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TELMISARTAN FAIR-MED 80 MG TABLETS

Active substance(s): TELMISARTAN

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Package leaflet: Information for the user
Telmisartan Fair-Med 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.
2.
3.
4.
5.
6.

What Telmisartan Fair-Med is and what it is used for
What you need to know before you take Telmisartan Fair-Med
How to take Telmisartan Fair-Med
Possible side effects
How to store Telmisartan Fair-Med
Contents of the pack and other information

1.

What Telmisartan Fair-Med is and what it is used for

Telmisartan Fair-Med 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 Fair-Med
blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure
is lowered.
Telmisartan Fair-Med 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 Fair-Med 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 Telmisartan Fair-Med

1

Do not take Telmisartan Fair-Med
• 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 FairMed 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 before taking
Telmisartan Fair-Med.
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 Telmisartan Fair-Med:
• 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 Telmisartan Fair-Med”.
• if you are taking digoxin.
You must tell your doctor if you think you are (or might become) pregnant. Telmisartan
Fair-Med 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 Fair-Med.

2

Telmisartan Fair-Med may be less effective in lowering the blood pressure in black
patients.
Children and adolescents
The use of Telmisartan Fair-Med in children and adolescents up to the age of 18 years is
not recommended.
Other medicines and Telmisartan Fair-Med
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 Fair-Med:
• 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
Fair-Med, 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 Fair-Med” and “Warning and precautions”).
• Digoxin.
The effect of Telmisartan Fair-Med may be reduced when you take NSAIDs (non
steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan Fair-Med 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 Fair-Med.
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 Fair-Med before you become
pregnant or as soon as you know you are pregnant and will advise you to take another
medicine instead of Telmisartan Fair-Med. Telmisartan Fair-Med 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

3

Tell your doctor if you are breast-feeding or about to start breastfeeding. Telmisartan
Fair-Med 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 Fair-Med. If you feel dizzy or
tired, do not drive or operate machinery.

3.

How to take Telmisartan Fair-Med

Always take Telmisartan Fair-Med exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose of Telmisartan Fair-Med is one tablet a day. Try to take the tablet
at the same time each day.
You can take Telmisartan Fair-Med with or without food. The tablets should be
swallowed with some water or other non-alcoholic drink. It is important that you take
Telmisartan Fair-Med every day until your doctor tells you otherwise. If you have the
impression that the effect of Telmisartan Fair-Med is too strong or too weak, talk to your
doctor or pharmacist.
For treatment of high blood pressure, the usual dose of Telmisartan Fair-Med 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. Telmisartan FairMed 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 Fair-Med is one 80
mg tablet once a day. At the beginning of the preventive therapy with Telmisartan FairMed 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 Fair-Med 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 Fair-Med
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.

4

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 Fair-Med:
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 (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 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 creatine phosphokinase in the
blood.

5

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 national reporting
system. By reporting side effects you can help provide more information on the safety of this
medicine.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5.

How to store Telmisartan Fair-Med

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 temperature storage conditions. You should
store your medicine in the original package in order to protect from moisture. Remove
your Telmisartan Fair-Med tablet from the blister only directly prior to intake.
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 Fair-Med contains
The active substance is telmisartan.
Each tablet contains 80 mg telmisartan.
The other ingredients are mannitol (E421), Povidone K29/32, sodium hydroxide,
meglumine, magnesium stearate.
What Telmisartan Fair-Med looks like and contents of the pack
Telmisartan Fair-Med 80 mg tablets are white to off-white, oblong, un-coated tablets
about 16.10 mm in length and about 7.80 mm in width with 'C' debossed on one side and
'05' debossed on the other side.

6

Telmisartan Fair-Med is available in blister packs containing
98 or 100 tablets.

14, 28, 30, 56, 84, 90,

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fair-Med Healthcare GmbH
Planckstrasse 13, Hamburg 22765,
Germany
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the
following names:
Belgium:
Telmisartan Fair-Med 20mg, 40mg, 80mg, Comprimés
Czech Republic: Telmisartan Fair-Med 20mg, 40mg, 80mg
France:
Telmisartan Fair-Med 20mg, 40mg, 80mg, Comprimés
Greece:
Telmisartan/Fair-Med 20mg, 40mg, 80mg Δισκία
Germany:
Telmisartan Fair-Med Healthcare 20mg, 40mg, 80mg Tabletten
Hungary:
Telmizartán Fair-Med 20mg, 40mg, 80mg Tabletta
Ireland:
Telmisartan Fair-Med 20mg, 40mg, 80mg Tablets
Italy:
Telmisartan Fair-Med
Netherlands: Telmisartan Fair-Med, 20mg, 40mg, 80mg tabletten
Poland:
Telmisartan Fair-Med
Portugal:
Telmisartan Fair-Med
Romania:
Telmisartan Fair-Med 20mg, 40mg, 80mg Comprimate
Slovakia:
Telmisartan Fair-Med 20mg, 40mg, 80mg, Tablety
Spain:
Τelmisartán Fair-Med 20mg, 40mg, 80mg Comprimidos EFG
United Kingdom:
Telmisartan Fair-Med 20mg, 40mg, 80mg Tablets

This leaflet was last revised in July 2015.

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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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