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 brand names of the same medicine.
Please read the 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

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 the active substance 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),
• to reduce the risk of heart attack or stroke,
• to reduce or delay worsening of kidney function (regardless of whether the patient has diabetes),
• to treat heart failure (when the heart is unable to pump sufficient 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 lips, face, throat, or tongue.

• if the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red spots on hands, feet, and 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 physician.
• 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, the patient should not take Piramil 5 mg. If in 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, 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 (desensitization);
• 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.
• a blood test has shown high potassium levels in the patient;
• the patient is taking medicines or has conditions that may cause low blood sodium levels. 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 may increase the risk of angioedema:
• racecadotril (a medicine used to treat diarrhoea);
• medicines used to prevent organ transplant rejection and to treat cancer (mTOR inhibitors, e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin and other medicines in the dipeptidyl peptidase-4 inhibitor group (DPP-4 inhibitors) (medicines used to treat diabetes).
• the patient has been diagnosed with a collagenosis such as scleroderma or systemic lupus erythematosus;
• the patient is taking any of the following antihypertensive medicines:
• an 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 section "When not to use Piramil 5 mg".
• the patient is pregnant (or planning pregnancy), she must inform her 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 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 above 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.

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 immunosuppressant 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 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 an angiotensin II receptor antagonist or aliskiren (see also information in 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 sugar 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 above 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 be 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 taken during this period 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 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.
Piramil 5 mg is available in the following doses: 1.25 mg, 2.5 mg, 5 mg, 10 mg.
Taking the medicine

• Take the medicine orally, every day at the same time.
• Swallow the tablets 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 discontinuing it or reducing its dose before starting treatment with Piramil 5 mg.

Reducing 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.

Reducing or delaying worsening of 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, consult a doctor immediately or go to the nearest hospital. The patient should not drive but ask someone else to drive or call an ambulance. Bring 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the following severe adverse effects, stop taking this medicine and
contact a doctor 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 peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If any of the following symptoms occur, inform a doctor immediately:

• Increased heart rate, irregular or strong heartbeat (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, any signs of bleeding (e.g., bleeding gums), purplish spots on the skin, 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 that 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 inflammation or liver damage.

Other adverse effects
Inform your doctor if any of the following symptoms worsen or persist for more than a few days.
Common (may occur in fewer 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 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, diarrhea, indigestion, nausea, or vomiting.
• Skin rash with or without raised lumps.
• Chest pain.
• Muscle cramps or pain.
• Higher than normal potassium levels in the blood, detected in laboratory tests.

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

• Balance disorders (vertigo).
• Itching of the skin 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"), symptoms of which include abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased daytime urine output.
• Excessive sweating.
• Loss or decrease in appetite (anorexia).
• Rapid 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 peeling of the skin, itchy lumpy 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 levels in blood tests.

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

• Increased sensitivity to sunlight.

Other reported adverse effects
Inform your doctor if any of the following symptoms become severe or persist for more than a few days.
Adverse effects 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 mouth.
• Low blood cell count detected in blood tests.
• Lower than normal sodium levels in blood tests.
• Color change in fingers and toes upon exposure to cold, accompanied by tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Disorders of smell.
• Hair loss.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 effects helps to provide more information on the safety of this medicine.

5. How to store Piramil 5 mg

Keep the 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 information on the immediate packaging:
Ch.-B./verwendbar bis: see imprint – batch number/expiry date: see imprint
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will 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.
• Other ingredients are: microcrystalline cellulose, hypromellose, sodium hydrogen carbonate, sodium stearyl fumarate, pregelatinized starch, corn starch.

What Piramil 5 mg looks like and contents of the pack
White, elongated, biconvex tablets with a dividing line on both sides and engraved "R 5" on one side. The tablet can be divided into two equal doses.
The tablets are packed in Al/Al blisters in a cardboard box.
Pack size: 30 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
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Number of Marketing Authorisation in Germany, the country of export: 53329.02.00
Number of Parallel Import Authorisation: 291/20