Tolura 80 mg tablets

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). ?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.

Do not take Tolura

• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Tolura tablets (see section Further information for a list of other ingredients).
• 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 any of the above applies to you, tell your doctor or pharmacist before taking Tolura.

Take special care with Tolura

Please tell 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.

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.

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

As with all other angiotensin II receptor antagonists, Tolura may be less effective in lowering the blood pressure in black patients.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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).

As with other blood pressure lowering medicines, 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.

Taking Tolura with food and drink

You can take Tolura with or without food.

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

No information is available on the effect of Tolura on the ability to drive or operate machinery. Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Important information about some of the ingredients of Tolura

Tolura contains lactose and sorbitol (E420).
If you are intolerant to some sugars, consult your doctor before taking Tolura.

Always take Tolura exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual 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.

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 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.

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 product, ask your doctor or pharmacist.

Like all medicines, Tolura can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows:

Very common Affects more than 1 user in 10 Common Affects 1 to 10 users in 100 Uncommon Affects 1 to 10 users in 1,000 Rare Affects 1 to 10 users in 10,000 Very rare Affects less than 1 user in 10,000 Not known Frequency cannot be estimated from available data

Uncommon side effects:
High potassium levels, fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), low blood pressure (hypotension), shortness of breath, abdominal pain, diarrhoea, dry mouth, discomfort in the abdomen, bloating, increased sweating, itching, muscle pain (myalgia), kidney impairment including acute kidney failure, and pain in the chest.

Rare side effects:
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), low platelet count (thrombocytopenia), feeling anxious, feeling sad (depression), impaired vision, fast heart beat (tachycardia), dizziness on standing up (orthostatic hypotension), upset stomach, vomiting, abnormal liver function, redness of skin, rapid swelling of the skin and mucosa (angioedema), hives (urticaria), joint pain (arthralgia), back pain, muscle cramps, pain in extremity, symptoms of weakness, flu-like-illness, increased levels of uric acid, creatinine, hepatic enzymes or creatine phosphokinase in the blood.

Side effects of unknown frequency:
Urinary tract infections, increase in certain white blood cells (eosinophilia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), slow heart rate (bradycardia), drug rash, eczema (a skin disorder), inflammation of the tendons, ineffectiveness of Tolura, decreased haemoglobin (a blood protein), sepsis* (often called ?blood poisoning?, is a severe infection with whole-body inflammatory response which can lead to death).

* In a long-term study involving more than 20,000 patients, more patients treated with telmisartan experienced sepsis compared with patients who received no telmisartan. The event may have happened by chance or could be related to a mechanism currently not known.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Tolura 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.

Store in the original package in order 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 to protect the environment.

What Tolura contains

• 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.

What Tolura looks like and contents of the pack

Tolura 80 mg tablets are white to almost white, biconvex, capsule shape tablets.

Tolura is available in blister packs containing 14, 28, 30, 56, 84, 90 and 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia
KRKA Polska Sp. z o.o., Ul. Równoleg-a 5, 02-235 Warsaw, Poland

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

BelgiëBelgiqueBelgien KRKA, d.d., Novo mesto TélTel 32 03 321 63 52 LuxembourgLuxemburg KRKA, d.d., Novo mesto TélTel 32 03 321 63 52

KRKA Te. 359 02 962 34 50 Magyarország KRKA Magyarország Kereskedelmi Kft. Tel. 361 0 355 8490

eská republika KRKA R, s.r.o. Tel 420 0 221 115 150 Malta KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66

Danmark KRKA Sverige AB Tlf 46 08 643 67 66 SE Nederland KRKA, d.d., Novo mesto Tel 32 3 321 63 52 BE

Deutschland TAD Pharma GmbH Tel 49 0 4721 6060 Norge KRKA Sverige AB Tlf 46 08 643 67 66 SE

Österreich Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel 372 06 597 365 KRKA Pharma GmbH, Wien Tel 43 01 66 24 300

QUALIA PHARMA S.A. 30 0210 2832941 Polska KRKA Polska Sp.z.o.o Tel. 48 022 573 7500

España KRKA, d.d., Novo mesto Tel 34 061 5089 809 Portugal KRKA Farmacêutica, Unipessoal Lda. Tel 351 021 46 43 650

France KRKA, d.d., Novo mesto Tél 32 3 321 63 52 BE România KRKA Romania S.R.L., Bucharest Tel 402 01 310 66 05

Ireland KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66 Slovenija KRKA, d.d., Novo mesto Tel 386 0 1 47 51 100

Ísland KRKA Sverige AB Sími 46 08 643 67 66 SE Slovenská republika KRKA Slovensko, s.r.o., Tel 421 0 2 571 04 501

Italia KRKA, d.d., Novo mesto Tel 39 069448827 SuomiFinland KRKA Sverige AB PuhTel 46 08 643 67 66 SE

Kipa Pharmacal Ltd. 357 24 651 882 Sverige KRKA Sverige AB Tel 46 08 643 67 66 SE

Latvija KRKA, d.d., Novo mesto Tel 371 0733 8610 United Kingdom Consilient Health UK Ltd. Tel 44 02089562310

Lietuva

KRKA, d.d., Novo mestoTel: + 370 5 236 27 40

This leaflet was last approved in