Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tolura

Document Subject

Generated Narrative: MedicinalProductDefinition mpbf55777f1fad69c8fa791ca2ceb30315

identifier: http://ema.europa.eu/identifier/14 tablets: EU/1/10/632/008

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Tolura 40 mg tablets

type: Full name

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-bf55777f1fad69c8fa791ca2ceb30315

identifier: http://ema.europa.eu/identifier/14 tablets: EU/1/10/632/008

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - tolura

Attesters

What is in this leaflet:

1. What Tolura is and what it is used for
2. What you need to know before you take Tolura
3. How to take Tolura
4. Possible side effects
5. How to store Tolura
6. Contents of the pack and other information

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.

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.

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.

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.

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.

What Tolura contains

The active substance is telmisartan. Each tablet contains 40 mg 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). 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, 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. R wnoleg a 5, 02-235 Warszawa, Poland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27

Luxembourg/Luxemburg KRKA Belgium, SA. Te .: + 359 (02) 962 34 T l/Tel: + 32 (0) 487 50 73 62 (BE) esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Malta E.J. Busuttil Ltd. Tel: + 356 21 445 Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606-0 Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

KRKA
: + 30 2100101 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA - FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5 KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 United Kingdom (Northern Ireland) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3This leaflet was last revised in Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu Package leaflet: Information for the user Tolura 80 mg tablets telmisartan Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.