Tolura - patient leaflet, side effects, dosage

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 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.

2. What you need to know before you take 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 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.

Warnings and precautions

Talk to your doctor 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 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.

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.

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”.

Children and adolescents

The use of Tolura in children and adolescents up to the age of 18 years is not recommended.

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 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 antagonists, 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.

Pregnancy and breast-feeding

Pregnancy

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.

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 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.

3. How to take Tolura

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 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.

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 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), 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, discomfort in the abdomen, 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, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with 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.

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 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.

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 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.

6. Contents of the pack and other information

What Tolura contains

• – The active substance is telmisartan. Each tablet contains 40 mg telmisartan.

What Tolura looks like and contents of the pack

Tolura 40 mg tablets are white to almost white, biconvex, oval tablets.

Tolura is available in blister packs 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, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

Manufacturers

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

KRKA-POLSKA Sp. z o.o., ul. Rownolegla 5, 02–235 Warszawa, Poland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien	Lietuva
KRKA Belgium, SA.	UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62	Tel: + 370 5 236 27 40

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 Farmacéutica, Sociedade Unipessoal Lda.

Tel: + 351 (0)21 46 43 650

Romania

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)

Consilient Health Limited

Tel: + 353 (0)1 2057760

Detailed information on this medicinal product is available on the website of the European Medicines

Agency