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MODURETIC TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE / HYDROCHLOROTHIAZIDE

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Package leaflet: Information for the user

Moduretic® 50 mg/5 mg
tablets

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(Hydrochlorothiazide & Amiloride
Hydrochloride)

Technical Info

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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 or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Moduretic is and what it is used for
2. What you need to know before you take
Moduretic
3. How to take Moduretic
4. Possible side effects
5 How to store Moduretic
6. Contents of the pack and other information
1. What Moduretic is and what it is used for
Moduretic contains amiloride and
hydrochlorothiazide. They belong to the group of
medicines known as water tablets (diuretics). They
work by increasing the amount of urine that passes
from your body. This lowers your blood pressure or
removes excess water from your body.
Moduretic is used for:
• heart failure
• high blood pressure
• fluid retention caused by a liver disease called
‘cirrhosis’.
2. What you need to know before you take
Moduretic
Do not take Moduretic tablets:
• if you are allergic to hydrochlorothiazide and
amiloride hydrochloride or any of the other
ingredients of this medicine (listed in section 6)
• if you have diabetes (a high blood sugar level)
• if you have been told by your doctor you have
high levels of urea, creatinine, potassium or
calcium in your blood
• if you are allergic to a type of antibiotic called
sulfonamides, such as sulfamethoxazole
• if you are allergic to acetazolamide which is a
diuretic used to remove fluid from the body and
to treat high pressure in the eye (glaucoma),
heart problems and sometimes fits or epilepsy
• if you are allergic to any other ‘thiazide’ water
tablet (diuretic)
• if you are taking potassium sparing water
tablets (diuretics) such as eplerenone,
spironolactone or triamterene
• if you are taking a potassium supplement or
medicine containing potassium or you eat
potassium-rich foods
• if you suffer from kidney or liver disease
• if you have Addison’s disease
Do not take Moduretic if any of the above applies
to you. If you are not sure talk to your doctor or
pharmacist before taking Moduretic.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Moduretic if:
• you have been told by your doctor you
have high levels of uric acid, cholesterol or
triglycerides (a type of cholesterol) in your
blood
• you are taking digitalis such as digoxin - used
for heart failure and abnormal heart beat
• you are being given fluids by a tube inserted
into one of your veins
• you have recently suffered from severe
vomiting or diarrhoea
• you have Systemic Lupus Erythematosus
• you are elderly
• you have gout
If you are not sure talk to your doctor or pharmacist
before taking Moduretic.
Children and adolescents
Do not give this medicine to children under
18 years of age as limited data is available.
Other medicines and Moduretic
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines, including medicines obtained without a
prescription. This includes herbal medicines. This is
because Moduretic can affect the way some other
medicines work. Also some other medicines can
affect the way Moduretic works.
It is important to tell your doctor or pharmacist if
you take:
• angiotensin converting enzyme inhibitors
(ACE inhibitors) such as enalapril used to treat
high blood pressure or heart problems
• angiotensin II receptor antagonists such as
losartan - used to treat high blood pressure or
diabetics with kidney damage
• other medicines for high blood pressure
• medicines for diabetes such as insulin or
chlorpropamide
• lithium - used for depression
• non steroidal anti-inflammatory drugs (NSAIDs),
such as aspirin or ibuprofen - used to reduce
high temperature (fever), pain or for arthritis
• barbiturates - used to help you sleep or to
reduce anxiety
• painkillers such as codeine, dihydrocodeine,
dextropropoxyphene, diamorphine, morphine,
pentazocine and pethidine
• cholestyramine and colestipol - used to treat
high cholesterol (hyperlipidaemia)
• steroids - used to treat lots of different
conditions such as rheumatism, arthritis, allergic
conditions, skin problems, asthma or a type of
blood disorder
• ACTH to test whether your adrenal glands are
working properly
• medicines injected for allergic reactions such as
adrenaline (also known as epinephrine)
• tacrolimus - used after a liver or kidney
transplant to prevent rejection
• ciclosporin - used for rheumatoid arthritis or to
prevent rejection after a transplant
• ‘non-depolarising’ muscle relaxants such as
tubocurarine
• Trilostane - used to treat breast cancer or
overactive adrenal glands (such as in Conn's
syndrome, Cushing's syndrome).

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In addition, if you are going to have an operation,
make sure the doctor treating you knows you are
taking Moduretic.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking Moduretic.

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Tests while you are taking Moduretic
When you are on this medication it may affect
some tests on blood or urine samples. Please
remind your doctor you are taking Moduretic if he
or she wants you to have any tests.
If you have diabetes or your doctor suspects you
have diabetes, you may need to have some tests
before receiving treatment with Moduretic.
Moduretic with food, drink and alcohol
Your doctor may have asked you to change your
diet slightly and not to eat certain foods which
contain a lot of potassium. These foods include
milk, bananas, raisins and prunes. Your doctor will
tell you what food you should not eat. If you are
unsure about what food you should avoid, ask your
doctor before taking Moduretic tablets.
Your doctor may have told you that you should
keep alcohol intake to a minimum while you are
taking Moduretic. Alcohol may increase the effects
of Moduretic so that you feel dizzy or light-headed
when you stand up quickly.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you are pregnant, think
you may be pregnant or are planning to have a baby.
Usually, your doctor will advise you to take another
medicine instead of Moduretic, as Moduretic is not
recommended during pregnancy. This is because
Moduretic crosses the placenta and its use after the
third month of pregnancy may cause potentially
harmful foetal and neonatal effects.
Breastfeeding
Tell your doctor if you are breast-feeding or
about to start breast-feeding. Moduretic is not
recommended for mothers who are breast feeding.
Driving and using machines
This medicine may make you feel tired or dizzy.
Do not drive or operate machinery until you have
discussed this with your doctor or you know if you
are affected.
Moduretic contains 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.
3. How to take Moduretic
Taking this medicine
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
You should take this medicine by mouth. The
amount you take each day will depend on your
illness. The number of tablets to be taken will be on
the label of your medicine.
The recommended doses are:
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.
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.
If you take more Moduretic than you should
If you take too
much Moduretic by
mistake, contact your doctor or seek medical help
immediately.
If you forget to take Moduretic
• If you forget to take your dose, skip the missed
dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a
forgotten dose.
If you stop taking Moduretic
Do not stop taking Moduretic without speaking to
your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Moduretic can cause side
effects, although not everybody gets them. The
following side effects may happen with this
medicine:
Stop taking Moduretic and see a doctor straight
away, if you notice any of the following serious
side effects that may rarely occur. You may need
urgent medical treatment:
• allergic reactions - the signs may include
inflamed blood vessels, difficulties breathing or
swallowing, collapse, redness, blisters, peeling
skin, muscle pains, chills, a general feeling of
being unwell, ulcers in your mouth, eyes or
genitals.
Other side effects include:
Allergic reactions
• purplish or reddish-brown spots, skin irritation,
increased sensitivity to sunlight and a nettle like
rash (urticaria).
Heart and circulation
• irregular heart beat of your heart that can lead
to fainting and dizziness, palpitations
• feeling light headed when you stand quickly
• fast heart beat, chest pains (angina).
Blood
• anaemia - signs include unusual tiredness or
loss of colour in the lining of the eyes and skin
around the eyes
• other blood disorders which can result in high
temperature (fever), a sore throat, being unable
to stop bleeding from a cut
• changes in the levels of various chemicals in the
blood which are usually detected by blood or
urine tests.
Stomach and gut
• feeling sick (nausea) or being sick (vomiting),
indigestion, diarrhoea, constipation, stomach
ache and stomach cramps, wind, bloated
feeling, hiccups
• bleeding from your gut - signs may include
blood in your faeces or a darker colour of faeces
• liver problems such as jaundice - signs may
include yellowing of the skin and/or whites of
the eyes
• an inflamed pancreas - signs may include
feeling sick (nausea) and being sick (vomiting)
with pain in the stomach area and back
• swelling of the glands that make saliva
• your mouth may become dry
• a bad taste in your mouth
• lack or loss of appetite
• feeling thirsty.
Chest
• difficulty breathing
• blocked nose
• cough.

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Technical Info

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Nervous system
• feeling dizzy, feeling like you are spinning
(vertigo), pins and needles
• feeling sleepy, or sometimes feeling that you
can not sleep
• stupor, a type of brain disorder called
encephalopathy
• feeling nervous, confused, depressed or restless
• feeling shaky (tremors)
• headache, blackouts.
Skin and hair
• flushing, sweating
• rash, itching
• hair loss.
Eyes or ears
• an increase in the pressure in the eye which is
usually picked up in eye examinations
• changes in vision
• ringing in the ears.
Joints and muscles
• joint pain, pain in the fingers and toes, gout
• neck, shoulder and back pain
• leg ache, muscle cramps.
Urinary
• difficulty or pain urinating, an increase in the
amount of urine passed
• contractions of the bladder which can lead to
an increase in how often you need to pass urine
• kidney disorders which may lead to a reduced
amount of urine being passed
• passing urine at night, incontinence.
Sexual
• lower sex drive
• impotence.
General/Other
• a general feeling of being unwell, feeling tired,
weakness, dehydration.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 Moduretic
Keep this medicine out of the sight and reach of
children.
Do not use the medicine after the expiry date
which is stated on the carton after 'EXP'. The expiry
date refers to the last day of that month.
Store below 25°C. Protect from moisture.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Moduretic contains
• The active substances in Moduretic
tablets are amiloride hydrochloride and
hydrochlorothiazide. Each Moduretic tablet
contains 5 mg amiloride hydrochloride and
50 mg hydrochlorothiazide
• The other ingredients are calcium hydrogen
phosphate (E341), guar gum, lactose hydrous,
magnesium stearate (E572), maize starch,
pregelatinised maize starch and sunset yellow
aluminium lake (E110).
What Moduretic looks like and contents of the
pack
Moduretic tablets are peach-coloured,
diamond-shaped tablets, marked ‘MSD 917’ and
scored on both sides.
Moduretic is available in calendar packs of
28 tablets.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is
Merck Sharp & Dohme Limited, Hertford Road,
Hoddesdon, Hertfordshire, EN11 9BU, UK.
Moduretic Tablets are manufactured by
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN,
Haarlem, Netherlands.
This leaflet was last revised in April 2015
This leaflet gives you the most important patient
information about Moduretic. If you have any
questions after you have read it, ask your doctor
or pharmacist.
© Merck Sharp & Dohme Limited 2015. All rights
reserved.
PIL.MOD-T.14.UK.4203.IB-0008

Profile: BG148x520_260
Profile Revision:
7
Profile Revision Date: 050708
Dimensions (mm):
148 x 520mm

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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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