PRITOR 40 mg Таблетка

Содержание инструкции

1. Pritor 20 mg tablets
   1. What Pritor is and what it is used for
   2. What you need to know before taking Pritor
   3. How to take Pritor
   4. Possible side effects
   5. How to store Pritor
   6. Contents of the pack and other information
2. Pritor 40 mg tablets
   1. What Pritor is and what it is used for
   2. What you need to know before taking Pritor
   3. How to take Pritor
   4. Possible side effects
   5. How to store Pritor
   6. Contents of the pack and other information
3. Pritor 80 mg tablets
   1. What Pritor is and what it is used for
   2. What you need to know before taking Pritor
   3. How to take Pritor
   4. Possible side effects
   5. How to store Pritor
   6. Contents of the pack and other information

Pritor 20 mg tablets

telmisartan

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Pritor is and what it is used for
• 2. What you need to know before you take Pritor
• 3. How to take Pritor
• 4. Possible side effects
• 5. How to store Pritor
• 6. Contents of the pack and other information

1. What Pritor is and what it is used for

Pritor belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance present in the body that causes constriction of blood vessels, thereby increasing blood pressure. Pritor blocks the effect of angiotensin II, causing relaxation of blood vessels and thus reducing blood pressure.

Pritor is used forthe treatment of essential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not caused by other conditions. High blood pressure, if left untreated, can damage blood vessels in many organs and this can sometimes cause heart attack, heart or kidney failure, stroke or blindness. Normally, high blood pressure does not give symptoms before such damage occurs. Therefore, it is important to have your blood pressure measured regularly to check if it is within the normal range.

Pritor is also used toreduce cardiovascular events (e.g. heart attack or stroke) in adults at risk because their blood supply to the heart or legs is reduced or blocked or because they have had a stroke or have high-risk diabetes. Your doctor can tell you if you are at high risk for these events.

2. What you need to know before taking Pritor

Do not take Pritor

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months (it is best to avoid taking Pritor even in the early stages of pregnancy - see the Pregnancy section).
• if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you are in any of the conditions listed above, tell your doctor or pharmacist before taking
Pritor.

Warnings and precautions
Talk to your doctor before taking Pritor if you suffer from 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 of one or both kidneys).
• Liver diseases.
• Heart problems.
• Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to, for example, diuretic therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before taking Pritor:

• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• 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 the section “Do not take Pritor”.
• if you are taking digoxin.

You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Pritor is not recommended in early pregnancy and should not be taken if
you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the Pregnancy section).
In case of surgery or anesthesia, you must inform your doctor that you are taking Pritor.
Pritor may be less effective in reducing blood pressure in patients of African ethnicity.

Children and adolescents
The use of Pritor is not recommended in children and adolescents under 18 years of age.

Other medicines and Pritor
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Your doctor may decide to change the dose of these other medicines or
take other precautions. In some cases, it may be necessary to stop taking one
of these medicines. This applies especially to the medicines listed below, taken
simultaneously with Pritor:

• Medicines containing lithium to treat some types of depression.
• Medicines that can increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics (some “diuretics”), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses together with Pritor, can cause excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the sections: “Do not take Pritor” and “Warnings and precautions”).
• Digoxin.

The effect of Pritor may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs,
e.g. aspirin or ibuprofen) or corticosteroids.
Pritor may increase the effect of other medicines used to reduce high blood pressure or
medicines that can potentially reduce blood pressure (e.g. baclofen, amifostine).
Furthermore, the lowering of blood pressure may be aggravated by alcohol, barbiturates, narcotics
or antidepressants. You may feel this lowering of blood pressure as dizziness when getting
up. Consult your doctor if you need to change the dose of other medicines while taking
Pritor.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). As a rule, your doctor will advise you to stop taking Pritor before
starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Pritor. Pritor is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months as it can
cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Pritor is not
recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or was
born prematurely.

Driving and using machines
Some patients may experience undesirable effects, such as fainting or feeling dizzy
(vertigo) when taking Pritor. If you experience these effects, do not drive or
use machines.

Pritor contains sorbitol
This medicine contains 84.32 mg of sorbitol per tablet.

Pritor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Pritor

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet a day. Try to take the tablet at the same time each day.
You can take Pritor with or without food. The tablets must be swallowed whole with a little water
or other non-alcoholic beverage. It is important to take Pritor every day until your doctor tells you
otherwise. If you feel that the effect of Pritor is too strong or too weak, consult your doctor or
pharmacist.
For the treatment of high blood pressure, the usual dose of Pritor for most patients is one 40 mg tablet
once a day to control blood pressure for a period of 24 hours. Your doctor may have recommended a lower
dose of 20 mg per day. Pritor can also be used in combination with diuretics such as hydrochlorothiazide,
for which an additive effect has been demonstrated in combination with Pritor in terms of blood pressure
reduction.
For the reduction of cardiovascular events, the usual dose of Pritor is one 80 mg tablet once a day.
At the beginning of preventive therapy with Pritor 80 mg, blood pressure should be checked frequently.
If your liver is not functioning properly, you should not exceed the usual dose of 40 mg per day.

If you take more Pritor than you should
If you have accidentally taken too many tablets, contact your doctor, pharmacist or the emergency room of
the nearest hospital immediately.

If you forget to take Pritor
If you forget to take the medicine, do not worry. Take it as soon as you remember, then continue as
before. If you miss a dose for one day, take the normal dose the next day. Do not
takea double dose to make up for missed 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.
li manifestino.

Some side effects can be serious and require immediate medical attention
You should go to your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called “blood infection” is a serious infection with inflammatory response
of the entire organism), rapid swelling of the skin and mucous membranes (angioedema); these effects
are rare (may occur in up to 1 in 1,000 people), but extremely serious and
patients should stop taking the medicine and consult a doctor immediately. If
these effects are not treated they can be fatal.

Possible side effects of Pritor
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for the 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, sinusitis,
common cold), deficiency of red blood cells (anemia), high levels of potassium, difficulty
falling asleep, feeling sad (depression), fainting (syncope), feeling dizzy (vertigo), slowed heartbeat (bradycardia), low blood pressure (hypotension) in
patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension),
shortness of breath, cough, abdominal pain, diarrhea, stomach pain, bloated stomach, vomiting,
feeling of itching, increased sweating, drug rash, back pain,
muscle cramps, muscle pain (myalgia), kidney impairment (including acute renal
failure), chest pain, feeling of weakness, increased levels of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood infection” is a serious infection with inflammatory response
of the entire organism that can lead to death), increase in some 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 of anxiety,
drowsiness, impaired vision, fast heartbeat (tachycardia), dry mouth,
stomach discomfort, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more prone to experiencing this side effect), rapid swelling of the
skin and mucous membranes which can also be fatal (angioedema, even with fatal outcome), eczema
(skin disease), skin redness, urticaria, severe drug rash, joint pain (arthralgia), pain in a limb, tendon pain, flu-like illness,
decrease in hemoglobin (a blood protein), increased uric acid levels, increased
liver enzymes or creatine phosphokinase in the blood, low sodium levels.
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 occurred by chance or may be related to a currently
unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during the 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 through the national reporting system as detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pritor

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 pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from moisture. Only remove the Pritor tablet from the
blister immediately before taking it.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pritor contains
The active ingredient is telmisartan. Each tablet contains 20 mg of telmisartan.
The other ingredients are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420) and magnesium
stearate.

Description of the appearance of Pritor and contents of the pack
Pritor 20 mg tablets are white, round, with the code “50H” imprinted on one side.
Pritor is available in blisters containing 14, 28, 30, 56, 90 or 98 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België / Belgique / Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Lietuva
UAB Bayer
Tel. +370 52 33 68 68

България
Байер България ЕООД
Тел. +359 02 424 72 80

Luxembourg / Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Česká republika
Bayer s.r.o.
Tel: +420 266 101 111

Magyarország
Bayer Hungária Kft.
Tel.: +36-14 87-41 00

Danmark
Bayer A/S
Tlf: +45-45 23 50 00

Malta
Alfred Gera and Sons Ltd.
Tel: +356-21 44 62 05

Deutschland
Bayer Vital GmbH
Tel: +49-(0)214-30 513 48

Nederland
Bayer B.V.
Tel: +31-(0)297-28 06 66

Eesti
Bayer OÜ
Tel: +372 655 85 65

Norge
Bayer AS
Tlf. +47 23 13 05 00

Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 618 75 00

Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0

España
Bayer Hispania S.L.
Tel: +34-93-495 65 00

Polska
Bayer Sp. z o.o.
Tel.: +48-22-572 35 00

France
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54

Portugal
Bayer Portugal Lda
Tel: +351-21-416 42 00

Hrvatska
Bayer d.o.o.
Tel: +385-(0)1-6599 900

România
SC Bayer SRL
Tel.: +40 21 528 59 00

Ireland
Bayer Limited
Tel: +353-1-216-3300

Slovenija
Bayer d. o. o.
Tel.: +386-1-58 14 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2 59 21 31 11

Italia
Bayer S.p.A.
Tel: +39-02-397 81

Suomi/Finland
Bayer Oy
Puh/Tel.: +358-20 785 21

Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58

Sverige
Bayer AB
Tel: +46-(0)8-580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

United Kingdom (Northern Ireland)
Bayer AG
Tel: +44 (0) 118 206 3000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Pritor 40 mg tablets

telmisartan

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Pritor is and what it is used for
• 2. What you need to know before you take Pritor
• 3. How to take Pritor
• 4. Possible side effects
• 5. How to store Pritor
• 6. Contents of the pack and other information

1. What Pritor is and what it is used for

Pritor belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance present in the body that causes constriction of blood vessels, thereby increasing blood pressure. Pritor blocks the effect of angiotensin II, causing relaxation of the blood vessels and thus reducing blood pressure.

Pritor is used forthe treatment of essential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not caused by other conditions. High blood pressure, if left untreated, can damage blood vessels in many organs and this can sometimes cause heart attack, heart or kidney failure, stroke or blindness. Normally, high blood pressure does not give symptoms before such damage occurs. Therefore, it is important to have your blood pressure measured regularly to check if it is within the normal range.

Pritor is also used toreduce cardiovascular events (e.g. heart attack or stroke) in adults at risk because their blood supply to the heart or legs is reduced or blocked or because they have had a stroke or have high-risk diabetes. Your doctor can tell you if you are at high risk for these events.

2. What you need to know before taking Pritor

Do not take Pritor

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months (it is best to avoid taking Pritor even in the early stages of pregnancy - see the Pregnancy section).
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease.
• if you have diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you are in any of the conditions listed above, tell your doctor or pharmacist before taking
Pritor.

Warnings and precautions
Talk to your doctor before taking Pritor if you suffer from 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 of one or both kidneys).
• Liver diseases.
• Heart problems.
• Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to, for example, diuretic therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before taking Pritor:

• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• 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 the section “Do not take Pritor”.
• if you are taking digoxin.

You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Pritor is not recommended in the early stages of pregnancy and should not be taken if
you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the Pregnancy section).
In case of surgery or anesthesia, you must inform the doctor that you are taking Pritor.
Pritor may be less effective in lowering blood pressure in patients of African ethnicity.

Children and adolescents
The use of Pritor is not recommended in children and adolescents under 18 years of age.

Other medicines and Pritor
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Your doctor may decide to change the dose of these other medicines or
take other precautions. In some cases, it may be necessary to stop taking one of
these medicines. This particularly applies to the medicines listed below, taken
simultaneously with Pritor:

• Medicines containing lithium to treat some types of depression.
• Medicines that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some “diuretics”), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses together with Pritor, can cause excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Pritor” and “Warnings and precautions”).
• Digoxin.

The effect of Pritor may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs,
e.g. aspirin or ibuprofen) or corticosteroids.
Pritor may increase the effect of other medicines used to lower high blood pressure or of
medicines that can potentially lower blood pressure (e.g. baclofen, amifostine).
In addition, the lowering of blood pressure may be aggravated by alcohol, barbiturates, narcotics
or antidepressants. You may feel this lowering of blood pressure as dizziness when getting
up. Consult your doctor if you need to change the dose of other medicines while taking
Pritor.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). As a rule, your doctor will advise you to stop taking Pritor before
starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Pritor. Pritor is not recommended in the early stages of
pregnancy and should not be taken if you are pregnant for more than 3 months as it can
cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Pritor is not
recommended for women who are breastfeeding and your doctor may choose another treatment for you if you want to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
Some patients may experience undesirable effects, such as fainting or feeling dizzy
(vertigo) when taking Pritor. If you experience these effects, do not drive or
use machines.

Pritor contains sorbitol
This medicine contains 168.64 mg of sorbitol per tablet.

Pritor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Pritor

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one tablet a day. Try to take the tablet at the same time
each day.
You can take Pritor with or without food. The tablets must be swallowed whole with a little water
or other non-alcoholic beverage. It is important to take Pritor every day until your doctor tells you
otherwise. If you feel that the effect of Pritor is too strong or too weak, ask your
doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Pritor for most
patients is one 40 mg tablet once a day to control blood pressure for a
period of 24 hours. However, sometimes your doctor may advise a lower dose of
20 mg or a higher dose of 80 mg. Alternatively, Pritor can be used in association with
diuretics such as hydrochlorothiazide, for which an additive effect has been demonstrated in association with
Pritor in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Pritor is one 80 mg
tablet once a day. At the beginning of preventive therapy with Pritor 80 mg, blood pressure
must be checked frequently.
If your liver is not functioning properly, the usual dose of 40 mg per
day must not be exceeded.

If you take more Pritor than you should
If you have accidentally taken too many tablets, contact your doctor, pharmacist or
the emergency room of the nearest hospital immediately.

If you forget to take Pritor
If you forget to take the medicine, do not worry. Take it as soon as you remember, then
continue as before. If you miss a dose for one day, take the normal dose the next day. Do not
takea double dose to make up for missed 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 require immediate medical attention
You should see a doctor immediately if you experience any of the following symptoms:
Sepsis* (often called “blood infection” is a serious infection with an inflammatory response
throughout the body), rapid swelling of the skin and mucous membranes (angioedema); these effects
are rare (may affect up to 1 in 1,000 people), but extremely serious and
patients should stop taking the medicine and consult a doctor immediately. If
these effects are not treated they can be fatal.

Possible side effects of Pritor
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for the 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, sinusitis,
common cold), low red blood cell count (anemia), high potassium levels, difficulty
falling asleep, feeling sad (depression), fainting (syncope), feeling dizzy (vertigo), slow heartbeat
(bradycardia), low blood pressure (hypotension) in
patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension),
shortness of breath, cough, abdominal pain, diarrhea, stomach pain, bloated stomach, vomiting,
itchy skin, increased sweating, drug rash, back pain,
muscle cramps, muscle pain (myalgia), kidney impairment (including acute renal
failure), chest pain, feeling weak, increased creatinine levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood infection” is a serious infection with an inflammatory response
throughout the body that can lead to death), increased number of 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,
drowsiness, impaired vision, fast heartbeat (tachycardia), dry mouth,
stomach discomfort, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more
prone to experience this side effect), rapid swelling of the
skin and mucous membranes which can also be fatal (angioedema, including fatal outcome), eczema
(skin disease), skin redness, urticaria, severe drug rash, joint pain (arthralgia), pain in a limb, tendon pain, flu-like illness,
decreased hemoglobin (a blood protein), increased uric acid levels, increased
liver enzymes or creatine phosphokinase in the blood, low sodium levels.
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 occurred by chance or may be related to a currently
unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during the 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 side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pritor

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 pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from moisture. Only remove the Pritor tablet from the
blister immediately before taking it.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pritor contains
The active ingredient is telmisartan. Each tablet contains 40 mg of telmisartan.
The other ingredients are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420) and magnesium
stearate.

Description of Pritor and contents of the pack
Pritor 40 mg tablets are white, oblong in shape, with the code “51H” imprinted on one
side.
Pritor is available in blisters containing 14, 28, 30, 56, 90, 98 or 280 tablets or in divisible blisters
for unit dose containing 28 × 1 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België / Belgique / Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Lietuva
UAB Bayer
Tel. +370 52 33 68 68

България
Байер България ЕООД
Тел. +359 02 424 72 80

Luxembourg / Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Česká republika
Bayer s.r.o.
Tel: +420 266 101 111

Magyarország
Bayer Hungária Kft.
Tel.: +36-14 87-41 00

Danmark
Bayer A/S
Tlf: +45-45 23 50 00

Malta
Alfred Gera and Sons Ltd.
Tel: +356-21 44 62 05

Deutschland
Bayer Vital GmbH
Tel: +49-(0)214-30 513 48

Nederland
Bayer B.V.
Tel: +31-(0)297-28 06 66

Eesti
Bayer OÜ
Tel: +372 655 85 65

Norge
Bayer AS
Tlf. +47 23 13 05 00

Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 618 75 00

Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0

España
Bayer Hispania S.L.
Tel: +34-93-495 65 00

Polska
Bayer Sp. z o.o.
Tel.: +48-22-572 35 00

France
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54

Portugal
Bayer Portugal Lda
Tel: +351-21-416 42 00

Hrvatska
Bayer d.o.o.
Tel: +385-(0)1-6599 900

România
SC Bayer SRL
Tel.: +40 21 528 59 00

Ireland
Bayer Limited
Tel: +353-1-216-3300

Slovenija
Bayer d. o. o.
Tel.: +386-1-58 14 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2 59 21 31 11

Italia
Bayer S.p.A.
Tel: +39-02-397 81

Suomi/Finland
Bayer Oy
Puh/Tel.: +358-20 785 21

Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58

Sverige
Bayer AB
Tel: +46-(0)8-580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

United Kingdom (Northern Ireland)
Bayer AG
Tel: +44 (0) 118 206 3000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Pritor 80 mg tablets

telmisartan

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Pritor is and what it is used for
• 2. What you need to know before you take Pritor
• 3. How to take Pritor
• 4. Possible side effects
• 5. How to store Pritor
• 6. Contents of the pack and other information

1. What Pritor is and what it is used for

Pritor belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance present in the body that causes constriction of blood vessels, thereby increasing blood pressure. Pritor blocks the effect of angiotensin II, causing relaxation of blood vessels and thus reducing blood pressure.

Pritor is used forthe treatment of essential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not caused by other conditions. High blood pressure, if left untreated, can damage blood vessels in many organs and this can sometimes cause heart attack, heart or kidney failure, stroke or blindness. Normally, high blood pressure does not give symptoms before such damage occurs. Therefore, it is important to have your blood pressure measured regularly to check if it is within the normal range.

Pritor is also used toreduce cardiovascular events (e.g. heart attack or stroke) in adults at risk because their blood supply to the heart or legs is reduced or blocked or because they have had a stroke or have high-risk diabetes. Your doctor can tell you if you are at high risk for these events.

2. What you need to know before taking Pritor

Do not take Pritor

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months (it is best to avoid taking Pritor even in the early stages of pregnancy - see the Pregnancy section).
• if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you are in any of the conditions listed above, tell your doctor or pharmacist before taking
Pritor.

Warnings and precautions
Talk to your doctor before taking Pritor if you suffer from 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 of one or both kidneys).
• Liver diseases.
• Heart problems.
• Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to, for example, diuretic therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before taking Pritor:

• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• 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 what is stated under “Do not take Pritor”.
• if you are taking digoxin.

You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Pritor is not recommended in early pregnancy and should not be taken if
you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the Pregnancy section).
In case of surgery or anesthesia, you must inform your doctor that you are taking Pritor.
Pritor may be less effective in lowering blood pressure in patients of African ethnicity.

Children and adolescents
The use of Pritor is not recommended in children and adolescents under 18 years of age.

Other medicines and Pritor
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Your doctor may decide to change the dose of these other medicines or
take other precautions. In some cases it may be necessary to stop taking one
of these medicines. This applies especially to the medicines listed below, taken
simultaneously with Pritor:

• Medicines containing lithium to treat some types of depression.
• Medicines that can increase potassium levels in the blood such as salt substitutes containing potassium, potassium-sparing diuretics (some “diuretics”), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses together with Pritor, can induce excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also what is stated under: “Do not take Pritor” and “Warnings and precautions”).
• Digoxin.

The effect of Pritor may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs,
e.g. aspirin or ibuprofen) or corticosteroids.
Pritor may increase the effect of other medicines used to lower high blood pressure or of
medicines that can potentially lower blood pressure (e.g. baclofen, amifostine).
Furthermore, the lowering of blood pressure may be aggravated by alcohol, barbiturates, narcotics
or antidepressants. You may experience this lowering of blood pressure as dizziness when getting up
to your feet. Consult your doctor if you need to change the dose of other medicines while taking
Pritor.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). As a rule, your doctor will advise you to stop taking Pritor before
starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Pritor. Pritor is not recommended in early pregnancy and should not be taken if
you are pregnant for more than 3 months as it can
cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Pritor is not
recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
Some patients may experience undesirable effects, such as fainting or a feeling of dizziness
(vertigo) when taking Pritor. If you experience these undesirable effects, do not drive or
use machines.

Pritor contains sorbitol
This medicine contains 337.28 mg of sorbitol per tablet. Sorbitol is a source of fructose.
If your doctor has told you that you are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize
fructose, talk to your doctor before taking this medicine.

Pritor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Pritor

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet a day. Try to take the tablet at the same time
every day.
You can take Pritor with or without food. The tablets must be swallowed whole with some water
or other non-alcoholic beverage. It is important to take Pritor every day until your doctor tells you
otherwise. If you feel that the effect of Pritor is too strong or too weak, consult your
doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Pritor for most
patients is one 40 mg tablet once a day to control blood pressure for a
period of 24 hours. However, sometimes your doctor may advise a lower dose of
20 mg or a higher dose of 80 mg. Alternatively, Pritor can be used in association with
diuretics such as hydrochlorothiazide, for which an additive effect has been demonstrated in association with
Pritor in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Pritor is one 80 mg
tablet once a day. At the beginning of preventive therapy with Pritor 80 mg, blood
pressure should be checked frequently.
If your liver is not functioning properly, the usual dose of 40 mg per
day should not be exceeded.

If you take more Pritor than you should
If you have accidentally taken too many tablets, contact your doctor, pharmacist or
the emergency room of the nearest hospital immediately.

If you forget to take Pritor
If you forget to take the medicine, do not worry. Take it as soon as you remember, then
continue as before. If you miss a dose for one day, take the normal dose the next day. Do not
takea double dose to make up for missed 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 require immediate medical attention
You should seek immediate medical attention if you experience any of the following symptoms:
Sepsis* (often called “blood poisoning” is a serious infection with inflammatory response of the
entire organism), rapid swelling of the skin and mucous membranes (angioedema); these side
effects are rare (may affect up to 1 in 1,000 people), but extremely serious and patients must stop
taking the medicine and consult a doctor immediately. If these effects are not treated they can be fatal.

Possible side effects of Pritor
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for the 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, sinusitis,
common cold), deficiency of red blood cells (anemia), high levels of potassium, difficulty
falling asleep, feeling sad (depression), fainting (syncope), feeling dizzy (vertigo), slowed
heartbeat (bradycardia), low blood pressure (hypotension) in patients treated for high blood
pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal
pain, diarrhea, stomach pain, bloated stomach, vomiting, feeling itchy, increased sweating, drug
rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment (including acute
renal failure), chest pain, feeling weak, increased levels of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood poisoning” is a serious infection with inflammatory response of the
entire organism that can lead to death), increase in some 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, drowsiness, impaired
vision, fast heartbeat (tachycardia), dry mouth, stomach discomfort, taste disturbance (dysgeusia),
abnormal liver function (Japanese patients are more likely to experience this side effect), rapid
swelling of the skin and mucous membranes which can also be fatal (angioedema, including fatal
outcome), eczema (skin disease), skin redness, urticaria, severe drug eruption, joint pain
(arthralgia), pain in a limb, tendon pain, flu-like illness, decreased hemoglobin (a blood
protein), increased levels of uric acid, increased liver enzymes or creatine phosphokinase in the
blood, low levels of sodium.
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 occurred by chance or may be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during the 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 side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
listed in Annex V. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Pritor

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 pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from moisture. Only remove the Pritor tablet from the
blister immediately before taking it.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pritor contains
The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.
The other ingredients are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420) and magnesium
stearate.

Description of the appearance of Pritor and contents of the pack
Pritor 80 mg tablets are white, oblong-shaped, with the code “52H” imprinted on one
side.
Pritor is available in blisters containing 14, 28, 30, 56, 90, 98 or 280 tablets or in divisible blisters
for unit dose containing 28 × 1 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België / Belgique / Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Lietuva
UAB Bayer
Tel. +370 52 33 68 68

България
Байер България ЕООД
Тел. +359 02 424 72 80

Luxembourg / Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Česká republika
Bayer s.r.o.
Tel: +420 266 101 111

Magyarország
Bayer Hungária Kft.
Tel.: +36-14 87-41 00

Danmark
Bayer A/S
Tlf: +45-45 23 50 00

Malta
Alfred Gera and Sons Ltd.
Tel: +356-21 44 62 05

Deutschland
Bayer Vital GmbH
Tel: +49-(0)214-30 513 48

Nederland
Bayer B.V.
Tel: +31-(0)297-28 06 66

Eesti
Bayer OÜ
Tel: +372 655 85 65

Norge
Bayer AS
Tlf. +47 23 13 05 00

Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 618 75 00

Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0

España
Bayer Hispania S.L.
Tel: +34-93-495 65 00

Polska
Bayer Sp. z o.o.
Tel.: +48-22-572 35 00

France
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54

Portugal
Bayer Portugal Lda
Tel: +351-21-416 42 00

Hrvatska
Bayer d.o.o.
Tel: +385-(0)1-6599 900

România
SC Bayer SRL
Tel.: +40 21 528 59 00

Ireland
Bayer Limited
Tel: +353-1-216-3300

Slovenija
Bayer d. o. o.
Tel.: +386-1-58 14 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2 59 21 31 11

Italia
Bayer S.p.A.
Tel: +39-02-397 81

Suomi/Finland
Bayer Oy
Puh/Tel.: +358-20 785 21

Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58

Sverige
Bayer AB
Tel: +46-(0)8-580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

United Kingdom (Northern Ireland)
Bayer AG
Tel: +44 (0) 118 206 3000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .