Ampril 10 mg tablets

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Ampril 10 mg tablets
Ramiprilum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Ampril is and what it is 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 pack and other information

1. What Ampril is and what it is 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 in the body of substances that may increase blood pressure,
• reducing tension and widening blood vessels,
• helping the heart pump blood through the body.

Ampril may be used:

• in the treatment of high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay worsening of kidney function (in patients with or without diabetes),
• in the treatment of heart failure (when the heart is unable to pump sufficient blood to meet the body's needs),
• in the treatment following a heart attack complicated by heart failure.

2. Important information before using Ampril

When not to use 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 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.
• If the patient is undergoing dialysis or other blood filtration procedures. Depending on the type of equipment used, Ampril may not be suitable.
• 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 section below "Pregnancy and breastfeeding").
• If the patient has very low or unstable blood pressure. The doctor will assess the blood pressure.
• 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 using sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat).

If any of the above situations apply, Ampril must not be used. If in doubt about using this medicine, consult a doctor before starting Ampril.

Warnings and precautions

Before using Ampril, contact your doctor or pharmacist if:

• The patient has heart, liver, or kidney disease;
• The patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics (water tablets), or dialysis);
• Desensitisation treatment for bee or wasp venom (allergy desensitisation) is planned;
• Anaesthetics are to be administered. These may be used during surgical or dental procedures. It may be necessary to stop Ampril treatment one day before the procedure – consult your doctor.
• The patient has high potassium levels in the blood (seen in blood test results);
• The patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may recommend regular blood tests, especially to check blood sodium levels, particularly in elderly patients.
• The patient is taking any of the following medicines, which increase the risk of angioedema (rapid swelling under the skin, e.g. in the throat):
  • Racecadotril, a medicine used to treat diarrhoea,
  • Temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs and in cancer treatment),
  • Vildagliptin, a medicine used to treat diabetes.
• The patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• The patient is taking any of the following medicines used to treat high blood pressure:
  • An angiotensin II receptor antagonist (Angiotensin Receptor Blockers, ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
  • Aliskiren. The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to use Ampril:".

Inform your doctor if you suspect or are planning pregnancy. Ampril is not recommended during the first 3 months of pregnancy, and from the fourth month of pregnancy onwards, use of Ampril can seriously harm the unborn child (see section "Pregnancy and breastfeeding").

Children and adolescents

Ampril is not recommended for use in 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 (or if there is any doubt), consult a doctor before starting Ampril.

Ampril and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription (including herbal medicines). Ampril may affect the action of other medicines, and other medicines may affect the action of Ampril.

Inform your doctor if the patient is taking any of the following medicines, as they may weaken the effect of Ampril:

• Painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs - NSAIDs, such as ibuprofen or indometacin, 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.

Inform your doctor if the patient is taking any of the following medicines. They may increase the risk of adverse effects when used together with Ampril:

• Painkillers and anti-inflammatory medicines (e.g. NSAIDs such as ibuprofen or indometacin, and acetylsalicylic acid);
• Medicines used to treat cancer (chemotherapy);
• Diuretics (water tablets), 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 co-trimoxazole, also known as trimethoprim/sulfamethoxazole, used for bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs);
• Steroid anti-inflammatory medicines, such as prednisolone;
• Allopurinol (used to reduce uric acid levels in the blood);
• Procainamide (used for heart rhythm disorders);
• Vildagliptin (used to treat type 2 diabetes);
• Racecadotril (a medicine used to treat diarrhoea);
• Medicines often used to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and precautions".

Inform your doctor if the patient is taking any of the following medicines. Their effect may be altered when taking Ampril:

• Antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Ampril may reduce blood glucose levels. Blood glucose levels should be monitored regularly during Ampril treatment.
• Lithium (used for psychiatric disorders). Ampril may increase lithium levels in the blood. The doctor will closely monitor blood lithium levels.

If any of the above situations apply (or if there is any doubt), consult a doctor before starting Ampril. The treating doctor may need to adjust the dose and/or take other precautions:

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

Ampril with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you suspect or are planning 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 seriously harm the unborn child. If a woman taking Ampril becomes pregnant, she should inform her doctor immediately. The doctor should recommend switching to another appropriate medicine before conception.

Breastfeeding

Ampril must not be used during breastfeeding.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Drowsiness or dizziness may occur while taking Ampril. The likelihood of such symptoms is higher at the beginning of Ampril treatment and after increasing the dose. If drowsiness or dizziness occurs, do not drive or operate tools or machinery.

Ampril contains lactose monohydrate and sodium

If the patient has been told by a doctor that they have an intolerance to certain sugars, they should consult their doctor before taking this medicine.

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

3. How to take Ampril

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The following are available on the market: Ampril 2.5 mg tablets, Ampril 5 mg tablets, Ampril 10 mg tablets.
Taking the medicine

• Take this medicine orally, at the same time each day.
• Swallow the tablets whole with liquid.
• Do not crush or chew the tablets.

Dosage
Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the dose until blood pressure is controlled.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics (water pills), your doctor may discontinue or reduce the dose of the diuretic before starting Ampril. Reducing the risk of heart attack or stroke
• The usual starting 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 function

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the dose.
• The usual dose is 5 mg or 10 mg once daily.

Heart failure treatment

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

After a heart attack

• The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust the dose.
• The usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Elderly patients

• Your doctor will recommend a lower starting dose and adjust the dose more slowly.

Taking more Ampril than prescribed
Contact your doctor immediately or go to the nearest hospital emergency department.
Do not drive yourself; ask someone to take you to the hospital or call an ambulance.
Bring the medicine packaging with you so the doctor knows which medicine has been taken.
If you miss a dose of Ampril

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

Stopping Ampril
Do not stop taking this medicine unless your doctor tells you to. Do not stop taking Ampril just because you feel better. Stopping treatment may cause your high blood pressure to worsen.
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.
If any of the following serious adverse reactions occur, stop taking Ampril tablets immediately and
contact your doctor straight away – urgent medical attention may be required:

• Swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with itching and rash. These may be symptoms of a severe allergic reaction to Ampril.
• Severe skin reactions, including rash, ulceration of the mouth, worsening of pre-existing skin disorders, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme). If any of the following symptoms occur, inform your doctor immediately:
• Rapid heartbeat, irregular or forceful heartbeats (palpitations), chest pain, chest tightness or more serious events such as heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of lung-related disorders.
• Easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purplish spots on the skin, or increased frequency of infections, sore throat and fever, fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders.
• Severe abdominal pain which may radiate to the back. This could be a symptom of pancreatitis.
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, or yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders such as hepatitis or liver damage.

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

Common adverse reactions (may occur in up to 1 in 10 patients):

• Headache or feeling tired.
• Dizziness. The likelihood of this is higher at the beginning of treatment with Ampril and after dose increases.
• Fainting, hypotension (abnormally low blood pressure), particularly after a rapid change from lying to sitting or standing position.
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhoea, indigestion, nausea or vomiting.
• Rash with or without raised skin lesions.
• Chest pain.
• Muscle cramps or muscle pain.
• Increased potassium levels in the blood, detected in laboratory tests.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Balance disorders (vertigo-type dizziness).
• Itching of the skin and unusual skin sensations such as numbness, tingling, pricking, burning or crawling sensations (paresthesia).
• Loss or disturbance of taste.
• Sleep disturbances.
• Depression, anxiety, nervousness or restlessness, particularly motor restlessness.
• Nasal congestion, breathing difficulties or worsening of asthma.
• Intestinal swelling known as "intestinal angioedema", with symptoms including abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dryness of the oral mucosa.
• Increased urine output during the day.
• Excessive sweating.
• Loss of or reduced appetite (anorexia).
• Rapid or irregular heartbeat. Swelling of hands and feet. This may be a sign of increased fluid retention in the body.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men or women.
• Increased number of certain white blood cells (eosinophilia), detected in blood tests.
• Liver, pancreas or kidney function abnormalities, detected in blood tests.

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• Feeling of uneasiness or disorientation.
• Redness and swelling of the tongue.
• Severe peeling of the skin, itchy nodular rash.
• Nail disorders (e.g. loosening or separation of the nail from the nail bed).
• Skin rash or bruising.
• Skin spots and cold extremities.
• Redness, itching, swelling or watering of the eyes.
• Hearing disturbances and tinnitus (ringing in the ears).
• Weakness.
• Decreased number of red blood cells, white blood cells or platelets, or decreased hemoglobin levels, detected in blood tests.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• Increased sensitivity to sunlight.

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

• Concentrated urine (dark-coloured urine), nausea, vomiting, muscle cramps, disorientation and seizures; these symptoms may be caused by inappropriate secretion of antidiuretic hormone (ADH); if these symptoms occur, contact your doctor immediately.

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

• Difficulty concentrating.
• Swelling of the lips.
• Low blood cell count, detected in blood tests.
• Decreased sodium levels, detected in blood tests.
• Change in finger colour upon exposure to cold, together with tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Changes in sense of smell.
• Hair loss.

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

5. How to store Ampril 10 mg tablets

Keep this medicine 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 stated month.
Store below 25°C, in the original packaging.
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 packaging and other information

What Ampril contains

• The active substance is ramipril. Each Ampril 10 mg tablet contains 10 mg of ramipril.
• The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized starch, sodium stearyl fumarate. See section 2 "Ampril contains lactose monohydrate and sodium".

What Ampril looks like and contents of the pack
Ampril 10 mg are white to off-white, flat, elongated tablets measuring 11.0 x 5.5 mm.
Pack sizes: 30 or 60 tablets in OPA-Al-PVC/Al blisters in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, the country of export:
Krka d.d. Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Manufacturer:
Krka d.d. Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation numbers in Romania, the country of export: 12119/2019/01
12119/2019/03
Parallel import licence number: 240/17