Ramizek Combi

Leaflet attached to the packaging: patient information

Ramizek Combi, 2.5 mg + 5 mg, hard capsules

Ramizek Combi, 5 mg + 5 mg, hard capsules

Ramizek Combi, 5 mg + 10 mg, hard capsules

Ramizek Combi, 10 mg + 5 mg, hard capsules

Ramizek Combi, 10 mg + 10 mg, hard capsules

Ramipril + Amlodipine

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

• You should keep this leaflet, so that you can read it again if 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ramizek Combi and what is it used for

Ramizek Combi contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). Amlodipine belongs to a group of medicines called calcium channel blockers.
The action of ramipril is based on:

• 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 into the body

The action of amlodipine is based on:

• Relaxing and dilating blood vessels, which makes it easier for blood to flow through these vessels.

Ramizek Combi is used to treat high blood pressure (hypertension) in patients whose blood pressure is adequately controlled when taking ramipril and amlodipine in the same doses as in Ramizek Combi, but in separate preparations.

2. Important information before taking Ramizek Combi

When not to take Ramizek Combi:

• If you are allergic to ramipril, amlodipine (active substances), other ACE inhibitors, or any other calcium channel blockers, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: itching, redness of the skin, or difficulty breathing.
• If you have 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 you have taken or are currently taking sacubitril with valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.
• If you are undergoing dialysis or other blood filtration. Depending on the type of device used, Ramizek Combi may not be suitable for you.
• If you have kidney disease related to reduced blood flow to the kidneys (renal artery stenosis).
• In the last 6 months of pregnancy (see below, "Pregnancy, breastfeeding, and fertility").
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If your blood pressure is very low or unstable. Your doctor will monitor your blood pressure.
• If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body).
• If you have been diagnosed with heart failure after a heart attack.

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

Warnings and precautions

Before starting to take Ramizek Combi, you should discuss it with your doctor, pharmacist, or nurse. You should inform your doctor if any of the following situations apply to you:

• If you have heart, liver, or kidney disease.
• If you have recently had a heart attack
• If you have recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, or prolonged use of diuretics or dialysis).
• If you are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings (allergen immunotherapy).
• If you are to be anesthetized. This may be related to surgery or dental procedures. It may be necessary to stop taking Ramizek Combi the day before the procedure; to get information, you should contact your doctor.
• If you have high potassium levels in the blood (as shown in blood test results).
• If you are taking medicines or have conditions that may lower sodium levels in the blood. Your doctor may order regular blood tests, especially to check sodium levels in the blood, particularly in elderly patients.
• If you have been diagnosed with collagenosis, such as scleroderma or systemic lupus erythematosus.
• If you are taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Ramizek Combi" and "Warnings and precautions".
• You should tell your doctor if you suspect you are pregnant (or may become pregnant). It is not recommended to take Ramizek Combi during the first 3 months of pregnancy, and it may seriously harm the baby after 3 months of pregnancy (see below, "Pregnancy, breastfeeding, and fertility").
• If you have significantly increased blood pressure (hypertensive crisis).
• If it is necessary to increase the dose in elderly patients.
• If you experience a persistent dry cough.
• If your blood pressure does not decrease sufficiently. Medicines in this class are likely to be less effective in black patients.
• If you are taking any of the following medicines, the risk of angioedema may increase:
• Racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent the rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• saxagliptin, a medicine used to treat type 2 diabetes.
• sacubitril in combination with valsartan (sacubitril with valsartan - see section 2 "When not to take Ramizek Combi").

If you experience sudden swelling of the lips and face, tongue and throat, neck, and sometimes also hands and feet, difficulty swallowing or breathing, hives or hoarseness ("angioedema"). These may be symptoms of a severe allergic reaction. Such a reaction can occur at any time during treatment, and the risk of its occurrence is higher in black patients. If such symptoms occur, you should immediately inform your doctor.

Children and adolescents

Ramizek Combi should not be used in children and adolescents under 18 years of age due to the lack of data on this population.

Ramizek Combi and other medicines

You should 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.
You should tell your doctor about taking any of the following medicines. These medicines may reduce the effectiveness of Ramizek Combi:

• Pain-relieving and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or 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)
• St. John's Wort (used to treat depression).

You should tell your doctor about taking any of the following medicines. They may increase the risk of side effects when taken with Ramizek Combi:

• sacubitril in combination with valsartan - used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Ramizek Combi"),
• erythromycin, clarithromycin (antibiotics)
• anticancer medicines (chemotherapy)
• medicines belonging to the class of mTOR inhibitors; e.g., temsirolimus, everolimus, sirolimus, tacrolimus (used to treat certain types of cancer or to prevent the rejection of transplanted organs) ⦁ tacrolimus (used to control the body's immune response, allowing the body to accept a transplanted organ). See the "Warnings and precautions" section.
• cyclosporine, an immunosuppressive medicine used to prevent the rejection of transplanted organs
• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid)
• diuretics (diuretics), such as furosemide
• medicines that increase potassium levels in the blood, such as: spironolactone, triamterene, amiloride, potassium supplements (including salt substitutes), trimethoprim used alone or in combination with sulfamethoxazole (used to treat bacterial infections) and heparin (a blood thinner),
• corticosteroid anti-inflammatory medicines, such as prednisolone
• allopurinol (a medicine used to reduce uric acid levels in the blood)
• procainamide (a medicine used to treat heart rhythm disorders)
• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection)
• verapamil, diltiazem (medicines used to treat heart rhythm disorders or high blood pressure)
• dantrolene (a medicine given by infusion in case of severe body temperature disorders).
• saxagliptin (used to treat type 2 diabetes.) See the "Warnings and precautions" section,
• racecadotril (used to treat diarrhea) See the "Warnings and precautions" section,

Your doctor may need to change the dose and/or take other precautions:
If you are taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the heading "When not to take Ramizek Combi" and "Warnings and precautions".
You should tell your doctor about taking any of the following medicines. Ramizek Combi may affect their action:

• medicines used to treat diabetes, such as oral anti-diabetic medicines and insulin. Ramizek Combi may lower blood sugar levels. You should carefully monitor your blood sugar levels while taking Ramizek Combi.
• lithium (a medicine used to treat mental disorders). Ramizek Combi may increase lithium levels in the blood. Your doctor will carefully monitor your lithium levels.
• simvastatin (a medicine that lowers cholesterol). Ramizek Combi may increase simvastatin levels in the blood.

If you are taking any of the above medicines (or are unsure about this), you should consult your doctor before taking Ramizek Combi.

Taking Ramizek Combi with food, drink, and alcohol

Ramizek Combi can be taken with or without food.
Drinking alcohol while taking Ramizek Combi may cause dizziness or drowsiness; if you have any doubts about the amount of alcohol allowed while taking Ramizek Combi, you should consult your doctor, as the effects of blood pressure-lowering medicines and alcohol add up.
People taking Ramizek Combi should not consume grapefruits or grapefruit juice. This is because grapefruits and grapefruit juice can cause an increase in the level of the active substance amlodipine in the blood, which may lead to unpredictable intensification of the action of Ramizek Combi, lowering blood pressure.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ramizek Combi should not be taken during the first 12 weeks of pregnancy and should not be taken from the 13th week of pregnancy, as taking it during pregnancy may harm the baby..
If you become pregnant while taking Ramizek Combi, you should immediately inform your doctor. If you are planning to become pregnant, your doctor will change this medicine to alternative treatment.
Breastfeeding
Ramizek Combi should not be taken during breastfeeding.
Before taking any medicine, you should consult your doctor or pharmacist.
Fertility
There is not enough data on the potential impact of the medicine on fertility.

Driving and using machines

Ramizek Combi may affect your ability to drive or use machines. If Ramizek Combi causes you to feel nauseous, dizzy, or tired, or gives you a headache, you should not drive or use machines; in such a case, you should immediately contact your doctor. Such symptoms may occur especially at the beginning of treatment or when changing medicines.

Ramizek Combi contains sodium

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

3. How to take Ramizek Combi

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
If you feel that the action of Ramizek Combi is too strong or too weak, you should consult your doctor or pharmacist.
The medicine should be taken orally, once a day, at the same time, before or after a meal.
The capsule should be swallowed whole, with a liquid.
You should not take Ramizek Combi with grapefruit juice.
Ramizek Combi should be taken once a day.
Your doctor may adjust the dose depending on your response to the medicine.
The maximum daily dose is one capsule of 10 mg + 10 mg.

Elderly patients

Your doctor will use a lower initial dose and will increase the dose more slowly.

Use in children and adolescents

Ramizek Combi should not be used in children and adolescents under 18 years of age due to the lack of data on this population.

Taking a higher dose of Ramizek Combi than recommended

Taking too many capsules may cause a decrease in blood pressure, even to dangerously low values. You may then feel dizzy, disoriented, or weak; you may also faint. If blood pressure drops severely, shock may develop - the skin will then become cool and clammy, and you may lose consciousness.
If you have taken too many capsules, you should immediately contact your doctor or go to the emergency department of the nearest hospital. You should not drive a vehicle to get to the hospital - you should ask someone else to drive you or call an ambulance. You should take the medicine packaging with you, so that the doctor knows what medicine you have taken.
Even up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Ramizek Combi

If you miss a capsule, you should not take the missed dose. You should take the next dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping treatment with Ramizek Combi

Your doctor will inform you about the duration of treatment. Stopping treatment without your doctor's advice may cause the disease to recur.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, you should stop taking Ramizek Combi and immediately contact your doctor - 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 Ramizek Combi.
• Severe skin reactions, including rash, (ulcers in the mouth, exacerbation of existing skin conditions, redness, blistering, or peeling of the skin (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme). The frequency of these side effects is unknown (cannot be estimated from the available data).

You should immediately inform your doctor if you experience any of the following symptoms:

• Rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, tightness in the chest, or more severe disorders, including heart attack and stroke. These side effects are common (chest pain, tightness in the chest, palpitations) or uncommon (rapid heartbeat, heart attack, or stroke).
• Sudden wheezing, shortness of breath, or difficulty breathing. These are common side effects that may be symptoms of lung disease.
• Easy bruising, longer-than-usual bleeding time, any signs of bleeding (e.g., bleeding from the gums), purple spots on the skin, bruising, 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. These side effects have an unknown frequency.
• Severe abdominal pain, which may radiate to the back. This may be a symptom of pancreatitis. This is an uncommon side effect.
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver disorders, such as inflammation or liver damage. These are very rare side effects.

Other side effects:
You should inform your doctor if any of the following symptoms worsen or persist for more than a few days.
Very common side effects: occurring in at least 1 in 10 patients

• Swelling (fluid retention)

Common side effects (may occur in up to 1 in 10 people):

• Drowsiness, dizziness (especially at the beginning of treatment)
• Palpitations (perceptible heartbeat), sudden flushing (especially of the face)
• Swelling of the ankles, visual disturbances, double vision
• Headache or feeling tired, weak
• 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, stomach pain or intestinal pain, diarrhea, constipation, indigestion, 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 in blood tests).

Uncommon side effects (may occur in up to 1 in 100 people):

• Mood swings, insomnia
• Tremors, pain, malaise
• Ringing in the ears
• Sneezing/nasal congestion due to sinusitis (rhinitis)
• Heartburn, dryness of the mucous membranes of the mouth
• Hair loss, increased sweating, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate, especially at night, increased frequency of urination
• Impotence, erectile dysfunction in men, decreased libido in men and women
• Discomfort or enlargement of the breasts in men
• Joint pain, back pain
• Weight gain or weight loss
• Balance disorders (dizziness)
• Itching of the skin and unusual sensations on the skin, such as numbness, tingling, prickling, burning, or stabbing (paresthesia), loss of pain sensation
• Hives
• Loss or disturbance of taste
• Depression, anxiety, increased nervousness or restlessness
• Nasal congestion, difficulty breathing, or worsening of asthma
• Intestinal swelling, known as "angioedema of the intestine", whose symptoms are abdominal pain, vomiting, and diarrhea
• Loss or decreased appetite (anorexia)
• Blurred vision
• Fever
• Increased white blood cell count of a certain type (eosinophilia), as shown in blood tests
• Disorders of liver, pancreas, or kidney function, as shown in blood tests.

Rare side effects (may occur in up to 1 in 1,000 people):

• Feeling of uncertainty or confusion
• Redness and swelling of the tongue
• Severe peeling of the skin, itchy rash
• Nail diseases (e.g., loosening or separation of the nail from the nail bed)
• Skin rash or bruising
• Vasculitis, often with skin rash
• Spots on the skin and discoloration of the fingers
• Redness, itching, swelling, or tearing of the eyes
• Hearing disorders
• Decreased red blood cell count, white blood cell count, or platelet count (which may result in unusual bruising or bleeding) or hemoglobin levels, as shown in blood tests

Very rare side effects (may occur in up to 1 in 10,000 people):

• Sensitivity to sunlight
• Increased blood sugar levels (hyperglycemia)
• Gum swelling
• Abdominal bloating (gastritis)
• Disorders of liver function, hepatitis, yellowing of the skin (jaundice)
• Increased muscle tension
• A disorder involving stiffness, tremors, and/or movement disorders

Side effects with an unknown frequency (frequency cannot be estimated from the available data):

• concentrated urine (dark-colored), nausea, or vomiting, muscle cramps, and seizures, which may be due to abnormal secretion of ADH (antidiuretic hormone - vasopressin). If the following symptoms occur, you should immediately consult your doctor
• tremors, stiffness of posture, mask-like face, slow movements, and dragging of the feet while walking

Other observed side effects:
You should inform your doctor if any of the following symptoms worsen or persist for more than a few days.

• Difficulty concentrating
• Swelling of the lips
• Decreased sodium levels in the blood, as shown in blood tests
• Change in the color of the fingers and toes in response to cold, followed by a feeling of tingling or pain in response to heat (Raynaud's phenomenon)
• Slowed or impaired reactions
• Disorders of smell
• Feeling of burning
• Psoriasis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 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 Ramizek Combi

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after: "EXP:".
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Ramizek Combi contains

• The active substances of the medicine are: 2.5 mg + 5 mg, hard capsules: each capsule contains 2.5 mg of ramipril and 5 mg of amlodipine in the form of amlodipine besylate. 5 mg + 5 mg, hard capsules: each capsule contains 5 mg of ramipril and 5 mg of amlodipine in the form of amlodipine besylate. 5 mg + 10 mg, hard capsules: each capsule contains 5 mg of ramipril and 10 mg of amlodipine in the form of amlodipine besylate. 10 mg + 5 mg, hard capsules: each capsule contains 10 mg of ramipril and 5 mg of amlodipine in the form of amlodipine besylate.

10 mg + 10 mg, hard capsules: each capsule contains 10 mg of ramipril and 10 mg of amlodipine in the form of amlodipine besylate.

• The other ingredients of the medicine are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, sodium carboxymethylcellulose (type A), sodium stearyl fumarate, red iron oxide (E 172), titanium dioxide (E 171), gelatin, and for the 10 mg + 10 mg strength: yellow iron oxide (E 172), black iron oxide (E 172).

What Ramizek Combi looks like and contents of the pack

Ramizek Combi, 2.5 mg + 5 mg, hard capsules: hard gelatin capsules, approximately 19 mm in length, cap: opaque, light pink; body: opaque, white. Capsule contents: white or almost white powder.
Ramizek Combi, 5 mg + 5 mg, hard capsules: hard gelatin capsules, approximately 19 mm in length, cap: opaque, pink; body: opaque, white. Capsule contents: white or almost white powder.
Ramizek Combi, 5 mg + 10 mg, hard capsules: hard gelatin capsules, approximately 19 mm in length, cap: opaque, reddish-brown; body: opaque, white. Capsule contents: white or almost white powder.
Ramizek Combi, 10 mg + 5 mg, hard capsules: hard gelatin capsules, approximately 19 mm in length, cap: opaque, dark pink; body: opaque, white. Capsule contents: white or almost white powder.
Ramizek Combi, 10 mg + 10 mg, hard capsules: hard gelatin capsules, approximately 19 mm in length, cap: opaque, brown; body: opaque, white. Capsule contents: white or almost white powder.
Ramizek Combi is available in packs containing 30, 56, 60, 90, 96, 98, or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
IASIS Pharmaceuticals Hellad S.A.
137 Filis Avenue, 134 51 Athens
Greece

This medicinal product has been authorized in the EEA member states under the following names:

Austria
Ramipril/Amlodipin Genericon
Bulgaria
Impactin Duo
Cyprus
RAMI_AMLO
Czech Republic
Ramil Combi
Greece
RAMI-AMLO
Poland
Ramizek Combi
Romania
Ramipril/Amlodipina Adamed
Slovakia
Ramizek
Sweden
Ramipril/Amlodipine Adamed
Italy
DUOTENS

Date of last revision of the leaflet:

• 11.2023