Ramizek combi: detailed information

Package leaflet: Information for the patient

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
Ramiprilum + Amlodipinum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
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

What Ramizek Combi is and what it is used for
Important information before taking Ramizek Combi
How to take Ramizek Combi
Possible side effects
How to store Ramizek Combi
Contents of the pack 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 includes:

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

The action of amlodipine includes:

Relaxing and widening blood vessels, which improves blood flow through these vessels.

Ramizek Combi is used for the treatment of hypertension (high blood pressure) in patients whose blood
pressure is adequately controlled with a combination of ramipril and amlodipine at the same doses as in
Ramizek Combi, but taken as separate preparations.

2. Important information before taking Ramizek Combi

When not to take Ramizek Combi:

If you are allergic to ramipril, amlodipine (the active substances), other medicines in the class of ACE inhibitors, 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, skin redness, or difficulty breathing.
If you have ever had a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red spots on 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 certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat) increases.
If you are undergoing dialysis or another type of blood filtration. Depending on the type of equipment used, Ramizek Combi may not be suitable for you.
If you have kidney diseases associated with reduced blood flow to the kidneys (renal artery stenosis).
During the last 6 months of pregnancy (see below, section "Pregnancy, breastfeeding and fertility").
If you have diabetes or impaired kidney function 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 aortic valve stenosis (narrowing of the aorta) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body).
If heart failure following myocardial infarction has been diagnosed in you.

Do not take Ramizek Combi if any of the above situations apply to you. If in doubt, speak to your doctor before taking Ramizek Combi.
Warnings and precautions
Before starting treatment with Ramizek Combi, discuss this with your doctor, pharmacist, or nurse. Inform your doctor if any of the following situations apply to you:

If you have heart, liver, or kidney diseases.
If you have recently had a myocardial infarction.
If you have recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics (water tablets), or dialysis).
If you are undergoing treatment to reduce allergic reactions to bee or wasp venom (desensitisation).
If you are scheduled for anaesthesia. This may be related to a surgical or dental procedure. It may be necessary to stop taking Ramizek Combi one day before the procedure; contact your doctor for advice.
If you have been diagnosed with high potassium levels in the blood (in blood test results).
If you are taking medicines or have conditions that may reduce sodium levels in the blood. Your doctor may order regular blood tests, especially to check blood sodium levels, 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:
- An angiotensin II receptor antagonist (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney disorders related to diabetes.
- Aliskiren. Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to take Ramizek Combi".
Inform your doctor if you suspect you are pregnant (or may become pregnant). Use of Ramizek Combi is not recommended during the first 3 months of pregnancy and may seriously harm the unborn child after 3 months of pregnancy (see section below "Pregnancy, breastfeeding and fertility").
If you have been diagnosed with a significant increase in blood pressure (hypertensive crisis).
If dose increase is necessary in elderly patients.
If you develop a dry cough that persists for a long time.
If your blood pressure is not sufficiently lowered. Medicines in this group 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 diarrhoea;
- Medicines used to prevent rejection of transplanted organs and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
- Vildagliptin, a medicine used to treat 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 hands and feet,
difficulty swallowing or breathing, hives, or hoarseness (angioedema), these may be symptoms of a severe
allergic reaction. Such a reaction may occur at any time during treatment, and the risk is higher in black patients.
If such symptoms occur, inform your doctor immediately.
Children and adolescents
Ramizek Combi is not recommended for use in children and adolescents under 18 years of age due to
lack of data in this population.
Ramizek Combi and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Inform your doctor if you are taking any of the following medicines. These medicines may reduce the effectiveness of Ramizek Combi:

Medicines used to relieve pain and for anti-inflammatory purposes (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, noradrenaline, or adrenaline. Your doctor will monitor your blood pressure.
Rifampicin (an antibiotic used to treat tuberculosis)
St. John's wort (used to treat depression).

Inform your doctor if you are taking any of the following medicines. They may increase the risk of adverse effects when taken together 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 mTOR inhibitor class; e.g. temsirolimus, everolimus, sirolimus, tacrolimus (used to treat certain types of cancer or to prevent rejection of transplanted organs) ⦁ tacrolimus (used to control the body's immune response, allowing the body to accept a transplanted organ). See section "Warnings and precautions".
Cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs
Medicines used to relieve pain and for anti-inflammatory purposes (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid)
Diuretics (water tablets), such as furosemide
Medicines that increase potassium levels in the blood, such as: spironolactone, triamterene, amiloride, potassium supplements (including salt substitutes), trimethoprim used as monotherapy or in combination with sulfamethoxazole (used to treat bacterial infections), and heparin (a blood-thinning medicine),
Steroidal anti-inflammatory medicines, such as prednisolone
Allopurinol (a medicine used to reduce uric acid levels in the blood)
Procainamide (a medicine used for heart rhythm disorders)
Ketoconazole, itraconazole (antifungal medicines)
Ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV infection)
Verapamil, diltiazem (medicines used to treat heart rhythm disorders or hypertension)
Dantrolene (a medicine administered by infusion in cases of severe temperature disorders).
Vildagliptin (used to treat type 2 diabetes). See section "Warnings and precautions",
Racecadotril (used to treat diarrhoea). See section "Warnings and precautions",

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

Medicines used for diabetes, such as oral antidiabetic medicines and insulin. Ramizek Combi may reduce blood glucose levels. Blood glucose levels should be closely monitored during treatment with Ramizek Combi.
Lithium (a medicine used for psychiatric disorders). Ramizek Combi may cause increased lithium levels in the blood. Your doctor will closely monitor lithium levels.
Simvastatin (a medicine to lower cholesterol levels). Ramizek Combi may cause increased simvastatin levels in the blood.

If you are taking any of the medicines listed above (or are unsure), you should speak to 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 lightheadedness. If you have any doubts about the amount of alcohol allowed while taking Ramizek Combi, discuss this with your doctor, as the effects of blood pressure-lowering medicines and alcohol are additive.
Patients taking Ramizek Combi should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to unpredictable intensification of the blood pressure-lowering effect of Ramizek Combi.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ramizek Combi during the first 12 weeks of pregnancy and must not take this medicine from the 13th week of pregnancy, as its use during pregnancy may harm the unborn child.
If you become pregnant while taking Ramizek Combi, inform your doctor immediately. If you are planning a pregnancy, your doctor will switch you to an appropriate alternative treatment.
Breastfeeding
Do not take Ramizek Combi during breastfeeding.
Before taking any medicine, consult your doctor or pharmacist.
Fertility
There is insufficient data on the potential effect of the medicine on fertility.
Driving and operating machinery
Ramizek Combi may affect your ability to drive or operate machinery. If Ramizek Combi causes nausea, dizziness, fatigue, or headache, do not drive or operate machinery; in such cases, contact your doctor immediately. These 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, meaning the medicine is considered "sodium-free".

3. How to take Ramizek Combi

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are unsure,
you should contact your doctor or pharmacist.
If you feel that the effect of Ramizek Combi is too strong or too weak, you should consult your doctor or
pharmacist.
This medicine should be taken orally, once daily at the same time each day, either before or after a meal.
The capsule should be swallowed whole with liquid.
Do not take Ramizek Combi with grapefruit juice.
Ramizek Combi should be taken once daily.
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 starting dose and adjust the dose more slowly.
Use in children and adolescents
Ramizek Combi is not recommended for use in children and adolescents under 18 years of age due to
lack of data in this population.
Taking more Ramizek Combi than recommended
Taking too many capsules may cause a drop in blood pressure, even to dangerously low levels. The
patient may then experience dizziness, lightheadedness, or weakness; fainting may also occur. In cases of
severe drop in blood pressure, shock may develop – the skin becomes cold and clammy, and the patient
may lose consciousness.
If too many capsules have been taken, contact a doctor immediately or go to the nearest hospital
emergency department. The patient must not drive to the hospital – ask someone else to drive or call an
ambulance. Bring the medicine packaging with you. This will help the doctor identify which medicine has
been taken.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur even up to
24–48 hours after taking the medicine.
If you forget to take Ramizek Combi
If you miss a dose, do not take the missed dose. Take the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.
Stopping Ramizek Combi
Your doctor will inform you how long to continue treatment. Stopping treatment without your doctor’s
advice may cause your condition to return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following serious adverse reactions occur, stop taking Ramizek Combi and contact your doctor immediately – urgent medical care may be necessary:

Swelling of the face, lips or throat, making swallowing or breathing difficult, as well as itching and rash. These may be symptoms of a severe allergic reaction to Ramizek Combi.
Severe skin reactions, including rash, (oral ulcers, worsening of existing skin diseases, redness, blistering or peeling of the skin (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme). The frequency of occurrence of the above-mentioned adverse reactions is unknown (cannot be estimated from available data).

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

Increased heart rate, irregular or stronger heartbeat (palpitations), chest pain, chest tightness or more serious disturbances, including myocardial infarction and stroke. These adverse reactions occur frequently (chest pain, chest tightness, palpitations) or uncommonly (increased heart rate, myocardial infarction or stroke).
Sudden wheezing, shortness of breath or difficulty breathing. These are common adverse reactions which may indicate lung disorders.
Easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purpuric skin spots, petechiae or more frequent than usual infections, sore throat and fever, fatigue, fainting, dizziness or paleness of the skin. These may be symptoms of blood or bone marrow disorders. These adverse reactions have unknown frequency.
Severe upper abdominal pain, which may radiate to the back. This may be a symptom of pancreatitis. This is an uncommon adverse reaction.
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 hepatitis or liver damage. These are very rare adverse reactions.

Other adverse reactions:
Inform your doctor if any of the following symptoms worsen or persist for more than a few days.
Very common adverse reactions: occurring in at least 1 out of 10 patients

Fluid retention (edema)

Common adverse reactions (may occur in up to 1 out of 10 people):

Drowsiness, dizziness (especially at the beginning of treatment)
Palpitations (awareness of heartbeat), sudden flushing (especially of the face)
Swelling around the ankles, visual disturbances, double vision
Headache or feeling of fatigue, weakness
Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly from a lying position
Dry, persistent cough, sinusitis or bronchitis
Abdominal pain, stomach or intestinal pain, diarrhea, constipation, indigestion, nausea or vomiting
Skin rash, with or without raised lesions
Chest pain
Muscle cramps or muscle pain
Increased blood potassium levels (detected in blood tests)

Uncommon adverse reactions (may occur in up to 1 out of 100 people):

Mood swings, insomnia
Tremor, pain, malaise
Tinnitus
Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
Heartburn, dryness of the oral mucosa
Hair loss, excessive sweating, red skin spots, skin discoloration
Problems with urination, increased need to urinate, especially at night, increased frequency of urination
Inability to achieve erection, impotence in men, decreased libido in men and women
Discomfort or enlargement of the breasts in men
Joint pain, back pain
Increase or decrease in body weight
Balance disturbances (dizziness)
Itching and unusual skin sensations such as numbness, tingling, pricking, burning or stinging (paresthesia), loss of pain sensation
Urticaria (hives)
Loss or disturbances of taste sensation
Depression, anxiety, increased nervousness or restlessness
Nasal congestion, breathing difficulties or worsening of asthma
Intestinal swelling referred to as "intestinal angioedema", with symptoms such as abdominal pain, vomiting and diarrhea
Loss or decrease of appetite (anorexia)
Blurred vision
Fever
Increase in a certain type of white blood cells (eosinophilia), detected in blood tests
Liver, pancreas or kidney function abnormalities, detected in blood tests

Rare adverse reactions (may occur in up to 1 out of 1000 people):

Feeling of uneasiness or confusion
Redness and swelling of the tongue
Severe peeling of the skin, itchy nodular rash
Nail disorders (e.g. loosening or separation of the nail from the nail bed)
Skin rash or development of bruises
Vasculitis (inflammation of blood vessels), often with skin rash
Skin spots and cold extremities
Redness, itching, swelling or watering of the eyes
Hearing disturbances
Decrease in red blood cells, white blood cells or platelets (which may result in unusual bruising or easy bleeding) or hemoglobin levels, detected in blood tests

Very rare adverse reactions (may occur in up to 1 out of 10,000 people):

Increased sensitivity to sunlight
Increased blood sugar levels (hyperglycemia)
Swelling of the gums
Abdominal bloating (inflammation of the gastric mucosa)
Liver function disturbances, hepatitis, yellowing of the skin (jaundice)
Increased muscle tension
Disorder involving stiffness, tremor and/or movement disturbances

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

Concentrated urine (dark-colored), nausea or vomiting, muscle cramps, confusion and seizures, which may result from inappropriate ADH secretion (antidiuretic hormone - vasopressin). If these symptoms occur, contact your doctor immediately.
Tremor, rigidity, mask-like facial expression, slowed movements and shuffling gait

Other observed adverse reactions:
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, detected in blood tests
Color change in fingers and toes in response to cold, followed by tingling or pain upon warming (Raynaud's phenomenon)
Slowed or impaired reactions
Smell disturbances
Burning sensation
Psoriasis

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ramizek Combi

Keep this medicine out of sight and reach of children.
Store below 30°C.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ramizek Combi contains

The active substances are: 2.5 mg + 5 mg, hard capsules: each capsule contains 2.5 mg ramipril and 5 mg amlodipine as amlodipine besylate. 5 mg + 5 mg, hard capsules: each capsule contains 5 mg ramipril and 5 mg amlodipine as amlodipine besylate. 5 mg + 10 mg, hard capsules: each capsule contains 5 mg ramipril and 10 mg amlodipine as amlodipine besylate. 10 mg + 5 mg, hard capsules: each capsule contains 10 mg ramipril and 5 mg amlodipine as amlodipine besylate.

10 mg + 10 mg, hard capsules: each capsule contains 10 mg ramipril and 10 mg amlodipine as amlodipine besylate.

Other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch gel, sodium carboxymethyl starch (type A), sodium stearyl fumarate, iron oxide red (E 172), titanium dioxide (E 171), gelatin. Additionally, for the 10 mg + 10 mg strength: iron oxide yellow (E 172), iron oxide black (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 Authorisation Holder and Manufacturer
Marketing Authorisation 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 is authorised 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
11.2023