Ramipril + Amlodipine + Hidrohlorothiazide Adamed

Leaflet accompanying the packaging: patient information

Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 2.5 mg + 5 mg + 12.5 mg, hard capsules
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 12.5 mg, hard capsules

Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 25 mg, hard capsules

Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 10 mg + 25 mg, hard capsules

Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 5 mg + 25 mg, hard capsules

Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 10 mg + 25 mg, hard capsules

Ramipril + Amlodipine + Hydrochlorothiazide

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 Ramipril + Amlodipine + Hydrochlorothiazide Adamed and what is it used for
• 2. Important information before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed
• 3. How to take Ramipril + Amlodipine + Hydrochlorothiazide Adamed
• 4. Possible side effects
• 5. How to store Ramipril + Amlodipine + Hydrochlorothiazide Adamed
• 6. Contents of the packaging and other information

1. What is Ramipril + Amlodipine + Hydrochlorothiazide Adamed and what is it used for

What is it used for
Ramipril + Amlodipine + Hydrochlorothiazide Adamed contains three active substances: ramipril, amlodipine, and hydrochlorothiazide.
Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) and works by:
reducing the production of substances in the body that can increase blood pressure,
reducing tension and dilating blood vessels,
making it easier for the heart to pump blood to all parts of the body.
Amlodipine belongs to a group of medicines called calcium antagonists and works by:
reducing tension and dilating blood vessels, making it easier for blood to flow.
Hydrochlorothiazide belongs to a group of so-called thiazide diuretics and works by:
increasing the amount of urine excreted, which reduces blood pressure.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed is used to treat high blood pressure (hypertension) in adult patients who have achieved adequate blood pressure control by taking the active substances separately in the same doses as in the combination medicine.

2. Important information before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed

Adamed

When not to take Ramipril + Amlodipine + Hydrochlorothiazide Adamed

if you are allergic to ramipril, amlodipine, or hydrochlorothiazide (active substances), or to other calcium antagonists, ACE inhibitors, or sulfonamide derivatives, or to any of the excipients of this medicine (listed in section 6),
if you have severe narrowing of the aortic valve (aortic stenosis) or are in cardiogenic shock (a condition in which the heart cannot supply enough blood to the body),
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 chronic heart failure in adults, as the risk of angioedema may increase,
if you are undergoing dialysis or blood filtration of another type - depending on the equipment used, the administration of Ramipril + Amlodipine + Hydrochlorothiazide Adamed may not be suitable for you,
if you have severe kidney problems,
if you are unable to urinate (anuria),
if you have liver problems,
if you have kidney problems where blood flow to the kidney is reduced (renal artery stenosis),
in the last 6 months of pregnancy (see also subsection "Pregnancy, breastfeeding, and fertility"),
if your blood pressure is very low or unstable,
if you have heart failure after a heart attack,
if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.
You must not take Ramipril + Amlodipine + Hydrochlorothiazide Adamed if any of the above conditions apply to you. If in doubt, consult your doctor before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed.

Warnings and precautions

Before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed, you should discuss it with your doctor or pharmacist. You should tell your doctor if you have or have had any of the following conditions:
you are elderly and need to increase the dose of the medicine;
you have heart, liver, or kidney problems;
you have recently had a heart attack;
you have very high blood pressure (hypertensive crisis);
you have lost a lot of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-sodium diet, taking diuretics for a long time, or undergoing dialysis);
you are breastfeeding;
you have allergies or asthma;
you are going to undergo desensitization treatment to reduce your allergy to bee or wasp venom (desensitization);
you are going to receive anesthesia, e.g., before surgery or a dental procedure - it may be necessary to stop taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed for a day before the procedure; you should consult your doctor;
you have high levels of potassium in your blood, as shown in blood tests;
you have low levels of potassium in your blood (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat);
you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, tremors, or convulsions);
you are taking medicines or have conditions that may cause low sodium levels in your blood - your doctor may order regular blood tests, especially to check sodium levels in your blood (especially in elderly patients);
you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, or cramps);
you have gout attacks (deposits of uric acid crystals in the joints);
you are taking any of the following medicines, which may increase the risk of angioedema:

• racecadotril, a medicine used to treat diarrhea; medicines used to prevent the rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• saxagliptin, a medicine used to treat type 2 diabetes. If you have collagenosis, such as scleroderma or systemic lupus erythematosus; if you have experienced vision problems or eye pain, especially if you are at risk of developing glaucoma or are allergic to penicillin or sulfonamides. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - they may occur within a few hours to a week after taking the medicine; if you have experienced hypersensitivity reactions to light - you should stop taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed; you have diabetes - it may be necessary to modify the dose of insulin or oral antidiabetic medicines; you are taking any of the following antihypertensive medicines:
• angiotensin II receptor antagonist (also known as sartan, e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney disease,
• aliskiren; if you have had skin cancer or if an unexpected skin change appears during treatment - the use of hydrochlorothiazide, especially long-term and in high doses, may increase the risk of developing certain types of skin and lip cancer (non-melanoma skin cancer); during treatment with Ramipril + Amlodipine + Hydrochlorothiazide Adamed, you should protect your skin from sunlight and UV radiation; if you have had breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed, you should seek medical help immediately.

Your doctor may order regular checks of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also subsection "When not to take Ramipril + Amlodipine + Hydrochlorothiazide Adamed".
If you are pregnant, planning to become pregnant, or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed is not recommended during the first 12 weeks of pregnancy. It should not be taken after the 13th week of pregnancy, as it may harm the baby. If you become pregnant while taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed, you should inform your doctor immediately. Your doctor will suggest switching to a different medicine before planned pregnancy.

Children and adolescents

Ramipril + Amlodipine + Hydrochlorothiazide Adamed should not be used in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

Ramipril + Amlodipine + Hydrochlorothiazide Adamed 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, including those available without a prescription (including herbal medicines). Ramipril + Amlodipine + Hydrochlorothiazide Adamed may affect the action of other medicines, and other medicines may affect the action of Ramipril + Amlodipine + Hydrochlorothiazide Adamed. Your doctor may order a change in the dose of the medicine and/or take other precautions:
if you are taking an angiotensin II receptor antagonist or aliskiren (see also subsections "When not to take Ramipril + Amlodipine + Hydrochlorothiazide Adamed" and "Warnings and precautions").
The following medicines may reduce the effect of Ramipril + Amlodipine + Hydrochlorothiazide Adamed:
analgesic and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid);
medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or epinephrine - your doctor will monitor your blood pressure regularly;
rifampicin (an antibiotic used to treat tuberculosis);
St. John's Wort (Hypericum perforatum, a herbal medicine used to treat depression);
chelating resins (substances used mainly to treat high levels of lipids in the blood).
The following medicines may increase the risk of side effects when taken with Ramipril + Amlodipine + Hydrochlorothiazide Adamed:
analgesic and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid);
a combination medicine containing sacubitril and valsartan, used to treat chronic heart failure in adults (see section 2, subsection "When not to take Ramipril + Amlodipine + Hydrochlorothiazide Adamed");
medicines used to prevent the rejection of a transplanted organ, such as cyclosporine;
medicines that may reduce potassium levels in the blood, such as laxatives, glucocorticoids, tetracosactide, amphotericin B (used to treat fungal infections), and corticotropin (ACTH, used to test adrenal function);
diuretics (e.g., furosemide);
desmopressin (used in diabetes or urological disorders);
corticosteroid anti-inflammatory medicines, such as prednisolone;
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 used in monotherapy or in combination with sulfamethoxazole in bacterial infections, and heparin (a blood thinner));
medicines used to treat heart conditions, including arrhythmias;
calcium or calcium supplements;
allopurinol (used to reduce uric acid levels in the blood);
procainamide (used to treat arrhythmias);
cholestyramine (used to reduce lipid levels in the blood);
carbamazepine, oxcarbazepine (antiepileptic medicines);
ketokonazole, itraconazole (used to treat fungal infections);
ritonavir, indinavir, nelfinavir (protease inhibitors used in HIV-infected patients);
verapamil, diltiazem (used to treat certain heart conditions and high blood pressure);
dantrolene (given by infusion in severe body temperature disorders);
temsirolimus (used to treat cancer);
sirolimus, everolimus (used to prevent the rejection of a transplanted organ);
saxagliptin (used to treat type 2 diabetes);
racecadotril (an anti-diarrheal medicine);
tacrolimus (an immunosuppressant that enables the body to accept a transplanted organ);
other medicines that lower blood pressure, such as phosphodiesterase inhibitors (used to treat erectile dysfunction), nitrates, alpha-adrenergic blockers (used in urology to reduce muscle tension in the prostate and urethra), and other medicines used to treat prostate disorders (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin), tricyclic antidepressants, and neuroleptics, phenothiazine derivatives, dopamine agonists, levodopa used in Parkinson's disease, baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis), amifostine;
medicines that affect gut motility, such as anticholinergic medicines;
domperidone (used to prevent nausea and vomiting);
medicines used to treat malaria (e.g., halofantrine, lumefantrine);
medicines used in allergic reactions (e.g., mizolastine, mequitazine);
antibiotics used to treat infections (e.g., amphotericin B, clarithromycin, erythromycin, levofloxacin, moxifloxacin, penicillin, spiramycin);
methadone (used to treat addiction to certain substances);
vandetanib, toremifene (medicines used to treat certain cancers), and other anticancer medicines (used in chemotherapy);
vinpocetine (used to treat neurological disorders related to aging)
Medicines whose action may be affected by Ramipril + Amlodipine + Hydrochlorothiazide Adamed:
medicines used to treat diabetes (oral hypoglycemic agents and insulin) - Ramipril + Amlodipine + Hydrochlorothiazide Adamed may reduce blood sugar levels, so blood sugar levels should be closely monitored during its use;
lithium (used to treat mental illnesses) - Ramipril + Amlodipine + Hydrochlorothiazide Adamed may increase lithium levels in the blood, so your doctor will closely monitor lithium levels in the blood;
simvastatin (a medicine used to reduce cholesterol levels) - since amlodipine increases simvastatin exposure, your doctor will recommend reducing the dose of simvastatin in patients taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed;
quinine (an antimalarial medicine);
medicines containing iodine (contrast agents) used in imaging tests, e.g., X-rays;
oral anticoagulants, such as warfarin;
digitalis glycosides: Ramipril + Amlodipine + Hydrochlorothiazide Adamed increases the toxicity of digitalis glycosides in patients treated with these medicines.
If any of the above situations apply to you (or you are in doubt), you should consult your doctor before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed.

Athletes

Hydrochlorothiazide may give a positive result in a doping test.

Ramipril + Amlodipine + Hydrochlorothiazide Adamed with food, drink, and alcohol

Ramipril + Amlodipine + Hydrochlorothiazide Adamed can be taken before or after a meal.
You should not eat grapefruits or drink grapefruit juice while taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed, as they may cause an increase in the level of the active substance amlodipine in the blood and, consequently, an unpredictable increase in the blood pressure-lowering effect of Ramipril + Amlodipine + Hydrochlorothiazide Adamed.
Drinking alcohol while taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed may cause dizziness or fainting. People interested in the allowed amount of alcohol during treatment should discuss it with their doctor, as the effects of blood pressure-lowering medicines and alcohol may add up.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant (or may be pregnant), you should tell your doctor. Ramipril + Amlodipine + Hydrochlorothiazide Adamed should not be taken during the first 12 weeks of pregnancy. It should not be taken after the 13th week of pregnancy, as it may harm the baby. If you become pregnant while taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed, you should inform your doctor immediately. Your doctor will suggest switching to a different medicine before planned pregnancy.
Breastfeeding
Ramipril + Amlodipine + Hydrochlorothiazide Adamed should not be used during breastfeeding. Before taking any medicine, you should consult your doctor or pharmacist.
Fertility
There is not enough data on the potential impact on fertility.

Driving and using machines

Ramipril + Amlodipine + Hydrochlorothiazide Adamed may affect your ability to drive or operate machines. If you experience nausea, dizziness, fatigue, or headaches while taking the medicine, you should not drive or operate machines. You should contact your doctor immediately.

Ramipril + Amlodipine + Hydrochlorothiazide Adamed contains sodium

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

3. How to take Ramipril + Amlodipine + Hydrochlorothiazide Adamed

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are in doubt, you should consult your doctor or pharmacist. The recommended dose is one capsule of Ramipril + Amlodipine + Hydrochlorothiazide Adamed at the strength prescribed by your doctor, taken once a day. Depending on the treatment outcome, your doctor may adjust the dose. The maximum dose is one capsule of 10 mg + 10 mg + 25 mg, taken once a day. The medicine should be taken orally, once a day, at the same time, before or after a meal. The hard capsules should be swallowed whole with a liquid. The hard capsules should not be crushed or chewed. The medicine should not be taken with grapefruit juice. Liver and kidney disease
Your doctor may adjust the dose of the medicine if you have liver or kidney disease.
Elderly
Your doctor may reduce the initial dose and gradually increase it.

Use in children and adolescents

Ramipril + Amlodipine + Hydrochlorothiazide Adamed should not be used in children and adolescents under 18 years of age due to the lack of data on efficacy and safety.

Taking a higher dose of Ramipril + Amlodipine + Hydrochlorothiazide Adamed than recommended

Adamed

Taking too many capsules may cause a significant decrease in blood pressure, even to dangerously low levels. You may experience dizziness, fainting, or weakness. A significant decrease in blood pressure may cause shock. Your skin may be cool and moist, and you may lose consciousness. Even 24-48 hours after taking the medicine, you may experience shortness of breath caused by excess fluid accumulation in the lungs (pulmonary edema). If you have taken an overdose of the medicine, you should seek medical help immediately. You should not drive yourself, but ask someone else to drive you or call an ambulance. You should take the medicine packaging with you so that the doctor can see what medicine you have taken.

Missing a dose of Ramipril + Amlodipine + Hydrochlorothiazide Adamed

If you miss a dose of the medicine, 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 Ramipril + Amlodipine + Hydrochlorothiazide Adamed

Your doctor will inform you how long you should take the medicine. Stopping treatment without consulting your doctor 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 experience any of the following serious side effects, you should stop taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed and contact your doctor immediately - you may need urgent treatment.

Swelling of the face, lips, or throat that makes swallowing or breathing difficult, as well as itching and rash. These may be symptoms of a severe allergic reaction to Ramipril + Amlodipine + Hydrochlorothiazide Adamed.
Severe skin reactions, including rash, ulcers of the mucous membranes, blistering rash on the lips, eyes, mouth, and skin, exacerbation of existing skin disease, redness, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
Unexpected sunburn or skin inflammation (dry, nodular, or blistering rash) on sun-exposed skin.

If you experience any of the following symptoms, you should inform your doctor immediately:

sudden wheezing, shortness of breath, or difficulty breathing, rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, or more severe disorders, including heart attack and stroke;
shortness of breath or cough: these may be symptoms of lung diseases, including pneumonia;
easy bruising, prolonged bleeding, or any signs of bleeding (e.g., bleeding from the gums), purpura, or increased susceptibility to infections, sore throat, and fever, fatigue, fainting, or dizziness: these may be symptoms of blood or bone marrow disorders;
severe stomach pain that may radiate to the back: this may be a symptom of pancreatitis;
fever, chills, fatigue, loss of appetite, stomach pain, nausea, jaundice (yellowing of the skin and eyes): these may be symptoms of liver disorders, such as hepatitis or liver damage.

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: may occur in at least 1 in 10 people
edema
decreased potassium levels in the blood (hypokalemia)
increased lipid levels in the blood (hyperlipidemia)
Common(may occur in less than 1 in 10 people)
headache, dizziness, drowsiness (especially at the beginning of treatment), feeling of exhaustion (fatigue)
feeling of heartbeat (palpitations)
edema of the ankles
low blood pressure (hypotension), especially when standing up quickly or sitting down (orthostatic hypotension), fainting, sudden flushing of the skin (especially on the face and neck)
dry, irritating cough, sinusitis, bronchitis, shortness of breath
stomach pain, diarrhea, indigestion, nausea, vomiting, changes in bowel habits (including diarrhea and constipation), loss of appetite
skin rash with elevated patches or without them, hives
chest pain
muscle cramps or pain
decreased magnesium and sodium levels in the blood, as shown in blood tests
feeling of weakness and lack of strength (weakness)
increased uric acid (hyperuricemia) or potassium (hyperkalemia) levels in the blood, as shown in blood tests
difficulty achieving or maintaining an erection (impotence)
vision disturbances (including double and blurred vision)
Uncommon(may occur in less than 1 in 100 people)
edema of the hands and feet (peripheral edema), which may be a sign of excessive water retention
intestinal edema (angioedema of the small intestine), whose symptoms are abdominal pain, vomiting, and diarrhea
mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia)
ringing in the ears (tinnitus)
sneezing, runny nose, nasal congestion due to inflammation of the nasal mucosa (rhinitis)
difficulty breathing (bronchospasm), including asthma exacerbation
dryness of the mucous membranes of the mouth, heartburn
changes in urination, increased urination during the day, increased nocturia
acute kidney failure (significant reduction in urine output)
general malaise
weight gain or loss
feeling of spinning (vertigo of peripheral origin), tremors
hair loss (alopecia)
itching of the skin, red spots on the skin, skin discoloration
numbness or tingling of the limbs, abnormal sensations on the skin, such as numbness, tingling, prickling, burning, or itching (paresthesia), loss of pain sensation
loss or disturbance of taste
excessive sweating
joint pain, back pain, generalized pain
increased body temperature/fever
decreased libido in men and women, discomfort or breast enlargement in men (gynecomastia)
increased white blood cell count (eosinophilia), as shown in blood tests
abnormal liver function (increased liver enzyme activity and/or increased bilirubin levels), pancreas (increased pancreatic enzyme activity), or kidney (increased creatinine levels) function, as shown in blood tests
Rare(may occur in less than 1 in 1,000 people)
feeling of trembling or confusion, balance disturbances
redness and swelling of the tongue (glossitis)
skin inflammation with peeling (exfoliative dermatitis)
nail diseases (e.g., nail loosening or separation from the nail bed)
redness, itching, swelling, or tearing of the eyes (conjunctivitis)
hearing disturbances
liver function disorders, which may be accompanied by yellowing of the eyes and skin (jaundice)
irregular heartbeat
skin spots and cold limbs
reduced red blood cell count, white blood cell count (including neutropenia or agranulocytosis, leukopenia), or hemoglobin levels
low platelet count in the blood, sometimes with bleeding or bruising under the skin (thrombocytopenia)
abnormal blood test results showing increased blood sugar levels, glucose in the urine, worsening of diabetes in diabetic patients
increased sensitivity of the skin to light (phototoxicity)
increased calcium levels in the blood (hypercalcemia)
Very rare(may occur in less than 1 in 10,000 people)
hepatitis (mostly with cholestasis)
rash on the face, joint pain, symptoms such as 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, fever (lupus erythematosus), lupus erythematosus exacerbation,
vascular inflammation with symptoms such as rash, purpura, fever (vasculitis)
severe skin reaction causing rash, redness of the skin, blistering on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
gum hypertrophy
increased muscle tone
peripheral neuropathy, which can cause muscle weakness, numbness, or tingling (peripheral neuropathy)
abdominal distension (gastritis)
vascular inflammation, often with skin rash (vasculitis)
disorders affecting balance and movement, such as stiffness, tremors, and/or movement difficulties
severe stomach pain (pancreatitis)
hemolysis, which can cause pallor, fatigue, shortness of breath, and dark urine (hemolytic anemia)
allergic reactions (hypersensitivity reaction)
disturbance of acid-base balance, which can cause disorientation, fatigue, muscle cramps, and rapid breathing (hypochloremic alkalosis)
breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary edema)
acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion)
Frequency not known(cannot be estimated from the available data)
You should inform your doctor if any of the following symptoms worsen or persist for more than a few days.
attention disturbances
change in finger and toe color after cooling and feeling of numbness or pain after warming (Raynaud's phenomenon)
slowed or disturbed reactions
feeling of burning
smell disturbances
severe skin disease causing rash, redness of the skin, blistering on the lips, eyes, or mouth, peeling of the skin, fever (erythema multiforme)
urine concentration (dark urine), nausea, or vomiting, muscle cramps, confusion, and convulsions, which may be caused by inadequate secretion of antidiuretic hormone (vasopressin) - if such symptoms occur, you should seek medical help as soon as possible
tremors, stiffened posture, mask-like face, slowed movements, and a shuffling, unsteady gait.
sudden vision loss at a distance (acute myopia), vision loss, or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute glaucoma)
skin and lip cancer (non-melanoma skin cancer)

5. How to store Ramipril + Amlodipine + Hydrochlorothiazide Adamed

Store at a temperature below 30°C.
Store in a place out of sight and reach of children.
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.
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 Ramipril + Amlodipine + Hydrochlorothiazide Adamed contains

Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 2.5 mg + 5 mg + 12.5 mg, hard capsules:
Each capsule contains 2.5 mg of ramipril, 5 mg of amlodipine (in the form of 6.934 mg of amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 12.5 mg, hard capsules:
Each capsule contains 5 mg of ramipril, 5 mg of amlodipine (in the form of 6.934 mg of amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 25 mg, hard capsules:
Each capsule contains 5 mg of ramipril, 5 mg of amlodipine (in the form of 6.934 mg of amlodipine besylate), and 25 mg of hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 10 mg + 25 mg, hard capsules:
Each capsule contains 5 mg of ramipril, 10 mg of amlodipine (in the form of 13.868 mg of amlodipine besylate), and 25 mg of hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 5 mg + 25 mg, hard capsules:
Each capsule contains 10 mg of ramipril, 5 mg of amlodipine (in the form of 6.934 mg of amlodipine besylate), and 25 mg of hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 10 mg + 25 mg, hard capsules:
Each capsule contains 10 mg of ramipril, 10 mg of amlodipine (in the form of 13.868 mg of amlodipine besylate), and 25 mg of hydrochlorothiazide.

• Other ingredients:

Contents of the capsule:microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, sodium carboxymethyl starch (type A), sodium stearyl fumarate
Coating of the capsule (2.5 mg + 5 mg + 12.5 mg):red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
Coating of the capsule (5 mg + 5 mg + 25 mg):red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
Coating of the capsule (5 mg + 10 mg + 25 mg):red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), gelatin
Coating of the capsule (10 mg + 5 mg + 25 mg):red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
Coating of the capsule (10 mg + 10 mg + 25 mg):red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), gelatin
Coating of the capsule (5 mg + 5 mg + 12.5 mg):red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), gelatin
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 2.5 mg + 5 mg + 12.5 mg, hard capsules:
A light pink and ivory-colored capsule.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 12.5 mg, hard capsules:
A pink and light gray capsule.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 25 mg, hard capsules:
A pink and ivory-colored capsule.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 10 mg + 25 mg, hard capsules:
A burgundy and gray capsule.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 5 mg + 25 mg, hard capsules:
A dark pink and yellow capsule.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 10 mg + 25 mg, hard capsules:
A brown and caramel-colored capsule.
The packaging contains 10, 28, 30, 60, or 100 hard capsules in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
Ramipril/Amlodipin/HCT Genericon
Bulgaria
Рамира Трио 5 mg/5 mg/12,5 mg твърди капсули
Pамиприл/Амлодипин/Xидрохлоротиазид Адамед
Croatia
Pinmirol Plus
Czech Republic
Ramipril/Amlodipine/Hydrochlorothiazide Adamed
Germany
Ramipril + Amlodipin + Hydrochlorotiazid Adamed
Greece
Rami-Amlo Plus
Italy
Ramloid
Portugal
Paniltri
Slovakia
Ramipril/Amlodipín/Hydrochlorotiazid Adamed
Logo
Adamed Pharma S.A.

For more information on this medicine, please contact:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: 08.2023