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AMILORIDE HYDROCHLORIDE 5MG TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE

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AMILORIDE HYDROCHLORIDE
5 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE 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.
2.
3.
4.
5.
6.

What Amiloride is and what it is used for
Before you take Amiloride
How to take Amiloride
Possible side effects
How to store Amiloride
Further information

1

• 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).

WHAT AMILORIDE IS AND WHAT IT IS USED FOR

Please tell your doctor or pharmacist if you are taking or
• Amiloride is a diuretic (“water tablet”) which increases have recently taken any other medicines, including
urine output and so reduces fluid retention. It is often
medicines obtained without a prescription.
prescribed in combination with another similar type of Pregnancy and breast-feeding
medicine (i.e. another diuretic), as its main function is If you are pregnant, planning to become pregnant or
to maintain the level of potassium in the blood in
breast-feeding ask your doctor or pharmacist for advice
cases where you may become prone to potassium loss. before taking any medicine.
• Amiloride is used:
Driving and using machines

in the treatment of patients with congestive heart Amiloride is not known to affect your ability to drive or
failure
operate machinery.

for high blood pressure
Important information about some of the ingredients of

for fluid retention associated with liver disease.
Amiloride
Patients who are intolerant to lactose should note that
BEFORE YOU TAKE AMILORIDE
amiloride tablets contain a small amount of lactose. If
you have been told by your doctor that you have an
Do NOT take Amiloride if you:
intolerance to some sugars, contact your doctor before
• are allergic (hypersensitive) to amiloride or any of the taking this medicinal product.
other ingredients of this medicine
• suffer from any kidney failure or disease, including
HOW TO TAKE AMILORIDE
failure to pass urine and damage due to diabetes
• have high levels of potassium in your blood
Always take amiloride exactly as your doctor has told
you. You should check with your doctor or pharmacist if
• are taking potassium supplements
you are not sure.
• are taking another diuretic (“water tablet”) also
The tablets should be swallowed preferably with a glass
designed to maintain your potassium levels.
of water. If you are taking another diuretic (“water
Take special care with Amiloride
tablet”) as well as amiloride, you should take them both
Tell your doctor before you start to take this medicine if
at the same time.
you:
The usual dose is:
• suffer from diabetes
• suffer from any form of blood mineral salt imbalance
Adults:
• have any liver problems.
(a)When taken on its own:
10 mg (2 tablets) per day in the morning, or twice daily
Taking other medicines
(one 5 mg tablet in the morning and one 5 mg tablet in
Do not take Amiloride in combination with:
the evening). However, your doctor may prescribe up to
• other diuretics (”water tablet”) also designed to
20 mg (4 tablets) a day until your condition has stabilised.
maintain your potassium levels, such as
Your
doctor may then slowly reduce your dosage over a
spironolactone or drospirenone.
period of time.
Talk to your doctor if you are taking any of the following:
(b) When taken in combination with another diuretic
• potassium salts or are on a special diet of
• High blood pressure:
potassium-rich food
The usual dose is 5 mg or 10 mg per day (1 to 2
• lithium (used to treat depression)

2

3

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.

4

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.
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
















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.

5

HOW TO 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
environment.

6

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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