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MODURET-25 TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE / HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MODURET 25®
25 mg/2.5 mg tablets
(Hydrochlorothiazide & 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 or pharmacist.
• 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Moduret 25 is and what it is used for
2. What you need to know before you take Moduret 25
3. How to take Moduret 25
4. Possible side effects
5 How to store Moduret 25
6. Contents of the pack and other information
1. What Moduret 25 is and what is it used for
Moduret 25 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.
Moduret 25 is used for:
• heart failure
• high blood pressure
• fluid retention caused by a liver disease called ‘cirrhosis’.

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2. What you need to know before you take Moduret 25
Do not take Moduret 25 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 Moduret 25 if any of the above applies to you. If you are
not sure talk to your doctor or pharmacist before taking Moduret 25.
Warnings and precautions
Talk to your doctor or pharmacist before taking Moduret 25 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
Moduret 25.
Children and adolescents
Do not give this medicine to children under 18 years of age as
limited data is available.

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Other medicines and Moduret 25
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 Moduret 25 can affect the way some other
medicines work. Also some other medicines can affect the way
Moduret 25 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
In addition, if you are going to have an operation, make sure the
doctor treating you knows you are taking Moduret 25.
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking Moduret 25.
Tests while you are taking Moduret 25
When you are on this medication it may affect some tests on
blood or urine samples. Please remind your doctor you are taking
Moduret 25 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
Moduret 25.
Moduret 25 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
Moduret 25 tablets.
Your doctor may have told you that you should keep alcohol
intake to a minimum while you are taking Moduret 25. Alcohol
may increase the effects of Moduret 25 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 Moduret 25,
as Moduret 25 is not recommended during pregnancy. This is
because Moduret 25 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. Moduret 25 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.
Moduret 25 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.

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Technical Info

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485697A01

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Profile

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Profile Revision:
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Dimensions (mm):
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4. Possible side effects
Like all medicines, Moduret 25 can cause side effects, although not
everybody gets them. The following side effects may happen with
this medicine:
Stop taking Moduret 25 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.

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 Moduret 25
Keep this medicine out of the sight and reach of children.
Do not use the medicine past 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 light.
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 Moduret 25 contains
• The active substances in Moduret 25 tablets are
amiloride hydrochloride and hydrochlorothiazide.
Each Moduret 25 tablet contains 2.5 mg amiloride
hydrochloride and 25 mg hydrochlorothiazide
• The other ingredients are calcium hydrogen phosphate (E341),
guar gum, lactose hydrous, magnesium stearate (E572),
maize starch and pregelatinised maize starch.
What Moduret 25 looks like and contents of the pack
Moduret 25 tablets are off-white, diamond-shaped tablets, marked
with identification number ‘923’ on one side and scored on the
other side.
Moduret 25 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.
Moduret 25 Tablets are manufactured by Merck Sharp & Dohme BV,
Waarderweg 39, 2031 BN, Haarlem, Netherlands.
This leaflet was last revised in August 2015
This leaflet gives you the most important patient information
about Moduret 25. If you have any questions after you have read it,
ask your doctor or pharmacist.
© Merck Sharp & Dohme Limited 2015. All rights reserved.
PIL.MUE.14.UK.4205.IB-0007

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3. How to take Moduret 25
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 one tablet each day.
• Your doctor may change your dose to two tablets given
each day.
• Your doctor may spread out the doses or give it all together as
a single dose.
Heart failure
• The usual starting dose is one tablet each day.
• Your doctor may change your dose.
• You should not take more than four tablets in a day.
Fluid retention due to cirrhosis
• The usual starting dose is two tablets each day.
• Your doctor may change your dose.
• You should not take more than four tablets in a day.
If you take more Moduret 25 than you should
If you take too much Moduret 25 by mistake, contact your doctor
or seek medical help immediately.
If you forget to take Moduret 25
• 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 Moduret 25
Do not stop taking Moduret 25 without speaking to your doctor.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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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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