Axtil

Leaflet accompanying the packaging: patient information

AXTIL, 2.5 mg, tablets

AXTIL, 5 mg, tablets

AXTIL, 10 mg, tablets

Ramipril

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

• Keep this leaflet, so you can read it again if you need to .
• 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 another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1.

What Axtil is and what it is used for

Axtil contains the active substance ramipril, which belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
The action of Axtil is based on:

• reducing the production of substances by the body that can increase blood pressure,
• relaxing and dilating blood vessels,
• facilitating the pumping of blood by the heart throughout the body.

Axtil can be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of developing or worsening existing kidney disease (regardless of whether diabetes is present),
• to treat heart failure, when the heart is not able to pump enough blood needed by the body,
• to treat patients with heart failure after a heart attack.

2. Important information before taking Axtil

When not to take Axtil:

• 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, swelling, or difficulty breathing,

swelling of the lips, face, throat, or tongue.
In patients who have previously experienced 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 has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat).

• In patients undergoing dialysis or other types of blood filtration. Depending on the device used, Axtil may not be suitable for the patient.
• In patients with reduced blood flow to the kidney (renal artery stenosis).
• In patients with very low or unstable blood pressure. The assessment should be made by a doctor. During the last 6 months of pregnancy (see section "Pregnancy and breastfeeding"). If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should not take Axtil.
In case of doubts, the patient should consult a doctor before taking Axtil.

Warnings and precautions

Before starting Axtil, the patient should discuss it with their doctor or pharmacist:

• In case of heart, liver, or kidney problems,
• In case of significant loss of salt or fluids by the body (due to vomiting, diarrhea, excessive sweating, being on a low-salt diet, taking diuretics for a long time, or dialysis),
• In case of planned desensitization to bee or wasp stings,
• In case of planned administration of an anesthetic. Such medications are given before surgeries or dental procedures. It may be necessary to stop taking Axtil one day in advance; the patient should ask their doctor for advice,
• In case of high potassium levels in the blood (based on blood test results),
• If the patient is taking medications or has 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,
• In case of collagen vascular disease, such as scleroderma or systemic lupus erythematosus,
• The patient should inform their doctor if they are pregnant or breastfeeding, or if they plan to become pregnant. Axtil is not recommended during the first 3 months of pregnancy, and above the third month of pregnancy, the medicine may have a harmful effect on the fetus, see section "Pregnancy and breastfeeding",
• If the patient is 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,
• If the patient is black, there is a higher risk of angioedema and Axtil may be less effective in lowering blood pressure in black patients than in patients of other races,
• If the patient is taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Axtil".
Before starting Axtil, the patient should inform their doctor if any of the above points apply to them or if they are unsure.

Children and adolescents

Axtil should not be used in children and adolescents under 18 years of age, as safety and efficacy in children have not yet been established.

Axtil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. Axtil may affect the action of some medicines. Additionally, some medicines may affect the action of Axtil.
The doctor 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 the heading "When not to take Axtil" and "Warnings and precautions").

The patient should inform their doctor if they are taking any of the following medicines, as they may reduce the effectiveness of Axtil:

• medicines used to relieve 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, norepinephrine, or adrenaline. In such cases, blood pressure should be monitored.

The patient should inform their doctor if they are taking any of the following medicines, as they may increase the risk of side effects when taken with Axtil:

• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and acetylsalicylic acid),
• anticancer medicines (chemotherapy),
• medicines used to prevent organ rejection and to treat cancer (e.g., cyclosporine),
• diuretics (e.g., furosemide),
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection, and heparin, a medicine used to thin the blood to prevent clots)
• corticosteroids, such as prednisolone,
• allopurinol (used to lower uric acid levels in the blood),
• procainamide (used to treat irregular heart rhythm),
• temsirolimus (used to treat cancer),
• medicines commonly used to prevent organ rejection (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

The patient should inform their doctor if they are taking any of the following medicines, as Axtil may affect their action:

• antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Axtil may lower blood glucose levels. Blood glucose levels should be monitored carefully while taking Axtil,
• lithium (used to treat mental illnesses). Axtil may increase lithium levels in the blood, so they should be closely monitored. Before starting Axtil, the patient should inform their doctor if any of the above points apply to them, even if they are unsure.

Axtil with food, drink, and alcohol

• Consuming alcohol with Axtil may lead to dizziness or a feeling of emptiness in the head. If the patient is unsure how much alcohol they can drink while taking Axtil, they should discuss it with their doctor, as alcohol can enhance the effects of blood pressure-lowering medicines.
• Axtil 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 their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor if they think they are pregnant (or plan to become pregnant).
Axtil should not be used during the first 12 weeks of pregnancy, and it should not be used after the 13th week of pregnancy, as it may harm the fetus.
If the patient becomes pregnant while taking Axtil, they should immediately inform their doctor. A change in treatment should be considered before planned pregnancy.
Breastfeeding
Axtil should not be taken during breastfeeding.

Driving and using machines

While taking Axtil, dizziness may occur. The risk of this increases when starting Axtil or increasing the dose. In such cases, the patient should not drive or use machines.

Axtil contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Axtil.

Axtil contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Axtil

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

How to take Axtil

• The medicine should be taken orally every day at the same time.
• The tablets should be swallowed with a liquid.

The doctor may prescribe a different product containing ramipril if the necessary doses of Axtil are not available.
Recommended dose
Treatment of high blood pressure

• The recommended initial dose is 1.25 mg or 2.5 mg once daily.
• The dose should be gradually increased until the desired blood pressure values are achieved.
• The maximum dose is 10 mg once daily.
• If the patient is also taking diuretics (water pills), the doctor may recommend stopping or reducing the dose of such a medicine before starting Axtil. Prevention of heart attack or stroke
• The initial dose is usually 2.5 mg once daily.
• The doctor may decide to increase the dose.
• The usual dose is 10 mg once daily. Treatment to reduce or delay the worsening of kidney disease
• The initial dose may be 1.25 mg or 2.5 mg once daily.
• The doctor will determine the appropriate dose.
• The recommended dose is 5 mg or 10 mg once daily. Treatment of heart failure
• The recommended initial dose is 1.25 mg once daily.
• The doctor will determine the appropriate dose.
• The maximum dose is 10 mg per day. It is recommended to take the dose twice a day. Treatment after a heart attack
• The recommended initial dose is 1.25 mg once daily to 2.5 mg twice daily.
• The doctor will determine the appropriate dose.
• The recommended dose is 10 mg per day. It is recommended to take the dose twice a day.

Elderly patients
The doctor will reduce the initial dose of Axtil and will increase the dose more slowly.

What to do if you take more Axtil than you should

The patient should immediately consult their doctor or contact the nearest emergency department. They should not go to the hospital alone; they should ask someone to accompany them or call an ambulance. The patient should take the packaging of the medicine with them, so it will be known which medicine is involved.

What to do if you forget to take Axtil

• If the patient forgets to take a dose, they should take the next dose at the usual time.
• The patient should not take a double dose to make up for the forgotten dose.

What to do if you stop taking Axtil

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking Axtil and immediately consult their doctor if they experience any of the following serious side effects - they 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 Axtil (uncommon - may affect up to 1 in 100 people).
• Severe skin reactions, including rash, ulcers in the mouth, worsening of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known - cannot be estimated from the available data).

The patient should immediately tell their doctor if they experience:

• Rapid heartbeat, irregular heartbeat, chest pain, tightness in the chest, or more serious conditions such as heart attack (uncommon - may affect up to 1 in 100 people) and stroke (frequency not known - cannot be estimated from the available data).
• Shortness of breath or cough. These may be symptoms of lung-related side effects (uncommon - may affect up to 1 in 100 people).
• Increased bruising, bleeding that lasts longer than usual, other bleeding (e.g., bleeding gums), purple spots on the skin, or a greater than usual tendency to infections, sore throat, and fever, feeling of tiredness, weakness, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders (frequency not known - cannot be estimated from the available data).
• Severe abdominal pain that may radiate to the back. This may be a symptom of pancreatitis (uncommon - may affect up to 1 in 100 people).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, vomiting, yellowing of the skin and eyes (jaundice). These may be symptoms of liver diseases, such as hepatitis or liver damage (frequency not known - cannot be estimated from the available data).

Other possible side effects:

The patient should inform their doctor if any of the following side effects worsen or last longer than a few days.
Common(may affect up to 1 in 10 people)

• Headache or feeling of tiredness.
• Dizziness. The risk of this increases when starting Axtil or increasing the dose.
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Dry, tickly cough, sinusitis, or bronchitis, shortness of breath.
• Stomach or intestinal pain, diarrhea, indigestion, nausea, or vomiting.
• Skin rash, including raised patches.
• Chest pain.
• Muscle cramps or pain.
• Increased potassium levels in the blood, as shown by laboratory tests.

Uncommon(may affect up to 1 in 100 people)

• Difficulty balancing (dizziness).
• Itching and unusual skin sensations, such as numbness, tingling, prickling, burning, or itching (paresthesia).
• Loss of or altered sense of taste.
• Sleep disturbances.
• Feeling depressed, anxious, more nervous than usual, or impatient.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Intestinal swelling (intestinal angioedema), which may cause symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Passing more urine than usual during the day.
• Sudden kidney failure.
• Excessive sweating.
• Lack of or decreased appetite (loss of appetite).
• Rapid or irregular heartbeat. Swelling of the hands and feet. This may be a sign of increased water retention by the body.
• Redness.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in men, decreased libido in men or women.
• Increased levels of certain white blood cells (eosinophilia) in blood tests.
• Blood tests showing changes in liver, pancreas, or kidney function.

Rare(may affect up to 1 in 1000 people)

• Trembling or disorientation.
• Redness and swelling of the tongue.
• Flaking of the skin, itchy, lumpy rash.
• Nail disorders (e.g., reduced adherence or separation of the nail from the nail bed).
• Rash or bruising of the skin.
• Spots on the skin and discoloration of the extremities.
• Redness, itching, swelling, or tearing of the eyes.
• Hearing or ringing in the ears.
• Feeling of weakness.
• Decrease in red blood cells, white blood cells, or platelets, or decrease in hemoglobin levels in blood tests.

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

• Increased sensitivity to sunlight.

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

• Concentrated urine (dark-colored), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to abnormal secretion of ADH (antidiuretic hormone, vasopressin). If the following symptoms occur, the patient should immediately consult their doctor.
• Difficulty concentrating.
• Swelling of the mouth.
• Increased levels of antibodies in blood tests.
• Decrease in blood cell count.
• Low sodium levels in blood tests.
• Change in finger and toe color in response to cold, followed by tingling or pain when warmed (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or weakened reactions.
• Feeling of burning.
• Disorders of smell.
• Hair loss.

Reporting side effects

If the patient experiences any side effects, including those 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:
Jerozolimskie Avenue 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Axtil

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister or packaging containing the tablets after: "EXP". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Axtil contains

• The active substance of Axtil is ramipril.
• The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pre-gelatinized corn starch, sodium stearyl fumarate, yellow iron oxide (E 172) (2.5 mg and 5 mg tablets), red iron oxide (E 172) (5 mg tablets).

What Axtil looks like and contents of the pack

Axtil 2.5 mg: capsules-shaped, flat, yellow tablets. Score line on one side and on the edges, with the marking R2.
Axtil 5 mg: capsules-shaped, flat, pink tablets. Score line on one side and on the edges, with the marking R3.
Axtil 10 mg: capsules-shaped, flat, white to off-white tablets. Score line on one side and on the edges, with the marking R4.
Packaging
Axtil 2.5 mg, 5 mg, and 10 mg tablets are available in aluminum/aluminum blisters, packaged in cardboard boxes containing 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Actavis Ltd.,
BLB016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
Extractum Pharma Ltd.,
1044 Budapest,
Megyeri út 64,
Hungary
Actavis (Balkanpharma) Dupnitsa AD
3 Samokovsko Shose Str.
Dupnitsa 2600
Bulgaria

Date of last revision of the leaflet: 07.2021