Tolura

Italy
Brand name Tolura
Form tablets
Active substance / Dosage
TELMISARTAN
Prescription type Prescription only
ATC code
C09CA07
Registration number 042284
Manufacturer KRKA D.D. NOVO MESTO
Tolura tablets

Table of Contents

Package leaflet: Information for the user

Tolura 40 mg tablets

telmisartan
Please read all of this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Tolura is and what it is used for

Tolura belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Tolura blocks the effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
Tolura is used to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by other conditions.
If left untreated, high blood pressure can damage blood vessels in many organs, which may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
Tolura is also used to reduce 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 determine whether you are at high risk of such events.

2. What you need to know before taking Tolura

Do not take Tolura

  • if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6).
  • if you are more than 3 months pregnant (it is better to avoid taking Tolura even in the early stages of pregnancy – see section Pregnancy).
  • if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
  • if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren. If you are in any of the above conditions, inform your doctor or pharmacist before taking Tolura.

Warnings and precautions
Talk to your doctor if you have or have ever had any of the following conditions or diseases:

  • Kidney disease or kidney transplant.
  • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
  • Liver diseases.
  • Heart problems.
  • Increased levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
  • Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ("diuretics"), low-salt diet, diarrhoea 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" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren. You must inform your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). Tolura is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy). If undergoing surgery or receiving anaesthetics, inform your doctor that you are taking Tolura. Tolura may be less effective in lowering blood pressure in patients of African origin. Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g. potassium) in your blood at regular intervals.

See also the information under the heading "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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may decide to adjust the dose of these other medicines or take additional precautions. In some cases, it may be necessary to stop taking one of these medicines. This particularly applies to the following medicines when taken at the same time as Tolura:

  • Medicines containing lithium used to treat certain types of depression.
  • Medicines that may 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 medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
  • Diuretics, especially when taken at high doses together with Tolura, may 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 Tolura" and "Warnings and precautions").
  • Digoxin. The effect of Tolura may be reduced when taking NSAIDs (non-steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids. Tolura may enhance the effect of other medicines used to lower blood pressure or medicines that may potentially reduce blood pressure (e.g. baclofen, amifostine). In addition, lowering of blood pressure may be worsened by alcohol, barbiturates, narcotics or antidepressants. You may experience this drop in blood pressure as dizziness when standing up. Consult your doctor if you need to adjust the dose of other medicines while taking Tolura. Pregnancy and breastfeeding Pregnancy Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will normally advise you to stop taking Tolura before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Tolura. Tolura is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy. Breastfeeding Inform your doctor if you are breastfeeding or planning to breastfeed. 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 a newborn or was born prematurely. Driving and using machines Some patients may experience dizziness or drowsiness when taking Tolura. If you experience these effects, do not drive or operate machinery. Tolura contains lactose and sorbitol (E420) If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains 149.8 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you have fructose intolerance, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.

3. How to take Tolura

Take Tolura exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose of Tolura is one tablet daily. Try to take the tablet at the same time each day.
You may take Tolura with or without food. Swallow the tablets with a little water or another non-alcoholic drink. It is important to take Tolura every day unless 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 daily to control blood pressure over a 24-hour period. 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 requiring a 20 mg dose of telmisartan. For these patients, an equivalent product containing the same active substance is available.
Tolura may also be used in combination with diuretics such as hydrochlorothiazide, with which it has been shown to have an additive effect in lowering blood pressure.
For reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once daily. During the initial phase of preventive treatment with Tolura 80 mg, blood pressure should be monitored frequently.
If your liver is not functioning properly, the usual daily dose of 40 mg must not be exceeded.
If you take more Tolura than you should
If you have taken too many tablets by mistake, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department.
If you forget to take Tolura
If you forget to take your medicine, do not worry. Take it as soon as you remember, then continue as before. If you miss a day's dose, take your normal dose the next day. Do not take a double dose to make up for the forgotten dose.
If you have any questions about the use of this medicine, consult 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 treatment:
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection" – a severe infection with an inflammatory response affecting the whole body), 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 their 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 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 (anaemia), high levels of potassium in the blood, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), sensation of dizziness (vertigo), slowed heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling of instability upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-related skin rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney 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" – a severe infection with an inflammatory response affecting the whole body that may 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, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, vision disturbances, rapid heartbeat (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), altered liver function (Japanese patients are more predisposed to this side effect), rapid swelling of the skin and mucous membranes which may also be fatal (angioedema, including fatal outcome), eczema (skin disorder), redness of the skin (urticaria), severe drug-related skin rash, joint pain (arthralgia), pain in the extremities, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase levels 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 mechanism currently unknown.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and blister after
Exp./Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via 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 substance is telmisartan. Each tablet contains 40 mg of telmisartan.
  • The other components 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 contents of the pack Tolura 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 Authorization 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 Authorization Holder:
Belgium/Belgium/Belgium Lithuania
KRKA Belgium, SA. UAB KRKA Lietuva
Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40
Bulgaria Luxembourg/Luxembourg
KRKA Bulgaria EOOD KRKA Belgium, SA.
Tel: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)
Czech Republic Hungary
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel: + 36 (1) 355 8490
Denmark Malta
KRKA Sverige AB E.J. Busuttil Ltd.
Tel: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885
Germany Netherlands
TAD Pharma GmbH KRKA Belgium, SA.
Tel: + 49 (0) 4721 606-0 Tel: + 32 (0) 487 50 73 62 (BE)
Estonia Norway
KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB
Tel: + 372 (0) 6 671 658 Tel: + 46 (0)8 643 67 66 (SE)
Greece Austria
KRKA ELLAS EPE KRKA Pharma GmbH, Vienna
Tel: + 30 2100101613 Tel: + 43 (0)1 66 24 300
Spain Portugal
KRKA Farmacéutica, S.L. KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 34 911 61 03 80 Tel: + 351 (0)21 46 43 650
France Romania
KRKA France Eurl KRKA Romania S.R.L., Bucharest
Tel: + 33 (0)1 57 40 82 25 Tel: + 4 021 310 66 05
Croatia Ireland
KRKA - FARMA d.o.o. KRKA Pharma Dublin, Ltd.
Tel: + 385 1 6312 100 Tel: + 353 1 413 3710
Iceland Slovenia
LYFIS ehf. KRKA, d.d., Novo mesto
Tel: + 354 534 3500 Tel: + 386 (0) 1 47 51 100
Latvia Slovakia
KRKA Latvija SIA KRKA Slovensko, s.r.o.
Tel: + 371 6 733 86 10 Tel: + 421 (0) 2 571 04 501
Italy Finland
KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy
Tel: + 39 02 3300 8841 Tel: + 358 20 754 5330
Cyprus Sweden
KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB
Tel: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)
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 .

Package leaflet: information for the user

Tolura 80 mg tablets

telmisartan
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 Tolura is and what it is used for

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

Tolura is used for the treatment of essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by other conditions.

If left untreated, high blood pressure can damage blood vessels in various organs, which may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage has occurred. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.

Tolura is also used for reducing 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 who have high-risk diabetes. Your doctor can determine whether you are at high risk for these events.

2. What you need to know before taking Tolura

Do not take Tolura

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

Warnings and precautions
Talk to your doctor if you have or have ever had any of the following conditions or diseases:

  • Kidney disease or kidney transplant.
  • Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
  • Liver diseases.
  • Heart problems.
  • Increased levels of aldosterone (water and salt retention in the body with imbalance of various minerals in the blood).
  • Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ("diuretics"), a low-salt diet, diarrhoea 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 have kidney problems related to diabetes.
  • aliskiren. You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Tolura is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy). If undergoing surgery or receiving anaesthetics, you must inform your doctor that you are taking Tolura. Tolura may be less effective in lowering blood pressure in patients of African origin. Your doctor may check your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.

See also information under the heading "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 medicines. Your doctor may decide to adjust 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 following medicines when taken concomitantly with Tolura:

  • Medicines containing lithium used to treat certain types of depression.
  • Medicines that may 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 when taken at high doses together with Tolura, may cause excessive loss of body water and low blood pressure (hypotension).
  • If you are taking an ACE inhibitor or aliskiren (see also information 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 enhance the effect of other medicines used to lower blood pressure or medicines that may potentially lower blood pressure (e.g. baclofen, amifostine). In addition, the lowering of blood pressure may be worsened by alcohol, barbiturates, narcotics or antidepressants. You may experience this drop in blood pressure as dizziness when standing up. Consult your doctor if you need to adjust the dose of your other medicines while taking Tolura. Pregnancy and breastfeeding Pregnancy Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Tolura before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Tolura. Tolura is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy. Breastfeeding Inform your doctor if you are breastfeeding or planning to breastfeed. 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 a newborn or was born prematurely. Driving and using machines Some patients may experience dizziness or drowsiness while taking Tolura. If you experience these effects, do not drive or operate machinery. Tolura contains lactose and sorbitol (E420) If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. This medicine contains 299.7 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 been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.

3. How to take Tolura

Take Tolura exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose of Tolura is one tablet daily. Try to take the tablet at the same time each day.
You may take Tolura with or without food. The tablets should be swallowed with a glass of water or
another non-alcoholic drink. It is important to take Tolura every day unless 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 daily to control blood pressure over a 24-hour period. However, your doctor may sometimes
prescribe a lower dose of 20 mg or a higher dose of 80 mg. Tolura tablets cannot be divided and are
therefore not suitable for patients requiring a 20 mg dose of telmisartan. For these patients, an equivalent
product containing the same active substance is available.
Tolura may also be used in combination with diuretics such as hydrochlorothiazide, with which it has
been shown to have an additive effect in reducing blood pressure.
For reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once daily. At the
start of preventive treatment with Tolura 80 mg, blood pressure should be monitored frequently.
If your liver is not functioning properly, the usual dose of 40 mg daily should not be exceeded.
If you take more Tolura than you should
If you accidentally take too many tablets, contact your doctor or pharmacist immediately, or go to the
nearest hospital emergency department.
If you forget to take Tolura
If you forget to take your dose, do not worry. Take it as soon as you remember, then continue as before.
If you miss a day's dose, take your normal dose the next day. Do not take a double dose to make up for
the missed dose.
If you have any questions about the use of this medicine, consult 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 treatment:
You must immediately contact your doctor if you experience any of the following symptoms:
Sepsis* (often called "blood infection" – a severe infection with a systemic inflammatory response), 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 their doctor immediately. If these effects are not treated, they may 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 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 (anaemia), high levels of potassium in the blood, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), sensation of dizziness (vertigo), slowed heartbeat (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling of instability upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-related skin rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney 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” – a severe infection with systemic inflammatory response that may lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, vision disturbances, rapid heartbeat (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), altered liver function (patients of Japanese origin are more likely to experience this side effect), rapid swelling of the skin and mucous membranes which may also be fatal (angioedema, including fatal outcomes), eczema (skin disorder), redness of the skin (urticaria), severe drug-related skin rash, joint pain (arthralgia), pain in the extremities, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased levels of uric acid, 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 treatment with telmisartan. However, it is not known whether telmisartan was the cause.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and blister after
Exp./Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tolura contains

  • The active substance is telmisartan. Each tablet contains 80 mg of telmisartan.
  • The other components 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 the contents of the pack
Tolura 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

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

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

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

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

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

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

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

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

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

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

Ísland
LYFIS ehf.
Sími: + 354 534 3500

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

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