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IMIDAPRIL HYDROCHLORIDE 10MG TABLETS

Active substance(s): IMIDAPRIL HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Tanatril® 10mg Tablets/
Imidapril Hydrochloride 10mg Tablets
(imidapril hydrochloride)
Your medicine is available using the above two
names but will be referred to as Tanatril throughout
the remainder of this leaflet.
Other strengths are also available.



if you are more than 3 months pregnant. (It is also
better to avoid Tanatril in early pregnancy - see
pregnancy section).
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
 if you are dehydrated due to treatment with diuretics
(‘water tablets’), dialysis, a low salt diet or
because you have had strong and prolonged
Read all of this leaflet carefully before you start taking
vomiting or diarrhoea. You are more likely to suffer
this medicine because it contains important information
from a very large drop in your blood pressure
for you.
(hypotension) when you start to take tablets and
 Keep this leaflet. You may need to read it again.
may feel faint or light-headed
 If you have any further questions, ask your
 if you have been told that you have a problem with
doctor or pharmacist.
your heart. Ask your doctor, if you are not sure if this
 This medicine has been prescribed for you only. Do
applies to you
not pass it on to others. It may harm them, even if
 if you have any liver problems
their signs of illness are the same as yours.
 if you suffer from diabetes
 If you get any side effects talk to your doctor or
 if you are taking potassium supplements or
pharmacist. This includes any possible side effects
potassium-containing salt substitutes
not listed in this leaflet. See section 4.
 if you are being treated with allopurinol to prevent
What is in this leaflet
gout, kidney stones, or high levels of uric acid
1. What Tanatril is and what it is used for
 if you are being treated with procainamide to correct
2. What you need to know before you take Tanatril
irregular heartbeats and to slow a rapid heart rate
3. How to take Tanatril
 if you are taking a lithium medicine used for the
4. Possible side effects
treatment of mania or depression
5. How to store Tanatril
 if you are allergic to insect bites and undergo a
6. Contents of the pack and other information
desensitisation treatment
 if you receive a treatment for your immune system,
1. What Tanatril is and what it is used for
for example after a transplant
Tanatril is used to treat high blood pressure
 if you have had a recent kidney transplant
(hypertension). Tanatril is one of a group of medicines
 if you are having a certain treatment called ‘LDL
called ACE (angiotensin-converting enzyme) inhibitors.
apheresis’ to reduce cholesterol-levels in your blood
 if you are suffering from a condition called
If you have high blood pressure, Tanatril works by
‘cerebrovascular disease’ (narrowing of the blood
widening blood vessels, so that blood passes through
vessels in the brain)
them more easily. Since blood pressure depends on the
 if you have a disease known as ‘collagen vascular
diameter of blood vessels, your blood pressure will be
disease’, such as rheumatoid arthritis
lowered by Tanatril. Also, it will be easier for your heart
 if you are undergoing any surgery or receive
to pump blood through the vessels around the body.
anaesthetics, tell your doctor or dentist
2. What you need to know before you take
 if your blood pressure is not sufficiently lowered.
Medicines of this type seem to be less effective in
Tanatril
persons with black skin
Do not take Tanatril
 if you are allergic to imidapril, other ACE inhibitors or  if you suffer from sudden swelling of the lips and
face, tongue and throat, neck, possibly also
any of the other ingredients of this medicine (listed in
hands and feet, difficulty to swallow or to
section 6)
breathe, hives or hoarseness (‘angioedema’). This
 if you have suffered from angioedema (a serious
may occur at any time during the treatment. Persons
allergic reaction that causes swelling of the
with black skin may have a higher risk of suffering
hands, feet or ankles, face, lips, tongue and
from this condition. If you develop such symptoms
throat and may lead to difficulty with swallowing
you should let your doctor know immediately.
or breathing) after taking a similar medicine to
 if you are taking any of the following medicines used
imidapril (ACE inhibitor)
to treat high blood pressure:
 if you or a close family member has suffered from
- an angiotensin II receptor blocker (ARBs) (also
angioedema before if you have any problem with
known as sartans - for example valsartan,
your kidneys or if you need to be dialysed
telmisartan, irbesartan), in particular if you have
 if you have diabetes or impaired kidney function and
diabetes-related kidney problems.
you are treated with a blood pressure lowering
- aliskiren
medicine containing aliskiren
S0098-28-PL-PIL-11.11.2015

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
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.





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.

You will need medical check-ups whilst you are taking
Tanatril, 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 Tanatril
Tell your doctor if you are taking, have recently taken or
might take any other medicines.

While taking Tanatril
If you develop any of the following symptoms you
should let your doctor know immediately:
 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.

Medicines:

Used for instance in the treatment of:

Potassium sparing diuretics (water tablets)
(spironolactone, triamterene or amiloride)
Potassium tablets or liquids or salt substitutes containing
potassium
Non-potassium sparing diuretics (water tablets)
(thiazide,furosemide)
Lithium
Non-steroiodal anti-inflammatory drugs (NSAIDs)
(indomethacin, diflunisal or diclofenac, celecoxib or
valdecoxib and asprin)
Injectable gold

heart failure, liver disease, certain kidney
diseases
low blood levels of potassium

Antihypertensives (such as methyldopa,
clonidine,moxonidine)
Nitroglycerin or other nitrates
Antidiabetics (insulin), oral antidiabetics
(metformin,pioglitazone)
Thrombolytics (clopidogrel); beta blockers
(bisoprolol,metoprolol)
Tricyclic antidepressants (such as amitriptyline);
neuroleptics(such as phenothiazines or butyrophenones)
Rifampicin

high blood pressure

Antacids (ranitidine, pantoprazole)
Sympathomimetics (medicines that stimulate the central
nervous system) such as ephedrine, salbutamol
(whichmay also be found in some cough/cold remedies)
andnoradrenaline or adrenaline
Allopurinol
Procainamide
Anaesthetics (agents suppressing nerve impulses)
Immunosuppressants (medicines that suppress the
body’simmune response)

high blood pressure, oedema (swelling of
the fingers, legs, toes and face)
mania or depression
muscle pain, stiffness and inflammation
(arthritis)
pain, stiffness and inflammation (arthritis)

heart disease, chest pain
diabetes
heart attack, high blood pressure
depression and mental disorders
tuberculosis (known as TB), and other
mycobacterial infections
heartburn, sour stomach and acid
indigestion
low blood pressure, shock, heart failure,
asthma or allergies

prevention of gout, treatment of kidney
stones or high levels of uric acid
irregular heartbeats and to slow a rapid
heart rate
used when you undergo surgery, even at
the dentist
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

Pregnancy
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.

Breast-feeding
Tell your doctor if you are breast-feeding or about to
start breast-feeding. Tanatril 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.

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

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

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 5mg 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 10mg or even 20mg.

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





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

Uncommon side effects

5. How to store Tanatril

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.

(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
 vomiting
 pain in the upper abdomen
 indigestion (stomach upset)
 bronchitis
 viral infection
 upper respiratory tract infection
 chest pain
 pain in limbs
 swelling of the fingers, legs and toes (oedema)

Keep out of the sight and reach of children.
Do not store your tablets above 30ºC. Store in the
original package. Protect from moisture.

Tanatril Tablets are not suitable for the use in
children.

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.

6. Contents of the pack and other
information
What Tanatril contains


Rare side effects
(may affect up to 1 in 1000 people):
 reduction (lowering of number) of white blood cells,
which makes infections more likely
 reduction (lowering of number) of red blood cells,
which can make the skin pale and cause weakness
and breathlessness.
Effects on the results of blood tests:
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:
 blurred vision
 disorder of balance; confusion; ringing in the ears
4. Possible side effects
 weariness; depression; sleep disorders; impotence
Like all medicines, this medicine can cause side effects,  taste disturbance
although not everybody gets them.
 changes in heart rhythm (faster, irregular); heart
attack; stroke-like symptoms without lasting damage
It is very important that you immediately contact
 increased risk of bleeding or bruising
your doctor and stop taking Tanatril if you develop
 hives; redness of the skin
any of the following symptoms:
 hair loss
 headache; dizziness; light headedness, perhaps
 shortness of breath; wheezing
along with impaired vision. This is especially
 Inflammations – for example of the nasal cavities
important at the start of treatment or when the
(sinusitis), tongue (glossitis), liver (hepatitis),
dose is increased
pancreas (pancreatitis) or of the stomach-lining
 difficulty in breathing
(gastritis)
 rash or itching
 diarrhoea; constipation; dry mouth
 a serious allergic reaction which causes swelling of
 intestinal blockage; swelling of the intestines causing
your face or throat (angioedema)
cramping
 blistering of the skin, mouth, eyes and genitals (toxic
 kidney problems
epidermal necrolysis, Stevens-Johnson syndrome)
 fever
 yellowing of the skin or whites of the eyes caused by
 muscle pain; joint pain.
liver or blood problems (jaundice).
Reporting of side effects
Tell your doctor or pharmacist, if you develop any
If you get any side effects, talk to your doctor,
of the following side effects:
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
Common side effects
effects directly via the Yellow Card Scheme at:
(may affect up to 1 in 10 people):
www.mhra.gov.uk/yellowcard.
 fatigue/sleepiness
By reporting side effects you can help provide more
 cough
information on the safety of this medicine.
 feeling sick (nausea).
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Do not use Tanatril after the expiry date, which is stated
on the carton and blister. The expiry date refers to the
last day of that month.
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.



The active substance is imidapril hydrochloride.
Each tablet contains 10mg of imidapril
hydrochloride.
The other ingredients are calcium hydrogen
phosphate (anhydrous), maize starch
(pregelatinised), lactose monohydrate,
croscarmellose sodium and glycerol
palmitostearate.

What Tanatril looks like and contents of the
pack
Tantril Tablets are off-white, capsule shaped, biconvex tablets with a plane edge, scored on both
sides.
Your medicine is available in blister packs containing
28 tablets per pack.
Manufacturer: Valeant Sp. z o.o. sp. j.
ul. Przemysłowa 2
35-959 Rzeszów, Poland
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon,
London, NW9 6AQ.
PL 33902/0098

POM

Leaflet revised: 11/11/2015
Tanatril® is a registered trademark of Mitsubishi
Tanabe Pharma Corporation.
S0098-28-PL-PIL-11.11.2015

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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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