KINZALMONO 40 mg Coated Tablet

Зміст інструкції

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

Kinzalmono 20 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 Kinzalmono is and what it is used for
• 2. What you need to know before you take Kinzalmono
• 3. How to take Kinzalmono
• 4. Possible side effects
• 5. How to store Kinzalmono
• 6. Contents of the pack and other information

1. What is Kinzalmono and what it is used for

Kinzalmono 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. Kinzalmono blocks the effect of angiotensin II, causing relaxation of the blood vessels and thus reducing blood pressure.

Kinzalmono is used forthe treatment of essential (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.

Kinzalmono 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 Kinzalmono

Do not take Kinzalmono

• 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 Kinzalmono 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
Kinzalmono.

Warnings and precautions
Talk to your doctor before taking Kinzalmono if you suffer from or have ever suffered from any of the
following conditions or diseases:

• 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, diarrhoea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before taking Kinzalmono:

• 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 Kinzalmono”.
• 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). Kinzalmono 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 during this period (see the Pregnancy section).
In case of surgery or anaesthesia, you must inform your doctor that you are taking Kinzalmono.
Kinzalmono may be less effective in lowering blood pressure in patients of African ethnicity.

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

Other medicines and Kinzalmono
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. 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 Kinzalmono:

• Medicines containing lithium to treat certain 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 in high doses together with Kinzalmono, can cause 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 Kinzalmono” and “Warnings and precautions”).
• Digoxin.

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

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 Kinzalmono
before starting pregnancy or as soon as you find out you are pregnant and
will advise you to take another medicine instead of Kinzalmono. Kinzalmono 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. Kinzalmono
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 feeling dizzy
(vertigo) when taking Kinzalmono. If you experience these undesirable effects, do not drive or
use machines.

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

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

3. How to take Kinzalmono

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 Kinzalmono with or without food. The tablets must be swallowed whole with a little
water or other non-alcoholic beverage. It is important to take Kinzalmono every day until your
doctor tells you otherwise. If you feel that the effect of Kinzalmono is too strong or
too weak, consult your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Kinzalmono for most
patients is one 40 mg tablet once a day to control blood pressure
for a period of 24 hours. Your doctor has recommended a lower dose of 20 mg per day.
Kinzalmono can also be used in association with diuretics such as hydrochlorothiazide, for which
an additive effect has been demonstrated in association with Kinzalmono in terms of reducing
blood pressure.
For the reduction of cardiovascular events, the usual dose of Kinzalmono is one tablet from
80 mg once a day. At the beginning of prevention therapy with Kinzalmono 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 Kinzalmono 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 Kinzalmono
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 doubts about 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 may 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 infection” is a serious infection with inflammatory response
throughout the body), 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 Kinzalmono
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), impaired kidney function (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 inflammatory response
throughout the body that can lead to death), increased number of 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 prone to experience 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,
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 indicated in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Kinzalmono

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. Remove the Kinzalmono
tablet from the blister only 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 Kinzalmono 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 Kinzalmono and contents of the pack
Kinzalmono 20 mg tablets are white, round, with the code “50H” imprinted on one side.
Kinzalmono is available in blisters containing 14, 28, 56 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 .

Kinzalmono 40 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 Kinzalmono is and what it is used for
• 2. What you need to know before you take Kinzalmono
• 3. How to take Kinzalmono
• 4. Possible side effects
• 5. How to store Kinzalmono
• 6. Contents of the pack and other information

1. What is Kinzalmono and what it is used for

Kinzalmono 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. Kinzalmono blocks the effect of angiotensin II, causing a relaxation of the blood vessels and thus reducing blood pressure.

Kinzalmono 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.

Kinzalmono 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 Kinzalmono

Do not take Kinzalmono

• 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 Kinzalmono 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
Kinzalmono.

Warnings and precautions
Talk to your doctor before taking Kinzalmono if you suffer from or have ever suffered from any of the
following conditions or diseases:

• 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 Kinzalmono:

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

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

Other medicines and Kinzalmono
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. 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 Kinzalmono:

• Medicines containing lithium to treat certain 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 in high doses together with Kinzalmono, 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 Kinzalmono” and “Warnings and precautions”).
• Digoxin.

The effect of Kinzalmono may be reduced when you take NSAIDs (non-steroidal anti-inflammatory
drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Kinzalmono can 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. Consult your doctor if you need to change the dose of other
medicines while taking Kinzalmono.

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 Kinzalmono
before starting a pregnancy or as soon as you find out you are pregnant and
will advise you to take another medicine instead of Kinzalmono. Kinzalmono is not
recommended in the early stages of pregnancy and must 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. Kinzalmono
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 operating machinery
Some patients may experience undesirable effects, such as fainting or dizziness (vertigo) when taking Kinzalmono. If you experience these undesirable effects, do not drive or
operate machinery.

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

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

3. How to take Kinzalmono

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 Kinzalmono with or without food. The tablets must be swallowed whole with a little
water or other non-alcoholic beverage. It is important to take Kinzalmono every day until your
doctor tells you otherwise. If you feel that the effect of Kinzalmono is too strong or
too weak, consult your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Kinzalmono 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, Kinzalmono may be used in association
with diuretics such as hydrochlorothiazide, for which an additive effect has been demonstrated in association
with Kinzalmono in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Kinzalmono is one tablet of
80 mg once a day. At the beginning of preventive therapy with Kinzalmono 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 Kinzalmono 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 Kinzalmono
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 doubts about 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 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 Kinzalmono
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 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 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. skin 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, including 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 side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Kinzalmono

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. Remove the Kinzalmono
tablet from the blister only 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 Kinzalmono 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 the appearance of Kinzalmono and contents of the pack
Kinzalmono 40 mg tablets are white, oblong in shape, with the code “51H” imprinted on
one side.
Kinzalmono is available in blisters containing 14, 28, 56 or 98 tablets or in unit-dose divisible blisters
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 .

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

1. What is Kinzalmono and what it is used for

Kinzalmono 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. Kinzalmono blocks the effect of angiotensin II, causing relaxation of the blood vessels and thus reducing blood pressure.

Kinzalmono 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.

Kinzalmono 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 Kinzalmono

Do not take Kinzalmono

• 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 Kinzalmono 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
Kinzalmono.

Warnings and precautions
Talk to your doctor before taking Kinzalmono if you suffer from or have ever suffered from any of the
following conditions or diseases:

• 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 Kinzalmono:

• 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 Kinzalmono”.
• 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). Kinzalmono 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 during this period (see the Pregnancy section).
In case of surgery or anesthesia, you must inform the doctor that you are taking Kinzalmono.
Kinzalmono may be less effective in reducing blood pressure in patients of African ethnicity.

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

Other medicines and Kinzalmono
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. 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 in particular to the medicines listed below, taken
simultaneously with Kinzalmono:

• Medicines containing lithium to treat certain 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 Kinzalmono, 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 Kinzalmono” and “Warnings and precautions”).
• Digoxin.

The effect of Kinzalmono may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Kinzalmono may increase the effect of other medicines used to reduce 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 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 Kinzalmono.

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 Kinzalmono
before starting a pregnancy or as soon as you find out you are pregnant and
will advise you to take another medicine instead of Kinzalmono. Kinzalmono 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. Kinzalmono
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 side effects such as fainting or dizziness when taking Kinzalmono. If you experience these side effects, do not drive or
use machines.

Kinzalmono 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.

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

3. How to take Kinzalmono

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 daily. Try to take the tablet at the same time
each day.
You can take Kinzalmono with or without food. The tablets must be swallowed whole with some
water or other non-alcoholic beverage. It is important to take Kinzalmono every day until your
doctor tells you otherwise. If you feel that the effect of Kinzalmono is too strong or
too weak, consult your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Kinzalmono 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, Kinzalmono may be used in association
with diuretics such as hydrochlorothiazide, for which an additive effect has been demonstrated in association
with Kinzalmono in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Kinzalmono is one tablet of
80 mg once a day. At the beginning of preventive therapy with Kinzalmono 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 Kinzalmono 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 Kinzalmono
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 everyone will experience them.

Some side effects may be serious and require immediate medical attention
You should immediately see a doctor 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 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 Kinzalmono
Common side effects (may occur in up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for the reduction of cardiovascular
events.
Uncommon side effects (may occur in 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 potassium levels, 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 creatinine levels in the blood.
Rare side effects (may occur in 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., skin 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 experience this side effect), rapid swelling of the
skin and mucous membranes which can also be fatal (angioedema, even with a fatal outcome), eczema
(skin disease), skin redness, urticaria, severe drug-related skin 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 occur in 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 experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kinzalmono

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. Remove the Kinzalmono
tablet from the blister only 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 Kinzalmono 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 Kinzalmono and contents of the pack
Kinzalmono 80 mg tablets are white, oblong in shape, with the code “52H” imprinted on
one side.
Kinzalmono is available in blisters containing 14, 28, 56 or 98 tablets or in divisible unit-dose blisters
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 .