Ramipril + amlodipine + hydrochlorothiazide adamed: detailed information

Patient Information Leaflet

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
Ramiprilum + Amlodipinum + Hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet:

What Ramipril + Amlodipine + Hydrochlorothiazide Adamed is and what it is used for
What you need to know before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed
How to take Ramipril + Amlodipine + Hydrochlorothiazide Adamed
Possible side effects
How to store Ramipril + Amlodipine + Hydrochlorothiazide Adamed
Contents of the pack and other information

1. What Ramipril + Amlodipine + Hydrochlorothiazide Adamed is and what it is 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 in the body of a substance that can increase blood pressure,
reducing tension and widening 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 channel blockers and works by:
reducing tension and widening blood vessels, which improves blood flow.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics and works by:
increasing the volume of urine produced, which reduces blood pressure.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed is used to treat high blood pressure (hypertension) in adult patients whose blood pressure has been adequately controlled using the same doses of the individual active substances given separately as tablets.

2. What you need to know before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed

Do not take Ramipril + Amlodipine + Hydrochlorothiazide Adamed if:

you are allergic to ramipril, amlodipine or hydrochlorothiazide (the active substances), to other calcium channel blockers, ACE inhibitors or sulphonamide-derived medicines, or to any of the other ingredients of this medicine (listed in section 6),
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),
you have ever had a severe allergic reaction called "angioedema" – symptoms include: itching, hives, red spots on hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing,
you have taken or are currently taking sacubitril with valsartan, a medicine used to treat certain types of chronic heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases,
you are undergoing dialysis or other types of blood filtration – depending on the equipment used, taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed may not be suitable for you,
you have severe kidney function problems,
you are unable to pass urine (anuria),
you have liver function problems,
you have kidney function problems due to reduced blood flow to the kidneys (renal artery stenosis),
you are in the last 6 months of pregnancy (see below under "Pregnancy, breastfeeding and fertility"),
your blood pressure is very low or unstable,
you have heart failure following a heart attack,
you have diabetes or kidney function problems and are taking a blood pressure-lowering medicine containing aliskiren.

Do not take Ramipril + Amlodipine + Hydrochlorothiazide Adamed if any of the above conditions apply to you. If you are in any doubt, speak to your doctor before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed.
Tell your doctor if any of the following apply to you or have applied to you in the past:

you are elderly and a dose increase is needed;
you have heart, liver or kidney function problems;
you have recently had a heart attack;
you have very high blood pressure (hypertensive crisis);
you have lost a large amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-sodium diet, long-term use of diuretics or dialysis);
you are breastfeeding;
you have allergies or asthma;
you are undergoing treatment to reduce sensitivity to bee or wasp venom (desensitisation);
you are due to have anaesthesia, e.g. before surgery or a dental procedure – you may need to stop taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed one day before the procedure; consult your doctor;
you have high potassium levels in your blood, as shown in blood tests;
you have low potassium levels in your blood (with or without symptoms such as muscle weakness, muscle cramps or irregular heartbeat);
you have low sodium levels in your blood (with or without symptoms such as fatigue, confusion, muscle twitching or seizures);
you are taking medicines or have conditions that may cause low sodium levels in your blood – your doctor may recommend regular blood tests, especially to monitor blood sodium levels (particularly in elderly patients);
you have high calcium levels in your blood (with or without symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness or cramps);
you have attacks of gout (uric acid crystal deposits in the joints);
you are taking any of the following medicines, as the risk of angioedema may increase:
- racecadotril, a medicine used to treat diarrhoea;
- medicines used to prevent organ transplant rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
- vildagliptin, a medicine used to treat diabetes;
you have been diagnosed with a collagen disease such as scleroderma or systemic lupus erythematosus;
you experience worsening vision or eye pain, especially if you are at risk of developing glaucoma or are allergic to penicillin or sulphonamide medicines. These may be symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye – these may occur from a few hours to a week after taking the medicine;
you experience photosensitivity reactions – in such cases, stop taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed;
you have diabetes – your insulin dose or oral antidiabetic medicines may need adjustment;
you are taking any of the following antihypertensive medicines:
- an angiotensin II receptor antagonist (also called a sartan, e.g. valsartan, telmisartan, irbesartan), especially if you have kidney disease due to diabetes,
- aliskiren;
you have previously had skin cancer or develop unexpected skin changes during treatment – long-term and high-dose use of hydrochlorothiazide may increase the risk of certain types of skin and lip cancers (non-melanoma skin cancer); during treatment with Ramipril + Amlodipine + Hydrochlorothiazide Adamed, protect your skin from sunlight and UV radiation;
you have previously had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed, seek medical help immediately.

Your doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium). See also the section "Do not take Ramipril + Amlodipine + Hydrochlorothiazide Adamed if".
Inform your doctor if you are pregnant, planning a pregnancy or suspect you may be pregnant. Ramipril + Amlodipine + Hydrochlorothiazide Adamed is not recommended during the first 3 months of pregnancy, and after the 3rd month of pregnancy, taking this medicine may be very harmful to the unborn child (see section "Pregnancy, breastfeeding and fertility").

Children and adolescents
Ramipril + Amlodipine + Hydrochlorothiazide Adamed is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy.

Ramipril + Amlodipine + Hydrochlorothiazide Adamed and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained 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 recommend a dose adjustment and/or additional precautions:

if you are taking an angiotensin II receptor antagonist or aliskiren (see also sections "Do not take Ramipril + Amlodipine + Hydrochlorothiazide Adamed if" and "Warnings and precautions").

The following medicines may reduce the effect of Ramipril + Amlodipine + Hydrochlorothiazide Adamed:

painkillers 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, noradrenaline or adrenaline – your doctor will recommend regular blood pressure monitoring;
rifampicin (an antibiotic used to treat tuberculosis);
St John's wort – Hypericum perforatum (a herbal medicine used to treat depression);
bile acid sequestrants (substances mainly used to treat high blood lipid levels).

The following medicines may increase the risk of side effects when taken together with Ramipril + Amlodipine + Hydrochlorothiazide Adamed:

painkillers 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, "Do not take Ramipril + Amlodipine + Hydrochlorothiazide Adamed if");
medicines used to prevent organ transplant rejection, such as cyclosporine;
medicines that may reduce potassium levels in the blood, such as medicines used to treat constipation (laxatives), glucocorticosteroids, tetracosactide, amphotericin B (used to treat fungal infections) and corticotrophin (ACTH, used to assess adrenal gland function);
diuretics (water tablets), such as furosemide;
desmopressin (used in diabetes or urological disorders);
steroid 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 for bacterial infections, and heparin (a blood-thinning medicine));
medicines used for heart diseases, including heart rhythm disorders;
calcium tablets or other calcium supplements;
allopurinol (used to reduce uric acid levels in the blood);
procainamide (used for heart rhythm disorders);
cholestyramine (used to reduce blood lipid levels);
carbamazepine, oxcarbazepine (antiepileptic medicines);
ketoconazole, itraconazole (used to treat fungal infections);
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in HIV patients);
verapamil, diltiazem (used to treat certain heart diseases and high blood pressure);
dantrolene (given by infusion in severe body temperature disorders);
temsirolimus (used to treat cancer);
sirolimus, everolimus (used to prevent organ transplant rejection);
vildagliptin (used to treat type 2 diabetes);
racecadotril (an anti-diarrhoeal medicine);
tacrolimus (an immunosuppressant that helps the body accept a transplanted organ);
other blood pressure-lowering medicines, such as phosphodiesterase-5 inhibitors (used to treat erectile dysfunction), nitrates, alpha-adrenolytic medicines (used in urology to reduce smooth muscle tension in the prostate and urethra), other medicines used to treat prostate diseases (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 diseases such as multiple sclerosis), amifostine;
medicines affecting gastrointestinal motility, such as anticholinergic medicines;
domperidone (prevents nausea and vomiting);
medicines used to treat malaria (e.g. halofantrine, lumefantrine);
medicines used for 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 ageing).

Medicines whose action may be affected by Ramipril + Amlodipine + Hydrochlorothiazide Adamed:

medicines used to treat diabetes (oral hypoglycaemics and insulin) – Ramipril + Amlodipine + Hydrochlorothiazide Adamed may reduce blood sugar levels, so blood glucose levels should be closely monitored during treatment;
lithium (used for psychiatric disorders) – Ramipril + Amlodipine + Hydrochlorothiazide Adamed may increase lithium levels in the blood, so your doctor will recommend close monitoring of blood lithium levels;
simvastatin (a medicine used to reduce cholesterol) – since amlodipine increases exposure to simvastatin, your doctor will recommend reducing the simvastatin dose in patients taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed;
quinine (an antimalarial medicine);
iodine-containing medicines (contrast agents), used during imaging tests, e.g. X-rays;
oral anticoagulants, such as warfarin;
cardiac glycosides: Ramipril + Amlodipine + Hydrochlorothiazide Adamed increases the toxicity of cardiac glycosides in patients treated with these medicines.

If any of the above situations apply to you (or you have any doubts), speak to your doctor before taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed.

Athletes
Hydrochlorothiazide may give a positive result in anti-doping tests.

Ramipril + Amlodipine + Hydrochlorothiazide Adamed with food, drink and alcohol
Ramipril + Amlodipine + Hydrochlorothiazide Adamed can be taken before or after food.
Do not eat grapefruit or drink grapefruit juice while taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed, as they may increase blood levels of the active substance amlodipine and, consequently, unpredictably intensify the blood pressure-lowering effect of Ramipril + Amlodipine + Hydrochlorothiazide Adamed.
Drinking alcohol while taking Ramipril + Amlodipine + Hydrochlorothiazide Adamed may cause dizziness or drowsiness. People interested in the acceptable amount of alcohol during treatment should discuss this with their doctor, as the effects of blood pressure-lowering medicines and alcohol may be additive.

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
If you are pregnant (or may be pregnant), tell your doctor. Do not take Ramipril + Amlodipine + Hydrochlorothiazide Adamed during the first 12 weeks of pregnancy. It must not be used after the 13th week of pregnancy, as taking the medicine at this time may harm the unborn child. If you become pregnant while being treated with Ramipril + Amlodipine + Hydrochlorothiazide Adamed, inform your doctor immediately. Your doctor will recommend switching to another medicine before a planned pregnancy.

Breastfeeding
Do not take Ramipril + Amlodipine + Hydrochlorothiazide Adamed while breastfeeding. Before taking any medicine, consult your doctor or pharmacist.

Fertility
There is insufficient data on the potential effect on fertility.

Driving and using machines
Ramipril + Amlodipine + Hydrochlorothiazide Adamed may affect the ability to drive or operate machinery. If you feel nauseous, dizzy, tired or have headaches while taking this medicine, do not drive or operate machinery. Contact your doctor immediately.

Ramipril + Amlodipine + Hydrochlorothiazide Adamed contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to use Ramipril + Amlodipine + Hydrochlorothiazide Adamed

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
contact your doctor or pharmacist.
The recommended dose is 1 capsule of Ramipril + Amlodipine + Hydrochlorothiazide Adamed at the strength prescribed by your doctor, taken once daily.
Depending on the treatment outcome, your doctor may adjust the dose.
The maximum dose is 1 capsule of 10 mg + 10 mg + 25 mg taken once daily.
The medicine should be taken orally every day at the same time, with or without food.
Hard capsules should be swallowed whole with liquid.
Hard capsules must not be crushed or chewed.
Do not take this medicine with grapefruit juice.

Liver and kidney disease
In patients with liver or kidney disease, your doctor may adjust the dose of the medicine.

Elderly patients
Your doctor may reduce the initial dose and gradually increase it.
Use of Ramipril + Amlodipine + Hydrochlorothiazide Adamed is not recommended in very elderly and frail patients.

Use in children and adolescents
Ramipril + Amlodipine + Hydrochlorothiazide Adamed is not recommended for use in children and adolescents under 18 years of age due to lack of data on efficacy and safety.

Taking more Ramipril + Amlodipine + Hydrochlorothiazide Adamed than recommended
Taking too many capsules may cause a significant drop in blood pressure, even to dangerously low levels. Dizziness, lightheadedness, fainting, or weakness may occur. A marked drop in blood pressure may lead to shock. The patient's skin may become cold and clammy, and loss of consciousness may occur. Within 24 to 48 hours after taking the medicine, breathlessness caused by fluid accumulation in the lungs (pulmonary edema) may develop. In case of overdose, seek immediate medical help. The patient should not drive but ask someone else for assistance or call an ambulance. Take the medicine packaging with you so the doctor can see which medicine has been taken.

If you miss a dose of Ramipril + Amlodipine + Hydrochlorothiazide Adamed
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

Stopping Ramipril + Amlodipine + Hydrochlorothiazide Adamed
Your doctor will advise you on how long to take the medicine. Stopping treatment without prior consultation with your doctor may cause the condition to return.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the following serious adverse effects, treatment with Ramipril + Amlodipine + Hydrochlorothiazide Adamed must be discontinued immediately and the doctor must be contacted immediately – prompt treatment may be necessary.
Swelling of the face, lips or throat causing difficulty in swallowing or breathing, 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, ulceration of the mucous membranes of the mouth, rash with blister formation around the lips, eyes, or oral cavity, worsening of pre-existing skin disease, redness, intense itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
Unexpected sunburn or skin inflammation (dry, nodular or vesicular rash) on skin exposed to sunlight.
If any of the listed symptoms occur, the doctor must be informed immediately:
sudden wheezing, shortness of breath or difficulty breathing, rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, chest tightness or more severe disturbances, including myocardial infarction and stroke;
shortness of breath or cough: these may indicate lung diseases, including inflammation;
easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purplish spots on the skin or increased susceptibility to infections, sore throat and fever, feeling of fatigue, fainting, dizziness or pale skin: these may be symptoms of blood or bone marrow disorders;
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, yellowing of the skin or eyes (jaundice): these may be symptoms of liver disorders, such as inflammation or liver damage.

Other adverse effects
Inform the doctor if any of the following symptoms worsen or persist for longer than a few days.

Very common (may affect at least 1 in 10 people):
oedema
decreased potassium levels in blood (hypokalaemia)
increased lipid levels in blood (hyperlipidaemia)

Common (may affect less than 1 in 10 people):
headache, dizziness, drowsiness (especially at the beginning of treatment), feeling of exhaustion (fatigue)
awareness of heartbeat (palpitations)
ankle swelling
low blood pressure (hypotension), especially when standing up or sitting down quickly (orthostatic hypotension), fainting, sudden reddening of the skin (especially face and neck)
dry, irritating cough, sinusitis, bronchitis, shortness of breath
abdominal pain, diarrhoea, indigestion, nausea, vomiting, bowel rhythm disturbances (including diarrhoea and constipation), loss of appetite
skin rash with or without raised bumps, urticaria
chest pain
muscle cramps or muscle pain
decreased magnesium and sodium levels in blood, detected in blood tests
feeling of weakness and lack of strength (asthenia)
increased levels of uric acid (hyperuricaemia) or potassium (hyperkalaemia) in blood, detected in blood tests
difficulty in achieving or maintaining erection (impotence)
vision disturbances (including double or blurred vision)

Uncommon (may affect less than 1 in 100 people):
swelling of hands and feet (peripheral oedema), which may indicate retention of larger than normal amounts of fluid
intestinal swelling (intestinal angioedema), symptoms of which include abdominal pain, vomiting and diarrhoea
mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia)
ringing in the ears (tinnitus)
sneezing, runny nose due to inflammation of the nasal mucosa (rhinitis), nasal congestion
difficulty breathing (bronchospasm), including worsening of asthma
dryness of the oral mucosa, heartburn
urination disturbances, increased daytime urine output, increased nocturnal urination
acute kidney failure (marked reduction in urine output)
general malaise
increase or decrease in body weight
sensation of spinning (peripheral dizziness), tremor
hair loss (alopecia)
itching of the skin, red skin spots, skin discoloration
numbness or tingling of limbs, unusual skin sensations such as numbness, tingling, pricking, burning or tickling (paraesthesia), lack of pain sensation
loss or disturbances of taste
excessive sweating
joint pain, back pain, generalised pain
increased body temperature/fever
decreased libido in men and women, discomfort or breast enlargement in men (gynaecomastia)
increased number of certain white blood cells (eosinophilia) detected in blood tests
liver function abnormalities detected in blood tests (increased liver enzyme activity and/or increased conjugated bilirubin levels), pancreatic (increased pancreatic enzyme activity) or kidney (increased creatinine levels)
Rare (may affect less than 1 in 1000 people):
feeling of trembling or confusion, balance disturbances
redness and swelling of the tongue (glossitis)
inflammation and peeling of the skin, itchy nodular rash (exfoliative dermatitis)
nail disorders (e.g. loosening or separation of the nail from the nail bed)
redness, itching, swelling or watering of the eyes (conjunctivitis)
hearing disturbances
liver function disorder, which may be accompanied by yellowing of the eyes and skin (jaundice)
irregular heartbeat
skin spots and cold extremities
decreased number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leukopenia) or haemoglobin concentration, detected in blood tests
low number of platelets in blood, sometimes with bleeding or skin bruising (thrombocytopenia)
increased blood glucose levels detected in blood tests, presence of glucose in urine, worsening of diabetes in diabetic patients
increased skin sensitivity to light (photosensitivity)
increased calcium levels in blood (hypercalcaemia)

Very rare (may affect less than 1 in 10,000 people):
liver inflammation (in most cases with cholestasis)
rash on the face, joint pain, muscle complaints, fever (lupus erythematosus), reactivation of systemic lupus erythematosus
inflammation of blood vessels with symptoms such as rash, purplish-red spots on the skin, fever (necrotising vasculitis)
severe skin reaction causing rash, skin redness, blister formation on lips, eyes or in the mouth, skin peeling, fever (toxic epidermal necrolysis)
gingival hyperplasia
increased muscle tension
peripheral nerve disease which may cause muscle weakness, tingling or numbness (peripheral neuropathy)
abdominal distension (gastritis)
inflammation of blood vessels, often with skin rash
disorders involving stiffness, tremor and/or difficulty moving
severe abdominal pain (pancreatitis)
damage to red blood cells causing paleness, fatigue, shortness of breath, dark urine colour (haemolytic anaemia)
allergic reactions (hypersensitivity reactions)
acid-base imbalance disorder causing disorientation, fatigue, muscle cramps and spasms, rapid breathing (hypochloraemic alkalosis)
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary oedema)
acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion)

Frequency not known (cannot be estimated from available data):
Inform the doctor if any of the following symptoms significantly worsen or persist for longer than a few days.
attention disturbances
change in colour of fingers and toes after cold exposure, and sensation of tingling or pain upon warming (Raynaud's phenomenon)
slowed or impaired reactions
burning sensation
smell disturbances
severe skin disease causing rash, skin redness, blister formation on lips, eyes or in the mouth, skin peeling, fever (erythema multiforme)
urine concentration (dark colour), nausea or vomiting, muscle cramps, confusion and seizures, which may be caused by inappropriate antidiuretic hormone (vasopressin) secretion – if such symptoms occur, contact the doctor as soon as possible
tremor, rigid posture, mask-like face, slowed movements and shuffling, unsteady gait
sudden loss of distance vision (acute myopia), blurred vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute closed-angle glaucoma)
skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ramipril + Amlodipine + Hydrochlorothiazide Adamed

Store below 30°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister after EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack 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 ramipril, 5 mg amlodipine (as 6.934 mg amlodipine besylate), 12.5 mg hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 12.5 mg, hard capsules:
Each capsule contains 5 mg ramipril, 5 mg amlodipine (as 6.934 mg amlodipine besylate), 12.5 mg hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 5 mg + 25 mg, hard capsules:
Each capsule contains 5 mg ramipril, 5 mg amlodipine (as 6.934 mg amlodipine besylate), 25 mg hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 5 mg + 10 mg + 25 mg, hard capsules:
Each capsule contains 5 mg ramipril, 10 mg amlodipine (as 13.868 mg amlodipine besylate), 25 mg hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 5 mg + 25 mg, hard capsules:
Each capsule contains 10 mg ramipril, 5 mg amlodipine (as 6.934 mg amlodipine besylate), 25 mg hydrochlorothiazide.
Ramipril + Amlodipine + Hydrochlorothiazide Adamed, 10 mg + 10 mg + 25 mg, hard capsules:
Each capsule contains 10 mg ramipril, 10 mg amlodipine (as 13.868 mg amlodipine besylate), 25 mg hydrochlorothiazide.

Other ingredients:

Capsule contents: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, pregelatinized maize starch, sodium carboxymethyl starch (type A), sodium stearyl fumarate
Capsule shell (2.5 mg + 5 mg + 12.5 mg): iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
Capsule shell (5 mg + 5 mg + 25 mg): iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
Capsule shell (5 mg + 10 mg + 25 mg): iron oxide red (E 172), iron oxide black (E 172), titanium dioxide (E 171), gelatin
Capsule shell (10 mg + 5 mg + 25 mg): iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
Capsule shell (10 mg + 10 mg + 25 mg): iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), titanium dioxide (E 171), gelatin
Capsule shell (5 mg + 5 mg + 12.5 mg): iron oxide red (E 172), iron oxide black (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 grey 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 grey 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.

Pack sizes contain 10, 28, 30, 60 or 100 hard capsules in blister packs, packed in a cardboard box.
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
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Ramipril/Amlodipin/HCT Genericon
Bulgaria Ramira Trio 5 mg/5 mg/12.5 mg hard capsules
Ramipril/Amlodipine/Hydrochlorothiazide Adamed
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 further information about this medicinal product, please contact:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów