TANATRIL 5MG TABLETS

Active substance: IMIDAPRIL HYDROCHLORIDE

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567_01866_V2_TANATRIL_567_01866_V2 21/10/10 11:41 Page1

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Tanatril® 5 mg, 10 mg & 20 mg Tablets
Active substance: Imidapril
taking this medicine.




If you have any further questions, ask your doctor
or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.



please tell your doctor or pharmacist.

1. What Tanatril is and what it is used for
2. Before you take Tanatril
3. How to take Tanatril
4.
5. How to store Tanatril
6. Further information

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 (angiotensin-converting
enzyme) inhibitors.

Take special care with 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
vomiting or diarrhoea. You are more likely

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.



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Before you take Tanatril

Do not take Tanatril
• if you are allergic (hypersensitive) to imidapril,
other ACE inhibitors or any of the other
ingredients of Tanatril. These are listed in
section 6 ‘Further Information’

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











angioedema before
if you have any problem with your kidneys
or if you need to be dialysed
• 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.


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
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 desensitisation treatment
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






‘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





ered.
in persons with black skin.
sudden swelling of the lips
and face, tongue and throat, neck, possibly
breathe, hives or hoarseness (‘angioedema’).
This may occur at any time during the treatment.
Persons with black skin may have a higher risk

such symptoms you should let your doctor know
immediately.
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).
Tanatril Tablets are not suitable for the use in
children.

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


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.


Taking other medicines
Please tell your doctor if you are taking or have recently taken any of the following medicines, or other
medicines including those obtained without prescription.
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
potassium

low blood levels of potassium

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

legs, toes and face)

Lithium

mania or depression

valdecoxib and aspirin)
Injectable gold
Antihypertensives (such as methyldopa, clonidine,
moxonidine)

high blood pressure

Nitroglycerin or other nitrates

heart disease, chest pain

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

diabetes

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

heart attack, high blood pressure

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

depression and mental disorders

Rifampicin

tuberculosis (known as TB), and other mycobacterial
infections

Antacids (ranitidine, pantoprazole)

heartburn, sour 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
allergies

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

567_01866_V2_TANATRIL_567_01866_V2 21/10/10 11:41 Page2

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.
Breastfeeding
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 breastfeed, 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
Important information about some of the
ingredients of Tanatril
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.

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How to take Tanatril

Always take Tanatril exactly as your doctor has told
you. You must 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.

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.
The doctor may want you to start on 2.5 mg
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
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 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 heart beat, 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
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



100):




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

4








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













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)
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





fatigue/sleepiness
cough
feeling sick (nausea).




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






changes in heart rhythm (faster, irregular); heart
attack; stroke-like symptoms without lasting
damage
increased risk of bleeding or bruising
hives; redness of the skin
hair loss
shortness of breath; wheezing









(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
kidney problems
fever
muscle pain; joint pain.

Further information

What Tanatril contains
• The active substance is imidapril (as
hydrochloride). Each tablet contains 5mg, 10mg
or 20mg 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 pack
biconvex in shape with a plane edge and a break
line on both sides.
Your medicine is available in blister packs containing
28 tablets per pack.



please tell your doctor or pharmacist.



6

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.

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.

reported with this class of medicine:
• blurred vision
• disorder of balance; confusion; ringing in the ears
• weariness; depression; sleep disorders; impotence
• taste disturbance

5

How to store Tanatril

Keep out of the reach and sight of children.
Do not store your tablets above 30ºC. Keep them
in the pack in which they were supplied to you.
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.

Marketing Authorisation Holder:
Mitsubishi Pharma Europe Limited,
6th Floor, Dashwood House,
69 Old Broad Street,
London, EC2M 1QS,
United Kingdom.
Manufacturer:
Chiesi Limited,
Cheadle Royal Business Park,
Cheadle SK8 3GY
in 08/2010

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Phone 0161 488 488 5555
Phone 0161 5555 for help.for help.

CP0030/4
01866 V2/CP0030/6

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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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