40 mg, 80 mg tablets
telmisartan
What Tolura is and what it is used for
Tolura belongs to a group of medicines called angiotensin II inhibitors. Angiotensin II is a body-specific substance that causes the blood vessels to constrict, leading to a rise in blood pressure. Tolura inhibits this effect of angiotensin II, which leads to the dilation of the blood vessels and lowering of blood pressure et al.
Tolura is used to treat elevated blood pressure, so-called essential hypertension in adults. Essential means that high blood pressure is not caused by any other disease.
High blood pressure that is not treated can cause damage to the blood vessels in several organs. This can lead to heart attacks, heart or kidney failure, stroke, or blindness. Most of the time, high blood pressure causes no symptoms before the damage occurs. It is therefore important to regularly measure blood pressure et to check if it is within normal values.
Tolura is also used to reduce the number of cardiovascular events (such as heart attack or stroke/bleeding in the brain) in adults who are at risk because of reduced or blocked blood supply to the heart or legs, or who have had a stroke or have high-risk diabetes. Your doctor can tell you if you are at high risk of such events.
What you need to know before you use Tolura
Do not use Tolura
- if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
- pregnant women should not use Tolura during the last 6 months of pregnancy. (Even earlier in pregnancy it is good to avoid Tolura, see Pregnancy and breastfeeding).
- if you have severe liver problems such as cholestasis or biliary obstruction (problems with the outflow of bile from the liver and gallbladder) or any other severe liver disease.
- if you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.
If any of the above apply to you, tell your doctor or pharmacist before using Tolura.
Warnings and precautions
Talk to your doctor if you have or have had any of the following diseases or conditions:
- Kidney disease or kidney transplant.
- Renal artery stenosis (narrowing of the blood vessels in one or both kidneys).
- Liver disease.
- Heart problems.
- Increased aldosterone levels (water or salt accumulations in the body and altered mineral balance in the blood).
- Low blood pressure ( hypotension ), can occur if you are dehydrated (have lost a lot of body fluid) or have a lack of salt due to diuretic treatment (water-reducing treatment), a diet with low salt intake, diarrhea, or vomiting.
- High level of potassium in the blood.
- Diabetes.
Talk to your doctor before taking Tolura:
- if you take digoxin.
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- the aliskiren
If you think you are pregnant (or become pregnant) during treatment, contact your doctor. Tolura is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it can then cause birth defects, see Pregnancy and breastfeeding.
During surgery or anesthesia, you must tell your doctor that you are using Tolura.
Tolura may be less effective in treating blood pressure et in patients of color.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not use Tolura”.
Children and young people
Tolura is not recommended for the treatment of children or adolescents up to the age of 18.
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 need to change the dose of other medicines or take other precautions. In some cases, you may need to stop treatment with a medicine. This is especially true if the medicines below are taken at the same time as Tolura:
- Medicines containing lithium treat certain types of depression.
- Medicines that increase the level of potassium in the blood, e.g. potassium-containing salt substitutes, potassium-sparing diuretics (some diuretics), ACE inhibitors, angiotensin II inhibitors, non-steroidal anti-inflammatory drugs ( NSAIDs, e.g. aspirin or ibuprofen ), heparin, immunosuppressive drugs (eg ciclosporin or tacrolimus) and trimethoprim ( antibiotics ).
- Diuretics (water tablets), especially if taken in high doses together with Tolura, can lead to excessive fluid loss and low blood pressure ( hypotension ).
- If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not use Tolura” and “Warnings and precautions”).
- Digoxin.
The effect of Tolura can be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, eg aspirin or ibuprofen ) or corticosteroids.
Tolura may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can lower blood pressure et al (eg baclofen, amifostine).
In addition, low blood pressure can be worsened by alcohol, barbiturates, narcotics, and antidepressants. You may notice it as dizziness when you stand up. You should consult a doctor if you need to adjust the dose of one of your other medicines while taking Tolura.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you think you are ( or may become ) pregnant during treatment, contact your doctor. Usually, your doctor will suggest that you stop taking Tolura before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Tolura should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Breast-feeding
Tell your doctor if you are breastfeeding or intend to start breastfeeding. Tolura is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed your baby, especially if your baby is a newborn or was born prematurely.
Driving ability and use of machinery
Some people feel dizzy and tired when taking Tolura. If you feel dizzy or tired, do not drive or operate machinery.
Tolura contains lactose and sorbitol (E 420)
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
This medicine contains 149.8 mg of sorbitol per tablet. Sorbitol is a source of fructose. If you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that makes it impossible to break down fructose, consult a doctor before using this medicine.
How to use Tolura
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
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. You should swallow the tablets with a glass of water or another non-alcoholic drink. It is important to take Tolura every day until the doctor gives other instructions. Contact your doctor or pharmacist if you feel that the effect of Tolura is too strong or too weak.
For the treatment of high blood pressure, the normal dose of Tolura for most patients is one 40 mg tablet once a day to control blood pressure it for 24 hours. In some cases, the doctor may recommend a lower dose, 20 mg daily, or a higher dose, 80 mg daily. Tolura tablets are not divisible, therefore they are unsuitable for patients who require a dose of 20 mg telmisartan. For these patients, an equivalent product with the same active substance is available. Alternatively, Tolura can be used together with a diuretic (fluid-reducing medicine) such as hydrochlorothiazide, which has been shown to have an additional blood pressure-lowering effect together with Tolura.
To reduce the number of cardiovascular events, the usual dose is one Tolura 80 mg tablet once a day. At the beginning of preventive treatment with Tolura 80 mg, blood pressure must be checked frequently.
If you have impaired liver function, the normal dose should not exceed 40 mg once a day.
If you have used too much Tolura
If you have taken too much, contact your doctor, pharmacist, or nearest emergency department immediately.
If you forget to use Tolura
If you should forget to take the medicine, do not worry. Take one dose as soon as you remember and continue as before. If you forget the medicine one day, take the usual dose the next day. You should not take a double dose to compensate.
If you have further questions about this medicine, contact your doctor or pharmacist.
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 treatment.
Contact your doctor immediately if you experience any of the following symptoms:
Sepsis* (which is often called “blood poisoning” is a severe infection with inflammatory reactions throughout the body), rapid swelling of the skin and mucous membranes ( angioedema ). These side effects are rare (may affect up to 1 in 1,000 users) but extremely serious and patients should stop taking the medicine and see a doctor immediately. The conditions can be fatal if left untreated.
Possible side effects of Tolura
Common side effects (may affect up to 1 in 10 users):
Low blood pressure ( hypotension ) in users treated to reduce the number of cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 users):
Urinary tract infections, upper respiratory infection (eg, sore throat, inflamed sinuses, the common cold), lack of red blood cells ( anemia ), high potassium levels, difficulty sleeping, low mood (depression), fainting ( syncope ), a feeling of dizziness ( vertigo ), slow heart rhythm ( bradycardia ), low blood pressure ( hypotension ) in users treated for high blood pressure, dizziness when standing up ( orthostatic hypotension ), shortness of breath, cough, stomach pain, diarrhea, gastrointestinal discomfort, swelling, vomiting, itching, sweating, skin rash due to medication, back pain, muscle spasm, muscle pain ( myalgia ), reduced kidney function including acute kidney failure, chest pain, weakness and increased level of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 users):
Sepsis* (which is often called “blood poisoning”, is a severe infection with inflammatory reactions throughout the body, which can lead to death), increased number of certain white blood cells (eosinophilia), low platelet count ( thrombocytopenia ), severe allergic reactions ( anaphylactic reaction ), allergic reactions (e.g. skin rash, itching , difficulty breathing, wheezing, facial swelling or low blood pressure ), low blood sugar (in patients with diabetes ), restlessness, somnolence , visual disturbances, rapid heartbeat ( tachycardia ), dry mouth, upset stomach, altered sense of taste ( dysgeusia ), abnormal liver function (Japanese patients are at greater risk of this side effect), rapid swelling of the skin and mucous membranes that can lead to death ( angioedema even with a fatal outcome), eczema (a skin disease), skin redness , hives , severe skin rashes due to medicines, joint pain ( arthralgia ), pain in the extremities , pain in the tendons, flu-like illness, reduced levels of hemoglobin (a blood protein), increased levels of uric acid , increased levels of liver enzymes or creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 users):
Progressive scarring of lung tissue (interstitial lung disease)**
* These side effects may be coincidental or related to a mechanism that is currently unknown.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan is the cause.
How Tolura should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Store at a maximum of 30°C.
Store in the original packaging. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is telmisartan. Each tablet contains 20 mg, 40 mg, and 80 mg of telmisartan, respectively.
- Other ingredients in Tolura 20 mg are povidone, meglumine, sodium hydroxide, lactose monohydrate, sorbitol (E 420), and magnesium stearate.
- Other ingredients in Tolura 40 mg are povidone, meglumine, sodium hydroxide, lactose monohydrate, sorbitol (E 420), and magnesium stearate.
- Other ingredients in Tolura 80 mg are povidone, meglumine, sodium hydroxide, lactose monohydrate, sorbitol (E 420), and magnesium stearate.
See section 2 “Tolura contains lactose and sorbitol (E 420)”.
Appearance and package sizes of the medicine
Tolura 40 mg tablets are white to off-white, biconvex, oval tablets.
Tolura 80 mg tablets are white to almost white, biconvex, oval tablets, and capsule-shaped tablets.
Tolura is available in blister packs of 14, 28, 30, 56, 84, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o. o., ul. Równoległa 5, 02-235 Warsaw, Poland