PIRAMIL 5 MG

Patient Information Leaflet

Caution! Keep this leaflet. The information on the immediate packaging is 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 brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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 to pump blood to all parts of the body more easily.

Piramil 5 mg may be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay worsening kidney function (regardless of whether the patient has diabetes),
• to treat heart failure (when the heart is unable to pump enough blood for the body's needs),
• to 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 called "angioedema". 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 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 requires medical evaluation.
• if the patient has diabetes or kidney function disorders and is taking a blood pressure-lowering medicine containing aliskiren.
• if the patient is taking or has recently taken a medicine containing sacubitril with valsartan (a medicine used in adults for the treatment of chronic heart failure), as this increases the risk of angioedema (sudden swelling of tissues, e.g., in the throat area).

If any of the above 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 taking 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, diarrhea, excessive sweating, low-salt diet, long-term use of diuretics, or dialysis);
• the patient is undergoing treatment to reduce allergy to bee or wasp venom (desensitization);
• the patient is due to receive anesthesia (for surgery or dental procedures). It may be necessary to stop Piramil 5 mg one day before the procedure; therefore, consult your doctor.
• 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, especially to monitor blood sodium levels, particularly 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 rejection of transplanted organs and in cancer treatment (mTOR inhibitors, e.g., temsirolimus, sirolimus, everolimus);
  • vildagliptin and other medicines in the dipeptidyl peptidase-4 (DPP-4) inhibitor class (medicines used in the treatment of 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 kidney disease due to diabetes;
  • aliskiren. The doctor may regularly monitor kidney function, blood pressure, and blood electrolyte levels (e.g., potassium). See also information in the 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 after the 3rd month of pregnancy (see below "Pregnancy and breastfeeding").

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, has recently taken, or plans to take. This is because Piramil 5 mg may interact with certain other medicines, affecting their actions.

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, 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 taking them together with Piramil 5 mg may increase the risk of adverse effects:

• 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 potassium-containing salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medicines that increase blood potassium levels (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 clots]);
• corticosteroid anti-inflammatory medicines, such as prednisolone;
• allopurinol (a medicine used to reduce blood uric acid levels);
• procainamide (a medicine used for heart rhythm disorders);
• vildagliptin (a medicine used in the treatment of type 2 diabetes);
• racecadotril (an antidiarrheal 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 class or aliskiren (see also information in the sections "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 blood lithium levels.

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 may have 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 it may seriously harm the unborn child.

If a 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 a 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, the patient should not drive, operate tools, or machinery.

3. How to use 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, Piramil 10 mg.

Taking the medicine

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

Dosage

Treatment of arterial hypertension

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

Reduction of the risk of myocardial infarction or stroke

• The initial dose is usually 2.5 mg once daily.
• Your doctor may subsequently increase the dose.
• The usual dose is 10 mg once daily.

Reduction or delay of worsening kidney function

• The initial dose is usually 1.25 mg or 2.5 mg once daily.
• Your doctor may subsequently adjust the dose.
• The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The initial dose is usually 1.25 mg once daily.
• Your 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.

Treatment following myocardial infarction

• The initial dose is usually 1.25 mg or 2.5 mg once daily.
• Your 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, contact your doctor 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 along 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 doubts regarding 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 everybody will experience them.
If the patient experiences any of the following serious adverse reactions, the use of this medicine must be discontinued and medical advice must be sought immediately – 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 symptoms listed below occur, medical advice must be sought immediately:

• Rapid heartbeat, irregular or forceful palpitations, chest pain, chest tightness or more serious disturbances, including myocardial infarction and stroke.
• Shortness of breath or cough. These may indicate lung disorders.
• Easy bruising, prolonged bleeding time compared to normal, any signs of bleeding (e.g. bleeding gums), purplish spots on the skin or increased frequency of infections, sore throat and fever, feeling of fatigue, fainting, dizziness or paleness of the 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, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage.

Other adverse reactions
Inform your doctor if any of the following symptoms worsen or persist for longer than a few days.
Common (may occur in less 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 an increase in 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 less than 1 in 100 people)

• Balance disorders (vertigo-type dizziness).
• Itching of the skin and sensory disturbances of the skin such as numbness, tingling, pricking, burning or crawling sensations (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 urinary frequency during the day.
• Excessive sweating.
• Loss of or reduced appetite (anorexia).
• Rapid or irregular heartbeat.
• Swelling of hands and feet. These may be symptoms 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 less than 1 in 1000 people)

• Feeling of disorientation or confusion.
• Redness and swelling of the tongue.
• Severe skin peeling, itchy or 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 haemoglobin concentration in blood tests.

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

• Increased sensitivity to sunlight.

Other reported adverse reactions
Inform your 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 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.
• Colour change of 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 reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 provide more information on the safety of this medicine.

5. How to store Piramil 5 mg

Keep this medicine out of the 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.
Do not store above 25°C.
Translation of some abbreviations appearing on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung - batch number and expiry date: see embossing
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, pregelatinized corn starch, sodium hydrogen carbonate, sodium stearyl fumarate, hypromellose.

What Piramil 5 mg looks like and contents of the pack

• White, elongated, biconvex tablets with a break line on both sides and engraved with the code “R 5” on one side. The tablet can be divided into two equal doses.
• The tablets are packed in aluminium/aluminium blisters, inside a cardboard box. Each pack contains 30 tablets.

For further 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:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana
Slovenia
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Number of Marketing Authorisation in Germany, the country of export: 53329.02.00
Number of Parallel Import Authorisation: 115/18