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INDAPAMIDE HEMIHYDRATE TABLETS 2.5 MG

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Indapamide hemihydrate
tablets 2.5 mg
(indapamide hemihydrate)

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
I
•  f 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
I
•  f 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:
W
1.  hat Indapamide is and what it is used for.
W
2.  hat you need to know before you
take Indapamide.
3. How to take Indapamide.
P
4.  ossible side effects.
5. How to store Indapamide.
6. Contents of the pack and other information.
1. What Indapamide is and what it is
used for

2. What you need to know before you
take Indapamide
Do not take Indapamide:
i
• f you are allergic to indapamide or a
sulphonamide-type medicine (e.g. certain
antibiotics), or any of the other ingredients of
this medicine (listed in section 6). Signs of an
allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips,
tongue or throat
• f you have ever had severe liver failure or
i
problems or suffer from liver problems which
affect your brain and central nervous system
(hepatic encephalopathy)
• f you have recently suffered from a head injury,
i
stroke or bleeding within the brain
• f you have low levels of potassium in your
i
blood (hypokalaemia)
• f you have experienced severe kidney failure.
i

TBC
1111121

Warnings and precautions - Talk to your doctor
or pharmacist before taking indapamide:
• f you have had low levels of potassium in your
i
blood in the past. Low levels of potassium can
occur in someone with heart disease or high
blood pressure
• f you have kidney problems
i
• f you suffer from an overactive adrenal gland
i
causing symptoms such as muscle weakness,
spasms and high blood pressure
• f you get swelling of the face, lips, mouth,
i
tongue or throat which may cause difficulty
in swallowing or breathing (angioneurotic
oedema) you need to stop this treatment
and be monitored by your doctor until all
swelling has disappeared
• f you need to have a test to check how well your
i
parathyroid gland is working
• f you suffer from gout
i
• f you are diabetic
i
• f you suffer from an overactive parathyroid
i
gland (leading to too much calcium in the
blood) which can cause soft bones
• f you are an athlete and play competitive
i
sports. This medicine contains an active
ingredient which may give a positive reaction
in doping tests
• f you have heart rhythm problems
i
• f you have liver problems
i
• f you have had photosensitivity reactions;
i
symptoms of sunburn (such as redness, itching,
swelling, blistering) which may occur more
quickly than normal.
Your doctor may do blood tests to check for low
sodium or potassium levels or high calcium levels.
Other medicines and Indapamide - Tell your
doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This is because indapamide can affect the way
that some medicines work and some medicines
can affect the way that indapamide works.
You should not take indapamide tablets with
lithium (used to treat depression) due to the
increased level of lithium in the blood.
Make sure to tell your doctor if you are taking any
of the following medicines, as special care may
be required:
•  edicines for heart rhythm problems such
m
as quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide or ibutilide

TBC

Indapamide belongs to a group of medicines
called diuretics (or 'water tablets'). Your doctor will
prescribe Indapamide to help treat high blood
pressure (essential hypertension). When used at
the normal recommended dose Indapamide does
not normally increase urine production but does
lower blood pressure. The exact way in which
Indapamide lowers blood pressure is not known
but treatment with Indapamide may take several
months to reach full effect. It may be used on its
own or in combination with other medicines for
the treatment of high blood pressure.

•  alofantrine (antiparasitic drug used to treat
h
certain types of malaria), which may cause a
problem with your heart rhythm when taken
together with indapamide tablets
•  incamine IV (used to increase blood flow to
v
the brain), which may cause a problem with
your heart rhythm when taken together with
indapamide tablets
b
•  epridil (used to treat angina pectoris, a
condition causing chest pain)
c
•  isapride (used to treat reduced movement of
the gullet and stomach)
d
•  iphemanil (used to treat gastro-intestinal
problems such as ulcers, too much acid,
overactive digestive system) which may cause
a problem with your heart rhythm when taken
together with indapamide tablets
s
•  parfloxacin, moxifloxacin, erythromycin IV
(antibiotics used to treat infections), which may
cause a problem with your heart rhythm when
taken together with indapamide tablets
•  ther diuretics ('water tablets') such as
o
furosemide. Your doctor may want to monitor
you more closely
m
•  edicines to treat a heart condition e.g. digoxin
•  teroids e.g. prednisolone or hydrocortisone
s
• laxatives
•  edicines used to treat mental disorders such
m
as depression, anxiety or schizophrenia (for
example tricyclic antidepressants, antipsychotic
drugs, such as chlorpromazine, cyamemazine,
levomepromazine, thioridazine, trifluoperazine,
amisulpride, sulpiride, sultopride, diapride,
droperidol, haloperidol, neuroleptics) which
may cause a problem with your heart rhythm
when taken together with indapamide tablets
p
•  entamidine (used to treat certain types
of pneumonia)
•  izolastine (used to treat allergic reactions,
m
such as hayfever)
•  on-steroidal anti-inflammatory drugs for
n
pain relief (e.g. ibuprofen) or high doses of
acetylsalicylic acid (aspirin)
•  ngiotensin converting enzyme (ACE) inhibitors
a
(used to treat high blood pressure and high
blood pressure)
•  ral corticosteroids used to treat various
o
conditions including severe asthma and
rheumatoid arthritis
•  aclofen (to treat muscle stiffness occurring in
b
diseases like multiple sclerosis)
•  otassium sparing diuretics (amiloride,
p
spironolactone, triamterene)
•  etformin (to treat diabetes)
m
• odinated contrast media (used for tests
i
involving X-rays)
•  alcium tablets or other calcium supplements
c
c
•  iclosporin, tacrolimus or other medicines
to depress the immune system after organ
transplantation to treat autoimmune
diseases, or to treat severe rheumatic or
dermatological diseases
t
•  etracosactide (to treat Crohn's disease)
•  arbenoxolone, to treat ulcers
c
•  mphotericin B administered by injection into a
a
vein (used to treat fungal infections).

1111121

Package leaflet:
Information for the patient

Pregnancy, breast-feeding and fertility Indapamide should not be given to pregnant
mothers unless the benefits to the mother
outweigh the risks to the baby. Ask your doctor or
pharmacist for advice before taking any medicine.
Do not use this medicine if you are breast-feeding
or planning to breast-feed.
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 - Do not drive or
operate machinery if you feel dizzy or drowsy,
or you have eyesight problems while taking this
medicine. These effects are more likely at the start
of treatment and after the dose increases or if
another medicine for the treatment of high blood
pressure is added.
Indapamide 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 Indapamide
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Indapamide should be swallowed whole with a
drink of water. It may take several months before
this treatment shows its full effect. However, if
there is not a steady lowering of blood pressure,
your doctor may wish to add another medicine
(such as a beta-blocker, ACE inhibitor, methyldopa
or clonidine), to your treatment, to help lower
your blood pressure. If your doctor starts you
on an ACE inhibitor e.g. Captopril, he may
stop Indapamide treatment a few days before,
to avoid a sudden fall in your blood pressure
(hypotension). Some patients may need regular
blood tests to check their blood salt (sodium,
potassium) levels and kidney function.
The recommended dose is:
Adults (including older people): One tablet
(2.5 mg) daily, taken in the morning.
Use in children and adolescents: Indapamide
should not be given to children or adolescents.

LT1295AE

Date: 23 Apr 2014
Description Indapamide 2.5mg 28/30/56/60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 410764

SAP No. N/A

Superceded Affiliate Item Code 10004867

Vendor Job No. 228059

TrackWise PR No. 410764

Proof No. 2

MA No. 04569/0232
Packing Site/Printer N/A
Supplier Code LT1295AE
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

Time: 16:19
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9.2 pt

If you take more Indapamide than you should
- Contact your doctor or go to your nearest
hospital emergency department immediately.
Take the container and any remaining tablets with
you. Symptoms of overdose include low blood
pressure, muscle weakness and disturbances with
your blood salt levels and severe dehydration
which can change the amount of urine produced
by your kidneys. Other symptoms include cramps,
dizziness, drowsiness, confusion and you may feel
or be sick (nausea or vomiting).
If you forget to take Indapamide - Take the next
dose of Indapamide as soon as you remember
unless it is almost time for your next dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Indapamide - If you suddenly
stop taking Indapamide you may experience side
effects. Speak to your doctor first before stopping
this medicine.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects

Not known (frequency cannot be estimated from
the available data): • raised glucose levels in the
blood that can make you feel more thirsty or pass
more urine than usual • low blood potassium
levels, more likely in elderly patients or those with
heart problems, hyperaldosteronism or with a
history of gout • low sodium levels in the blood
with low blood volume • feeling dehydrated •
irritability and muscle twitching. This may be due
to an imbalance in your blood called metabolic
alkalosis • feeling faint • weight loss
• change in liver enzyme tests • worsening of an
inflammatory disease of the connective tissues
with symptoms such as fever, weakness, fatigue,
joint pain and skin lesions (lupus erythematosus)
• allergic reactions, mainly affecting the skin,
more likely in patients with a history of allergy or
asthma • impotence • kidney problems (causing
symptoms of tiredness, increased need to urinate,
itchy skin, feeling sick, swollen extremities)
• increased sensitivity to sunlight or ultraviolet
light (e.g. sun bed use) leading to excessive skin
redness and sunburn • raised urate levels in the
blood that can make you feel more thirsty or pass
more urine than usual • dizziness.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

If any side effect gets serious, or if you notice
any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

Stop taking Indapamide and tell your doctor
immediately or go to your nearest hospital
emergency department if you think you may
have any of the following side effects:

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.

Rare (may affect up to 1 in 1,000 people): • skin
rash, which may blister, and looks like small
targets • central dark spots surrounded by
a paler area, with dark ring around the edge
(erythema multiforme).

You can also report side effects directly via the
Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

Very rare (may affect up to 1 in 10,000 people):
• inflammation of the pancreas (pancreatitis):
severe upper stomach pain, often with nausea
and vomiting • lack of white blood cells with the
following symptoms; fever, severe chills, sore
throat or mouth ulcers (agranulocytosis)
• swelling of the face, lips, mouth, tongue or
throat, which may cause difficulty in swallowing
or breathing (angioedema) • a widespread rash
with blisters and peeling skin, particularly around
the mouth, nose, eyes and genitals (Stevens
Johnson syndrome) • a widespread rash with
blisters and skin peeling on much of the body
surface (toxic epidermal necrolysis) • kidney
failure (kidney disease with little or no urine,
drowsiness, nausea, vomiting, breathlessness
blood or protein loss in urine).

5. How to store Indapamide

Not known (frequency cannot be estimated from
the available data): • Heart rhythm irregularities
known as Torsades de pointes (causing
palpitations, feeling of the heart pounding),
low blood pressure; which could lead to death
• abnormal liver function (with symptoms such
as tiredness, loss of appetite, feeling or being
sick, swollen extremities, yellow skin). In cases of
liver failure, there is a possibility of experiencing
a brain disease caused by severe liver problems
(hepatic encephalopathy).
These are serious side effects. You may need
medical attention.
Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:
Common (may affect up to 1 in 10 people):
• skin rash.
Uncommon (may affect up to 1 in 100 people):
• dizziness upon standing up from a sitting or
lying position • being sick (vomiting) • purple
or red-brown spots visible through the
skin (purpura).

Keep this medicine out of the sight and reach
of children. Do not use this 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 in a cool, dry place. 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 Indapamide contains - The active
substance is indapamide hemihydrate.
Each tablet contains 2.5 mg indapamide
hemihydrate. The other ingredients are: lactose;
cellulose, microcrystalline; sodium starch
glycolate; croscarmellose sodium type A;
magnesium stearate. The film-coating contains:
hydroxypropylmethylcellulose; polyethylene
glycol 400; titanium dioxide (E171).
What Indapamide looks like and contents of the
pack - Indapamide tablets are white biconvex film
coated tablet, marked 'IE 2.5' on one side and 'G'
on the other side.
Indapamide is available in blisters of 28, 30, 56 or
60 tablets or in containers of 30, 60, 100, 250 or
500 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.

Rare (may affect up to 1 in 1,000 people):
• spinning sensation (vertigo) • feeling tired
• headache • numbness or tingling in the arms or
legs • feeling sick • constipation • muscle cramps
• dry mouth.
Very rare (may affect up to 1 in 10,000 people):
• other blood disorders when the numbers of
different types of cells in the blood may fall, which
may cause fever, chills, sore throat, ulcers in the
mouth and throat (leucopenia), unusual bleeding
or you may bruise more easily than normal
(thrombocytopenia) • tiredness, headaches,
being short of breath when exercising, dizziness
and looking pale; frequent infections such as
fever, severe chills, sore throat or mouth ulcers;
bleeding or bruising more easily than normal,
nosebleeds (these may be signs of haemolytic
or aplastic anaemia) • raised calcium levels in the
blood that can lead to a loss of appetite, nausea,
vomiting, constipation, stomach pain • a fast, slow
or irregular heartbeat • low blood pressure • hives
(urticaria) • abnormal liver function tests.

This leaflet was last revised
410764
in 04/2014 LT1295AE

Date: 23 Apr 2014
Description Indapamide 2.5mg 28/30/56/60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 410764

SAP No. N/A

Superceded Affiliate Item Code 10004867

Vendor Job No. 228059

TrackWise PR No. 410764

Proof No. 2

MA No. 04569/0232
Packing Site/Printer N/A
Supplier Code LT1295AE
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

Time: 16:19
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9.2 pt

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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