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TELMISARTAN 80 MG TABLETS

Active substance(s): TELMISARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Telmisartan 20 mg Tablets
Telmisartan 40 mg Tablets
Telmisartan 80 mg Tablets

Telmisartan

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.

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

to the medicines listed below taken at the
same time with Telmisartan:

What Telmisartan is and what it is
used for

• 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
anti-inflammatory 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 this
medicine, may lead to excessive loss of
body water and low blood pressure
(hypotension).
• aliskiren, a medicine used to treat high
blood pressure
• digoxin

Telmisartan belongs to a group 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 lowered.
Telmisartan is used to treat essential
hypertension (high blood pressure). ʻEssentialʼ
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 sometimes lead to heart attack,
heart or kidney failure, stroke, or blindness.
There are usually no symptoms of high blood
pressure before damage occurs. Therefore it
is important to measure blood pressure
regularly to check if it is within the normal
range.

The effect of this medicine may be reduced if
you also take NSAIDs (e.g. aspirin or
ibuprofen) or corticosteroids.

Telmisartan is also used to reduce
cardiovascular events (i.e. heart attack or
stroke) in patients 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.

2

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.

What you need to know before you
take Telmisartan

Taking Telmisartan with food and drink
You can take Telmisartan with or without
food.

Do NOT take Telmisartan if you:
• are allergic to telmisartan or any of the
other ingredients of this medicine (listed in
section 6 and the end of section 2).
• are more than 3 months pregnant. (It is
also better to avoid Telmisartan in early
pregnancy – see pregnancy section.)
• have severe liver problems such as
cholestasis or biliary obstruction (problems
with the drainage of bile from the liver and
gall bladder) or any other severe liver
disease.
• if you have diabetes mellitus or impaired
kidney function and you are treated with
aliskiren

Pregnancy and breast-feeding
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.

If any of the above situations applies to you,
tell your doctor or pharmacist before taking
Telmisartan

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.

Warnings and precautions
Tell 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 problems
• 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'), a
low-salt diet, diarrhoea or vomiting
• elevated potassium levels in your blood
• diabetes.

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.
Telmisartan 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

Talk to your doctor before taking Telmisartan:
• if you are taking aliskiren, a medicine used
to treat high blood pressure
• if you are taking digoxin.

Always take Telmisartan exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.

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 (see
pregnancy section).

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.
• Tablets with a score line can be divided
into equal halves

In case of surgery or anaesthesia, tell your
doctor that you are taking Telmisartan.

Telmisartan may be less effective in lowering
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.

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.
However, sometimes your doctor may
recommend a lower dose of 20 mg or a
higher dose of 80 mg.

Your doctor may need to change the dose of
these medicines or take other precautions. In
some cases you may have to stop taking
one of the medicines. This applies especially

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How to take Telmisartan

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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.

are more likely to experience this side effect)
• rapid swelling of the skin and mucosa
which can also lead to death (angioedema
also with fatal outcome)
• 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

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.
Use in children
The use of Telmisartan in children and
adolescents up to the age of 18 years is not
recommended.
Use in the elderly
No dosing adjustment is necessary for
elderly patients.

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.

Use in impaired liver function
If your liver is not working properly, the usual
dose should not be more than 40 mg once
daily.
Use in impaired kidney function
No dosage adjustment is necessary in
patients with impaired kidney function.
If you have severe kidney function
impairment or if you are undergoing
haemodialysis your doctor may prescribe a
lower starting dose of 20 mg.

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:
www.mhra.gov.uk/yellowcard. By reporting
side affects you can help provide more
information on the safety of this medicine.

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.

5

If you forget to take Telmisartan
If you forget to take a dose, do 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.

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 label after EXP.
The expiry date refers to the last day of that
month.

If you stop taking Telmisartan
Always consult your doctor if you wish to
stop taking this medicine. Even if you feel
well, it may be necessary to continue taking
this medicine.

Store in the original package in order to
protect from moisture.

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

4

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.

Possible side effects

6

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:

Contents of the pack and other
information

What Telmisartan contains

Telmisartan 20 mg, tablets
The active substance is telmisartan. Each
tablet contains 20 mg of telmisartan.

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.

Telmisartan 40 mg, tablets
The active substance is telmisartan. Each
tablet contains 40 mg of telmisartan.

Telmisartan 80 mg, tablets
The active substance is telmisartan. Each
tablet contains 80 mg of telmisartan.
The other ingredients are:
Sodium Hydroxide
Meglumine
Povidone K25
Lactose monohydrate
Povidone
Crospovidone
Lactose anhydrous
Magnesium Stearate

Possible side effects:

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
to 100 people):
• urinary tract infections
• upper respiratory tract infection (e.g. sore
throat, inflamed sinuses, common cold)
• deficiency in red blood cells (anaemia)
• high potassium levels
• difficulty falling asleep (insomnia)
• feeling sad (depression)
• fainting (syncope)
• feeling of spinning (vertigo)
• slow heart rate (bradycardia)
• low blood pressure (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.

– for further information on lactose see end
of Section 2

What Telmisartan looks like and contents
of the pack

Telmisartan 20 mg, tablets
White, round, plain tablet, debossed with ʻ20ʼ
on one side.
Telmisartan 40 mg, tablets
White, oblong, plain tablet, scored on one
side and debossed with ʻ40ʼ on the other
side.

Telmisartan 80 mg, tablets
White, oblong, plain tablet, scored on one
side and debossed with ʻ80ʼ on the other
side.

20mg
Al//Al blisters containing 7, 10, 14, 20, 21,
28, 30, 50, 56, 60, 84, 90, 98, 100 tablets.

40 mg, 80 mg
Al//Al blisters containing 7, 10, 14, 20, 21,
28, 30, 50, 56, 60, 84, 90, 98, 100 tablets.

Al//Al unit dose blisters containing 28 tablets.

Not all pack sizes may be marketed.

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
• abnormal liver function (Japanese patients

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How to store Telmisartan

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder

Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR
United Kingdom

Manufacturer
Lek pharmaceuticals d.d. Ljubljana, Slovenia
Lek pharmaceuticals d.d. Lendava, Slovenia
Lek S.A. Warszawa, Poland
Salutas Pharma GmbH, Barleben, Germany
Salutas Pharma GmbH, Gerlingen, Germany
S.C. Sandoz, S.R.L., Str. Livezeni nr 7A,
540472, Targu Mures, Romania
Lek S.A, ul. Podlipie 16, 95-010 Stryków,
Poland
This leaflet was last revised 01/2014.

SZ00000LT000
00000000

Artwork Proof Box
Ref: V009: CDS update for SPC & PIL + National phase
Proof no.
006.2

Date prepared:
27/01/2014

Colours:
Black
Dimensions: 165 x 620 mm

Font size:
10pt
Fonts:
Helvetica

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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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