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 further questions, you should ask your 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 Ramipril + Amlodipine + Hydrochlorothiazide Adamed
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, which makes 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 individual active substances in the same doses as in the combination medicine, but in the form of separate tablets.

2. Important information before taking Ramipril + Amlodipine + Hydrochlorothiazide 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, taking 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 "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 medicine that lowers blood pressure 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 are or have been in any of the following situations:
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 seizures);
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, as the risk of angioedema may increase:

• 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.

Your doctor may order regular checks of your kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also "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 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 switch you to a different medicine before you become pregnant.

Children and adolescents

Ramipril + Amlodipine + Hydrochlorothiazide Adamed should not be taken by 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 need to change the dose of the medicine and/or take other precautions:
if you are taking a medicine that belongs to a group of angiotensin II receptor antagonists or aliskiren (see also "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 "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 to treat 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 alone 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 immunosuppressive medicine that allows the body to accept a transplanted organ);
other blood pressure-lowering medicines, 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 conditions (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 the movement of the digestive tract, such as anticholinergic medicines;
domperidone (used to prevent nausea and vomiting);
medicines used to treat malaria (e.g., halofantrine, lumefantrine);
medicines used to treat 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 types of cancer) and other anticancer medicines (used in chemotherapy);
vincamine (used to treat neurological disorders related to aging)

Medicines whose effects 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 close monitoring of blood sugar levels is necessary during its use;
lithium (used to treat mental illnesses) - Ramipril + Amlodipine + Hydrochlorothiazide Adamed may increase lithium levels in the blood, so close monitoring of lithium levels in the blood is necessary;
simvastatin (a medicine used to reduce cholesterol levels) - since amlodipine increases exposure to simvastatin, your doctor may reduce the dose of simvastatin if you are 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 taking 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 increase the levels of the active substance amlodipine in the blood and, consequently, the unpredictable intensification of 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 think you 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 switch you to a different medicine before you become pregnant.
Breastfeeding
Ramipril + Amlodipine + Hydrochlorothiazide Adamed 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 on fertility.

Driving and using machines

Ramipril + Amlodipine + Hydrochlorothiazide Adamed may affect your ability to drive or use machines. If you experience nausea, dizziness, fatigue, or headaches while taking the medicine, you should not drive or use 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 result of the treatment, 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 drink of water.
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.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed should not be taken by elderly patients who are frail.

Use in children and adolescents

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

Taking more than the prescribed dose of Ramipril + Amlodipine + Hydrochlorothiazide Adamed

Adamed

Taking too many capsules may cause a significant drop in blood pressure, even to dangerously low levels. You may experience dizziness, fainting, or weakness. A significant drop in blood pressure can 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 due to excess fluid accumulating in the lungs (pulmonary edema). If you have taken too much 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 packaging of the medicine 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 worsen.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ramipril + Amlodipine + Hydrochlorothiazide Adamed 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, making it difficult to swallow or breathe, 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, or genitals, 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, lumpy, 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, tightness in the chest, or more severe disorders, including heart attack and stroke;
shortness of breath or cough: these may be symptoms of lung disease, including pneumonia;
easy bruising, longer than usual bleeding time, any signs of bleeding (e.g., bleeding from the gums), purple spots on the skin, or increased susceptibility to infections, sore throat, and fever, feeling tired, fainting, dizziness, or paleness: these may be symptoms of blood disease or bone marrow disease;
severe stomach pain, which 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 affect more than 1 in 10 people):
edema
low potassium levels in the blood (hypokalemia)
high lipid levels in the blood (hyperlipidemia)
Common(may affect up to 1 in 10 people):
headache, dizziness, drowsiness (especially at the beginning of treatment), feeling tired (fatigue)
feeling your heartbeat (palpitations)
swelling 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
abdominal pain, diarrhea, indigestion, nausea, vomiting, changes in bowel habits (including diarrhea and constipation)
rash, itching
chest pain
muscle cramps or pain
low magnesium and sodium levels in the blood, as shown in blood tests
feeling weak and lacking energy (weakness)
high uric acid levels (hyperuricemia) or potassium levels (hyperkalemia) in the blood, as shown in blood tests
erectile dysfunction (impotence)
vision disturbances (including double vision and blurred vision)
Uncommon(may affect up to 1 in 100 people):
swelling of the hands and feet (peripheral edema), which may be a sign of water retention
intestinal edema (intestinal angioedema), whose symptoms include abdominal pain, vomiting, and diarrhea
mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia)
ringing in the ears (tinnitus)
runny nose, stuffy nose, and sinusitis due to inflammation of the nasal mucosa (sinusitis)
breathing difficulties (bronchospasm), including asthma exacerbation
dry mouth, heartburn
urination disorders, increased urination during the day, increased nocturnal urination
acute kidney failure (markedly reduced urine output)
general malaise
weight gain or loss
dizziness (peripheral vertigo)
tremors
hair loss (alopecia)
itching, 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), lack of pain sensation
loss of taste
excessive sweating
joint pain, back pain, general pain
fever
Rare(may affect up to 1 in 1,000 people):
liver inflammation (in most cases with cholestasis)
rash on the face, joint pain, symptoms such as rash, red spots on the skin, fever (lupus erythematosus), lupus exacerbation,
vasculitis with symptoms such as rash, purpura, fever (lethal 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, tingling, or numbness (peripheral neuropathy)
abdominal distension (gastritis)
vasculitis, often with skin rash
disorders including stiffness, tremors, and/or movement difficulties
severe stomach pain (pancreatitis)
hemolytic anemia, which can cause pallor, fatigue, shortness of breath, and dark urine color
allergic reactions (hypersensitivity reaction)
acid-base imbalance, 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)
Very rare(may affect up to 1 in 10,000 people):
liver inflammation (in most cases with cholestasis)
rash on the face, joint pain, symptoms such as rash, red spots on the skin, fever (lupus erythematosus), lupus exacerbation,
vasculitis with symptoms such as rash, purpura, fever (lethal 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, tingling, or numbness (peripheral neuropathy)
abdominal distension (gastritis)
vasculitis, often with skin rash
disorders including stiffness, tremors, and/or movement difficulties
severe stomach pain (pancreatitis)
hemolytic anemia, which can cause pallor, fatigue, shortness of breath, and dark urine color
allergic reactions (hypersensitivity reaction)
acid-base imbalance, 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):
attention disorders
change in finger and toe color after cooling and a feeling of tingling or pain after warming (Raynaud's phenomenon)
slowed or impaired reactions
burning sensation
smell disorders
severe skin disease causing rash, redness of the skin, blistering on the lips, eyes, or mouth, peeling of the skin, fever (erythema multiforme)
concentrated urine (dark urine color), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be caused by inadequate secretion of antidiuretic hormone (vasopressin) - if you experience such symptoms, you should contact your doctor as soon as possible
tremors, stiff 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 choroidal effusion or acute angle-closure glaucoma)
skin and lip cancer (non-melanoma skin cancer)

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, 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
phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramipril + Amlodipine + Hydrochlorothiazide Adamed

Store in 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:

Capsule contents:microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, sodium carboxymethylcellulose (type A), sodium stearyl fumarate
Capsule shell (2.5 mg + 5 mg + 12.5 mg):red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
Capsule shell (5 mg + 5 mg + 25 mg):red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
Capsule shell (5 mg + 10 mg + 25 mg):red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), gelatin
Capsule shell (10 mg + 5 mg + 25 mg):red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
Capsule shell (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
Capsule shell (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:
Opaque capsule with a light pink cap and an ivory-colored body.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 12.5 mg, hard capsules:
Opaque capsule with a pink cap and a light gray body.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 25 mg, hard capsules:
Opaque capsule with a pink cap and an ivory-colored body.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 10 mg + 25 mg, hard capsules:
Opaque capsule with a burgundy cap and a gray body.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 5 mg + 25 mg, hard capsules:
Opaque capsule with a dark pink cap and a yellow body.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 10 mg + 25 mg, hard capsules:
Opaque capsule with a brown cap and a caramel-colored body.
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

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