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DIUREXAN TABLETS 20MG

Active substance(s): XIPAMIDE / XIPAMIDE / XIPAMIDE

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Package leaflet: Information for the user

Diurexan 20 mg tablets
Xipamide
Please read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may have 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.
In this leaflet:
1. What Diurexan is for
2. Before you take Diurexan
3. How to take Diurexan
4. Possible side effects
5. How to store Diurexan
6. Further information

1. What Diurexan is for
Diurexan belongs to the group of medicines know
as diuretics. Diuretics are often referred to as water
tablets.
Diurexan removes excess water from the body by
increasing how often you urinate. It is used to treat
high blood pressure (hypertension) and too much
fluid in the body (oedema), often caused by heart
failure or problems with your liver or kidneys.

2. Before you use Diurexan
Do not take Diurexan if:
• You are allergic to Xipamide
• You are allergic to any of the other ingredients of
Diurexan (listed in section 6)
• You have low levels of salts in your blood sometimes caused by severe vomiting or diarrhoea
• You have liver disease that is causing you to
­become unconscious
• You have severe kidney disease
You have untreated Addison’s disease – a condition
• 
in which your adrenal glands so not produce
­sufficient levels of natural steroid in the blood
• You have symptomatic hyperuricaemia,
for ­example gout or you have too much uric
acid in your urine
• You have gallstones
• You have hypercalcaemia (high levels of calcium
in your blood)
• You have pre-existing hypovolaemia (low blood
volume sometimes caused by severe vomiting,
dehydration, severe bleeding)
• You are pregnant or think you may be pregnant
• You are breast feeding
If any of the above applies to you, talk to your
­doctor or pharmacist.
Check with your doctor before taking Diurexan if:
• You have diabetes
• You have kidney or liver disease
• You have an enlarged prostate gland or trouble
urinating
You suffer with coronary or cerebral arteriosclerosis
• 
(narrowing of the arteries in the heart or brain)
• Your body produces too much aldosterone, a
hormone which controls salt and water balance
(hyperaldosteronism)
• You have diarrhoea
• You are malnourished (a severe lack of food)
• You are being sick
• You are over 65 years
• You have an intolerance to some sugars
• You are alcohol dependent
Tell your doctor if you are taking any of the
­following medicines:
• Any other diuretic medicines
• Medicines to treat high blood pressure

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• Cardiac glycosides, such as digoxin, used to
treat heart problems
• Anti-diabetics, such as insulin, used to treat
­diabetes
• Lithium (to treat mental problems)
• Antipsychotics (to treat schizophrenia)
• Anti-depressants (to treat depression)
• Medicines to treat an irregular or abnormally fast
or slow heart beat
• Medicines or substances that affect your heart
rate (check the patient information leaflet of your
medicine)
• Non-steroidal anti-inflammatory drugs (NSAIDs)
such as indomethacin
• Baclofen, a medicine used to treat muscle
­spasticity problems, i.e. for the treatment of
­multiple sclerosis (MS)
• Anti-epileptic medicines such as phenytoin and
carbamazepine used to treat epilepsy and bipolar
disorder
• Amifostine, a medicine used to protect against
the effects of chemotherapy and radiotherapy
• Medicines for treating urological diseases
• Immunosuppressant’s, such as cyclosporine and
tacrolimus (to prevent transplanted organs being
rejected)
• Chemotherapy medicines such as cytostatics,
used to treat cancer
• Cholesterol lowering medicines such as
colestipol and cholestyramine
• Halofantrine, used to treat malaria
• 
Mizolastine, an anti-histamine used to treat allergies
If you are taking any of these medicines at the same
time as Diurexan, your doctor may adjust the dose
of you take.
Also tell you doctor if you are taking:
• Steroids used to treat many conditions including
asthma, arthritis, eczema and dermatitis
• ACTH, a medicine used to test if your pituitary
gland is working properly
• Carbenoxolone used to treat ulcers and
­inflammation of the oesophagus (gullet)
• Antibiotics used to treat fungal and bacterial
­infections
• Laxatives
These medicines may cause the level of potassium
in your blood to fall when used at the same time as
Diurexan.
Tell your doctor or pharmacist if you are taking any
other medicines, including medicines obtained
without a prescription.
Taking with food and drink:
Avoid drinking alcohol while taking Diurexan.
Pregnancy and breast-feeding
Do not take Diurexan if you are pregnant, trying to
become pregnant or are breastfeeding.
Driving and using machines
Diurexan may affect your reactions and therefore
your road safety and ability to use machinery.
Do not drive or operate machinery of you feel
­unwell.

3. How to take Diurexan
Always take Diurexan exactly as your doctor has
told you. You should check with your doctor or
pharmacist is you are not sure.
Important:
Your doctor will choose the dose that is right for
you. Your dose will be shown clearly on the label
that your pharmacist puts on your medicine. If it
does not, or you are not sure, ask your doctor or
pharmacist.

28.06.16 16:20

For high blood pressure:
The usual dose is one tablet per day, taken early in
the morning.
For excessive fluid retention:
The usual starting dose is two tablets per day,
­taken early in the morning.
Once your doctor has seen how the medicine is
working, they may change your dose. They may
­reduce it to one tablet per day. If the medicine is
not having much effect your doctor may increase
your dose to 3 or 4 tablets per day.
Medical check-ups:
Takin Diurexan for a long time can cause you to lose
potassium from your blood. You doctor will check
for this and may prescribe you extra potassium
­especially if you are elderly or getting little potassium
in your diet.
If you take more Diurexan than you should:
If you accidentally take too much Diurexan,
go immediately to the nearest hospital casualty
­department or your doctor. Taking too much of this
medicine may cause you to lose too much fluid from
your body. This can cause you to feel or be sick,
feel faint, dizzy, or confused and change the
­make-up of your blood. You may have your
­stomach washed out and an infusion into your vein
to replace lost fluids.
If you forget to take Diurexan:
Do not take a double dose to make up for a missed
dose. Simply take your dose as planned.
If you have any further question on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Diurexan can cause side effects,
although not everybody gets them.
Seek immediate medical help if you have any of
the following symptoms:
• You have difficulty breathing
• Your face or throat swells
• You have a severe rash that may blister
Tell your doctor if you have any of the following
symptoms, they may need to stop your treatment
with Diurexan:
• An allergic skin reaction which may cause
redness, itching or a rash
• Severe stomach pains and feeling or being
sick
• Muscle cramps or weakness
• Extreme tiredness
• Dizziness upon standing
• Blurred vision
Very common side effects
(affects more than 1 in 10 people):
• 
Low potassium levels in the blood (hypokalaemia)
which may make cause headaches, muscles
cramps, or weakness and make you feel or
be sick
Common side effects
(affect less than 1 in 10 people):
• Tiredness or exhaustion
• Anxiety
• Agitation
• Headache
• Dizziness
• Dry mouth
• Sweating
• Palpitations (awareness of an abnormal beating
of the heart)
• Dizziness or light-headedness upon standing
which may cause you to collapse (you may have
low blood pressure)
• Effects on your stomach or intestine such as
stomach pain, constipation and diarrhoea
• Muscle spasms or cramps
• Dehydration

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• Low sodium, magnesium or chloride levels in the
blood (hyponatraemia, hypomagnesaemia and
hypochloremia respectively) which may cause
headaches, muscle cramps or weakness and
make you feel or be sick
Uncommon side effects
(affect less than 1 in 100 people):
• Photosensitivity (sensitivity to sunlight)
Rare side effects (affect less than 1 in 1000 people):
• Disturbed or blurred vision
• 
Pancreatitis (sudden inflammation of the pancreas)
• Inflammation of the gall bladder or gall stones
• Allergic skin reactions which may cause redness,
itching or a rash
• Hyperlipidemia (raised lipid levels in your blood)
Very rare side effects
(affect less than 1 in 10,000 people):
• Problems with your blood cells, such as a low
white blood cell count or anemia
• Jaundice
• Problems with your kidneys
Reporting of side effects
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
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Diurexan
Keep out of the reach and sight of children.
Do not use Diurexan after the expiry date which 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. Return any medicine you no
longer need to your pharmacist.

6. Further information
What Diurexan contains
The active substance is Xipamide. Each tablet
­contains 20 mg of Xipamide.
The other ingredients are maize starch, mannitol,
cellulose powder, colloidal silicon dioxide, magnesium stearate and purified water.
What Diurexan looks like
Diurexan tablets are white and round with a notch
on one side and an “A” on the other. They are about
6mm in diameter. They come in blister strips strips
of 14 tablets with 10 blister strips in a box.
Marketing Authorisation Holder is:
Meda Pharmaceuticals Ltd, Skyway House,
­Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU United Kingdom.
Manufacturer is:
Sidefarma, S.A., Rua da Guiné, nº 26,
2689-514 ­Prior Velho, PORTUGAL.
This leaflet was last updated on June 2016
If this leaflet is difficult to see or read and you
would like it in a different format, please contact
Meda Pharmaceuticals Ltd, Skyway House,
­Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU United Kingdom.

56UK21064045-01

28.06.16 16:20

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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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