TANATRIL 5MG TABLETS

Active substance: IMIDAPRIL HYDROCHLORIDE

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567_FR01866-V3_TANATRIL 07/07/14 11:42 Page1

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Package leaflet:
Tanatril® 5mg, 10 mg & 20mg Tablets
Active substance: Imidapril
Read all of this leaflet carefully before you
start taking this medicine.
• 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 symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
In this leaflet
1. What Tanatril is and what it is used for
2. Before you take Tanatril
3. How to take Tanatril
4. Possible side effects
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.
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’
• 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 dyalised
• 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.

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 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
• 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
• 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.

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

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

legs, toes and face)

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).

Lithium

mania or depression

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:
• 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

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

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_FR01866-V3_TANATRIL 07/07/14 11:42 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.
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 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 affects you.
Important informations 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 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

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

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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
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 the following side effects:
Common side effects
(affecting less than 1 in 10 people):
• fatigue/sleepiness
• cough
• feeling sick (nausea).

Uncommon side effects
(affecting less than 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)
Rare side effects
(affecting less than 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
• weariness; depression; sleep disorders;
impotence
• taste disturbance

• 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
• 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
• kidney problems
• fever
• muscle pain; joint pain.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor of pharmacist.

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How to store Tanatril

Keep out of the reach and sight of children.
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.
Medicines should not be disposed of via
wastewater of hoursehold waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

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Further Informations

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
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 marketed.
Marketing Authorisation Holder:
Mitsubishi Tanabe Pharma Europe Limited,
6th Floor, Dashwood House,
69 Old Broad Street,
London, EC2M 1QS,
United Kingdom.
Manufacturer:
Chiesi Limited,
Cheadle Royal Business Park,
Highfield
Cheadle SK8 3GY
This leaflet was last revised in 06/2014
Is this leaflet hard to see or read ?
0161 488 5555 for help.
FR01866.V3 / CP0030/7

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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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