Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 29831/0006.
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 your pharmacist.
This medicine has been prescribed only 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 these 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 Tablets are and what they are used for 2. Before you take Amiloride Tablets 3. How to take Amiloride Tablets 4. Possible side effects 5. How to store Amiloride Tablets 6. Further information
1. What Amiloride Tablets are and what they are used for
The name of your medicine is Amiloride 5mg Tablets. It contains amiloride hydrochloride. This 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).
It works by helping you to pass more water (urine) than you usually do.
2. Before you take Amiloride Tablets
Do not take Amiloride Tablets and tell your doctor if:
You are allergic (hypersensitive) to amiloride or any other ingredients in this medicine (listed in Section 6 below). Signs of an allergic reaction include: a rash, itching or shortness of breath
You have kidney problems
Your doctor has told you that you have high potassium levels or you are taking other potassium conserving drugs or potassium supplements
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 Tablets.
Take special care with Amiloride Tablets
Before you take Amiloride Tablets tell your doctor if:
You are elderly or seriously ill
You have diabetes
You have liver problems
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 Tablets.
Tests
Tell your doctor or nurse you are taking Amiloride 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 three days before your test.
Taking other medicines
Please tell your doctor of 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 Tablets can affect the way some other medicines work. Also, some medicines can affect the way Amiloride Tablets work.
In particular, tell your doctor if you are taking any of the following:
Lithium - used for depression
Medicines used to treat high blood pressure including ACE inhibitors, angiotensin-II antagonists, alpha-blockers, beta-blockers, calcium channel blockers and hydralazine
Nitrates - used for angina
Quinidine - used to treat heart rhythm disorders
Medicines or supplements containing potassium (including table salt substitutes)
Trilostane – used to treat kidney and skin cancer (melanoma)
Ciclosporin or tacrolimus – used after transplants to stop the rejection of organs
General anaesthetics, used to stop pain during surgery
Non-steroidal anti-inflammatory (NSAID) medicines such as indometacin, diclofenac and ibuprofen. 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
Chlorpropramide - used to treat diabetes
Carbamazepine - used for epilepsy
Levodopa – used to treat Parkinson’s disease
Medicines used to treat depression including tricyclic antidepressants (such as amitriptyline) and monoamine oxidase inhibitors (MAOIs – such as phenelzine)
Phenothiazines – used to treat mental illness
Medicines used to treat inflammation (such as cortisone and hydrocortisone)
Tizanidine or baclofen – used to relax muscles
Carbenoxolone – used to treat stomach ulcers
Some oral contraceptives (the pill) or oestrogen (female sex hormone) preparations
Alprostadil – used to treat male impotence and for heart defects in infants.
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.
Taking Amiloride Tablets with food and drink
If you feel dizzy while taking the tablets drinking alcohol can make this problem worse.
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
If you feel dizzy while taking Amiloride Tablets do not drive or operate dangerous machinery.
Important information about what is in Amiloride Tablets
This medicine contains:
Lactose monohydrate. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine.
3. How to take Amiloride Tablets
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the 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 Tablets taken alone
10mg each day
This may be increased to 20mg each day.
Amiloride Tablets taken with other diuretics High blood pressure and Congestive heart failure
5mg or 10mg each day.
Cirrhosis of the liver
5mg each day.
Children
This medicine is not usually given to children under the age of 18.
Older People
Your doctor will decide how many Amiloride Tablets to give you.
If you take more Amiloride Tablets than you should
Talk to a doctor or go to a hospital straight way.
Take the medicine pack with you so the doctor knows what you have taken.
If you forget to take Amiloride 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Amiloride Tablets can cause side effects although not everybody gets them.
If you have an allergic reaction to Amiloride Tablets see a doctor straight away
An allergic reaction may include:
Any kind of skin rash, flaking skin, boils or sore lips and mouth
Sudden wheezing, fluttering or tightness of the chest or collapse.
If you get any of the following side effects, stop taking Amiloride Tablets and see your doctor as soon as possible:
Chest pain including angina pain
Unusual heart beats
Yellowing of the skin and the whites of the eyes (jaundice)
Feeling dizzy, particularly when standing up
Disease of the brain (encephalopathy)
Difficulty breathing
Problems with your sight
Changes in the results of blood tests. These include changes in the way your liver is working or changes in red or white blood cell levels. They also include changes in sodium or potassium levels which can cause dry mouth, thirst, headaches, muscle cramps and weakness.
Tell your doctor if you get any of these side effects:
Feeling sick or being sick
Diarrhoea or constipation
Stomach pain
Skin rash, itching
Hair loss
Pins and needles
Feeling confused
Mood or personality changes
Feeling sleepy
Coughing
Changes in your sexual drive and function.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Amiloride Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C
Do not use after the expiry date which is stated on the blister and carton (Exp: month, year)
The expiry date refers to the last day of that month
Do not use Amiloride Tablets if you notice a change in the appearance of the medicine. Talk to your pharmacist
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
6. Further information
What Amiloride Tablets contains
The active ingredient is amiloride hydrochloride
The other ingredients are lactose monohydrate, starch, povidone, sodium starch glycollate, magnesium stearate, dispersed quinoline yellow lake E104 and isopropanol.
What Amiloride Tablets look like and contents of the pack
Amiloride Tablets are yellow, round tablets marked AML5 with a breakline on one side and CP on the reverse.
They are available in blister packs of 28 tablets.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference number
Amiloride 5mg Tablets PL 29831/0006
This service is provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK
Manufacturer
CP Pharmaceuticals Ltd Ash Road North Wrexham LL13 9UF UK