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Amiloride 5mg Tablets Bp

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiloride 5mg Tablets BP

(Amiloride Hydrochloride)

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 gets 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 5mg tablets are and what are they used for

2.    Before you take Amiloride 5mg tablets

3.    How to take Amiloride 5mg tablets

4.    Possible side effects

5.    How to store Amiloride 5mg tablets

6.    Further information

1. WHAT AMILORIDE 5MG TABLETS ARE AND WHAT ARE THEY USED FOR

The name of your medicine is Amiloride 5 mg tablets (called Amiloride in this leaflet). It contains amiloride hydrochloride.

Amiloride belongs to a group of medicines called diuretics (water tablets).

Amiloride can be used to stop the build up of extra water in your body. It does this without loss of potassium from your body. This extra water can lead to high blood pressure, heart problems (congestive heart failure) and liver problems (hepatic cirrhosis).

Amiloride works by helping you to pass more water (urine) than you usually do.

2. BEFORE YOU TAKE

AMILORIDE 5MG TABLETS

Do not take Amiloride 5mg tablets and tell your doctor :

•    If you are allergic (hypersensitive) to amiloride or any other ingredients in Amiloride tablets (see section 6). Signs of an allergic reaction include: rashes, itching or shortness of breath.

•    If your doctor has told you that you have high potassium levels.

•    If you have an illness called ‘Addison's disease'(endocrine disorder).This is when your adrenal glands are not working properly. It can cause weakness, tiredness, weight loss and low blood pressure.

•    If you have kidney problems. This includes those caused by diabetes.

•    If you are not passing any water (urine).

•    If the person taking the medicine is a child under 18 years old.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Amiloride 5mg tablets.

Take special care with Amiloride 5mg tablets

Before taking Amiloride 5mg tablets, tell your doctor:

•    If you have diabetes.

•    If you have liver problems.

•    If your doctor has told you that you have too much acid in your blood. This can be caused by diabetes or heart or lung disease.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amiloride 5mg tablets.

Tests:

Inform your doctor or nurse that you are taking Amiloride 5mg tablets, if you are going to have a glucose tolerance test. This is because this medicine can affect the results. You will need to stop taking this medicine at least three days before your test.

Taking other medicines

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

This is because Amiloride can affect the way some other medicines work. Also, some medicines can affect the way Amiloride works.

In particular, tell your doctor if you are taking any of the following:

•    Medicines used for heart failure (such as captopril, lisinopril, candesartan).

•    Diuretics (water tablets) such as furosemide and spironolactone.

•    Non-steroidal anti-inflammatory medicines such as ibuprofen and diclofenac. Your doctor may want to carry out tests on your kidneys and the level of potassium in your blood, especially if you are an older person.

•    Trilostane used for Cushings syndrome or breast cancer.

•    Chlorpropamide used to treat diabetes.

•    Cyclosporin or tacrolimus used after transplants to stop the rejection of organs.

•    Lithium used for depression.

•    Medicines or supplements containing Potassium (including table salt substitutes).

•    Baclofen used to treat spastic movement disorders.

This medicine does not cause loss of potassium from your body as other water tablets do. Therefore it is not necessary for you to get extra potassium in your diet or take supplements. Too much potassium could even be harmful.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.

Driving and using machines

Amiloride 5mg tablets may make some people feel drowsy. Do not drive a car or operate dangerous machinery until you know how it affects you.

Important information about some of the ingredients of Amiloride 5mg tablets:

Amiloride 5mg tablets contains Lactose monohydrate - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE AMILORIDE 5MG TABLETS

Always take Amiloride 5mg tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Take this medicine by mouth.

•    If you are taking a single dose, take it in the morning.

•    If you are taking more than one dose, take the last dose before 6pm. Unless your doctor tells you otherwise.

•    Plan your doses so that they do not affect your personal activities and sleep.

•    Your doctor will check your progress regularly to make sure the medicine is working properly.

Adults

The usual doses for adults are:

Amiloride taken alone

•    10mg each day.

•    This may be increased to 20mg each day. Amiloride taken with other diuretics High blood pressure

•    The usual starting dose is half a tablet each day.

•    Your doctor may change your dose to one tablet given each day.

•    Your doctor may spread out the dose or give it as a single dose.

Congestive heart failure

•    The usual starting dose is half a tablet each day.

•    Your doctor may change your dose.

•    You should not take more than two tablets in a day.

Fluid retention due to cirrhosis

•    The usual starting dose is one tablet each day.

•    Your doctor may change your dose.

•    You should not take more than two tablets in a day.

Older People: Your doctor will decide how much Amiloride dose to give you.

Children: This medicine is not usually given to children under the age of 18.

If you take more Amiloride 5mg tablets than you should

Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Amiloride 5mg tablets

Do not take a double dose (two doses at the same time) to make up for a forgotten dose. Take your next dose as soon as you remember, then go on as before. However, if it is nearly time for the next dose, skip the missed dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amiloride can cause side effects particularly when treatment is first started, although not everybody gets them.

If you have an allergic reaction, stop taking Amiloride 5mg tablets and see a doctor straight way.

The allergic reactions may include:

•    Any kind of skin rash, flaking skin, boils or sore lips and mouth.

•    Sudden wheeziness, fluttering or tightness of the chest or collapse.

•    Swelling of the face, neck and throat.


If you experience any of the following side effects, stop taking Amiloride 5mg tablets and contact your doctor as soon as possible:

•    Chest pain including angina pain.

•    Unusual heart beats.

•    Bleeding in the stomach. Signs include passing black stools.

•    Yellowing of the skin and the whites of the eyes (jaundice).

•    Feeling dizzy, particularly when standing up.

•    Disease of the brain (encephalopathy).

•    Feeling depressed.

•    Difficulty in breathing.

•    Problems with your sight and increased pressure in the eye.

•    Worsening of the effects of a stomach ulcer.

•    Pain while passing urine and spasms of the bladder.

•    Changes in the results of blood tests. These include changes in the way your liver is working, changes in red or white blood cell levels or changes in sodium or potassium levels.

Tell your doctor if you get any of these side effects:

•    Headache.

•    Feeling sick or being sick.

•    Diarrhoea or constipation.

•    Stomach pain and wind.

•    Feeling weak or tired.

•    Painful swelling of the joints (gout).

•    Pain in the back, neck or shoulder, fingers, toes and joints.

•    Skin rash, itching.

•    Feeling thirsty and dry mouth.

•    Loss of appetite.

•    Hair loss.

•    Muscle cramps, pins and needles.

•    Feeling nervous or confused.

•    Unable to sleep or feeling sleepy.

•    Coughing, blocked nose.

•    Ringing in the ears.

•    Changes in your sexual drive and function.

•    Shaking.

•    Increase in number of times and the amount

of water (urine) you pass. This may be because    your bladder is not emptying

completely or due to the medicine.

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

5. HOW TO STORE AMILORIDE 5MG TABLETS

Container packs: Do not store above 25°C. Keep in the original container. Keep the container tightly closed.

Blister packs: Do not store above 25°C. Store in the original package in order to protect from light.

Keep out of the reach and sight of children.

Do not use your tablets after the expiry date stated on the carton or label.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Amiloride 5mg Tablet contains

The active substance is Amiloride hydrochloride.

The other ingredients are Lactose monohydrate, Dibasic calcium phosphate dihydrate, Pregelatinised starch, Maize starch, Sodium starch glycolate and Magnesium stearate (see section 2 for Important information about some of the ingredients of Amiloride 5mg tablets).

What Amiloride 5mg tablets looks like and contents of the pack

Amiloride 5mg tablets are off white to creamy white, round, flat, uncoated, debossed with C and G on either side of the breakline and plain on the another side.

They are available in container packs of 100 and 500 tablets. They are also available in the blister packs of 28 and 84 tablets (Not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

This leaflet was last approved in {11/2011}.