Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - pritor

Document Subject

Generated Narrative: MedicinalProductDefinition mpef91ef40532d0dce19c71878e7b8816b

identifier: http://ema.europa.eu/identifier/EU/1/98/089/011 (14 tablets)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Pritor 20 mg tablets

type: Full name

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part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-ef91ef40532d0dce19c71878e7b8816b

identifier: http://ema.europa.eu/identifier/EU/1/98/089/011 (14 tablets)

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - pritor

Attesters

What is in this leaflet

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

Pritor 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. Pritor blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered. Pritor 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. Pritor 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 Pritor

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. (It is also better to avoid Pritor in early pregnancy
see pregnancy section.)

if you have severe liver problems such as cholestasis or biliary obstruction (problems with 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 Pritor. Warnings and precautions Talk to your doctor before taking Pritor 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 Pritor:

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 Pritor .

if you are taking digoxin. You must tell your doctor if you think you are (or might become) pregnant. Pritor 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 Pritor. Pritor may be less effective in lowering the blood pressure in black patients. Children and adolescents The use of Pritor in children and adolescents up to the age of 18 years is not recommended. Other medicines and Pritor 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 medications 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 Pritor:

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 Pritor, 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 Pritor and Warnings and precautions ).

Digoxin. The effect of Pritor may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids. Pritor 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 Pritor. 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 Pritor before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Pritor. Pritor 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. Pritor 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 Pritor. If you feel dizzy or tired, do not drive or operate machinery. Pritor contains sorbitol. This medicine contains 84.32 mg sorbitol in each tablet. Pritor contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

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 is one tablet a day. Try to take the tablet at the same time each day. You can take Pritor with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Pritor every day until your doctor tells you otherwise. If you have the impression that the effect of Pritor is too strong or too weak, talk to your doctor or pharmacist. For treatment of high blood pressure, the usual dose of Pritor for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period. Your doctor has recommended a lower dose of one 20 mg tablet daily. Pritor 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 Pritor. For reduction of cardiovascular events, the usual dose of Pritor is one 80 mg tablet once a day. At the beginning of the preventive therapy with Pritor 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 Pritor 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 Pritor 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 Pritor 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 this 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 after EXP . The expiry date refers to the last day of that month. This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Remove your Pritor tablet from the blister only directly prior to intake. 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 Pritor contains The active substance is telmisartan. Each tablet contains 20 mg telmisartan. The other ingredients are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate. What Pritor looks like and contents of the pack Pritor 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side. Pritor is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder Bayer AG 51368 Leverkusen Germany Manufacturer Bayer AG Kaiser-Wilhelm-Allee 51368 Leverkusen Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Belgi / Belgique / Belgien Bayer SA-NV T l/Tel: +32-(0)2-535 63 Lietuva UAB Bayer Tel. +370 52 33 68

. +359 02 424 72 Luxembourg / Luxemburg Bayer SA-NV T l/Tel: +32-(0)2-535 63 esk republika Bayer s.r.o. Tel: +420 266 101 Magyarorsz g Bayer Hung ria Kft. Tel.:+36-14 87-41 Danmark Bayer A/S Tlf: +45-45 23 50 Malta Alfred Gera and Sons Ltd. Tel: +356-21 44 62 Deutschland Bayer Vital GmbH Tel: +49-(0)214-30 513 Nederland Bayer B.V. Tel: +31-(0)297-28 06 Eesti Bayer O Tel: +372 655 85 Norge Bayer AS Tlf. +47 23 13 05
Bayer
: +30 210 618 75 sterreich Bayer Austria Ges. m. b. H. Tel: +43-(0)1-711 46-0 Espa a Bayer Hispania S.L. Tel: +34-93-495 65 Polska Bayer Sp. z o.o. Tel.: +48-22-572 35 France Bayer HealthCare T l (N vert): +33-(0)800 87 54 Portugal Bayer Portugal Lda Tel: +351-21-416 42 Hrvatska Bayer d.o.o. Tel: + 385-(0)1-6599 Rom nia SC Bayer SRL Tel.: +40 21 528 59 Ireland Bayer Limited Tel: +353 1 299 93 Slovenija Bayer d. o. o. Tel.: +386-1-58 14 sland Icepharma hf. S mi: +354 540 8Slovensk republika Bayer, spol. s r.o. Tel: +421 2 59 21 31 Italia Bayer S.p.A. Tel: +39-02-397 Suomi/Finland Bayer Oy Puh/Tel.: +358-20 785
NOVAGEM Limited : + 357 22 48 38 Sverige Bayer AB Tel: +46-(0)8-580 223 Latvija SIA Bayer Tel: +371 67 84 55 United Kingdom Bayer plc Tel: +44 (0) 118 206 3This leaflet was last revised in {MM/YYYY}. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: