PIRAMIL 5 MG

Package leaflet: Information for the patient

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 of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Piramil 5 mg is and what it is 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 pack and other information

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

Piramil 5 mg contains a medicine called ramipril. It belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).
Piramil 5 mg works by:

• reducing the production in the body of substances that may increase blood pressure,
• reducing tension and widening blood vessels,
• helping the heart pump blood to all parts of the body.

Piramil 5 mg may be used to:

• treat high blood pressure (hypertension),
• reduce the risk of heart attack or stroke,
• reduce the risk of or delay worsening kidney function (regardless of whether the patient has diabetes),
• treat heart failure, when the heart is unable to pump enough blood to meet the body's needs,
• treat patients after a heart attack complicated by heart failure.

2. Important information before using Piramil 5 mg

When not to use Piramil 5 mg

• if the patient is allergic to ramipril, to other ACE inhibitors, or to any of the components 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 experienced a severe allergic reaction known as "angioedema". Symptoms include: itching, hives, red spots on 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 5 mg may not be suitable.
• if the patient has kidney function disorders with reduced blood flow to the kidneys (renal artery stenosis).
• during the last 6 months of pregnancy (see below "Pregnancy and breastfeeding").
• if the patient's blood pressure is abnormally low or unstable. This must be evaluated 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 area). If any of the described situations apply, the patient should not take Piramil 5 mg. In case of doubt, consult a doctor before taking Piramil 5 mg.

Warnings and precautions
Before using Piramil 5 mg, discuss with your doctor or pharmacist if:

• the patient has heart, liver, or kidney function disorders;
• the patient has lost a large amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, low-salt diet, long-term use of diuretics, or dialysis);
• the patient is undergoing treatment to reduce sensitivity to bee or wasp venom (desensitisation);
• the patient is to receive anaesthesia (for surgery or dental procedures). It may be necessary to discontinue Piramil 5 mg one day before the procedure; therefore, consult your doctor.
• blood tests have shown high potassium levels in the patient;
• the patient is taking medicines or has conditions that may cause low sodium levels in the blood. The doctor may regularly order blood tests, especially to monitor sodium levels, particularly if the patient is elderly.
• the patient is taking any of the following medicines, as they may increase the risk of angioedema:
• racecadotril (a medicine used to treat diarrhoea);
• medicines used to prevent rejection of transplanted organs and to treat cancer (mTOR inhibitors, e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin and other medicines from the dipeptidyl peptidase-4 (DPP-4) inhibitor group (medicines used to treat diabetes).
• the patient has been diagnosed with collagenosis, such as scleroderma or systemic lupus erythematosus;
• the patient is taking any of the following antihypertensive medicines:
• angiotensin II receptor antagonist (medicines also known as sartans, e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney disease due to diabetes;
• aliskiren. The doctor may regularly monitor kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood. See also information in section "When not to use Piramil 5 mg".
• the patient is pregnant (or planning pregnancy), she must inform the doctor. Use of Piramil 5 mg is not recommended during the first 3 months of pregnancy and may be very harmful to the unborn child from the 4th month of pregnancy onwards (see section "Pregnancy and breastfeeding" below).

Children and adolescents

Piramil 5 mg is not recommended for 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 the described situations apply to the patient or the patient is unsure, consult a doctor before taking Piramil 5 mg.

Piramil 5 mg and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is because Piramil 5 mg may interact with certain other medicines, affecting their action.

Inform the doctor if the patient is taking any of the following medicines, as they may reduce the effectiveness of Piramil 5 mg:

• painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs, so-called NSAIDs, such as ibuprofen or indomethacin, and acetylsalicylic acid);
• medicines used to treat low blood pressure, shock, heart failure, bronchial asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. The doctor should monitor the patient's blood pressure.

Inform the doctor if the patient is taking any of the following medicines, as they may increase the risk of adverse effects when taken together with Piramil 5 mg:

• painkillers and anti-inflammatory medicines (e.g. 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 co-trimoxazole [medicines used to treat bacterial infections], cyclosporine [an immunosuppressive medicine used to prevent rejection of transplanted organs], and heparin [a medicine used to thin the blood and prevent blood clots]);
• corticosteroid anti-inflammatory medicines, such as prednisolone;
• allopurinol (a medicine used to reduce uric acid levels in the blood);
• procainamide (a medicine used for heart rhythm disorders);
• vildagliptin (a medicine used to treat type 2 diabetes);
• racecadotril (an antidiarrhoeal medicine).

The doctor may adjust the dose and/or recommend additional precautions if the patient is taking a medicine from the angiotensin II receptor antagonist group or aliskiren (see also information in section "When not to use Piramil 5 mg" and "Warnings and precautions").

Inform the doctor if the patient is taking any of the following medicines, as Piramil 5 mg may interfere with their action:

• antidiabetic medicines (oral and insulin). Piramil 5 mg may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Piramil 5 mg.
• lithium (used in psychiatric disorders). Piramil 5 mg may increase lithium levels in the blood. The doctor will recommend close monitoring of lithium levels in the blood.

If any of the described situations apply to the patient or the patient is unsure, consult a 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 drowsiness. Patients interested in the acceptable amount of alcohol during treatment should discuss this with their doctor, as the effects of blood pressure-lowering medicines and alcohol may be additive.
• Piramil 5 mg can be taken independently of meals.

Pregnancy and breastfeeding
Pregnancy
If the patient suspects she is pregnant (or could become pregnant), she should inform her doctor.
Piramil 5 mg should not be taken during the first 12 weeks of pregnancy and must not be used after the 13th week of pregnancy, as the medicine may seriously harm the unborn child.
If the patient becomes pregnant while being treated with Piramil 5 mg, she should inform her doctor immediately. The doctor will recommend switching to another medicine before planned pregnancy.

Breastfeeding
Piramil 5 mg should not be used during breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Piramil 5 mg may cause dizziness, especially at the beginning of treatment or when increasing the dose. In such cases, patients should not drive, operate tools, or machinery.

3. How to take Piramil 5 mg

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The following products are available on the market: Piramil 1.25 mg, Piramil 2.5 mg, Piramil 5 mg, and Piramil 10 mg.
Taking the medicine

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

Dosage
Treatment of arterial hypertension

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Based on blood pressure monitoring, your doctor may adjust the dose.
• The maximum dose is 10 mg once daily.
• If the patient is already taking a diuretic, the doctor may recommend discontinuing it or reducing its dose before starting treatment with Piramil 5 mg.

Reduction of the risk of myocardial infarction or stroke

• The usual starting dose is 2.5 mg once daily.
• The doctor may subsequently increase the dose.
• The usual maintenance dose is 10 mg once daily.

Reduction or delay of worsening kidney function

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• The doctor may subsequently adjust the dose.
• The usual maintenance dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
• The doctor may subsequently adjust the dose.
• The maximum dose is 10 mg once daily. It is preferable to divide this dose into two doses taken during the day.

Post-myocardial infarction treatment

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• The doctor may subsequently adjust the dose.
• The maximum dose is 10 mg once daily. It is preferable to divide this dose into two doses taken during the day.

Elderly patients
The doctor will reduce the initial dose and increase it more gradually.
Accidental overdose of Piramil 5 mg
In case of overdose, seek medical advice immediately or go to the nearest hospital. The patient should not drive but ask someone else for help or call an ambulance. Take the medicine packaging with you so the doctor can see which medicine has been taken.
Missed dose of Piramil 5 mg

• If a dose is missed, take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions, the use of this medicine must be discontinued and immediate contact with a doctor must be established – prompt treatment may be necessary.

• Swelling of the face, lips, or throat causing difficulty in swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction to this medicine.
• Severe skin reactions, including rash, ulceration of the oral mucosa, worsening of pre-existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If any of the listed symptoms occur, the doctor should be informed immediately:

• Increased heart rate, irregular or forceful heartbeat (palpitations), chest pain, chest tightness, or more severe disturbances, including myocardial infarction 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), purpuric skin spots, or increased frequency of infections, sore throat, fever, fatigue, 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, or yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage.

Other adverse reactions
Inform the doctor if any of the following symptoms worsen or persist for longer than a few days.
Common (may occur in fewer than 1 in 10 people)

• Headache or feeling of fatigue.
• Dizziness. These may occur more frequently at the beginning of treatment with Piramil 5 mg or after increasing the dose.
• Fainting, hypotension (abnormally low blood pressure), especially when rising quickly to a standing or sitting position.
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath.
• Abdominal pain, diarrhoea, indigestion, nausea, or vomiting.
• Skin rash with or without raised bumps.
• Chest pain.
• Muscle cramps or pain.
• Higher than normal potassium levels in the blood, as shown in laboratory tests.

Uncommon (may occur in fewer than 1 in 100 people)

• Balance disorders (vertigo-related dizziness).
• Skin itching and sensory disturbances such as numbness, tingling, pricking, burning, or crawling sensations on the skin (paresthesia).
• Loss or disturbances of taste.
• Sleep disturbances.
• Depression, anxiety, increased nervousness or restlessness.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Intestinal swelling (so-called "intestinal angioedema"), presenting with abdominal pain, vomiting, and diarrhoea.
• Heartburn, constipation, or dry mouth.
• Increased urine output during the day.
• Excessive sweating.
• Loss or decreased appetite (anorexia).
• Accelerated or irregular heartbeat.
• Swelling of hands and feet. These may be signs of increased fluid retention.
• Hot flushes.
• 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 impaired liver, pancreas, or kidney function.

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

• Feeling of disorientation or confusion.
• Redness and swelling of the tongue.
• Severe skin peeling, itchy, bumpy rash.
• Nail disorders (e.g., loosening or separation of the nail from the nail bed).
• Skin rash or bruising.
• Skin spots and cold extremities.
• Redness, itching, swelling, or watering of the eyes.
• Hearing disturbances and tinnitus.
• Feeling of weakness.
• Decreased number of red blood cells, white blood cells, or platelets, or decreased hemoglobin concentration in blood tests.

Very rare (may occur in fewer than 1 in 10,000 people)

• Increased sensitivity to sunlight.

Other reported adverse reactions
Inform the doctor if any of the following symptoms significantly worsen or persist for longer than a few days.
Adverse reactions occurring with unknown frequency (frequency cannot be estimated from available data):

• Concentrated urine (dark-colored urine), nausea or vomiting, muscle cramps, confusion, and seizures, which may be symptoms of inappropriate antidiuretic hormone (ADH) secretion. If such symptoms occur, contact a doctor as soon as possible.
• Difficulty concentrating.
• Swelling of the oral cavity.
• Low blood cell count detected in blood tests.
• Lower than normal sodium levels in blood tests.
• Color change in fingers and toes upon cold exposure, accompanied by tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Smell disturbances.
• Hair loss.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Piramil 5 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – Batch number/Expiry date: see imprint.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack 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 hydrogen carbonate, sodium stearyl fumarate, pregelatinized corn starch.

What Piramil 5 mg looks like and contents of the pack
White, elongated, flat tablets, with notches on both sides and embossed "R5" on one side. The tablet may be divided into two equal doses. The tablets are packed in blisters containing 10, 20, 30, 50, and 100 tablets. For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Hexal AG, Industriestrasse 25, 83607 Holzkirchen, Germany
Manufacturer:
Lek S.A., 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., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Germany, the country of export: 53329.02.00
Parallel Import Authorisation Number: 220/17