FLUDEX 1.5MG SR TABLETS

Active substance: INDAPAMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUDEX 1.5 mg SR tablets
INDAPAMIDE
prolonged-release tablets
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.
2.
3.
4.
5.
6.

1.

What FLUDEX 1.5 mg SR is and what it is used for
Before you take FLUDEX 1.5 mg SR
How to take FLUDEX 1.5 mg SR
Possible side effects
How to store FLUDEX 1.5 mg SR
Further information

WHAT FLUDEX 1.5 mg SR IS AND WHAT IT IS USED FOR

This medicine is intended to reduce high blood pressure (hypertension).
It is a prolonged-release film-coated tablet containing indapamide as active ingredient.
Indapamide is a diuretic. 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.

2.

BEFORE YOU TAKE FLUDEX 1.5 mg SR

Do not take FLUDEX 1.5 mg SR
- if you are allergic to indapamide or any other sulphonamide or to any of the other ingredients of
FLUDEX 1.5 mg SR,
- if you have severe kidney disease,
- if you have severe liver disease or suffer from a condition called hepatic encephalopathy (liver
problems which affect the brain and central nervous system),
- if you have low potassium levels in your blood.
Take special care with FLUDEX 1.5 mg SR
- 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 have had photosensitivity reactions.

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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.
Athletes should be aware that this medicine contains an active ingredient, which may give a positive
reaction in doping tests.
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 FLUDEX 1.5 mg SR 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, neuroleptics),
- bepridil (used to treat angina pectoris, a condition causing chest pain),
- cisapride (used to treat reduced movement of the gullet and stomach),
- diphemanil (used to treat gastro-intestinal problems such as ulcers, too much acid, overactive
digestive system),
- 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. Breastfeeding is not advisable if you are taking this
medicine.
Driving and using machines
This medicine can cause side effects such as dizziness or tiredness due to lowering of the blood
pressure (see section 4). These side effects are more likely to occur after initiation of the treatment and

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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 the ingredients of FLUDEX 1.5 mg SR
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 FLUDEX 1.5 mg SR

Instructions for proper use
One tablet each day, preferably in the morning. The tablets can be taken with or without food. 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 FLUDEX 1.5 mg SR than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately.
A very large dose of FLUDEX 1.5 mg SR could cause nausea (feeling sick), vomiting, low blood
pressure, cramps, dizziness, drowsiness, confusion and changes in the amount of urine produced by
the kidneys.
If you forget to take FLUDEX 1.5 mg SR
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 the forgotten dose.
If you stop taking FLUDEX 1.5 mg SR
As the treatment for high blood pressure is usually life-long, you should discuss with your doctor
before stopping this medicinal product.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, FLUDEX 1.5 mg SR can cause side effects, although not everybody gets them.
Common (less than 1 patient in 10 but more than 1 in 100):
Low potassium in the blood, which may cause muscle weakness.
Uncommon (less than 1 patient in 100 but more than 1 in 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.
Rare (less than 1 patient in 1000 but more than 1 in 10,000):
- Feeling of tiredness, dizziness, headache, pins and needles (paresthesia);
- Nausea (feeling sick), constipation, dry mouth;
- Increased risk of dehydration in the elderly and in patients suffering from heart failure.
Very rare (less than 1 patient in 10,000):
- Heart rhythm irregularities (causing palpitations, feeling of the heart pounding), low blood
pressure;

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Kidney disease (causing symptoms of tiredness, increased need to urinate, itchy skin, feeling sick,
swollen extremities);
Pancreatitis (inflammation of the pancreas which causes upper abdominal pain), abnormal liver
function (with symptoms such as tiredness, loss of appetite, feeling or being sick, swollen
extremities, yellow skin). In cases of liver failure, there is a possibility of getting hepatic
encephalopathy (liver problems which affect the brain and central nervous system);
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);
Angioedema and/or urticaria, severe skin manifestations. Angioedema is characterised by swelling
of the skin around the eyes, lips, hands or feet. It may cause swelling of the throat, tongue or
airways resulting in shortness of breath or difficulty in swallowing. If this occurs, contact your
doctor immediately.
If you suffer from systemic lupus erythematosus (a disorder of the immune system leading to
inflammation and damage to the joints, tendons and organs with symptoms including skin rashes,
tiredness, loss of appetite, weight gain and joint pain), this might get worse. Cases of
photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA
have also been reported.

Not known (frequency cannot be estimated from the available data):
- Changes may occur in your blood and your doctor may need to give you blood tests to check your
condition. The following changes in your blood test results 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,
. increased levels of liver enzymes.
- Abnormal ECG heart tracing
- Life-threatening irregular beat (Torsade de Pointes)
- Hepatitis
- Fainting
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 FLUDEX 1.5 mg SR

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date
refers to the last day of that month.
Store below 30°C.
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

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What FLUDEX 1.5 mg SR contains
The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.
The other ingredients are:
- tablet core: anhydrous colloidal silica (E551), hypromellose (E464), lactose monohydrate,
magnesium stearate (E470B), povidone
- film-coating: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate
(E470B), titanium dioxide (E171).
What FLUDEX 1.5 mg SR looks like and contents of the pack
This medicine is a white, round prolonged-release film-coated tablet.
The tablets are available in blisters of 10, 14, 15, 20, 30, 50, 60, 90 or 100 tablets packed in a
cardboard box. Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex – France

Manufacturer
Servier (Ireland) Industries Ltd
Gorey Road
Co. Wicklow – Arklow
IRELAND
This leaflet was last approved in 11/2011

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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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