Piramil 10 mg

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, 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 trade names for the same medicinal product.
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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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,
• making it easier for the heart to 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 meet the body's needs,
• to treat patients following 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 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 throat and tongue, swelling around 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 for 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. In case of doubt, consult a doctor before taking Piramil 10 mg.
Warnings and precautions

Talk to your doctor or pharmacist before taking Piramil 10 mg if:

• the patient has heart, liver or kidney function disorders;
• the patient has lost large amounts of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, low-salt diet, long-term use of diuretics, or dialysis);
• the patient is due to undergo 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 stop taking Piramil 10 mg one day before the procedure, so 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 may increase the risk of angioedema:
• racecadotril (a medicine used to treat diarrhoea);
• medicines used to prevent rejection of transplanted organs or 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 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 section "When not to use Piramil".
• 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 above situations apply to the patient or if the patient is unsure, consult a doctor before taking Piramil 10 mg.
Piramil 10 mg with 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 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:

• 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 cotrimoxazole [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 group of angiotensin II receptor antagonists or aliskiren (see also information in sections "When not to use Piramil" 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 above situations apply 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 should discuss with their doctor the acceptable amount of alcohol during treatment, 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 time 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 planned pregnancy.
Breastfeeding
Piramil 10 mg should not be used during breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
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 exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Piramil is available in the following strengths: 1.25 mg, 2.5 mg, 5 mg, 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 Piramil therapy.

Reduction of the risk of myocardial infarction or stroke

• The usual starting dose is 2.5 mg once daily.
• Your 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.
• Your 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.
• 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 usual starting dose is 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 slowly.

Overdose of Piramil 10 mg
In case of overdose, seek immediate medical advice from a doctor or go to the nearest hospital. The patient should not drive but ask someone else to drive or call an ambulance. Take the medicine packaging with you 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 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, treatment with this medicine must be discontinued and the doctor must be contacted 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, contact your doctor 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 more frequent 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 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 its 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).
• 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"), symptoms of which include abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dry mouth.
• Increased daytime urine output.
• Excessive sweating.
• Loss or decreased 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 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 coldness of the 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 fewer than 1 in 10,000 people)

• Hypersensitivity 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 the 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 your 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.
• Change in color 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 reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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 10 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.
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
Do not dispose of medicines 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 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 starch, corn starch.

What Piramil 10 mg looks like and contents of the pack
White, elongated, biconvex tablets with a score line on both sides and engraved with the
marking "R 10" 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 sizes: 30 and 60 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
ul. 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.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
German Marketing Authorisation number (country of export): 53329.04.00
Parallel Import Authorisation number: 336/20