TOLURA 20 mg Tabletka

Treść ulotki

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

Tolura 40 mg tablets

telmisartan

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

1. What is Tolura and what is it used for

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

Tolura 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, which 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.

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

2. What you need to know before taking Tolura

Do not take Tolura

• 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 Tolura 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 impaired kidney function and are being treated with a medicine that lowers blood pressure, containing aliskiren. If you are in any of the above conditions, tell your doctor or pharmacist before taking Tolura.

Warnings and precautions
Consult your doctor if you suffer from or have ever suffered from any of the following conditions or diseases:

• Kidney disease or kidney transplant.
• Stenosis of the renal artery (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 loss of water from the body) or have a salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult your doctor before taking Tolura:

• if you are taking digoxin.
• 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. You should tell your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). Tolura 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 administration of anesthetics, you must inform your doctor that you are taking Tolura. Tolura may be less effective in lowering blood pressure in patients of African ethnicity. 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 Tolura".

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

Other medicines and Tolura
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 Tolura:

• 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 antagonists, 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 with Tolura, 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 Tolura" and "Warnings and precautions”).
• Digoxin. The effect of Tolura may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids. Tolura may increase the effect of other medicines used to lower blood pressure or 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 Tolura. Pregnancy and breastfeedingPregnancy Tell your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). As a rule, your doctor will advise you to stop taking Tolura before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Tolura. Tolura 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 if you are planning to start breastfeeding. Tolura 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 machinesSome patients may experience dizziness or drowsiness when taking Tolura. If you experience these effects, do not drive or use machines. Tolura contains lactose and sorbitol (E420)If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine. This medicine contains 149.8 mg 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 where patients are unable to break down fructose, talk to your doctor before you take this medicine.

3. How to take Tolura

Take Tolura following the instructions of your doctor exactly. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose of Tolura is one tablet a day. Try to take the tablet at the
same time each day.
You can take Tolura with or without food. The tablets must be swallowed with some water or
another non-alcoholic beverage. It is important to take Tolura every day until your doctor tells you
otherwise. If you feel that the effect of Tolura is too strong or too weak, talk to
your doctor or pharmacist.
For the treatment of high blood pressure, the recommended dose of Tolura for most
patients is one 40 mg tablet a day to control blood pressure for a
period of 24 hours. However, sometimes your doctor may prescribe a lower dose of 20 mg or
a higher dose of 80 mg. Tolura tablets cannot be divided, therefore they are not
suitable for patients who require a 20 mg dose of telmisartan. For these patients, an equivalent
product with the same active ingredient is available.
Tolura can also be used in combination with diuretics such as hydrochlorothiazide, for which an additive effect has been demonstrated with the association with Tolura in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once
a day. At the beginning of preventive therapy with Tolura 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 Tolura than you should
If you have accidentally taken too many tablets, contact your doctor or pharmacist immediately,
or the emergency room of the nearest hospital.

If you forget to take Tolura
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 a missed dose.
If you have any questions 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 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 Tolura:
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), reduced red blood cells (anemia), high levels of potassium in the blood, difficulty
falling asleep, feeling of sadness (depression), fainting (syncope), feeling of
dizziness (vertigo), slowed heartbeat (bradycardia), low blood pressure (hypotension) in patients
treated for high blood pressure, feeling unstable when standing up (orthostatic hypotension), shortness
of breath, cough, abdominal pain, diarrhea, abdominal discomfort, swelling, vomiting, itching, increased
sweating, drug-related skin 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 an inflammatory response
throughout the body that can lead to death), increased levels of certain white blood cells (eosinophilia),
low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic
reaction (e.g. rash (skin eruption), itching, difficulty breathing, wheezing, swelling of the
face or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety,
drowsiness, vision changes, fast heartbeat (tachycardia), dry mouth, stomach discomfort, altered
taste (dysgeusia), altered liver function (patients of Japanese origin are more prone to experience
this side effect), rapid swelling of the skin and mucous membranes which can also lead to death
(angioedema, including fatal outcome), eczema (skin disorder), skin redness (urticaria), severe
drug-related skin rash, joint pain (arthralgia), pain in the extremities, tendon pain, flu-like illness,
decreased hemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or
creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people): Progressive
scarring of lung tissue (interstitial lung disease)**.
* The event may have 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 Tolura

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 package and blister after
Expiry Date/Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from light.
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 Tolura contains

• The active ingredient is telmisartan. Each tablet contains 40 mg of telmisartan.
• The other ingredients are povidone, meglumine, sodium hydroxide, lactose monohydrate, sorbitol (E420) and magnesium stearate. See paragraph 2 'Tolura contains lactose and sorbitol (E420)'. Description of the appearance of Tolura and contents of the packTolura 40 mg tablets are white to off-white, biconvex, oval tablets. Tolura is available in blisters containing 14, 28, 30, 56, 84, 90, 98 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., Ul. Równoległa 5, 02-235 Warszawa, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: +370 5 236 27 40

България
КРКА България ЕООД
Teл.: +359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: +420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: +36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: +46 (0)8 643 67 66 (SE)

Malta
E.J. Busuttil Ltd.
Tel: +356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: +49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: +372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: +46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: +43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: +48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: +351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Slovenija
KRKA, d.d., Novo mesto
Tel: +386 (0) 1 47 51 100

Ísland
LYFIS ehf.

Slovenská republika
KRKA Slovensko, s.r.o.
Sími: +354 534 3500 Tel: +421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: +357 24 651 882

Sverige
KRKA Sverige AB
Tel: +46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: +371 6 733 86 10

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

Tolura 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 they have the same symptoms as you, as it may 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 Tolura is and what it is used for
• 2. What you need to know before you take Tolura
• 3. How to take Tolura
• 4. Possible side effects
• 5. How to store Tolura
• 6. Contents of the pack and other information

1. What is Tolura and what is it used for

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

Tolura 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, which 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.

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

2. What you need to know before taking Tolura

Do not take Tolura

• 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 Tolura 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 impaired kidney function and are being treated with a medicine that lowers blood pressure, containing aliskiren. If you are in any of the above conditions, tell your doctor or pharmacist before taking Tolura.

Warnings and precautions
Talk to your doctor 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 loss of water from the body) or have a salt deficiency due to diuretic therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before taking Tolura:

• if you are taking digoxin.
• 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. You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Tolura is not recommended in early 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 administration of anesthetics, you must inform your doctor that you are taking Tolura. Tolura may be less effective in reducing blood pressure in patients of African ethnicity. 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 Tolura".

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

Other medicines and Tolura
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 Tolura:

• 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 antagonists, 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 with Tolura, 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 Tolura" and "Warnings and precautions”).
• Digoxin. The effect of Tolura may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids. Tolura may increase the effect of other medicines used to lower blood pressure or 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 Tolura. Pregnancy and breastfeedingPregnancy Tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Usually your doctor will advise you to stop taking Tolura before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Tolura. Tolura is not recommended in early 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. Tolura 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 machinesSome patients may experience dizziness or drowsiness when taking Tolura. If you experience these effects, do not drive or use machines. Tolura contains lactose and sorbitol (E420)If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains 299.7 mg sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic illness where patients are unable to break down fructose, talk to your doctor before you take this medicine.

3. How to take Tolura

Take Tolura following the instructions of your doctor exactly. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose of Tolura is one tablet a day. Try to take the tablet at the
same time each day.
You can take Tolura with or without food. The tablets must be swallowed with a little water or
another non-alcoholic beverage. It is important to take Tolura every day until your doctor tells you
otherwise. If you feel that the effect of Tolura is too strong or too weak, talk to
your doctor or pharmacist.
For the treatment of high blood pressure, the recommended dose of Tolura for most
patients is one 40 mg tablet a day to control blood pressure for a
period of 24 hours. However, sometimes your doctor may prescribe a lower dose of 20 mg or
a higher dose of 80 mg. Tolura tablets cannot be divided, therefore they are not
suitable for patients who require a 20 mg dose of telmisartan. For these patients, an equivalent
product with the same active ingredient is available.
Tolura can also be used in combination with diuretics such as hydrochlorothiazide, for which an additive effect has been demonstrated with the association with Tolura in terms of blood pressure reduction.
For the reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once a
day. At the beginning of preventive therapy with Tolura 80 mg, blood pressure must 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 Tolura than you should
If you have accidentally taken too many tablets, contact your doctor or pharmacist immediately,
or the emergency room of the nearest hospital.

If you forget to take Tolura
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 one day, take the normal dose the next day. Do not
takea double dose to make up for a missed dose.
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 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 Tolura:
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), reduced red blood cells (anemia), high levels of potassium in the blood, 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, feeling
unstable when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain,
diarrhea, abdominal discomfort, swelling, vomiting, 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 an inflammatory response
throughout the body that can lead to death), increased levels 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, changes in
vision, fast heartbeat (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), altered
liver function (the liver), (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 disorder), skin redness (urticaria), severe drug rash, joint pain (arthralgia),
pain in the extremities, tendon pain, flu-like illness, decreased hemoglobin (a blood protein),
increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of the 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, even those not listed in this leaflet, tell your doctor or pharmacist.
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 Tolura

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 package and blister after
Expiry Date/Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from light.
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. Package contents and other information

What Tolura contains

• The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.
• The other ingredients are povidone, meglumine, sodium hydroxide, lactose monohydrate, sorbitol (E420) and magnesium stearate. See section 2 'Tolura contains lactose and sorbitol (E420)'. Description of the appearance of Tolura and package contentsTolura 80 mg tablets are white to off-white, biconvex, capsule-shaped tablets. Tolura is available in blisters containing 14, 28, 30, 56, 84, 90, 98 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., Ul. Równoległa 5, 02-235 Warszawa, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: +370 5 236 27 40

България
КРКА България ЕООД
Teл.: +359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: +420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: +36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: +46 (0)8 643 67 66 (SE)

Malta
E.J. Busuttil Ltd.
Tel: +356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: +49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: +372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: +46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: +43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: +48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: +351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Slovenija
KRKA, d.d., Novo mesto
Tel: +386 (0) 1 47 51 100

Ísland
LYFIS ehf.

Slovenská republika
KRKA Slovensko, s.r.o.
Sími: +354 534 3500
Tel: +421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: +357 24 651 882

Sverige
KRKA Sverige AB
Tel: +46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: +371 6 733 86 10

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .