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 this leaflet carefully before taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of the Pack

• 1. What Polpril Plus is and what it is 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 Polpril Plus is and what it is 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 causes a slight increase in 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, 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, difficulty swallowing or breathing, swelling of the face, lips, throat, or tongue;
• if you have ever had a severe allergic reaction called angioedema; symptoms include itching, hives, red patches on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
• if you have undergone 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 related to reduced blood flow to the kidneys (renal artery stenosis);
• in the last 6 months of pregnancy (see also "Pregnancy and breastfeeding");
• 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 not treated).

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 undergo 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; if in doubt, consult your doctor;
• if you are scheduled to undergo desensitization treatment (to reduce allergy to 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 black; 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 used to treat 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 related to 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 system reactions to sunlight);
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (choroidal effusion) or increased pressure within 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 think you may be pregnant, or if you 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.

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 food and drink

Drinking alcohol while taking Polpril Plus may cause dizziness and fainting. If you have any doubts 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 think you may be pregnant, or if you 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, dizziness, headache, fatigue, weakness, or nausea may occur. This is more likely to happen at the beginning of treatment. If this happens, do not drive 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, ask your doctor or pharmacist.

Adults

The recommended dose is one capsule once daily, preferably taken 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.

If you take more Polpril Plus than you should

Immediately contact your doctor or go to the emergency department of your nearest hospital. Do not drive yourself; ask someone to drive you to the hospital or call an ambulance. Bring the package leaflet and any remaining capsules with you to show the doctor.

If you forget to take Polpril Plus

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

If you stop taking Polpril Plus

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, this medicine 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 – urgent medical attention may be required:

• swelling of the face, lips, or throat, which may cause difficulty swallowing or breathing, 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 gums), purple spots on the skin, or frequent infections, sore throat, and fever, fatigue, weakness, dizziness, or paleness of the 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 secretion of antidiuretic hormone (ADH).

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)

• high 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 nodules;
• 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) shown in blood tests;
• loss of appetite (anorexia), low sodium levels in the blood, which may lead to dehydration and low blood pressure;
• depression, anxiety, increased nervousness, sleep disturbances, including drowsiness;
• balance problems (dizziness), itching, and abnormal skin sensations, such as numbness, tingling, prickling, burning, or stinging; altered taste;
• vision disturbances (including blurred vision);
• myocardial ischemia, including angina pectoris or myocardial infarction, rapid or irregular heartbeat, palpitations;
• flushing;
• stuffy nose, difficulty breathing, or worsening of asthma;
• pancreatitis, intestinal edema (swelling of the intestines) characterized by abdominal pain, vomiting, and diarrhea;
• heartburn, constipation, or dry mouth;
• blood tests showing changes in liver, pancreas, or kidney function;
• angioedema (see the first dash 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 shown in blood tests;
• low chloride levels in the blood, low magnesium levels in the blood;
• feeling of trembling or disorientation;
• tremors, balance disturbances;
• fatigue (weakness);
• conjunctivitis ("pink eye");
• hearing loss, tinnitus (ringing in the ears);
• vasoconstriction, hypoperfusion (decreased 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)

• high 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 suppression);
• irregular heartbeat;
• pancreatitis;
• abnormal liver function;
• reactions to light (change in skin appearance) after exposure to sunlight or artificial UV light;
• severe skin reactions; see the second dash 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;
• difficulty concentrating;
• 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 and toe color when cold, followed by tingling or pain upon warming (Raynaud's phenomenon);
• inflammation of the mucous membrane lining the mouth (mucosal inflammation) with small ulcers;
• acute liver failure, hepatitis; if you have liver problems, taking Polpril Plus may cause a condition called hepatic encephalopathy (brain and nerve damage due to liver disease);
• hair loss;
• breast enlargement in men (gynecomastia);
• abnormal ECG heart tracing;
• changes in blood and your doctor may order blood tests to check your condition. The following changes in blood test results may occur:
• increased blood glucose levels in patients with diabetes;
• increased uric acid levels, a substance that can cause or worsen gout (joint pain, especially in the feet);
• increased liver enzyme activity.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported 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. Side effects can also be reported to the marketing authorization holder.

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 labeled 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. This 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); the 5 mg + 2.5 mg, 10 mg + 1.25 mg, and 10 mg + 2.5 mg capsules contain: red iron oxide (E 172); the 5 mg + 1.25 mg, 5 mg + 2.5 mg, and 10 mg + 1.25 mg capsules contain: yellow iron oxide (E 172).

What Polpril Plus looks like and contents of the pack

Polpril Plus, 5 mg + 1.25 mg: Hard yellow gelatin capsules with printing on the body "5+1.25"; 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 printing on the body "5 mg+2.5 mg"; 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 printing on the body "10 mg+1.25 mg"; 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 printing on the body "10 mg+2.5 mg"; 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 leaflet: