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What is Tolura and what is it used?
Tolura belongs to a group of medicines known as antagonists of angiotensin II. Angiotensin II is a substance produced in your body which causes blood vessels to narrow, thus increasing your blood pressure. Tolura blocks the effect of angiotensin II, so that the blood vessels relax and blood pressure is lowered.
Tolura is used to treat essential hypertension (high blood pressure) in adults. 'Essential' means that the high blood pressure is not caused by another disease.
If left untreated, high blood pressure can damage blood vessels in several organs, which can sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. Usually high blood pressure has no symptoms before damage occurs. It is therefore important to regularly measure blood pressure to verify if it is within normal limits.
Tolura is also used to reduce cardiovascular events (ie heart attack or stroke) in patients at risk due to reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you have an increased risk of such incidents.
2. What you need to know before taking Tolura
Do not take Tolura:
if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6);
if you are pregnant after the third month (better to avoid the use of Tolura in early pregnancy - see Pregnancy section);
if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Tell your doctor or pharmacist before taking Tolura, if any of the above apply to you.
Warnings and Precautions
Talk to your doctor if you have 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 to one or both kidneys);
elevated levels of aldosterone (retention of water and salt in the body, accompanied by imbalance of other minerals in the blood);
low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), a diet low in salt, diarrhea or vomiting ;
increased levels of potassium in the blood;
You should tell your doctor if you think you are (or might become) pregnant. Tolura is not recommended in early pregnancy and must not be taken after the third month of pregnancy because it may cause serious harm to your baby if used at that stage (see pregnancy section).
In case of surgery or anesthesia, you should tell your doctor that you are taking Tolura.
Tolura may be less effective in lowering blood pressure in black patients.
Children and adolescents
Not recommended the use of Tolura in children and adolescents up to 18 years.
Other medicines and Tolura
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. May be necessary for your doctor to change the dose of these medicines or take other precautions. In some cases it may be necessary to stop taking one of the medicines. This is particularly true for the drugs listed below, when used together with Tolura:
drugs containing lithium used to treat certain types of depression;
drugs that may increase blood potassium levels such as potassium-containing salt substitutes, potassium-sparing diuretics (tablets, enhancing the excretion of water), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen) heparin, immunosuppressives (eg cyclosporin or tacrolimus), and the antibiotic trimethoprim;
diuretics (water tablets), especially if taken in high doses together with Tolura, may lead to excessive loss of body water and low blood pressure (hypotension).
The effect of Tolura may be reduced when administered with an NSAID (nonsteroidal anti-inflammatory drugs such as aspirin or ibuprofen) or steroids.
Tolura may increase the effect of lowering the blood pressure of the other drugs used to treat high blood pressure.
Pregnancy and lactation
You should tell your doctor if you think you are (or might become) pregnant. Usually, your doctor will advise you to stop taking Tolura before you become pregnant or as soon as you know 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 three months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Tell your doctor if you are breastfeeding or plan to start breastfeeding. Tolura is not recommended for mothers who are breastfeeding, and your doctor may prescribe other treatments if you want to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Some people feel dizzy or tired when taking Tolura.
If you feel dizzy or tired, do not drive or operate machinery.
Tolura contains lactose and sorbitol (E420).
If you have an intolerance to some sugars, consult your doctor before taking Tolura.
3. How to take Tolura
Always take Tolura exactly as your doctor tells you. If you are not sure, ask 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 can take Tolura with or without food. The tablets should be swallowed with water or soft drink. It is important that you take Tolura every day until your doctor tells you otherwise. If the effect of Tolura you are too strong or too weak, talk to your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Tolura for most patients is one 40 mg tablet once a day to control blood pressure over 24 hours. However, sometimes your doctor may recommend a lower dose - 20 mg per day or higher dose - 80 mg daily. Tolura may also be used in combination with diuretics (water tablets) such as hydrochlorothiazide, to give a further lowering effect on blood pressure Tolura.
Reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once daily. At the beginning of the preventive therapy with Tolura 80 mg should be frequently monitored blood pressure.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
If you take more dose Tolura
If you accidentally take too many tablets, contact your doctor, pharmacist or nearest emergency center.
If you forget to take Tolura
If you forget to take a dose, do not worry. Take it as soon as you remember and then carry on as usual. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up the missed dose.
If you have any further questions on the use of this product, 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 treatment.
You should visit your doctor immediately if you experience any of the following symptoms:
Sepsis * (often called "blood poisoning" - severe infection with inflammation throughout the body), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1000 people) but very serious. Patients should stop taking the drug immediately and consult a doctor. If not treated, these reactions 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 infection (eg sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anemia), high potassium levels in the blood, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness on standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea , stomach discomfort, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute renal failure, chest pain, feeling of weakness, and increased level of creatinine in the blood.
Rare side effects (may affect up to 1 in 1000 people):
Sepsis * (often called "blood poisoning" is a severe infection with an inflammatory process in the whole body, which can lead to death), increased number of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (such as rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), reduced blood sugar levels (in diabetic patients), anxiety, drowsiness, impaired vision, fast heartbeat (tachycardia), dry mouth, upset stomach, abnormal liver function (more likely that adverse reaction occur in Japanese patients), rapid swelling of the skin and mucosa (angioedema), eczema (a skin disorder), redness skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like illness, decreased hemoglobin (a blood protein), increased levels of uric acid, increased hepatic 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) **.
* This event can occur accidentally or could be related to a mechanism currently not known.
** Cases of progressive scarring of lung tissue have been reported during administration of telmisartan. However, it is not known whether the cause is telmisartan.
If you get any side effects with your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store Tolura
Keep out of the reach and sight 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.
Store in the original package in order to protect from light.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
The active substance is telmisartan. Each tablet contains 80 mg telmisartan.
The other ingredients are povidone, meglumine, sodium hydroxide, lactose monohydrate, sorbitol (E420), and magnesium stearate.
Tolura looks like and contents of the pack
Tolura 80 mg tablets are white to off-white, biconvex tablets with the form of capsules. Tolura is available in blister packs containing 14, 28, 30, 56, 84, 90 or 98 tablets.
Not all pack sizes may be marketed.
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