Delmuno 2,5

Leaflet accompanying the packaging: information for the user

Delmuno 2.5, 2.5 mg + 2.5 mg, film-coated tablets

Delmuno 5, 5 mg + 5 mg, film-coated tablets

Ramipril + Felodipine

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

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Table of contents of the leaflet

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

1. What is Delmuno and what is it used for

Delmuno contains two active substances: ramipril and felodipine.

• Ramipril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by blocking the production of substances that increase blood pressure and by relaxing and widening blood vessels.
• Felodipine belongs to a group of medicines called calcium antagonists. It works by relaxing and widening blood vessels, which helps to lower blood pressure.

Delmuno is used to treat high blood pressure (essential hypertension) in patients who are already taking the same doses of ramipril or felodipine as contained in Delmuno.

2. Important information before taking Delmuno

When not to take Delmuno:

• ramipril or any other ACE inhibitor;
• felodipine or any other dihydropyridine derivative (a group of medicines);
• any of the other ingredients of this medicine (listed in section 6);
• in patients with hemodynamically significant stenosis of the heart valves;
• in patients with dynamic stenosis of the outflow tract from the heart;

Avoid concomitant use of Delmuno and extracorporeal therapeutic procedures such as dialysis or hemofiltration using certain high-flux membranes (e.g., polyacrylonitrile) and low-density lipoprotein apheresis using dextran sulfate. Do not take Delmuno if any of the above conditions apply to the patient. In case of doubts, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Before starting Delmuno, discuss it with your doctor or pharmacist. Be cautious in the following cases:

• If the patient is taking any of the following medicines, as the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.
• In case of "angioedema", the medicine should be discontinued immediately (see "When not to take Delmuno"). The risk of angioedema may also increase when used concomitantly with other medicines that can cause angioedema.
• If the patient has concomitant heart failure, hypertensive nephropathy, kidney problems, or post-kidney transplant, monitoring of kidney function is recommended.
• If the patient has kidney problems or diabetes.
• If the patient is taking medicines that increase potassium levels (potassium-sparing diuretics, potassium supplements, including salt substitutes, or other medicines that may increase potassium levels). The doctor may recommend regular blood tests, especially to measure potassium levels in the blood. The use of potassium-sparing diuretics, potassium supplements, and other medicines that increase potassium levels in the blood increases the risk of hyperkalemia (high potassium levels) and is therefore not recommended during treatment with Delmuno.

The 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 Delmuno". In case of doubts whether any of the above conditions apply to the patient, consult a doctor or pharmacist before starting treatment with this medicine. Patients treated with Delmuno may be advised by their doctor to have regular blood tests to measure sodium levels.

Delmuno and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription, including herbal preparations. This is important because Delmuno may affect the action of other medicines, and some medicines may affect the action of Delmuno.

The following medicines are not recommended for concomitant use with Delmuno:

• potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection, and heparin, used to thin the blood to prevent clots) - concomitant use of these medicines requires close monitoring of potassium levels in the blood;
• phenytoin, carbamazepine, and barbiturates. These medicines are usually used to treat epilepsy and seizures. Barbiturates are also used to treat sleep disorders;
• rifampicin, used to treat tuberculosis;
• St. John's wort preparations;
• macrolide antibiotics (erythromycin), telithromycin, azole derivatives (itraconazole, ketoconazole) - used to treat infections;
• HIV protease inhibitors - medicines used to treat HIV infection;
• aliskiren (used to treat high blood pressure) - the use of Delmuno with aliskiren is contraindicated in patients with diabetes or moderate to severe kidney problems (see "When not to take Delmuno") and is not recommended in other patients;
• angiotensin II receptor antagonists (medicines used to treat high blood pressure). The use of Delmuno and angiotensin II receptor antagonists is contraindicated in patients with kidney problems associated with diabetes (see "When not to take Delmuno") and is not recommended in other patients.

Caution is advised when concomitantly using Delmuno with the following medicines:

• blood pressure-lowering medicines (antihypertensive medicines) and other medicines that lower blood pressure (nitrates, antipsychotic medicines, opioids, and anesthetics);
• procainamide, used to treat heart rhythm disorders;
• heparin, used to thin the blood;
• lithium preparations, used to treat mania, depression, and manic-depressive illness;
• theophylline, used to treat asthma;
• adrenergic agonists, such as adrenaline or noradrenaline (medicines that can affect the heart or blood vessels);
• allopurinol, used to treat gout;
• non-steroidal anti-inflammatory medicines (NSAIDs) - used to relieve pain and inflammation;
• immunosuppressive medicines - used to treat rheumatoid arthritis or after organ transplantation;
• tacrolimus - a medicine given to prevent transplant rejection, e.g., of a kidney or liver;
• cytostatics - used to treat cancer and other medicines that can affect blood counts;
• insulin, sulfonylurea derivatives (glibenclamide), metformin, wildagliptin, and other medicines used to treat diabetes;
• corticosteroids;
• desensitizing medicines - reducing allergy to bee or wasp venom;
• wildagliptin (used to treat diabetes);
• racecadotril (a medicine used to treat diarrhea);
• temsirolimus, sirolimus, everolimus (used to prevent transplant rejection and to treat cancer).

The doctor may recommend changing the dose and/or taking other precautions:

• If the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "When not to take Delmuno" and "Warnings and precautions").

In case of doubts whether any of the above medicines are relevant to the patient, consult a doctor or pharmacist before starting treatment with this medicine.

Delmuno with food and drink

• Taking the medicine with alcohol may enhance its effect.
• It is not recommended to take the medicine with grapefruit juice.
• Increasing the amount of salt in the diet may reduce the effect of the medicine.
• The medicine should be taken on an empty stomach or after a light meal.

Pregnancy and breastfeeding

Do not take Delmuno:

If the patient suspects she may have become pregnant while taking Delmuno, she should contact her doctor immediately.

Driving and using machines

After taking this medicine, dizziness or lightheadedness may occur. In such cases, do not drive vehicles, use tools, or operate machines.

Delmuno contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Delmuno contains macrogolglycerol hydroxystearate (hydrogenated polyoxyethylene castor oil)

The medicine may cause gastrointestinal upset and diarrhea.

Delmuno contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Delmuno

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. Delmuno is intended for use in adults only and should not be given to children.

Method of administration

Oral administration. The tablets should be taken on an empty stomach or after a light meal. The tablets should be swallowed whole, washed down with half a glass of water or other liquid. The tablets should not be divided, crushed, or chewed. The tablets should not be taken with grapefruit juice or alcohol.

Recommended dose

The recommended dose is 1 Delmuno 2.5 tablet or 1 Delmuno 5 tablet taken once a day. The doctor may start treatment with Delmuno 2.5 and then switch to Delmuno 5 to increase the dose. The maximum daily dose is 2 Delmuno 2.5 tablets or 1 Delmuno 5 tablet taken once a day. Patients with mild to moderate liver problems: the doctor may individually adjust the dose based on liver function. Patients with mild to moderate kidney problems: the doctor may individually adjust the dose based on kidney function. Patients taking diuretics: the doctor may individually adjust the dose based on the diuretics taken.

Use in children

Delmuno should not be used in children.

Taking a higher dose of Delmuno than recommended

In case of taking a higher dose of Delmuno than recommended, the doctor or the emergency department of the nearest hospital should be notified immediately. The medicine packaging should be taken along, so the doctor knows which medicine was taken. Dizziness or lightheadedness may occur due to low blood pressure.

Missing a dose of Delmuno

In case of missing a dose, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Delmuno

Treatment should be continued until the doctor decides otherwise. The medicine should not be stopped just because the patient feels better. In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Stop taking Delmuno and contact your doctor immediately if you experience any of the following serious side effects – you may need urgent medical attention:

• 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 Delmuno.
• Severe skin reactions, including rash, ulcers of the mucous membranes, exacerbation of existing skin disease, redness, blistering, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor as soon as possible if you experience:

• Increased heart rate, irregular or forceful heartbeat (palpitations), chest pain, tightness in the chest, or more severe disorders, including heart attack and stroke.
• Shortness of breath or cough. These may be symptoms of lung disorders.
• Easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding from the gums), purple spots, skin discoloration, or more frequent infections, sore throat, and fever, feeling tired, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders.
• Sudden severe abdominal 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 problems, such as hepatitis or liver damage.

Side effects are listed by frequency:

Very common(may affect more than 1 in 10 people):

• Peripheral edema.

Common(may affect up to 1 in 10 people):

• Edema of the hands and feet - may be a sign of fluid accumulation in the body,
• headache or feeling tired,
• dizziness - more likely to occur when starting Delmuno or increasing the dose,
• fainting, low blood pressure (abnormally low blood pressure), especially when standing up quickly from a sitting or lying position,
• sudden flushing (especially of the face),
• dry, persistent cough, sinusitis, or bronchitis, shortness of breath,
• stomach pain or intestinal problems, digestive disorders, diarrhea, nausea, or vomiting,
• skin rash with or without raised patches,
• chest pain,
• muscle cramps or muscle pain,
• increased potassium levels in the blood, as shown by blood tests.

Uncommon(may affect up to 1 in 100 people):

• balance disorders (dizziness of labyrinthine origin),
• itching and abnormal sensations, such as numbness, tingling, prickling, burning, or stinging (paresthesia),
• loss or change of taste,
• sleep disorders, including drowsiness,
• depression, anxiety, increased nervousness or restlessness,
• nasal congestion, difficulty breathing, or worsening of asthma,
• intestinal edema, with symptoms such as abdominal pain, vomiting, and diarrhea,
• abdominal pain, constipation, or dry mouth,
• increased frequency of urination during the day,
• excessive sweating,
• loss or decreased appetite (anorexia),
• rapid or irregular heartbeat,
• low blood pressure,
• blurred vision,
• joint pain,
• fever,
• transient impotence in men and decreased libido in men and women,
• increased white blood cell count of a certain type (eosinophilia), as shown by blood tests,
• liver, pancreas, or kidney function disorders, as shown by blood tests,
• myocardial ischemia, including angina pectoris or heart attack,
• angioedema, most commonly swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash (very rarely may cause airway obstruction and be fatal) or other allergic reactions (hypersensitivity),
• pancreatitis, which can be fatal (very rare cases of fatal pancreatitis have been reported with ACE inhibitors).

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

• feeling of uncertainty or disorientation,
• tremors, balance disorders,
• redness and swelling of the tongue,
• severe skin peeling or blistering, itchy rash with patches,
• nail disorders (e.g., loosening or separation of the nail from the nail bed),
• skin spots and discoloration of the fingers and toes,
• vasculitis,
• redness, itching, swelling, or tearing of the eyes,
• hearing or ringing in the ears,
• weakness,
• decreased red blood cell, white blood cell, or platelet count, or hemoglobin level, as shown by blood tests,
• yellowing of the skin or eyes (jaundice), liver damage,
• decreased potency in men and women.

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

• sensitivity to sunlight,
• gum hypertrophy or gingivitis,
• vasculitis of the skin,
• increased blood sugar levels, as shown by blood tests.

Other side effects(frequency not known - cannot be estimated from available data):

• cerebral ischemia (stroke or transient ischemic attack),
• concentration disorders, slowed or impaired reactions,
• swelling of the mucous membranes of the mouth,
• intestinal obstruction,
• decreased blood cell count, as shown by blood tests (bone marrow failure, pancytopenia), decreased sodium levels in the blood, as shown by blood tests,
• change in finger color when cold and tingling or pain when warming up (Raynaud's phenomenon),
• breast enlargement in men,
• burning sensation,
• change in sense of smell,
• low hemoglobin levels (hemolytic anemia),
• anaphylactic or pseudoanaphylactic reactions (the frequency and severity of anaphylactic or pseudoanaphylactic reactions are increased when ACE inhibitors are used with bee or wasp venom),
• increased antinuclear antibody titers,
• severe skin reactions, including rash, ulcers of the mucous membranes, exacerbation of existing skin disease (psoriasis), psoriatic-like skin inflammation, redness, blistering, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme),
• acute liver failure, hepatitis (rarely fatal),
• decreased potency in men and women.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell 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 181 C, 02-222 Warsaw. Tel.: +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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Delmuno

Store in a temperature below 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging and blisters after "Expiry date". The expiry date refers to the last day of the month stated. 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 packaging and other information

What Delmuno contains

• The active substances of Delmuno are: ramipril and felodipine. One Delmuno 2.5 tablet contains 2.5 mg of ramipril and 2.5 mg of felodipine as active substances. One Delmuno 5 tablet contains 5 mg of ramipril and 5 mg of felodipine as active substances.
• The other ingredients are: yellow iron oxide (E 172), red iron oxide (E 172), hydroxypropylcellulose, hypromellose 5 mPa·s, hypromellose 6 mPa·s, hypromellose 50 mPa·s, hypromellose 10,000 mPa·s, anhydrous lactose, maize starch, microcrystalline cellulose, synthetic paraffin, macrogol 6000, macrogolglycerol hydroxystearate, propyl gallate, silicon dioxide, sodium stearyl fumarate, titanium dioxide (E 171).

What Delmuno looks like and contents of the packaging

Film-coated tablet. The film-coated, round, biconvex, bilayer tablets contain felodipine in a prolonged-release form (gel matrix) in one layer and a rapidly released ramipril in the other layer. The packaging contains 28 tablets.

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH, Brüningstrasse 50, D-65926 Frankfurt am Main, Germany

Manufacturer

Opella Healthcare Hungary Ltd., Manufacturing Site Veresegyhaz, Levai u.5, 2112 Veresegyhaz, Hungary, Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, 37100 Tours, France. For more detailed information, please contact the representative of the marketing authorization holder in Poland: Sanofi Sp. z o.o., ul. Marcina Kasprzaka 6, 01-211 Warsaw, Tel.: +48 22 280 00 00. Date of last revision of the leaflet:June 2024