Piramil 10 mg

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Piramil 10 mg (Ramipril - 1 A Pharma),10 mg, tablets
Ramiprilum
Piramil 10 mg and Ramipril - 1 A Pharma are different trade names for the same medicine.

You should 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 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 10 mg and what is it used for
• 2. Important information before taking Piramil 10 mg
• 3. How to take Piramil 10 mg
• 4. Possible side effects
• 5. How to store Piramil 10 mg
• 6. Contents of the packaging and other information

1. What is Piramil 10 mg and what is it used for

Piramil 10 mg contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Piramil 10 mg works by:

• reducing the production in the body of substances that can increase blood pressure,
• reducing tension and widening blood vessels,
• making it easier for the heart to pump blood to all parts of the body.

Piramil 10 mg 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 10 mg

When not to take Piramil 10 mg

• 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 in the throat, swelling of the throat and tongue, swelling around the 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 10 mg 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 examine this 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 the above situations apply to the patient, they should not take Piramil 10 mg.
In case of doubts, the patient should consult a doctor before taking Piramil 10 mg.

Warnings and precautions

Before taking Piramil 10 mg, the patient should discuss it with their doctor or pharmacist if:

• the patient has heart, liver, or kidney function disorders;
• the patient has 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);
• the patient is to undergo desensitization treatment (e.g. for bee or wasp venom allergy);
• the patient is to receive anesthesia (for surgery or dental procedure). It may be necessary to discontinue Piramil 10 mg for a day before the procedure, so the patient should consult their doctor.
• blood tests have shown high potassium levels in the patient's blood;
• the patient is taking medicines or has 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.
• 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);
• wildagliptin and other dipeptidyl peptidase-4 inhibitors (DDP-4) (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-lowering medicines:
• angiotensin II receptor antagonist (also known as sartans, e.g. valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease;
• aliskiren. The doctor will 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 10 mg" and "Warnings and precautions" sections.
• the patient is pregnant (or plans to become pregnant) and must inform their doctor. Taking Piramil 10 mg 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 below "Pregnancy and breastfeeding").

Children and adolescents

Piramil 10 mg should not be given to 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 the above situations apply to the patient or the patient is unsure, they should consult their doctor before taking Piramil 10 mg.

Piramil 10 mg 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.
The reason is the possible interaction between Piramil 10 mg and some other medicines.

• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. 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 they may increase the risk of side effects when taken with Piramil 10 mg:

• medicines used to treat pain and inflammation (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 supplements (including salt substitutes containing potassium), potassium-sparing diuretics (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], cyclosporin [a medicine that suppresses the immune system, used to prevent transplant rejection] and heparin [a medicine used to thin the blood and prevent blood clots]);
• 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);
• wildagliptin (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 from the group of angiotensin II receptor antagonists or aliskiren (see also the information in the "When not to take Piramil 10 mg" and "Warnings and precautions" sections).

• medicines used to treat diabetes (oral and insulin). Piramil 10 mg may lower blood sugar levels. During treatment with Piramil 10 mg, the patient should regularly monitor their blood sugar levels.
• lithium (used to treat mental illnesses). Piramil 10 mg may increase lithium levels in the blood. The doctor will recommend close monitoring of lithium levels in the blood.

If any of the above situations apply to the patient or the patient is unsure, they should consult their doctor before taking Piramil 10 mg.

Piramil 10 mg with food, drinks, and alcohol

• Drinking alcohol while taking Piramil 10 mg may cause dizziness or fainting. People interested in the allowed amount of alcohol during treatment should discuss this with their doctor, as the effects of blood pressure-lowering medicines and alcohol may add up.
• Piramil 10 mg 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 10 mg 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 during treatment with Piramil 10 mg, they should immediately inform their doctor. The doctor will propose a change to another medicine before planned pregnancy.
Breastfeeding
Piramil 10 mg should not be used during breastfeeding.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Piramil 10 mg 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.

Piramil 10 mg contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Piramil 10 mg

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Piramil 1.25 mg, Piramil 2.5 mg, Piramil 5 mg, and Piramil 10 mg are available on the market.

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 the medicine.
• The maximum dose is 10 mg once a day.
• If the patient is already taking a diuretic, the doctor may recommend discontinuing 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 modify 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 modify 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 modify 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 10 mg 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 packaging of the medicine with them so that the doctor can see what medicine was taken.

Missing a dose of Piramil 10 mg

• 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 10 mg can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking the medicine and contact their doctor immediately - prompt treatment may be necessary.

• Swelling of the face, lips, or throat that makes swallowing or breathing difficult, 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 inform their doctor immediately:

• 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), purpura, or more frequent infections, sore throat, and fever, feeling of tiredness, fainting, dizziness, or paleness of the skin. These may be symptoms of a blood or bone marrow disorder.
• Severe stomach pain that 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). 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 of tiredness.
• Dizziness. It may occur more frequently at the beginning of treatment with Piramil 10 mg or when increasing the dose.
• Fainting, 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.
• Rash.
• 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 feeling of crawling under the skin (paresthesia).
• Loss of or disturbance 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"), the symptoms of which 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).
• Accelerated or irregular heartbeat.
• Swelling of the hands and feet. It 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 of confusion or disorientation.
• 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).
• Rash or bruising.
• Spots on the skin and discoloration of the extremities.
• Redness, itching, swelling, or tearing of the eyes.
• Hearing or ringing in the ears.
• Feeling of weakness.
• Decreased number of red blood cells, white blood cells, or platelets, 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 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 seizures, which may be symptoms of inappropriate antidiuretic hormone secretion (SIADH). If such symptoms occur, the patient should contact their doctor as soon as possible.
• Difficulty concentrating.
• Mouth swelling.
• Low sodium levels in the blood.
• Change in finger and toe color upon cooling and feeling of tingling or pain upon 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 inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Piramil 10 mg

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The medicine should not be stored at temperatures above 25°C. It should be stored in the original packaging.
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. Contents of the packaging and other information

What Piramil 10 mg contains

• The active substance is ramipril. Each tablet contains 10 mg of ramipril.
• The other ingredients are: microcrystalline cellulose, hypromellose, sodium hydrogen carbonate, sodium stearyl fumarate, cornstarch.

What Piramil 10 mg looks like and contents of the packaging

White, flat (biconvex), scored tablets with a notch on both sides, with the inscription "R 10" on one side.
The tablet can be divided into two equal doses.
The tablets are packaged in aluminum/aluminum blisters in a cardboard box.
Pack sizes: 30 and 60 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany

Manufacturer:

LEK S.A.
ul. Podlipie 16
95-010 Stryków
Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana
Slovenia

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:57778.04.00

Parallel import authorization number: 119/22 Date of leaflet approval: 07.03.2022

[Information about the trademark]