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Amiloride Hydrochloride 5mg Tablets

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AMILORIDE HYDROCHLORIDE 5 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking

this medicine.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Amiloride is and what it is used for

2.    Before you take Amiloride

3.    How to take Amiloride

4.    Possible side effects

5.    How to store Amiloride

6.    Further information

WHAT AMILORIDE IS ANDWHAT IT IS USED FOR

*    Amiloride is a diuretic ("water tablet") which increases urine output and so reduces fluid retention. It is often prescribed in combination with another similar type of medicine (i.e. another diuretic), as its main function is to maintain the level of potassium in the blood in cases where you may become prone to potassium loss.

*    Amiloride is used:

*    in the treatment of patients with congestive heart failure

*    for high blood pressure

*    for fluid retention associated with liver disease.

BEFORE YOU TAKE AMILORIDE

Do NOT take Amiloride if you:

*    are allergic (hypersensitive) to amiloride or any of the other ingredients of this medicine

*    suffer from any kidney failure or disease, including failure to pass urine and damage due to diabetes

*    have high levels of potassium in your blood

*    are taking potassium supplements

*    are taking another diuretic ("water tablet") also designed to maintain your potassium levels.

Take special care with Amiloride

Tell your doctor before you start to take this medicine if you:

*    suffer from diabetes

*    suffer from any form of blood mineral salt imbalance

*    have any liver problems.

Taking other medicines

Do not take Amiloride in combination with:

* other diuretics ("water tablet") also designed to maintain your potassium levels, such as spironolactone or drospirenone.

Talk to your doctor if you are taking any of the following:

*    potassium salts or are on a special diet of potassium-rich food

*    lithium (used to treat depression)

*    ACE inhibitors (used to treat high blood pressure and heart failure), e.g. captopril or enalapril

*    any other drugs used to lower your blood pressure, e.g. prazosin, beta-blockers, e.g. sotalol, mexiletine or calcium channel blockers (also used for angina and an abnormal heartbeat) e.g. verapamil, nifedipine or amlodipine

*    non-steroidal anti-inflammatory drugs (NSAIDs) used to treat conditions such as arthritis or rheumatism, e.g. ibuprofen

*    terfenadine (an antihistamine)

*    antipsychotics, e.g. pimozide or thioridazine

*    ciclosporin or tacrolimus (used following organ transplant)

*    trilostane (used to treat Cushing's syndrome and primary hyperaldosteronism)

*    moxisylyte (used to treat Raynaud's syndrome)

*    baclofen or tizanidine (muscle relaxants)

*    amiodarone, disopyramide, flecainide or quinidine (used to control heart arrhythmias)

*    lidocaine (a local anaesthetic)

*    chlorpropamide (an antidiabetic drug)

*    cisplatin (an anti-cancer drug)

*    oestrogens or the combined contraceptive pill

*    alprostadil (used to treat impotence).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding If you are pregnant, planning to become pregnant or breast-feeding ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amiloride is not known to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Amiloride

Patients who are intolerant to lactose should note that amiloride tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

e HOWTO TAKE AMILORIDE

Always take amiloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed preferably with a glass of water. If you are taking another diuretic ("water tablet") as well as amiloride, you should take them both at the same time.

The usual dose is:

Adults:

(a) When taken on its own:

10 mg (2 tablets) per day in the morning, or twice daily (one 5 mg tablet in the morning and one 5 mg tablet in the evening). However, your doctor may prescribe up to 20 mg (4 tablets) a day until your condition has stabilised. Your doctor may then slowly reduce your dosage over a period of time.

(b)    When taken in combination with another diuretic

*    High blood pressure:

The usual dose is 5 mg or 10 mg per day (1 to 2


tablets), taken along-side your other medication.The maximum daily dose is 20 mg (4 tablets).

*    Congestive heart failure:

The initial dose is 5 to 10 mg per day (1 to 2 tablets), taken along-side your other medication. Your doctor may adjust this dose according to your condition.The maximum daily dose is 20 mg (4 tablets).

*    Fluid retention associated with liver disease:

Treatment usually begins with a low dose, such as 5 mg per day (1 tablet), taken along-side your other medication.This level may be adjusted by your doctor according to your condition.

Children:

Amiloride should not be used in children.

The Elderly:

Your doctor will carefully monitor your response to the amiloride and adjust your dose according to your condition.

If you see another doctor or go into hospital, let the doctor or the staff know what medicines you are taking.

If you take more Amiloride than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause signs of dehydration, thirst and changes in blood mineral concentrations. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Amiloride

If you have missed a dose, take the dose as quickly as possible unless it is nearly time to take the next one. Never take two doses together.Take the remaining doses at the correct time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, amiloride can cause side effects, although not everybody gets them. If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

*    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or nettle rash).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects would indicate a high potassium content in the blood and you should discuss this with your doctor immediately:

*    numbness and tingling

*    muscle paralysis

*    heart rhythm disturbances.

*    headaches, dizziness, vertigo

*    nervousness, confusion, depression

*    problems with your eye sight

*    yellowing of the skin and whites of the eyes

*    pins-and-needles, itching, shaking

*    weakness, fatigue

*    muscle cramps, back pain, neck or shoulder pain, joint pain, and pain in the extremities

*    nasal congestion, a cough

*    hair loss

*    ringing in the ears

*    problems with your bladder and passing urine

*    temporary impotence, a decreased sexual desire

*    difficulty sleeping, or a general feeling of sleepiness

*    there have been reports of a nervous system disorder characterised by tremors, fits, confusion, unconsciousness and unresponsiveness.This particularly affects patients with severe liver disease who may in addition, suffer from increased jaundice.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOWTO STORE AMILORIDE

Keep out of the reach and sight of children. Do not store above 25°C, keep in the original package or container supplied. Do not use Amiloride after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the envi ronment.

FURTHER INFORMATION

What Amiloride contains:

*    The active ingredient is amiloride hydrochloride. Each tablet contains 5.68 mg amiloride hydrochloride equivalent to 5 mg amiloride hydrochloride anhydrous.

*    The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate, talc, magnesium stearate and silica colloidal anhydrous.

What Amiloride looks like and contents of the pack:

*    Yellow, flat bevel-edged tablets. Engraved 1A5 on one side and plain on the reverse.

*    The product is available in pack sizes of 7, 10, 12, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:TEVA UK Limited, Eastbourne, BN22 9AG.

PL 00289/0727

This leaflet was last revised: AUGUST 2007


TEVA UK Limited


The following side effects have also been reported:

*    breathing difficulties

*    chest pain, an irregular heart beat, palpitations which are the awareness of your heart beating

*    increased potasium levels in the blood

*    nausea, loss of appetite, indigestion

*    abdominal pain, wind, vomiting, diarrhoea, constipation, black or blood stained bowel movements

*    thirst, dryness of the mouth

*    mild skin rash