Piramil 10 mg

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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 trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Piramil 10 mg contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Piramil 10 mg works by:

• reducing the production of substances in the body that can 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 can be used to:

• treat high blood pressure (hypertension),
• reduce the risk of heart attack or stroke,
• reduce the risk of or delay kidney function deterioration (regardless of whether the patient has diabetes),
• treat heart failure (when the heart is not able to pump enough blood for the body),
• treat heart failure after a heart attack.

2. Important information before taking Piramil 10 mg

When not to take Piramil 10 mg

• if the patient is allergic to ramipril, other ACE inhibitors, or any of the ingredients 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 had a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red spots 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 for them.
• if the patient has kidney function disorders with reduced blood flow to the kidneys (renal artery stenosis).
• in the last 6 months of pregnancy(see below "Pregnancy and breastfeeding").
• if the patient's blood pressure is abnormally low or unstable. This needs to be checked 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 these situations apply to the patient, they should not take Piramil 10 mg. In case of doubts, the patient should consult a doctor before taking Piramil 10 mg.

Warnings and precautions

Before taking Piramil 10 mg, the patient should discuss it with their doctor or pharmacist if:

• the patient has heart, liver, or kidney function disorders;
• the patient has lost a lot of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, taking diuretics for a long time, or undergoing dialysis);
• the patient is going to undergo desensitization treatment (e.g., for bee or wasp stings);
• the patient is going to receive anesthesia (for surgery or dental procedures). It may be necessary to stop taking Piramil 10 mg the day before the procedure, so the patient should consult their doctor.
• a test has shown that the patient has a high level of potassium in their blood;
• the patient is taking medicines or has disorders that can cause a decrease in sodium levels in the blood. The doctor may regularly order blood tests to check sodium levels, especially 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 transplant rejection and treat cancer (mTOR inhibitors, e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin and other dipeptidyl peptidase-4 (DPP-4) inhibitors (medicines used to treat type 2 diabetes).
• the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• the patient is taking one of the following blood pressure-lowering medicines:
• angiotensin II receptor antagonist (also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease;
• aliskiren. The doctor will regularly check kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also the information in section "When not to take Piramil 10 mg" and "Warnings and precautions".
• the patient is pregnant (or plans to become pregnant) and must inform their doctor. Taking 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 below "Pregnancy and breastfeeding").

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 been established.
If any of these situations apply to the patient or the patient is unsure, they should consult their doctor before taking Piramil 10 mg.

Piramil 10 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is because Piramil 10 mg and some other medicines may interact with each other.
The patient should inform their doctor if they are taking any of the following medicines, as they may reduce the effect of Piramil 10 mg:

• pain 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, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. The doctor should monitor the patient's blood pressure.

The patient should inform their doctor if they are taking any of the following medicines, as they may increase the risk of side effects when taken with Piramil 10 mg:

• pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid);
• cancer medicines (chemotherapy);
• temsirolimus (a cancer medicine);
• sirolimus, everolimus (medicines used to prevent transplant rejection);
• diuretics, such as furosemide;
• potassium supplements (including salt substitutes containing potassium), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole [medicines used to treat bacterial infections], cyclosporin [a medicine that suppresses the immune system, used to prevent transplant rejection], and heparin [a medicine used to thin the blood and prevent blood clots]);
• corticosteroids, such as prednisolone;
• allopurinol (a medicine used to reduce uric acid levels in the blood);
• procainamide (a medicine used to treat heart rhythm disorders);
• wildagliptin (a medicine used to treat type 2 diabetes);
• racecadotril (an anti-diarrheal medicine).

The doctor may change the dose of Piramil 10 mg and/or recommend other precautions if the patient is taking an angiotensin II receptor antagonist or aliskiren (see also the information in section "When not to take Piramil 10 mg" and "Warnings and precautions").
The patient should inform their doctor if they are taking any of the following medicines, as Piramil 10 mg may affect their action:

• medicines used to treat diabetes (oral and insulin). Piramil 10 mg may lower blood sugar levels. The patient should regularly check their blood sugar levels while taking Piramil 10 mg.
• lithium (used to treat mental illnesses). Piramil 10 mg may increase lithium levels in the blood. The doctor will closely monitor lithium levels in the blood.

If any of these situations apply to the patient or the patient is unsure, they should consult their 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 fainting. Patients who want to know the allowed amount of alcohol during treatment should discuss it with their doctor, as the effects of blood pressure-lowering medicines and alcohol may add up.
• Piramil 10 mg can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or thinks they may be pregnant, they should tell their doctor.
Piramil 10 mg should not be taken during the first 12 weeks of pregnancy and should not be used after the 13th week of pregnancy, as it may seriously harm the baby.
If the patient becomes pregnant while taking Piramil 10 mg, they should immediately inform their doctor. The doctor will suggest switching to a different medicine before planned pregnancy.
Breastfeeding
Piramil 10 mg should not be used during breastfeeding.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Piramil 10 mg may cause dizziness, especially at the beginning of treatment or when the dose is increased. In such cases, the patient should not drive vehicles, operate tools, or machines.

3. How to take Piramil 10 mg

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Piramil 1.25 mg, Piramil 2.5 mg, Piramil 5 mg, and Piramil 10 mg are available on the market.

Taking the medicine

• The medicine should be taken orally, once a day, at the same time.
• The tablets should be swallowed with a liquid.
• The tablets should not be crushed or chewed.

How much to take

Treating high blood pressure

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• Based on blood pressure control, the doctor may adjust the dose of Piramil 10 mg.
• The maximum dose is 10 mg once a day.
• If the patient is already taking a diuretic, the doctor may recommend stopping it or reducing the dose before starting Piramil 10 mg.

Reducing the risk of heart attack or stroke

• The initial dose is usually 2.5 mg once a day.
• The doctor may then increase the dose of Piramil 10 mg.
• The usual dose is 10 mg once a day.

Reducing or delaying kidney function deterioration

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• The doctor may then adjust the dose of Piramil 10 mg.
• The usual dose is 5 mg or 10 mg once a day.

Treating heart failure

• The initial dose is usually 1.25 mg once a day.
• The doctor may then adjust the dose of Piramil 10 mg.
• The maximum dose is 10 mg once a day. It is recommended to take it divided into two doses a day.

Treating heart failure after a heart attack

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• The doctor may then adjust the dose of Piramil 10 mg.
• The maximum dose is 10 mg once a day. It is recommended to take it divided into two doses a day.

Elderly patients
The doctor will reduce the initial dose and increase it more slowly.

Taking more Piramil 10 mg than prescribed

In case of overdose, the patient should consult their doctor or go to the nearest hospital immediately. The patient should not drive a car but ask someone else to drive or call an ambulance. The patient should take the packaging of the medicine with them so that the doctor can see what medicine was taken.

Missing a dose of Piramil 10 mg

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

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Piramil 10 mg can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking Piramil 10 mg and contact their doctor immediately – they may need urgent treatment.

• Swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to this medicine.
• Severe skin reactions, including rash, ulcers in the mouth, worsening of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If the patient experiences any of the following symptoms, they should inform their doctor immediately:

• Increased heart rate, irregular or strong heartbeat (palpitations), chest pain, tightness in the chest, or more serious disorders, including heart attack 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), purplish spots on the skin, or more frequent infections, sore throat, and fever, feeling tired, fainting, dizziness, or paleness of the skin. These may be symptoms of a blood or bone marrow disorder.
• 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, vomiting, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as inflammation or liver damage.

Other side effects

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days.
Frequent(may occur in less than 1 in 10 people)

• Headache or feeling tired.
• Dizziness. This may occur more frequently at the beginning of treatment with Piramil 10 mg or when the dose is increased.
• Fainting, low blood pressure, especially when standing up quickly or sitting up.
• Dry, persistent cough, sinusitis, or bronchitis, shortness of breath.
• Abdominal pain, diarrhea, nausea, vomiting.
• Rash.
• Chest pain.
• Muscle cramps or pain.
• Higher than usual potassium levels in the blood, shown in laboratory tests.

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

• Balance disorders (dizziness of labyrinthine origin).
• Itching of the skin and disorders of sensation in the skin, such as numbness, tingling, prickling, burning, or a feeling of crawling under the skin (paresthesia).
• Loss of or disorders of taste.
• Sleep disorders.
• Depression, anxiety, increased nervousness or restlessness.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Intestinal edema (so-called "angioedema of the intestine"), whose symptoms are abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased urination during the day.
• Excessive sweating.
• Loss of or decreased appetite (anorexia).
• Increased or irregular heartbeat.
• Swelling of the hands and feet. This may be a sign of retaining more fluid than usual.
• Hot flashes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men and women.
• Increased levels of certain white blood cells (eosinophilia) detected in blood tests.
• Blood test results indicating liver, pancreas, or kidney function disorders.

Rare(may occur in less than 1 in 1000 people)

• Feeling disoriented or confused.
• 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).
• Rash or bruising.
• Spots on the skin and discoloration of the extremities.
• Redness, itching, swelling, or tearing of the eyes.
• Hearing or ringing in the ears.
• Feeling weak.
• Decreased levels of red or white blood cells or platelets, or hemoglobin levels in blood tests.

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

• Sensitivity to sunlight.

Other reported side effects

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days.
Side effects with unknown frequency(frequency cannot be estimated from the available data):

• Concentrated urine (dark urine), nausea, or vomiting, muscle cramps, confusion, and convulsions, which may be symptoms of inappropriate antidiuretic hormone (ADH) secretion. If such symptoms occur, the patient should contact their doctor as soon as possible.
• Difficulty concentrating.
• Swelling of the mouth.
• Low levels of certain blood cells detected in blood tests.
• Lower than usual sodium levels in blood tests.
• Change in finger and toe color after cooling and feeling of tingling or pain after warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Disorders of smell.
• Hair loss.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Piramil 10 mg

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should not be stored above 25°C.

Translation of some abbreviations on the blister pack:

Ch.-B./verwendbar bis: see embossing – Batch number/Expiry date: see embossing (on the edge of the blister pack).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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, maize starch, sodium hydrogen carbonate, sodium stearyl fumarate, hypromellose.

What Piramil 10 mg looks like and contents of the pack

• White, oblong, biconvex tablets with a score line on both sides and the inscription "R 10" on one side. The tablet can be divided into two equal doses.
• The tablets are packaged in aluminum/aluminum blisters, in a cardboard box. The packaging contains 30 tablets.

For more detailed information, the patient should consult the marketing authorization holder or the parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 53329.04.00

Parallel import authorization number: 114/18 Date of leaflet approval: 05.04.2023

[Information about the trademark]