Egiramlon

Package Leaflet: Information for the Patient

Egiramlon, 5 mg + 5 mg, Hard Capsules

Egiramlon, 5 mg + 10 mg, Hard Capsules

Egiramlon, 10 mg + 5 mg, Hard Capsules

Egiramlon, 10 mg + 10 mg, Hard Capsules

Ramipril + Amlodipine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet::

• 1. What is Egiramlon and what is it used for
• 2. Important information before taking Egiramlon
• 3. How to take Egiramlon
• 4. Possible side effects
• 5. How to store Egiramlon
• 6. Contents of the pack and other information

1. What is Egiramlon and what is it used for

Egiramlon contains two active substances called ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors), while amlodipine belongs to a group of medicines called calcium antagonists.
Ramipril works by:

• reducing the production of substances in the body that can increase blood pressure,
• relaxing and dilating blood vessels,
• making it easier for the heart to pump blood throughout the body.

Amlodipine works by:

• relaxing and dilating blood vessels, making it easier for blood to flow through them.

Egiramlon can be used to treat high blood pressure (hypertension) in patients whose blood pressure is adequately controlled when taking the individual active substances at the same dose as in this combination product, but in separate preparations.

2. Important information before taking Egiramlon

When not to take Egiramlon

• If you are allergic to ramipril, amlodipine (active substances), other calcium antagonists or ACE inhibitors, or any of the other ingredients of this medicine (listed in section 6). This may be a skin rash, itching, or difficulty breathing.
• If you have a severe narrowing of the aortic valve or are in cardiogenic shock (a condition where the heart is unable to supply the body with enough blood).
• If you have 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 lips, difficulty breathing and swallowing.
• If you are undergoing dialysis or other blood filtration treatment. Depending on the device used, treatment with Egiramlon may not be suitable.
• If you have kidney problems that reduce blood flow to the kidney (renal artery stenosis).
• During the last 6 months of pregnancy (it is also recommended to avoid taking Egiramlon during early pregnancy, see "Pregnancy and breastfeeding" below).
• If you have abnormally low or unstable blood pressure. This must be assessed by your doctor.
• If you have heart failure after a heart attack.
• If you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.
• If you are taking a medicine containing sacubitril/valsartan (for the treatment of heart failure). In this case, the risk of angioedema (a severe allergic reaction) may increase.

If any of the above situations apply to you, do not take Egiramlon. If in doubt, consult your doctor before taking Egiramlon.

Warnings and precautions

Before starting to take Egiramlon, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had any of the following conditions:

• if you are elderly and require a dose increase;
• if you have heart, liver, or kidney problems;
• if you have a significant increase in blood pressure (hypertensive crisis);
• if you have a significant loss of salt or fluids from the body (due to vomiting, diarrhea, excessive sweating, a low-salt diet, prolonged use of diuretics, or dialysis);
• if you are scheduled for desensitization treatment to reduce allergy to bee or wasp stings;
• if you are scheduled for anesthesia - both for surgery and dental procedures. It may be necessary to stop taking Egiramlon the day before anesthesia; consult your doctor;
• if you have high levels of potassium in the blood (detected in a blood test);
• if you are taking medicines that lower sodium levels in the blood or have conditions that can lead to low sodium levels in the blood - your doctor may recommend regular blood tests to check sodium levels in the blood, especially if you are elderly;
• if you are taking medicines called mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), wildagliptin, or racecadotril, as they may increase the risk of angioedema (a severe allergic reaction);
• if you have collagenosis, such as scleroderma or systemic lupus erythematosus;
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan, such as valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also "When not to take Egiramlon".

If any of the above situations apply to you (or if you have any doubts), consult your doctor before taking Egiramlon.

Children and adolescents

Egiramlon should not be used in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

Egiramlon and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. This is necessary because Egiramlon may affect the action of other medicines. Other medicines may also affect the action of Egiramlon.
Tell your doctor about taking any of the following medicines now or recently, as well as planning to take them. These medicines may weaken the action of Egiramlon:

• medicines used to relieve pain and inflammation (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, norepinephrine, or adrenaline - your doctor will monitor your blood pressure;
• rifampicin (an antibiotic used to treat tuberculosis);
• Hypericum perforatum(St. John's Wort used to treat depression).

Tell your doctor about taking any of the following medicines now or recently, as well as planning to take them. These medicines may increase the risk of side effects when taken with Egiramlon. Your doctor may recommend a dose change, take other precautions, or even recommend stopping one of the medicines:

• sacubitril and valsartan - do not take Egiramlon with medicines containing sacubitril + valsartan; if you have taken sacubitril + valsartan, wait 36 hours after the last dose of sacubitril + valsartan before starting to take Egiramlon (see "When not to take Egiramlon"), and after stopping Egiramlon, wait 36 hours after the last dose of Egiramlon before starting to take sacubitril + valsartan:
• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid);
• cancer medicines (used in chemotherapy);
• medicines used to prevent the rejection of a transplanted organ, such as cyclosporine;
• diuretics (such as furosemide);
• medicines that can increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (used to thin the blood);
• corticosteroids, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat heart rhythm disorders);
• temsirolimus (used to treat cancer);
• sirolimus, everolimus (used to prevent the rejection of a transplanted organ);
• wildagliptin (used to treat type 2 diabetes);
• medicines called NEP inhibitors, such as racecadotril (used to treat diarrhea);
• ketokonazole, itraconazole (used to treat fungal infections);
• erythromycin, clarithromycin (antibiotics);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV-infected patients);
• verapamil, diltiazem (used to treat certain heart conditions and high blood pressure);
• dantrolene (used in the treatment of severe body temperature disorders);
• other antihypertensive medicines;
• angiotensin II receptor antagonists (AIIRA) or aliskiren (see also "When not to take Egiramlon" and "Warnings and precautions");
• trimethoprim and cotrimoxazole (used to treat bacterial infections);
• tacrolimus (used to control the immune system's response, allowing the body to accept a transplanted organ).

Tell your doctor about taking any of the following medicines. Egiramlon may affect the action of these medicines:

• antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Egiramlon may lower blood sugar levels. When taking Egiramlon, regularly check your blood sugar levels.
• lithium (used to treat mental disorders). Egiramlon may increase lithium levels in the blood. Your doctor will recommend regular monitoring of lithium levels in the blood.
• sirolimus, temsirolimus, and everolimus (medicines used to modify the immune system's response - mTOR inhibitors). Egiramlon may increase exposure to these medicines.
• cyclosporine (used to modify the immune system's response - an immunosuppressive medicine).
• simvastatin (a cholesterol-lowering medicine).

If any of the above situations apply to you (or if you have any doubts), consult your doctor before taking Egiramlon.

Egiramlon with food, drink, and alcohol

• Egiramlon can be taken before or after a meal.
• Do not drink grapefruit juice or eat grapefruits while taking Egiramlon, as grapefruits and grapefruit juice can increase the levels of the active substance amlodipine in the blood, which may lead to unpredictable and increased blood pressure-lowering effects.
• -Drinking alcohol while taking Egiramlon may cause dizziness or a feeling of "emptiness" in the head. If in doubt about how much alcohol can be consumed while taking Egiramlon, consult your doctor, as blood pressure-lowering medicines and alcohol can enhance each other's sedative effects.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant or think you may be pregnant.
Do not take Egiramlon during the first 12 weeks of pregnancy and do not take it after the 13th week of pregnancy, as it may harm the baby.
If you become pregnant while taking Egiramlon, tell your doctor immediately. If you are planning to become pregnant, your doctor will recommend a different, suitable medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk.
Do not take Egiramlon while breastfeeding.

Driving and using machines

Egiramlon may affect your ability to drive and use machines. If the medicine causes nausea, dizziness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately.

Egiramlon contains colorants

The 5 mg + 5 mg and 10 mg + 5 mg hard capsule shells contain Allura Red AC-FD&C Red 40 (E 129).
The 5 mg + 10 mg and 10 mg + 10 mg hard capsule shells contain azorubine, carmoisine (E 122).
These colorants may cause allergic reactions.

3. How to take Egiramlon

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

• Take the medicine orally, once a day, at the same time, before or after a meal.
• Swallow the capsules whole with a drink of water.
• Do not crush or chew the capsules.
• Do not take Egiramlon with grapefruit juice.

Dosage

• The recommended dose is one capsule of the prescribed strength.
• Depending on the effect achieved, your doctor may adjust the dose.
• The maximum dose is one capsule of 10 mg + 10 mg once a day.

Patients with liver and kidney disease
The dose of Egiramlon may need to be adjusted in case of liver and kidney disease.
Elderly patients
Your doctor will recommend a lower initial dose and will increase the dose more slowly.
Egiramlon should not be used in very elderly or frail patients.
Use in children and adolescents
Egiramlon should not be used in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.
If you feel that the effect of Egiramlon is too strong or too weak, consult your doctor.
It is important not to stop taking the capsules. Do not delay your visit to the doctor until you have finished the capsules.

Taking more than the prescribed dose of Egiramlon

Taking too much of the medicine can cause a significant and potentially dangerous drop in blood pressure. You may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. In the case of a very significant drop in blood pressure, shock may occur. The patient's skin may become cool and moist, and they may lose consciousness. Up to 24-48 hours after taking the medicine, shortness of breath may occur due to excess fluid accumulating in the lungs (pulmonary edema).
If you have taken too much Egiramlon, contact your doctor immediately.
Do not drive yourself to the hospital, ask someone to drive you or call an ambulance. Take the medicine packaging with you, so your doctor knows what medicine you have taken.

Missing a dose of Egiramlon

There is no need to worry. If you forget to take a capsule, skip that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Egiramlon

Your doctor will decide how long you should take the medicine. If you stop taking the medicine earlier than recommended by your doctor, your condition may worsen again.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Egiramlon can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Egiramlon and contact your doctor immediately – you may need urgent medical attention:

• Swelling of the face, lips, or throat, causing difficulty swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction to Egiramlon.
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions.

Inform your doctor immediately if you experience:

• Rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more serious disorders, including heart attack or stroke;
• Shortness of breath or cough. These may be symptoms of lung disease;
• Bruising or bleeding easily, prolonged bleeding, bleeding of various types (e.g., bleeding from the gums), red spots on the skin, or an increased tendency to infections, sore throat, and fever, feeling of tiredness, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders;
• Severe abdominal pain that may radiate to the back. This may be a symptom of pancreatitis;
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, vomiting, or yellowing of the skin and eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage.

Other side effects:

If any of the following side effects get worse or last longer than a few days, tell your doctor.
Very common(may affect up to 1 in 10 people)

• Swelling (fluid retention)

Common(may affect up to 1 in 10 people)

• Drowsiness (especially at the start of treatment)
• Palpitations (feeling of strong heartbeat), sudden flushing of the face
• Headache, feeling of tiredness or weakness (asthenia)
• Dizziness - more likely to occur when starting to take Egiramlon or when the dose is increased
• Visual disturbances (including double vision)
• Changes in bowel movements (including diarrhea and constipation)
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up quickly or sitting up from a lying position
• Dry, persistent cough, sinusitis, or bronchitis
• Abdominal pain or stomach discomfort, diarrhea, nausea, or vomiting
• Rash with elevated patches or without
• Chest pain
• Muscle cramps or muscle pain
• Swelling of the ankles
• Increased potassium levels in the blood, detected in blood tests

Uncommon(may affect up to 1 in 100 people)

• Mood changes, insomnia
• Tremors
• Ringing in the ears
• Sneezing/ runny nose due to sinusitis
• Hives
• Hair loss
• Rash
• Itching of the skin, skin discoloration
• Urination at night, urinary disorders, increased frequency of urination
• Worsening of kidney function (including kidney failure)
• Pain, malaise
• Back pain
• Weight gain or weight loss
• Discomfort and breast enlargement in men
• Balance disorders (dizziness of labyrinthine origin)
• Itching or abnormal sensations, such as numbness, tingling, prickling, or burning of the skin (paresthesia), reduced pain sensation (hypoesthesia)
• Loss of or altered taste
• Sleep disorders
• Depression, anxiety, increased nervousness, or restlessness
• Nasal congestion or worsening of asthma
• Intestinal edema called "angioedema of the intestine", manifested by abdominal pain, vomiting, and diarrhea
• Heartburn, dryness of the mucous membranes of the mouth
• Abdominal bloating (gastritis)
• Increased urination during the day
• Excessive sweating
• Loss of or decreased appetite (anorexia)
• Accelerated, slowed, or irregular heartbeat
• Swelling of the hands and feet, which may be a sign of fluid retention in the body
• Blurred vision
• Joint pain
• Fever
• Impotence in men, decreased libido in men or women
• Increased levels of a certain type of white blood cell (eosinophilia), detected in a blood test
• Disorders of liver, pancreas, or kidney function, detected in blood tests
• Heart attack

Rare(may affect up to 1 in 1,000 people)

• Feeling of uncertainty or confusion
• Redness and swelling of the tongue
• Severe skin peeling or skin separation, itchy rash with bumps (exfoliative dermatitis)
• Nail disorders (e.g., loosening or separation of the nail plate 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 disorders
• Decreased red blood cell count, white blood cell count, or platelet count, or decreased hemoglobin levels, detected in blood tests
• Vasoconstriction, hypoperfusion, vasculitis

Very rare(may affect up to 1 in 10,000 people)

• Increased blood sugar levels (hyperglycemia)
• Pancreatitis
• Hepatitis, jaundice
• Increased sensitivity to sunlight
• Gingival hyperplasia
• Increased muscle tone
• Vasculitis

Other reported side effects(frequency not known, cannot be estimated from available data)
If any of the following side effects get worse or last longer than a few days, tell your doctor.

• Concentration disorders
• Mouth swelling
• Mouth ulcers
• Decreased blood cell count, detected in blood tests
• Decreased sodium levels in the blood, detected in blood tests
• Change in finger and toe color after exposure to cold, followed by tingling or pain after warming (Raynaud's phenomenon)
• Slowed or impaired reactions
• Burning sensation
• Psoriasis
• Positive antinuclear antibody test results (detected in some blood tests)
• Concentrated urine (dark-colored), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures, which may be due to abnormal antidiuretic hormone (ADH, vasopressin) secretion - if you experience such symptoms, contact your doctor immediately
• Tremors, stiffness, mask-like facial expression, slow movements, and shuffling gait

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Egiramlon

Do not store above 25°C.
Store in the original package to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton {year/month}. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration (e.g., discoloration).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Egiramlon contains

• The active substances are:

Egiramlon, 5 mg + 5 mg, hard capsules
5 mg of ramipril and 5 mg of amlodipine in each capsule.
Egiramlon, 10 mg + 5 mg, hard capsules
10 mg of ramipril and 5 mg of amlodipine in each capsule.
Egiramlon, 5 mg + 10 mg, hard capsules
5 mg of ramipril and 10 mg of amlodipine in each capsule.
Egiramlon, 10 mg + 10 mg, hard capsules
10 mg of ramipril and 10 mg of amlodipine in each capsule.

• Other ingredients are: crospovidone, hypromellose, microcrystalline cellulose, glycerol dibehenate, titanium dioxide (E171) (5 mg + 5 mg, 5 mg + 10 mg, 10 mg + 5 mg, 10 mg + 10 mg), gelatin (5 mg + 5 mg, 5 mg + 10 mg, 10 mg + 5 mg, 10 mg + 10 mg), iron oxide red (E172) (5 mg + 10 mg, 10 mg + 5 mg), brilliant blue FCF-FD&C Blue 1 (E133) (5 mg + 5 mg, 10 mg + 5 mg), Allura Red AC-FD&C Red 40 (E129) (5 mg + 5 mg, 10 mg + 5 mg), carmoisine (E122) (5 mg + 10 mg, 10 mg + 10 mg), indigo carmine-FD&C Blue 2 (E132) (5 mg + 10 mg, 10 mg + 10 mg).

What Egiramlon looks like and contents of the pack

Egiramlon, 5 mg + 5 mg, hard capsules
Hard, gelatin capsules, self-locking, size 2, with an opaque, amethyst-colored (dark pink) body and an opaque, amethyst-colored (dark pink) cap, filled with a white or almost white granulate.
Egiramlon, 5 mg + 10 mg, hard capsules
Hard, gelatin capsules, self-locking, size 0, with an opaque, flesh-colored (light pink) body and an opaque, brown cap, filled with a white or almost white granulate.
Egiramlon, 10 mg + 5 mg, hard capsules
Hard, gelatin capsules, self-locking, size 0, with an opaque, flesh-colored body and an opaque, amethyst-colored (dark pink) cap, filled with a white or almost white granulate.
Egiramlon, 10 mg + 10 mg, hard capsules
Hard, gelatin capsules, self-locking, size 0, with an opaque, brown body and an opaque, brown cap, filled with a white or almost white granulate.
The pack contains 28, 30, 56, 60, 90, or 100 hard capsules in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

PROTERAPIA Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw

Manufacturer

Egiramlon, 5 mg + 5 mg, 5 mg + 10 mg, 10 mg + 5 mg, and 10 mg + 10 mg
EGIS Pharmaceuticals PLC
H-1165 Budapest, Bökényföldi út 118-120.
Hungary
Egiramlon, 5 mg + 5 mg, 10 mg + 5 mg, and 10 mg + 10 mg
EGIS Pharmaceuticals PLC
9900 Körmend Mátyás király utca 65
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Егирамлон 5 mg/5 mg капсули, твърди
Егирамлон 5 mg/10 mg капсули, твърди
Егирамлон 10 mg/5 mg капсули, твърди
Егирамлон 10 mg/10 mg капсули, твърди
Czech Republic
Egiramlon
Hungary
Egiramlon 5 mg/5 mg kemény kapszula
Egiramlon 5 mg/10 mg kemény kapszula
Egiramlon 10 mg/5 mg kemény kapszula
Egiramlon 10 mg/10 mg kemény kapszula
Latvia
Ramlon 5 mg/5 mg cietās kapsulas
Ramlon 5 mg/10 mg cietās kapsulas
Ramlon 10 mg/5 mg cietās kapsulas
Ramlon 10 mg/10 mg cietās kapsulas
Lithuania
Ramlon 5 mg/5 mg kietos kapsulės
Ramlon 5 mg/10 mg kietos kapsulės
Ramlon 10 mg/5 mg kietos kapsulės
Ramlon 10 mg/10 mg kietos kapsulės
Poland
Egiramlon
Slovakia
Egiramlon 5 mg/5 mg
Egiramlon 5 mg/10 mg
Egiramlon 10 mg/5 mg
Egiramlon 10 mg/10 mg

Date of last revision of the package leaflet: 23.06.2022