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TELMISARTAN BRISTOL LABORATORIES 80MG TABLETS

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

1. What this medicine 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 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.

2. What you need to know before you take this
medicine

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.
Talk to your doctor before taking this medicine :
• 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. See also information under the heading
“Do not take this medicine”.
• if you are taking digoxin.
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).
In case of surgery or anaesthesia, you should tell your doctor that
you are taking this medicine. 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.

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Do not take this medicine:
• if you are allergic to telmisartan or any of the other ingredients of
this medicine (listed in section 6).

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

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Taking other medicines
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 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 telmisartan, may lead to excessive loss of body
water and low blood pressure (hypotension).
• If you are taking an ACE-inhibitor or aliskiren (see also
information under the headings “Do not take this medicine” and
“Warning and precautions”).
• Digoxin.
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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Telmisartan 20 mg tablets
Telmisartan 40 mg tablets
Telmisartan 80 mg tablets

• if you are more than 3 months pregnant. (It is also better to avoid
this medicine 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.

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.
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.

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Package leaflet: Information for the patient

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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 is one tablet a day. Try to take
the tablet at the same time each day.
You can take this medicine with or without food. The tablets should be
swallowed with some water or other non-alcoholic drink. It is important
that you take this medicine every day until your doctor tells you
otherwise. If you have the impression that the effect of this medicine
is too strong or too weak, talk to your doctor or pharmacist.
For treatment of high blood pressure, the usual dose of this medicine
for most patients is one 40 mg tablet once a day to control blood
pressure over the 24-hour period. Your doctor has recommended a
lower dose of one 20 mg tablet daily. This medicine 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 this medicine.

Possible side effects of Telmisartan:
Common (may affect up to 1 to 10 people)
Low blood pressure (hypotension) in users treated for reduction of
cardiovascular events.
Uncommon (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 (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, and increased level of creatinine in
the blood.

If you forget to take this medicine
If you forget to take a dose, just take your next dose as normal. 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 a forgotten dose.

Rare (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), 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 creatinine
phosphokinase in the blood.

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

Very rare (may affect up to 1 in 10,000 people)
Progressive scarring of lung tissue (interstitial lung disease)**.

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 of this medicine than you should
If you take more of this medicine than you should, talk to a doctor or
your nearest hospital emergency department immediately.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage
conditions. Store in the original package in order to protect
from moisture.
• 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.
• 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 this medicine contains
• The active substance is telmisartan. Each film-coated tablet
contains 20 mg, 40 mg or 80 mg of telmisartan.
• The other ingredients are mannitol, povidone, meglumine,
sodium hydroxide, magnesium stearate.
What this medicine looks like and contents of the pack
• Telmisartan 20 mg Tablets are white to off-white, round shaped,
un-coated tablets about 6.95 mm in diameter with ‘C’ debossed
on one side and ’03 ‘ debossed on the other side.
• Telmisartan 40 mg Tablets are white to off-white, oblong,
uncoated tablets about 11.90 mm in length and 5.80 mm width
with ‘C’ debossed on one side and ’04 ‘ debossed on the other
side.
• Telmisartan 80 mg Tablets are white to off-white, oblong,
un-coated tablets about 16.10 mm in length and 7.80 mm
width with ‘C’ debossed on one side and ’05 ‘ debossed on the
other side.
• This medicine is available in aluminium blister packs of 14,
28, 56 or 98 tablets. Not all pack sizes may be marketed.

* 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.

Telmisartan 20 mg Tablets; PL 17907/0539, PA 1240/019/001
Telmisartan 40 mg Tablets; PL 17907/0540, PA 1240/019/002
Telmisartan 80 mg Tablets; PL 17907/0541, PA 1240/019/003

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 for UK and at: www.hpra.ie or
E-mail: medsafety@hpra.ie for Ireland. By reporting side effects you

This leaflet was last revised in May 2016

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5. How to store this medicine

Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, UK
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk

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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

can help provide more information on the safety of this medicine.

To request a copy of this leaflet in Braille, large print or audio
format, please contact the licence holder at the address (or
telephone, fax, e-mail) above.
V5 04-05-16 D1

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3. How to take this medicine

and patients should stop taking the medicine and see their doctor
immediately. If these effects are not treated they could be fatal.

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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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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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