Piramil 1,25 mg

Leaflet accompanying 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 essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. 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 not listed in the leaflet, they should inform 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. Contents of the packaging and other information

1. What is Piramil and what is it used for

Piramil contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Piramil works by:
reducing the production of substances in the body 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 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 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 problems with reduced blood flow to the kidneys (renal artery stenosis).
during the last 6 months of pregnancy(see "Pregnancy and breastfeeding" below).
if the patient's blood pressure is abnormally low or unstable. This needs to be checked by a doctor.
if the patient has diabetes or kidney problems 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 these situations apply to the patient, they should not take Piramil.
In case of doubt, consult a doctor before taking Piramil.

Warnings and precautions

Before taking Piramil, discuss it with a doctor or pharmacist if:
the patient has heart, liver, or kidney problems;
the patient has lost a lot of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term use of diuretics, or dialysis);
the patient is going to undergo desensitization to bee or wasp venom;
the patient is going to have anesthesia (for surgery or dental procedures). It may be necessary to stop taking Piramil the day before the procedure, so consult a doctor.
a test has shown high levels of potassium in the patient's blood;
the patient is taking medicines or has conditions that may 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.
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 transplant rejection and treat cancer (mTOR inhibitors, e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin and other dipeptidyl peptidase-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 blood pressure 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.
If any of these situations apply to the patient or the patient is unsure, consult a doctor before taking Piramil.

Piramil and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
The reason is the possibility of interaction between Piramil and some other medicines.
Inform the doctor about taking any of the following medicines, as they may reduce the effect of Piramil:

Inform the doctor about taking any of the following medicines, as they may increase the risk of side effects when taken with Piramil:

Inform the doctor about taking any of the following medicines, as Piramil may affect their action:

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 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 may seriously harm the baby.
If the patient becomes pregnant while taking Piramil, they should inform their doctor immediately. The doctor will suggest switching to another medicine before planned pregnancy.
Breastfeeding
Piramil should not be used during breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Piramil may cause dizziness, especially at the beginning of treatment or when increasing the dose.
In such cases, do 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 doubt, consult a doctor or pharmacist.

Taking the medicine

Take the medicine orally, once a day, at the same time.
Swallow the tablets with a liquid.
Do not crush or chew the tablets.

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 Piramil.
The maximum dose is 10 mg once a day.
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 Piramil.
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 Piramil.
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 Piramil.
The maximum dose is 10 mg once a day, preferably taken in two divided doses throughout the 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 Piramil.
The maximum dose is 10 mg once a day, preferably taken in two divided doses throughout the day.
Elderly patients
The doctor will reduce the initial dose and increase it more slowly.

Taking more than the recommended dose of Piramil

In case of overdose, consult a 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.
Take the medicine packaging with you, so the doctor can see what medicine was taken.

Missing a 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 the missed dose.
In case of further doubts about taking this medicine, consult a 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 severe side effects, they should stop taking Piramil and contact their doctor immediately – prompt treatment may be needed.

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, ulcers in the mouth, worsening of existing skin conditions, 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 inform their doctor immediately:

Rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, tightness in the chest, or more severe disorders, including heart attack and stroke.
Shortness of breath or cough. These may indicate lung diseases.
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 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, vomiting, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as inflammation or liver damage.

Other side effects

Tell the doctor if any of the following symptoms worsen or persist for more than a few days.
Common(may affect up to 1 in 10 people)
Headache or feeling tired.
Dizziness. This may occur more frequently at the beginning of Piramil treatment or when increasing the dose.
Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or sitting down quickly.
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, as shown in laboratory tests.
Uncommon(may affect up to 1 in 100 people)
Balance disorders (dizziness of vestibular origin).
Itching of the skin and sensory disturbances, such as numbness, tingling, prickling, burning, or a feeling of walking on air (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. This may be a sign of excessive water retention.
Hot flashes.
Blurred vision.
Joint pain.
Fever.
Impotence, decreased libido in men and women.
Increased white blood cell count (eosinophilia) detected in blood tests.
Blood test results indicating liver, pancreas, or kidney disorders.
Rare(may affect up to 1 in 1,000 people)
Feeling confused or disoriented.
Tongue redness and swelling.
Severe skin peeling, itchy, lumpy rash.
Nail disorders (e.g., nail loosening or separation from the nail bed).
Skin rash or bruising.
Spots on the skin and discoloration of the limbs.
Redness, itching, swelling, or tearing of the eyes.
Hearing disorders and ringing in the ears.
Feeling weak.
Decreased red blood cell, white blood cell, or platelet count, or hemoglobin levels in blood tests.
Very rare(may affect up to 1 in 10,000 people)
Sensitivity to sunlight.

Other reported side effects

Tell the doctor if any of the following symptoms worsen 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), nausea, or vomiting, muscle cramps, confusion, and convulsions, which may be symptoms of inappropriate antidiuretic hormone secretion (SIADH). If such symptoms occur, contact a 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.
Feeling of burning.
Smell disorders.
Hair loss.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform 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: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Piramil

Keep the medicine 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 packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste.
Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 score line on both sides.
The score line is not intended for breaking the tablet.
Piramil 2.5: Yellow, oblong, speckled tablets with a score line on one side.
The tablet can be divided into equal doses.
Piramil 5: Pink, oblong, speckled tablets with a score line on one side.
The tablet can be divided into equal doses.
Piramil 10: White or almost white, oblong tablets with a score line on one side.
The tablet can be divided into equal doses.
Tablets are packaged in OPA/Aluminum/PE/PE/Aluminum blisters in a carton.
Pack 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

For more information on this medicine and its names in the Member States of the European Economic Area, please 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
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