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AMILORIDE 5MG TABLETS BP

Active substance(s): AMILORIDE HYDROCHLORIDE / AMILORIDE HYDROCHLORIDE / AMILORIDE HYDROCHLORIDE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Amiloride 5 MG

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9.5

Version No.

5 (Page 1 of 2)

Date

24_10_16 (Amiloride-5 (ACC-UK)NEW-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

PACKAGE LEAFLET: INFORMATION FOR
THE USER

Amiloride 5 mg Tablets
BP
(Amiloride Hydrochloride)

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Amiloride 5 mg tablets are and what
are they used for
2. What you need to know before you take
Amiloride 5 mg tablets
3. How to take Amiloride 5 mg tablets
4. Possible side effects
5. How to store Amiloride 5 mg tablets
6. Contents of the pack and other information

1. What Amiloride 5 mg tablets
are and what are they used for
Amiloride 5 mg tablets belong to a group of
medicines called diuretics (water tablets).
Amiloride 5 mg tablets can be used on their
own (monotherapy) or with other drugs such
as thiazide diuretics. They may be used for:
• high blood pressure
• congestive heart failure
• liver cirrhosis with swelling of the abdomen
(ascites).

2. What you need to know before
you take Amiloride 5 mg
tablets
Do not take Amiloride 5 mg tablets:
• if you are allergic to amiloride hydrochloride
or any of the other ingredients of this
medicine (listed in section 6).
• if you are giving the tablets to a child
• if you are taking any potassium conserving
drugs or potassium supplements
• if you are not producing any urine
• if you are pregnant or breastfeeding
or if you have:

Approved By
Quality Assurance

• atomoxetine (used to treat ADHD)
• corticosteroids used to reduce inflammation
• levodopa (used in Parkinson’s disease)
• moxisylyte (used in Raynaud’s syndrome)
• muscle relaxants such as baclofen and
tizanidine
• nitrates (used for certain heart conditions)
• oestrogen and drospirenone (contraception
(female hormones))
• alprostidil (used for erectile dysfunction)
• potassium salts
Amiloride 5 mg tablets with alcohol
Avoid alcohol when taking this medicine, your
blood pressure may drop too much.
Pregnancy, breast-feeding and fertility
The use of Amiloride 5 mg tablets is not
recommended in pregnant women. Contact
your doctor before breast feeding as you
should either not breast feed or stop taking
Amiloride 5 mg tablets.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
If you feel dizzy while taking Amiloride 5 mg
Tablets do not drive or operate dangerous
machinery
Amiloride 5 mg tablets contain Lactose
monohydrate
Amiloride 5 mg tablets contain 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.
Diabetic tests
If you are to be tested for diabetes or need to
have other tests related to diabetes, tell your
doctor you are taking Amiloride 5 mg tablets.
The tablets may need to be stopped at least
three days before the test, as they can
interfere with the results

3. How to take Amiloride 5 mg
tablets
Always take Amiloride 5 mg tablets exactly as
your doctor has told you. If you are not sure,
check with your doctor or pharmacist.
Swallow the tablets.
The recommended dose is:
Monotherapy:
Two tablets a day either as a single or divided
dose, to a maximum of four tablets a day and
then gradually reduced to a maintenance
dose.

• high blood levels of potassium
(hyperkalaemia)
• severe kidney disease or kidney failure
• diabetic neuropathy (diabetic nerve damage
causing pain, weakness or numbness).

High blood pressure:

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 5 mg tablets.

One to two tablets a day up to four tablets a
day and then gradually reduced to a
maintenance dose.

Warnings and precautions

Liver cirrhosis with swelling of the
abdomen (ascites):

Talk to your doctor, pharmacist or nurse
before using Amiloride 5 mg tablets:
• if you have or have had high levels of acid
in the body (metabolic or respiratory acidosis)
caused by heart disease
• if you have severe liver disease
• if you have kidney impairment
• if you have disturbances of blood chemicals
• if you are elderly.
• if you have diabetes

One to two tablets a day up to four tablets a day.
Congestive heart failure:

One tablet initially up to four tablets and then
gradually reduced to a maintenance dose.
Elderly:
The dosage will depend on your kidney
function, blood chemical levels and response
to treatment. If you are elderly, it is particularly
important to take this medicine exactly as
prescribed.

Children

Children:

Amiloride 5 mg tablets are not to be used in
children

Not recommended.

Other medicines and Amiloride 5 mg
tablets
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Especially:
• lithium (for some mental illnesses)
• antidiabetic drugs such as chlorpropamide
• ciclosporin and tacrolimus (used in
rheumatism, psoriasis and to prevent organ
rejection)
• medicines for high blood pressure such as
ACE inhibitors (captopril or enalapril),
Angiotensin II antagonists (losartan,
valsartan), beta blockers (sotolol), calcium
channel blockers (amlodipine, diltiazem),
adrenergic neurone blockers, alphablockers
(prazosin), clonidine, diazoxide, methyldopa,
moxonidine, hydralazine, minoxidil and
sodium nitroprusside
• non-steroidal anti-inflammatory drugs
(NSAIDs) for pain e.g. ibuprofen or naproxen
• antidepressants such as MAOIs, tricyclics,
St Johns Wort
• carbamazepine (used in epilepsy)
• aldesleukin and trilostane (used in certain
cancers)
• general anaesthetic
• antipsychotics such as amisulpride and
pimozide, phenothiazines such as
chlorpromazine or anxiolytics and hypnotics
such as diazepam (used in mental illness)

If you take more Amiloride 5 mg tablets
than you should
If you (or someone else) swallow a lot of
tablets at the same time, or you think a child
may have swallowed any, contact your nearest
hospital casualty department or tell your doctor
immediately. Symptoms of an overdose
include dehydration and changes in the levels
of certain chemicals in the blood.
If you forget to take Amiloride 5 mg tablets
If you forget to take a dose take it as soon as
you remember it and then take the next dose
at the right time. Do not take a double dose to
make up for a forgotten dose.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking this medicine and go to your
nearest Accident and Emergency
department or contact your doctor
immediately if you get any of the following
signs of an allergic reaction:
• swelling of the face, lips, tongue or throat,
difficulty in swallowing or breathing or a skin
rash

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Amiloride 5 MG

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9.5

Version No.

5 (Page 2 of 2)

Date

24_10_16 (Amiloride-5 (ACC-UK)NEW-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

Please tell your doctor or pharmacist if you
notice any of the following side effects,
they get worse or if you notice anything not
listed.
• Metabolism: changes in levels of body
chemicals (increased blood potassium or
decreased blood sodium).
• Nervous system: depression, difficulty
sleeping or sleepiness, confusion,
nervousness, dizziness, pins and needles,
feeling of spinning (vertigo), tremors and
brain disease (characterised by poor
concentration, confusion and delirium).
• Heart: chest pain (angina), irregular
(arrhythmia) or pounding (palpitation) heart
beats, dizziness on standing due to low blood
pressure, heart block.
• Breathing: cough, difficulty breathing.
• Stomach and intestines: stomach pain or
bleeding, indigestion, wind, loss of appetite,
thirst, constipation, diarrhoea, feeling or
being sick, dry mouth.
• Liver and pancreas: jaundice (yellow skin or
eyes).
• Skin: skin rash, itching, hair loss.
• Muscles and joints: joint pain, muscle
cramps, gout.
• Urinary and genital: pain on passing water,
frequent or copious water production, bladder
spasms, decreased desire for sex and
inability to maintain an erection.
• Senses: stuffy nose, ringing in the ears,
increased pressure in the eyes, visual
disturbances.
• Other: back, chest, neck and shoulder pain,
pain in the hands and feet, tiredness,
weakness, headache.
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.
By reporting side effects you can help provide
more information on the safety of this
medicine.

5. How to store Amiloride 5 mg
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. The expiry date
refers to the last day of that month.
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. Contents of the pack and
other information
What Amiloride 5 mg 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 5 mg tablets).
What Amiloride 5 mg tablets looks like and
contents of the pack
Amiloride 5 mg 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 revised in 10/2016.

INP001
10 00000 0 000000

Expand Transcript

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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