Polpril Plus

Package Leaflet: Information for the Patient

Polpril Plus, 5 mg + 1.25 mg, hard capsules
Polpril Plus, 5 mg + 2.5 mg, hard capsules
Polpril Plus, 10 mg + 1.25 mg, hard capsules
Polpril Plus, 10 mg + 2.5 mg, hard capsules
Ramipril+ Indapamide

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Polpril Plus and what is it used for
• 2. Important information before taking Polpril Plus
• 3. How to take Polpril Plus
• 4. Possible side effects
• 5. How to store Polpril Plus
• 6. Contents of the pack and other information

1. What is Polpril Plus and what is it used for

Polpril Plus contains two active substances called ramipril and indapamide. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). They work by reducing the production of substances that may increase blood pressure in the body and by dilating blood vessels, making it easier for the heart to pump blood through them. Indapamide belongs to a class of medicines called diuretics. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it only slightly increases the amount of urine produced. Each of these active substances lowers blood pressure and they work together to control blood pressure. This medicine is used to treat high blood pressure (hypertension) as a replacement therapy in adult patients whose blood pressure is adequately controlled with ramipril and indapamide in the same doses as in the combination therapy, but as separate tablets.

2. Important information before taking Polpril Plus

When not to take Polpril Plus

• if you are allergic to ramipril or indapamide, other ACE inhibitors or other sulfonamides or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue.
• if you have ever had a severe allergic reaction called angioedema. Symptoms include itching, hives, red patches on the palms of the hands, soles of the feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• if you have had dialysis or other types of blood filtration. Depending on the type of equipment used, Polpril Plus may not be suitable for you;
• if you have kidney disease associated with reduced blood flow to the kidneys (renal artery stenosis);
• in the last 6 months of pregnancy (see also "Pregnancy and breastfeeding" below);
• if you are breastfeeding;
• if your blood pressure is very low or unstable. Your doctor should assess your blood pressure.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, e.g., around the throat) may increase;
• if you have severe liver problems or a condition called hepatic encephalopathy (a brain disorder caused by liver damage);
• if you have severe kidney problems;
• if you have low potassium levels in your blood (hypokalemia);
• if you have uncontrolled heart failure (especially if untreated).

If any of the above situations apply to you (or if you are unsure), consult your doctor before taking Polpril Plus.

Warnings and precautions

Before taking Polpril Plus, discuss it with your doctor or pharmacist. Be particularly cautious when taking Polpril Plus:

• if you have lost a significant amount of salt or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, or prolonged use of diuretics or dialysis);
• if you are to receive anesthesia. It may be given in connection with a surgical or dental procedure. It may be necessary to discontinue treatment with Polpril Plus the day before the procedure, in case of doubt, consult your doctor;
• if you are scheduled to undergo desensitization treatment (e.g., for bee or wasp stings);
• if you have high potassium or low sodium levels in your blood;
• if you have a collagen vascular disease (when immune system problems affect collagen in the body), such as scleroderma (a chronic disease that mainly affects the skin) or systemic lupus erythematosus (a long-term inflammatory disease in which the immune system attacks healthy tissues);
• if you are of black origin. There is a higher risk of sudden, usually painful, severe angioedema, mainly of the face and reduced effectiveness of ramipril;
• if you have a cough. Consult your doctor if it worsens;
• if you are taking any of the following medicines for high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if you have kidney problems associated with diabetes;
• aliskiren;
• if you are taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat type 2 diabetes;
• if you have heart, liver, or kidney disease;
• if you have diabetes (you should regularly check your blood sugar levels);
• if you have gout;
• if you are sensitive to light (immune reactions to sunlight);
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye - they may occur within a few hours to weeks after taking Polpril Plus. Without treatment, these symptoms may lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at increased risk of developing these symptoms;
• if you have electrolyte imbalances in your blood or dehydration;
• if you are to undergo a test to assess parathyroid function.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Polpril Plus if you are pregnant or breastfeeding.

Your doctor may recommend that you have your white blood cell count checked. More frequent checks are recommended:

• at the start of treatment
• in patients with kidney problems or collagen vascular diseases or
• when taking medicines that affect blood cell counts.

Your doctor may recommend regular blood tests to check your kidney function, blood pressure, and electrolyte levels (such as sodium, potassium). You should inform athletes that Polpril Plus contains the active substance indapamide, which may cause a positive result in anti-doping tests. See also "When not to take Polpril Plus" above.

Children and adolescents

Polpril Plus is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

Polpril Plus with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. Do not take Polpril Plus:

• with lithium (used to treat depression).

The effect of Polpril Plus may be altered by other medicines. Inform your doctor if you are taking any of the following medicines, as special caution may be necessary:

• sacubitril/valsartan, used to treat chronic heart failure in adults (see also "When not to take Polpril Plus" above);
• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid);
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);
• diuretics (tablets that help produce urine), such as furosemide;
• blood pressure-lowering medicines;
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline, as well as dopamine, dobutamine, epinephrine, and isoprenaline;
• corticosteroids for inflammatory conditions, such as prednisolone;
• allopurinol (used to lower uric acid levels in the blood);
• procainamide (used to treat irregular heart rhythms);
• temsirolimus (used to treat cancer);
• sirolimus, everolimus, and other mTOR inhibitors (used to prevent transplant rejection);
• vildagliptin (used to treat type 2 diabetes);
• racecadotril (used to treat diarrhea);
• medicines that may alter blood cell counts;
• erythromycin injections (an antibiotic used to treat infections);
• medicines used to treat irregular heart rhythms (quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, digitalis preparations);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics);
• bepridil (used to treat angina pectoris, a condition that causes chest pain);
• cisapride (used to treat limited mobility of the esophagus and stomach);
• difemanil (used to treat stomach problems, such as ulcers, excessive acid, or hyperactive stomach);
• sparfloxacin, moxifloxacin (antibiotics used to treat infections);
• vinpocetine injections (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
• halofantrine (an antiparasitic medicine used to treat certain types of malaria);
• pentamidine (used to treat certain types of pneumonia);
• mizolastine (used to treat allergic reactions, such as high fever);
• amphotericin B injections (an antifungal medicine);
• oral corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis;
• laxatives that stimulate bowel movements;
• baclofen (used to treat muscle stiffness that occurs in conditions such as multiple sclerosis);
• diabetes medicines (such as metformin) and insulin;
• iodine-containing contrast agents (used during diagnostic tests using X-rays);
• medicines containing calcium or other calcium supplements;
• tetracosactide (used to treat Crohn's disease).

Your doctor may recommend a dose change and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "When not to take Polpril Plus" and "Warnings and precautions").

Polpril Plus with food and drink

Drinking alcohol while taking Polpril Plus may cause dizziness and drowsiness. If you are unsure about the amount of alcohol allowed while taking Polpril Plus, consult your doctor, as the effects of alcohol and blood pressure-lowering medicines may add up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Polpril Plus if you are pregnant or breastfeeding.

Driving and using machines

Polpril Plus has a minor to moderate influence on the ability to drive and use machines. While taking Polpril Plus, you may experience dizziness, headache, fatigue, weakness, or nausea. This is more likely to occur at the start of treatment. If this happens, do not drive, use tools, or operate machinery.

3. How to take Polpril Plus

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Adults

The recommended dose is one capsule once a day, preferably in the morning with a sufficient amount of liquid (e.g., a glass of water).

Children and adolescents

Polpril Plus is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

Overdose

If you have taken more than the prescribed dose of Polpril Plus, immediately contact your doctor or go to the emergency department of the nearest hospital. Do not drive yourself, ask someone to drive you to the hospital or call an ambulance. Bring the package leaflet with you to show the doctor what you have taken.

Missed dose

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the forgotten capsule.

Stopping treatment

Do not stop taking Polpril Plus suddenly or change the prescribed dose without consulting your doctor, as your condition may worsen. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Polpril Plus can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Polpril Plus and contact your doctor immediately – you may need urgent medical attention:

• swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to Polpril Plus.
• severe skin reactions, including rash, ulcers of the mucous membranes, worsening of existing skin conditions, redness, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, tightness in the chest, or more serious conditions, including heart attack or stroke;
• shortness of breath or cough, which may be symptoms of lung disease;
• easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding from the gums), purple spots on the skin, or more frequent infections, sore throat, and fever, fatigue, weakness, dizziness, or pale skin, which may be symptoms of blood or bone marrow disorders;
• severe abdominal pain radiating to the back, which may be a symptom of pancreatitis;
• fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice), or liver damage;
• concentrated urine (dark color), nausea, muscle cramps, confusion, and seizures, which may be caused by abnormal antidiuretic hormone (ADH) secretion.

Other side effects

Tell your doctor if any of the following side effects get worse or persist for more than a few days.

Common(affecting less than 1 in 10 people)

• increased potassium levels in the blood, low potassium levels in the blood shown in blood tests;
• headache and dizziness;
• fainting, low blood pressure (abnormally low blood pressure), especially when standing up quickly or sitting down;
• dry, irritating cough, sinusitis, or bronchitis, shortness of breath;
• gastritis and/or enteritis, stomach or intestinal pain, diarrhea, nausea, or vomiting;
• allergic reaction (especially in people who tend to have allergic or asthmatic reactions) leading to skin rashes with spots and bumps;
• muscle cramps or pain;
• chest pain or feeling of tiredness.

Uncommon(affecting less than 1 in 100 people)

• increased number of certain white blood cells (eosinophilia) detected in blood tests;
• loss of or decreased appetite (anorexia), low sodium levels in the blood, which may lead to dehydration and low blood pressure;
• depression, anxiety, increased nervousness, or restlessness, sleep disturbances, including drowsiness;
• balance problems (dizziness), itching, and abnormal skin sensations, such as numbness, tingling, prickling, or burning of the skin (paresthesia), loss of or altered taste;
• vision disturbances (including blurred vision);
• myocardial ischemia, including angina pectoris or myocardial infarction, rapid or irregular heartbeat, palpitations, swelling of the ankles, feet, or fingers;
• flushing;
• stuffy nose, difficulty breathing, or worsening of asthma;
• pancreatitis, intestinal angioedema (a condition characterized by abdominal pain, vomiting, and diarrhea);
• heartburn, constipation, or dry mouth;
• blood tests showing changes in liver, pancreas, or kidney function;
• swelling of the face, lips, or throat. See the first bullet point at the beginning of section 4.
• excessive sweating;
• rash, purple spots on the skin (purpura), skin discoloration;
• joint pain;
• kidney problems, including acute kidney failure, increased need to urinate;
• decreased sex drive in men or women, impotence (inability to achieve or maintain an erection);
• fever.

Rare(affecting less than 1 in 1,000 people)

• decreased number of red blood cells, white blood cells, or platelets, or hemoglobin levels detected in blood tests;
• low chloride levels in the blood, low magnesium levels in the blood;
• feeling of trembling or disorientation;
• tremors, balance problems;
• fatigue (weakness);
• conjunctivitis ("pink eye");
• hearing loss, ringing in the ears (tinnitus);
• vasoconstriction, hypoperfusion (reduced blood flow), vasculitis;
• tongue swelling (tongue edema);
• jaundice (yellowing of the skin and eyes), liver cell damage;
• severe skin peeling or shedding, hives, nail problems (e.g., loosening or separation of the nail from the nail bed);
• weakness (asthenia).

Very rare(affecting less than 1 in 10,000 people)

• increased calcium levels in the blood;
• decreased number of certain blood cells, which may cause weakness, bruising, or increased risk of infection (hemolytic anemia); aplastic anemia (bone marrow failure);
• irregular heartbeat;
• pancreatitis;
• abnormal liver function;
• reactions to sunlight (changes in skin appearance) after exposure to sunlight or artificial UV light;
• severe skin reactions. See the second bullet point at the beginning of section 4.

Frequency not known(frequency cannot be estimated from the available data)

• bone marrow failure, pancytopenia (low number of red blood cells, white blood cells, and platelets), hemolytic anemia;
• severe allergic reactions;
• syndrome of inappropriate antidiuretic hormone secretion;
• concentration problems;
• cerebrovascular disorders, including stroke, feeling of burning, change in smell;
• worsening of vision or eye pain due to high pressure [possible symptoms of choroidal effusion or acute angle-closure glaucoma];
• life-threatening irregular heartbeat (torsades de pointes);
• change in finger or toe color when cold, followed by tingling or pain upon warming (Raynaud's phenomenon);
• mouth ulcers (ulcers of the mucous membrane lining the mouth);
• acute liver failure, liver inflammation. If you have liver problems, taking Polpril Plus may cause a condition called hepatic encephalopathy (brain and nerve damage that can occur as a complication of liver disease);
• hair loss;
• breast enlargement in men (gynecomastia);
• abnormal electrocardiogram (ECG) of the heart;
• changes in blood tests, and your doctor may recommend blood tests to check your condition. The following changes in blood test results may occur:
• increased glucose levels in the blood in patients with diabetes;
• increased uric acid levels in the blood, a substance that can cause or worsen gout;
• increased liver enzyme activity.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polpril Plus

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month. The packaging is marked with "EXP" for the expiry date and "Lot" for the batch number. 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 protect the environment.

6. Contents of the pack and other information

What Polpril Plus contains

• The active substances are ramipril and indapamide. Each 5 mg + 1.25 mg capsule contains 5 mg of ramipril and 1.25 mg of indapamide. Each 5 mg + 2.5 mg capsule contains 5 mg of ramipril and 2.5 mg of indapamide. Each 10 mg + 1.25 mg capsule contains 10 mg of ramipril and 1.25 mg of indapamide. Each 10 mg + 2.5 mg capsule contains 10 mg of ramipril and 2.5 mg of indapamide.
• The other ingredients are: capsule contents: microcrystalline cellulose, mannitol, magnesium stearate; capsule shell: gelatin (bovine); 5 mg + 2.5 mg; 10 mg + 1.25 mg; 10 mg + 2.5 mg capsules contain: iron oxide red (E 172); 5 mg + 1.25 mg; 5 mg + 2.5 mg; 10 mg + 1.25 mg capsules contain: iron oxide yellow (E 172).

What Polpril Plus looks like and contents of the pack

Polpril Plus, 5 mg + 1.25 mg: Hard yellow gelatin capsules with "5+1.25" printed on the body; capsule size - No. 3 (length approximately 16 mm), containing a white or almost white powder or slightly compressed larger agglomerates. Polpril Plus, 5 mg + 2.5 mg: Hard gelatin capsules with a yellow body and orange cap, with "5 mg+2.5 mg" printed on the body; capsule size - No. 1 (length approximately 19.5 mm), containing a white or almost white powder or slightly compressed larger agglomerates. Polpril Plus, 10 mg + 1.25 mg: Hard orange gelatin capsules with a red cap, with "10 mg+1.25 mg" printed on the body; capsule size - No. 1 (length approximately 19.5 mm), containing a white or almost white powder or slightly compressed larger agglomerates. Polpril Plus, 10 mg + 2.5 mg: Hard red gelatin capsules with "10 mg+2.5 mg" printed on the body; capsule size - No. 1 (length approximately 19.5 mm), containing a white or almost white powder or slightly compressed larger agglomerates. The medicine is packaged in aluminum/OPA/aluminum/PVC blisters in a cardboard box containing 28 or 84 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Metalowca 2, 39-460 Nowa Dęba

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: ПОЛПРИЛ ПЛЮС 5 mg/1.25 mg твърди капсули, ПОЛПРИЛ ПЛЮС 5 mg/2.5 mg твърди капсули, ПОЛПРИЛ ПЛЮС 10 mg/1.25 mg твърди капсули, ПОЛПРИЛ ПЛЮС 10 mg/2.5 mg твърди капсули

Date of last revision of the package leaflet: