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
Ramiprilum + Amlodipinum
Please read the entire 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Egiramlon is and what it is 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 Egiramlon is and what it is used for

Egiramlon contains two active substances: 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 in the body of substances that may increase blood pressure,
• relaxing and widening blood vessels,
• helping the heart pump blood throughout the body.

Amlodipine works by:

• relaxing and widening blood vessels, allowing blood to flow through them more easily.

Egiramlon may be used for the treatment of high blood pressure (hypertension) in patients whose blood pressure is adequately controlled with the individual active substances given at the same doses as those contained in this fixed combination product, but administered as separate preparations.

2. Important information before using Egiramlon

When not to use Egiramlon

• If the patient is allergic to ramipril, amlodipine (active substances), other calcium channel blockers or ACE inhibitors, or any of the other ingredients of this medicine (listed in section 6). This may include itching, skin redness or difficulty breathing.
• If the patient has significant aortic valve stenosis or is in cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body).
• 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, puffiness around the eyes and lips, difficulty breathing and swallowing.
• If the patient is undergoing dialysis or another type of blood filtration. Depending on the equipment used, treatment with Egiramlon may not be appropriate.
• If the patient has kidney disorders causing reduced blood flow to the kidney (renal artery stenosis).
• During the last 6 months of pregnancy (it is also advisable to avoid using Egiramlon in early pregnancy; see section “Pregnancy and breastfeeding” below).
• If the patient has abnormally low or unstable blood pressure. This must be evaluated by a physician.
• If the patient has heart failure following a heart attack.
• If the patient has diabetes or impaired kidney function and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient is taking a combination medicine containing sacubitril and valsartan (used in heart failure treatment). In such cases, the risk of angioedema – a severe allergic reaction – may increase.

If any of the above situations apply, Egiramlon must not be used. In case of
doubt, consult a doctor before using Egiramlon.
Warnings and precautions
Before starting to take Egiramlon, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has had any of the following conditions:

• if the patient is elderly and requires a dose increase;
• if the patient has heart, liver or kidney disorders;
• if the patient experiences a significant increase in blood pressure (hypertensive crisis);
• if there has been substantial loss of salt or fluids from the body (due to vomiting, diarrhoea, excessive sweating, low-salt diet, prolonged use of diuretics or dialysis);
• if desensitisation treatment is planned to reduce allergy to bee or wasp venom;
• if anaesthesia is planned – both for surgery and dental procedures. It may be necessary to discontinue Egiramlon one day before anaesthesia; consult your doctor;
• if the patient has high potassium levels in the blood (detected in a blood laboratory test);
• if the patient is taking medicines that reduce sodium levels in the blood or has conditions that may cause low sodium levels in the blood – the doctor may recommend regular blood tests to monitor blood sodium levels, especially in elderly patients;
• if the patient is taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin 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:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan, for example valsartan, telmisartan, irbesartan, especially if the patient has kidney disorders related to diabetes;
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels
(e.g. potassium).
See also the section “When not to use Egiramlon”.

• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. Egiramlon is not recommended during the first three months of pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy and breastfeeding”).

If any of the above situations apply to the patient (or if there are any doubts), consult a doctor before
using Egiramlon.
Children and adolescents
Egiramlon is not recommended for use in children and adolescents under 18 years of age due to lack
of data on safety and efficacy.
Egiramlon 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 necessary because Egiramlon may affect the action of other medicines. Likewise, other medicines may affect the action of Egiramlon.
Inform your doctor if you are currently or recently taking, or plan to take, 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).

Inform your doctor if you are currently or recently taking, or plan to take, any of the following medicines. These medicines may increase the likelihood of adverse effects when taken together with Egiramlon. The doctor may recommend changing the dose, taking other precautions or even discontinuing one of the medicines:

• sacubitril and valsartan – Egiramlon must not be taken with medicines containing sacubitril + valsartan; if the patient has taken sacubitril + valsartan, wait 36 hours after the last dose of sacubitril + valsartan before starting Egiramlon (see “When not to use Egiramlon”), and after stopping Egiramlon, wait 36 hours after the last dose of Egiramlon before starting 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 rejection of transplanted organs, such as cyclosporine;
• diuretics (water tablets), such as furosemide;
• medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts and heparin (used to thin the blood);
• corticosteroid anti-inflammatory medicines, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used for heart rhythm disorders);
• temsirolimus (used in the treatment of malignant tumours);
• sirolimus, everolimus (used to prevent rejection of transplanted organs);
• vildagliptin (used in the treatment of type 2 diabetes);
• medicines called neprilysin inhibitors (NEP), such as racecadotril (used to treat diarrhoea);
• ketoconazole, itraconazole (used to treat fungal infections);
• erythromycin, clarithromycin (antibiotics);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV-infected patients);
• verapamil, diltiazem (used to treat certain heart diseases and high blood pressure);
• dantrolene (used intravenously for serious temperature disorders);
• other antihypertensive medicines;
• angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also sections “When not to use Egiramlon” and “Warnings and precautions”);
• trimethoprim and cotrimoxazole (used to treat bacterial infections);
• tacrolimus (used to control immune system reactions, allowing the body to accept a transplanted organ).

Inform your doctor if you are taking any of the following medicines. Egiramlon may affect the action of these medicines:

• antidiabetic medicines, such as oral glucose-lowering agents and insulin. Egiramlon may lower blood glucose levels. Blood sugar levels should be monitored regularly during treatment with Egiramlon.
• lithium (used to treat psychiatric disorders). Egiramlon may increase lithium levels in the blood. The doctor will recommend regular monitoring of blood lithium levels.
• sirolimus, temsirolimus and everolimus (medicines used to modify immune system activity – so-called mTOR inhibitors). Egiramlon may increase exposure to these medicines.
• cyclosporine (used to modify immune system activity – an immunosuppressant).
• simvastatin (a medicine that lowers cholesterol levels).

If any of the above situations apply to the patient (or if there are any doubts), consult a doctor before
using Egiramlon.
Egiramlon with food, drink and alcohol

• Egiramlon can be taken before or after meals.
• While taking Egiramlon, do not drink grapefruit juice or eat grapefruits, as grapefruit and grapefruit juice may increase the plasma concentration of the active substance
• amlodipine, potentially causing unpredictable intensification of the blood pressure-lowering effect of Egiramlon.
• Drinking alcohol while taking Egiramlon may cause dizziness or a feeling of “emptiness” in the head. In case of doubt about how much alcohol may be consumed while taking Egiramlon, consult your doctor, as medicines used to lower blood pressure and alcohol may mutually enhance their sedative effects.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a
child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you are pregnant or suspect you may be pregnant.
Do not use Egiramlon during the first 12 weeks of pregnancy and must not be used after the 13th
week of pregnancy, as its use may harm the unborn child.
Inform your doctor immediately if you become pregnant while taking Egiramlon. If planning pregnancy, your doctor will recommend using another suitable medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk.
Do not take Egiramlon while breastfeeding.
Driving and operating machinery
Egiramlon may affect the ability to drive and operate machinery. If the medicine causes nausea, dizziness, fatigue or headache, do not drive or operate machinery and contact your doctor immediately.
Egiramlon contains colouring agents
The hard capsule shell of the 5 mg + 5 mg and 10 mg + 5 mg strengths contains Allura Red AC-FD&C Red 40 (E 129).
The hard capsule shell of the 5 mg + 10 mg and 10 mg + 10 mg strengths contains azorubine, carmoisine (E 122).
These colouring agents may cause allergic reactions.

3. How to take Egiramlon

This medicine should always be taken as advised by your doctor. If in doubt, consult your doctor or pharmacist.

Method of administration

• This medicine should be taken orally, at the same time each day, either before or after a meal.
• Capsules should be swallowed whole with liquid.
• Do not crush or chew the capsules.
• Do not take Egiramlon with grapefruit juice.

Dosage

• The recommended dose is 1 capsule at the strength prescribed by your doctor.
• Depending on the response, your doctor may adjust the dose.
• The maximum dose is 1 capsule of 10 mg + 10 mg once daily.

Patients with liver or kidney disease
Dosage may need to be adjusted in patients with liver or kidney disease.
Elderly patients
Your doctor may prescribe a lower starting dose and increase it gradually.
Egiramlon is not recommended for use in very elderly or severely debilitated patients.
Use in children and adolescents
Egiramlon is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy.

If you feel the medicine's effect is too strong or too weak, consult your doctor.
It is important not to interrupt treatment. Do not delay your doctor's visit until the capsules are used up.

Taking more Egiramlon than recommended
Taking too high a dose may cause significant, even dangerous, lowering of blood pressure. Symptoms may include dizziness, a sensation of "emptiness" in the head, fainting, or weakness. In cases of severe hypotension, shock may occur.
The patient's skin may become cold and clammy, and loss of consciousness may occur.
Breathlessness due to fluid accumulation in the lungs (pulmonary oedema) may occur up to 24–48 hours after taking the medicine.
If an overdose of Egiramlon is taken, seek medical advice immediately.
Do not drive yourself to hospital—ask someone to drive you or call an ambulance. Bring the medicine packaging with you so the doctor knows which medicine has been taken.

If you forget to take Egiramlon
There is no cause for concern. If you forget to take a capsule, simply skip the missed dose. Take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Egiramlon
Your doctor will determine how long you should take the medicine. If you stop taking the medicine earlier than advised, your condition may return.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If any of the following severe adverse symptoms occur, stop taking Egiramlon immediately
and seek medical advice without delay – urgent medical treatment may be required:

• Swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with skin itching and rash. These may be symptoms of a severe allergic reaction to Egiramlon.
• Severe skin reactions, including intense rash, urticaria, redness of the entire skin surface, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.

Contact your doctor immediately if any of the following occur:

• Rapid heartbeat, irregular or forceful heartbeats (palpitations), chest pain, feeling of chest tightness, or more serious disturbances, including heart attack or stroke;
• Shortness of breath or cough. These may be symptoms of lung disease;
• Easy bruising, prolonged bleeding time, various types of bleeding (e.g. bleeding gums), red spotted petechiae on the skin, or increased susceptibility to infections, sore throat and fever, feeling of fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders;
• Severe upper abdominal pain that 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:
If any of the following adverse effects worsen or persist for more than a few days, inform your doctor.
Very common (may affect at least 1 in 10 patients)

• Fluid retention (oedema)

Common (may affect less than 1 in 10 patients)

• Drowsiness (particularly at the beginning of treatment)
• Palpitations (sensation of forceful heartbeat), sudden flushing of the face
• Headache, feeling of fatigue or weakness (asthenia)
• Dizziness – more likely to occur at the beginning of Egiramlon treatment or after dose increase
• Visual disturbances (including double vision)
• Changes in bowel habits (including diarrhoea and constipation)
• Fainting, hypotension (abnormally low blood pressure), especially upon rapid standing or sitting up from a lying position
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath
• Stomach or abdominal pain, diarrhoea, indigestion, nausea or vomiting
• Skin rash with or without raised lesions
• Chest pain
• Muscle cramps or pain
• Swelling around the ankles
• Increased blood potassium levels, detected in blood tests

Uncommon (may affect less than 1 in 100 patients)

• Mood changes, insomnia
• Tremor
• Tinnitus (ringing in the ears)
• Sneezing/runny nose due to inflammation of the nasal lining (rhinitis)
• Urticaria
• Hair loss
• Rash
• Itching, skin discoloration
• Nocturia (urination at night), urinary disturbances, increased frequency of urination
• Worsening kidney function (including kidney failure)
• Pain, malaise
• Back pain
• Increase or decrease in body weight
• Discomfort and enlargement of the breast in men
• Balance disorders (vestibular dizziness)
• Itching or unusual sensory sensations such as numbness, tingling, pricking, burning or creeping sensations on the skin (paresthesia), reduced pain sensation (hypoesthesia)
• Loss or change of taste
• Sleep disturbances
• Depressed mood, anxiety, increased nervousness or restlessness
• Nasal congestion or worsening of asthma
• Intestinal swelling known as “intestinal angioedema”, presenting with abdominal pain, vomiting and diarrhoea
• Heartburn, dryness of the oral mucosa
• Abdominal bloating (gastrointestinal distension)
• Passing larger amounts of urine than usual during the day
• Excessive sweating
• Loss or reduced appetite (anorexia)
• Rapid, slow or irregular heartbeat
• Swelling of hands and feet, which may be a sign of fluid retention
• Blurred vision
• Joint pain
• Fever
• Impotence in men, decreased libido in men or women
• Increased number of certain types of white blood cells (eosinophilia), detected in blood laboratory tests
• Liver, pancreas or kidney function abnormalities, detected in blood laboratory tests
• Heart attack

Rare (may affect less than 1 in 1000 patients)

• Feeling of uneasiness or confusion
• Redness and swelling of the tongue
• Severe peeling or shedding of skin, itchy nodular rash (exfoliative dermatitis)
• Nail disorders (e.g. loosening or separation of the nail plate from the nail bed)
• Skin rash or bruising
• Skin spots and cold extremities
• Redness, itching, swelling or watering of the eyes
• Hearing disturbances
• Decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin concentration, detected in blood laboratory tests
• Vasoconstriction, hypoperfusion, vasculitis

Very rare (may affect less than 1 in 10,000 patients)

• Increased blood sugar levels (hyperglycaemia)
• Pancreatitis
• Hepatitis, yellowing of the skin (jaundice)
• Photosensitivity (increased sensitivity to sunlight)
• Gingival hyperplasia (overgrowth of the gums)
• Increased muscle tone
• Vasculitis

Other reported adverse effects (frequency unknown, cannot be estimated from available data)
If any of the following adverse effects worsen or persist for more than a few days, inform your doctor.

• Concentration disturbances
• Oral cavity oedema
• Inflammation of the oral mucosa with small ulcers
• Decreased number of blood cells, detected in blood laboratory tests
• Decreased sodium concentration in blood, detected in blood laboratory tests
• Colour change of fingers of hands and feet upon cold exposure, followed by tingling or pain upon warming (Raynaud's phenomenon)
• Slowed or impaired reactions
• Burning sensation
• Psoriasis
• Positive antinuclear antibody titre (detected in certain blood tests)
• Concentrated (dark-coloured) urine, nausea or vomiting, muscle cramps, confusion and seizures, which may result from inappropriate antidiuretic hormone (ADH, vasopressin) secretion – if such symptoms occur, seek medical advice immediately
• Tremor, rigidity, facial masking, slowed movements and shuffling gait, unsteady walking

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this 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 stated month.
Do not use this medicine if visible signs of deterioration are observed (e.g. discoloration).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 ramipril and 5 mg amlodipine in each capsule.
Egiramlon, 10 mg + 5 mg, hard capsules
10 mg ramipril and 5 mg amlodipine in each capsule.
Egiramlon, 5 mg + 10 mg, hard capsules
5 mg ramipril and 10 mg amlodipine in each capsule.
Egiramlon, 10 mg + 10 mg, hard capsules
10 mg ramipril and 10 mg amlodipine in each capsule.

• Other components are: crospovidone, hypromellose, microcrystalline cellulose, glyceryl 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), indigotine-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, self-sealing Coni Snap-type capsules, unmarked, size 2, with an opaque amethyst-coloured (dark pink) body and an opaque amethyst-coloured (dark pink) cap, filled with white or almost white granules.
Egiramlon, 5 mg + 10 mg, hard capsules
Hard, gelatin, self-sealing Coni Snap-type capsules, unmarked, size 0, with an opaque flesh-coloured (light pink) body and an opaque chestnut-coloured cap, filled with white or almost white granules.
Egiramlon, 10 mg + 5 mg, hard capsules
Hard, gelatin, self-sealing Coni Snap-type capsules, unmarked, size 0, with an opaque flesh-coloured body and an opaque amethyst-coloured (dark pink) cap, filled with white or almost white granules.
Egiramlon, 10 mg + 10 mg, hard capsules
Hard, gelatin, self-sealing Coni Snap-type capsules, unmarked, size 0, with an opaque chestnut-coloured body and an opaque chestnut-coloured cap, filled with white or almost white granules.
The pack contains 28, 30, 56, 60, 90 or 100 hard capsules in blisters within a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PROTERAPIA Spółka z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Poland

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 authorised 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