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DIURELIX XL 1.5 MG PROLONGED-RELEASE TABLETS

Active substance(s): INDAPAMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Diurelix XL 1.5 mg Prolonged-release Tablets

indapamide

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 Diurelix XL is and what it is used for
2. What you need to know before you take Diurelix XL
3. How to take Diurelix XL
4. Possible side effects
5. How to store Diurelix XL
6. Contents of the pack and other information

1

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quinidine, hydroquinidine, disopyramide, amiodarone, sotalol,
dofetilide and ibutilide)
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as multiple sclerosis)
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including selective cyclooxigenase-2 (COX-2) inhibitors (e.g.
celecoxib) or high dose of salicylic acid
• amphotericin B by injection (a medicine to treat severe
fungal disease)
• tetracosactide (a medicine to treat Crohn’s disease)
• vincamine by injection (a medicine used to treat circulatory
problems in the brain)

What Diurelix XL is and what it is used for

Diurelix XL belongs to a group of medicines known as
sulfonamide diuretics (water tablets).
The active ingredient in Diurelix XL is indapamide. Most
diuretics increase the amount of urine produced by the kidneys.
However, indapamide is different from other diuretics, as it only
causes a slight increase in the amount of urine produced.
Diurelix XL is used to treat high blood pressure (hypertension).

2

What you need to know before you take
Diurelix XL

Do NOT take Diurelix XL if you:
• are allergic to indapamide or any other sulfonamide or to any
of the other ingredients of this medicine (listed in section 6
and end of section 2)
• have severe liver disease or suffer from a condition called
hepatic encephalopathy (degenerative disease of the brain)
• have a severe kidney disease or if you are receiving
dialysis
• have low blood potassium

Warnings and precautions
Talk to your doctor or pharmacist before taking Diurelix XL if you:
• have liver problems
• have diabetes
• suffer from gout
• have any other heart problems
• have problems with your kidneys
• if you need to have a test to check how well your
parathyroid gland is working
• have had or develop increased sensitivity of the skin to
sun (photosensitivity)

Ask your doctor if you are not sure what these medicines are.
Pregnancy and breast-feeding
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.
Pregnancy
Diurelix XL is not recommended during pregnancy. If you
become pregnant while taking this medicine, stop taking it
immediately and tell your doctor.

Your doctor may give you blood tests to check for low sodium or
potassium levels or high calcium levels.

Breast-feeding
Do not take this medicine if you are breast-feeding.

Talk to your doctor if you are an athlete taking a doping test, as
Diurelix XL contains an active ingredient that can cause positive
results in a doping test.

Driving and using machines
Diurelix XL does not affect alertness but different reactions such
as dizziness or weakness in relation to the decrease in blood
pressure may occur in certain patients. These side effects are
more likely to occur after initiation of the treatment and after
dose increases. If affected, your ability to drive or to operate
machinery may be impaired.

If you think any of these situations may apply to you or you have
any questions or doubts about taking your medicine, you should
consult your doctor or pharmacist.

Children and adolescents
Do not give this medicine to children and adolescents due to a
lack of data on safety and efficacy.

Diurelix XL 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

Other medicines and Diurelix XL
Tell your doctor or pharmacist if you are taking, have recently
taken or might take, any other medicines.

In particular, before taking Diurelix XL, you must check with your
doctor if you are taking any of the following:

How to take Diurelix XL

Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.

• other medicines for treating high blood pressure and heart
failure (ACE inhibitors)
• medicines used to treat mental disorders such as
depression, anxiety, schizophrenia (e.g. tricyclic
antidepressants, antipsychotic drugs, neuroleptics),
• potassium-sparing diuretics (water tablets like amiloride,
spironolactone, triamterene)
• mizolastine (a medicine to treat for hay fever or allergies)
• corticosteroids used to treat various conditions including
severe asthma and rheumatoid arthritis

The normal dose is one tablet once a day.
Take your tablet with a glass of water preferably in the morning.
It is important that you swallow whole tablet. The tablet must
NOT be chewed or crushed.

Continued on the next page >>

Artwork Proof Box
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brain)
• hepatitis (liver disease with yellowing of the skin and eyes
and itching)
• increased sensitivity of the skin to sunlight
• abnormal ECG heart tracing
• If you have systemic lupus erythematosus (a disorder of the
immune system leading to inflammation and damage to the
joints, tendons and organs) then your symptoms may worsen.

Treatment for high blood pressure is usually life-long.

Older people
Older people can be treated with Diurelix XL when kidney
function is normal or only minimally impaired.

Use in children and adolescents
Use of Diurelix XL is not recommended for use in children
and adolescents (see also Section 2: Warnings and
precautions).

The following changes in your blood may occur (your doctor
may need to order blood tests to check your condition):
• low potassium
• low sodium that may lead to dehydration and low blood
pressure
• increase in uric acid, a substance associated with gout
• increase in blood glucose (especially important for diabetic
patients)
• increased levels of liver enzymes

If you take more Diurelix XL than you should
If you (or someone else) swallow a lot of the tablets all together
or if you think a child has swallowed any of the tablets, contact
your nearest hospital casualty department / your doctor
immediately / a poison centre. An overdose is likely to cause
heart and dehydration problems. If marked low blood pressure
occurs (symptoms such as dizziness or faintness), lying down
with the legs raised can help. Please take this leaflet, any
remaining tablets and the container with you to the hospital or
doctor so that they know what tablets were consumed.

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 Yellow Card
Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this
medicine.

If you forget to take Diurelix XL
It is important to take your medicine every day as regular
treatment is more effective.
However, if you forget to take one or more doses, take another
as soon as you remember and then go on as prescribed. DO
NOT take a double dose to make up for a forgotten dose.

5

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

4

How to store Diurelix XL

Keep this medicine out of the sight and reach of children.

Possible side effects

Do not use this medicine after the expiry date which is stated on
tablet blister and carton after EXP. The expiry date refers to the
last day of that month.

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

Do not store above 25°C and in the original package to protect
from moisture.

The following side effects are important and will require
immediate action if you experience them. You should stop
taking Diurelix XL and see your doctor immediately if the
following symptoms occur:

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.

Very rare side effects that may affect up to 1 in 10,000 people
• swelling of the face, lips, mouth, tongue, eyes or windpipe
which can cause great difficulty in breathing
• severe, extensive, blistering skin rash
• unexplained fever, soreness of the throat or other flu-like
symptoms caused by a profound fall in the numbers of white
blood cells

6

Contents of the pack and other information

What Diurelix XL contains
The active substance is indapamide. Each tablet contains
1.5 mg indapamide.

Not known (frequency cannot be estimated from the available
data):
• life-threatening irregular heartbeats (Torsade de Pointes)
• fainting

The other ingredients are:
Tablet core:
lactose monohydrate (for further information on lactose see
end of Section 2); povidone K30; hypromellose; silica,
colloidal anhydrous; cellulose, microcrystalline; magnesium
stearate

Other possible side effects

Common (may affect up to 1 in 10 people):
• allergic reactions mainly in people who are prone to allergic
and asthmatic reactions and causing skin rashes with macules
(flat discoloured area) and papules (small raised lumps)

Film coating:
hypromellose, macrogol 6000, titanium dioxide (E171)

Uncommon (may affect up to 1 in 100 people):
• vomiting
• allergic reactions mainly in people prone to allergic and
asthmatic reactions and mainly affecting the skin causing
purpura (red pinpoints on skin)

What Diurelix XL looks like and contents of the pack
Diurelix XL is a white, round, biconvex film-coated
prolonged-release tablet.

Diurelix XL is packed in blisters (PVC/PVDC/Al blister or Al/Al
blister) of various pack sizes.

Rare (may affect up to 1 in 1,000 people):
• dizziness (spinning sensation)
• feeling of tiredness
• headache
• pins and needles (paresthesia)
• nausea (feeling sick)
• constipation
• dry mouth

10, 14, 15, 20, 28, 30, 50, 60, 90, 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
United Kingdom:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Very rare (may affect up to 1 in 10,000 people):
• heart rhythm irregularities (causing palpitations, feeling of the
heart pounding)
• low blood pressure (hypotension)
• inflammation of the pancreas leading to upper abdominal pain
• liver problems that may become severe
• kidney problems that may become severe
• a fall in the numbers of blood cells which can be seen as
easy bruising and bleeding, anaemia (pale lips or skin,
tiredness, breathlessness) or flu-like symptoms
• skin hives
• changes in your blood may occur (your doctor may need to
order blood tests to check your condition): increased calcium
in the blood

Malta:
Sandoz d.d.,
Verovskova 57, 1000 Ljubljana,
Slovenia.

Manufacturer
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana,
Slovenia or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany or Lek S.A., ul.
Domaniewska 50 C, 02-672 Warszawa, Poland.

Not known (frequency can not be estimated from the available
data):
• hepatic encephalopathy (severe liver disease that affects the

This leaflet was last revised in 01/2014.

Artwork Proof Box
Ref: Variation V005 - SPC & PIL update in line with originator
Proof no.
003.0

Date prepared:
17/01/2014

Colours:
Black
Dimensions: 165 x 310 mm

Font size:
7pt
Fonts:
Helvetica

SZ00000LT000

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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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