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Frusid Tablets

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PATIENT INFORMATION LEAFLET

FRUSID TABLETS

Furosemide 40 mg Tablets PLEASE READ THIS LEAFLET CAREFULLY BEFORE

YOU START TAKING THIS MEDICINE.

KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED

ALL THE PRESCRIBED COURSE OF FRUSID.

IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION.

What is in your medicine?

The name of this medicine is FRUSID. Each tablet contains 40mg Furosemide BP together with the following ingredients: lactose, maize starch, potato starch, colloidal silicone dioxide, magnesium stearate.

The active ingredient in this medicine is Furosemide. This is the new name for Frusemide. The ingredient itself has not changed.

Frusid tablets are round, white, bevelled edged and engraved Frusid on one side, with a break-line on the other.

Frusid is available in blister packs of 28, 30, 56, 60, 84, 100, 500 and 1000 and in plastic containers of 28, 30, 56, 60, 84, 100, 500 and 1000 tablets.

Frusid belongs to a group of medicines called diuretics, and they are used to help reduce the amount of water in the body. They work by acting on the kidneys to increase the flow of urine.

The name and address of the Product Licence holder is:

Chelonia Healthcare Limited, Boumpqulinas 11, 3rd Floor, Nicosia, Cyprus. P.C.1060

The manufacturer of Frusid tablets is: DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE.

Why have you been prescribed Frusid?

In adults Frusid is used to treat high blood pressure (hypertension) in those patients who are not helped by other medicines, or in those patients who have kidney problems. Frusid is also used in the treatment of swelling, particularly of the feet and ankles which occurs with heart failure, liver and kidney disease.

Frusid may also be used for other conditions as determined by your doctor.

Before taking your medicine.

Before taking this medicine tell your doctor if you have ever had any unusual or allergic reactions to Furosemide or other diuretics, or to any of the ingredients in Frusid tablets. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives or dyes.

The presence of other medical problems may affect the use of Frusid. Make sure to tell your doctor if you have any other medical problems, especially:

   Diabetes

•    Absence of, or inability to pass,    urine

•    A lowering of the salt solutions in the blood which are normally present in sufficient amounts

•    Hypersensitivity to sulphonamides

•    Prostatic enlargement

•    Heart disease

•    High blood pressure and reduced blood volume

•    Liver disease or liver failure

•    Kidney failure

•    Porphyria

Use in pregnancy and while breast-feeding

If you are pregnant, planning a pregnancy or breast-feeding contact your doctor before taking Furosemide.

Can you drive while taking Frusid?

The ability to drive and to use machines may be affected due to reduced mental alertness.

Can you take Frusid with other medicines?

Before you begin using any new medicine (whether it is prescription or non-prescription), or if you develop any new medical problem while using this medicine, check with your doctor or pharmacist.

It is important that your doctor and pharmacist know if you are taking any of the following:

•    Non-Steroidal Anti-Inflammatory drugs

•    Drugs used for diabetes

•    Salicylates

•    Muscle relaxing    drugs

•    Antibiotics

•    Glucocorticoids

•    Lithium

•    Pressor amines

•    Cardiac glycosides

•    Another type of diuretic called metolazone

Some of the drugs listed above may interact with Frusid so that the

effect of the action of Frusid may be affected, and your doctor may therefore wish to consider an alternative medicine to Frusid.

If you are taking this medicine for high blood pressure, be sure not to take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (non-prescription) medicines.

While using this medicine be especially careful in testing for sugar in your blood or urine.

When and how to take Frusid 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.

Usual doses stated below:

Adults: Dosage will vary from 1-3 tablets daily or on alternate days. The usual initial dose is 1 tablet (40mg) daily which should be adjusted to achieve the effective dose. In mild oedema 1 tablet on alternate days or on three consecutive days of the week is recommended. In patients with resistant oedema daily doses of 2 or 3 tablets may be required.

Children: The dosage range is from 1mg to 3mg/kg of bodyweight daily.

Elderly: Dosage may be adjusted by your doctor until the required response is achieved because in the elderly Furosemide is generally eliminated more slowly.

What to do if you take too many tablets at the same time?

If you think you may have taken an overdose of this medicine you must obtain emergency help at once. Go to your doctor or nearest hospital casualty department straight away. Take with you any remaining tablets and the container so that the medicine can be identified.

What if you miss a dose?

Should you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not take two doses at once.

What side effects can Frusid cause?

Along with its needed effects, the medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Side effects such as sickness, feeling of excessive tiredness and stomach upset occasionally occur but do not require that the treatment be stopped. Body calcium may be depleted. Blood pressure and blood levels of sodium, potassium and magnesium may be reduced. A temporary increase in cholesterol and blood fats may also occur. Acid products in the blood may rise or fall.

Although the occurrences of allergic reactions, for example skin rashes, are infrequent treatment should be stopped when these occur.

As with other sulphonamide based diuretics (drugs that increase the passing of water) an increase in blood uric acid and creatinine may occur and in rare cases gout may result.

On rare occasions your skin may become sensitive to light.

As a rare complication bone marrow depression may occur and may require withdrawal of treatment.

In kidney impairment, loss of hearing and ringing in the ears are rare side effects.

If you notice any other effects, check with your doctor.

Storing your medicine?

Store in a well closed container, below 25°C in a dry place.

Keep out of reach of children.

Do not take this medicine after the expiry date which is printed on the container.

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.

PL 33414/0047

This leaflet was revised in February 2009