INDIPAM XL 1.5MG PROLONGED-RELEASE TABLETS

Active substance: INDAPAMIDE

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Indipam XL 1.5mg Prolonged-Release
Tablets
Indapamide
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 get serious, or
if you notice any side effects not listed
in this leaflet, please tell your Doctor or
Pharmacist.
In this leaflet:
1. What Indipam XL 1.5mg ProlongedRelease Tablets are and what they are
used for
2. Before you take Indipam XL 1.5mg
Prolonged-Release Tablets
3. How to take Indipam XL 1.5mg
Prolonged-Release Tablets
4. Possible side effects
5. How to store Indipam XL 1.5mg
Prolonged-Release Tablets
6. Further information
1. WHAT INDIPAM XL 1.5MG PROLONGED•
RELEASE TABLETS ARE AND WHAT THEY
ARE USED FOR
Indapamide belongs to a class of medicines
called “diuretics” which increase urine
production by the kidneys.
It is used to treat high blood pressure
(essential hypertension).
2. BEFORE YOU TAKE INDIPAM XL 1.5MG
PROLONGED-RELEASE TABLETS
Do not take Indipam XL 1.5mg
Prolonged-Release Tablets if
you:








Are allergic (hypersensitive) to
Indapamide or any of the other
ingredients of this medicine
Are allergic (hypersensitive) to other
medicines in the same chemical class
as Indapamide (“Sulphonamides”),
such as trimethoprim or
Co-Trimoxazole
Have severe liver disease or
a condition called Hepatic
Encephalopathy (damage to the
brain and nerves which can occur as a
complication of liver problems)
Have severe kidney disease
Have been told by your Doctor that
you have low levels of potassium in
your blood

Take special care with Indipam XL 1.5mg
Prolonged-Release Tablets:
Tell your Doctor before you start to take
this medicine if you suffer from or have
previously suffered from any of the
following:

H
 eart disease, heart failure or heart
rhythm problems

Diabetes (please check your blood
sugar levels regulary)

Gout

Kidney problems

Liver problems
Indapamide affects the levels of potassium
and sodium in the blood. Your Doctor may
conduct blood tests to monitor levels of
potassium and sodium in your blood before
and during your treatment. This is especially
important in patients, who are at high risk
to develop electrolyte disturbances (such
as elderly, patients who are taking many
medicines or malnourished patients).
Indapamide may increase the sensitivity
of your skin to sunlight. If this happens
you should tell your Doctor as he/she may
decide to stop your treatment. In case
of an administration of Indapamide, it is
recommended to protect exposed areas to
the sun or to artificial UVA.
If the function of your parathyroid gland is
to be examined: tell your Doctor, who will
suspend your treatment with Indapamide.
Athletes should be aware that Indapamide
may give a positive reaction in drug tests.
If you think any of these situations may
apply to you or you have any questions of
doubts about taking your medicine, you
should consult your Doctor or Pharmacist.
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.
The effects of Indapamide may be altered
or undesirable effects may occur if you are
also taking the following medicines. Talk
to your Doctor if you are taking any of the
following:
Combinations that are not recommended:
• Lithium (used in the treatment of
depression): you should not take
Indapamide with lithium due to the
risk of increased levels of lithium in the
blood with signs of overdose.
Combinations requiring precautions for use:
Torsade des pointes (special form of heart
rhythm disorders) may be induced by
taking:
• Medicines used in the treatment of
irregular heart beat such as Quinidine,
Hydroquinidine, Disopyrimide,
Amiodarone, Sotalol, Dofetilide or
Ibutilide
• Medicines used in the treatment of
Psychoses such as Chlorpromazine,
Cyamemazine, Levomepromazine,
Thioridazine, Trifluoperazine,
Amisulpride, Sulpiride, Sultopride,
Tiapride, Droperidol or Haloperidol



Various other drugs such as Bepridil
(used for the treatment of Angina),
Cisapride and Diphemanil (used for
the treatment of gastro-intestinal
problems), Intravenous Erythromycin,
Pentamidine, Moxifloxacin,
sparfloxacin (used for treatment of
infection), Halofantrine (used for the
treatment of Malaria), Mizolastine
(used in the treatment of allergy),
intravenous Vincamine (used to treat
circulatory problems in the brain)

Non-Steroidal anti-inflammatory drugs
(sometimes called N.S.A.I.D’s) used in the
treatment of pain and inflammation (e.g.
Ibuprofen, Diclofenac and Indometacin),
including selective Cyclooxygenase-2
(COX-2) inhibitors (such as Celecoxib,
Etoricoxib) and high doses of Aspirin
(3g or more a day):

Possible reduction in the blood
pressure lowering effect of
indapamide. Risk of acute kidney
failure in patients with decreased body
water (dehydration). Adequate fluid
intake is essential.
ACE inhibitors used to treat high blood
pressure and heart failure (e.g. Captopril,
Enalapril, Perindopril):
Risk of a severe reduction in blood pressure
and/or acute kidney failure when treatment
with an ACE inhibitor is started in patients
with pre-existing sodium depletions
(particulary in patients with Renal Artery
Stenosis)
The effect of indapamide may be altered or
undesirable effects may occur if you are also
taking any of the following:
• Metformin (used in the treatment of
diabetes)
• Baclofen (used in the treatment of
muscle spasm)
• Ciclosporin and Tacrolimus (used
for the treatment of auto-immune
disorders or to suppress the immune
system following a transplant)
• Steroids (e.g. Prednisolone,
Hydrocortisone or Fludrocortisone)
used to treat various conditions
including severe Asthma and
Rheumatoid Arthritis

stimulant laxatives (e.g. Senna)

some medicines used to treat heart
failure and some heart rhythm
disorders (e.g. Digoxin, Digitoxin)

Some potassium-sparing diuretics
(water tablets) such as Amiloride,
Spironolactone, Triamterene

certain water tablets which may
cause a decrease of blood potassium
levels such as Bendroflumethiazide,
Furosemide, Piretanide, Bumetanide
and Xipamide

Some Antidepressants (e.g.
Imipramine), Neuroleptics (used to
treat mental disorders)

Some Iodine containing medicines
(used in the diagnosis of some
illnesses)

Tetracosactide (used in the diagnosis of
some illnesses and treatment of gastrointestinal problems)

Medicines containing calcium
Taking Indapamide with food and drink
Food and drink have no impact on the way
that your medicine works. You may take it
with or after food or on an empty stomach.
Pregnancy and breast-feeding
Pregnancy:
This medicine is not recommended during
pregnancy. Please tell your Doctor if you are
pregnant or wish to become pregnant.
Breast-feeding:
The active ingredient is excreted in milk.
Breastfeeding is not advisable if you are
taking this medicine. Ask your Doctor or
Pharmacist for advice before taking any
medicine.
Driving and using machines
Indapamide lowers blood pressure which
may make you feel light-headed and dizzy
in relation to the decrease in blood pressure,
especially at the start of the treatment or
when another antihypertensive is added.
If affected do not drive or operate heavy
machinery.
Important information about some of
the ingredients of Indipam XL 1.5mg
Prolonged-Release Tablets
Your medicine contains the sugar 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 INDIPAM XL 1.5MG
PROLONGED-RELEASE TABLETS
Always take Indapamide exactly as your
Doctor has told you. You should check
with your Doctor or Pharmacist if you are
not sure.
The usual dose is 1 tablet per day which
should preferably be taken in the morning.
Patients with impaired renal function
Patients with severe renal failure
(creatinin-clearance below 30
ml/min) must not be treated
with Indapamide (see section
2. “DO NOT TAKE INDIPAM XL
1.5MG PROLONGED-RELEASE
TABLETS”). Thiazide and related
diuretics are fully effective only
when renal function is normal or
only minimally impaired.
Patients with impaired liver function
Patients with severe hepatic impairment
must not be treated with Indapamide (see
section 2. “DO NOT TAKE INDIPAM XL
1.5MG PROLONGED-RELEASE TABLETS”).

AAAF1651

continued...

Indapamide SR (Indipam SR) 1.5mg Prolonged Release Tablets PIL - UK

colours/plates:
1. Black

item no: AAAF1651

dimensions: 160x528

print proof no: 3

pharmacode:

origination date: 26.03.13

min pt size:

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 23.04.13

Technical Approval

revised by: SA

date sent: 26.03.13

supplier: Pharmapack

technically app. date: 28.03.13

Non Printing Colours
1.
2.
3.

Elderly
Elderly patients can be treated with
Indapamide when renal function is normal
or only minimally impaired.
Children and adolescents
Indapamide is not recommended for use
in children and adolescents due to a lack of
data on safety and efficacy.
Method of administration
Your tablets should be swallowed whole
with a sufficient amount of water (such as
a glass of water). Do not crush or chew the
tablets. Indapamide can be taken without
regard to meals.








Duration of treatment:



The duration of treatment will be decided
by the treating Doctor. If you have the
impression that the effect of Indapamide is
too strong or too weak, talk to your Doctor
or Pharmacist.



If you take more Indipam XL 1.5mg
Prolonged-Release Tablets than you
should
In case of an overdose, there will be an
increased rate of side effects, an increased
diuretic effect with a risk of blood pressure
drop and disturbances of the water and
electrolyte balance. If you have accidentally
taken more Indapamide than you should,
contact your Doctor immediately for advice.
Symptoms of an overdose may include
nausea, vomiting, low blood pressure
(leading to lightheadedness), cramps,
dizziness, drowsiness, confusion, excessive
production of urine or low production of
urine.
If you forget to take Indipam XL 1.5mg
Prolonged-Release Tablets
If you forget to take a tablet then take it
as soon as you remember. However, do
not take a double dose to make up for a
forgotten dose.

Indapamide may cause low levels of
chloride in the blood, which may lead
to Metabolic Alkalosis (low acidity of
the blood).
Indapamide may cause increased
blood sugar levels.
If you have existing liver problems,
taking Indapamide may cause
a condition called Hepatic
Encephalopathy (damage to the
brain and nerves which can occur as a
complication of liver disease).
If you suffer from a condition
called “Acute Disseminated Lupus
Erythmatosus” (rare, widespread
inflammatory disease), taking
Indapamide may worsen the disease.
Taking Indapamide may make your
skin more sensitive to UV light (see
“Take special care with Indipam XL
1.5mg Prolonged-Release Tablets”
above).
Indapamide may cause high levels of
uric acid in the blood leading to gout
attacks.
If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your Doctor.

5. HOW TO STORE INDIPAM XL 1.5MG
PROLONGED-RELEASE TABLETS
Keep out of the reach and sight of children.
This medicinal product does not require
any special storage conditions.
Do not use this medicine after the expiry
date stated on the carton and container.
The expiry date refers to the last day of that
month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
Pharmacist how to dispose of medicines.
These measures will help to protect the
environment.
6. FURTHER INFORMATION

If you stop taking Indipam XL 1.5mg
Prolonged-Release Tablets
Treatment for high blood pressure is
normally life-long. You should not stop
taking your medicine without discussing it
with your Doctor first.

What Indipam XL 1.5mg ProlongedRelease Tablets contain:

If you have any further questions on the
use of this product, ask your doctor or
Pharmacist.

The other ingredients are:
Tablet core: lactose monohydrate, starch,
pregelatinised; hypromellose, silica,
colloidal anhydrous magnesium stearate
(vegetable).

4. POSSIBLE SIDE EFFECTS
Like all medicines, Indapamide can cause
side effects, although not everybody gets
them. The following side effects can occur:
Common (affecting fewer than one person
in 10 but more than one person in 100):

Allergic reaction (especially in people
who tend to have allergic or Asthmatic
reactions) leading to skin rashes with
macules and papules
Uncommon (affecting fewer than one
person in 100 but more than one person in
1,000):

Vomiting

Allergic reaction (especially in people
who tend to have allergic or Asthmatic
reactions) leading to purple spots or
patches on the skin
Rare (affecting fewer than one person in
1,000 but more than one person in 10,000):

Dizziness (vertigo)

Tiredness

Headache

Pins and needles (paresthesia)

Nausea (feeling sick)

Constipation (infrequent bowel
movements; hard, dry stools)

Dry mouth
Very rare (affecting fewer than one person
in 10,000):

Reduction in blood platelets, which
increases risk of bleeding or bruising

Reduction in the number of white
blood cells, which makes infections
more likely; which may be severe
(agranulocytosis)

Reduction in levels of certain blood
cells which can cause weakness,
bruising or make infections more
likely (Haemolytic Anaemia); Aplastic
Anaemia (a bone marrow depression)

Inflammation of the pancreas, which
causes severe pain in the abdomen
and back (Pancreatitis)

Irregular heart beat

Low blood pressure, which may cause
lightheadedness

Kidney problems

Liver problems (detected by blood
tests)

Increases in the levels of calcium in
your blood

Serious allergic reactions (Angioedema,
especially in people who tend to have
allergic or Asthmatic reactions) with
swelling of the face, lips or tongue and
nettle rash, swelling of the mucous
membranes of the throat or airways
resulting in shortness of breath or
difficulty of swallowing. If this occurs,
contact your Doctor immediately.

Serious allergic reaction with flue
like symptoms, blistering of the skin,
mouth, eyes and genital organs (Toxic
Epidermic Necrolysis, Steven Johnson
Syndrome). If this occurs, contact your
Doctor immediately.





The active substance is: indapamide
Each prolonged-release tablet contains
1.5mg of indapamide.

Tablet coating: hypromellose, macrogol
6000, titanium dioxide (E171).
What Indipam XL 1.5mg ProlongedRelease Tablets look like and contents of
the pack:
White, round, prolonged-release, filmcoated tablet.
30 prolonged-release tablets in blister packs
(PVC / aluminium).
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavíkurvegur 76-78, 220 Hafnarfjordur,
Iceland
Manufacturer
PharmaPack International B.V.
Bleiswijkseweg 51, 2712 PB Zoetermeer,
The Netherlands
This leaflet was last revised in April 2013

If you would like a
leaflet with larger
text, please contact
01271 311257.

The following side-effects may also
occur. However, based on available
data it is not possible to give an
indication of how common these are:
Indapamide may cause low levels of
sodium and potassium in your blood.
Your doctor may monitor these levels
via blood tests (see above – “Take
special care with Indipam XL 1.5mg
Prolonged-Release Tablets”).
Indapamide may cause decreased
blood volume (Hypovolaemia) with
dehydration and fall in the blood
pressure on standing up (Orthostatic
Hypotension).

Actavis, Barnstaple, EX32 8NS, UK

AAAF1651

Indapamide SR (Indipam SR) 1.5mg Prolonged Release Tablets PIL - UK

colours/plates:
1. Black

item no: AAAF1651

dimensions: 160x528

print proof no: 3

pharmacode:

origination date: 26.03.13

TORPL007

min pt size:

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 23.04.13

Technical Approval

revised by: SA

date sent: 26.03.13

supplier: Pharmapack

technically app. date: 28.03.13

Non Printing Colours
1.
2.
3.

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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