TANATRIL 5MG TABLETS
Active substance(s): IMIDAPRIL HYDROCHLORIDE
Information for the patient
Tanatril 5mg, 10 mg & 20mg Tablets
Active substance: Imidapril
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
• 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 Tanatril is and what it is used for
2. What you need to know before you take
3. How to take Tanatril
4. Possible side effects
5. How to store Tanatril
6. Contents of the pack and other information
What Tanatril is and what it is
Tanatril is used to treat high blood pressure
(hypertension). Tanatril is one of a group of
medicines called ACE (angiotensin-converting
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.
What you need to know before
you take Tanatril
Do not take Tanatril
• 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
• if you have diabetes or impaired kidney function
and you are treated with a blood pressure
lowering medicine containing aliskiren
• 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
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
• 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
• 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
• if you are taking potassium supplements or
potassium-containing salt substitutes
• 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
• if you are taking a lithium medicine used for the
treatment of mania or depression
• if you are allergic to insect bites and undergo a
• if you receive a treatment for your immune system,
for example after a transplant
• 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)
• 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
• 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.
• if you are taking any of the following medicines
used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also
known as sartans - for example valsartan,
telmisartan, irbesartan), in particular if you have
diabetes-related kidney problems.
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
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
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.
• 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.
Used for instance in the treatment of:
Potassium sparing diuretics (water tablets) (spironolactone,
triamterene or amiloride)
heart failure, liver disease, certain kidney diseases
Potassium tablets or liquids or salt substitutes containing
low blood levels of potassium
Non-potassium sparing diuretics (water tablets) (thiazide,
legs, toes and face)
mania or depression
valdecoxib and aspirin)
Antihypertensives (such as methyldopa, clonidine,
high blood pressure
Nitroglycerin or other nitrates
heart disease, chest pain
Antidiabetics (insulin), oral antidiabetics (metformin,
Thrombolytics (clopidogrel); beta blockers (bisoprolol,
heart attack, high blood pressure
Tricyclic antidepressants (such as amitriptyline); neuroleptics
(such as phenothiazines or butyrophenones)
depression and mental disorders
tuberculosis (known as TB), and other mycobacterial
Antacids (ranitidine, pantoprazole)
heartburn, sore stomach and acid indigestion
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
low blood pressure, shock, heart failure, asthma or
prevention of gout, treatment of kidney stones or high
levels of uric acid
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
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.
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.
Tell your doctor if you are breast-feeding or about
to start breast-feeding. 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 new-born, or was born
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.
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.
• Take the tablets about 15 minutes before your
• Swallow the tablets with plenty of water
• Take your tablets at the same time each day
• The tablet can be divided into equal doses
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.
The doctor may want you to start on
2.5 mg once a day,
• if you have mild kidney problems or liver
• 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
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.
Tanatril Tablets are not suitable for the use
If you take more Tanatril than you should
If you have accidentally taken more than your
prescribed dose, contact your doctor
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
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 have any further questions on the use of
this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
It is very important that you immediately
contact your doctor and stop taking Tanatril if
you develop any of the following symptoms:
• headache; dizziness; light headedness, perhaps
along with impaired vision. This is especially
important at the start of treatment or when the
dose is increased
• difficulty in breathing
• 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
• 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):
• 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
• tingling or numbness in the hands or feet
• swelling and irritation inside the nose
• pain in the upper abdomen
• indigestion (stomach upset)
• viral infection
• upper respiratory tract infection
• chest pain
• pain in limbs
• swelling of the fingers, legs and toes
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
• weariness; depression; sleep disorders;
• taste disturbance
• changes in heart rhythm(faster, irregular);
heart attack; stroke-like symptoms without
• increased risk of bleeding or bruising
• hives; redness of the skin
• hair loss
• shortness of breath; wheezing
• Inflammations- for example of the nasal
cavities (sinusitis), tongue (glossitis), liver
(hepatitis), pancreas (pancreatitis) or of the
• diarrhoea; constipation; dry mouth
• intestinal blockage; swelling of the intestines
• kidney problems
• muscle pain; joint pain.
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
How to store Tanatril
Keep this medicine out of the sight and reach of
Do not store your aluminium/aluminium blister
packed tablets above 30ºC.
Do not store your PVC/PVdC/aluminium blister
packed tablets above 25ºC.
Keep them in the pack in which they were
supplied to you.
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.
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
Contents of the pack and other
What Tanatril contains
• The active substance is imidapril (as
hydrochloride). Each tablet contains 5 mg,
10 mg or 20 mg of imidapril hydrochloride.
• The other ingredients are calcium hydrogen
phosphate (anhydrous), maize starch
(pregelatinised), lactose monohydrate,
croscarmellose sodium and glycerol distearate.
What Tanatril looks like and contents of the
Tanatril tablets are off-white in colour and are
biconvex in shape with a plane edge and a
break line on both sides.
Your medicine is available in aluminium/
aluminium or PVC/PVdC/aluminium blister
packs containing 7, 10, 14, 15, 20, 28, 30, 50,
56, 84, 90, 100, and 1000 tablets
Not all packaging material or pack sizes may be
Marketing Authorisation Holder:
Mitsubishi Tanabe Pharma Europe Limited,
6th Floor, Dashwood House,
69 Old Broad Street,
London, EC2M 1QS,
Central Pharma (Contract Packing) Limited
Caxton Road, Bedford,
MK41 0XZ, United Kingdom.
This medicinal product is authorised in the
Member States of the EEA under the
Tanatril: Austria, France, Greece, United
Cardipril: Portugal. Hipertene: Spain.
This leaflet was last revised in 04/2016
Is this leaflet hard to see or read?
For help contact:
Telephone number: 0207 382 9000
Email address: email@example.com
Mitsubishi Tanabe Pharma Europe Ltd
14 March 2016 — (as Issue 01)
148 x 400 mm
United Kingdom - (UK)
3 mm (TBC)
QRD Doc Ref.
uk-pl-0260 EN 5-10-20-tracked V2.0 April 2016.doc
Client Job No.:
Main title: (custom EPS graphic)
Sub-titles: Helvetica Neue Bold— 10 pt
Body copy: Helvetica Neue - Regular — 8 pt
Black - K
PD-UK-TAN-PIL0000-v02 - (**
25 April 2016
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.