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INDAPAMIDE HEMIHYDRATE 2.5 MG FILM-COATED TABLETS

Active substance(s): INDAPAMIDE HEMIHYDRATE

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Indapamide hemihydrate
2.5 mg Film-coated Tablets
(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.
• 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 Indapamide is and what it is used for
2. What you need to know before you
take Indapamide
3. How to take Indapamide
4. Possible 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
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 substantially
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.

2. What you need to know before you
take Indapamide
Do not take Indapamide:

• if you are allergic to indapamide or a
sulfonamide-type medicine (e.g. certain
antibiotics or other diuretics), 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
• if you have ever had severe liver failure or
problems or suffer from liver problems which
affect your brain and central nervous system
(hepatic encephalopathy)
• if you have recently suffered from a stroke or
bleeding within the brain
• if you have low levels of potassium in your blood
(hypokalaemia)
• if you have experienced severe kidney failure.

Warnings and precautions

TBC
1111121

Talk to your doctor or pharmacist before
taking Indapamide:
• if you have had low levels of potassium in your
blood in the past. Low levels of potassium can
occur, for example, in someone with heart
disease or high blood pressure
• if you have other kidney problems
• if you suffer from an overactive adrenal gland
causing symptoms such as muscle weakness,
spasms and high blood pressure
• if you suffer from gout
• if you are diabetic
• if you suffer from an overactive parathyroid gland
(leading to too much calcium in the blood),
which can cause soft bones
• if you have heart rhythm problems, heart failure
(a weakness of the heart muscle) or reduced
blood flow to the heart (such as angina)
• if you have other liver problems, especially that
causing fluid accumulation in the stomach and
abdomen (ascites)
• If you are not able to eat normally, or can
only manage limited food intake and
are malnourished
• if you have had photosensitivity reactions e.g.
symptoms of sunburn (such as redness, itching,
swelling, blistering) which may occur more
quickly than normal. This medicine may increase
the risk of this occurring and you may need to
use sunscreen or avoid sunlight or artificial UV
light e.g. sunbeds. Whilst taking this medicine,
if you notice reddening of the skin or other
sunburn like symptoms, stop taking and talk to
your doctor
• if you are an athlete and play competitive sports.
This medicine contains an active ingredient which
may give a positive reaction in doping tests

You should not take indapamide tablets with
lithium (used to treat depression) due to the risk of
increased levels of lithium in the blood.
Make sure to tell your doctor if you are taking any of
the following medicines, as they may cause a problem
with your heart rhythm when taken together with
indapamide, and special care may be required:
• medicines for heart rhythm problems such
as quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide or
digoxin (which may also be used for other
problems e.g. heart failure)
• halofantrine (antiparasitic drug used to treat
certain types of malaria)
• vincamine IV (used to increase blood flow to
the brain)
• bepridil (used to treat angina pectoris, a
condition causing chest pain)
• cisapride (used to treat reduced movement of the
gullet and stomach)
• diphemanil (used to treat gastro-intestinal
problems such as ulcers, too much acid,
overactive digestive system)
• sparfloxacin, moxifloxacin, erythromycin IV
(antibiotics used to treat infections)
• medicines used to treat mental health conditions
such as depression, anxiety or schizophrenia
(for example tricyclic antidepressants, or
antipsychotics (which may also be known
as ‘neuroleptics’) such as chlorpromazine,
cyamemazine, levomepromazine, thioridazine,
trifluoperazine, amisulpride, sulpiride, sultopride,
tiapride, droperidol, or haloperidol)
• pentamidine (used to treat certain types
of pneumonia)
• mizolastine (used to treat allergic reactions, such
as hayfever)
If you are taking any of the following medicines,
special care may also be required:
• non-steroidal anti-inflammatory drugs for pain
relief (e.g. ibuprofen), similar medicines known as
COX-2 inhibitors (e.g. celecoxib) or high doses of
acetylsalicylic acid (aspirin)
• angiotensin converting enzyme (ACE) inhibitors
(used to treat high blood pressure and high
blood pressure)
• oral steroids (e.g. prednisolone or
hydrocortisone), used to treat various conditions
including severe asthma and rheumatoid arthritis
• baclofen (to treat muscle stiffness occurring in
diseases like multiple sclerosis)
• other diuretics (‘water tablets’) such as
furosemide, or potassium sparing diuretics
(amiloride, spironolactone, triamterene)
• metformin (to treat diabetes)
• iodinated contrast media (used for tests involving
X-rays)
• calcium tablets or other calcium supplements
• ciclosporin, tacrolimus or other medicines
to depress the immune system after organ
transplantation to treat autoimmune
diseases, or to treat severe rheumatic or
dermatological diseases
• tetracosactide (to treat Crohn’s disease)
• carbenoxolone, to treat ulcers
• amphotericin B administered by injection into a
vein (used to treat fungal infections).
• laxatives (e.g. senna, bisacodyl)

Pregnancy and breast-feeding

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 as this medicine may
pass into the milk.
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 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 medicine.

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.

Your doctor may do blood tests to check for low
sodium or potassium levels, high calcium levels
and kidney function.

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 betablocker, 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, they may stop indapamide treatment
a few days before, to avoid a sudden fall in your
blood pressure (hypotension).

If you need to have a test to check how well your
parathyroid gland is working, tell the doctor or
hospital staff that you are taking this medicine.

Some patients may need regular blood tests to
check their blood salt (sodium, potassium, calcium)
levels and kidney function.

Other medicines and Indapamide

The recommended dose is:

During treatment

Talk to your doctor or pharmacist:
• if you get swelling of the face, lips, mouth,
tongue or throat which may cause difficulty in
swallowing or breathing (angioneurotic oedema)

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.

Description Indapamide 2.5 mg 56,28
Component Type Leaflet
Affiliate Item Code 679179
Superceded Affiliate Item Code 410764
TrackWise PR No. 679179
MA No. 04569/0232
Packing Site/Printer NA
Supplier Code LT1295AF

Pharma Code TBC
SAP No. NA
Vendor Job No. 259843
Trackwise Proof No. 1
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. NA
Barcode Info NA

Sign-offs

TBC
1111121

Package leaflet: Information for the patient

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.

Date: 28 Jul 2015
No. of colours
Colours

1

Time: 10:50
Page Count

1/2

Black

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

Body Text Size 9 pt
Min Text Size used 9 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. Talk 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
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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:
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)
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 or leucopenia)
• lack of certain blood cells, or damage to the
red blood cells, with the following symptoms;
tiredness, headaches, being short of breath when
exercising, dizziness, looking pale, nosebleeds
(haemolytic or aplastic anaemia)
• 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).

• 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 enzymes, which may be seen in
blood 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. If this occurs, stop taking
this medicine and talk to your doctor.
• raised urate levels in the blood that can make you
feel more thirsty or pass more urine than usual
• dizziness.

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, website:
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 Indapamide
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 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: hypromellose;
macrogol 400; titanium dioxide (E171).

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. Changes in heart rhythm
may be seen on a recording of the electrical
activity of the heart (‘ECG)
• 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).

What Indapamide looks like and contents of
the pack

These are serious side effects. You may need
medical attention.

Manufacturer: Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland.

Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:

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 with a plastic spacer
at the top of the pack 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.

This leaflet was last revised in 08/2015

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).
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
platelets in the blood may fall, which may cause
unusual bleeding or you may bruise more easily
than normal (thrombocytopenia)
• 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.
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, an
overactive adrenal gland (hyperaldosteronism) or
with a history of gout
• low sodium levels in the blood with low
blood volume

Description Indapamide 2.5 mg 56,28
Component Type Leaflet
Affiliate Item Code 679179
Superceded Affiliate Item Code 410764
TrackWise PR No. 679179
MA No. 04569/0232
Packing Site/Printer NA
Supplier Code LT1295AF

Pharma Code TBC
SAP No. NA
Vendor Job No. 259843
Trackwise Proof No. 1
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. NA
Barcode Info NA

Sign-offs

679179
LT1295AF

Date: 28 Jul 2015
No. of colours
Colours

1

Time: 10:50
Page Count

2/2

Black

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

Body Text Size 9 pt
Min Text Size used 9 pt

Expand view ⇕

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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