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VARBIM XL 1.5 MG PROLONGED-RELEASE TABLETS.

Active substance(s): INDAPAMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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.

IN THIS LEAFLET:
1. What Varbim XL is and what it is used for
2. Before you take Varbim XL
3. How to take Varbim XL
4. Possible side effects
5. How to store Varbim XL
6. Further information

1

WHAT VARBIM XL IS AND WHAT IT IS
USED FOR

Varbim XL 1.5 mg Prolonged-release Tablets, belong
to a class of medicines called “diuretics” which
increase urine production by the kidneys.
Varbim XL is used to treat high blood pressure.

2

BEFORE YOU TAKE VARBIM XL

Do not take Varbim XL 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 Varbim XL
Tell your doctor before you start to take this medicine
if you suffer from or have previously suffered from any
of the following:
• Heart disease, heart failure or heart rhythm problems
• Diabetes (please check your blood sugar levels
regularly)
• 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 at high risk of developing electrolyte
disturbances (such as the elderly, patients taking
several other medicines or patients with a poor diet).
Varbim XL 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. If your doctor
decides to restart or continue your treatment you should
take measures to protect your skin from the sun and
should avoid exposure to artificial UVA (e.g. tanning
machines).
If the performance of your parathyroid gland is due to be
evaluated, then tell your doctor. Your doctor may advise
you to stop taking your tablets in advance of your test.
Athletes should be aware that Varbim XL may give a
positive reaction in drug tests.
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.
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 Varbim XL 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:
• Lithium (used in the treatment of depression): you
should not take Varbim XL with lithium due to the

adolescents due to a limited experience in these age
groups.
Duration of treatment
Your doctor will decide the duration of treatment.
Do not change the dose, even if you think your Varbim
XL is not working properly. If this is the case, consult
your doctor.
If you take more Varbim XL than you should
If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has accidentally
swallowed any of the tablets, contact your nearest
hospital casualty department or your doctor
immediately. 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. 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.
If you forget to take Varbim XL
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.
If you stop taking Varbim XL
Treatment for high blood pressure is normally
life-long. You should not stop taking your medicine
without discussing it with your doctor first.

risk of increased levels of lithium in the blood unless
your doctor considers it to be absolutely necessary
• Quinidine, hydroquinidine, disopyrimide,
amiodarone, sotalol, dofetilide or ibutilide (used in
the treatment of irregular heartbeat)
• Medicines used in the treatment of schizophrenia
such as chlorpromazine, thioridazine, amisulpride
or haloperidol
• 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)
• Erythromycin injection, pentamidine, moxifloxacin,
sparfloxacin and amphoteracin B injection (used for
treatment of infection)
• Mizolastine (used in the treatment of allergy)
• Bepridil (used for the treatment of angina)
• Cisapride and Diphemanil (used for the treatment of
gastro-intestinal problems)
• Halofantrine (used for the treatment of malaria)
• Vincamine injection (used to treat circulatory
problems in the brain)
• Steroids (e.g. prednisolone, hydrocortisone or
fludrocortisone) used to treat various conditions
including severe asthma and rheumatoid arthritis
• Stimulant laxatives (e.g. senna)
• 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) and cyclo-oxygenase-2 (COX-2)
inhibitors (such as celecoxib and etoricoxib)
• High doses of aspirin (3 g or more a day)
• ACE inhibitors used to treat high blood pressure
and heart failure (e.g. captopril, enalapril, perindopril)
• Some medicines used to treat heart failure (e.g.
digoxin, digitoxin)
• Some potassium-sparing diuretics (water tablets)
such as amiloride, spironolactone, triamterene
• Certain water tablets which may cause a decrease in
the levels of potassium in your blood such as
bendroflumethiazide, furosemide, piretanide,
bumetanide and xipamide
• Some antidepressants (e.g. imipramine) and
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 gastro-intestinal problems)
• Medicines containing calcium.
Taking Varbim XL 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
The use of Varbim XL is not recommended if you are
pregnant, breast-feeding or trying to have a baby.
Consult your doctor if any of these situations apply to you.
Driving and using machines
Varbim XL lowers blood pressure which may make you
feel light-headed and dizzy, especially at the start of
treatment or when another medicine to reduce or
control high blood pressure is added to your treatment.
If affected do not drive or operate heavy machinery.
Important information about some of the ingredients
of Varbim XL
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

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

4

HOW TO TAKE VARBIM XL

Always take Varbim XL exactly as your doctor has told
you. You should check with your doctor if you are not sure.
The usual dose is 1 tablet per day which should
preferably be taken in the morning. Your tablets should
be swallowed whole with a sufficient amount of water.
Do not crush or chew the tablets.
Patients with kidney problems
Patients with severe kidney problems should not take
Varbim XL (see section 2 “DO NOT TAKE”). Varbim XL are
fully effective only when your kidneys work properly or
are only slightly impaired. Ask your doctor if unsure.
Patients with liver problems
Patients with severe liver problems should not take
Varbim XL (see section 2 “DO NOT TAKE”).
Elderly
Elderly patients can be treated with Varbim XL provided
that your kidneys are healthy or are only slightly impaired.
Children and adolescents
Varbim XL is not recommended for use in children and

TEVA UK Limited

VARBIM XL 1.5 mg
PROLONGED-RELEASE TABLETS
Indapamide

POSSIBLE SIDE EFFECTS

Like all medicines, Varbim XL can cause side effects,
although not everybody gets them.
If the following happens, stop taking the tablets and
tell your doctor immediately or go to the casualty
department at your nearest hospital:
• An allergic reaction (swelling of the face, lips,
tongue, throat or airways leading to severe
difficulty in breathing; skin rash or hives)
• An allergic reaction with flu like symptoms,
blistering of the skin, mouth, eyes and genital
organs (toxic epidermic necrolysis or Steven
Johnson syndrome).
These are very serious but rare side effects. You may
need urgent medical attention or hospitalisation.
The following side effects have been reported at the
approximate frequencies shown:
Common (affecting fewer than one person in 10 but
more than one person in 100):
• Low levels of potassium in the blood which may
cause muscle weakness. Your doctor may monitor
these levels via blood tests (see above - “Take
Special Care with Varbim XL”)
• Allergic reaction (especially in people who are
prone to allergic reactions and asthma attacks)
leading to skin rashes with macules (flat
discoloured area) and papules (small raised lumps).
Uncommon (affecting fewer than one person in 100
but more than one person in 1,000):
• Vomiting
• Allergic reaction (especially in people who are
prone to allergic reactions and asthma attacks)
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
(leucopenia), which makes infections more likely
and may be serious (agranulocytosis) or bone
marrow suppression (aplastic anaemia). If you
suffer from unexplained fever, soreness of the
throat or other flu-like symptoms then contact your
doctor straight away as this could indicate that
levels of white blood cells in your blood are too low
• Reduction in levels of red blood cells (anaemia)
which can cause weakness, paleness, a fast
heartbeat and breathlessness
• 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 are prone to allergic reactions and
asthma attacks) with swelling of the face, lips,
tongue, throat or airways and nettle rash. The
swelling of the throat or airways may cause
shortness of breath or difficulty in swallowing. If
this occurs, contact your doctor immediately
• Serious allergic reaction with flu like symptoms,
blistering of the skin, mouth, eyes and genital
organs (toxic epidermic necrolysis or Steven
Johnson syndrome). If this occurs, contact your
doctor immediately.
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:
• Varbim XL 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 Varbim XL”)
• Varbim XL may cause a decrease in your blood
volume (hypovolaemia) with a loss of water and a
fall in the blood pressure on standing up
(orthostatic hypotension)
• Varbim XL may cause low levels of chloride in your
blood, which may lead to a metabolic alkalosis (low
acidity of the blood)
• Varbim XL may increase the levels of sugar in your
blood
• If you have existing liver problems, taking Varbim
XL 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 Varbim XL may
worsen the disease
• Taking Varbim XL may make your skin more
sensitive to UV light (see “Take Special Care with
Varbim XL” above)
• Varbim XL may cause high levels of uric acid in your
blood leading to gout attacks (painful swelling and
redness in the joints, most commonly in the big toe).
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 VARBIM XL

Keep out of the reach and sight of children.
This medicinal product does not require any special
storage conditions.
Do not use Varbim XL after the expiry date that is
stated on the carton. 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 no longer required. These
measures will help to protect the environment.

6

FURTHER INFORMATION

What Varbim XL contains:
• The active substance is indapamide. Each tablet
contains 1.5 mg indapamide
• The other ingredients are: lactose monohydrate,
pregelatinised starch, hypromellose, colloidal
silicon dioxide, magnesium stearate, macrogol
6000, titanium dioxide.
What Varbim XL looks like and contents of the pack:
• White to off-white, round shaped, prolongedrelease, film-coated tablets
• The tablets are packed in blister packs of 14, 15, 28,
30, 50, 60, 90, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: TEVA UK Limited,
Eastbourne, BN22 9AG.
Manufacturer: IVAX Pharmaceuticals s.r.o, Ostravska
29/305, 747 70 Opava-Komarov, Czech Republic.
This leaflet was last revised: April 2008.
PL 00289/1038

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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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