Piramil 5 mg

Leaflet accompanying the packaging: patient information

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

Piramil 5 mg(Ramipril HEXAL 5 mg)

5 mg, tablets

Ramiprilum
Piramil 5 mg and Ramipril HEXAL 5 mg 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 specifically for you. 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Piramil 5 mg and what is it used for

Piramil 5 mg contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Piramil 5 mg 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 5 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 (heart failure),
• treat heart failure after a heart attack.

2. Important information before taking Piramil 5 mg

When not to take Piramil 5 mg

• 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 5 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. 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 5 mg. In case of doubt, the patient should consult their doctor before taking Piramil 5 mg.

Warnings and precautions

Before taking Piramil 5 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 stings);
• the patient is to receive anesthesia (for surgery or dental procedures). It may be necessary to stop taking Piramil 5 mg the day before the procedure, so the patient should consult their doctor about this.
• blood tests have shown high potassium levels 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);
• wildagliptin 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 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 may regularly check kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the information in section "When not to take Piramil 5 mg" and "Warnings and precautions".
• the patient is pregnant (or plans to become pregnant) and must inform their doctor about this. Taking Piramil 5 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 5 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 yet been established.
If any of these situations apply to the patient or the patient is unsure, they should consult their doctor before taking Piramil 5 mg.

Piramil 5 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 possibility of interaction between Piramil 5 mg and some other medicines.

• 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 about taking any of the following medicines, as they may increase the risk of side effects when taken with Piramil 5 mg:

• medicines used to treat pain and inflammation (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 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 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 an angiotensin II receptor antagonist or aliskiren (see also the information in section "When not to take Piramil 5 mg" and "Warnings and precautions").
The patient should inform their doctor about taking any of the following medicines, as Piramil 5 mg may affect their action:

• medicines used to treat diabetes (oral and insulin). Piramil 5 mg may lower blood sugar levels. The patient should regularly check their blood sugar levels while taking Piramil 5 mg.
• lithium (used to treat mental illnesses). Piramil 5 mg 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 the patient is unsure, they should consult their doctor before taking Piramil 5 mg.

Piramil 5 mg with food, drink, and alcohol

• Drinking alcohol while taking Piramil 5 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 5 mg 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 5 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 may seriously harm the baby.
If the patient becomes pregnant while taking Piramil 5 mg, they should immediately inform their doctor. The doctor will propose a change to another medicine before planned pregnancy.
Breastfeeding
Piramil 5 mg should not be used during breastfeeding.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Piramil 5 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.

3. How to take Piramil 5 mg

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, 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 stopping it or reducing the dose before starting Piramil 5 mg.

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 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 the medicine.
• 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 more than the recommended dose of Piramil 5 mg

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 the doctor can see what medicine was taken.

Missing a dose of Piramil 5 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. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Piramil 5 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, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to the medicine.
• Severe skin reactions, including rash, mouth ulcers, 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 serious disorders, including heart attack and stroke.
• Shortness of breath or cough. These may indicate lung diseases.
• Easy bruising, prolonged bleeding, or any signs of bleeding (e.g., bleeding gums), purpura, 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

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. These may occur more frequently at the beginning of treatment with Piramil 5 mg or when 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.
• Rash.
• Chest pain.
• Muscle cramps or pain.
• Higher than normal potassium levels in the blood, as 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 ants crawling on the skin (paresthesia).
• Loss of or altered 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 urination during the day.
• Excessive sweating.
• Loss of or decreased appetite (anorexia).
• Accelerated or irregular heartbeat.
• Swelling of the hands and feet. These may be symptoms of excessive water retention.
• Hot flashes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men and women.
• Increased white blood cell count detected in blood tests.
• Abnormal liver, pancreas, or kidney function test results.

Rare(may occur in less than 1 in 1000 people)

• Feeling disoriented or confused.
• 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).
• 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 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 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 white blood cell count detected in blood tests.
• Lower than normal 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 inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Piramil 5 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.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung– Batch number/Expiry date: see imprint.
The medicine should not be stored above 25°C.
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 5 mg contains

• The active substance is ramipril. Each tablet contains 5 mg of ramipril.
• The other ingredients are: microcrystalline cellulose, hypromellose, sodium bicarbonate, sodium stearylfumarate, maize starch.

What Piramil 5 mg looks like and contents of the pack

White, oblong, flat tablets with a notch on both sides and "R5" embossed on one side.
The tablet can be divided into two equal doses.
The tablets are packaged in blisters containing 10, 20, 30, 50, and 100 pieces.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Hexal AG, Industriestrasse 25, 83607 Holzkirchen, 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:53329.02.00
Parallel import authorization number:220/17

Date of leaflet approval: 06.05.2022

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