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CARDIDE SR 1.5MG PROLONGED RELEASE TABLETS
Active substance(s): INDAPAMIDE / INDAPAMIDE / INDAPAMIDE
231-30-57678-D LEA INDAPAMIDE (CARDIDE) SR 1.5mg PR TAB TUK
12 May 2016
PANTONE® GREEN C
Pharma code 155 (0011100)
First bar is 105mm from the top edge of the leaflet.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cardide SR:
• if you have any heart rhythm problems
• if you have problems with your liver or kidneys
• if you are diabetic
• if you need to have a test to check how well your
parathyroid gland is working
• if you suffer from gout
• if you get any skin problems such as a rash, change in
skin colour, swelling or if your skin becomes sensitive to
sunlight (photosensitive) while you are taking this
This medicine can cause side effects due to lowering of the
blood pressure such as dizziness or tiredness (see section
4). These side effects are more likely to occur after initiation
of the treatment and after dose increases. If this occurs,
you should refrain from driving and other activities
requiring alertness. However, under good control, these
side effects are unlikely to occur.
Cardide SR contains Lactose
Patients who are intolerant to LACTOSE should note that
Cardide SR contains a small amount of LACTOSE. If you
have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this
Before you start taking Cardide SR and during your
treatment your doctor may give you blood tests to check
the levels of sodium, potassium and calcium in your blood.
to take Cardide SR 1.5mg
This is especially important for the Older people or
patients who suffer from liver disease, heart disease or
have an overactive parathyroid gland.
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
Athletes should be aware that this medicinal product
pharmacist if you are not sure.
contains an active ingredient that could give a positive
result during doping tests.
Other medicines and Cardide SR
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take Cardide SR in combination with:
• Lithium (used to treat depression) due to the risk of
increased levels of lithium in the blood
Tell your doctor if you are taking any of the following as
your dose may need to be adjusted:
• chlorpromazine, thioridazine, amisulpride, sulpiride,
haloperidol (used to treat schizophrenia and other
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The recommended dose is 1.5 mg (one tablet) preferably in
the morning swallowed whole with water and not chewed.
Patients with kidney problems
Cardide SR is not recommended for patients with kidney
Patients with liver problems
Cardide SR is not recommended for patients with liver
Older people can be treated with Cardide SR providing you
have no problems with your kidneys.
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Top of page cut-off to middle of registration mark: 44 mm.
• quinidine, hydroquinidine, disopyramide, amiodarone,
sotalol, dofetilide and ibutilide (used to treat abnormal
• bepridil (used to treat high blood pressure and chest
Package leaflet: Information for the user
Read all of this leaflet carefully before you start taking this • cisapride and diphemanil (used to treat gastric problems)
• antibiotics such as erythromycin injection, pentamidine,
medicine because it contains important information for
sparfloxacin and moxifloxacin
• halofantrine (used to treat malaria)
• Keep this leaflet. You may need to read it again.
• mizolastine (used to treat allergic reactions)
• If you have any further questions, ask your doctor or
• vincamine injection (used to increase the blood flow to
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs • non-steroidal anti-inflammatory drugs (N.S.A.I.Ds) used
for pain relief and to treat inflammation such as
of illness are the same as yours.
ibuprofen, cyclooxygenase-2 (COX-2) specific inhibitors
• If you get any side effects talk to your doctor or
such as celecoxib or high doses of acetylsalicylic acid.
pharmacist. This includes any possible side effects not
• angiotensin converting enzyme (A.C.E.) inhibitors used
listed in this leaflet. See section 4.
to treat hypertension and congestive heart failure such as
What is in this leaflet:
captopril, enalapril or perindopril.
• amphotericin B injection (used to treat fungal infections)
1. What Cardide SR 1.5mg Prolonged–released Tablets is
• Steroids such as hydrocortisone, prednisolone (used to
and what it is used for
treat severe asthma and rheumatoid arthritis), and
2. What you need to know before you take Cardide SR
tetracosactide (used in the diagnosis of some illnesses
1.5mg Prolonged-release Tablets
and in the treatment of Crohn's disease)
3. How to take Cardide SR 1.5mg Prolonged-release Tablets
• stimulant laxatives such as senna and glycerol
4. Possible side effects
suppositories (used to relieve constipation)
5. How to store Cardide SR 1.5mg Prolonged-release
• baclofen (a muscle relaxant)
• medicines used to treat heart failure such as digoxin and
6. Contents of the pack and other information
• potassium-sparing diuretics such as amiloride,
1 Tablets is and what it is used for
spironolactone and triamterene
• metformin (used to treat diabetes)
• antidepressants such as imipramine and neuroleptics
Cardide SR belongs to a class of medicines known as
(used to treat mental disorders)
diuretics which increase urine production by the kidneys.
• medicines containing calcium
Cardide SR is used to treat high blood pressure
• medicines that reduce the body's natural immunity
(immunosuppressive agents) such as ciclosporin and
If you are going for an X-ray, do tell your doctor that you
you need to know before you take
are taking indapamide as additional precautions need to be
Cardide SR 1.5mg Prolonged-release Tablets
Do not take Cardide SR
Cardide SR with food, drink and alcohol
• if you are allergic to indapamide or any of the other
Cardide SR can be taken with meals
ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to other medicines in Pregnancy, breast-feeding and fertility
the same chemical class as Indapamide known as
‘sulfonamides’ such as trimethoprim or co-trimoxazole
Cardide SR should not be taken during pregnancy or while
• if you suffer from severe kidney disease
breast-feeding. If you are pregnant or breast-feeding, think
• if you have severe liver disease
you may be pregnant or planning to have a baby,, ask your
• if you suffer from a brain and central nervous system
doctor or pharmacist for advice before taking any
disorder caused by liver disease (hepatic
Driving and using machines
• if you have a low potassium level in your blood.
Cardide SR 1.5 mg
TEVA UK Ref:
231-30-57678-D LEA INDAPAMIDE (CARDIDE) SR 1.5mg PR TAB TUK
12 May 2016
PANTONE® GREEN C
• a reduction in potassium levels in the blood, which may
cause muscle weakness
• a reduction in sodium levels in the blood and decreased
blood volume which may lead to dehydration or
If you take more Cardide SR than you should
dizziness and light-headedness upon standing due to low
If you (or someone else) swallow a lot of the tablets all
• an increase in uric acid levels in the blood which may
together or if you think a child has swallowed any of the
cause or worsen cases of gout (a condition which causes
tablets, contact your nearest hospital casualty department
pain, inflammation and swelling in one, or more, of the
or your doctor immediately. You may experience the
following if you have taken too many tablets: nausea,
• an increase in blood glucose levels in diabetic patients
vomiting, low blood pressure, cramps, feeling dizzy,
• photosensitivity reactions (change in skin appearance)
drowsiness, confusion, an increase or decrease in
after exposure to the sun or artificial Ultraviolet A (UVA)
urination. Please take this leaflet, any remaining tablets
and the container with you to the hospital or doctor so that
they know which tablets were consumed.
Reporting of side effects
Use in children and adolescents
Cardide SR is not recommended for use in children and
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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.
Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill
If you stop taking Cardide SR
in a paper form available from your local pharmacy.
Treatment for high blood pressure is normally life-long and By reporting side effects you can help provide more
information on the safety of this medicine.
therefore you should not stop taking Cardide SR without
talking to your doctor.
If you forget to take Cardide SR
If you forget to take a tablet, just carry on with the next
dose as usual. Do not take a double dose to make up for a
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following side effects have been reported at the
approximate frequencies shown:
Common: may affect up to 1 in 10 people
• maculopapular rashes (allergic reaction on the skin that
creates large areas of redness with small bumps).
How to store Cardide SR 1.5mg
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 blister foil and carton after EXP. The expiry
date refers to the last day of that month.
This medicinal product does not require any special
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.
Uncommon: may affect up to 1 in 100 people
6 Contents of the pack and other information
• allergic reactions mainly in people prone to allergic and What Cardide SR 1.5mg Prolonged – Release Tablets
asthmatic reactions and mainly affecting the skin causing contain
purpura (red pinpoints on skin)
• The active substance is indapamide. Each Cardide SR
1.5mg Prolonged-Release Tablet contains 1.5 mg of
Rare: may affect up to 1 in 1,000 people
• vertigo (a feeling of dizziness)
• The other ingredients are lactose monohydrate,
hypromellose (Methocel K4M Premium), silica colloidal
anhydrous and magnesium stearate.
• paresthesia (pins and needles)
• The tablet coating (Opadry II white 33G28707) contains:
hypromellose 6cP (E464), titanium dioxide (E171), lactose
monohydrate, macrogol 3000 and triacetin.
• dry mouth.
What Cardide SR 1.5mg Prolonged –Release Tablets look
Very Rare: may affect up to 1 in 10,000 people
like and contents of the pack
• increased calcium levels in the blood
• irregular heart beat
Cardide SR 1.5mg Prolonged–Release Tablets are white,
• low blood pressure
biconvex, round tablets debossed ‘1.5’ on one side and
• reduction in blood platelets, which may increase the risk plain on the other.
of bleeding or bruising
• reduction in the number of white blood cells, which may Cardide SR comes in pack sizes of 10, 14, 15, 20, 28, 30, 50,
60, 90, 98 and 100 tablets.
make infections more likely
• bone marrow failure (causing a reduction of all blood cell Not all pack sizes may be marketed.
types) or anaemia (decrease in red blood cells)
Marketing Authorisation Holder and Manufacturer
• inflammation or infection of the pancreas
TEVA UK Limited, Eastbourne, BN22 9AG
• kidney failure
• allergic reactions such as angioedema and/or urticaria,
This leaflet was last revised in April 2015
severe skin manifestations. Angioedema is characterised
by swelling of the skin of extremities or face, swelling of PL 00289/1298
the lips or tongue, swelling of the mucous membranes of
the throat or airways resulting in shortness of breath or
difficulty of swallowing. If this occurs, contact your
• severe allergic reactions such as toxic epidermic
necrolysis and Steven Johnson syndrome which may
cause flu like symptoms and blistering or peeling of the
skin. If this occurs, contact your doctor immediately
• liver problems
Not known: frequency cannot be estimated from the
• worsening of a condition called hepatic encephalopathy
in patients with liver problems which could cause
damage to the brain and nerves.
• patients suffering from acute disseminated lupus
erythematosus (a rare inflammatory disease) may find
their condition is worsened while taking this medicine.
323 x 200
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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.