MODURETIC TABLETS

Active substance: HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MODURETIC® 50 mg/5 mg tablets
(Hydrochlorothiazide & Amiloride Hydrochloride)

In this leaflet:
1. What Moduretic is and what it is used for
2. Before you take Moduretic
3. How to take Moduretic
4. Possible side effects
5 How to store Moduretic
6. Further 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. Before you take Moduretic
Moduretic tablets are not for use in children
Do not take Moduretic 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 Moduretic if any of the above applies to you.
If you are not sure talk to your doctor or pharmacist before
taking Moduretic.
Take special care with Moduretic
Check with 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.
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. This is because Moduretic can affect the way
some other medicines work. Also some other medicines can
affect the way Moduretic works.
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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).
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.
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
Taking Moduretic 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 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 or if you think
that you are. 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.
Important information about some of the ingredients of
Moduretic
Moduretic 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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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.

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Technical Info

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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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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 Moduretic
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 Moduretic contains
Active ingredients
The active ingredients in Moduretic tablets are amiloride
hydrochloride and hydrochlorothiazide. Each Moduretic
tablet contains 5 mg amiloride hydrochloride and 50 mg
hydrochlorothiazide
Other ingredients:
The other ingredients are calcium hydrogen phosphate
(E341), guar gum, lactose, 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 and are 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 December 2013
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 2010. All rights reserved.
PIL.MUE-T.13.UK.4022 

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3. How to take Moduretic
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 Moduretic 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 immediately 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 product,
ask your doctor or pharmacist.

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Technical Info

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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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