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TELMISARTAN AMNEAL 20MG TABLETS

Active substance(s): TELMISARTAN

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Telmisartan - PIL - UK

Review - 4

5 mm

What is in this leaflet:
1. What Telmisartan is and what it
is used for
2. What you need to know before
you take Telmisartan
3. How to take Telmisartan
4. Possible side effects
5. How to store Telmisartan
6. Contents of the pack and other
information

1. What Telmisartan is
and what it is used for
Telmisartan belongs to a class of
medicines known as angiotensin
II receptor antagonists.
Angiotensin II is a substance
produced in your body which
causes your blood vessels to
narrow, thus increasing your
blood pressure. Telmisartan
blocks the effect of angiotensin
II so that the blood vessels relax,
and your blood pressure is

Talk to your doctor before taking
Telmisartan:
• if you are taking any of the
following medicines used to
treat high blood pressure:
- an ACE-inhibitor (for
example enalapril, lisinopril,
ramipril), in particular if you
have diabetes-related kidney
problems.
- aliskiren
• if you are taking digoxin.
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 Telmisartan”
You must tell your doctor if you
think you are (or might become)
pregnant. Telmisartan 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

Do not take Telmisartan
• if you are allergic to
telmisartan or any other
ingredients of this medicine
(listed in section 6).
• if you are more than 3
months pregnant. (It is also
better to avoid Telmisartan
in early pregnancy – see
pregnancy section.)
• if you have severe liver
problems such as cholestasis
or biliary obstruction
(problems with the drainage
of the bile from the liver and
gall bladder) or any other
severe liver disease.
• if you have diabetes or
impaired kidney function and
you are treated with a blood
pressure lowering medicine
containing aliskiren .
If any of the above applies to you,
tell your doctor or pharmacist

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Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if
you think you are (or might
become) pregnant. Your doctor
will normally advise you to stop
taking Telmisartan before you
become pregnant or as soon as
you know you are pregnant and
will advise you to take another
medicine instead of Telmisartan.
Telmisartan 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. Telmisartan 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
Some people feel dizzy or tired
when taking Telmisartan. If you
feel dizzy or tired, do not drive or
operate machinery.

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2. What you need to
know before you take
Telmisartan

The effect of Telmisartan may be
reduced when you take NSAIDs
(non steroidal anti-inflammatory
medicines, e.g. aspirin or
ibuprofen) or corticosteroids.
Telmisartan may increase
the blood pressure lowering
effect of other medicines used
to treat high blood pressure
or of medicines with blood
pressure lowering potential
(e.g. baclofen, amifostine).
Furthermore, low blood pressure
may be aggravated by alcohol,
barbiturates, narcotics or
antidepressants. You may notice
this as dizziness when standing
up. You should consult with your
doctor if you need to adjust the
dose of your other medicine while
taking Telmisartan.

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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.

(see pregnancy section).
In case of surgery or anaesthesia,
you should tell your doctor that
you are taking telmisartan.
Telmisartan may be less effective
in lowering the blood pressure in
black patients.
Children and adolescents
The use of Telmisartan in children
and adolescents up to the age of
18 years is not recommended.
Other medicines and
Telmisartan
Tell your doctor or pharmacist
if you are taking, have recently
taken or might take any other
medicines. Your doctor may need
to change the dose of these
other medicines or take other
precautions. In some cases you
may have to stop taking one
of the medicines. This applies
especially to the medicines listed
below taken at the same time
with Telmisartan:
• Lithium containing medicines
to treat some types of
depression.
• Medicines that may increase
blood potassium levels
such as salt substitutes
containing potassium,
potassium-sparing diuretics
(certain ‚water tablets‘),
ACE inhibitors, angiotensin
II receptor antagonists,
NSAIDs (non steroidal antiinflammatory medicines, e.g.
aspirin or ibuprofen), heparin,
immunosuppressives (e.g.
cyclosporin or tacrolimus),
and the antibiotic
trimethoprim.
• Diuretics (‚water tablets‘),
especially if taken in
high doses together with
Telmisartan, may lead to
excessive loss of body water
and low blood pressure
(hypotension).
• If you are taking an ACEinhibitor or aliskiren (see
also information under
the headings “Do not take
Telmisartan” and “Warnings
and precautions”).
• digoxin.

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Telmisartan 20mg, tablet
Telmisartan 40mg, tablet
Telmisartan 80mg, tablet

before taking Telmisartan.
Warnings and precautions
Talk to your doctor if you are
suffering or have ever suffered
from any of the following
conditions or illnesses:
• Kidney disease or kidney
transplant.
• Renal artery stenosis
(narrowing of the blood
vessels to one or both
kidneys).
• Liver disease.
• Heart trouble.
• Raised aldosterone levels
(water and salt retention
in the body along with
imbalance of various blood
minerals).
• Low blood pressure
(hypotension), likely to
occur if you are dehydrated
(excessive loss of body
water) or have salt deficiency
due to diuretic therapy
(‚water tablets‘), low-salt
diet, diarrhoea, or vomiting.
• Elevated potassium levels in
your blood.
• Diabetes.

Size: 255 x 210 mm

Package leaflet: Information
for the user

lowered.
Telmisartan is used to treat
essential hypertension (high
blood pressure) in adults.
‘Essential’ means that the high
blood pressure is not caused by
any other condition.
High blood pressure, if not
treated, can damage blood
vessels in several organs, which
could lead sometimes to heart
attack, heart or kidney failure,
stroke, or blindness. There are
usually no symptoms of high
blood pressure before damage
occurs. Thus it is important to
regularly measure blood pressure
to verify if it is within the normal
range.
Telmisartan is also used to
reduce cardiovascular events (i.e.
heart attack or stroke) in adults
who are at risk because they
have a reduced or blocked blood
supply to the heart or legs, or
have had a stroke or have high
risk diabetes. Your doctor can
tell you if you are at high risk for
such events.

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Telmisartan - PIL - UK

Review - 4

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Like all medicines, this medicine
can cause side effects, although
not everybody gets them.
Some side effects can be
serious and need immediate
medical attention:
You should see your doctor
immediately if you experience any
of the following symptoms:
Sepsis* (often called „blood
poisoning“, is a severe infection
with whole-body inflammatory
response), rapid swelling of the
skin and mucosa (angioedema);
these side effects are rare (may
affect up to 1 in 1,000 people)
but are extremely serious and
patients should stop taking the
medicine and see their doctor
immediately. If these effects are
not treated they could be fatal.
Possible side effects of
Telmisartan:
Common side effects (may
affect up to 1 in 10 people):
Low blood pressure (hypotension)
in users treated for reduction of
cardiovascular events.
Uncommon side effects (may
affect up to 1 in 100 people):
• urinary tract infections,
• upper respiratory tract
infections (e.g. sore throat,
inflamed sinuses, common
cold),
• deficiency in red blood cells
(anaemia),
• high potassium levels,
• difficulty falling asleep,
• feeling sad (depression),
• fainting (syncope),
• feeling of spinning (vertigo),
• slow heart rate (bradycardia),
• low blood pressure

eczema (a skin disorder),
redness of skin,
hives (urticaria),
severe drug rash,
joint pain (arthralgia),
pain in extremity,
tendon pain,
flu-like-illness,
decreased haemoglobin (a
blood protein),
• increased levels of uric acid,
• increased hepatic enzymes
or creatine phosphokinase in
the blood.
Very rare side effects (may
affect up to 1 in 10,000 people):
Progressive scarring of lung
tissue (interstitial lung disease)**.
* The event may have happened
by chance or could be related
to a mechanism currently not
known.
**Cases of progressive scarring
of lung tissue have been reported
during intake of telmisartan.
However, it is not known whether
telmisartan was the cause.
Reporting of side effects:
If you get any side effects, talk to
your doctor or pharmacist. 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.

What Telmisartan contains
The active substance is
telmisartan.
Telmisartan 20mg, Tablet
contains 20 mg telmisartan.
Telmisartan 40mg, Tablet
contains 40 mg telmisartan.
Telmisartan 80mg, Tablet
contains 80 mg telmisartan.
The other ingredients are
povidone (K25), meglumine,
sodium hydroxide, mannitol
(E421), talc and magnesium
stearate.
What Telmisartan looks like
and contents of the pack
Telmisartan 20mg, Tablet: White
to off-white, round shaped,
uncoated tablet, debossed with
‘AN’ on one side and ‘291’ on
other side.
Telmisartan 40mg, Tablet:
White to off-white, modified
capsule shaped, uncoated tablet,
debossed with ‘AN’ on one side
and ‘292’ on other side.
Telmisartan 80mg, Tablet:
White to off-white, modified
capsule shaped, uncoated tablet,
debossed with ‘AN293’ on one
side and plain on other side.
Telmisartan is available in blister
packs containing 28, 56 and 98
tablets.
Not all pack sizes may be
marketed in your country.

5. How to store
Telmisartan

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4. Possible side effects

6. Contents of the pack
and other information











Marketing Authorisation
Holder and Manufacturer

Keep this medicine out of the
sight and reach of children.
Do not use this medicine after
the expiry date which is stated on
the carton after “EXP”. The expiry
date refers to the last day of that
month.
This medicine does not require
any special storage conditions.
Do not throw away any 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.

Marketing Authorisation
Holder:
Amneal Pharma Europe Limited
MATHESON, 70 sir John
Rogerson’s Quay,
Dublin 2, Ireland
Manufacturer:
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
This leaflet was last revised
in 03/2015..

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Always take Telmisartan exactly
as your doctor has told you.
Check with your doctor or
pharmacist if you are not sure.
The recommended dose of
Telmisartan is one tablet a day.
Try to take the tablet at the same
time each day.
You can take Telmisartan with or
without food. The tablets should
be swallowed with some water
or other non-alcoholic drink.
It is important that you take
Telmisartan every day until your
doctor tells you otherwise. If you
have the impression that the
effect of Telmisartan is too strong
or too weak, talk to your doctor or
pharmacist.
For treatment of high blood
pressure, the usual dose of
Telmisartan for most patients is
one 40 mg tablet once a day to
control blood pressure over the
24-hour period. Your doctor may
recommend a lower dose of one
20 mg tablet daily. Telmisartan
may also be used in combination
with diuretics (‚water tablets‘)
such as hydrochlorothiazide
which has been shown to have
an additive blood pressure
lowering effect with Telmisartan.
For reduction of cardiovascular
events, the usual dose of
Telmisartan is one 80 mg tablet
once a day.
At the beginning of the preventive
therapy with Telmisartan 80
mg, blood pressure should be
frequently monitored.
If your liver is not working
properly, the usual dose should
not exceed 40 mg once daily.
If you take more Telmisartan
than you should
If you accidentally take too many
tablets, contact your doctor,
pharmacist, or your nearest
hospital emergency department
immediately.
If you forget to take
Telmisartan
If you forget to take a dose, do

(hypotension) in users treated
for high blood pressure,
• dizziness on standing up
(orthostatic hypotension),
• shortness of breath,
• cough,
• abdominal pain,
• diarrhoea,
• discomfort in the abdomen,
• bloating,
• vomiting,
• itching,
• increased sweating,
• drug rash,
• back pain,
• muscle cramps, muscle pain
(myalgia),
• kidney impairment including
acute kidney failure,
• pain in the chest,
• feeling of weakness,
• increased level of creatinine
in the blood.
Rare side effects (may affect
up to 1 in 1,000 people):
• Sepsis* (often called „blood
poisoning“, is a severe
infection with whole-body
inflammatory response which
can lead to death),
• increase in certain white
blood cells (eosinophilia),
• low platelet count
(thrombocytopenia),
• severe allergic reaction
(anaphylactic reaction),
• allergic reaction (e.g. rash,
itching, difficulty breathing,
wheezing, swelling of the
face or low blood pressure),
• low blood sugar levels (in
diabetic patients),
• feeling anxious,
• somnolence,
• impaired vision,
• fast heart beat (tachycardia),
• dry mouth,
• upset stomach,
• taste disturbance
(dysgeusia),
• abnormal liver function
(Japanese patients are more
likely to experience these
side effect),
• rapid swelling of the skin and
mucosa which can also lead
to death (angioedema also
with fatal outcome),

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not worry. Take it as soon as
you remember then carry on as
before. If you do not take your
tablet on one day, take your
normal dose on the next day. Do
not take a double dose to make
up for forgotten individual doses.
If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.

Size: 255 x 210 mm

3. How to take
Telmisartan

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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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