Aporami

Package leaflet: Information for the user

ApoRami, 1.25 mg, tablets
ApoRami, 2.5 mg, tablets
ApoRami, 5 mg, tablets
ApoRami, 10 mg, tablets
Ramiprilum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What ApoRami is and what it is used for

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

ApoRami works by:

• Reducing the body's production of a substance that can raise blood pressure
• Reducing tension and widening blood vessels
• Helping the heart pump blood around the body more easily

ApoRami may be used to:

• Treat high blood pressure (hypertension)
• Reduce the risk of heart attack or stroke
• Reduce the risk of or delay the onset of kidney problems (regardless of whether the patient has diabetes)
• Treat heart failure (when the heart does not pump enough blood to meet the body's needs)
• Treat heart failure following a heart attack.

2. Important information before taking ApoRami

When not to take ApoRami:

• If you are allergic (hypersensitive) to ramipril, to any other ACE inhibitor, or to any of the other ingredients of ApoRami 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 you have ever had a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red patches on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or swallowing.
• If you are currently taking or have recently taken sacubitril/valsartan, a medicine used to treat chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling under the skin, e.g. in the throat) is increased.
• If you are undergoing dialysis or another form of blood filtration. Depending on the type of equipment used, ApoRami may not be suitable.
• If you have a condition involving reduced blood flow to the kidney (renal artery stenosis).
• During pregnancy beyond the third month (see section "Pregnancy and breastfeeding").
• If your blood pressure is very low or unstable. This should be assessed by your doctor.
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are taking any of the following medicines, as they may increase the risk of angioedema:
  • racecadotril, used to treat diarrhoea;
  • medicines used to prevent organ transplant rejection or to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
  • vildagliptin, used to treat diabetes.

If any of the above apply to you, do not take ApoRami. If you are unsure about using this medicine, please consult your doctor before starting treatment.

Warnings and precautions

Before starting ApoRami, discuss with your doctor or pharmacist if:

• You have heart, liver, or kidney problems.
• You have recently lost a significant amount of fluids or electrolytes due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics (water tablets), or dialysis.
• You are undergoing desensitisation treatment for bee or wasp venom (venom immunotherapy).
• You are due to have an anaesthetic. Such medicines are given before surgical or dental procedures. You may need to stop taking ApoRami one day before the procedure. If in doubt, consult your doctor.
• You have high potassium levels in your blood (detected by blood tests).
• You are taking any of the following medicines, which may increase the risk of angioedema (rapid swelling under the skin, e.g. in the throat):
  • sirolimus, everolimus, and other mTOR inhibitors (used to prevent organ transplant rejection), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 "When not to take ApoRami".
• You have collagen vascular disease such as scleroderma or systemic lupus erythematosus.
• You think you may be pregnant or are planning to become pregnant. ApoRami is not recommended during early pregnancy. Do not take it after the 3rd month of pregnancy, as it may cause serious harm to the unborn baby (see section "Pregnancy and breastfeeding").
• You are taking any of the following medicines used to treat 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.

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the information under the heading "When not to take ApoRami".

Children and adolescents

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

If any of the above situations apply (or are uncertain), please consult your doctor before starting ApoRami.

Other medicines and ApoRami

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription (including herbal medicines). ApoRami may affect the action of other medicines, and other medicines may affect the action of ApoRami.

Tell your doctor if you are taking any of the following medicines, as they may reduce the effectiveness of ApoRami:

• Painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs [NSAIDs] such as ibuprofen or indomethacin, and aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor may need to monitor your blood pressure.

Tell your doctor if you are taking any of the following medicines, as they may increase the risk of side effects when taken with ApoRami:

• Sacubitril/valsartan – used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take ApoRami")
• Painkillers and anti-inflammatory medicines (e.g. NSAIDs such as ibuprofen or indomethacin, and aspirin)
• Cancer treatments (chemotherapy)
• Medicines used to prevent organ transplant rejection, 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 for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant 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 in cancer treatment)
• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and precautions".
• Vildagliptin (used to treat type 2 diabetes)
• Racecadotril (used to treat diarrhoea)
• If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under "When not to take ApoRami" and "Warnings and precautions").

Tell your doctor if you are taking any of the following medicines, as their effects may be altered when taken with ApoRami:

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

If any of the above apply (or you are unsure), please consult your doctor before starting ApoRami.

ApoRami with food, drink, or alcohol

• Drinking alcohol while taking ApoRami may cause dizziness and drowsiness. If you are unsure about how much alcohol is safe while taking ApoRami, discuss this with your doctor, as alcohol may enhance the blood pressure-lowering effect of the medicine.
• ApoRami may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or 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 may be pregnant (or are planning to become pregnant). ApoRami 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 unborn child. If you become pregnant while taking ApoRami, inform your doctor immediately. Before becoming pregnant, it is recommended to switch to another medicine appropriate for use during pregnancy.

Breastfeeding
Do not take ApoRami while breastfeeding.

Always consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Dizziness may occur while taking ApoRami. The risk of dizziness is higher at the start of treatment and after a dose increase. If you feel dizzy, do not drive or operate machinery.

ApoRami contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to use ApoRami

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

Dosage

Treatment of high blood pressure

• The usual starting 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 pills), your doctor may discontinue or reduce the dose of the diuretic before starting ApoRami.

Prevention 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.

Reducing or delaying worsening of kidney function

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

Treatment of heart failure

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

Treatment after heart attack

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

Elderly patients
The starting dose should be lower, and dose escalation should be slower.

Taking the medicine

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

Taking more ApoRami than prescribed
Contact your doctor or go immediately 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 was taken.

If you miss a dose of ApoRami

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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following severe adverse effects occur, treatment with ApoRami must be stopped
immediately and medical advice must be sought urgently – immediate medical assistance 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 hypersensitivity reaction to ApoRami.
• Severe skin reactions, including rashes, mouth ulcers, worsening of pre-existing skin disorders, redness, blisters 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 stronger-than-usual heartbeats (palpitations), chest pain, chest tightness or more serious adverse effects such as heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of pulmonary adverse effects.
• Easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purpuric skin spots or increased frequency of infections, sore throat and fever, fatigue, weakness, dizziness or pale skin. These may indicate blood or bone marrow disorders.
• Severe abdominal pain which may radiate to the back. This may be a symptom of pancreatitis.
• Fever, chills, weakness, loss of appetite, abdominal pain, nausea, yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver disorders such as hepatitis or liver damage.

Other adverse effects
Inform your doctor if any of the following symptoms become severe or persist for more than a few days.
Common: occur in less than 1 in 10 patients

• Headache or feeling of fatigue.
• Dizziness. The risk is higher at the beginning of ApoRami treatment and after dose increases.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or after a rapid change from lying to sitting or standing position.
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath.
• Abdominal pain, diarrhoea, indigestion, nausea or vomiting.
• Skin rashes, including raised rashes.
• Chest pain.
• Muscle cramps or muscle pain.
• Higher than usual potassium levels in blood tests.

Uncommon: occur in less than 1 in 100 patients

• Balance disorders (dizziness).
• Itching and sensory disturbances such as numbness, tingling, pricking, burning or crawling sensations on the skin (paraesthesiae).
• Loss or disturbances of taste sensation.
• Sleep disorders.
• Depression, anxiety, nervousness or restlessness.
• Nasal congestion, difficulty breathing or worsening of asthma.
• Intestinal swelling known as "intestinal angioedema", with symptoms such as abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dry mouth.
• Increased urine output during the day.
• Excessive sweating.
• Loss or reduction of appetite (anorexia).
• Rapid or irregular heartbeat. Swelling of hands and feet. These may be symptoms of increased fluid retention.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men and women.
• Increased number of certain white blood cells in blood (eosinophilia).
• Blood test results indicating changes in liver, pancreas or kidney function.

Rare: occur in less than 1 in 1,000 patients

• Tremor or disorientation.
• Redness and swelling of the tongue.
• Flaking of the skin, itchy nodular rash.
• Nail disorders (e.g. reduced adhesion or separation of the nail from its bed).
• Skin rash or bruising.
• Skin spots and cold extremities.
• Redness, itching, swelling and watering of the eyes.
• Hearing disorders and tinnitus.
• Weakness.
• Blood tests: reduced number of red blood cells, white blood cells, platelets or haemoglobin concentration.

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

• Photosensitivity (increased sensitivity to sunlight).

Other reported adverse effects:
Inform your doctor if any of the following symptoms become severe or persist for more than a few days.

• Difficulty concentrating.
• Swelling of the lips.
• Detection of abnormally low blood cell counts in blood tests.
• Detection of lower than usual sodium levels in blood tests.
• Concentrated urine (dark colour), feeling unwell or actual illness, muscle cramps, confusion and seizures, which may be caused by inappropriate ADH (antidiuretic hormone) secretion. If such symptoms occur, the patient should contact a doctor as quickly as possible.
• Colour change of fingers upon cold exposure and tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Smell disturbances.
• Hair loss.

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

5. How to store ApoRami

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from moisture.
Keep the HDPE bottle tightly closed to protect from moisture.
Do not use the medicine after the expiry date stated on the carton, blister, and label following
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

6. Contents of the packaging and other information

What ApoRami contains
The active substance is ramipril. One tablet contains 1.25 mg, 2.5 mg, 5 mg, or 10 mg of ramipril.
The other ingredients are: pregelatinized starch, corn starch, monohydrate lactose, sodium bicarbonate,
sodium croscarmellose, yellow iron oxide (E172) (only in the 2.5 mg strength), red iron oxide (E172) (only in the 5 mg strength),
and sodium stearyl fumarate.

What ApoRami looks like and contents of the packaging
Tablet.
1.25 mg:
White or almost white, flat, bevelled-edged, round [5.0 mm in diameter], uncoated tablet, embossed with the letters "H" and "17" on one side and smooth on the other side.
2.5 mg:
Light yellow to yellow, bevelled-edged, round [5.0 mm in diameter], uncoated tablet, embossed with the letters "H" and "18" on one side and smooth on the other side. The tablet can be divided into equal doses.
5 mg:
Light pink, mottled, flat, bevelled-edged, round [6.0 mm in diameter], uncoated tablet, embossed with the letters "H" and "19" and a division line on one side and smooth on the other side. The tablet can be divided into equal doses.
10 mg:
White or almost white, flat, bevelled-edged, round [8.0 mm in diameter], uncoated tablet, embossed with the letters "H" and "20" and a division line on one side and smooth on the other side. The tablet can be divided into equal doses.

ApoRami tablets are available in:
PVC/Aluminium blisters.
HDPE bottles containing a cotton roll, with a PP cap with seal, packed in a cardboard box.

Packaging:
Blister: 14, 28, 30, 56 and 98 tablets
HDPE bottle: 250 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D lok. 27
01-909 Warszawa
Poland

Manufacturer/Importer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is registered in the EEA Member States under the following names:
Belgium Ramipril AB 2.5 mg / 5 mg / 10 mg, tablets
Czech Republic Rampiril Aurovitas 2.5 mg / 5 mg / 10 mg tablets
Netherlands Ramipril Aurobindo 1.25 mg / 2.5 mg, tablets
Poland ApoRami
Portugal Ramipril Aurovitas
Spain RAMIPRIL AUROVITAS 5 mg / 10 mg tablets EFG