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TENSAID XL 1.5 MG PROLONGED-RELEASE FILM-COATED TABLET.

Active substance(s): INDAPAMIDE

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160 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

TENSAID XL 1.5 mg
PROLONGED-RELEASE
FILM-COATED TABLETS
(indapamide)

Read all of this leaflet carefully before you
start using 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 Tensaid XL 1.5 mg is and what it is
used for.
2. Before you take Tensaid XL 1.5 mg.
3. How to take Tensaid XL 1.5 mg.
4. Possible side effects.
5. How to store Tensaid XL 1.5 mg.
6. Further information.
The name of the medicinal product is Tensaid XL
1.5 mg prolonged-release film-coated tablet,
but in the remainder of this leaflet it will be called
Tensaid XL 1.5 mg.
1. WHAT TENSAID XL 1.5 mg IS AND WHAT IT IS
USED FOR

It is a prolonged-release film-coated tablet
containing indapamide as active ingredient.
Tensaid XL is a diuretic. Most diuretics increase
the amount of urine produced by the kidneys.
However, Tensaid XL is different from other
diuretics, as it only causes a slight increase in
the amount of urine produced.
2. BEFORE YOU TAKE TENSAID XL 1.5 mg
Do not take Tensaid XL 1.5 mg:
• If you are allergic to indapamide or any other
sulphonamide or to any of the other ingredients
of Tensaid XL 1.5 mg.
• If you have severe kidney disease.
• If you have severe liver disease, or suffer from a
condition called hepatic encephalopathy.
• If you have low potassium levels in your blood.
Take special care with Tensaid XL 1.5 mg:
• if you have liver problems
• if you have diabetes
• if you suffer from gout
• if you have any heart rhythm problems or
problems with your kidneys
• if you need to have a test to check how well your
parathyroid gland is working.
You should tell your doctor if you had sensitivity
to sunlight.
Your doctor may give you blood tests to check
for low sodium or potassium levels or high
calcium levels.
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.
You should not take Tensaid XL 1.5 mg with lithium
(used to treat depression) due to the risk of
increased levels of lithium in the blood.
Make sure to tell your doctor if you are taking
any of the following medicines, as special care
may be required:
• medicines used for heart rhythm problems
(e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, ibutilide, dofetilide, digitalis)
• medicines used to treat mental disorders such as
depression, anxiety, schizophrenia… (e.g. tricyclic
antidepressants, antipsychotic drugs)
• bepridil (used to treat angina pectoris, a
condition causing chest pain)
• cisapride, diphemanil (used to treat
gastro-intestinal problems)
• sparfloxacin, moxifloxacin (antibiotics used to
treat infections)
• halofantrine (antiparasitic drug used to treat
certain types of malaria)
• pentamidine (used to treat certain types
of pneumonia)
• mizolastine (used to treat allergic reactions, such
as hay fever)
• non-steroidal anti-inflammatory drugs for pain
relief (e.g. ibuprofen) or high doses of
acetylsalicylic acid
• angiotensin converting enzyme (ACE)
inhibitors (used to treat high blood pressure
and heart failure)
• oral corticosteroids used to treat various
conditions including severe asthma and
rheumatoid arthritis
• stimulant laxatives
• baclofen (to treat muscle stiffness occurring in
diseases such as multiple sclerosis)
• potassium-sparing diuretics (amiloride,
spironolactone, triamterene)
• metformin (to treat diabetes)
• iodinated contrast media (used for tests
involving X-rays)
• calcium tablets or other calcium supplements
• ciclosporin, tacrolimus or other medicines to
depress the immune system after organ
transplantation, to treat autoimmune diseases,
or severe rheumatic or dermatological diseases
• tetracosactide (to treat Crohn's disease).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine. This medicine is not
recommended during pregnancy. When a
pregnancy is planned or confirmed, the switch to
an alternative treatment should be initiated as
soon as possible. Please tell your doctor if you are
pregnant or wish to become pregnant. The active
ingredient is excreted in milk. Breast-feeding is not
advisable if you are taking this medicine.
Driving and using machines
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.

Important information about some of
ingredients of Tensaid XL 1.5 mg
This medicine contains lactose monohydrate.
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 TENSAID XL 1.5 mg
Instructions for proper use
One tablet each day, preferably in the morning.
The tablets can be taken irrespective of meals.
They should be swallowed whole with water.
Do not crush or chew them. Treatment for high
blood pressure is usually life-long.
If you take more Tensaid XL 1.5 mg, than
you should
If you have taken too many tablets, contact your
doctor or pharmacist immediately. A very large
dose of Tensaid XL 1.5 mg could cause nausea,
vomiting, low blood pressure, cramps, dizziness,
drowsiness, confusion and changes in the amount
of urine produced by the kidneys.
If you forget to take Tensaid XL 1.5 mg
If you forget to take a dose of your medicine,
take the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Tensaid XL 1.5 mg
As the treatment for high blood pressure is usually
life-long, you should discuss with your doctor
before stopping this medicinal product.

• Angioedema and/or urticaria, severe skin
manifestations. Angioedema is characterised by
swelling of the skin of extremities or face,
swelling of 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 doctor
immediately. If you suffer from systemic lupus
erythematosus (a type of collagen disease), this
might get worse. Cases of photosensitivity
reactions (change in skin appearance) after
exposure to the sun or artificial UVA have also
been reported.
Some changes may occur in your laboratory
parameters and your doctor may need to give you
blood tests to check your condition. The following
changes in laboratory parameters may occur:
• low potassium in the blood
• low sodium in the blood that may lead to
dehydration and low blood pressure
• increase in uric acid, a substance which may
cause or worsen gout (painful joint(s) especially
in the feet)
• increase in blood glucose levels in
diabetic patients
• increase of calcium in blood.
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
5. HOW TO STORE TENSAID XL 1.5 mg
Keep out of the reach and sight of children.

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

Do not use Tensaid XL 1.5 mg after the expiry date
which is stated on the carton.

4. POSSIBLE SIDE EFFECTS

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.

Like all medicines, Tensaid XL 1.5 mg can cause
side effects, although not everybody gets them.
These can include:
Commonly (less than 1 patient per 10 but more
than 1 per 100): low potassium in the blood,
which may cause muscle weakness.
Uncommonly (less than 1 patient per 100 but
more than 1 per 1000): vomiting, allergic
reactions, mainly dermatological, such as skin
rashes, purpura (red pinpoints on skin) in
subjects with a predisposition to allergic and
asthmatic reactions.
Rarely (less than 1 patient per 1000 but more
than 1 per 10,000):
• Feeling of tiredness, dizziness, headache,
pins and needles (paresthesia).
• Gastro-intestinal disorders (such as nausea,
constipation), dry mouth.
• Increased risk of dehydration in the elderly and
in patients suffering from heart failure.
Very rarely (less than 1 patient per 10,000):
• Heart rhythm irregularities, low blood pressure.
• Kidney disease.
• Pancreatitis (inflammation of the pancreas
which causes upper abdominal pain), abnormal
liver function. In cases of liver failure, there is a
possibility of getting hepatic encephalopathy.
• Changes in blood cells, such as
thrombocytopenia (decrease in the number of
platelets which causes easy bruising and nasal
bleeding), leucopenia (decrease of white blood
cells which may cause unexplained fever,
soreness of the throat or other flu-like
symptoms – if this occurs, contact your doctor)
and anaemia (decrease in red blood cells).

6. FURTHER INFORMATION
What Tensaid XL 1.5 mg contains:
• The active substance is Indapamide.
• The other ingredients are:
Lactose monohydrate, hypromellose, anhydrous
colloidal silica, magnesium stearate, titanium
dioxide (E171), macrogol 6000, maize
pregelatinized starch.
What Tensaid XL 1.5 mg looks like and contents
of the pack
White, prolonged-release film-coated tablets.
Tensaid XL 1.5 mg, Prolonged-Release
Film-Coated Tablet is available in 10, 30, 90 or
100 tablets.
Marketing Authorisation Holder is
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
The manufacturer is
Gerard Laboratories, 35/36 Industrial Estate,
Grange Road, Dublin 13, Ireland.

This leaflet was last approved in:
February 2012

300 mm

This medicine is intended to reduce high blood
pressure (hypertension).

Athletes should be aware that this medicine
contains an active ingredient, which may give
a positive reaction in doping tests.

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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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