Medicine guide

Tolura

Prescription status not stated
Heart, blood pressure and circulation

Active substance: Telmisartan
Used in: Heart, blood pressure and circulation
Made by: Krka, d.d., Novo mesto
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

Tolura belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Tolura blocks the effect of angiotensin II so that the blood vessels relax, and your 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 any other condition.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Tolura is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a 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 are at high risk for such events.

From the package leaflet in EMA’s product information, p. 30 · 2026-07-08

Do not take it if

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

From the package leaflet in EMA’s product information, p. 30.

How to take it

These directions are for this exact strength and form. Another one is different.

Always take Tolura exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 should be swallowed whole with some water or other non-alcoholic drink. It is important that you take Tolura every day until your doctor tells you otherwise. If you have the impression that the effect of Tolura is too strong or too weak, talk to your doctor or pharmacist.
For 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 the 24 hour period. However, sometimes your doctor may recommend 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 dose of 20 mg of telmisartan. For these patients, an equivalent product with the same active ingredient is available. Tolura may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Tolura.
For reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once a day. At the beginning of the preventive therapy with Tolura 80 mg, blood pressure should be frequently monitored.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
If you take more Tolura than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
If you forget to take Tolura If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. 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 for forgotten individual doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 32–33.

Warnings and precautions

Talk to your doctor before taking Tolura if you are suffering 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).
Liver disease.
Heart trouble.
Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to e.g. diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting.
Elevated potassium levels in your 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), in particular if you have diabetes-related kidney problems,
aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Tolura”.
Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Tolura. Your doctor will decide on further treatment. Do not stop taking Tolura on your own.
You must tell your doctor if you think you are (or might become) pregnant. Tolura is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
In case of surgery or anaesthesia, you should tell your doctor that you are taking Tolura.
Tolura may be less effective in lowering the blood pressure in black patients.
Children and adolescents The use of Tolura in children and adolescents up to the age of 18 years is not recommended.

From the package leaflet in EMA’s product information, p. 31.

Pregnancy and breastfeeding

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally 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 when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Tolura is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

From the package leaflet in EMA’s product information, p. 32.

Other medicines

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 these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Tolura:
Lithium containing medicines to treat some types of depression.
Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. 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).
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Tolura” and “Warnings and precautions”).
Digoxin.
The effect of Tolura may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Tolura may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor if you need to adjust the dose of your other medicine while taking Tolura.

From the package leaflet in EMA’s product information, p. 31–32.

Driving and using machines

Some people may experience side effects such as fainting or a feeling of spinning (vertigo) when taking Tolura. If you experience these side effects, do not drive or operate machinery.
Tolura contains lactose, sorbitol (E420) and sodium.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains 149.8 mg sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

From the package leaflet in EMA’s product information, p. 32.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention:
You should see your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.
Possible side effects of Tolura:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users 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, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), dizziness, fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, pain in the belly, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment (including acute kidney failure), pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can 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, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, discomfort in the belly, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema including fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood, low levels of sodium.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.
Not known (frequency cannot be estimated from the available data):
Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting, and diarrhoea has been reported after the use of similar products.
* The event may have happened by chance or could be related to a mechanism currently not known.
** Cases of progressive scarring of lung tissue have been reported during 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 possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 33–34.

How to store it

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 carton and blister after “EXP”.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 34.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

The other ingredients are povidone (K30), meglumine, sodium hydroxide, lactose monohydrate, sorbitol (E420) and magnesium stearate. See section 2: “Tolura contains lactose, sorbitol (E420) and sodium.” What Tolura looks like and contents of the pack Tolura 40 mg tablets are white to almost white, biconvex, oval tablets.

From the package leaflet in EMA’s product information, p. 34.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

Every strength and form (71)

BulgariaNo exact match for this strength and form

Every strength and form (8)

SpainNo exact match for this strength and form

Every strength and form (91)

FranceNo exact match for this strength and form

Every strength and form (23)

CanadaNo exact match for this strength and form

Every strength and form (36)

NetherlandsNo exact match for this strength and form

Every strength and form (45)

SwitzerlandNo exact match for this strength and form

Every strength and form (10)

Details

Made by	Krka, d.d., Novo mesto
Active substance	Telmisartan
Used in	Heart, blood pressure and circulation
Classification	C09CA07 · Heart, blood pressure and circulation
Generic	Yes — a generic medicine, according to the register
Authorised on	2010-06-04
Last updated by the regulator	2026-07-08
EMA product number	EMEA/H/C/001196

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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