PRITORPLUS 80 mg/25 mg TABLETS

Introduction

Package Leaflet: Information for the User

PritorPlus 80 mg/25 mg tablets

telmisartan/hydrochlorothiazide

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.

Contents of the pack

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

1. What is PritorPlus and what is it used for

PritorPlus is a combination of two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both active substances help to control high blood pressure.

• Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that makes your blood vessels narrow, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that your blood vessels relax and your blood pressure is reduced.

• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase the amount of urine you produce, leading to a decrease in your blood pressure.

High blood pressure, if left untreated, can damage the blood vessels in various organs, which can sometimes lead to a heart attack, heart failure, kidney failure, stroke, or blindness.

Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly check your blood pressure to ensure it is within the normal range.

PritorPlus is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with PritorPlus 80 mg/12.5 mg or in patients who have previously been stabilized with telmisartan and hydrochlorothiazide separately.

2. What you need to know before you take PritorPlus

Do not take PritorPlus

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or other medicines related to sulfonamides.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine at the start of your pregnancy - see section Pregnancy).
• if you have severe liver problems, such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease.
• if you have severe kidney disease.
• if your doctor determines that you have low potassium or high calcium levels in your blood that do not improve with treatment.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking PritorPlus.

Warnings and precautions

Consult your doctor before starting to take PritorPlus if you have or have had any of the following disorders or diseases:

• Low blood pressure (hypotension), which can occur if you are dehydrated (excessive loss of body water) or have a deficiency of salts due to treatment with diuretics, a low-sodium diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• High levels of aldosterone (water and salt retention in the body along with an imbalance of various minerals in the blood).
• Systemic lupus erythematosus (also called "lupus" or "SLE"), a disease in which the body's immune system attacks the body itself.
• The active ingredient hydrochlorothiazide can cause a rare reaction, leading to decreased vision and eye pain. These symptoms can be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and may appear between hours and weeks after taking PritorPlus. If left untreated, it can lead to permanent vision loss.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking PritorPlus.

Consult your doctor before starting to take PritorPlus:

• 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.

Your doctor may need to 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 PritorPlus".

• if you are taking digoxin.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking PritorPlus, seek medical attention immediately.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. PritorPlus is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby, see section Pregnancy.

Treatment with hydrochlorothiazide can cause an electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, somnolence, restlessness, pain or muscle cramps, nausea, vomiting, muscle fatigue, and an abnormally rapid heart rate (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.

You should also inform your doctor if you experience increased sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) that appear more quickly than usual.

If you are going to have surgery (including dental surgery) or anesthesia, inform your doctor that you are taking PritorPlus.

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

Children and adolescents

PritorPlus is not recommended for use in children and adolescents up to 18 years of age.

Other medicines and PritorPlus

Inform 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, it may be necessary to stop taking one of these medicines, especially if you are taking PritorPlus with any of the following medicines:

• Medicines containing lithium for the treatment of certain types of depression.
• Medicines associated with low potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and its derivatives.
• Medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines like heparin sodium (an anticoagulant).
• Medicines that are affected by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin) or medicines to control your heart rate (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines like certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g., terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents like metformin).
• Colestyramine and colestipol, medicines to reduce blood fat levels.
• Medicines to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medicines (medicines used to treat a variety of disorders, such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) like atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases).
• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for treating cancer, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take PritorPlus" and "Warnings and precautions").
• Digoxin.

PritorPlus may increase the effect of other medicines to lower blood pressure or medicines that may potentially lower blood pressure (e.g., baclofen, amifostine). Additionally, the decrease in blood pressure may be enhanced by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should inform your doctor about the need to adjust the dose of your other medicines while taking PritorPlus.

The effect of PritorPlus may be reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen).

Taking PritorPlus with food and drink

You can take PritorPlus with or without food.

Avoid drinking alcohol until you have talked to your doctor. Alcohol can further lower your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking PritorPlus before you become pregnant or as soon as you find out you are pregnant, and recommend that you take a different blood pressure-lowering medicine instead. PritorPlus is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

Breast-feeding

Inform your doctor if you are about to start or are breast-feeding, as it is not recommended to take PritorPlus during breast-feeding. Your doctor may decide to give you a treatment that is more suitable if you want to breast-feed.

Driving and using machines

Some patients feel dizzy or tired when taking PritorPlus. If you feel dizzy or tired, do not drive or use machines.

PritorPlus contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

PritorPlus contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

PritorPlus contains sorbitol

This medicine contains 338 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 the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take PritorPlus

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one tablet per day. Try to take one tablet each day at the same time. You can take PritorPlus with or without food. The tablets should be swallowed with a little water or other non-alcoholic drink. It is important that you take PritorPlus every day until your doctor tells you to stop.

If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

If you take more PritorPlus than you should

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function, including kidney failure, have also been reported. Due to the hydrochlorothiazide component, you may also experience very low blood pressure and low potassium levels in the blood, which can lead to nausea, somnolence, and muscle cramps and/or irregular heartbeat associated with concomitant use of medicines like digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist or the nearest hospital emergency department immediately.

If you forget to take PritorPlus

If you forget to take your medicine, do not worry. Take the dose as soon as you remember and then continue as before. If you do not take your tablet one day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

Sepsis* (frequently called "blood infection"), is a serious infection that involves an inflammatory reaction of the entire body, rapid swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis); these adverse effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and visit their doctor immediately. If these adverse effects are not treated, they can be fatal. An increase in the incidence of sepsis with telmisartan alone has been observed; however, it cannot be ruled out for PritorPlus.

Possible Adverse Effects of PritorPlus:

Frequent Adverse Effects (may affect up to 1 in 10 people)

Dizziness.

Infrequent Adverse Effects (may affect up to 1 in 100 people)

Decrease in blood potassium levels, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heartbeats (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to have or maintain an erection), chest pain, and increased blood uric acid levels.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

Bronchitis (inflammation of the lungs), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body itself, causing joint pain, skin rashes, and fever), sore throat, inflammation of the paranasal sinuses, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbances, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function disturbances (Japanese patients show a greater tendency to experience this adverse effect), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the limbs, muscle cramps, pseudogripal illness, pain, low sodium levels, increased creatinine, liver enzymes, or creatine phosphokinase levels in the blood.

Adverse reactions reported for one of the individual components may be potential adverse reactions of PritorPlus, even if they have not been observed in clinical trials with this product.

Telmisartan

The following additional adverse effects have been described in patients taking telmisartan alone:

Infrequent Adverse Effects (may affect up to 1 in 100 patients)

Upper respiratory tract infection (e.g., sore throat, sinusitis, common cold), urinary tract infections, red blood cell deficiency (anemia), high potassium levels, slow heart rate (bradycardia), cough, kidney function disturbances including acute renal failure, weakness.

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

Low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, drug rash), low blood sugar levels (in diabetic patients), drowsiness, stomach upset, eczema (a skin disorder), osteoarthritis, tendon inflammation, decreased hemoglobin (a blood protein).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

Progressive lung tissue fibrosis (interstitial lung disease)**

• This may have been a casual finding or be related to a currently unknown mechanism.

** Cases of progressive lung tissue fibrosis have been reported during telmisartan treatment. However, it is unknown whether telmisartan was the cause.

Hydrochlorothiazide

The following additional adverse effects have been described in patients taking hydrochlorothiazide alone:

Frequent Adverse Effects (may affect up to 1 in 10 people)

Nausea, low magnesium levels in the blood.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

Decrease in blood platelets, which increases the risk of bleeding and bruising (small purple-red marks on the skin or other tissues caused by bleeding), high calcium levels in the blood, headache.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

Increased blood pH (acid-base imbalance) due to low chloride levels in the blood, acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Unknown Frequency (cannot be estimated from available data)

Salivary gland inflammation, skin and lip cancer (non-melanoma skin cancer), decrease in blood cell count, including low red and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision, and eye pain (possible signs of fluid accumulation in the vascular layer of the eye [choroidal effusion] or acute angle-closure glaucoma), blood vessel inflammation (necrotizing vasculitis), pancreatitis, stomach upset, yellowing of the skin or eyes (jaundice), pseudolupus syndrome (a condition that mimics systemic lupus erythematosus, in which the body's immune system attacks the body itself), skin disorders such as blood vessel inflammation of the skin, increased sensitivity to sunlight, skin rash, redness of the skin, blistering of the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or dysfunction, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood glucose levels, difficulty controlling blood glucose levels in patients with diabetes mellitus, or fat in the blood.

Reporting Adverse Effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of PritorPlus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from moisture. Remove your PritorPlus tablet from the blister pack just before taking it.

Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pack cavities. If this is detected, no action is required on your part.

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

6. Package Contents and Additional Information

PritorPlus Composition

• The active ingredients are telmisartan and hydrochlorothiazide.

Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.

• The other ingredients are lactose monohydrate, magnesium stearate, corn starch, meglumine, microcrystalline cellulose, povidone K25, yellow iron oxide (E172), sodium hydroxide, sodium starch glycolate (type A), and sorbitol (E420).

Product Appearance and Package Contents

PritorPlus 80 mg/25 mg tablets are oblong, two-layer tablets, yellow and white, with the company anagram and the code 'H9' engraved.

PritorPlus is available in blister packs containing 14, 28, 30, 56, 90, or 98 tablets, or in single-dose blister packs containing 28 x 1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:{MM/AAAA}.

Other Sources of Information

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