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TELMISARTAN JUBILANT 20 MG TABLETS

Active substance(s): TELMISARTAN

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Package leaflet: Information for the user

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. Itmayharmthem,eveniftheirsignsofillnessarethesameasyours.
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.

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 lowered.

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”.), a
medicine used to treat high blood pressure.
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 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:
-

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.

-

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),
trimethoprim (an antibiotic).
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 Telmisartan” and “Warnings and
precautions”)
Digoxin

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.

The effect of Telmisartan may be reduced when you take NSAIDs (non steroidal
anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

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).

What you need to know before you take Telmisartan

Do not takeTelmisartan
-

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 or impaired kidney function and you are treated
with a blood pressure lowering medicine containing aliskiren (another
medicine used to treat essential hypertension (high blood pressure)).

If any of the above applies to you, tell your doctor or pharmacist 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.

Talk to your doctor or pharmacist before taking Telmisartan tablets:
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.

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.
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 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.
Telmisartan contains mannitol
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
3.

How to take Telmisartan

Always take this medicine 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 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 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.

5.

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. 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.
If your liver is not working properly, the usual dose should not exceed 40 mg
once daily.

Store in original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton and
blister after EXP. The expiry date refers to the last day of that month.

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 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.
4.

Possible side effects

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 to 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.
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 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.
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 (website: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the safety
of this medicine.

How to store Telmisartan

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

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

What Telmisartan looks like and contents of the pack
Telmisartan 20 mg tablets are white to off-white, round, flat face, beveled
edge tablets, approximately 7.16 mm in diameter and approximately 2.60 mm
thick, debossed with “B” on one side and plain on the other side.
Telmisartan 20 mg tablets is available in blister packs containing 14, 28, 56, or
98 tablets.
Telmisartan 40 mg tablets are white to off white, capsule shaped tablets,
approximately 12.15 mm in length, approximately 3.75 mm thick and
approximately 6.10 mm width, debossed with “H” on one side and plain on
other side.
Telmisartan 40 mg tablets is available in blister packs containing 14, 28, 56, 84
or 98 tablets.
Telmisartan 80 mg tablets are white to off white, oval shaped tablets,
approximately 16.40 mm in length, approximately 4.70 mm thick and
approximately 8.10 mm width, debossed with “D” on one side and plain on
other side.
Telmisartan 80 mg tablets is available in blister packs containing 14, 28, 56, 84
or 98 tablets.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder and Manufacturer
Marketing authorisation holder
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22, block C
9820 Merelbeke
Belgium
Manufacturer
PSI Supply n.v.
Axxes Business Park
Guldensporenpark 22, block C
9820 Merelbeke
Belgium
This medicinal product is authorised in the Member States of the EEA
under the following names:
Sweden
Telmisartan Jubilant 20 mg tabletter
Telmisartan Jubilant 40 mg tabletter
Telmisartan Jubilant 80 mg tabletter
United Kingdom
Telmisartan Jubilant 20 mg tablets
Telmisartan Jubilant 40 mg tablets
Telmisartan Jubilant 80 mg tablets
Bulgaria
Telmisartan Jubilant 20 mg Таблетка
Telmisartan Jubilant 40 mg Таблетка
Telmisartan Jubilant 80 mg Таблетка
This leaflet was last revised in 12/2014.

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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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