NATRILIX SR 1.5MG SUSTAINED RELEASE COATED TABLETS

Active substance: INDAPAMIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

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.
•  his medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
T
are the same as yours.
• f any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
I
or pharmacist.
In this leaflet:
1. What Natrilix SR is and what it is used for
2. Before you take Natrilix SR
3. How to take Natrilix SR
4. Possible side effects
5. How to store Natrilix SR
6. Further information

• f you have severe kidney disease,
i
• f you have severe liver disease or suffer from a condition
i
called hepatic encephalopathy (liver problems which
affect the brain and central nervous system),
• f you have low potassium levels in your blood.
i
Take special care with Natrilix SR:
• f you have liver problems,
i
• f you have diabetes,
i
• f you suffer from gout,
i
• f you have any heart rhythm problems or problems with
i
your kidneys,
• f you need to have a test to check how well your
i
parathyroid gland is working.

1. WHAT NATRILIX 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 NATRILIX SR

You should tell your doctor if you have had photosensitivity
reactions.
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.

Do not take Natrilix SR:
• f you are allergic to indapamide or any other sulphonamide
i
or to any of the other ingredients of Natrilix SR,

Athletes should be aware that this medicine contains an
active ingredient, which may give a positive reaction in
doping tests.
1

0385_02.14.indd 1

Format 102#00
160 x 157 mm

04/11/11 14:42

NOIR 100%

PMS 293 U 100%

+ DEGRADÉ

+ DEGRADÉ

PMS 186 U 100%

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 Natrilix 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:
•  edicines used for heart rhythm problems (e.g. quinidine,
m
hydroquinidine, disopyramide, amiodarone, sotalol,
ibutilide, dofetilide, digitalis),
•  edicines used to treat mental disorders such
m
as depression, anxiety, schizophrenia (e.g. tricyclic
antidepressants, antipsychotic drugs, neuroleptics),
•  epridil (used to treat angina pectoris, a condition causing
b
chest pain),
•  isapride (used to treat reduced movement of the gullet
c
and stomach),
•  iphemanil (used to treat gastric problems such as ulcers,
d
too much acid, overactive digestive system),
•  parfloxacin, moxifloxacin (antibiotics used to treat
s
infections),
•  alofantrine (antiparasitic drug used to treat certain types
h
of malaria),
•  entamidine (used to treat certain types of pneumonia),
p
•  izolastine (used to treat allergic reactions, such as hay
m
fever),
•  on-steroidal anti-inflammatory drugs for pain relief (e.g.
n
ibuprofen) or high doses of acetylsalicylic acid,
•  ngiotensin converting enzyme (ACE) inhibitors (used to
a
treat high blood pressure and heart failure),
•  ral corticosteroids used to treat various conditions
o
including severe asthma and rheumatoid arthritis,
•  timulant laxatives,
s
•  aclofen (to treat muscle stiffness occurring in diseases
b
such as multiple sclerosis),
•  otassium-sparing diuretics (amiloride, spironolactone,
p
triamterene),
•  etformin (to treat diabetes),
m
• odinated contrast media (used for tests involving X-rays),
i

•  alcium tablets or other calcium supplements,
c
•  iclosporin, tacrolimus or other medicines to depress
c
the immune system after organ transplantation, to
treat autoimmune diseases, or severe rheumatic or
dermatological diseases,
• etracosactide (to treat Crohn’s disease).
t
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 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 Natrilix 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 NATRILIX 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.
2

0385_02.14.indd 2

04/11/11 14:42

Treatment for high blood pressure is usually life-long.

Very rare (less than 1 patient in 10,000):
-  eart rhythm irregularities (causing palpitations, feeling
H
of the heart pounding), low blood pressure;
-  idney disease (causing symptoms of tiredness, increased
K
need to urinate, itchy skin, feeling sick, swollen extremities);
-  ancreatitis (inflammation of the pancreas which causes
P
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);
-  hanges in blood cells, such as thrombocytopenia
C
(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);
-  ngioedema and/or urticaria, severe skin manifestations.
A
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):
-  hanges may occur in your blood and your doctor may
C
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,
- ow sodium in the blood that may lead to dehydration
l
and low blood pressure,
- ncrease in uric acid, a substance which may cause or
i

If you take more Natrilix SR than you should:
If you have taken too many tablets, contact your doctor or
pharmacist immediately.
A very large dose of Natrilix 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 Natrilix 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 Natrilix 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, Natrilix 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):
-  eeling of tiredness, dizziness, headache, pins and
F
needles (paresthesia);
-  ausea (feeling sick), constipation, dry mouth;
N
- ncreased risk of dehydration in the elderly and in patients
I
suffering from heart failure.
3

0385_02.14.indd 3

04/11/11 14:42

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.
-  bnormal ECG heart tracing
A
-  ife-threatening irregular beat (Torsade de Pointes)
L
-  epatitis
H
-  ainting
F
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

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

5. HOW TO STORE NATRILIX SR

This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria
FLUDEX RETARD 1.5 mg
Belgium
FLUDEX 1.5 mg
Cyprus
FLUDEX 1.5 mg
Czech Republic
TERTENSIF SR
Denmark
NATRILIX RETARD
Estonia
TERTENSIF SR
Finland
NATRILIX RETARD 1.5 mg
France
FLUDEX 1.5 mg
Germany
NATRILIX SR 1.5 mg
Greece
FLUDEX 1.5 mg
Hungary
PRETANIX
Ireland
NATRILIX SR
Italy
NATRILIX LP 1.5 mg
Latvia
TERTENSIF SR
Lithuania
TERTENSIF SR
Luxembourg
FLUDEX 1.5 mg
Malta
NATRILIX SR
Netherlands
FLUDEX SR 1.5 mg
Poland
INDAPAMIDE 1.5 mg SR SERVIER
Portugal
FLUDEX LP
Slovakia
TERTENSIF SR
Slovenia
TERTENSIF SR
Spain
TERTENSIF RETARD
United Kingdom
NATRILIX SR 1.5mg
This leaflet was last approved in 11.2011.

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
What Natrilix SR contains:
The active substance is indapamide. Each tablet contains
1.5 mg of indapamide.
The other ingredients are:
• ablet core: anhydrous colloidal silica (E551), hypromellose
t
(E464), lactose monohydrate, magnesium stearate
(E470B), povidone
•  ilm-coating: glycerol (E422), hypromellose (E464),
f
macrogol 6000, magnesium stearate (E470B), titanium
dioxide (E171).
What Natrilix SR looks like and contents of the pack:
This medicine is a white, round prolonged-release filmcoated tablet.
4

0385_02.14.indd 4

04/11/11 14:42

Expand view ⇕

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.

Hide
(web3)