Axtil

Package leaflet: Information for the user

AXTIL, 2.5 mg, tablets
AXTIL, 5 mg, tablets
AXTIL, 10 mg, tablets
Ramiprilum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• 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 personally. 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, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Axtil is and what it is used for
2. What you need to know 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 works by:

• reducing the body's production of substances that may increase blood pressure,
• relaxing and widening blood vessels,
• helping the heart pump blood more easily throughout the body.

Axtil may 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 or not),
• to treat heart failure, when the heart is unable to pump enough blood to meet the body's needs,
• in the treatment of patients with heart failure following a heart attack.

2. What you need to know before taking Axtil

Do not take Axtil if:

• You are 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, including swelling of the lips, face, throat, or tongue.
• You have previously experienced a severe allergic reaction called angioedema. Symptoms include itching, hives, red patches on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• You are taking or currently using sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because this increases the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat).
• You are undergoing dialysis or another type of blood filtration. Depending on the equipment used, Axtil may not be suitable for you.
• You have reduced blood flow to the kidney (renal artery stenosis).
• You have very low or unstable blood pressure. This assessment should be made by your doctor.
• You are in the last 6 months of pregnancy (see section "Pregnancy and breastfeeding").
• You have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, do not take Axtil.
If you are in any doubt, consult your doctor before taking Axtil.

Warnings and precautions
Before starting Axtil, discuss with your doctor or pharmacist if:

• You have problems with your heart, liver, or kidneys,
• You have lost a significant amount of salt or fluid from your body (due to vomiting, diarrhoea, excessive sweating, being on a low-salt diet, long-term use of diuretics, or dialysis),
• You are undergoing desensitisation treatment for bee or wasp stings,
• You are scheduled to receive an anaesthetic. These are given before surgery or dental procedures. You may need to stop taking Axtil one day beforehand; consult your doctor for advice,
• You have high potassium levels in your blood (based on blood test results),
• You are taking medicines or have conditions that may lower sodium levels in your blood. Your doctor may recommend regular blood tests, especially to check blood sodium levels, particularly in elderly patients,
• You have vascular collagen diseases such as scleroderma or systemic lupus erythematosus,
• You are pregnant or planning pregnancy. Axtil is not recommended during the first 3 months of pregnancy, and should not be used after the third month of pregnancy as it may seriously harm the unborn child. See section "Pregnancy and breastfeeding",
• You are taking any of the following medicines for high blood pressure:
  • an angiotensin II receptor antagonist (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
  • aliskiren,
• If you are of Black origin, there is a higher risk of angioedema, and Axtil may be less effective in lowering blood pressure in Black patients compared to patients of other races,
• If you are taking any of the following medicines, the risk of angioedema may increase:
  • racecadotril, a medicine used to treat diarrhoea,
  • medicines used to prevent rejection of transplanted organs or to treat cancer (e.g. temsirolimus, sirolimus, everolimus),
  • vildagliptin, a medicine used to treat diabetes.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information under the heading "Do not take Axtil if".
Before starting treatment with Axtil, inform your doctor if any of the above points apply to you, or if you are unsure.

Children and adolescents
Axtil is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy in this age group have not yet been established.

Axtil with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Axtil may affect the action of some medicines, and some medicines may affect the action of Axtil. Your doctor may need to adjust the dose and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under "Do not take Axtil if" and "Warnings and precautions").

Tell your doctor if you are taking any of the following medicines. They may reduce the effectiveness of Axtil:

• Medicines used for pain relief and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and acetylsalicylic acid),
• Medicines for low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. In such cases, blood pressure should be monitored.

Tell your doctor if you are taking any of the following medicines. They may increase the risk of side effects when taken together with Axtil:

• Medicines used for pain relief and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, and acetylsalicylic acid),
• Anticancer medicines (chemotherapy),
• Medicines used to prevent rejection of transplanted organs, such as cyclosporine,
• Diuretics (water tablets), such as 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 for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots),
• Corticosteroid anti-inflammatory medicines, such as prednisolone,
• Allopurinol (used to lower uric acid levels in the blood),
• Procainamide (used for heart rhythm disorders),
• Temsirolimus (used to treat malignant tumours),
• Medicines most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitor medicines). See section "Warnings and precautions".

Tell your doctor if you are taking any of the following medicines. Axtil may affect their action:

• Antidiabetic medicines, such as oral glucose-lowering agents and insulin. Axtil may lower blood glucose levels. Blood glucose levels should be closely monitored during treatment with Axtil,
• Lithium (used for psychiatric disorders). Axtil may increase lithium levels in the blood, so levels should be closely monitored.

Before starting treatment with Axtil, inform your doctor if any of the above apply to you, even if you are uncertain.

Axtil with food, drink and alcohol

• Drinking alcohol with Axtil may cause dizziness or a feeling of emptiness in the head. If you are unsure how much alcohol you can drink while taking Axtil, discuss this with your doctor, as alcohol may enhance the blood pressure-lowering effect of the medicine.
• Axtil can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you think you are pregnant (or are planning to become pregnant).
Axtil is not recommended during the first 12 weeks of pregnancy and must not be used after the 13th week of pregnancy, as it may harm the unborn child.
If you become pregnant while taking Axtil, inform your doctor immediately. A change in treatment is recommended before a planned pregnancy.

Breast-feeding
Do not take Axtil while breast-feeding.

Driving and using machines
Dizziness may occur while taking Axtil. The risk of this is higher when starting treatment with Axtil or increasing the dose. In such cases, do not drive or operate tools or machinery.

Axtil contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Axtil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Axtil

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

How to take the medicine

• Take the medicine orally at the same time each day.
• Swallow the tablets with liquid.

Your doctor may prescribe another product containing ramipril if appropriate 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 you are taking diuretics (water tablets) concurrently, your doctor may recommend stopping or reducing the dose of such medicines before starting Axtil.

Prevention of heart attack or stroke

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

Treatment to reduce or delay worsening of kidney disease

• The initial dose may be 1.25 mg or 2.5 mg once daily.
• Your 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.
• Your doctor will determine the appropriate dose.
• The maximum dose is 10 mg per day. Twice-daily dosing is recommended.

Treatment following a heart attack

• The recommended initial dose is 1.25 mg once daily, increasing to 2.5 mg twice daily.
• Your doctor will determine the appropriate dose.
• The recommended dose is 10 mg per day. Twice-daily dosing is recommended.

Elderly patients
Your doctor will reduce the initial dose and adjust the dose more slowly.

Taking more Axtil than prescribed
Seek immediate medical advice from your doctor or go to the nearest emergency department. Do not travel to the hospital alone; get help from another person or call an ambulance. Take the medicine package with you so that it is clear which medicine was taken.

If you forget to take Axtil

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

Stopping Axtil
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Axtil and immediately contact your doctor if any of the following serious adverse reactions occur – immediate medical attention may be required:

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction to Axtil (not common – may occur in 1 in 100 people).
• Severe skin reactions, including rash, mouth ulcers, worsening of pre-existing skin disease, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency unknown adverse reaction – frequency cannot be estimated from available data).

Immediately tell your doctor if you experience:

• Rapid, irregular, or forceful heartbeat (palpitations), chest pain, chest tightness, or more serious conditions such as heart attack (not common – may occur in 1 in 100 people) and stroke (frequency unknown adverse reaction – frequency cannot be estimated from available data).
• Shortness of breath or cough. These may be symptoms of pulmonary adverse reactions (not common – may occur in 1 in 100 people).
• Increased bruising, bleeding lasting longer than usual, other bleeding (e.g. bleeding gums), purple spots on the skin, or increased tendency to infections, sore throat and fever, feeling of fatigue, weakness, dizziness, or pale skin. These may be symptoms of blood or bone marrow disorders (frequency unknown adverse reaction – frequency cannot be estimated from available data).
• Severe abdominal pain which may radiate to the back. These may be symptoms of pancreatitis (not common – may occur in 1 in 100 people).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin and eyes (jaundice). These may be symptoms of liver disorders such as hepatitis or liver damage (frequency unknown adverse reaction – frequency cannot be estimated from available data).

Other possible adverse reactions:
Inform your doctor if any of the following reactions worsen or persist for more than a few days.

Common (may occur in 1 in 10 people)

• Headache or feeling of fatigue.
• Dizziness. The risk of this condition is higher when starting treatment with Axtil or increasing the dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Dry, tickling cough, sinusitis or bronchitis, shortness of breath.
• Stomach or intestinal pain, diarrhoea, indigestion, nausea, or vomiting.
• Skin rashes, including raised rashes.
• Chest pain.
• Muscle cramps or muscle pain.
• Increased potassium levels in blood confirmed by laboratory tests.

Not common (may occur in 1 in 100 people)

• Difficulty maintaining balance (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning, or stinging of the skin (paresthesia).
• Loss of taste or altered taste.
• Sleep disturbances.
• Feeling depressed, anxious, more nervous than usual, or irritable.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Intestinal swelling (intestinal angioedema), presenting with symptoms such as abdominal pain, vomiting, and diarrhoea.
• Heartburn, constipation, or dry mouth.
• Increased daytime urine output.
• Acute kidney failure.
• Excessive sweating.
• Loss of appetite or reduced appetite (anorexia).
• Rapid or irregular heartbeat. Swelling of hands and feet. This may be a sign of increased fluid retention by the body.
• Redness.
• Blurred vision.
• Joint pain.
• Fever.
• Erectile dysfunction in men, decreased libido in men or women.
• Increased number of certain white blood cells (eosinophilia) in blood tests.
• Blood tests showing changes in liver, pancreas, or kidney function.

Rare (may occur in 1 in 1,000 people)

• Tremor or disorientation.
• Redness and swelling of the tongue.
• Flaking of the skin, itchy, bumpy rash.
• Nail disorders (e.g. decreased adhesion or separation of the nail from the nail bed).
• Rash or skin bruising.
• Skin spots and cold extremities.
• Redness, itching, swelling, or watering of the eyes.
• Hearing disturbances or ringing in the ears (tinnitus).
• Feeling of weakness.
• Decreased number of red blood cells, white blood cells, or platelets, or decreased haemoglobin levels in blood tests.

Very rare (may occur in 1 in 10,000 people)

• Increased sensitivity to sunlight.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

• Concentrated urine (dark in colour), nausea or vomiting, muscle cramps, confusion, and seizures, which may result from inappropriate ADH secretion (antidiuretic hormone – vasopressin). If any of these symptoms occur, contact your doctor immediately.
• Difficulty concentrating.
• Swelling of the mouth.
• Increased levels of antibodies in blood tests.
• Decreased number of blood cells in blood tests.
• Low sodium levels in blood test results.
• Discoloration of fingers and toes in response to cold, followed by tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or weakened reactions.
• Burning sensation.
• Smell disturbances.
• Hair loss.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Axtil

Keep the medicine out of sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the carton, blister pack, or container holding the tablets after "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Doing so helps protect the environment.

6. Contents of the pack and other information

What Axtil contains

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

What Axtil looks like and contents of the pack
Axtil 2.5 mg: capsule-shaped, flat, yellow tablets. Scored on one side and along the sides, marked R2.
Axtil 5 mg: capsule-shaped, flat, pink tablets. Scored on one side and along the sides, marked R3.
Axtil 10 mg: capsule-shaped, flat, white to off-white tablets. Scored on one side and along the sides, marked R4.
Packaging
Axtil 2.5 mg, 5 mg, 10 mg tablets are available in aluminium/aluminium blisters packed in cardboard boxes containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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