PIRAMIL 10 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. Piramil 5 mg, 5 mg, tablets
   2. Piramil 10 mg, 10 mg, tablets
   3. It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   4. Table of contents of the leaflet:
2. What is Piramil and what is it used for
3. Important information before taking Piramil
   1. When not to take Piramil
   2. Warnings and precautions
   3. Children and adolescents
   4. Piramil and other medicines
   5. Piramil with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
4. How to take Piramil
   1. Taking the medicine
   2. How much to take
   3. Taking a higher dose of Piramil than recommended
   4. Missing a dose of Piramil
5. Possible side effects
   1. 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.
   2. The patient should immediately inform their doctor if they experience any of the following symptoms:
   3. Other side effects
   4. Other reported side effects
   5. Reporting side effects
6. How to store Piramil
7. Package contents and other information
   1. What Piramil contains
   2. What Piramil looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information about the medicine and its names in the Member States of the European Economic Area, please contact:

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

It is recommended to keep this leaflet, so that it can be re-read if necessary.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. It should not be given to others.
The medicine may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects 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. 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 "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 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 their 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, taking diuretics for a long time, or undergoing dialysis);
they are going to undergo desensitization treatment for bee or wasp stings;
they are going to have anesthesia (for surgery or dental procedures). It may be necessary to stop taking Piramil the day before the procedure, so the patient should consult their doctor about this.
a test has shown that the patient has 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);
• 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 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.
• the patient is pregnant (or plans to become pregnant) and must inform their doctor. Taking Piramil is not recommended during the first 3 months of pregnancy and may be very harmful to the baby after the 3rd month of pregnancy (see "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 been established yet.
If any of these situations apply to the patient or they are 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 if they are taking any of the following medicines, as they may reduce the effect of Piramil:

pain 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 epinephrine. The doctor should monitor the patient's blood pressure.
The patient should inform their doctor if they are taking any of the following medicines, as taking them with Piramil may increase the risk of side effects:

pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs, NSAIDs, such as ibuprofen or indomethacin, and acetylsalicylic acid);
cancer medicines (chemotherapy);
temsirolimus (a cancer 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);
vildagliptin (a medicine used to treat type 2 diabetes);
racecadotril (an anti-diarrheal medicine).
The doctor may change the dose of Piramil and/or recommend other precautions if the patient is taking an angiotensin II receptor antagonist or aliskiren (see also the information in the "When not to take Piramil" and "Warnings and precautions" sections).
The patient should inform their doctor if they are taking any of the following medicines, as Piramil may affect their action:

anti-diabetic medicines (oral 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 closely monitor lithium levels in the blood.
If any of these situations apply to the patient or they are 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 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 immediately inform their doctor. The doctor will propose 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 cases, 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.
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 modify the dosage of Piramil.
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 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 modify 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 modify the dose of Piramil.
The maximum dose is 10 mg once a day. It is recommended 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 modify the dose of Piramil.
The maximum dose is 10 mg once a day. It is recommended 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 package of Piramil with them, so 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 Piramil.
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).

The patient should immediately inform their doctor if they experience any of the following symptoms:

Rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, tightness in the chest, or more severe heart 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 from the gums), purple spots on the skin, or more frequent infections, sore throat, and fever, feeling tired, fainting, dizziness, or paleness of the skin. These may be symptoms of a blood or bone marrow disorder.
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 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. This 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 getting up quickly from a lying or sitting position.
Dry, persistent cough, sinusitis, or bronchitis, shortness of breath.
Stomach 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 occur in less than 1 in 100 people)
Balance disorders (dizziness of vestibular origin).
Itching of the skin and sensory disturbances, such as numbness, tingling, prickling, burning, or feeling of ants crawling on the skin (paresthesia).
Loss of or changes in 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 or decreased appetite (anorexia).
Rapid or irregular heartbeat.
Swelling of the hands and feet. This may be a sign of retaining more fluid than usual.
Hot flashes.
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 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, lumpy 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, white blood cell, or platelet count, or hemoglobin level 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. If such symptoms occur, 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.
Feeling of burning.
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 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 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.
Piramil should not be used after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
The medicine should not be stored above 25°C. It should be stored in the original packaging to protect it 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.
The 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, oblong, speckled tablets with a notch on one side.
The tablet can be divided into equal doses.
Piramil 5: Pink, oblong, speckled 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.
The tablets are packaged in OPA/Aluminum/PE/PE/Aluminum blisters in a carton box.
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

For more information about the 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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