Ampril Hd

Leaflet accompanying the packaging: information for the user

Ampril HL, 2.5 mg + 12.5 mg, tablets

Ampril HD, 5 mg + 25 mg, tablets

ramipril + hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 HL, Ampril HD and what is it used for
• 2. Important information before taking Ampril HL, Ampril HD
• 3. How to take Ampril HL, Ampril HD
• 4. Possible side effects
• 5. How to store Ampril HL, Ampril HD
• 6. Contents of the packaging and other information

1. What is Ampril HL, Ampril HD and what is it used for

Ampril HL, Ampril HD is a combination medicine containing ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). The medicine works by:

• reducing the amount of substances produced by the body that increase blood pressure,
• relaxing and dilating blood vessels,
• making it easier for the heart to pump blood throughout the body.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. The action of the medicine is to increase the amount of urine excreted, which leads to a decrease in blood pressure.
Ampril HL, Ampril HD is used to treat high blood pressure. Both active substances work together to lower blood pressure. These substances are used in combination if treatment with only one of them is ineffective.

2. Important information before taking Ampril HL, Ampril HD

When not to take Ampril HL, Ampril HD

• if the patient is allergic to ramipril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic (hypersensitive) to medicines similar to Ampril HL, Ampril HD (other ACE inhibitors or sulfonamide derivatives). 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. 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;

• if the patient is undergoing dialysis or other blood filtration procedures. Depending on the device used, Ampril HL, Ampril HD may not be suitable;
• if severe liver disease has been diagnosed;
• if there is an abnormal amount of electrolytes (calcium, potassium, sodium) in the blood;
• if there are kidney disorders, consisting of reduced blood flow to the kidneys (renal artery stenosis);
• during the last 6 months of pregnancy (see also "Pregnancy and breastfeeding" below);
• during breastfeeding (see also "Pregnancy and breastfeeding" below);
• if the patient has diabetes or kidney function disorders 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 (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases.

Do not take Ampril HL, Ampril HD if any of the above situations apply to the patient. In case of doubts, consult a doctor before taking Ampril HL, Ampril HD.

Warnings and precautions

Before starting to take Ampril HL, Ampril HD, the patient should discuss it with their doctor or pharmacist:

• if there are heart, liver or kidney disorders;
• in case of loss of a large amount of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a diet low in salt, prolonged use of diuretics or dialysis therapy);
• if allergy treatment is planned (desensitization therapy);
• if anesthesia is planned. It may be used in the case of surgical or dental procedures. It may be necessary to stop taking Ampril HL, Ampril HD one day before the planned procedure; consult a doctor;
• if high levels of potassium are found in the blood (based on blood test results);
• if there is collagenosis of the vessels, such as scleroderma or systemic lupus erythematosus;
• if the patient has a history of malignant skin tumor or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses for a long time, may increase the risk of certain types of malignant skin tumors and lip tumors (non-melanoma skin cancer). During treatment with Ampril HL, Ampril HD, the skin should be protected from sunlight and UV radiation;
• if the patient has a history of breathing or lung problems (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Ampril HL, Ampril HD, they should seek medical attention immediately;
• if the patient is taking any of the following medicines, the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as sartan - e.g. valsartan, telmisartan, irbesartan, especially if the patient has kidney function disorders associated with diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure and electrolyte levels (e.g. potassium) in the blood. See also "When not to take Ampril HL, Ampril HD" and "Warnings and precautions".
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or increased pressure in the eye, which can occur within a few hours to weeks after taking Ampril HL, Ampril HD. If left untreated, they can lead to permanent vision loss. Patients with a history of penicillin or sulfonamide allergy may be more prone to developing this disease.

The patient should inform their doctor if they suspect or plan to become pregnant. Ampril HL, Ampril HD should not be taken during the first 3 months of pregnancy, and if taken after 3 months of pregnancy, it may cause serious harm to the fetus (see "Pregnancy and breastfeeding" below).

Children and adolescents

Ampril HL, Ampril HD should not be taken by children and adolescents under the age of 18.
This medicine has never been used in these age groups.
If any of the above situations apply to the patient (or in case of doubts), the patient should consult a doctor before starting to take Ampril HL, Ampril HD.

Ampril HL, Ampril HD and other medicines

The patient should tell 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 HL, Ampril HD may affect the action of other medicines. Other medicines may also affect the action of Ampril HL, Ampril HD.
The patient should inform their doctor if they are taking any of the following medicines. They may weaken the effect of Ampril HL, Ampril HD:

• medicines used for pain and inflammation (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. In this case, the doctor will monitor the patient's blood pressure.

The patient should inform their doctor if they are taking any of the following medicines. They may increase the risk of side effects when taken with Ampril HL, Ampril HD:

• medicines used for pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin and acetylsalicylic acid);
• medicines that lower potassium levels in the blood. These are medicines used for constipation, diuretics, amphotericin B (used to treat fungal infections) and ACTH (a hormone given in a test of adrenal function);
• medicines used to treat cancer (chemotherapy);
• medicines used to treat heart diseases, including anti-arrhythmic medicines;
• medicines used to prevent organ rejection, such as cyclosporine;
• diuretics, such as furosemide;
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, heparin (used to thin the blood to prevent clots), trimethoprim and co-trimoxazole (also known as trimethoprim/sulfamethoxazole) (used to treat bacterial infections);
• corticosteroids, such as prednisolone;
• calcium supplements;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat heart rhythm disorders);
• cholestyramine (used to lower cholesterol levels in the blood);
• carbamazepine (used to treat epilepsy);
• racecadotril (a medicine used to treat diarrhea);
• medicines often used to prevent organ rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors) or wildagliptin (used to treat diabetes). See "Warnings and precautions".

The patient should inform their doctor if they are taking any of the following medicines. Their action may be changed when taken with Ampril HL, Ampril HD:

• medicines used to treat diabetes, such as oral medicines that lower blood sugar levels and insulin. Ampril HL, Ampril HD may lower blood sugar levels. The patient should carefully monitor their blood sugar levels while taking Ampril HL, Ampril HD;
• lithium (used to treat mental disorders). Ampril HL, Ampril HD may increase lithium levels in the blood. The doctor will carefully monitor lithium levels in the blood;
• muscle relaxants;
• quinine (used to treat malaria);
• preparations containing iodine, which may be used during X-ray examinations - traditional and during computer tomography in the hospital;
• penicillin (used to treat infections);
• oral anticoagulants (oral anticoagulants), such as warfarin.

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

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "When not to take Ampril HL, Ampril HD" and "Warnings and precautions").

If any of the above situations apply to the patient (or in case of doubts), the patient should consult a doctor before starting to take Ampril HL, Ampril HD.
Tests
The patient should consult a doctor or pharmacist before starting to take the medicine:

• if parathyroid function tests are planned. Ampril HL, Ampril HD may affect the test results;
• if doping tests are to be performed (in athletes). Ampril HL, Ampril HD may cause a positive result.

Taking Ampril HL, Ampril HD with food, drink and alcohol

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

Pregnancy and breastfeeding

The patient should inform their doctor if they are pregnant, suspect they may be pregnant or plan to become pregnant.
Ampril HL, Ampril HD should not be taken during the first 12 weeks of pregnancy and should not be taken after the 13th week of pregnancy, as taking the medicine during pregnancy may cause harm to the fetus.
If the patient becomes pregnant while taking Ampril HL, Ampril HD, they should immediately inform their doctor. Before planned pregnancy, the medicine should be changed to another one suitable for use during pregnancy.
Ampril HL, Ampril HD should not be taken during breastfeeding.
Before taking any medicine, the patient should consult a doctor or pharmacist.

Driving and using machines

The patient should not drive or operate machines until they know how Ampril HL, Ampril HD affects them. While taking Ampril HL, Ampril HD, dizziness may occur. The risk of dizziness is higher when starting to take Ampril HL, Ampril HD and after increasing the dose. In this case, the patient should not drive, use tools or operate machines.

Ampril HL, Ampril HD contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Ampril HL, Ampril HD

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
How to take the medicine

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

Dose

Treatment of high blood pressure
The doctor will adjust the dose of the medicine until blood pressure is controlled.
Elderly patients
The doctor will reduce the initial dose and gradually adjust the dose.

Taking a higher dose of Ampril HL, Ampril HD than recommended

If a higher dose of Ampril HL, Ampril HD than recommended is taken, the patient should immediately inform their doctor or go to the emergency department of the nearest hospital. The patient should not drive; they should be driven by someone else or call an ambulance. The patient should take the medicine packaging with them, so that the doctor knows which medicine was taken.

Missing a dose of Ampril HL, Ampril HD

If a dose is missed, the patient should take the next dose at the usual time.
The patient should not take a double dose to make up for the missed tablet.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

In case of any of the following serious side effects, the patient should stop taking Ampril HL, Ampril HD and immediately consult a doctor - emergency medical attention may be necessary:

• swelling of the face, lips or throat, making swallowing or breathing difficult, as well as itching and rash. These may be symptoms of a severe allergic reaction to Ampril HL, Ampril HD;
• severe skin reactions, including rash, mouth ulcers, exacerbation of existing skin disease, redness, blistering or peeling of the skin (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme);
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion) (very rare (may occur in less than 1 in 10,000 patients)).

The patient should immediately consult a doctor if they experience:

• rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, feeling of pressure in the chest or other serious disorders, including heart attack and stroke;
• shortness of breath, cough, fever lasting 2 to 3 days and decreased appetite. These may be symptoms of lung disease, including pneumonia;
• easy bruising, prolonged bleeding, any signs of bleeding (e.g. bleeding from the gums), purpura 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, jaundice (yellowing of the skin or eyes). These may be symptoms of liver disorders, such as hepatitis or liver damage.

Other side effects include:

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

Common(may occur in less than 1 in 10 patients):

• headache, weakness or fatigue.
• dizziness. Dizziness is more likely to occur when starting to take Ampril HL, Ampril HD and after increasing the dose.
• dry, irritating cough or bronchitis.
• higher than usual blood sugar levels, found in laboratory tests. In patients with diabetes, this may worsen the disease.
• higher than usual levels of uric acid or lipids in the blood, found in laboratory tests.
• pain, redness and swelling of the joints.

Uncommon(may occur in less than 1 in 100 patients):

• skin rash with or without itching.
• sudden redness (especially of the face and neck), fainting, low blood pressure (abnormally low blood pressure), especially when standing up or sitting down quickly.
• balance disorders (dizziness of vestibular origin).
• itching and abnormal sensations on the skin, such as numbness, tingling, prickling, burning or "pins and needles" (paresthesia).
• loss or disturbance of taste.
• sleep disorders.
• low mood, anxiety, increased nervousness or irritability.
• nasal congestion, sinusitis, shortness of breath.
• gingivitis, swelling of the mouth.
• redness, itching, swelling or tearing of the eyes.
• ringing in the ears.
• blurred vision.
• hair loss.
• chest pain.
• muscle pain.
• constipation, stomach pain or abdominal pain.
• nausea or vomiting.
• increased urine production during the day.
• excessive sweating or thirst.
• loss or decreased appetite (anorexia), decreased hunger.
• rapid or irregular heartbeat.
• swelling of the arms and legs. This may be a symptom of water retention in the body.
• fever.
• sexual disorders in men.
• decreased red blood cell count, white blood cell count or platelet count, or decreased hemoglobin levels, found in laboratory tests.
• liver, pancreas or kidney function disorders, found in laboratory tests.
• decreased potassium levels in the blood, found in laboratory tests.

Very rare(may occur in less than 1 in 10,000 patients):

• vomiting, diarrhea or heartburn.
• redness and swelling of the tongue or dryness of the oral mucosa.
• increased potassium levels in the blood, found in laboratory tests.

Unknown(frequency cannot be estimated from the available data):

• malignant skin tumors and lip tumors (non-melanoma skin cancer).
• concentrated urine (dark-colored), nausea or vomiting, muscle cramps, disorientation and seizures, which may be symptoms of inappropriate antidiuretic hormone (ADH) secretion
• if such symptoms occur, the patient should immediately consult a doctor.

Other reported side effects:

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

• difficulty concentrating, anxiety or confusion.
• change in finger color on the hands and feet when cold and tingling or pain when warming the fingers. This may be a symptom of Raynaud's disease.
• breast enlargement in men.
• blood clots.
• hearing disorders.
• decreased tearing of the eyes.
• yellow vision.
• blurred vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive accumulation of fluid between the choroid and sclera - acute glaucoma or acute angle-closure glaucoma).
• dehydration.
• swelling, pain and redness of the cheeks (parotitis).
• intestinal edema, called angioedema of the intestine, manifesting as abdominal pain, vomiting and diarrhea.
• increased sensitivity to sunlight.
• severe skin peeling, itching, lumpy rash or other skin reactions, such as red rash on the face or forehead.
• skin rash or bruising.
• spots on the skin and discoloration of the limbs.
• nail disorders (e.g. separation or detachment of the nail plate from the nail bed).
• muscle stiffness or inability to move the jaw (tetany).
• muscle weakness or cramps.
• decreased sexual desire in men or women.
• blood in the urine. This may be a symptom of kidney disease (interstitial nephritis).
• increased sugar levels in the urine.
• increased white blood cell count (eosinophilia), found in laboratory tests.
• too few blood cells (pancytopenia), found in laboratory tests.
• changes in electrolyte levels, such as sodium, calcium, magnesium and chlorides in the blood, found in laboratory tests.
• slowed or disturbed reflexes.
• disorders of smell.
• difficulty breathing or worsening of asthma.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ampril HL, Ampril HD

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
Do not store above 30°C.
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 HL, Ampril HD contains

• The active substances of the medicine are ramipril and hydrochlorothiazide. Ampril HL: each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide. Ampril HD: each tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide.
• Other ingredients are: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch and sodium stearyl fumarate. See section 2 "Ampril HL, Ampril HD contains lactose and sodium".

What Ampril HL, Ampril HD looks like and contents of the pack

Ampril HL: white to off-white, uncoated, flat tablets in the shape of a capsule, with a dividing line on one side, marked "12.5". The dividing line on the tablet is only to facilitate breaking the tablet, to make it easier to swallow, and not to divide it into equal doses.
Ampril HD: white to off-white, uncoated, flat tablets in the shape of a capsule, with a dividing line on one side and side walls, marked "25". The tablet can be divided into equal doses.
Packaging: 30 tablets in blisters in a cardboard box

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Date of last revision of the leaflet:28.10.2022