Skip to Content

IMIDAPRIL HYDROCHLORIDE 5MG TABLETS

Active substance(s): IMIDAPRIL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
S0202 LEAFLET Tanatril 20150930



PACKAGE LEAFLET: INFORMATION FOR THE USER

TANATRIL 5mg TABLETS
(imidapril hydrochloride)
Your medicine is known by Tanatril 5mg Tablets but will be referred
to as Tanatril throughout the following leaflet.

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.

-

an angiotensin II receptor blocker (ARBs) (also known as
sartans - for example valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related kidney problems.

-

aliskiren

Your doctor may check your kidney function, blood pressure,
and the amount of electrolytes (e.g. potassium) in your blood at
regular intervals.
See also information under the heading Do not take Tanatril

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.


if you are taking any of the following medicines used to treat
high blood pressure:

You must tell your doctor if you think you are (or might become)
pregnant. Tanatril is not recommended in early pregnancy, and
must not be taken if you are more than 3 months pregnant, as it
may cause serious harm to your baby if used at that stage (see
pregnancy section).
Children and adolescents
Tanatril Tablets are not suitable for use in children.
While taking Tanatril

What is in this leaflet

If you develop any of the following symptoms you should let your
doctor know immediately:

1. What Tanatril is and what it is used for



You feel dizzy after your first dose. A few people react to their
first dose or when their dose is increased by feeling dizzy,
weak, faint or sick.



High temperature, sore throat or mouth ulcers (these may be
symptoms of infection caused by lowering of the number of
white blood cells).



Yellowing of the skin and whites of eyes (jaundice) that may be
sign of liver disease.

2. What you need to know before you take Tanatril
3. How to take Tanatril
4. Possible side effects
5. How to store Tanatril
6. Contents of the pack and other information
1. WHAT TANATRIL IS AND WHAT IT IS USED FOR
Tanatril is used to treat high blood pressure (hypertension).
Tanatril is one of a group of medicines called ACE (angiotensinconverting enzyme) inhibitors.
If you have high blood pressure, Tanatril works by widening blood
vessels, so that blood passes through them more easily. Since
blood pressure depends on the diameter of blood vessels, your
blood pressure will be lowered by Tanatril. Also, it will be easier for
your heart to pump blood through the vessels around the body.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANATRIL
Do not take Tanatril

Other medicines and Tanatril
Tell your doctor if you are taking, have recently taken or might take
any other medicines.
Used for Instance in the
treatment of:

Potassium sparing diuretics
(water tablets) (spironolactone,
triameterene or amiloride)

heart failure, liver disease,
certain kidney diseases

Potassium tablets or liquids or
salt substitutes containing
potassium

low blood levels of potassium

if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren

Non-potassium sparing diuretics
(water tablets) (thiazide,
furosemide)

high blood pressure, oedema
(swelling of the fingers, legs,
toes and face)

if you are more than 3 months pregnant. (It is also better to
avoid Tanatril in early pregnancy - see pregnancy section).

Lithium

mania or depression

Non-steroidal anti-Inflammatory
drugs (NSAIDs) (indomethacin,
diflunisal or diclofenac,
celecoxib or valdecoxib and
aspirin)

muscle pain, stiffness and
inflammation (arthritis)

Injectable gold

pain, stiffness and inflammation
(arthritis)

Antihypertensives (such as
methyldopa, clonidine,
moxonidine)

high blood pressure

if you are allergic to imidapril, other ACE inhibitors or any of the
other ingredients of this medicine (listed in section 6)



if you have suffered from angioedema (a serious allergic
reaction that causes swelling of the hands, feet or ankles, face,
lips, tongue and throat and may lead to difficulty with
swallowing or breathing) after taking a similar medicine to
imidapril (ACE inhibitor)



if you or a close family member has suffered from angioedema
before if you have any problem with your kidneys or if you need
to be dialysed





If any of these situations applies to you, do not take Tanatril.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Tanatril

-

You will be closely monitored when you start your treatment or if
your dose is changed. Your doctor will advise you how often you
will need to see him/her.

Medicines:



-

You will need medical check-ups whilst you are taking Tanatril,
which may involve regular blood tests.

if you are dehydrated due to treatment with diuretics (‘water
tablets’), dialysis, a low salt diet or because you have had
strong and prolonged vomiting or diarrhoea. You are more likely
to suffer from a very large drop in your blood pressure
(hypotension) when you start to take tablets and may feel faint
or light-headed
if you have been told that you have a problem with your heart.
Ask your doctor, if you are not sure if this applies to you

-

if you have any liver problems

-

if you suffer from diabetes

Nitroglycerin or other nitrates

heart disease, chest pain

-

if you are taking potassium supplements or potassiumcontaining salt substitutes

diabetes

-

if you are being treated with allopurinol to prevent gout, kidney
stones, or high levels of uric acid

Antidiabetics (insulin), oral
antidiabetics (metformin,
pioglitazone)

-

if you are being treated with procainamide to correct irregular
heartbeats and to slow a rapid heart rate

heart attack, high blood
pressure

-

if you are taking a lithium medicine used for the treatment of
mania or depression

Thrombolytics (clopidogrel);
beta blockers (bisoprolol,
metoprolol)

-

if you are allergic to insect bites and undergo a desensitisation
treatment

depression and mental
disorders

-

if you receive a treatment for your immune system, for example
after a transplant

Tricyclic antidepressants (such
as amitriptyline); neuroleptics
(such as phenothiazines or
butyrophenones)
Rifampicin

tuberculosis (known as TB), and
other mycobacterial infections

-

if you have had a recent kidney transplant

-

if you are having a certain treatment called 'LDL apheresis' to
reduce cholesterol-levels in your blood

-

if you are suffering from a condition called 'cerebrovascular
disease' (narrowing of the blood vessels in the brain)

Antacids (ranitidine,
pantoprazole)

heartburn, sour stomach and
acid indigestion

-

if you have a disease known as 'collagen vascular disease',
such as rheumatoid arthritis

low blood pressure, shock,
heart failure, asthma or allergies

-

if you are undergoing any surgery or receive anaesthetics, tell
your doctor or dentist

-

if your blood pressure is not sufficiently lowered. Medicines of
this type seem to be less effective in persons with black skin.

Sympathomimetics (medicines
that stimulate the central
nervous system) such as
ephedrine, salbutamol (which
may also be found in some
cough/cold remedies) and
noradrenaline or adrenaline

-

if you suffer from sudden swelling of the lips and face, tongue
and throat, neck, possibly also hands and feet, difficulty to
swallow or to breathe, hives or hoarseness ('angioedema’). This
may occur at any time during the treatment. Persons with black
skin may have a higher risk of suffering from this condition. If
you develop such symptoms you should let your doctor know
immediately.

Allopurinol

prevention of gout, treatment of
kidney stones or high levels of
uric acid

Procainamide

irregular heartbeats and to slow
a rapid heart rate

Anaesthetics (agents
suppressing nerve impulses)

used when you undergo
surgery, even at the dentist

Immunosuppressants
(medicines that suppress the
body's immune response)

used e.g. when you have had a
recent organ transplant

Your doctor may need to change your dose and/or to take other
precautions:
If you are taking an angiotensin II receptor blocker (ARB) or
aliskiren (see also information under the headings Do not take
Tanatril and Warnings and precautions.



cough



feeling sick (nausea).

Uncommon side effects
(may affect up to 1 in 100 people):


feeling your heartbeat (palpitations)



narrowing of the blood vessels in the brain (cerebrovascular
disease)



fainting



tingling or numbness in the hands or feet



swelling and irritation inside the nose

Pregnancy



vomiting

You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Tanatril before you become pregnant or as soon as you know you
are pregnant and will advise you to take another medicine instead
of Tanatril. Tanatril is not recommended in early pregnancy, and
must not be taken when more than 3 months pregnant, as it may
cause serious harm to your baby if used after the third month of
pregnancy.



pain in the upper abdomen



indigestion (stomach upset)



bronchitis



viral infection



upper respiratory tract infection



chest pain

Breast-feeding



pain in limbs

Tell your doctor if you are breast-feeding or about to start breastfeeding. Tanatril is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if
you wish to breast-feed, especially if your baby is newborn, or was
born prematurely.

• swelling of the fingers, legs and toes (oedema).
Rare side effects
(may affect up to 1 in 1000 people):


reduction (lowering of number) of white blood cells, which
makes infections more likely

Tanatril may make you feel dizzy or sleepy. Do not drive or operate
machinery until you know if Tanatril affects you.



reduction (lowering of number) of red blood cells, which can
make the skin pale and cause weakness and breathlessness.

Tanatril contains lactose.

Effects on the results of blood tests:

If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

Tanatril may also cause changes in the composition of your blood.
Your doctor will conduct regular blood tests and will explain the
results to you.
The following side effects have also been reported with this
class of medicine:

Driving and using machines

3. HOW TO TAKE TANATRIL
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist, if you are not sure.
Instructions:


Take the tablets about 15 minutes before your meals



Swallow the tablets with plenty of water



Take your tablets at the same time each day

• The tablet can be divided into equal doses
Dosage (adults)
The usual starting dose is 5 mg per day. After 3 weeks your blood
pressure needs to be measured again to check the results. Your
doctor might increase the daily dose to 10 mg or even 20 mg.



blurred vision



disorder of balance; confusion; ringing in the ears



weariness; depression; sleep disorders; impotence



taste disturbance



changes in heart rhythm (faster, irregular); heart attack; strokelike symptoms without lasting damage



increased risk of bleeding or bruising



hives; redness of the skin



hair loss

The doctor may want you to start on 2.5 mg once a day,



shortness of breath; wheezing



Inflammations - for example of the nasal cavities (sinusitis),
tongue (glossitis), liver (hepatitis), pancreas (pancreatitis) or of
the stomach-lining (gastritis)



diarrhoea; constipation; dry mouth



intestinal blockage; swelling of the intestines causing cramping

Your doctor will start your treatment with 2.5 mg once a day and
increase this to 10 mg depending on how you get on.



kidney problems



fever

Tanatril Tablets are not suitable for the use in children.

• muscle pain; joint pain.
Reporting of side effects



if you have mild kidney problems or liver problems,



if you have heart problems, chest pain, problems related to
blood vessels in the brain, low salt and/or fluid levels, or



if there is a risk that your blood pressure could fall suddenly.

Patients over 65 years of age

If you take more Tanatril than you should
If you have accidentally taken more than your prescribed dose,
contact your doctor immediately. Remember to take the pack and
any remaining tablets with you. The most common signs and
symptoms of overdose are fall in blood pressure, shock and stupor
(a state of almost complete lack of consciousness), slower
heartbeat, disturbances in the levels of potassium or other
electrolytes and kidney failure. This can result in a feeling of general
discomfort, feeling your heartbeat or in swelling of the fingers, legs
and toes (oedema).
If you forget to take Tanatril
Simply leave out that dose completely and then take your next dose
at the right time. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Tanatril
Do not stop taking Tanatril, unless your doctor has advised you to
do so. If you stop taking your medicine, your blood pressure may
increase. If your blood pressure becomes too high, it may affect the
function of your heart and kidneys.

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 TANATRIL


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Store in the original package.



Do not use after the expiry date printed on the carton label or
blister strip. The expiry date refers to the last day of that month.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

What Tanatril contains

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



Each tablet contains 5mg of the active ingredient, imidapril
hydrochloride.

It is very important that you immediately contact your doctor
and stop taking Tanatril if you develop any of the following
symptoms:



Tanatril tablets also contain the following: calcium hydrogen
phosphate, pregelatinized starch, lactose monohydrate,
croscarmellose sodium and glycerol distearate.



What Tanatril looks like and contents of the pack

headache; dizziness; light headedness, perhaps along with
impaired vision. This is especially important at the start of
treatment or when the dose is increased

It is a small oblong-shaped tablet with a score line on each side.
Tanatril tablets are available as blister packs of 28 tablets.



difficulty in breathing

Product Licence holder



rash or itching



a serious allergic reaction which causes swelling of your face or
throat (angioedema)



blistering of the skin, mouth, eyes and genitals (toxic epidermal
necrolysis, Stevens-Johnson syndrome)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer



yellowing of the skin or whites of the eyes caused by liver or
blood problems (jaundice).
Tell your doctor or pharmacist, if you develop any of the
following side effects:
Common side effects
(may affect up to 1 in 10 people):


fatigue/sleepiness

This product is manufactured by G.L. Pharma GmbH, 8502
Lannach, Austria.
POM

PL 19488/0202

Leaflet revision date: 30 September 2015
Tanatril is a registered trade mark of Tanabe Seiyaku Co Ltd,
Japan.
S0202 LEAFLET Tanatril 20150930

you develop such symptoms you should let your doctor know
immediately.

S0202 LEAFLET Imidapril tablets 20150930

PACKAGE LEAFLET: INFORMATION FOR THE USER

IMIDAPRIL HYDROCHLORIDE 5mg TABLETS



Your medicine is known by Imidapril Hydrochloride 5mg Tablets but
will be referred to as Imidapril Tablet throughout the following
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.

if you are taking any of the following medicines used to treat
high blood pressure:
-

an angiotensin II receptor blocker (ARBs) (also known as
sartans - for example valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related kidney problems.

-

aliskiren

Your doctor may check your kidney function, blood pressure,
and the amount of electrolytes (e.g. potassium) in your blood at
regular intervals.
See also information under the heading Do not take Imidapril
Tablet
You must tell your doctor if you think you are (or might become)
pregnant. Imidapril Tablet is not recommended in early pregnancy,
and must not be taken if you are more than 3 months pregnant, as it
may cause serious harm to your baby if used at that stage (see
pregnancy section).

What is in this leaflet

Children and adolescents

1. What Imidapril Tablet is and what it is used for

Imidapril Tablet is not suitable for use in children.

2. What you need to know before you take Imidapril Tablet

While taking Imidapril Tablet

3. How to take Imidapril Tablet

If you develop any of the following symptoms you should let your
doctor know immediately:

4. Possible side effects



You feel dizzy after your first dose. A few people react to their
first dose or when their dose is increased by feeling dizzy,
weak, faint or sick.

1. WHAT IMIDAPRIL TABLET IS AND WHAT IT IS USED FOR



Imidapril Tablet is used to treat high blood pressure
(hypertension). Imidapril Tablet is one of a group of medicines
called ACE (angiotensin-converting enzyme) inhibitors.

High temperature, sore throat or mouth ulcers (these may be
symptoms of infection caused by lowering of the number of
white blood cells).



Yellowing of the skin and whites of eyes (jaundice) that may be
sign of liver disease.

5. How to store Imidapril Tablet
6. Contents of the pack and other information

If you have high blood pressure, Imidapril Tablet works by widening
blood vessels, so that blood passes through them more easily.
Since blood pressure depends on the diameter of blood vessels,
your blood pressure will be lowered by Imidapril Tablet. Also, it will
be easier for your heart to pump blood through the vessels around
the body.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANATRIL
Do not take Imidapril Tablet


if you are allergic to imidapril, other ACE inhibitors or any of the
other ingredients of this medicine (listed in section 6)



You will need medical check-ups whilst you are taking Imidapril
Tablet, which may involve regular blood tests.
You will be closely monitored when you start your treatment or if
your dose is changed. Your doctor will advise you how often you
will need to see him/her.
Other medicines and Imidapril Tablet
Tell your doctor if you are taking, have recently taken or might take
any other medicines.
Medicines:

if you have suffered from angioedema (a serious allergic
reaction that causes swelling of the hands, feet or ankles, face,
lips, tongue and throat and may lead to difficulty with
swallowing or breathing) after taking a similar medicine to
imidapril (ACE inhibitor)

Used for instance in the
treatment of:

Potassium sparing diuretics
(water tablets) (spironolactone,
triamterene or amiloride)

heart failure, liver disease,
certain kidney diseases



if you or a close family member has suffered from angioedema
before if you have any problem with your kidneys or if you need
to be dialysed

Potassium tablets or liquids or
salt substitutes containing
potassium

low blood levels of potassium



if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren

Non-potassium sparing diuretics
(water tablets) (thiazide,
furosemide)

high blood pressure, oedema
(swelling of the fingers, legs,
toes and face)



if you are more than 3 months pregnant. (It is also better to
avoid Imidapril Tablet in early pregnancy - see pregnancy
section).

If any of these situations applies to you, do not take Imidapril
Tablet.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Imidapril Tablet
-

-

if you are dehydrated due to treatment with diuretics (‘water
tablets’), dialysis, a low salt diet or because you have had
strong and prolonged vomiting or diarrhoea. You are more likely
to suffer from a very large drop in your blood pressure
(hypotension) when you start to take tablets and may feel faint
or light-headed
if you have been told that you have a problem with your heart.
Ask your doctor, if you are not sure if this applies to you

Lithium

mania or depression

Non-steroidal anti-Inflammatory
drugs (NSAIDs) (indomethacin,
diflunisal or diclofenac,
celecoxib or valdecoxib and
aspirin)

muscle pain, stiffness and
inflammation (arthritis)

Injectable gold

pain, stiffness and inflammation
(arthritis)

Antihypertensives (such as
methyldopa, clonidine,
moxonidine)

high blood pressure

-

if you have any liver problems

Nitroglycerin or other nitrates

heart disease, chest pain

-

if you suffer from diabetes

diabetes

-

if you are taking potassium supplements or potassiumcontaining salt substitutes

Antidiabetics (insulin), oral
antidiabetics (metformin,
pioglitazone)

-

if you are being treated with allopurinol to prevent gout, kidney
stones, or high levels of uric acid

-

If you are being treated with procainamide to correct irregular
heartbeats and to slow a rapid heart rate

Thrombolytics (clopidogrel);
beta blockers (bisoprolol,
metoprolol)

heart attack, high blood
pressure

-

if you are taking a lithium medicine used for the treatment of
mania or depression

depression and mental
disorders

-

if you are allergic to insect bites and undergo a desensitisation
treatment

Tricyclic antidepressants (such
as amitriptyline); neuroleptics
(such as phenothiazines or
butyrophenones)

-

if you receive a treatment for your immune system, for example
after a transplant

Rifampicin

-

if you have had a recent kidney transplant

tuberculosis (known as TB), and
other mycobacterial infections

-

if you are having a certain treatment called 'LDL apheresis' to
reduce cholesterol-levels in your blood

-

Antacids (ranitidine,
pantoprazole)

heartburn, sour stomach and
acid indigestion

if you are suffering from a condition called 'cerebrovascular
disease' (narrowing of the blood vessels in the brain)

-

low blood pressure, shock,
heart failure, asthma or allergies

if you have a disease known as 'collagen vascular disease',
such as rheumatoid arthritis

-

if you are undergoing any surgery or receive anaesthetics, tell
your doctor or dentist

-

if your blood pressure is not sufficiently lowered. Medicines of
this type seem to be less effective in persons with black skin.

Sympathomimetics (medicines
that stimulate the central
nervous system) such as
ephedrine, salbutamol (which
may also be found in some
cough/cold remedies) and
noradrenaline or adrenaline
Allopurinol

-

if you suffer from sudden swelling of the lips and face, tongue
and throat, neck, possibly also hands and feet, difficulty to
swallow or to breathe, hives or hoarseness ('angioedema’). This
may occur at any time during the treatment. Persons with black
skin may have a higher risk of suffering from this condition. If

prevention of gout, treatment of
kidney stones or high levels of
uric acid

Procainamide

irregular heartbeats and to slow
a rapid heart rate

Anaesthetics (agents
suppressing nerve impulses)

used when you undergo
surgery, even at the dentist

Immunosuppressants
(medicines that suppress the
body's immune response)

used e.g. when you have had a
recent organ transplant

Your doctor may need to change your dose and/or to take other
precautions:
If you are taking an angiotensin II receptor blocker (ARB) or
aliskiren (see also information under the headings Do not take
Imidapril Tablet and Warnings and precautions.



cough



feeling sick (nausea).

Uncommon side effects
(may affect up to 1 in 100 people):


feeling your heartbeat (palpitations)



narrowing of the blood vessels in the brain (cerebrovascular
disease)



fainting



tingling or numbness in the hands or feet



swelling and irritation inside the nose

Pregnancy



vomiting

You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Imidapril Tablet before you become pregnant or as soon as you
know you are pregnant and will advise you to take another medicine
instead of Imidapril Tablet. Imidapril Tablet is not recommended in
early pregnancy, and must not be taken when more than 3 months
pregnant, as it may cause serious harm to your baby if used after
the third month of pregnancy.



pain in the upper abdomen



indigestion (stomach upset)



bronchitis



viral infection



upper respiratory tract infection



chest pain

Breast-feeding



pain in limbs

Tell your doctor if you are breast-feeding or about to start breastfeeding. Imidapril Tablet is not recommended for mothers who are
breast-feeding, and your doctor may choose another treatment for
you if you wish to breast-feed, especially if your baby is newborn, or
was born prematurely.

• swelling of the fingers, legs and toes (oedema).
Rare side effects
(may affect up to 1 in 1000 people):


reduction (lowering of number) of white blood cells, which
makes infections more likely

Imidapril Tablet may make you feel dizzy or sleepy. Do not drive or
operate machinery until you know if Imidapril Tablet affects you.



reduction (lowering of number) of red blood cells, which can
make the skin pale and cause weakness and breathlessness.

Imidapril Tablet contains lactose.

Effects on the results of blood tests:

If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

Imidapril Tablet may also cause changes in the composition of your
blood. Your doctor will conduct regular blood tests and will explain
the results to you.
The following side effects have also been reported with this
class of medicine:

Driving and using machines

3. HOW TO TAKE IMIDAPRIL TABLET
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist, if you are not sure.
Instructions:


Take the tablets about 15 minutes before your meals



Swallow the tablets with plenty of water



Take your tablets at the same time each day

• The tablet can be divided into equal doses
Dosage (adults)



blurred vision



disorder of balance; confusion; ringing in the ears



weariness; depression; sleep disorders; impotence



taste disturbance



changes in heart rhythm (faster, irregular); heart attack; strokelike symptoms without lasting damage

The usual starting dose is 5 mg per day. After 3 weeks your blood
pressure needs to be measured again to check the results. Your
doctor might increase the daily dose to 10 mg or even 20 mg.



increased risk of bleeding or bruising



hives; redness of the skin



hair loss

The doctor may want you to start on 2.5 mg once a day,



shortness of breath; wheezing



Inflammations - for example of the nasal cavities (sinusitis),
tongue (glossitis), liver (hepatitis), pancreas (pancreatitis) or of
the stomach-lining (gastritis)



diarrhoea; constipation; dry mouth



intestinal blockage; swelling of the intestines causing cramping

Your doctor will start your treatment with 2.5 mg once a day and
increase this to 10 mg depending on how you get on.



kidney problems



fever

Imidapril Tablet is not suitable for the use in children.

• muscle pain; joint pain.
Reporting of side effects



if you have mild kidney problems or liver problems,



if you have heart problems, chest pain, problems related to
blood vessels in the brain, low salt and/or fluid levels, or



if there is a risk that your blood pressure could fall suddenly.

Patients over 65 years of age

If you take more Imidapril Tablet than you should
If you have accidentally taken more than your prescribed dose,
contact your doctor immediately. Remember to take the pack and
any remaining tablets with you. The most common signs and
symptoms of overdose are fall in blood pressure, shock and stupor
(a state of almost complete lack of consciousness), slower
heartbeat, disturbances in the levels of potassium or other
electrolytes and kidney failure. This can result in a feeling of general
discomfort, feeling your heartbeat or in swelling of the fingers, legs
and toes (oedema).
If you forget to take Imidapril Tablet
Simply leave out that dose completely and then take your next dose
at the right time. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Imidapril Tablet
Do not stop taking Imidapril Tablet, unless your doctor has advised
you to do so. If you stop taking your medicine, your blood pressure
may increase. If your blood pressure becomes too high, it may
affect the function of your heart and kidneys.

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 IMIDAPRIL TABLET


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Store in the original package.



Do not use after the expiry date printed on the carton label or
blister strip. The expiry date refers to the last day of that month.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

What Imidapril Tablet contains

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



Each tablet contains 5mg of the active ingredient, imidapril
hydrochloride.

It is very important that you immediately contact your doctor
and stop taking Imidapril Tablet if you develop any of the
following symptoms:



Imidapril Tablet also contains the following: calcium hydrogen
phosphate, pregelatinized starch, lactose monohydrate,
croscarmellose sodium and glycerol distearate.



What Imidapril Tablet looks like and contents of the pack

headache; dizziness; light headedness, perhaps along with
impaired vision. This is especially important at the start of
treatment or when the dose is increased

It is a small oblong-shaped tablet with a score line on each side.
Imidapril Tablet is available as blister packs of 28 tablets.



difficulty in breathing

Product Licence holder



rash or itching



a serious allergic reaction which causes swelling of your face or
throat (angioedema)



blistering of the skin, mouth, eyes and genitals (toxic epidermal
necrolysis, Stevens-Johnson syndrome)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer



yellowing of the skin or whites of the eyes caused by liver or
blood problems (jaundice).
Tell your doctor or pharmacist, if you develop any of the
following side effects:
Common side effects
(may affect up to 1 in 10 people):


fatigue/sleepiness

This product is manufactured by G.L. Pharma GmbH, 8502
Lannach, Austria.
POM

PL 19488/0202

Leaflet revision date: 30 September 2015
S0202 LEAFLET Imidapril tablets 20150930

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