Piramil 10 mg

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is 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 for the same medicine.
Please read this leaflet carefully before taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

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 the active substance ramipril. It belongs to a group of medicines called 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),
• 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 for the body's needs),
• 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 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 condition 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).

If any of the above situations apply, the patient should not take Piramil 10 mg. If in doubt, consult a doctor before taking Piramil 10 mg.

Warnings and precautions

Before using Piramil 10 mg, discuss with a 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, prolonged use of diuretics, or dialysis);
• the patient is undergoing treatment to reduce allergy to bee or wasp venom (desensitisation);
• the patient is to receive anaesthesia (for surgery or dental procedures). It may be necessary to discontinue Piramil 10 mg one day before the procedure; therefore, consult a doctor.
• 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 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 from the group of dipeptidyl peptidase-4 (DPP-4) inhibitors (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 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 10 mg".
• the patient is pregnant (or planning pregnancy), she must inform the doctor. Use of Piramil 10 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 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 above situations 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 currently or recently taken, as well as any medicines the patient plans to take. This is because Piramil 10 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 10 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 10 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 potassium-containing salt substitutes), 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 transplant rejection], 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 group of angiotensin II receptor antagonists or aliskiren (see also information in the 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 affect their action:

• antidiabetic medicines (oral and insulin). Piramil 10 mg may lower blood sugar levels. Blood sugar levels should be monitored regularly during treatment with Piramil 10 mg.
• lithium (used in psychiatric disorders). Piramil 10 mg may increase lithium levels in the blood. The doctor will recommend close monitoring of lithium levels in the blood.

If any of the above situations 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 become 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 immediately inform her doctor. The doctor will recommend switching to another medicine before planned pregnancy.

Breast-feeding

Piramil 10 mg should not be used during breast-feeding.

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 use Piramil 10 mg

This medicine should always be taken as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Available on the market are: 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.
• Tablets should be taken 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, the 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 10 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 kidney function deterioration

• 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 starting 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.
Bring the medicine packaging along so the doctor can see which medicine has been 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 a missed dose.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If the patient experiences any of the following serious adverse effects, the use of this medicine must be discontinued and medical advice must be sought 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, 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, medical advice should be sought 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 disorders.
• Easy bruising, prolonged bleeding time, 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 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, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage.

Other adverse effects
Inform your doctor if any of the following symptoms worsen or persist for longer than a few days.
Common (may affect 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 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 affect fewer than 1 in 100 people)

• Balance disorders (vertigo).
• Itching of the skin and sensory disturbances of the skin such as numbness, tingling, pricking, burning or crawling sensations on the skin (paresthesias).
• 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"), manifested by abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dryness of the mouth.
• Increased frequency of urination during the day.
• Excessive sweating.
• Loss or decrease of 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 affect 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 development of bruises.
• 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 levels in blood tests.

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

• Hypersensitivity to sunlight.

Other reported adverse effects
Inform your doctor if any of the following symptoms significantly worsen or persist for longer 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, medical advice should be sought 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.
• Change in color 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 effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 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.
Do not store above 25°C.
Translation of some abbreviations appearing on the blister pack:
Ch.-B./verwendbar bis: siehe Prägung – Batch number/Expiry date: see embossing (on the edge of the blister).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

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

What Piramil 10 mg looks like and contents of the pack

• White, elongated, biconvex tablets with a break line on both sides and engraved "R 10" on one side. The tablet can be divided into two equal doses.
• The tablets are packed in aluminium/aluminium blisters, in a cardboard box. The 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
Poland
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
German Marketing Authorisation number (country of export): 53329.04.00
Parallel Import Authorisation number: 114/18