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The active ingredients in FRUMIL tablets are:

frusemide BP (furosemide INN) 40mg amiloride hydrochloride BP equivalent to 5mg of anhydrous amiloride hydrochloride.

FRUMIL tablets also contain the following inactive ingredients: lactose, maize starch, microcrystalline cellulose, sodium starch glycollate, talc, sunset yellow dye (E110), colloidal anhydrous silica and magnesium stearate.

FRUMIL is available in blister packs of 28 and 56 tablets and dispensing packs of 100 and 500 tablets.

FRUMIL is one of a group of medicines called diuretics (sometimes described as "water tablets").

FRUMIL, like all water tablets, causes you to pass more urine ("water") than you usually do. With FRUMIL this occurs mainly after 1 or 2 hours. This is normal and you should not worry about this.

The Product Licence and Product Authorisation for FRUMIL is held by:

Rorer Pharmaceuticals Limited, Eastbourne, East Sussex, a member of the Rhône-Poulenc Rorer group of companies.

FRUMIL tablets are manufactured by:

May & Baker Limited, Dagenham, Essex, a member of the Rhône-Poulenc Rorer group of companies.

WHY HAVE YOU BEEN PRESCRIBED

FRUMIL TABLETS ?

FRUMIL tablets may be prescribed when there is a build-up of excess water in the body. Excess water can build up in certain conditions which affect the heart, blood vessels, lungs, kidneys or liver.

For example: if the heart is not pumping properly, water can build up in some parts of the body (most noticeably the ankles). This may result in shortness of breath and excessive tiredness.

Your doctor may prescribe these tablets for other reasons. Ask your doctor for any information you need.

BEFORE TAKING YOUR

FRUMIL TABLETS

If the answer is YES to any of the following questions, you


should discuss the matter with your doctor or pharmacist before taking any of the tablets.

Are you sensitive or allergic to any other diuretics (water tablets) '?
If you know you are sensitive or allergic to any of the inactive ingredients you should inform your doctor or pharmacist.
Are you taking any other water tablets ?
Are you taking any medication which contains potassium?
Are you pregnant, planning a pregnancy, or suspect you could be pregnant ?
Are you breast feeding ?
Is the patient under 12 years old ?
Do you have any liver, kidney or prostate problems, or difficulty in passing urine?
Do you suffer from gout, diabetes or Addison's disease?
Are you taking any of the following medicines: digoxin, lithium, muscle relaxants or medication to treat high blood pressure?

HOW SHOULD YOU TAKE YOUR

FRUMIL TABLETS?

The usual dose of FRUMIL tablets is one or two tablets first thing in the morning.

It is important to take your tablets at the right time. Take them as directed by your doctor. The pharmacist's label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.

The tablets should he swallowed with a small glass of water or milk.

Keep taking your medicine until your doctor tells you to stop.

If you forget to take your FRUMIL tablets in the morning, you can take them as soon as you remember. Then continue the following morning as before.

If you accidentally take too much, or if a child has swallowed any of your tablets, contact your nearest hospital casualty department or tell your doctor immediately.

DOES FRUMIL HAVE SIDE EFFECTS ?

As well as benefits, a medicine may occasionally have some unwanted effects in some patients.

The following minor side-effects of FRUMIL are well known. You should not need to worry about them unless they become troublesome, in which case contact your doctor:

tiredness,
gastric upset. including feeling or being sick. diarrhoea or constipation,
dry mouth


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