INFORMATION FOR THE PATIENT

(each FRUMIL FORTE tablet contains frusemide 80mg and amiloride hydrochloride 10mg)

This leaflet should be read carefully before you start to take these tablets. This leaflet is a summary of the important information about your tablets. If you have any questions, or are not sure about anything to do with your treatment, ask your doctor or pharmacist for more information.

WHAT ARE FRUMIL FORTE TABLETS?

The active ingredients in FRUMIL FORTE tablets are:

frusemide BP 80mg

amiloride hydrochloride BP 10mg

FRUMIL FORTE tablets also contain the following inactive ingredients: lactose, maize starch, microcrystalline cellulose, sodium starch glycollate, chalk, sunset yellow dye (E110), aerosil and magnesium stearate.

FRUMIL FORTE is available in packs of 28 and 56 tablets.

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

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

The Product Licence for FRUMIL FORTE is held by:

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

FRUMIL FORTE 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 FORTE TABLETS ?

FRUMIL FORTE 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 FORTE 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 FORTE TABLETS?

The usual dose of FRUMIL FORTE tablets is one tablet 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 FORTE 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 FORTE 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 FORTE 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

If you get any of the following tell your doctor immediately:

  • skin rash or itchy skin,
  • confusion,
  • hearing difficulty or ringing in the ears,
  • dizziness,
  • aching or swollen joints.

FRUMIL FORTE may occasionally alter the composition of your blood. Your doctor may therefore want to do some blood tests from time to time. FRUMIL FORTE may cause reversible changes in liver and kidney function which would be noticed in a blood test. Remember to tell any doctor who does a blood test on you that you are taking FRUMIL FORTE.

Like all medicines, FRUMIL FORTE may have unwanted effects which are very rare. If you notice any change in your health whilst taking this medicine, tell your doctor immediately.

EXPIRY DATE

The expiry date can be found in two places:

  1. On the end flap of the FRUMIL FORTE carton. It is written as "EXP". and is the latest of the two dates stamped on to the canon.
  1. The date at one end of the strip

In both places the date is written as the first three letters of the month, followed by the last two numbers of the year. For example: MAR 95 means that the expiry date is the end of March 1995.

YOU MUST NOT TAKE THE TABLETS AFTER THE EXPIRY DATE.

If in doubt, check with your doctor or pharmacist.

STORAGE OF YOUR FRUMIL FORTE TABLETS

Keep your medicine in the original packaging and away from direct sunlight.

Keep them in a cool (below 25°C), dry place.

Do not keep the tablets if your doctor decides to stop treatment. Return them to your pharmacist who will arrange for their destruction.

REMEMBER. These tablets are only for you. Only a doctor may prescribe them for you. Never give them to others. They may harm other people even if their symptoms appear the same as yours.

LIVING WITH YOUR HEART

What you can do to help yourself

Your doctor will give you advice on the various ways you can help your heart and build up your general health.

FRUMIL FORTE is sometimes used for treating conditions that may affect the heart, although your doctor may have given you FRUMIL FORTE for some other reason.

If you would like to know more about why you have been given FRUMIL FORTE, check with your doctor.

Changing your diet

If you are overweight your heart has more to cope with. So it's a good idea to get as close to your "ideal" weight as possible. If you do not know what your "ideal" weight should be, check with your doctor, surgery nurse or pharmacist.

Whatever weight you are, it's also important to cut down the amount of fat you eat, preferably by up to a quarter. You can do this by:

  • eating less red meat and more chicken, fish and vegetables,
  • grilling rather than frying food,
  • buying skimmed or semi-skimmed milk rather than full-fat milk,
  • eating low fat cheese,
  • including more fibre in your diet by eating more cereals, potatoes, leafy vegetables and fruit.

Giving up smoking

Medical research has clearly shown that smoking is bad for the heart, so it's important that you stop smoking now. You'll not only feel better and breathe more easily, but you'll also be saving lots of money.

Stress - and how to avoid it

You can help your heart by learning to enjoy relaxation and avoid stressful situations. Obviously you can't avoid stress altogether but if you follow a regular routine that puts less pressure on you then you'll be all the better for it.

What about alcohol?

Moderate drinking, such as half a pint of beer or a glass or two of wine a day, but not every day, won't harm the heart. However, you should avoid drinking more than this as it may affect your heart and increase your weight into the bargain.

Finding the right exercise

Your doctor can advise you on a planned programme of activity. This will improve your general health without putting too much of a strain on your heart. At first, you should avoid walking up steep hills or staircases with lots of steps. Eventually, though, you can build up to a regular routine of walking, swimming or cycling, or a combination of these.

For further advice

If you would like more information or guidance it is worth approaching the following support group.

Family Heart Association (Tel: 0865 370292).

™ FRUMIL and the green blister strip are trademarks

this leaflet was revised September 1993 © 1993 Rhône-Poulenc Rorer