Tolura 40 mg tablets

2. What you need to know before you take 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 more than 3 months pregnant. (In any case, it is better to avoid taking this medicine during the first few months of pregnancy - see section Pregnancy.)
• if you have severe liver problems, such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gall bladder) or any other severe liver disease.
• if you have diabetes or kidney impairment and you are treated with a blood pressure medicine containing aliskiren.

If any of these apply to you, tell your doctor or pharmacist before taking Tolura.

Warnings and precautions

Tell your doctor if you are suffering or have ever suffered from 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 disease.
• Heart problems.
• High levels of aldosterone (water and salt retention in the body, along with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension) which may occur if you are dehydrated (excessive loss of water from the body) or have low salt levels due to treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Tell 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Tolura is not recommended during the first few months of pregnancy (first trimester) and should not be used after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

In case of surgery or anesthesia, inform your doctor that you are taking Tolura.

Tolura may be less effective in lowering blood pressure in black patients.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Tolura”.

Children and adolescents

Tolura is not recommended for children and adolescents under 18 years.

Using Tolura with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to change the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important for the following medicines when taken with Tolura:

Medicines containing lithium for treating some types of depression.

• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Tolura, may cause excessive water loss and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Tolura” and “Warnings and precautions”).
• Digoxin.

The effect of Tolura may be reduced when you use NSAIDs (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 medicines that may potentially lower blood pressure (e.g., baclofen, amifostine).

Additionally, the reduction in blood pressure may be increased by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should 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 are pregnant, think you may be pregnant, or plan to 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 to treat your high blood pressure. Tolura is not recommended during the first few months of pregnancy and should not be used after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding, as Tolura is not recommended for use during breastfeeding. Your doctor may decide to prescribe a different treatment if you want to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Some people feel dizzy or tired when taking Tolura. If you feel dizzy or tired, 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, consult your doctor before taking this medicine.

This medicine contains 149.8 mg of 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 you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder, in which you cannot break down fructose, consult your doctor before taking this medicine.

3. How to take Tolura

Always take this medicine 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 once 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 with a little water or another non-alcoholic drink. It is important that you take Tolura every day until your doctor tells you to stop. 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 usual dose of Tolura for most patients is one 40 mg tablet once a day to control blood pressure over a 24-hour period. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg. Tolura tablets cannot be divided, and therefore, it is not suitable for patients who need a 20 mg dose of telmisartan. For these patients, a different medicine with the same active substance is available. Tolura can also be used in combination with diuretics, such as hydrochlorothiazide, which has been shown to have an additional blood pressure-lowering effect with Tolura.

For the reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once a day. When starting preventive treatment 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 a day.

If you take more Tolura than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or the 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 and then continue as before. If you do not take your tablet on one day, take your normal dose the next day. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tolura can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention:

If you experience any of the following symptoms, you should see your doctor immediately:

Sepsis* (often called “blood infection”, a severe infection that involves an inflammatory reaction of 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 are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these side 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 users treated for cardiovascular event reduction.

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), anemia (low red blood cell count), high potassium levels, insomnia (difficulty sleeping), depression, fainting (syncope), dizziness (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, symptoms of weakness, and high creatinine levels in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

Sepsis* (often called “blood infection”, a severe infection that involves an inflammatory reaction of the whole body and can cause death), increased eosinophils (a type of white blood cell), 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), anxiety, somnolence, vision disturbances, increased heart rate (tachycardia), dry mouth, stomach upset, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin disorder), skin redness, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, pseudogrip syndrome, decrease in hemoglobin (a blood protein), increased blood 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) **.

• This may have been an isolated case or may be related to an 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 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 Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton after “EXP”. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Tolura Composition

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 section 2 "Tolura contains lactose and sorbitol (E420)."

Appearance of Tolura and Package Contents

Tolura 40 mg tablets are white or almost white, biconvex, and oval.

Tolura is available in blisters of 14, 28, 30, 56, 84, 90, 98, and 100 tablets in a box. Not all pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

KRKA-POLSKA Sp. z o.o., Ul. Równolegla 5, 02-235 Warszawa, Poland

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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