Document: leaflet IVAX PHARMACEUTICALS_PL 17521-0019 change

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What is in your medicine?

The name of this medicine is: Bendrofluazide/Bendroflumethiazide Tablets 2.5 (5)mg which contains Bendrofluazide/ Bendroflumethiazide together with the inactive ingredients lactose, maize starch, pregelatinised starch, sodium starch glycollate, magnesium stearate. Bendrofluazide is available in tablets in strengths of 2.5mg and 5mg, and in tablet containers and blister packs of 28, 30, 50, 56,60,84,100,2 50, 500 and 1000. Bendrofluazide 2.5mg tablets and 5mg tablets are round white tablets. The 2.5mg tablet is marked MP18 and the 5mg tablet is marked MP19.

The Manufacturer is:

DDSA Pharmaceuticals Limited,

310 Old Brampton Road, London SW5 9JL The Product Licence holder is:

Metwest Pharmaceuticals Limited 15 Runnelfield, Harrow on the Hill, Middlesex HA1 3NY

How does Bendrofluazide work?

Bendrofluazide is a diuretic which is helpful in reducing blood pressure.

Why have you been prescribed Bendrofluazide?

Bendrofluazide 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 Bendrofluazide, then please ask your doctor.

Before taking your medicine

Before taking this medicine, tell your doctor if you have ever had any unusual or allergic reactions to Bendrofluazide or any of the other ingredients of Bendrofluazide 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 which you should not take with Bendrofluazide.

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; increase of calcium in the blood (hypercalcaemia); a reduced blood potassium (hypokalaemia) or sodium (hyponatraemia); or an increase of uric acid in the blood (hyperuricaemia). Also tell your doctor if you are receiving lithium or digitalis treatment.

Diabetes may be aggravated by Bendrofluazide and the control of diabetics receiving sulfonylureas (such as metformin) may be impaired. This medicine may aggravate gout. A condition known as porphyria - a blood disorder must be treated with caution. Bendrofluazide 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; and ulceration of the palate and gums. Hair loss and sensitivity to light.

Also tell your doctor if you take alcohol, barbiturates or opioid drugs such as codeine or if you take corticosteroids such as prednisolone.

Use in pregnancy

Bendrofluazide should be avoided during pregnancy as there is not sufficient evidence of its safety. Because Bendrofluazide passes into the breast milk it should be avoided in mothers who wish to breast-feed.

Expectant mothers who receive Bendrofluazide may be at an increased risk of acute pancreatic bleeding; newborn infants whose mothers have taken Bendrofluazide during pregnancy may suffer from a blood condition known as thrombocytopenia.

Can you take Bendrofluazide 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 Bendrofluazide with other medicines, but there are some medicines that can interfere with Bendrofluazide.

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 nonsteroidal anti-inflammatory drugs for example aspirin, ibuprofen, indomethacin used to treat pain and inflammation. Corticosteroids such as prednisolone may aggravate reduced blood potassium.

This medicine may increase the blocking effects of drugs which 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 Bendrofluazide 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. Usual dosages stated below:

Adults: Oedema (accumulation of fluid in body tissue, particularly the legs). 5mg given orally once daily in the morning.

This dose can be increased to 10mg if required. Many patients will respond as quickly to a daily dose of 2.5mg or 5mg 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 Omg once daily, either alone or in conjunction with other antihypertensive medicines.

Children: The suggested daily dose is 1mg per kilo of bodyweight, or at the discretion of the physician.

Elderly: Particular caution is needed in the elderly.

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 Bendrofluazide cause?

If you have problems consult your doctor but do not stop treatment until you have done so.

The following side effects may be experienced:

A mild loss of appetite. Indigestion may be avoided by taking the medicine after food. Hair loss, a sensitivity to light.

Some patients may experience impotence (inability to perform the sexual function). 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, 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 a symptom of a certain type of anaemia. Inflammation of the pancreas, liver stones, hypersensitivity reactions including inflammation of the lung (pneumonitis), an increase of fluid in the lung and 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.

Tablet containers: Do not store above 25°C. Store in the original container and keep the container tightly closed.

Blister packs: 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 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.

Product Licence 17521/0018 and 17521/0019 This leaflet was revised in July 2003 BEN0025and 0050TP/LEA002

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.