Piramil 2,5 mg

Leaflet attached to the packaging: patient information

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

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. 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 any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Piramil and what is it used for
• 2. Important information before taking Piramil
• 3. How to take Piramil
• 4. Possible side effects
• 5. How to store Piramil
• 6. Package contents and other information

1. What is Piramil and what is it used for

Piramil contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Piramil works by:
reducing the production in the body of substances that can increase blood pressure,
reducing tension and dilating blood vessels,
making it easier for the heart to pump blood to all parts of the body.
Piramil can be used to:
treat high blood pressure (hypertension),
reduce the risk of heart attack or stroke,
reduce the risk of or delay kidney function deterioration (regardless of whether the patient has diabetes),
treat heart failure (when the heart is not able to pump enough blood for the body),
treat heart failure after a heart attack.

2. Important information before taking Piramil

When not to take Piramil

if the patient is allergic to ramipril, other ACE inhibitors, or any of the 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 had a severe allergic reaction called "angioedema". Its 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 or swallowing.
if the patient is undergoing dialysis or other types of blood filtration. Depending on the equipment used, Piramil may not be suitable for them.
if the patient has kidney function disorders in which blood flow to the kidneys is reduced (renal artery stenosis).
in the last 6 months of pregnancy(see below "Pregnancy and breastfeeding").
if the patient's blood pressure is abnormally low or unstable. It is necessary to check this with a doctor.
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 tissue, e.g., in the throat).
If any of these situations apply to the patient, they should not take Piramil.
In case of doubts, the patient should consult a doctor before taking Piramil.

Warnings and precautions

Before taking Piramil, the patient should discuss it with their doctor or pharmacist if:
they have heart, liver, or kidney function disorders;
they have lost a lot of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term use of diuretics, or dialysis);
they are going to undergo desensitization to bee or wasp venom;
they are going to have anesthesia (for surgery or dental procedure). It may be necessary to stop taking Piramil the day before the procedure, so the patient should consult their doctor.
a test has shown that they have high levels of potassium in their blood;
they are taking medicines or have disorders that can cause low sodium levels in the blood.
The doctor may regularly order blood tests to check sodium levels in the blood, especially if the patient is elderly.
they are taking any of the following medicines, as this can increase the risk of angioedema:

• racecadotril (a medicine used to treat diarrhea);
• medicines used to prevent transplant rejection and treat cancer (mTOR inhibitors, e.g., temsirolimus, sirolimus, everolimus);
• saxagliptin and other dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) (medicines used to treat type 2 diabetes);
• the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• the patient is taking one of the following antihypertensive medicines:
• angiotensin II receptor antagonist (medicines also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease;
• aliskiren. The doctor may regularly monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the information in the "When not to take Piramil" and "Warnings and precautions" sections.

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 been established yet.
If any of these situations apply to the patient or the patient is unsure, they should consult their doctor before taking Piramil.

Piramil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, as Piramil may interact with some other medicines.
The patient should inform their doctor about taking any of the following medicines, as they may reduce the effect of Piramil:
analgesic 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, asthma, or allergies, such as ephedrine, norepinephrine, or adrenaline. The doctor should monitor the patient's blood pressure.
The patient should inform their doctor about taking any of the following medicines, as they may increase the risk of side effects when taken with Piramil:
analgesic and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs, 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-sparing medicines (e.g., spironolactone, triamterene, amiloride) and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole [medicines used to treat bacterial infections], cyclosporine [a medicine that suppresses the immune system, used to prevent transplant rejection] and heparin [a medicine used to thin the blood and prevent clotting]);
corticosteroids, such as prednisolone;
allopurinol (a medicine used to reduce uric acid levels in the blood);
procainamide (a medicine used to treat heart rhythm disorders);
saxagliptin (a medicine used to treat type 2 diabetes);
racecadotril (an anti-diarrheal medicine).
The doctor may change the dose of the medicine and/or recommend other precautions if the patient is taking a medicine that belongs to the class of angiotensin II receptor antagonists or aliskiren (see also the information in the "When not to take Piramil" and "Warnings and precautions" sections).
The patient should inform their doctor about taking any of the following medicines, as Piramil may affect their action:
oral hypoglycemic medicines and insulin. Piramil may lower blood sugar levels.
The patient should regularly monitor their blood sugar levels while taking Piramil.
lithium (used to treat mental illnesses). Piramil may increase lithium levels in the blood. The doctor will recommend close monitoring of lithium levels in the blood.
If any of these situations apply to the patient or the patient is unsure, they should consult their doctor before taking Piramil.

Piramil with food, drink, and alcohol

Drinking alcohol while taking Piramil may cause dizziness or fainting.
People interested in the allowed amount of alcohol during treatment should discuss it with their doctor, as the effects of blood pressure-lowering medicines and alcohol may add up.
Piramil can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
If the patient suspects that they are pregnant (or may have become pregnant), they should tell their doctor.
Piramil should not be taken during the first 12 weeks of pregnancy and should not be used after the 13th week of pregnancy, as the medicine taken during this time may seriously harm the baby.
If the patient becomes pregnant while taking Piramil, they should immediately inform their doctor. The doctor will suggest a change to another medicine before planned pregnancy.
Breastfeeding
Piramil should not be used during breastfeeding.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Piramil may cause dizziness, especially at the beginning of treatment or when increasing the dose.
In such a case, the patient should not drive vehicles, operate tools, or machines.

3. How to take Piramil

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

Taking the medicine

The medicine should be taken orally, once a day, at the same time every day.
The tablets should be swallowed with a liquid.
The tablets should not be crushed or chewed.

How much to take

Treating high blood pressure
The initial dose is usually 1.25 mg or 2.5 mg once a day.
Based on blood pressure control, the doctor may adjust the dosage of the medicine.
The maximum dose is 10 mg once a day.
If the patient is already taking a diuretic, the doctor may recommend stopping it or reducing the dose before starting Piramil therapy.
Reducing the risk of heart attack or stroke
The initial dose is usually 2.5 mg once a day.
The doctor may then increase the dose of the medicine.
The usual dose is 10 mg once a day.
Reducing or delaying kidney function deterioration
The initial dose is usually 1.25 mg or 2.5 mg once a day.
The doctor may then adjust the dose of the medicine.
The usual dose is 5 mg or 10 mg once a day.
Treating heart failure
The initial dose is usually 1.25 mg once a day.
The doctor may then adjust the dose of the medicine.
The maximum dose is 10 mg once a day. It is preferred to take it divided into two doses a day.
Treating heart failure after a heart attack
The initial dose is usually 1.25 mg or 2.5 mg once a day.
The doctor may then adjust the dose of the medicine.
The maximum dose is 10 mg once a day. It is preferred to take it divided into two doses a day.
Elderly patients
The doctor will reduce the initial dose and increase it more slowly.

Taking a higher dose of Piramil than recommended

In case of overdose, the patient should consult their doctor or go to the nearest hospital immediately.
The patient should not drive a car but ask someone else to drive or call an ambulance.
The patient should take the medicine packaging with them so that the doctor can see what medicine was taken.

Missing a dose of Piramil

In case of a missed dose, the patient should take the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.
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, Piramil can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking Piramil and contact their doctor immediately – they may need urgent treatment.

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 this medicine.
Severe skin reactions, including rash, mouth ulcers, exacerbation of existing skin disease, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If the patient experiences any of the following symptoms, they should immediately inform their doctor:

Rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, tightness in the chest, or more serious disorders, including heart attack and stroke.
Shortness of breath or cough. They may indicate lung disease.
Easy bruising, longer than usual bleeding time, any signs of bleeding (e.g., bleeding gums), purple spots on the skin, or more frequent infections, sore throat, and fever, feeling tired, fainting, dizziness, or paleness of the skin. They may be symptoms of a blood or bone marrow disorder.
Severe stomach pain, which may radiate to the back. It may be a symptom of pancreatitis.
Fever, chills, fatigue, loss of appetite, stomach pain, nausea, vomiting, yellowing of the skin or eyes (jaundice). They may be symptoms of liver disorders, such as inflammation or liver damage.

Other side effects

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days.
Common(may occur in less than 1 in 10 people)
Headache or feeling tired.
Dizziness. It may occur more frequently at the beginning of Piramil treatment or after increasing the dose.
Fainting, low blood pressure (abnormally low blood pressure), especially when standing up quickly or sitting up.
Dry, persistent cough, sinusitis, or bronchitis, shortness of breath.
Abdominal pain, diarrhea, indigestion, nausea, or vomiting.
Skin rash with or without raised patches.
Chest pain.
Muscle cramps or pain.
Higher than usual potassium levels in the blood, shown in laboratory tests.
Uncommon(may occur in less than 1 in 100 people)
Balance disorders (dizziness of labyrinthine origin).
Itching of the skin and sensory disturbances, such as numbness, tingling, prickling, burning, or crawling sensation on the skin (paresthesia).
Taste disturbances or loss of taste.
Sleep disorders.
Depression, anxiety, increased nervousness, or restlessness.
Nasal congestion, difficulty breathing, or worsening of asthma.
Intestinal edema (so-called "angioedema of the intestine"), whose symptoms are abdominal pain, vomiting, and diarrhea.
Heartburn, constipation, or dry mouth.
Increased urine production during the day.
Excessive sweating.
Loss of appetite (anorexia).
Accelerated or irregular heartbeat.
Swelling of the hands and feet. It may be a sign of excessive water retention.
Hot flashes.
Blurred vision.
Joint pain.
Fever.
Impotence, decreased libido in men and women.
Increased levels of certain white blood cells (eosinophilia) detected in blood tests.
Blood test results indicating liver, pancreas, or kidney function disorders.
Rare(may occur in less than 1 in 1000 people)
Feeling confused or disoriented.
Redness and swelling of the tongue.
Severe skin peeling, itchy, papular rash.
Nail disorders (e.g., loosening or separation of the nail from the nail bed).
Skin rash or bruising.
Spots on the skin and discoloration of the extremities.
Redness, itching, swelling, or tearing of the eyes.
Hearing disorders and ringing in the ears.
Feeling weak.
Decreased red blood cell count, white blood cell count, or platelet count, or hemoglobin levels in blood tests.
Very rare(may occur in less than 1 in 10,000 people)
Sensitivity to sunlight.

Other reported side effects

The patient should inform their doctor if any of the following symptoms worsen significantly or persist for more than a few days.
Side effects with unknown frequency(frequency cannot be estimated from the available data):
Concentrated urine (dark urine color), nausea, or vomiting, muscle cramps, confusion, and convulsions, which may be symptoms of inappropriate antidiuretic hormone (ADH) secretion.
In case of such symptoms, the patient should contact their doctor as soon as possible.
Difficulty concentrating.
Mouth swelling.
Low white blood cell count detected in blood tests.
Lower than usual sodium levels in blood tests.
Change in finger and toe color after cooling and feeling of tingling or pain after warming (Raynaud's phenomenon).
Breast enlargement in men.
Slowed or impaired reactions.
Burning sensation.
Smell disorders.
Hair loss.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.
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: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301/fax: +48 22 49 21 309/e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Piramil

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Package contents 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.
Other ingredients are: microcrystalline cellulose, maize starch, silicon dioxide, glycine hydrochloride, glycerol dibehenate.
Piramil 2.5 mg: yellow iron oxide (E 172).
Piramil 5 mg: red iron oxide (E 172).

What Piramil looks like and contents of the pack

Piramil 1.25: White or almost white, oblong tablets with a notch on both sides.
The score line is not intended for breaking the tablet.
Piramil 2.5: Yellow, speckled, oblong tablets with a notch on one side.
The tablet can be divided into equal doses.
Piramil 5: Pink, speckled, oblong tablets with a notch on one side.
The tablet can be divided into equal doses.
Piramil 10: White or almost white, oblong tablets with a notch on one side.
The tablet can be divided into equal doses.
Tablets are packaged in blisters of OPA/Aluminum/PE/PE/Aluminum foil in a carton.
Package sizes:
Piramil 1.25: 20, 28, 30, 50, and 100 tablets.
Piramil 2.5 and Piramil 5: 10, 20, 28, 30, 50, and 100 tablets.
Piramil 10: 28, 30, and 60 tablets.

Marketing authorization 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

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
Date of last revision of the leaflet:09/2019
Sandoz logo