Package leaflet: Information for the patient

Piramil 1.25 mg, 1.25 mg, tablets
Piramil 2.5 mg, 2.5 mg, tablets
Piramil 5 mg, 5 mg, tablets
Piramil 10 mg, 10 mg, tablets
Ramipril
Read this leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
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.
This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents:

What Piramil is and what it is used for
Important information before taking Piramil
How to take Piramil
Possible side effects
How to store Piramil
Contents of the pack and other information

1. What Piramil is and what it is used for

Piramil contains a medicine called ramipril. It belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).
Piramil works by:
reducing the production in the body of substances that may increase blood pressure,
reducing tension and widening blood vessels,
helping the heart to pump blood to all parts of the body.
Piramil may be used to:
treat high blood pressure (hypertension),
reduce the risk of heart attack or stroke,
reduce the risk of or delay worsening of kidney function (regardless of whether the patient has diabetes),
treat heart failure, when the heart is unable to pump enough blood to meet the body's needs,
treat patients after a heart attack complicated by heart failure.

2. Important information before taking Piramil

When not to take Piramil
if the patient is allergic to ramipril, to other ACE inhibitors, or to any of the components
of this medicine (listed in section 6).
Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling
of lips, face, throat, or tongue.
if the patient has ever experienced a severe allergic reaction called "angioedema".
Symptoms include: itching, hives, red spots on hands, feet, and throat, swelling of the throat and tongue,
swelling around eyes and mouth, difficulty breathing or swallowing.
if the patient is undergoing dialysis or other types of blood filtration. Depending on the equipment used,
Piramil may not be suitable.
if the patient has kidney function disorders with reduced blood flow to the kidneys (renal artery stenosis).
during the last 6 months of pregnancy (see below "Pregnancy and breastfeeding").
if the patient's blood pressure is abnormally low or unstable. This requires medical evaluation.
if the patient has diabetes or kidney function disorders and is taking a blood pressure-lowering medicine
containing aliskiren.
if the patient has taken or is currently taking a medicine containing sacubitril with valsartan (a medicine used
in adults to treat chronic heart failure), as this increases the risk of angioedema (sudden swelling of tissues, e.g., in the throat).
If any of the above situations apply, the patient should not take Piramil.
In case of doubt, consult a doctor before taking Piramil.

Warnings and precautions
Before taking Piramil, discuss with your doctor or pharmacist if:
the patient has heart, liver, or kidney function disorders;
the patient has lost large amounts of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating,
a low-salt diet, long-term use of diuretics, or dialysis);
the patient is undergoing treatment to reduce sensitivity to bee or wasp venom (desensitization);
the patient is to receive anesthesia (for surgery or dental procedures). It may be necessary to stop taking
Piramil one day before the procedure; therefore, consult your doctor.
a blood test has shown high potassium levels in the patient;
the patient is taking medicines or has conditions that may reduce sodium levels in the blood.
The doctor may regularly order blood tests, especially to monitor sodium levels, particularly if the patient is elderly.
the patient is taking any of the following medicines, as they increase the risk of angioedema:

racecadotril (a medicine used to treat diarrhea);
medicines used to prevent organ transplant rejection and to treat cancer (mTOR inhibitors, e.g., temsirolimus, sirolimus, everolimus);
vildagliptin and other medicines from the group of dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) (medicines used to treat diabetes).
the patient has been diagnosed with collagenosis, such as scleroderma or systemic lupus erythematosus;
the patient is taking any of the following antihypertensive medicines:
angiotensin II receptor antagonist (medicines also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney disease due to diabetes;
aliskiren.
The doctor may regularly monitor kidney function, blood pressure, and blood electrolyte levels (e.g., potassium). See also information in the section "When not to take Piramil".
if the patient is pregnant (or planning pregnancy), she must inform the doctor. Use of Piramil is not recommended during the first 3 months of pregnancy and may be very harmful to the fetus after the 3rd month of pregnancy (see section "Pregnancy and breastfeeding" below).

Children and adolescents
Piramil is not recommended for children and adolescents under 18 years of age, as the safety and efficacy of ramipril in children have not yet been established.
If any of the described situations apply to the patient or if the patient is unsure, consult a doctor before taking Piramil.

Piramil with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is because Piramil and certain other medicines may interact and affect each other's action.
Inform your doctor if the patient is taking any of the following medicines, as they may weaken the effect of Piramil:
painkillers and anti-inflammatory medicines (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, bronchial asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. The doctor should monitor the patient's blood pressure.
Inform your doctor if the patient is taking any of the following medicines, as they may increase the risk of adverse effects when taken together with Piramil:
painkillers and anti-inflammatory medicines (e.g., NSAIDs such as ibuprofen or indomethacin, and acetylsalicylic acid);
anticancer medicines (chemotherapy);
temsirolimus (an anticancer medicine);
sirolimus, everolimus (medicines used to prevent transplant rejection);
diuretics such as furosemide;
potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medicines that increase potassium levels in blood (e.g., trimethoprim and co-trimoxazole [medicines used to treat bacterial infections], cyclosporine [an immunosuppressive medicine used to prevent organ transplant rejection], and heparin [a medicine used to thin the blood and prevent clots]);
steroidal anti-inflammatory medicines such as prednisolone;
allopurinol (a medicine used to reduce uric acid levels in blood);
procainamide (a medicine used for heart rhythm disorders);
vildagliptin (a medicine used to treat type 2 diabetes);
racecadotril (an anti-diarrheal medicine).
The doctor may adjust the dose and (or) recommend additional precautions if the patient is taking a medicine from the group of angiotensin II receptor antagonists or aliskiren (see also information in sections "When not to take Piramil" and "Warnings and precautions").

Inform your doctor if the patient is taking any of the following medicines, as Piramil may interfere with their action:
antidiabetic medicines (oral and insulin). Piramil may lower blood sugar levels. Blood sugar levels should be monitored regularly during treatment with Piramil.
lithium (used in psychiatric disorders). Piramil may increase lithium levels in blood. The doctor will recommend close monitoring of lithium levels in blood.
If any of the described situations apply to the patient or if the patient is unsure, consult a doctor before taking Piramil.

Piramil with food, drink, and alcohol
Drinking alcohol while taking Piramil may cause dizziness or drowsiness. Patients interested in the acceptable amount of alcohol during treatment should discuss this with their doctor, as the effects of blood pressure-lowering medicines and alcohol may be additive.
Piramil can be taken independently of meals.

Pregnancy and breastfeeding
Pregnancy
If the patient suspects she is pregnant (or could become pregnant), she should inform her doctor.
Piramil should not be taken during the first 12 weeks of pregnancy and must not be used after the 13th week of pregnancy, as the medicine taken during this period may seriously harm the unborn child.
If the patient becomes pregnant while being treated with Piramil, she should inform her doctor immediately. The doctor will recommend switching to another medicine before a planned pregnancy.
Breastfeeding
Piramil should not be used during breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Piramil may cause dizziness, especially at the beginning of treatment or when increasing the dose. In such cases, the patient should not drive or operate tools or machinery.

3. How to use Piramil

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.

Taking the medicine
The medicine should be taken orally, at the same time each day.
Tablets should be taken with liquid.
Do not crush or chew the tablets.

Dosage
Treatment of arterial hypertension
The initial dose is usually 1.25 mg or 2.5 mg once daily.
Based on blood pressure monitoring, the doctor may adjust the dosage.
The maximum dose is 10 mg once daily.
If the patient is already taking a diuretic, the doctor may recommend discontinuing it or reducing its dose before starting Piramil therapy.

Reduction of the risk of myocardial infarction or stroke
The initial dose is usually 2.5 mg once daily.
The doctor may subsequently increase the dose.
The usual dose is 10 mg once daily.

Reduction or delay of worsening kidney function
The initial dose is usually 1.25 mg or 2.5 mg once daily.
The doctor may subsequently adjust the dose.
The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure
The initial dose is usually 1.25 mg once daily.
The doctor may subsequently adjust the dose.
The maximum dose is 10 mg once daily. It is preferable to divide this dose into two doses taken during the day.

Treatment after myocardial infarction
The initial dose is usually 1.25 mg or 2.5 mg once daily.
The doctor may subsequently adjust the dose.
The maximum dose is 10 mg once daily. It is preferable to divide this dose into two doses taken during the day.

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

Accidental overdose of Piramil
In case of overdose, seek medical advice immediately or go to the nearest hospital. The patient should not drive but ask someone else to drive or call an ambulance. Bring the medicine packaging with you so the doctor can see which medicine has been taken.

Missed dose of Piramil
If a dose is missed, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

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 experiences them.
If the patient experiences any of the following serious adverse reactions, treatment with this medicine must be discontinued and immediate contact with a doctor is required – prompt treatment may be necessary.
Swelling of the face, lips or throat causing difficulty in swallowing or breathing, as well as itching and rash.
These may be symptoms of a severe allergic reaction to this medicine.
Severe skin reactions, including rash, ulceration of the oral mucosa, worsening of pre-existing skin disease, 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, the doctor must be informed immediately:
Rapid heartbeat, irregular or strong heartbeats (palpitations), chest pain, chest tightness or more severe disturbances, including myocardial infarction and stroke.
Shortness of breath or cough. These may indicate lung diseases.
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, feeling of fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders.
Severe stomach pain, which may radiate to the back. This may be a symptom of pancreatitis.
Fever, chills, fatigue, loss of appetite, stomach pain, nausea, 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 longer than a few days.
Common (may affect less than 1 in 10 people)
Headache or feeling of fatigue.
Dizziness. These may occur more frequently at the beginning of treatment with Piramil or after increasing the dose.
Fainting, hypotension (abnormally low blood pressure), especially when rising quickly to a standing or sitting position.
Dry, persistent cough, sinusitis or bronchitis, shortness of breath.
Abdominal pain, diarrhoea, indigestion, nausea or vomiting.
Skin rash, with or without raised bumps.
Chest pain.
Muscle cramps or pain.
Higher than normal potassium levels in the blood, detected in laboratory tests.
Uncommon (may affect less than 1 in 100 people)
Balance disorders (vestibular dizziness).
Itching and sensory disturbances of the skin, such as numbness, tingling, pricking, burning or crawling sensations (paresthesia).
Loss or disturbances of taste.
Sleep disturbances.
Depression, anxiety, increased nervousness or restlessness.
Nasal congestion, difficulty breathing or worsening of asthma.
Intestinal swelling (so-called "intestinal angioedema"), manifested by abdominal pain, vomiting and diarrhoea.
Heartburn, constipation or dry mouth.
Increased frequency of urination during the day.
Excessive sweating.
Loss or decrease 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 (eosinophilia) detected in blood tests.
Blood test results indicating impaired liver, pancreas or kidney function.
Rare (may affect less than 1 in 1,000 people)
Feeling of disorientation or confusion.
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 development of bruises.
Skin spots and cold extremities.
Redness, itching, swelling or watering of the eyes.
Hearing disturbances and ringing in the ears.
Feeling of weakness.
Decreased number of red blood cells, white blood cells or platelets, or decreased hemoglobin levels in blood tests.
Very rare (may affect less than 1 in 10,000 people)
Hypersensitivity to sunlight.
Other reported adverse reactions
Inform your doctor if any of the following symptoms become severe or persist for longer than a few days.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Concentrated urine (dark urine), nausea or vomiting, muscle cramps, confusion and seizures, which may be symptoms of inappropriate antidiuretic hormone (ADH) secretion. If such symptoms occur, contact a doctor as soon as possible.
Difficulty concentrating.
Swelling of the mouth.
Low blood cell count detected in blood tests.
Lower than normal sodium levels in blood tests.
Change in color of fingers and toes upon cold exposure, accompanied by 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for 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 / e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Piramil

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package after EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Piramil contains
The active substance is ramipril. Each tablet contains 1.25 mg, 2.5 mg, 5 mg, or 10 mg of ramipril.
The other ingredients are: microcrystalline cellulose, pregelatinized maize starch, silicon dioxide, glycine hydrochloride, glycerol dibehenate.
Piramil 2.5 mg: iron oxide yellow (E 172).
Piramil 5 mg: iron oxide red (E 172).

What Piramil looks like and contents of the pack
Piramil 1.25: Elongated, white or almost white tablets, scored on both sides.
The dividing line on the tablet is not intended for splitting the tablet.
Piramil 2.5: Elongated, mottled, light yellow tablets, scored on one side.
The tablet can be divided into equal doses.
Piramil 5: Elongated, mottled, light pink tablets, scored on one side.
The tablet can be divided into equal doses.
Piramil 10: Elongated, white or almost white tablets, scored on one side.
The tablet can be divided into equal doses.

The tablets are packed in blisters made of OPA/Aluminium/PE/PE/Aluminium, contained in a cardboard box.
Pack sizes:
Piramil 1.25 mg: 20, 28, 30, 50 and 100 tablets.
Piramil 2.5 mg and Piramil 5 mg: 10, 20, 28, 30, 50 and 100 tablets.
Piramil 10 mg: 28, 30 and 60 tablets.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Lek S.A.
ul. Domaniewska 50 C
02-672 Warszawa
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

For further information about this medicinal product and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00