Bendroflumethiazide Tablets
Patient Information Leaflet
= BENDROFLUMETHIAZIDE = TABLETS 2.5 AND 5 mg
™ Please read this leaflet carefully before you start taking this medicine. Keep this leaflet until you have finished all the prescribed course of Bendroflumethiazide. If you have any questions concerning your medicine ask your doctor or pharmacist for more information.
WHAT IS IN YOUR MEDICINE ?
The active ingredient in this medicine is Bendroflumethiazide. This is the new name for Bendrofluazide. The ingredient itself has not changed.
Bendroflumethiazide Tablets 2.5 (5) mg which contain Bendroflumethiazide together with the inactive ingredients lactose, maize starch, pregelatinised starch, sodium starch glycollate, magnesium stearate. Bendroflu-methiazide is available in tablets in strengths of 2.5 mg and 5 mg, and in blister packs of 28. Bendroflumethiazide 2.5 mg Tablets and 5 mg Tablets are round white tablets. The 2.5 mg tablet is marked MP1 8 and the 5 mg tablet is marked MP1 9.
The Manufacturer is:
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London, SW5 9JQ. The Product Licence holder is:
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill, Middlesex, HA1 3 NY.
Distributed by: Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1 TL.
HOW DOES BENDROFLUMETHIAZIDE WORK?
Bendroflumethiazide is a diuretic which is helpful in reducing blood pressure.
WHY HAVE YOU BEEN PRESCRIBED BENDROFLUMETHIAZIDE ?
Bendroflumethiazide belongs to a group of medicines known as diuretics which increase the flow of urine and is used in the treatment of oedema (fluid build-up in the tissues below the skin] associated with mild or moderate heart failure and for the treatment of mild or moderate hypertension (high blood pressure).
If you are not sure why you have been prescribed Bendroflumethiazide, then please ask you doctor.
BEFORE TAKING YOUR MEDICINE
Before taking this medicine, tell your doctor if you have ever had any unusual or allergic reactions to Bendroflumethiazide or any of the other ingredients of Bendroflumethiazide or other thiazide diuretics.
It is important that your doctor is aware of any other medication you are taking, whether it is prescribed or bought without a prescription. Your doctor will be able to identify medicines that you should not take with Bendroflumethiazide. Also tell your doctor or pharmacist
if you are allergic to any other substances such as foods, preservatives or dyes.
It is important that you tell your doctor if you are pregnant, or likely to become pregnant, or if you are breast-feeding.
The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor or pharmacist if you have any other medical problems, especially:
• Kidney or liver disease, including liver stones
• Inflammation of the lung
• High blood pressure
• Addison's disease
• High levels of calcium in the blood (hypercalcaemia);
• Low levels of blood potassium (hypokalaemia) or sodium (hyponatraemia)
• An increase of uric acid in the blood (hyperuricaemia)
• An intolerance to some sugars, including lactose.
• If you are receiving Lithium or digitalis treatment.
Diabetes may be aggravated by Bendroflumethiazide and the control of diabetics receiving sulpohylureas (such as Metformin] may be impaired. This medicine may aggravate gout.
A condition known as porphyria - a blood disorder, must be treated with caution. Bendroflumethiazide may aggravate systemic lupus erythematosus - an inflammatory disease causing redness of the cheeks and raised skin rashes of the face, neck, upper chest and elbows, blistering, ulceration of the palate and gums, hair loss and sensitivity to light.
Also tell your doctor if you take alcohol, barbiturates or opiod drugs such as Codeine or if you take corticosteroids such as Prednisolone.
USE IN PREGNANCY
Bendroflumethiazide should be avoided during pregnancy as there is not sufficient evidence of its safety. Because Bendroflu-methiazide passes into the breast milk it should be avoided in mothers who wish to breast-feed. Expectant mothers who receive Bendroflumethiazide may be at an increased risk of acute pancreatic bleeding; newborn infants whose mothers have taken Bendro-flumethiazide during pregnancy may suffer from a blood condition known as thrombo-cytopenia.
CAN YOU TAKE BENDROFLUMETHIAZIDE WITH OTHER MEDICINES ?
It is very important to tell your doctor or pharmacist about all the medicines which you are taking, whether prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere.
You can take Bendroflumethiazide with other medicines, but there are some medicines that can interfere with Bendroflumethiazide. This includes medicines such as:
• Carbenoxolone (used to treat stomach ulcers]
• Digitalis (used to treat heart conditions]
• Potassium (to treat potassium deficiency]
• Medicines known as non-steroidal antiinflammatory drugs for example Aspirin, Ibuprofen, Indometacin used to treat pain and
* inflammation.
J Corticosteroids such as Prednisolone may “ aggravate reduced blood potassium. This “ medicine may increase the blocking effects — of drugs that relax muscles and may also increase the effects of other antihypertensive medicines. A fall in blood pressure when changing to an upright position may be increased by alcohol, barbiturates and opioids.
WHEN AND HOW TO TAKE BENDROFLUMETHIAZIDE TABLETS
Take this medicine by mouth and only in the doses prescribed by your doctor. Do not take more of it, and do not take it more often or for a longer time than your doctor ordered. You will be prescribed the lowest dose necessary to control your symptoms. If you are elderly and/or on long term treatment, you will need regular blood tests, in particular for blood potassium levels.
Usual dosages stated below:
Adults: Oedema (accumulation of fluid in body tissue, particularly the legs). 5 mg given orally once daily in the morning. This dose can be increased to 1 0 mg if required. Many patients will respond as quickly to a daily dose of 2.5 mg or 5 mg on only two or three days in the week. Sometimes a single dose once a week may be sufficient.
Essential hypertension (high blood pressure). 2.5-1 0 mg once daily, either alone or in conjunction with other anti-hypertensive medicines.
Children: The dose will depend on the bodyweight of your child. Your doctor will tell you how much the dose should be.
Elderly: Particular caution is needed in the elderly. Your doctor may prescribe a reduced dose, especially if you suffer from kidney failure.
WHAT TO DO IF TOO MANY TABLETS ARE TAKEN AT THE SAME TIME
If you accidentally take more tablets than recommended contact your nearest doctor or hospital casualty department at once. Take any remaining tablets with you and keep in the original container or packaging so that they can be identified.
WHAT IF YOU MISS A DOSE
If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not take two doses at once.
If you feel that this medicine is not working as well after you have taken it for a short time (1-2 weeks] do not increase the dose, instead check with your doctor.
WHAT SIDE EFFECTS CAN BENDROFLUMETHIAZIDE CAUSE ?
If you have problems, consult your doctor but do not stop treatment until you have done so. The following effects may be experienced:
* A mild loss of appetite. Indigestion may be avoided by taking the medicine after food.
* Some patients may experience impotence (inability to perform the sexual function). This is reversible upon stopping treatment. * Various types of anaemia may occur. Be sure to tell your doctor if you are suffering from bruising or an unusually bad sore throat. This could be a symptom of a certain type of anaemia.
* A blood disorder known as porphyria.
* Inflammation of the pancreas may occur. * In some patients there is an increase in uric acid levels in the blood, with or without the development of gout. * A fall in blood pressure when changing from a lying or sitting position to a standing up position. * A decrease in blood levels of potassium, sodium, magnesium. An increase in blood levels of calcium. An increase in blood sugar, altered concentration of lipids (fats), rashes, various blood disorders, bruising or an unusually bad sore throat which could be symptoms of a certain type of anaemia. * If you experience any of the following symptoms: unusual thirst, lethargy, confusion, weakness, drowsiness, muscle cramps, scanty production of urine, abnormal heart rhythm, seizures, nausea or vomiting, you should inform your doctor promptly so that your body fluid and salt levels can be checked.
* Inflammation of the pancreas, * liver stones,
* hypersensitivity reactions including inflammation of the lung (pneumonitis).
* Sensitivity to light. * An increase of fluid in the lung * severe skin reactions.
If you notice any of the above reactions or side effects, or if you notice any unusual or worrying changes contact your doctor.
STORING YOUR MEDICINE
You must keep this medicine in a safe place where children cannot get it.
Do not store above 25°C. Store in the original package and keep container in the outer carton.
On the label you will find the words "Expiry Date" followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.
A REMINDER
REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours. This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
Bendroflumethiazide Tablets 2.5 mg and 5 mg Product Licence 1 7521 /001 8 and 17521/0019
This leaflet was revised in December 2004 BEN0025 and 005/LEA004 302862