (used in some cancers and Cushing’s syndrome)
• oestrogens and combined oral contraceptives
• sympathomimetics (used as decongestant, asthma or heart medicine)
• Theophylline is a xanthine (used in breathing problems such as asthma)
• acetazolamide, which is used to treat glaucoma (increased pressure in the eye), epilepsy or for preventing altitude sickness
• if you are receiving adrenocorticotropic (ACTH) hormone
• opioids (strong-pain relieving medicines)
• barbiturates (medicines used to treat either fits or to help you sleep)

Tell your doctor if you are having or have had tests for thyroid problems.

Pregnancy, breast-feeding and fertility

If you are pregnant or thinking of becoming pregnant, check with your doctor before you use Bendroflumethiazide Tablets. Your doctor will decide if you should take them.

Do not breast-feed if you are taking Bendroflumethiazide Tablets. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bendroflumethiazide tablets may cause dizziness, drowsiness and mental confusion. Make sure you are not affected before driving or operating machinery.

Bendroflumethi­azide tablets with food, drink and alcohol

Alcohol can affect the way Bendroflumethiazide Tablets work. During treatment with Bendroflumethiazide Tablets, talk to your doctor before consuming alcoholic drinks.

Tests

During treatment with Bendroflumethiazide tablets, your doctor may want to monitor your kidney function. If you are elderly or on long term treatment XXXXXXXX

10 mm

Same size artwork 400 x 140 mm Front

10 mm

with Bendroflumethiazide tablets, your doctor may want to monitor the level of chemicals in your body by carrying out tests.

Bendroflumethiazide may interfere with a number of laboratory tests including estimation of serum protein-bound iodine and tests of parathyroid function.

Bendroflumethi­azide Tablets contain Lactose

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

|           3. How to take Bendroflumethiazide Tablets           |

• Always take this medicine exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.
• The number of tablets you need will depend on your condition.
• Swallow the tablets with water in the morning (to avoid frequent urination at night).

Doses:

Adults and children 12 years and over:

• High blood pressure: 2.5 mg to 5 mg once a day.
• Oedema: Initially 5–10mg once a day or once every other day. The maintenance dose is 5–10mg one to three times a week.

Elderly:

Your doctor may prescribe you a lower dose especially if you have impaired kidney function.

Children under 12 years:

A more appropriate formulation may be used. Initially 400micrograms per kilogram of body weight a day. The maintenance dose is 50–100 micrograms per kilogram of body weight, a day.

If you take more Bendroflumethiazide Tablets than you should

If you accidently take too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/ Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily. Symptoms of an overdose include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, fits (seizures) muscle cramps, increase in the frequency and amount of urination, thirst, decreased volume within blood vessels, low blood pressure, circulation problems (peripheral circulatory failure), low blood levels of potassium (hypokalaemia), magnesium (hypomagnaesia), calcium (hypocalcaemia) and sodium (hyponatraemia), low or increased blood sugar levels (hypoglycaemia or hyperglycaemia), lack of appetite (anorexia) and central nervous system depression (drowsiness, tiredness and coma).

If you forget to take Bendroflumethiazide tablets

If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Serious side effects

Stop taking this medicine and seek medical advice immediately if you have any of the following reactions:

• severe allergic reaction (anaphylaxis). The signs of an allergic reaction may include rash, itching, difficulty breathing and/or swelling of your lips, face, throat or tongue
• systemic lupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• inflammation of the lungs that can cause a cough or shortness of breath
• inflammation of the kidney which can cause you to have a fever or to pass more or less urine than normal
• severe stomach pain which may reach through to your back (pancreatitis)
• fluid in the lungs that can cause you to cough up blood and make it difficult for you to breathe
• serious skin condition with blistering of the skin
• feeling sick (nausea) or being sick (vomiting)
• loss of appetite
• feeling dizzy or light headed, especially when standing up (low blood pressure)
• changes to various types of blood cells (shown in blood tests) (symptoms like sore mouth, fever, sore throat, mouth ulcers)
• thrombocytopenia (excessive bruising or prolonged bleeding from cuts)
• feeling weak, tired, drowsy or sleepy
• feeling confused
• muscle cramp
• sudden headache
• fits (seizures)
• skin rash caused by exposure to light (photosensitivity).
• Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Cholestasis (decrease in bile)
• Cholecystitis (inflammation in gall bladder)

Other side effects that may be experienced while taking this medicine are

Not known: frequency cannot be estimated from the available data

• headache
• dizziness
• tingling or numbness in the hands or feet
• drowsiness
• diarrhoea
• constipation
• dry mouth and thirst
• inflammation of blood vessels, often with skin rash (vasculitis)
• an increase in uric acid in your blood (gout)
• being unable to achieve an erection (impotence)
• diabetes
• changes in the salts and electrolytes in your blood (shown in blood tests)
• an increase in the levels of certain types of lipids and cholesterol in your blood (shown in blood tests)
• pale stools, dark urine, yellowing of the skin or eyes (jaundice)
• severe pain in the lower back or sides (kidney stones)
• passing less urine than normal
• high level of calcium in the blood

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store bendroflumethiazide tablets

• Containers and blister carton: Do not store above 250C.
• Store in the original packaging and keep the packaging tightly closed in order to protect the tablets from light and moisture.
• 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 medicines 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 Bendroflumethiazide Tablets contain

• The active substance is bendroflumethi­azide. This is the new name for bendrofluazide. The ingredient itself has not changed.
• Bendroflumethiazide Tablets come in two strengths 2.5mg and 5mg. Each tablet contains either 2.5mg or 5mg of the active ingredient.
• The other ingredients are: lactose, pregelatinised starch, talc and stearic acid.

What Bendroflumethiazide Tablets look like and contents of the pack.

• Bendroflumethiazide 2.5 mg Tablets are white to almost white circular, biconvex, uncoated tablets.
• Bendroflumethiazide 5 mg Tablets are white to almost white, circular, flat, beveled edged, uncoated tablets with ‘5’ debossed on one side.
• Bendroflumethiazide Tablets come in blister packs containing 14, 28, 56 or 84 tablets and containers containing 50, 100, 250, 500 or 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

Email:

Bendroflumethi­azide 2.5 mg tablets; PL 17907/0082

Bendroflumethi­azide 5 mg tablets; PL 17907/0083

This leaflet was last revised in November 2020

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V15 18–11–20 D0

10 mm

Same size artwork 400 x 140 mm

Back

10 mm

30 mm |

PATIENT LEAFLET: INFORMATION FOR THE USER

BENDROFLUMETHI­AZIDE 2.5 MG

or 5 MG TABLETS

Bendroflumethi­azide

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 queries, 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 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 name of your medicine is Bendroflumethiazide 2.5 mg tablets or Bendroflumethiazide 5mg tablets. The active ingredient is Bendroflumethi­azide. Bendroflumethiazide tablets belong to a group of medicines called thiazide diuretics (water tablets). They may be used to:

• reduce fluid retention (oedema) particularly in the heart, kidneys, liver or that caused by medication, by increasing the flow of urine.
• reduce high blood pressure alone or with other medication.

2. what you need to know before you take bendroflumethiazide tablets

Do not take Bendroflumethiazide tablets and tell your doctor if you:

• are allergic to thiazides or any of the other ingredients in Bendroflumethiazide tablets (see section 6).
• have high levels of calcium in your blood (hypercalcaemia)
• have severe liver or kidney problems, or you are unable to pass water (urine)
• have underactive adrenal glands (Addison’s disease- syndrome due to low level of corticosteroid hormones secretion, symptoms include weakness, loss of energy, low blood pressure and dark pigmentation of the skin).
• low blood levels of sodium (hyponatraemia).
• low blood levels of potassium which has not responded to treatment (refractory hypokalaemia).
• or have had gout (high levels of uric acid in the blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia).

Warnings and Precautions

Check with your doctor, nurse or pharmacist before taking Bendroflumethiazide tablets if you:

• have taken high doses of Bendroflumethiazide Tablets or have taken the tablets for a long time, or if you have severe heart disease or are taking digitalis preparations (e.g. digoxin). Your doctor may decide you need to take potassium supplement tablets
• have problems with your liver or kidneys
• have photosensitive skin (risk of developing sunburn)
• suffer from a condition known as hyponatraemia (low blood levels of sodium), particularly if you are elderly
• have low blood levels of magnesium
• have low blood levels of potassium (hypokalaemia)
• have low blood levels of calcium (hypocalcaemia)
• have high blood cholesterol level (hyperlipidaemia)
• suffer from pancreatitis
• are diabetic or suffer from gout
• have a condition known as systemiclupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• Have liver disease caused by alcohol (alcoholic cirrhosis).
• Have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking this medicine. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

If you are elderly or have taken Bendroflumethiazide Tablets for a long time, your doctor will perform regular blood tests to check the levels of electrolytes (salts) in your blood.

Other medicines and Bendroflumethiazide Tablets

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

Especially:

• medicines used to treat high blood pressure including ACE inhibitors, (e.g. Enalapril) angiotensin-II antagonists (e.g. Losartan), alpha-blockers, such as prazosin, beta-blockers, calcium channel blockers (e.g. amlodipine and diltiazem), hydralazine, diazoxide and methyldopa
• medicines used for heart problems including amiodarone, disopyramide, flecainide, lidocaine, mexiletine, quinidine, sotalol, nitrates and cardiac glycosides (e.g. digoxin)
• medicines used to treat Parkinson’s di­sease, such as levodopa
• medicines used to treat epilepsy, such as carbamazepine
• medicines taken for depression and mental illness including tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), reboxetine, pimozide, sertindole, lithium and phenothiazines
• other diuretics including acetazolamide and loop diuretics
• medicines used for diabetes, such as chlorpropamide and insulin
• medicines used to treat asthma called beta-agonists
• medicines used in the treatment of gout, such as allopurinol
• medicines, called prostaglandins, such as alprostadil
• medicines used to treat fungal infections, such as amphotericin
• medicines used to treat bacterial infections, such as trimethoprim
• medicines used to treat malaria, such as halofantrine
• medicines used as dietary supplements, such as calcium salts or vitamin D
• medicines used to treat inflammation, such as prednisolone, cortisone and hydrocortisone
• medicines used to treat stomach ulcers, such as carbenoxolone
• medicines used to treat high blood cholesterol, such as cholestyramine and colestipol
• medicines, called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain or inflammation, such as indomethacin, ketorolac, ibuprofen, piroxicam or naproxen
• medicines, called antihistamines, used to treat allergies, such as terfenadine and astemizole
• medicines, called muscle relaxants, such as tizanidine, baclofen, tubocurarine, gallamine, alcuronium or pancuronium
• medicines used in the treatment of breast cancer, called hormone antagonists, such as toremifene
• medicines used to treat kidney and skin cancer (melanoma), such as aldesleukin
• medicines called general anaesthetics used to stop pain during surgery
• medicines used to suppress the immune system following organ transplants, such as ciclosporin.
• Thioridazine (antipsychotics)
• Medicines called sulfonylureas which are used in diabetes to control blood sugar levels
• moxisylyte (used in Raynaud’s syndrome)
• cisplatin (used to treat cancer)
• aminoglutethamide (used in some cancers and Cushing’s syndrome)
• oestrogens and combined oral contraceptives
• sympathomimetics (used as decongestant, asthma or heart medicine)
• Theophylline is a xanthine (used in breathing problems such as asthma)
• acetazolamide, which is used to treat glaucoma (increased pressure in the eye), epilepsy or for preventing altitude sickness
• if you are receiving adrenocorticotropic (ACTH) hormone
• opioids (strong-pain relieving medicines)
• barbiturates (medicines used to treat either fits or to help you sleep)

Tell your doctor if you are having or have had tests for thyroid problems.

Pregnancy, breast-feeding and fertility

If you are pregnant or thinking of becoming pregnant, check with your doctor before you use Bendroflumethiazide Tablets. Your doctor will decide if you should take them.

Do not breast-feed if you are taking Bendroflumethiazide Tablets. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bendroflumethiazide tablets may cause dizziness, drowsiness and mental confusion. Make sure you are not affected before driving or operating machinery.

Bendroflumethi­azide tablets with food, drink and alcohol

Alcohol can affect the way Bendroflumethiazide Tablets work. During treatment with Bendroflumethiazide Tablets, talk to your doctor before consuming alcoholic drinks.

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 level of chemicals in your body by carrying out tests.

XXXXXXXX

10 mm

Same size artwork 430 x 140 mm Front

10 mm

Bendroflumethiazide may interfere with a number of laboratory tests including estimation of serum protein-bound iodine and tests of parathyroid function.

Bendroflumethi­azide Tablets contain Lactose

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

|           3. How to take Bendroflumethiazide Tablets           |

• Always take this medicine exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.
• The number of tablets you need will depend on your condition.
• Swallow the tablets with water in the morning (to avoid frequent urination at night).

Doses:

Adults and children 12 years and over:

• High blood pressure: 2.5 mg to 5 mg once a day.
• Oedema: Initially 5–10mg once a day or once every other day. The maintenance dose is 5–10mg one to three times a week.

Elderly:

Your doctor may prescribe you a lower dose especially if you have impaired kidney function.

Children under 12 years:

A more appropriate formulation may be used. Initially 400micrograms per kilogram of body weight a day. The maintenance dose is 50–100 micrograms per kilogram of body weight, a day.

If you take more Bendroflumethiazide Tablets than you should

If you accidently take too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/ Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily. Symptoms of an overdose include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, fits (seizures) muscle cramps, increase in the frequency and amount of urination, thirst, decreased volume within blood vessels, low blood pressure, circulation problems (peripheral circulatory failure), low blood levels of potassium (hypokalaemia), magnesium (hypomagnaesia), calcium (hypocalcaemia) and sodium (hyponatraemia), low or increased blood sugar levels (hypoglycaemia or hyperglycaemia), lack of appetite (anorexia) and central nervous system depression (drowsiness, tiredness and coma).

If you forget to take Bendroflumethiazide tablets

If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Serious side effects

Stop taking this medicine and seek medical advice immediately if you have any of the following reactions:

• severe allergic reaction (anaphylaxis). The signs of an allergic reaction may include rash, itching, difficulty breathing and/or swelling of your lips, face, throat or tongue
• systemic lupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• inflammation of the lungs that can cause a cough or shortness of breath
• inflammation of the kidney which can cause you to have a fever or to pass more or less urine than normal
• severe stomach pain which may reach through to your back (pancreatitis)
• fluid in the lungs that can cause you to cough up blood and make it difficult for you to breathe
• serious skin condition with blistering of the skin
• feeling sick (nausea) or being sick (vomiting)
• loss of appetite
• feeling dizzy or light headed, especially when standing up (low blood pressure)
• changes to various types of blood cells (shown in blood tests) (symptoms like sore mouth, fever, sore throat, mouth ulcers)
• thrombocytopenia (excessive bruising or prolonged bleeding from cuts)
• feeling weak, tired, drowsy or sleepy
• feeling confused
• muscle cramp
• sudden headache
• fits (seizures)
• skin rash caused by exposure to light (photosensitivity).
• Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)

or acute angle-closure glaucoma).

• Cholestasis (decrease in bile)
• Cholecystitis (inflammation in gall bladder)

Other side effects that may be experienced while taking this medicine are

Not known: frequency cannot be estimated from the available data

• headache
• dizziness
• tingling or numbness in the hands or feet
• drowsiness
• diarrhoea
• constipation
• dry mouth and thirst
• inflammation of blood vessels, often with skin rash (vasculitis)
• an increase in uric acid in your blood (gout)
• being unable to achieve an erection (impotence)
• diabetes
• changes in the salts and electrolytes in your blood (shown in blood tests)
• an increase in the levels of certain types of lipids and cholesterol in your blood (shown in blood tests)
• pale stools, dark urine, yellowing of the skin or eyes (jaundice)
• severe pain in the lower back or sides (kidney stones)
• passing less urine than normal
• high level of calcium in the blood

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store bendroflumethiazide tablets

• Containers and blister carton: Do not store above 250C.
• Store in the original packaging and keep the packaging tightly closed in order to protect the tablets from light and moisture.
• 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 medicines 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 Bendroflumethiazide Tablets contain

• The active substance is bendroflumethi­azide. This is the new name for bendrofluazide. The ingredient itself has not changed.
• Bendroflumethiazide Tablets come in two strengths 2.5mg and 5mg.

Each tablet contains either 2.5mg or 5mg of the active ingredient.

• The other ingredients are: lactose, pregelatinised starch, talc and stearic acid.

What Bendroflumethiazide Tablets look like and contents of the pack.

• Bendroflumethiazide 2.5 mg Tablets are white to almost white circular, biconvex, uncoated tablets.
• Bendroflumethiazide 5 mg Tablets are white to almost white, circular, flat, beveled edged, uncoated tablets with ‘5’ debossed on one side.
• Bendroflumethiazide Tablets come in blister packs containing 14, 28, 56 or 84 tablets and containers containing 50, 100, 250, 500 or 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

Email:

Bendroflumethi­azide 2.5 mg tablets; PL 17907/0082

Bendroflumethi­azide 5 mg tablets; PL 17907/0083

This leaflet was last revised in November 2020

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V15 18–11–20 D0

10 mm

Same size artwork 430 x 140 mm

Back

5 mm

10 mm

24 mm

PATIENT LEAFLET: INFORMATION FOR THE USER

BENDROFLUMETHI­AZIDE 2.5 MG or 5 MG TABLETS Bendroflumethi­azide

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 queries, 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 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 name of your medicine is Bendroflumethiazide 2.5 mg tablets or Bendroflumethiazide 5mg tablets. The active ingredient is Bendroflumethi­azide.

Bendroflumethiazide tablets belong to a group of medicines called thiazide diuretics (water tablets). They may be used to:

• reduce fluid retention (oedema) particularly in the heart, kidneys, liver or that caused by medication, by increasing the flow of urine.
• reduce high blood pressure alone or with other medication.

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

Do not take Bendroflumethiazide tablets and tell your doctor if you:

• are allergic to thiazides or any of the other ingredients in Bendroflumethiazide tablets (see section 6).
• have high levels of calcium in your blood (hypercalcaemia)
• have severe liver or kidney problems, or you are unable to pass water (urine)
• have underactive adrenal glands (Addison’s disease- syndrome due to low level of corticosteroid hormones secretion, symptoms include weakness, loss of energy, low blood pressure and dark pigmentation of the skin).
• low blood levels of sodium (hyponatraemia).
• low blood levels of potassium which has not responded to treatment (refractory hypokalaemia).
• or have had gout (high levels of uric acid in the blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia).

Warnings and Precautions

Check with your doctor, nurse or pharmacist before taking Bendroflumethiazide tablets if you:

• have taken high doses of Bendroflumethiazide Tablets or have taken the tablets for a long time, or if you have severe heart disease or are taking digitalis preparations (e.g. digoxin). Your doctor may decide you need to take potassium supplement tablets
• have problems with your liver or kidneys
• have photosensitive skin (risk of developing sunburn)
• suffer from a condition known as hyponatraemia (low blood levels of sodium), particularly if you are elderly
• have low blood levels of magnesium
• have low blood levels of potassium (hypokalaemia)
• have low blood levels of calcium (hypocalcaemia)
• have high blood cholesterol level (hyperlipidaemia)
• suffer from pancreatitis
• are diabetic or suffer from gout
• have a condition known as systemiclupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• Have liver disease caused by alcohol (alcoholic cirrhosis).
• Have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking this medicine. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

If you are elderly or have taken Bendroflumethiazide Tablets for a long time, your doctor will perform regular blood tests to check the levels of electrolytes (salts) in your blood.

Other medicines and Bendroflumethiazide Tablets

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

Especially:

• medicines used to treat high blood pressure including ACE inhibitors, (e.g. Enalapril) angiotensin-II antagonists (e.g. Losartan), alpha-blockers, such as prazosin, beta-blockers, calcium channel blockers (e.g. amlodipine and diltiazem), hydralazine, diazoxide and methyldopa
• medicines used for heart problems including amiodarone, disopyramide, flecainide, lidocaine, mexiletine, quinidine, sotalol, nitrates and cardiac glycosides (e.g. digoxin)
• medicines used to treat Parkinson’s di­sease, such as levodopa
• medicines used to treat epilepsy, such as carbamazepine
• medicines taken for depression and mental illness including tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), reboxetine, pimozide, sertindole, lithium and phenothiazines
• other diuretics including acetazolamide and loop diuretics
• medicines used for diabetes, such as chlorpropamide and insulin
• medicines used to treat asthma called beta-agonists
• medicines used in the treatment of gout, such as allopurinol
• medicines, called prostaglandins, such as alprostadil
• medicines used to treat fungal infections, such as amphotericin
• medicines used to treat bacterial infections, such as trimethoprim
• medicines used to treat malaria, such as halofantrine
• medicines used as dietary supplements, such as calcium salts or vitamin D
• medicines used to treat inflammation, such as prednisolone, cortisone and hydrocortisone
• medicines used to treat stomach ulcers, such as carbenoxolone
• medicines used to treat high blood cholesterol, such as cholestyramine and colestipol
• medicines, called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain or inflammation, such as indomethacin, ketorolac, ibuprofen, piroxicam or naproxen
• medicines, called antihistamines, used to treat allergies, such as terfenadine and astemizole
• medicines, called muscle relaxants, such as tizanidine, baclofen, tubocurarine, gallamine, alcuronium or pancuronium
• medicines used in the treatment of breast cancer, called hormone antagonists, such as toremifene
• medicines used to treat kidney and skin cancer (melanoma), such as aldesleukin
• medicines called general anaesthetics used to stop pain during surgery
• medicines used to suppress the immune system following organ transplants, such as ciclosporin.
• Thioridazine (antipsychotics)
• Medicines called sulfonylureas which are used in diabetes to control blood sugar levels
• moxisylyte (used in Raynaud’s syndrome)
• cisplatin (used to treat cancer)
• aminoglutethamide (used in some cancers and Cushing’s syndrome)
• oestrogens and combined oral contraceptives
• sympathomimetics (used as decongestant, asthma or heart medicine)
• Theophylline is a xanthine (used in breathing problems such as asthma)
• acetazolamide, which is used to treat glaucoma (increased pressure in the eye), epilepsy or for preventing altitude sickness
• if you are receiving adrenocorticotropic (ACTH) hormone
• opioids (strong-pain relieving medicines)
• barbiturates (medicines used to treat either fits or to help you sleep) Tell your doctor if you are having or have had tests for thyroid problems.

Pregnancy, breast-feeding and fertility

If you are pregnant or thinking of becoming pregnant, check with your doctor before you use Bendroflumethiazide Tablets. Your doctor will decide if you should take them.

Do not breast-feed if you are taking Bendroflumethiazide Tablets. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bendroflumethiazide tablets may cause dizziness, drowsiness and mental confusion. Make sure you are not affected before driving or operating machinery.

Bendroflumethi­azide tablets with food, drink and alcohol

Alcohol can affect the way Bendroflumethiazide Tablets work. During treatment with Bendroflumethiazide Tablets, talk to your doctor before consuming alcoholic drinks.

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 level of chemicals in your body by carrying out tests.

Bendroflumethiazide may interfere with a number of laboratory tests including estimation of serum protein-bound iodine and tests of parathyroid function. XXXXX

10 mm

Same size artwork 400 x150 mm Front

10 mm

Bendroflumethi­azide Tablets contain Lactose

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

|         3. How to take Bendroflumethiazide Tablets         |

• Always take this medicine exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.
• The number of tablets you need will depend on your condition.
• Swallow the tablets with water in the morning (to avoid frequent urination at night).

Doses:

Adults and children 12 years and over:

• High blood pressure: 2.5 mg to 5 mg once a day.
• Oedema: Initially 5–10mg once a day or once every other day. The maintenance dose is 5–10mg one to three times a week.

Elderly:

Your doctor may prescribe you a lower dose especially if you have impaired kidney function.

Children under 12 years:

A more appropriate formulation may be used. Initially 400micrograms per kilogram of body weight a day. The maintenance dose is 50–100 micrograms per kilogram of body weight, a day.

If you take more Bendroflumethiazide Tablets than you should If you accidently take too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/ Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily. Symptoms of an overdose include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, fits (seizures) muscle cramps, increase in the frequency and amount of urination, thirst, decreased volume within blood vessels, low blood pressure, circulation problems (peripheral circulatory failure), low blood levels of potassium (hypokalaemia), magnesium (hypomagnaesia), calcium (hypocalcaemia) and sodium (hyponatraemia), low or increased blood sugar levels (hypoglycaemia or hyperglycaemia), lack of appetite (anorexia) and central nervous system depression (drowsiness, tiredness and coma).

If you forget to take Bendroflumethiazide tablets

If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

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

4. possible side effects

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

Serious side effects

Stop taking this medicine and seek medical advice immediately if you have any of the following reactions:

• severe allergic reaction (anaphylaxis). The signs of an allergic reaction may include rash, itching, difficulty breathing and/or swelling of your lips, face, throat or tongue
• systemic lupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• inflammation of the lungs that can cause a cough or shortness of breath
• inflammation of the kidney which can cause you to have a fever or to pass more or less urine than normal
• severe stomach pain which may reach through to your back (pancreatitis)
• fluid in the lungs that can cause you to cough up blood and make it difficult for you to breathe
• serious skin condition with blistering of the skin
• feeling sick (nausea) or being sick (vomiting)
• loss of appetite
• feeling dizzy or light headed, especially when standing up (low blood pressure)
• changes to various types of blood cells (shown in blood tests) (symptoms like sore mouth, fever, sore throat, mouth ulcers)
• thrombocytopenia (excessive bruising or prolonged bleeding from cuts)
• feeling weak, tired, drowsy or sleepy
• feeling confused
• muscle cramp
• sudden headache
• fits (seizures)
• skin rash caused by exposure to light (photosensitivity).
• Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Cholestasis (decrease in bile)
• Cholecystitis (inflammation in gall bladder)

Other side effects that may be experienced while taking this medicine are

Not known: frequency cannot be estimated from the available data

• headache
• dizziness
• tingling or numbness in the hands or feet
• drowsiness
• diarrhoea
• constipation
• dry mouth and thirst
• inflammation of blood vessels, often with skin rash (vasculitis)
• an increase in uric acid in your blood (gout)
• being unable to achieve an erection (impotence)
• diabetes
• changes in the salts and electrolytes in your blood (shown in blood tests)
• an increase in the levels of certain types of lipids and cholesterol in your blood (shown in blood tests)
• pale stools, dark urine, yellowing of the skin or eyes (jaundice)
• severe pain in the lower back or sides (kidney stones)
• passing less urine than normal
• high level of calcium in the blood

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: yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store bendroflumethiazide tablets

• Containers and blister carton: Do not store above 250C.
• Store in the original packaging and keep the packaging tightly closed in order to protect the tablets from light and moisture.
• 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 medicines 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 Bendroflumethiazide Tablets contain

• The active substance is bendroflumethi­azide. This is the new name

for bendrofluazide. The ingredient itself has not changed.

• Bendroflumethiazide Tablets come in two strengths 2.5mg and 5mg. Each tablet contains either 2.5mg or 5mg of the active ingredient.
• The other ingredients are: lactose, pregelatinised starch, talc and stearic acid.

What Bendroflumethiazide Tablets look like and contents of the pack.

• Bendroflumethiazide 2.5 mg Tablets are white to almost white circular, biconvex, uncoated tablets.
• Bendroflumethiazide 5 mg Tablets are white to almost white, circular, flat, beveled edged, uncoated tablets with ‘5’ debossed on one side.
• Bendroflumethiazide Tablets come in blister packs containing 14, 28, 56 or 84 tablets and containers containing 50, 100, 250, 500 or 1000 tablets. Not all pack sizes may be marketed.

10 mm

Same size artwork 400 x150 mm

Back

PATIENT LEAFLET: INFORMATION FOR THE USER

BENDROFLUMETHI­AZIDE 2.5 MG

or 5 MG TABLETS

Bendroflumethi­azide

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 queries, 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 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 name of your medicine is Bendroflumethiazide 2.5 mg tablets or Bendroflumethiazide 5mg tablets. The active ingredient is Bendroflumethi­azide. Bendroflumethiazide tablets belong to a group of medicines called thiazide diuretics (water tablets). They may be used to:

• reduce fluid retention (oedema) particularly in the heart, kidneys, liver or that caused by medication, by increasing the flow of urine.
• reduce high blood pressure alone or with other medication.

2. what you need to know before you take bendroflumethiazide tablets

Do not take Bendroflumethiazide tablets and tell your doctor if you:

• are allergic to thiazides or any of the other ingredients in Bendroflumethiazide tablets (see section 6).
• have high levels of calcium in your blood (hypercalcaemia)
• have severe liver or kidney problems, or you are unable to pass water (urine)
• have underactive adrenal glands (Addison’s disease- syndrome due to low level of corticosteroid hormones secretion, symptoms include weakness, loss of energy, low blood pressure and dark pigmentation of the skin).
• low blood levels of sodium (hyponatraemia).
• low blood levels of potassium which has not responded to treatment (refractory hypokalaemia).
• or have had gout (high levels of uric acid in the blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia).

Warnings and Precautions

Check with your doctor, nurse or pharmacist before taking Bendroflumethiazide tablets if you:

• have taken high doses of Bendroflumethiazide Tablets or have taken the tablets for a long time, or if you have severe heart disease or are taking digitalis preparations (e.g. digoxin). Your doctor may decide you need to take potassium supplement tablets
• have problems with your liver or kidneys
• have photosensitive skin (risk of developing sunburn)
• suffer from a condition known as hyponatraemia (low blood levels of sodium), particularly if you are elderly
• have low blood levels of magnesium
• have low blood levels of potassium (hypokalaemia)
• have low blood levels of calcium (hypocalcaemia)
• have high blood cholesterol level (hyperlipidaemia)
• suffer from pancreatitis
• are diabetic or suffer from gout
• have a condition known as systemiclupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• Have liver disease caused by alcohol (alcoholic cirrhosis).
• Have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking this medicine. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

If you are elderly or have taken Bendroflumethiazide Tablets for a long time, your doctor will perform regular blood tests to check the levels of electrolytes (salts) in your blood.

Other medicines and Bendroflumethiazide Tablets

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

Especially:

• medicines used to treat high blood pressure including ACE inhibitors, (e.g. Enalapril) angiotensin-II antagonists (e.g. Losartan), alpha-blockers, such as prazosin, beta-blockers, calcium channel blockers (e.g. amlodipine and diltiazem), hydralazine, diazoxide and methyldopa
• medicines used for heart problems including amiodarone, disopyramide, flecainide, lidocaine, mexiletine, quinidine, sotalol, nitrates and cardiac glycosides (e.g. digoxin)
• medicines used to treat Parkinson’s di­sease, such as levodopa
• medicines used to treat epilepsy, such as carbamazepine
• medicines taken for depression and mental illness including tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), reboxetine, pimozide, sertindole, lithium and phenothiazines
• other diuretics including acetazolamide and loop diuretics
• medicines used for diabetes, such as chlorpropamide and insulin
• medicines used to treat asthma called beta-agonists
• medicines used in the treatment of gout, such as allopurinol
• medicines, called prostaglandins, such as alprostadil
• medicines used to treat fungal infections, such as amphotericin
• medicines used to treat bacterial infections, such as trimethoprim
• medicines used to treat malaria, such as halofantrine
• medicines used as dietary supplements, such as calcium salts or vitamin D
• medicines used to treat inflammation, such as prednisolone, cortisone and hydrocortisone
• medicines used to treat stomach ulcers, such as carbenoxolone
• medicines used to treat high blood cholesterol, such as cholestyramine and colestipol
• medicines, called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain or inflammation, such as indomethacin, ketorolac, ibuprofen, piroxicam or naproxen
• medicines, called antihistamines, used to treat allergies, such as terfenadine and astemizole
• medicines, called muscle relaxants, such as tizanidine, baclofen, tubocurarine, gallamine, alcuronium or pancuronium
• medicines used in the treatment of breast cancer, called hormone antagonists, such as toremifene
• medicines used to treat kidney and skin cancer (melanoma), such as aldesleukin
• medicines called general anaesthetics used to stop pain during surgery
• medicines used to suppress the immune system following organ transplants, such as ciclosporin.
• Thioridazine (antipsychotics)
• Medicines called sulfonylureas which are used in diabetes to control blood sugar levels
• moxisylyte (used in Raynaud’s syndrome)
• cisplatin (used to treat cancer)
• aminoglutethamide (used in some cancers and Cushing’s syndrome)
• oestrogens and combined oral contraceptives
• sympathomimetics (used as decongestant, asthma or heart medicine)
• Theophylline is a xanthine (used in breathing problems such as asthma)
• acetazolamide, which is used to treat glaucoma (increased pressure in the eye), epilepsy or for preventing altitude sickness
• if you are receiving adrenocorticotropic (ACTH) hormone
• opioids (strong-pain relieving medicines)
• barbiturates (medicines used to treat either fits or to help you sleep)

Tell your doctor if you are having or have had tests for thyroid problems.

Pregnancy, breast-feeding and fertility

If you are pregnant or thinking of becoming pregnant, check with your doctor before you use Bendroflumethiazide Tablets. Your doctor will decide if you should take them.

Do not breast-feed if you are taking Bendroflumethiazide Tablets. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bendroflumethiazide tablets may cause dizziness, drowsiness and mental confusion. Make sure you are not affected before driving or operating machinery.

Bendroflumethi­azide tablets with food, drink and alcohol

Alcohol can affect the way Bendroflumethiazide Tablets work. During treatment with Bendroflumethiazide Tablets, talk to your doctor before consuming alcoholic drinks.

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 level of chemicals in your body by carrying out tests.

XXXXXXXX

Bendroflumethiazide may interfere with a number of laboratory tests including estimation of serum protein-bound iodine and tests of parathyroid function.

Bendroflumethi­azide Tablets contain Lactose

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

| 3. How to take Bendroflumethiazide Tablets |

• Always take this medicine exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.
• The number of tablets you need will depend on your condition.
• Swallow the tablets with water in the morning (to avoid frequent urination at night).

Doses:

Adults and children 12 years and over:

• High blood pressure: 2.5 mg to 5 mg once a day.
• Oedema: Initially 5–10mg once a day or once every other day. The maintenance dose is 5–10mg one to three times a week.

Elderly:

Your doctor may prescribe you a lower dose especially if you have impaired kidney function.

Children under 12 years:

A more appropriate formulation may be used. Initially 400micrograms per kilogram of body weight a day. The maintenance dose is 50–100 micrograms per kilogram of body weight, a day.

If you take more Bendroflumethiazide Tablets than you should

If you accidently take too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/ Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily. Symptoms of an overdose include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, fits (seizures) muscle cramps, increase in the frequency and amount of urination, thirst, decreased volume within blood vessels, low blood pressure, circulation problems (peripheral circulatory failure), low blood levels of potassium (hypokalaemia), magnesium (hypomagnaesia), calcium (hypocalcaemia) and sodium (hyponatraemia), low or increased blood sugar levels (hypoglycaemia or hyperglycaemia), lack of appetite (anorexia) and central nervous system depression (drowsiness, tiredness and coma).

If you forget to take Bendroflumethiazide tablets

If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Serious side effects

Stop taking this medicine and seek medical advice immediately if you have any of the following reactions:

• severe allergic reaction (anaphylaxis). The signs of an allergic reaction may include rash, itching, difficulty breathing and/or swelling of your lips, face, throat or tongue
• systemic lupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• inflammation of the lungs that can cause a cough or shortness of breath
• inflammation of the kidney which can cause you to have a fever or to pass more or less urine than normal
• severe stomach pain which may reach through to your back (pancreatitis)
• fluid in the lungs that can cause you to cough up blood and make it difficult for you to breathe
• serious skin condition with blistering of the skin
• feeling sick (nausea) or being sick (vomiting)
• loss of appetite
• feeling dizzy or light headed, especially when standing up (low blood pressure)
• changes to various types of blood cells (shown in blood tests) (symptoms like sore mouth, fever, sore throat, mouth ulcers)
• thrombocytopenia (excessive bruising or prolonged bleeding from cuts)
• feeling weak, tired, drowsy or sleepy
• feeling confused
• muscle cramp
• sudden headache
• fits (seizures)
• skin rash caused by exposure to light (photosensitivity).
• Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)

or acute angle-closure glaucoma).

• Cholestasis (decrease in bile)
• Cholecystitis (inflammation in gall bladder)

Other side effects that may be experienced while taking this medicine are

Not known: frequency cannot be estimated from the available data

• headache
• dizziness
• tingling or numbness in the hands or feet
• drowsiness
• diarrhoea
• constipation
• dry mouth and thirst
• inflammation of blood vessels, often with skin rash (vasculitis)
• an increase in uric acid in your blood (gout)
• being unable to achieve an erection (impotence)
• diabetes
• changes in the salts and electrolytes in your blood (shown in blood tests)
• an increase in the levels of certain types of lipids and cholesterol in your blood (shown in blood tests)
• pale stools, dark urine, yellowing of the skin or eyes (jaundice)
• severe pain in the lower back or sides (kidney stones)
• passing less urine than normal
• high level of calcium in the blood

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store bendroflumethiazide tablets

• Containers and blister carton: Do not store above 250C.
• Store in the original packaging and keep the packaging tightly closed in order to protect the tablets from light and moisture.
• 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 medicines 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 Bendroflumethiazide Tablets contain

• The active substance is bendroflumethi­azide. This is the new name for bendrofluazide. The ingredient itself has not changed.
• Bendroflumethiazide Tablets come in two strengths 2.5mg and 5mg.

Each tablet contains either 2.5mg or 5mg of the active ingredient.

• The other ingredients are: lactose, pregelatinised starch, talc and stearic acid.

What Bendroflumethiazide Tablets look like and contents of the pack.

• Bendroflumethiazide 2.5 mg Tablets are white to almost white circular, biconvex, uncoated tablets.
• Bendroflumethiazide 5 mg Tablets are white to almost white, circular, flat, beveled edged, uncoated tablets with ‘5’ debossed on one side.
• Bendroflumethiazide Tablets come in blister packs containing 14, 28, 56 or 84 tablets and containers containing 50, 100, 250, 500 or 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Telephone: 0044 (0)1442 200922

Fax: 0044 (0)1442 873717

Email:

Bendroflumethi­azide 2.5 mg tablets; PL 17907/0082

Bendroflumethi­azide 5 mg tablets; PL 17907/0083

This leaflet was last revised in November 2020

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V15 18–11–20 D0

PATIENT LEAFLET: INFORMATION FOR THE USER

BENDROFLUMETHI­AZIDE 2.5 MG or 5 MG TABLETS Bendroflumethi­azide

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 queries, 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 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 name of your medicine is Bendroflumethiazide 2.5 mg tablets or Bendroflumethiazide 5mg tablets. The active ingredient is Bendroflumethi­azide.

Bendroflumethiazide tablets belong to a group of medicines called thiazide diuretics (water tablets). They may be used to:

• reduce fluid retention (oedema) particularly in the heart, kidneys, liver or that caused by medication, by increasing the flow of urine.
• reduce high blood pressure alone or with other medication.

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

Do not take Bendroflumethiazide tablets and tell your doctor if you:

• are allergic to thiazides or any of the other ingredients in Bendroflumethiazide tablets (see section 6).
• have high levels of calcium in your blood (hypercalcaemia)
• have severe liver or kidney problems, or you are unable to pass water (urine)
• have underactive adrenal glands (Addison’s disease- syndrome due to low level of corticosteroid hormones secretion, symptoms include weakness, loss of energy, low blood pressure and dark pigmentation of the skin).
• low blood levels of sodium (hyponatraemia).
• low blood levels of potassium which has not responded to treatment (refractory hypokalaemia).
• or have had gout (high levels of uric acid in the blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia).

Warnings and Precautions

Check with your doctor, nurse or pharmacist before taking Bendroflumethiazide tablets if you:

• have taken high doses of Bendroflumethiazide Tablets or have taken the tablets for a long time, or if you have severe heart disease or are taking digitalis preparations (e.g. digoxin). Your doctor may decide you need to take potassium supplement tablets
• have problems with your liver or kidneys
• have photosensitive skin (risk of developing sunburn)
• suffer from a condition known as hyponatraemia (low blood levels of sodium), particularly if you are elderly
• have low blood levels of magnesium
• have low blood levels of potassium (hypokalaemia)
• have low blood levels of calcium (hypocalcaemia)
• have high blood cholesterol level (hyperlipidaemia)
• suffer from pancreatitis
• are diabetic or suffer from gout
• have a condition known as systemiclupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• Have liver disease caused by alcohol (alcoholic cirrhosis).
• Have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking this medicine. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

If you are elderly or have taken Bendroflumethiazide Tablets for a long time, your doctor will perform regular blood tests to check the levels of electrolytes (salts) in your blood.

Other medicines and Bendroflumethiazide Tablets

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

Especially:

• medicines used to treat high blood pressure including ACE inhibitors, (e.g. Enalapril) angiotensin-II antagonists (e.g. Losartan), alpha-blockers, such as prazosin, beta-blockers, calcium channel blockers (e.g. amlodipine and diltiazem), hydralazine, diazoxide and methyldopa
• medicines used for heart problems including amiodarone, disopyramide, flecainide, lidocaine, mexiletine, quinidine, sotalol, nitrates and cardiac glycosides (e.g. digoxin)
• medicines used to treat Parkinson’s di­sease, such as levodopa
• medicines used to treat epilepsy, such as carbamazepine
• medicines taken for depression and mental illness including tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), reboxetine, pimozide, sertindole, lithium and phenothiazines
• other diuretics including acetazolamide and loop diuretics
• medicines used for diabetes, such as chlorpropamide and insulin
• medicines used to treat asthma called beta-agonists
• medicines used in the treatment of gout, such as allopurinol
• medicines, called prostaglandins, such as alprostadil
• medicines used to treat fungal infections, such as amphotericin
• medicines used to treat bacterial infections, such as trimethoprim
• medicines used to treat malaria, such as halofantrine
• medicines used as dietary supplements, such as calcium salts or vitamin D
• medicines used to treat inflammation, such as prednisolone, cortisone and hydrocortisone
• medicines used to treat stomach ulcers, such as carbenoxolone
• medicines used to treat high blood cholesterol, such as cholestyramine and colestipol
• medicines, called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain or inflammation, such as indomethacin, ketorolac, ibuprofen, piroxicam or naproxen
• medicines, called antihistamines, used to treat allergies, such as terfenadine and astemizole
• medicines, called muscle relaxants, such as tizanidine, baclofen, tubocurarine, gallamine, alcuronium or pancuronium
• medicines used in the treatment of breast cancer, called hormone antagonists, such as toremifene
• medicines used to treat kidney and skin cancer (melanoma), such as aldesleukin
• medicines called general anaesthetics used to stop pain during surgery
• medicines used to suppress the immune system following organ transplants, such as ciclosporin.
• Thioridazine (antipsychotics)
• Medicines called sulfonylureas which are used in diabetes to control blood sugar levels
• moxisylyte (used in Raynaud’s syndrome)
• cisplatin (used to treat cancer)
• aminoglutethamide (used in some cancers and Cushing’s syndrome)
• oestrogens and combined oral contraceptives
• sympathomimetics (used as decongestant, asthma or heart medicine)
• Theophylline is a xanthine (used in breathing problems such as asthma)
• acetazolamide, which is used to treat glaucoma (increased pressure in the eye), epilepsy or for preventing altitude sickness
• if you are receiving adrenocorticotropic (ACTH) hormone
• opioids (strong-pain relieving medicines)
• barbiturates (medicines used to treat either fits or to help you sleep) Tell your doctor if you are having or have had tests for thyroid problems.

Pregnancy, breast-feeding and fertility

If you are pregnant or thinking of becoming pregnant, check with your doctor before you use Bendroflumethiazide Tablets. Your doctor will decide if you should take them.

Do not breast-feed if you are taking Bendroflumethiazide Tablets. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bendroflumethiazide tablets may cause dizziness, drowsiness and mental confusion. Make sure you are not affected before driving or operating machinery.

Bendroflumethi­azide tablets with food, drink and alcohol

Alcohol can affect the way Bendroflumethiazide Tablets work. During treatment with Bendroflumethiazide Tablets, talk to your doctor before consuming alcoholic drinks.

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 level of chemicals in your body by carrying out tests.

Bendroflumethiazide may interfere with a number of laboratory tests including estimation of serum protein-bound iodine and tests of parathyroid function. XXXXX

Bendroflumethi­azide Tablets contain Lactose

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

| 3. How to take Bendroflumethiazide Tablets |

• Always take this medicine exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.
• The number of tablets you need will depend on your condition.
• Swallow the tablets with water in the morning (to avoid frequent urination at night).

Doses:

Adults and children 12 years and over:

• High blood pressure: 2.5 mg to 5 mg once a day.
• Oedema: Initially 5–10mg once a day or once every other day. The maintenance dose is 5–10mg one to three times a week.

Elderly:

Your doctor may prescribe you a lower dose especially if you have impaired kidney function.

Children under 12 years:

A more appropriate formulation may be used. Initially 400micrograms per kilogram of body weight a day. The maintenance dose is 50–100 micrograms per kilogram of body weight, a day.

If you take more Bendroflumethiazide Tablets than you should If you accidently take too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/ Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily. Symptoms of an overdose include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, fits (seizures) muscle cramps, increase in the frequency and amount of urination, thirst, decreased volume within blood vessels, low blood pressure, circulation problems (peripheral circulatory failure), low blood levels of potassium (hypokalaemia), magnesium (hypomagnaesia), calcium (hypocalcaemia) and sodium (hyponatraemia), low or increased blood sugar levels (hypoglycaemia or hyperglycaemia), lack of appetite (anorexia) and central nervous system depression (drowsiness, tiredness and coma).

If you forget to take Bendroflumethiazide tablets

If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

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

4. possible side effects

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

Serious side effects

Stop taking this medicine and seek medical advice immediately if you have any of the following reactions:

• severe allergic reaction (anaphylaxis). The signs of an allergic reaction may include rash, itching, difficulty breathing and/or swelling of your lips, face, throat or tongue
• systemic lupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• inflammation of the lungs that can cause a cough or shortness of breath
• inflammation of the kidney which can cause you to have a fever or to pass more or less urine than normal
• severe stomach pain which may reach through to your back (pancreatitis)
• fluid in the lungs that can cause you to cough up blood and make it difficult for you to breathe
• serious skin condition with blistering of the skin
• feeling sick (nausea) or being sick (vomiting)
• loss of appetite
• feeling dizzy or light headed, especially when standing up (low blood pressure)
• changes to various types of blood cells (shown in blood tests) (symptoms like sore mouth, fever, sore throat, mouth ulcers)
• thrombocytopenia (excessive bruising or prolonged bleeding from cuts)
• feeling weak, tired, drowsy or sleepy
• feeling confused
• muscle cramp
• sudden headache
• fits (seizures)
• skin rash caused by exposure to light (photosensitivity).
• Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Cholestasis (decrease in bile)
• Cholecystitis (inflammation in gall bladder)

Other side effects that may be experienced while taking this medicine are

Not known: frequency cannot be estimated from the available data

• headache
• dizziness
• tingling or numbness in the hands or feet
• drowsiness
• diarrhoea
• constipation
• dry mouth and thirst
• inflammation of blood vessels, often with skin rash (vasculitis)
• an increase in uric acid in your blood (gout)
• being unable to achieve an erection (impotence)
• diabetes
• changes in the salts and electrolytes in your blood (shown in blood tests)
• an increase in the levels of certain types of lipids and cholesterol in your blood (shown in blood tests)
• pale stools, dark urine, yellowing of the skin or eyes (jaundice)
• severe pain in the lower back or sides (kidney stones)
• passing less urine than normal
• high level of calcium in the blood

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: yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store bendroflumethiazide tablets

• Containers and blister carton: Do not store above 250C.
• Store in the original packaging and keep the packaging tightly closed in order to protect the tablets from light and moisture.
• 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 medicines 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 Bendroflumethiazide Tablets contain

• The active substance is bendroflumethi­azide. This is the new name

for bendrofluazide. The ingredient itself has not changed.

• Bendroflumethiazide Tablets come in two strengths 2.5mg and 5mg. Each tablet contains either 2.5mg or 5mg of the active ingredient.
• The other ingredients are: lactose, pregelatinised starch, talc and stearic acid.

What Bendroflumethiazide Tablets look like and contents of the pack.

• Bendroflumethiazide 2.5 mg Tablets are white to almost white circular, biconvex, uncoated tablets.
• Bendroflumethiazide 5 mg Tablets are white to almost white, circular, flat, beveled edged, uncoated tablets with ‘5’ debossed on one side.
• Bendroflumethiazide Tablets come in blister packs containing 14, 28, 56 or 84 tablets and containers containing 50, 100, 250, 500 or 1000 tablets. Not all pack sizes may be marketed.