Piramil 10 mg

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Piramil 10 mg (Ramipril HEXAL 10 mg)
10 mg, tablets
Ramiprilum
Piramil 10 mg and Ramipril HEXAL 10 mg are different brand names of the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Piramil 10 mg is and what it is 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 pack and other information

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

Piramil 10 mg contains a medicine called ramipril. It belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).
Piramil 10 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 10 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 of kidney function (regardless of whether the patient has diabetes),
• to treat heart failure, when the heart is unable to pump sufficient blood to the body,
• to treat patients after a heart attack complicated by heart failure.

2. Important information before using Piramil 10 mg

When not to use Piramil 10 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 patches on the 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 10 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 situations described above apply, the patient should not take Piramil 10 mg. In case of doubt, consult a doctor before taking Piramil 10 mg.

Warnings and precautions
Before using Piramil 10 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 a dental procedure). It may be necessary to discontinue Piramil 10 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 reduce 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 diarrhoea);
• medicines used to prevent organ transplant rejection 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 collagenosis such as scleroderma or systemic lupus erythematosus;
• the patient is taking any of the following antihypertensive medicines:
• angiotensin II receptor antagonists (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 10 mg".
• the patient is pregnant (or planning pregnancy), she must inform her doctor. Use of Piramil 10 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 10 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 situations described above apply to the patient, or if the patient is unsure, consult a doctor before taking Piramil 10 mg.

Piramil 10 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 10 mg and certain other medicines may affect each other’s actions.
Inform the doctor if the patient is taking any of the following medicines, as they may weaken the effect of Piramil 10 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 they may increase the risk of adverse effects when taken together with Piramil 10 mg:

• painkillers and anti-inflammatory medicines (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 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 transplant rejection], 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 a medicine from the angiotensin II receptor antagonist group or aliskiren (see also information in sections "When not to use Piramil 10 mg" and "Warnings and precautions").
Inform the doctor if the patient is taking any of the following medicines, as Piramil 10 mg may interfere with their action:

• antidiabetic medicines (oral and insulin). Piramil 10 mg may lower blood sugar levels. Blood glucose levels should be monitored regularly during treatment with Piramil 10 mg.
• lithium (used in psychiatric disorders). Piramil 10 mg may increase blood lithium levels. The doctor will recommend close monitoring of blood lithium levels. If any of the situations described above apply to the patient or if the patient is unsure, consult a doctor before taking Piramil 10 mg.

Piramil 10 mg with food, drink, and alcohol

• Drinking alcohol while taking Piramil 10 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 10 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 10 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 10 mg, she should inform her doctor immediately. The doctor will recommend switching to another medicine before a planned pregnancy.
Breastfeeding
Piramil 10 mg should not be used during breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
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, operate tools, or machinery.

3. How to take Piramil 10 mg

This medicine should always be taken 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 taken with a drink.
• Tablets must not be crushed or chewed.

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 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 initiating treatment with Piramil 10 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 renal function deterioration

• 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 10 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 along so the doctor can see which medicine was taken.
Missed dose of Piramil 10 mg

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

If you have any further questions 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 everyone will experience them.
If any of the following serious adverse reactions occur in the patient, the medicine must be discontinued immediately and the doctor must be contacted immediately – prompt treatment may be required:

• 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, oral mucosal ulceration, 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 must be informed immediately:

• Rapid heartbeat, 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 diseases.
• Easy bruising, longer than usual bleeding time, any signs of bleeding (e.g. bleeding gums), purpuric skin spots, or more frequent infections, sore throat and 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 10 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 blood, as shown in laboratory tests.

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

• Balance disorders (vestibular dizziness).
• 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 more than usual.
• Nasal congestion, difficulty breathing or worsening of asthma.
• Intestinal swelling (so-called "intestinal angioedema"), manifested by abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dry mouth.
• Increased urine output during the day.
• 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 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 levels 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 worsen significantly 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 the doctor as quickly 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 of 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.
• Smell disturbances.
• Hair loss.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 10 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.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package 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, pregelatinized maize starch.

What Piramil 10 mg looks like and contents of the pack
White, oblong, flat tablets with notches on both sides and embossed "R10" on one side. The tablet may be divided into two equal doses. Tablets are packed in blisters containing 30 and 60 tablets. For more detailed information, please 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., 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 Authorization Number in Germany, the country of export: 53329.04.00
Parallel Import License Number: 280/17