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MODURET-25 TABLETS

Active substance: HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MODURET® 25 mg/2.5 mg tablets
(Hydrochlorothiazide & Amiloride
Hydrochloride)

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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 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 Moduret 25 is and what it is used for
2. Before you take Moduret 25
3. How to take Moduret 25
4. Possible side effects
5 How to store Moduret 25
6. Further information
1. What Moduret 25 is and what it is 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’.
2. Before you take Moduret 25
Moduret 25 tablets are not for use in children
Do not take Moduret 25 tablets if:
• you have ever had an allergic reaction to this medicine or to
any of its ingredients (listed in section 6)
• you have diabetes (a high blood sugar level)
• you have been told by your doctor you have high levels of
urea, creatinine, potassium or calcium in your blood
• you are allergic to a type of antibiotic called sulphonamides,
such as sulphamethoxazole
• 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
• you are allergic to any other ‘thiazide’ water tablet (diuretic)
• you are taking potassium sparing water tablets (diuretics)
such as eplerenone, spironolactone or triamterene
• you are taking a potassium supplement or medicine
containing potassium or you eat potassium-rich foods
• you suffer from kidney or liver disease
• 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.
Take special care with Moduret 25
Check with 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. This includes herbal medicines.

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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
Taking Moduret 25 with food and drink
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 or if you
think that you are. 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.
Important information about some of the ingredients of
Moduret 25
Moduret 25 contains lactose, which is a type of sugar. If you have
been told by your doctor that you cannot tolerate or digest some
sugars (have an intolerance to some sugars), talk to your doctor
before taking this medicine.

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Profile Revision:
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Profile Revision Date: 050708
Dimensions (mm):
148 x 260

3. How to take Moduret 25
Taking this medicine
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. If you are unsure
about the dose you should take, you must talk to your doctor or
pharmacist. The usual doses of Moduret 25 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
immediately 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 product, ask
your doctor or pharmacist.
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.

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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
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. How to store Moduret 25
Keep your medicine out of the reach and sight 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.
Keep your tablets in a dry place, below 25°C, protected from light.
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 Moduret 25 contains
Active ingredients
The active ingredients in Moduret 25 tablets are amiloride
hydrochloride and hydrochlorothiazide. Each Moduret 25 tablet
contains 2.5 mg amiloride hydrochloride and 25 mg
hydrochlorothiazide
Other ingredients:
The other ingredients are calcium hydrogen phosphate (E341),
guar gum, lactose, 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
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 February 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-T25.13.UK.4020

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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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