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TERTENSIF SR 1.5MG TABLETS

Active substance(s): INDAPAMIDE / INDAPAMIDE / INDAPAMIDE

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1218/230916/1/F

Natrilix ® SR 1.5mg Tablets
(indapamide)
Patient Information Leaflet
Your medicine is called Natrilix SR 1.5mg Tablets and will be referred to as
Natrilix SR throughout this Patient Information Leaflet.
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1

What Natrilix SR is and what it is used for

2

What you need to know before you take Natrilix SR

3

How to take Natrilix SR

4

Possible side effects

5

How to store Natrilix SR

6

Contents of the pack and other information

1

What Natrilix SR is and what it is used for

Natrilix SR 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.
This medicine is intended to reduce high blood pressure (hypertension) in
adults.

2

What you need to know before you take Natrilix SR

Do not take Natrilix SR:
* if you are allergic to indapamide or any other sulfonamide or to any of
the other ingredients of this medicine (listed in section 6),
* if you have severe kidney disease,
* if you have severe liver disease or suffer from a condition called hepatic
encephalopathy (degenerative disease of the brain),
* if you have low potassium levels in your blood.
Warnings and precautions
Talk to your doctor or pharmacist before taking Natrilix 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 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.
Athletes should be aware that this medicine contains an active ingredient
which may give a positive reaction in doping tests.
Other medicines and Natrilix SR
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
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:

* 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),
* sparfloxacin, moxifloxacin, erythromycin by injection (antibiotics used to
treat infections),
* vincamine by injection (used to treat symptomatic cognitive disorders in
elderly including memory loss),
* 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),
* amphotericin B by injection (anti-fungal medicines),
* 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:
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, 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 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.
Natrilix SR 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

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure. The recommended
dose is 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 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.

®

1218/230916/1/B

Natrilix SR 1.5mg Tablets
(indapamide)
Patient Information Leaflet (continued)
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 a 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 medicine, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking the medicinal product and see a doctor immediately, if you
experience any of the following side effects:
* Angioedema and/or urticaria. 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. (Very rare) (may affect up to 1 in 10,000 people)
Severe
skin reactions including intense skin rash, reddening of the skin
*
over your whole body, severe itching, blistering, peeling and swelling of the
skin, inflammation of mucous membranes (Stevens Johnson Syndrome)
or other allergic reactions, (Very rare) (may affect up to 1 in 10,000
people)
irregular beat. (Not known)
* Life-threatening
* Inflamed pancreas which may cause severe abdominal and back pain
accompanied with feeling very unwell (Very rare) (may affect up to 1 in
10,000 people)
of the brain caused by liver illness (Hepatic encephalopathy)
* Disease
(Not known)
* Inflammation of the liver (Hepatitis) (Not known)
In decreasing order of frequency, other side effects can include:
Common (may affect up to 1 in 10 people):
raised skin rash;
* Red
Allergic
reactions, mainly dermatological, in subjects with a predisposition
*
to allergic and asthmatic reactions.
Uncommon (may affect up to 1 in 100 people):
* Vomiting;
* Red pinpoints on skin (Purpura).
Rare (may affect up to 1 in 1000 people):
* Feeling of tiredness, headache, pins and needles (paraesthesia), vertigo;
* Gastro-intestinal disorders (such as nausea, constipation), dry mouth.
Very rare (may affect up to 1 in 10,000 people):
* 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);
level of calcium in blood;
* High
* Heart rhythm irregularities (causing palpitations, feeling of the heart
pounding), low blood pressure;
Kidney
disease (causing symptoms of tiredness, increased need to
*
urinate, itchy skin, feeling sick, swollen extremities);
* Abnormal hepatic function.
Not known:
* Fainting.
* 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.

Short sightedness (myopia)
Blurred vision
Visual impairment
Changes may occur in your blood 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,
- increased levels of liver enzymes,
* Abnormal ECG heart tracing.

*
*
*
*

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.

How to store Natrilix SR

5

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
* Do not use this medicine after the expiry date which is stated on the
carton and blister. The expiry dates refers to the last day of the month.
* Do not store above 30°C.
* Store in the original package.
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.
If the tablets become discoloured or show any signs of deterioration, ask
your pharmacist who will advise you what to do.

*

6

Contents of the pack and other information

What Natrilix SR contains:
The active substance is indapamide. Each prolonged-release film-coated
tablet contains 1.5 mg indapamide.
The other ingredients are:
* anhydrous colloidal silica, hypromellose, lactose, magnesium stearate,
povidone, glycerol, macrogol 6000, titanium dioxide (E171).
What Natrilix SR looks like and contents of the pack:
The tablets are white, round, plain, film-coated tablets.
The tablets are available in blister packs of 30 film-coated tablets.
Manufacturer and Licence Holder
The tablets are manufactured by ANPHARM Przedsiebiorstwo
Farmaceutyczne SA, ul. Annopol 6B, 03-236 Warsaw, Poland and are
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
POM

PL No: 15184/1218

Natrilix is a registered trademark of Biofarma.
Revision date: 23/09/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

®

1218/230916/2/F

Tertensif SR 1.5mg Tablets
(indapamide)
Patient Information Leaflet
Your medicine is called Tertensif SR 1.5mg Tablets and will be referred to as
Tertensif SR throughout this Patient Information Leaflet.
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1

What Tertensif SR is and what it is used for

2

What you need to know before you take Tertensif SR

3

How to take Tertensif SR

4

Possible side effects

5

How to store Tertensif SR

6

Contents of the pack and other information

1

What Tertensif SR is and what it is used for

Tertensif SR 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.
This medicine is intended to reduce high blood pressure (hypertension) in
adults.

2

What you need to know before you take Tertensif SR

Do not take Tertensif SR:
* if you are allergic to indapamide or any other sulfonamide or to any of
the other ingredients of this medicine (listed in section 6),
* if you have severe kidney disease,
if you have severe liver disease or suffer from a condition called hepatic
* encephalopathy
(degenerative disease of the brain),
* if you have low potassium levels in your blood.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tertensif SR:
have liver problems,
* ifif you
* you have diabetes,
suffer from gout,
* ifif you
* 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 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.
Athletes should be aware that this medicine contains an active ingredient
which may give a positive reaction in doping tests.
Other medicines and Tertensif SR
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
You should not take Tertensif 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),
* sparfloxacin, moxifloxacin, erythromycin by injection (antibiotics used to
treat infections),
* vincamine by injection (used to treat symptomatic cognitive disorders in
elderly including memory loss),
* 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),
* amphotericin B by injection (anti-fungal medicines),
* 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:
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, 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 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.
Tertensif SR 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 Tertensif SR

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure. The recommended
dose is 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 Tertensif SR than you should:
If you have taken too many tablets, contact your doctor or pharmacist
immediately.
A very large dose of Tertensif 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.

®

1218/230916/2/B

Tertensif SR 1.5mg Tablets
(indapamide)
Patient Information Leaflet (continued)
If you forget to take Tertensif 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 a forgotten dose.
If you stop taking Tertensif 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 medicine, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking the medicinal product and see a doctor immediately, if you
experience any of the following side effects:
* Angioedema and/or urticaria. 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. (Very rare) (may affect up to 1 in 10,000 people)
Severe
skin reactions including intense skin rash, reddening of the skin
*
over your whole body, severe itching, blistering, peeling and swelling of the
skin, inflammation of mucous membranes (Stevens Johnson Syndrome)
or other allergic reactions, (Very rare) (may affect up to 1 in 10,000
people)
irregular beat. (Not known)
* Life-threatening
* Inflamed pancreas which may cause severe abdominal and back pain
accompanied with feeling very unwell (Very rare) (may affect up to 1 in
10,000 people)
of the brain caused by liver illness (Hepatic encephalopathy)
* Disease
(Not known)
* Inflammation of the liver (Hepatitis) (Not known)
In decreasing order of frequency, other side effects can include:
Common (may affect up to 1 in 10 people):
raised skin rash;
* Red
Allergic
reactions, mainly dermatological, in subjects with a predisposition
*
to allergic and asthmatic reactions.
Uncommon (may affect up to 1 in 100 people):
* Vomiting;
* Red pinpoints on skin (Purpura).
Rare (may affect up to 1 in 1000 people):
* Feeling of tiredness, headache, pins and needles (paraesthesia), vertigo;
* Gastro-intestinal disorders (such as nausea, constipation), dry mouth.
Very rare (may affect up to 1 in 10,000 people):
* 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);
level of calcium in blood;
* High
* Heart rhythm irregularities (causing palpitations, feeling of the heart
pounding), low blood pressure;
Kidney
disease (causing symptoms of tiredness, increased need to
*
urinate, itchy skin, feeling sick, swollen extremities);
* Abnormal hepatic function.
Not known:
* Fainting.
* 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.

Short sightedness (myopia)
Blurred vision
Visual impairment
Changes may occur in your blood 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,
- increased levels of liver enzymes,
* Abnormal ECG heart tracing.

*
*
*
*

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.

How to store Tertensif SR

5

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
* Do not use this medicine after the expiry date which is stated on the
carton and blister. The expiry dates refers to the last day of the month.
* Do not store above 30°C.
* Store in the original package.
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.
If the tablets become discoloured or show any signs of deterioration, ask
your pharmacist who will advise you what to do.

*

6

Contents of the pack and other information

What Tertensif SR contains:
The active substance is indapamide. Each prolonged-release film-coated
tablet contains 1.5 mg indapamide.
The other ingredients are:
* anhydrous colloidal silica, hypromellose, lactose, magnesium stearate,
povidone, glycerol, macrogol 6000, titanium dioxide (E171).
What Tertensif SR looks like and contents of the pack:
The tablets are white, round, plain, film-coated tablets.
The tablets are available in blister packs of 30 film-coated tablets.
Manufacturer and Licence Holder
The tablets are manufactured by ANPHARM Przedsiebiorstwo
Farmaceutyczne SA, ul. Annopol 6B, 03-236 Warsaw, Poland and are
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
POM

PL No: 15184/1218

Natrilix is a registered trademark of Biofarma.
Revision date: 23/09/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Expand Transcript

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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