Bendroflumethiazide 5mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER Bendroflumethiazide 2.5mg Tablets Bendroflumethiazide 5mg Tablets
Bendroflumethiazide (Referred to as Bendroflumethiazide Tablets in the remainder of the leaflet)
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Read all of this leaflet carefully before
you start to take this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Bendroflumethiazide Tablets are and what they are used for
2. Before you take Bendroflumethiazide Tablets
3. How to take Bendroflumethiazide Tablets
4. Possible side effects
5. How to store Bendroflumethiazide Tablets
6. Further information
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1. What Bendroflumethiazide Tablets are and what they are used for
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The name of your medicine is Bendroflumethiazide Tablets. The active ingredient in your medicine is bendroflumethiazide. Bendroflumethiazide Tablets belong to a group of medicines called diuretics (water tablets) which increase the amount of urine you produce.
Bendroflumethiazide Tablets are used to treat high blood pressure (hypertension) and fluid retention (oedema) associated with kidney, liver or heart problems, and pre-menstrual syndrome.
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Do not take Bendroflumethiazide Tablets if you
• are allergic (hypersensitive) to bendroflumethiazide, or other sulphonamide-derived medicine or to any of the other ingredients in this medicine (see section 6. Further information)
• 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)
• are taking lithium carbonate.
Take special care with 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
• are seriously ill
• suffer from a condition known as hyponatraemia (low blood levels of sodium), particularly if you are elderly
• have low blood levels of magnesium
• are diabetic or suffer from gout
• have a condition known as systemic lupus erythematosus (an allergic condition which causes joint pain, skin rashes and fever)
• have severe asthma and are taking medicines called beta-agonists; these include salbutamol, terbutaline, formosterol and salmetrol.
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.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines and products can affect or be affected by treatment with Bendroflumethiazide Tablets:
• drinking alcohol when being treated with Bendroflumethiazide Tablets may cause your blood pressure to drop, making you feel dizzy or light headed, especially when standing up (orthostatic or postural hypotension)
• medicines used to treat high blood pressure including ACE inhibitors, angiotensin-II antagonists, alpha-blockers, such as prazosin, beta-blockers, calcium channel blockers, hydralazine, diazoxide and methyldopa
• medicines used for heart problems including amiodarone, disopyramide,
flecainide, lidocaine, mexiletine, quinidine, sotalol, nitrates and cardiac glycosides
• 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, primozide, 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 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 indometacin
• medicines, called antihistamines, used to treat allergies, such as terfenadine and astemizole
• medicines, called muscle relaxants, such as tizanidine
• 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.
Tell your doctor if you are having or have had tests for thyroid problems.
Taking Bendroflumethiazide Tablets with food and drink
Alcohol can affect the way Bendroflumethiazide Tablets work.
During treatment with Bendroflumethiazide Tablets, talk to your doctor before consuming alcoholic drinks.
Pregnancy
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.
Breast-feeding
Do not breast-feed if you are taking Bendroflumethiazide Tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machinery
Bendroflumethiazide Tablets may cause dizziness, drowsiness and mental confusion. Make sure you are not affected before driving or operating tools or machinery.
Important information about some of the ingredients of Bendroflumethiazide Tablets
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking this medicine.
3. How to take Bendroflumethiazide Tablets
Always take Bendroflumethiazide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Fluid retention
Adults: Your starting dose will be between two and four 2.5mg Bendroflumethiazide Tablets (or one to two 5mg Bendroflumethiazide Tablets) taken in the morning. The dose will then be kept at one 2.5mg tablet (or one 5mg tablet) a day on two to three days a week.
Your doctor will assess your condition and may decide that a single dose is enough.
Children: The dose given will depend on the size of your child. Your doctor will determine the suitable dose based on the weight of your child. The usual dose is 400jg/kg body weight every day to start with.
Your doctor will assess your child's condition and may decide to reduce their dose to 50|jg-100 jg/kg body weight.
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ARTWORK CHECK BOX
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Please be ready to give the following information:
|
Product name |
Reference number |
|
Bendroflumethiazide 2.5mg Tablets |
29831/0022 |
|
Bendroflumethiazide 5mg Tablets |
29831/0023 |
High blood pressure
Adults: The usual dose is one 2.5mg
tablet a day taken in the morning.
Pre-menstrual syndrome Adults: The usual dose is one 2.5mg tablet a day taken in the morning for seven days before your period is due.
Older People: You may need to take less than the usual adult dose. Your doctor will decide how many tablets you should take.
If you take more Bendroflumethiazide Tablets than you should
If you accidentally take too many tablets, you should contact your doctor or go to your nearest hospital casualty department immediately. Take this leaflet and any unused tablets with you to show the doctor.
Symptoms of an overdose include thirst, increase in the frequency and amount of urination and changes in the levels of salts and electrolytes in your blood. Treatment for overdosing involves fluid and electrolyte replacement.
If you forget to take Bendroflumethiazide Tablets
If you forget to take your medicine take it as soon as you remember. If it is almost time for your next dose do not take the missed dose at all. NEVER take a double dose to make up for the one missed.
If you stop taking Bendroflumethiazide Tablets
You may experience a skin rash, itchy skin or your skin may be more sensitive to sunlight than normal if you stop taking Bendroflumethiazide Tablets. Speak to your doctor if you notice these symptoms. Do not stop taking your medicine unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Bendroflumethiazide Tablets can cause side effects, although not everybody gets them.
If you notice any of these problems talk to your doctor straight away:
• 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
• inflammation of the lungs that can cause a cough or shortness of breath
• 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)
• feeling weak, tired, drowsy or sleepy
• feeling confused
• muscle cramp
• sudden headache
• fits (seizures)
• skin rash caused by exposure to light (photosensitivity).
Other side effects that may be experienced while taking this medicine are:
• 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)
• reduced sexual desire
• diabetes
• changes to various types of blood cells (shown in blood tests)
• 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)
• severe stomach pain which may reach through to your back (pancreatitis)
• pale stools, dark urine, yellowing of the skin or eyes (jaundice)
• inflammation of the kidney which can cause you to have a fever or to pass more or less urine than normal
• severe pain in the lower back or sides (kidney stones)
• passing less urine than normal
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 national reporting systems listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta:
ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bendroflumethiazide Tablets
Keep out of the reach and sight of children.
Do not use Bendroflumethiazide Tablets after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original container.
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 protect the environment.
6. Further information
What Bendroflumethiazide Tablets contain
The active ingredient is bendroflumethiazide.
Each Bendroflumethiazide 2.5mg Tablet contains 2.5mg of bendroflumethiazide.
Each Bendroflumethiazide 5mg Tablet contains 5mg of bendroflumethiazide.
The other ingredients are lactose powder, pregelatinised maize starch, maize starch, purified talc, magnesium stearate and water.
What Bendroflumethiazide Tablets look like and the contents of the pack
Bendroflumethiazide 2.5mg Tablets are white, circular flat faced tablets with bevelled edges, marked CP on one side and B 2.5 separated by a breakline on the other side.
Bendroflumethiazide 5mg Tablets are white, circular flat faced tablets with bevelled edges, marked CP on one side and B 5 separated by a breakline on the other side.
Bendroflumethiazide 2.5mg Tablets are available in the following packs:
• 500 tablets in polypropylene or polyethylene containers.
Bendroflumethiazide 5mg Tablets are available in the following packs:
• 50 tablets in amber glass bottles with a plastic cap
• 100, 250, 500 and 1000 and bulk amount of tablets in polypropylene or polyethylene containers.
Both strengths of tablets are available in the following packs:
• 10, 14, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, 100 or 112 tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd Ash Road North Wrexham LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only).
This is a service provided by the Royal National Institute of Blind People.
For the Republic of Ireland please call + 353 52 36253.
Leaflet revised: 03/2015 104271/7
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