Ampril 10 mg tabletki

Leaflet accompanying the packaging: patient information

Ampril 2.5 mg tablets

Ampril 5 mg tablets

Ampril 10 mg tablets

Ramipril

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ampril and what is it used for

Ampril contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Ampril works by:

• reducing the production of substances in the body that may increase blood pressure,
• reducing tension and dilating blood vessels,
• making it easier for the heart to pump blood throughout the body.

Ampril can be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay kidney function deterioration (in patients with diabetes, as well as without diabetes),
• to treat heart failure, if the heart is not able to pump enough blood to meet the body's needs,
• to treat heart failure after a heart attack.

2. Important information before taking Ampril

When not to take Ampril:

• If the patient is allergic to ramipril, any other ACE inhibitor, 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 lips, face, throat, or tongue.
• If the patient has ever had a severe allergic reaction called "angioedema". Its symptoms include: itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

stopach i gardle, obrzęk gardła i języka, obrzęki wokół oczu i warg, trudności w oddychaniu i
połykaniu.

• If the patient is undergoing dialysis or other blood filtration procedures. Depending on the type of device used, Ampril may not be a suitable medicine.
• If the patient has kidney problems related to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see also "Pregnancy and breastfeeding" below).
• If blood pressure is very low or unstable. The doctor will assess blood pressure.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic (long-term) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

Jeżeli którakolwiek z powyższych sytuacji dotyczy pacjenta, nie należy stosować leku Ampril. W
razie wątpliwości związanych ze stosowaniem tego leku, przed rozpoczęciem przyjmowania leku
Ampril należy zwrócić się do lekarza.

Warnings and precautions

Before taking Ampril, the patient should consult a doctor or pharmacist if:

• they have heart, liver, or kidney disease;
• they have recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, or long-term use of diuretics or dialysis);
• they are scheduled to undergo desensitization therapy for bee or wasp stings;
• they are scheduled to receive anesthesia. These may be used during surgical or dental procedures. It may be necessary to stop taking Ampril the day before the procedure - consult a doctor.
• they have high levels of potassium in the blood (visible in blood test results);
• they are taking medicines or have conditions that may lower sodium levels in the blood. The doctor may order regular blood tests, especially to check sodium levels in the blood, particularly in elderly patients.
• they are taking any of the following medicines, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases:
• racecadotril, a medicine used to treat diarrhea,
• temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer),
• wildagliptin, a medicine used to treat type 2 diabetes.
• they have collagenosis, such as scleroderma or systemic lupus erythematosus;
• they are taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren. The attending physician may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under "When not to take Ampril:".

Należy poinformować lekarza o podejrzeniu lub planowaniu ciąży. Nie zaleca się stosowania leku
Ampril w okresie pierwszych 3 miesięcy ciąży, a powyżej trzeciego miesiąca ciąży, stosowanie leku
Ampril może poważnie zaszkodzić dziecku (patrz punkt „Ciąża i karmienie piersią”).

Children and adolescents

Ampril is not recommended for children and adolescents under 18 years of age, as the safety and efficacy of this medicine in this patient group have not been established.
If any of the above situations apply to the patient (or there are doubts about it), before starting to take Ampril, they should consult a doctor.

Ampril and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription (including herbal medicines). Ampril may affect the action of other medicines, and other medicines may affect the action of Ampril.
The patient should inform their doctor about taking any of the following medicines, as they may weaken the effect of Ampril:

• pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and acetylsalicylic acid);
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. The doctor will assess blood pressure.

The patient should inform their doctor about taking any of the following medicines, as they may increase the risk of side effects when used with Ampril:

• pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and acetylsalicylic acid);
• cancer medicines (chemotherapy);
• diuretics, such as furosemide;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medicines that increase potassium levels in the blood (e.g., heparin, a medicine used to thin the blood to prevent clots; trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs);
• corticosteroid anti-inflammatory medicines, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat heart rhythm disorders);
• wildagliptin (used to treat type 2 diabetes);
• racecadotril (a medicine used to treat diarrhea);
• medicines that are often used to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See the "Warnings and precautions" section.

The patient should inform their doctor about taking any of the following medicines, as their action may be altered when used with Ampril:

• anti-diabetic medicines, such as oral glucose-lowering medicines and insulin. Ampril may lower blood glucose levels. When taking Ampril, blood glucose levels should be regularly monitored.
• lithium (used to treat mental disorders). Ampril may increase lithium levels in the blood. The doctor will closely monitor lithium levels in the blood.

If any of the above situations apply to the patient (or there are doubts about it), before starting to take Ampril, they should consult a doctor.
The attending physician may need to change the dose and/or take other precautions:

• if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under "When not to take Ampril:" and "Warnings and precautions").

Ampril with food and drink

• Consuming alcohol while taking Ampril may cause dizziness and a feeling of "emptiness" in the head. If in doubt about the amount of alcohol allowed while taking Ampril, the patient should consult a doctor, as blood pressure-lowering medicines and alcohol may enhance each other's effects.
• Ampril can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about suspected or planned pregnancy. Ampril is not recommended during the first 12 weeks of pregnancy and must not be taken after the 13th week of pregnancy, as it may cause serious harm to the fetus. If a woman taking Ampril becomes pregnant, she should immediately tell her doctor. The doctor will recommend changing the treatment to another medicine suitable for use during pregnancy.
Breastfeeding
Ampril must not be taken during breastfeeding.
Before taking any medicine, the patient should consult a doctor or pharmacist.

Driving and using machines

While taking Ampril, drowsiness or dizziness may occur. The likelihood of these symptoms is higher at the beginning of treatment with Ampril and after increasing the dose. If drowsiness or dizziness occurs, the patient should not drive or operate machinery.

Ampril contains lactose and sodium

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Ampril

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, the patient should consult a doctor or pharmacist.

Taking the medicine

• The medicine should be taken orally, once a day, at the same time.
• The tablets should be swallowed whole, with a drink of water.
• The tablets should not be crushed or chewed.

Dosage

Treatment of high blood pressure

• The usual initial dose is 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the dose until blood pressure is controlled.
• The maximum dose is 10 mg once a day.
• If the patient is taking diuretics, the doctor may stop or reduce the dose of the diuretic before starting Ampril.

Reducing the risk of heart attack or stroke

• The usual initial dose is 2.5 mg once a day.
• The doctor may decide to increase the dose.
• The usual dose is 10 mg once a day.

Treatment to reduce the risk of or delay kidney function deterioration

• The usual initial dose is 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the dose of the medicine.
• The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure

• The usual initial dose is 1.25 mg once a day.
• The doctor will adjust the dose of the medicine.
• The maximum dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Treatment after a heart attack

• The usual initial dose is 1.25 mg once a day to 2.5 mg twice a day.
• The doctor will adjust the dose of the medicine.
• The usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Elderly patients

• The doctor will recommend a lower initial dose and will gradually adjust the dose.

Taking a higher dose of Ampril than recommended

The patient should immediately consult a doctor or go to the emergency department of the nearest hospital. They should not drive themselves, but ask someone to drive them to the hospital or call an ambulance. They should take the packaging of the medicine with them, so the doctor knows what medicine was taken.

Missing a dose of Ampril

• If a dose is missed, the next dose should be taken at the usual time.
• The patient should not take a double dose of the medicine to make up for the missed dose.

Stopping treatment with Ampril

The patient should not stop taking the medicine unless their doctor tells them to. They should not stop taking Ampril just because their condition has improved. Stopping treatment may worsen high blood pressure.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

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

If the patient notices any of the following serious side effects, they should stop taking Ampril and immediately consult a doctor - urgent medical attention may be required:

• 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 Ampril.
• Severe skin changes, including rash, mouth ulcers, worsening of existing skin conditions, redness, blistering, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If the patient experiences any of the following, they should immediately inform their doctor:

• Rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, tightness in the chest, or more serious disorders, including heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of lung disorders.
• 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, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders.
• Severe abdominal pain, which may radiate to the back. This may be a symptom of pancreatitis.
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, vomiting, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as inflammation or liver damage.

Other side effects

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days.

Common side effects (may affect up to 1 in 10 people):

• Headache or feeling tired.
• Dizziness. The likelihood of this symptom is higher at the beginning of treatment with Ampril and after increasing the dose.
• Fainting, low blood pressure (abnormally low blood pressure) occurring especially after quickly changing position from lying down to sitting or standing.
• Dry, persistent cough, sinusitis, or bronchitis, shortness of breath.
• Stomach pain or abdominal pain, diarrhea, nausea, or vomiting.
• Rash with raised skin lesions or without.
• Chest pain.
• Muscle cramps or muscle pain.
• High levels of potassium in the blood, as shown in laboratory tests.

Uncommon side effects (may affect up to 1 in 100 people):

• Balance disorders (dizziness of labyrinthine origin).
• Itching of the skin and abnormal sensations on the skin, such as numbness, tingling, prickling, burning, or a feeling of crawling on the skin (paresthesia).
• Loss of or changes in taste.
• Sleep disorders.
• Depression, anxiety, nervousness, or restlessness, especially motor restlessness.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Intestinal edema called "angioedema of the intestine", whose symptoms are abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased urine production during the day.
• Excessive sweating.
• Loss of or decreased appetite (anorexia).
• Accelerated or irregular heartbeat. Swelling of the hands and feet. This may be a sign of excessive water retention in the body.
• Hot flashes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men or women.
• Increased white blood cell count (eosinophilia), as shown in blood tests.
• Disorders of liver, pancreas, or kidney function, as shown in blood tests.

Rare side effects (may affect up to 1 in 1,000 people):

• Feeling of uncertainty or disorientation.
• Redness and swelling of the tongue.
• Severe peeling of the skin, itchy papular rash.
• Nail disorders (e.g., loosening or separation of the nail from the nail bed).
• Rash or bruising.
• Spots on the skin and cold extremities.
• Redness, itching, swelling, or tearing of the eyes.
• Hearing disorders and ringing in the ears.
• Weakness.
• Decreased red blood cell count, white blood cell count, or platelet count, or hemoglobin levels, as shown in blood tests.

Very rare side effects (may affect up to 1 in 10,000 people):

• Sensitivity to sunlight.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Concentrated urine (dark urine color), nausea, vomiting, muscle cramps, disorientation, and seizures; these symptoms may be caused by inappropriate secretion of antidiuretic hormone (ADH); if these symptoms occur, the patient should immediately consult a doctor.

Other reported side effects:

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days:

• Difficulty concentrating.
• Swelling of the lips.
• Low white blood cell count, as shown in blood tests.
• Low sodium levels, as shown in blood tests.
• Change in finger color upon cooling and feeling of tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Smell disorders.
• Hair loss.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Ampril

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ampril contains

• The active substance of Ampril is ramipril. Each Ampril 2.5 mg tablet contains 2.5 mg of ramipril. Each Ampril 5 mg tablet contains 5 mg of ramipril. Each Ampril 10 mg tablet contains 10 mg of ramipril.
• The other ingredients are: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, corn starch (Starch 1500), sodium stearyl fumarate; Ampril 2.5 mg tablets also contain the dye Blend PB 22960 Yellow: lactose monohydrate, yellow iron oxide (E 172); Ampril 5 mg tablets also contain the dye Blend PB 24877 Pink: lactose monohydrate, red iron oxide (E 172), yellow iron oxide (E 172). See section 2 "Ampril contains lactose and sodium".

What Ampril looks like and contents of the packaging

Ampril 2.5 mg tablets: yellow, flat, oblong tablets, 10.0 x 5.0 mm in size
Ampril 5 mg tablets: pink, flat, oblong tablets, 8.8 x 4.4 mm in size
Ampril 10 mg tablets: white to off-white, flat, oblong tablets, 11.0 x 5.5 mm in size
Packaging: 30, 60, 90, or 100 tablets in blisters in a cardboard box
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Date of last revision of the leaflet:07.05.2019