Egiramlon

Leaflet accompanying the packaging: patient information

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 leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 the patient is 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 itching, redness of the skin, or difficulty breathing.
• If the patient has a significant narrowing of the aortic valve or is in cardiogenic shock (a condition in which the heart is unable to supply the body with enough blood).
• If the patient has ever had a severe allergic reaction called angioedema. Its 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 the patient is undergoing dialysis or other blood filtration. Depending on the device used, treatment with Egiramlon may not be suitable.
• If the patient has 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 the patient has abnormally low or unstable blood pressure. This must be assessed by a doctor.
• If the patient has heart failure after a heart attack.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient is taking a combination medicine containing sacubitril and valsartan (for the treatment of heart failure). In this case, the risk of angioedema may increase - a severe allergic reaction.

If any of the above situations apply to the patient, they should not take Egiramlon. In case of doubts, before taking Egiramlon, they should consult a doctor.

Warnings and precautions

Before starting to take Egiramlon, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor if they have or have had any of the following conditions:

• if the patient is elderly and requires a dose increase;
• if the patient has heart, liver, or kidney problems;
• if the patient has experienced a significant increase in blood pressure (hypertensive crisis);
• if there has been 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 desensitization treatment is planned to reduce allergy to bee or wasp venom;
• if anesthesia is planned - both for surgery and dental procedures. It may be necessary to stop taking Egiramlon the day before anesthesia; the patient should consult their doctor;
• if the patient has a high potassium level in the blood (detected in a blood test);
• if the patient is taking medicines that lower sodium levels in the blood or has conditions that may lead to low sodium levels in the blood - the doctor may recommend regular blood tests to check sodium levels in the blood, especially in elderly patients;
• if the patient is 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 the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan, e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes;
• aliskiren.

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

If any of the above situations apply to the patient (or in case of any doubts), before taking Egiramlon, they should consult a doctor.

Children and adolescents

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

Egiramlon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. This is necessary because Egiramlon may affect the action of other medicines. Other medicines may also affect the action of Egiramlon.
The patient should tell their doctor about taking any of the following medicines. These medicines may weaken the effect 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, noradrenaline, or adrenaline - the doctor will monitor blood pressure;
• rifampicin (an antibiotic used to treat tuberculosis);
• Hypericum perforatum(St. John's Wort used to treat depression).

The patient should tell their doctor about taking any of the following medicines. These medicines may increase the likelihood of side effects when taken with Egiramlon. The doctor may recommend a dose change, take other precautions, or even recommend stopping one of the medicines:

• sacubitril and valsartan - Egiramlon should not be taken with medicines containing sacubitril + valsartan; if the patient has taken sacubitril + valsartan, they should 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, they should 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);
• anticancer medicines (used in chemotherapy);
• medicines used to prevent the rejection of a transplanted organ, such as cyclosporine;
• diuretics (e.g., furosemide);
• medicines that may 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 malignant tumors);
• sirolimus, everolimus (used to prevent the rejection of a transplanted organ);
• wildagliptin (used to treat type 2 diabetes);
• medicines called neprilysin inhibitors (NEP), 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 diseases and high blood pressure);
• dantrolene (used in infusion for severe body temperature disorders);
• other antihypertensive medicines;
• angiotensin II receptor antagonists (AIIRA) or aliskiren (see also the "When not to take Egiramlon" and "Warnings and precautions" subsections);
• 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).

The patient should tell their 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. During treatment with Egiramlon, blood sugar levels should be regularly checked.
• lithium (used to treat mental disorders). Egiramlon may increase lithium levels in the blood. The doctor will recommend regular checks 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 medicine used to lower cholesterol levels).

If any of the above situations apply to the patient (or in case of any doubts), before taking Egiramlon, they should consult a doctor.

Egiramlon with food, drink, and alcohol

• Egiramlon can be taken before or after a meal.
• While taking Egiramlon, the patient should not drink grapefruit juice or eat grapefruits, as grapefruits and grapefruit juice may lead to an increase in the level of the active substance amlodipine in the blood, which may cause unpredictable intensification of Egiramlon's blood pressure-lowering effect.
• -Drinking alcohol while taking Egiramlon may cause dizziness or a feeling of "emptiness" in the head. In case of doubts about how much alcohol can be consumed while taking Egiramlon, the patient should consult a doctor, as blood pressure-lowering medicines and alcohol may enhance each other's sedative effects.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she is pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The patient should tell her doctor if she is pregnant or suspects she is pregnant.
Egiramlon should not be taken during the first 12 weeks of pregnancy and should not be taken after the 13th week of pregnancy, as it may harm the fetus.
The patient should immediately tell her doctor if she becomes pregnant while taking Egiramlon. If pregnancy is planned, the doctor will recommend taking a different, suitable medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk.
Egiramlon should not be taken during breastfeeding.

Driving and using machines

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

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

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.

Method of administration

• The medicine should be taken orally, once a day, at the same time, before or after a meal.
• The capsules should be swallowed whole with a liquid.
• The capsules should not be crushed or chewed.
• Egiramlon should not be taken with grapefruit juice.

Dosage

• The recommended dose is 1 capsule of the prescribed strength.
• Depending on the effect achieved, the doctor may adjust the dose.
• The maximum dose is 1 capsule of 10 mg + 10 mg per day.

Patients with liver and kidney disease
The dose of the medicine may be adjusted in case of liver and kidney disease.
Elderly patients
The doctor will recommend a lower initial dose and will increase the dose more slowly.
Egiramlon should not be taken by patients who are very elderly or frail.
Use in children and adolescents
Egiramlon should not be taken by children and adolescents under 18 years of age due to the lack of data on its safety and efficacy.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor.
It is important not to stop taking the capsules. The patient should not delay their doctor's visit until the capsules are finished.

Taking a higher dose of Egiramlon than recommended

Taking too much of the medicine may cause a significant and potentially dangerous drop in blood pressure. The patient may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. In 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.
Even 24-48 hours after taking the medicine, shortness of breath may occur due to excess fluid accumulating in the lungs (pulmonary edema).
In case of taking too much of the medicine, the patient should immediately consult a doctor.
The patient should not drive a car to the hospital, but should ask someone to drive them or call an ambulance. The patient should take the medicine packaging with them. This will allow the doctor to know what medicine was taken.

Missing a dose of Egiramlon

There is no need to worry. If the patient forgets to take a capsule, they should skip that dose and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Egiramlon

The doctor will decide how long the patient should take the medicine. If the patient stops taking the medicine earlier than recommended by the doctor, the disease may recur.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

In case of any of the following serious side effects, the patient should stop taking Egiramlon and immediately consult a doctor - emergency medical attention may be necessary:

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, as well as itching of the skin and rash. These may be symptoms of a severe allergic reaction to Egiramlon.
• Severe skin reactions, including severe rash, hives, redness of the skin all over the body, intense 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.

The patient should immediately tell their doctor if they experience:

• Increased heart rate, 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;
• Easy bruising, prolonged bleeding, bleeding of various types (e.g., bleeding from the gums), red spotted rash on the skin, or 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, yellowing of the skin or 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, the patient should tell their doctor.
Very common(may affect at least 1 in 10 people)

• Edema (fluid retention)

Common(may affect up to 1 in 10 people)

• Drowsiness (especially at the beginning of treatment)
• Palpitations (feeling of strong heartbeat), sudden flushing of the face
• Headache, feeling of tiredness or weakness (asthenia)
• Dizziness - its occurrence is more likely at the beginning of treatment with Egiramlon or after a dose increase
• 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 upset, diarrhea, nausea, or vomiting
• Rash
• 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 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)
• Taste disturbances
• 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 appetite (anorexia)
• Accelerated, slowed, or irregular heart rate
• 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 white blood cell count (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 peeling or separation of skin layers, itchy rash (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 level, 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, yellowing of the skin (jaundice)
• 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, the patient should tell their doctor.

• Concentration disorders
• Oral edema
• 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 freezing, followed by tingling or pain after warming up (Raynaud's phenomenon)
• Slowed or impaired reactions
• Burning sensation
• Psoriasis
• Positive antinuclear antibody test (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 such symptoms occur, the patient should immediately consult a doctor
• Tremors, stiffness, mask-like face, slow movements, and shuffling gait

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their 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 gather more information on the safety of the medicine.

5. How to store Egiramlon

Do not store above 25 °C.
Store in the original packaging 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 the month.
Do not use this medicine if visible signs of deterioration are observed (e.g., discoloration).
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 Egiramlon contains

• The active substances of the medicine 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 a non-transparent, amethyst-colored (dark pink) body and a non-transparent, 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 a non-transparent, flesh-colored (light pink) body and a non-transparent, 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 a non-transparent, flesh-colored body and a non-transparent, 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 a non-transparent, brown body and a non-transparent, brown cap, filled with a white or almost white granulate.
The packaging 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 Spółka 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 leaflet: 23.06.2022