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TELMISARTAN MYLAN 80MG TABLETS

Active substance(s): TELMISARTAN

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Telmisartan 20 mg tablets
Telmisartan 40 mg tablets
Telmisartan 80 mg tablets
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. W
 hat Telmisartan is and what it is used for
2. W
 hat you need to know before you take
Telmisartan
3. H
 ow to take Telmisartan
4. P
 ossible side effects
5. H
 ow to store Telmisartan
6. C
 ontents 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 which increases 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) in adults. ‘Essential’ means that
the high blood pressure is not caused by any other
condition.
If high blood pressure is not treated it can damage
blood vessels in some organs, which could possibly
lead 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 the risk of heart
attack or stroke in adults who are at risk because they
have a reduced or blocked blood supply to the heart
or legs, have had a stroke in the past or already have
organ damage caused by diabetes. Your doctor can
tell you if you are at high risk for such events.

2. What you need to know before you
take Telmisartan
Do not take Telmisartan

• if you are allergic to telmisartan or any of the 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 mellitus 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 before taking Telmisartan.

Warnings and precautions

TBC

Talk to your doctor if you are suffering or have ever
suffered from any of the following conditions or
illnesses:
• if you have kidney disease or have had a kidney
transplant
• if you have narrowing of the blood vessels to one
or both kidneys (renal artery stenosis)
• if you have any other liver disease
• if you suffer from heart trouble
• if you have low blood pressure (hypotension), likely
to occur if you have an excessive loss of body water
(dehydration), have low salt levels because you are
taking ‘water tablets’ or are on a low-salt diet or you
have diarrhoea or vomiting
• if you have water and salt retention in the body
along with imbalance of various blood minerals
(raised aldosterone levels)
• if you have high elevated potassium levels in
your blood
• if you have diabetes
Talk to your doctor or pharmacist before
taking Telmisartan:
• if you are taking digoxin
• 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
Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.

You must tell your doctor if you think that 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).
If you are having surgery or an anaesthetic,
you should tell your doctor that you are taking
Telmisartan.

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 your dose of these
other medicines and/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 (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. ciclosporin or
tacrolimus), and the antibiotic trimethoprim.
• ‘Water tablets’ (diuretics) e.g. furosemide,
hydrochlorothiazide, amiloride; especially if taken
in high doses together with Telmisartan may lead
to excessive loss of body water and low blood
pressure (hypotension).
• As with other blood pressure lowering medicines, the
effect of Telmisartan may be reduced when you take
NSAIDs (non-steroidal anti-inflammatory medicines,
e.g. aspirin or ibuprofen) or corticosteroids
• Other medicines to treat high blood pressure,
strong pain killers, barbiturates (for epilepsy),
baclofen (used to treat cerebral palsy and multiple
sclerosis), amifostine (used to prevent fever and
infections in patients receiving chemotherapy or
radiotherapy) or tablets for depression
• If you are taking an ACE‑inhibitor or aliskiren
(see also information under the headings
“Do not take Telmisartan” and “Warnings and
precautions”)
• Digoxin
Telmisartan may increase the blood pressure
lowering effect of other medicines used to treat high
blood pressure.

Telmisartan with alcohol

Telmisartan may increase the blood pressure
lowering effect if taken with alcohol, which may
make you feel dizzy or lightheaded and faint,
especially when standing after you have been sitting
or lying down.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
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. 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 taken 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 new born, or
was born prematurely.

Driving and using machines

Some people feel dizzy or tired when they are treated
for high blood pressure. If you feel dizzy or tired, do
not drive or operate machinery.

3. How to take Telmisartan
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose of Telmisartan will depend
on what you are taking this medicine for. You should
take your dose once a day and at the same time
each day.
For the treatment of high blood pressure, the
recommended dose is 40 mg once a day to control
high 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.
20 mg may be a high enough dose for some patients.
Telmisartan may also be used with diuretics (‘water
tablets’) such as hydrochlorothiazide which has been
shown to have an additive blood pressure lowering
effect with telmisartan.

See also information under the heading “Do not take
Telmisartan”

To reduce the risk of a heart attack or stroke the
recommended dose is 80 mg daily. At the beginning
of treatment your blood pressure should be
frequently monitored.

If you are black; as with all other angiotensin II
receptor antagonists, Telmisartan may be less effective
in lowering the blood pressure in black patients.

If you have the impression that the effect of
Telmisartan is too strong or too weak, talk to your
doctor or pharmacist.

TBC

Package leaflet: Information for the patient

Your medicine is available in 3 strengths: 20 mg,
40 mg and 80 mg

Use in children and adolescents

Children and adolescents under 18 years old should
not take Telmisartan.

Method of administration

Swallow the tablets whole with water or other
non-alcoholic drink.
You can take Telmisartan with or without food.

Patients with liver problems

If your liver is not working properly, the
recommended dose should not be higher than 40 mg
once daily.

Patients with kidney problems

If you have kidney problems, please discuss this with
your doctor. Your doctor may prescribe you a lower
starting dose of 20 mg 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.

Signs to look for are low blood pressure, dizziness,
increase or decrease in heart beat and kidney
problems.

If you forget to take Telmisartan

If you forget to take your tablets do not worry. Take
them 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 a forgotten dose.

If you stop taking Telmisartan

If you want to stop taking this medicine talk to your
doctor.

• Inflammation of the skin, marked by itching and
rash and often including blisters (eczema), redness
of skin, hives (urticaria)
• Joint pain (arthralgia), pain in extremity or
tendon pain
• Flu like symptoms (influenza like illness)
• An increase in some blood enzyme levels (levels
such as increased liver enzymes or creatine
phosphokinase) which shows up in blood tests
• Low blood sugar levels (in diabetic patients)
• Decreased haemoglobin (a blood protein) which
shows up in blood tests
• Increased level of uric acid, which shows up
in blood tests
• Sleepiness
• Stomach discomfort
*
In a long-term study involving more than
20,000 patients, more patients treated with
telmisartan experienced sepsis compared with
patients who received no telmisartan. The event may
have happened by chance or could be related to a
mechanism currently not known.
**
Most cases of abnormal liver function and liver
disorder from post-marketing experience with
telmisartan occurred in Japanese patients. Japanese
patients are more likely to experience this side effect.

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.

5. How to store Telmisartan

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

Keep this medicine out of the sight and reach of
children.

4. Possible side effects

Do not use this medicine after the expiry date which
is stated on the blister, carton and bottle after EXP.
The expiry date refers to the last day of that month.

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 as they
could be fatal if not treated:
• Sepsis * (often called “blood poisoning”, is a severe
infection with whole-body inflammatory response)
• Severe allergic reaction with symptoms such
as rash, itching, difficulty breathing, wheezing,
swelling of the face or low blood pressure
(anaphylactic reaction)
• Rapid swelling of the face, lips, mouth, tongue or
throat, which can cause difficulty in swallowing or
breathing (angioedema)
• Severe skin reactions, which may include blisters
and peeling of the skin (toxic skin reaction)
• Problems passing water with tiredness, feeling
and being sick, breathlessness and swelling of legs,
ankles or feet (Kidney impairment including
kidney failure)
• Shortness of breath with a dry or non-productive
cough with weight loss, due to progressive scarring
of lung tissue (interstitial lung disease) ***

Other possible side effects:
Common (may affect up to 1 in 10 people):

Store in the original package in order to protect
from light.
Do not use Telmisartan if you notice any
discolouration of the tablets.
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.

6. Contents of the pack and other
information
What Telmisartan contains

• The active substance is telmisartan.
• Each tablet contains 20 mg or 40 mg or 80 mg
telmisartan.
• The other ingredients are magnesium stearate,
povidone, meglumine, sodium hydroxide and
mannitol (E421).

What Telmisartan looks like and contents of the
pack

20 mg: White to off white, round flat, bevelled edged
tablets marked with ‘TN over 20’ on one side and ‘M’
on the other side.

• Low blood pressure (hypotension) in users treated
for reduction of cardiovascular events e.g. heart
attack or strokes

40 mg: White to off white, oblong tablets with sides
that curve outwards marked with ‘TN40’ on one side
and ‘M’ on the other side.

Uncommon (may affect up to 1 in 100 people):

80 mg: White to off white, oblong tablets with sides
that curve outwards marked with ‘TN80’ on one side
and ‘M’ on the other side.

• Upper respiratory tract infection (e.g. sore throat,
common cold, inflamed and swollen sinuses
causing pain, high temperature and tenderness)
• Urinary tract infection including inflammation of
the bladder lining
• Deficiency in red blood cells (anaemia), which
can make the skin pale and cause weakness and
breathlessness
• High potassium levels, which show up in blood tests
• Feeling sad (depression)
• Difficulty falling asleep
• Feeling of spinning (vertigo)
• Fainting (syncope)
• Dizziness or light-headedness, especially when
standing up (orthostatic hypotension)
• Slower heart beat (bradycardia)
• Low blood pressure (hypotension) in users treated
for high blood pressure
• Shortness of breath and chest pain
• Cough
• Stomach pain, diarrhoea, indigestion, bloating
or vomiting
• Rash, itchy skin
• Increased sweating
• Back pain, muscle pain (myalgia), muscle spasms
• Weakness
• Increase in level of a substance called creatinine in
the blood, which shows up in blood tests

Telmisartan is available in blister packs of 14, 28,
30, 56, 60, 84, 90, 98, 100 tablets and calendar pack
size of 28 tablets, and plastic bottles with plastic
cap containing an absorbent cotton and a desiccant
container (do not eat the desiccant) in pack sizes of
56, 60, 84, 90, 98, 280, 500, 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Manufacturers

McDermott Laboratories (trading as Gerard
Laboratories), 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., H-2900, Komárom,
Mylan útca.1, Hungary
This leaflet was last revised in 09/2015.

Rare (may affect up to 1 in 1,000 people):

• Reduction in blood platelets which increase risk of
bleeding or bruising
• Increase in certain white blood cells (eosinophilia),
which shows up in blood tests
• Feeling anxious
• Visual disturbance (impaired vision)
• Faster heart beat (tachycardia)
• Dry mouth
• Taste disturbance (dysgeusia)
• Abnormal liver function **

617677

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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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