Candesartan cilexetil + amlodipine + hydrochlorothiazide adamed: detailed information

Package leaflet: Information for the user

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, 16 mg + 5 mg + 12.5 mg,
hard capsules
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, 16 mg + 10 mg + 12.5 mg,
hard capsules
Candesartanum cilexetili + Amlodipinum + Hydrochlorothiazidum
Read 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.
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 experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Contents of the leaflet

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

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

The name of the medicine is Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. It is used to treat high blood pressure (hypertension) in adult patients. It contains three active substances: candesartan cilexetil, amlodipine besylate, and hydrochlorothiazide. Together, they work to lower blood pressure.

Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It relaxes and widens blood vessels, helping to reduce blood pressure.
Amlodipine, which belongs to a group of medicines called calcium channel blockers, also relaxes blood vessels, making it easier for blood to flow through them.
Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps the body get rid of water and salt (sodium) through urine, which helps lower blood pressure. The combined action of these substances helps reduce blood pressure. Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may be used to treat high blood pressure (hypertension) in adult patients whose blood pressure is adequately controlled with the individual components given at the same doses as in this fixed combination product, but administered as separate tablets.

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

Do not take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed:

if you are allergic to candesartan, amlodipine, hydrochlorothiazide, dihydropyridine derivatives, sulfonamides, or any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic to any of the ingredients of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed or are unsure, consult your doctor before taking this medicine.
if you have severe kidney disease.
if you are unable to produce urine (anuria).
if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.
if you have low levels of potassium or sodium, or high levels of calcium in your blood that have not improved with treatment.
if you have gout.
if you are more than 3 months pregnant (it is also best to avoid this medicine in early pregnancy – see section on pregnancy).
if you have severe liver problems with or without cholestasis (a disorder in bile secretion or blockage of bile flow from the gallbladder).
if you have poor tissue perfusion, with symptoms such as low blood pressure, slow heart rate, rapid heartbeat, or shock (including cardiogenic shock).
if you have very low blood pressure.
if blood flow from the heart is slowed or blocked. This may occur when blood vessels or heart valves carrying blood away from the heart become narrowed (aortic stenosis).
if you have low cardiac output after a heart attack (acute myocardial infarction). Do not take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed if any of the above apply to you.

Warnings and precautions
Before taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, discuss this with your doctor, pharmacist, or nurse.
Tell your doctor if you are taking any of the following medicines used to treat high blood pressure:

an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems due to diabetes.
aliskiren.
an ACE inhibitor together with a medicine belonging to a group known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see section "Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed and other medicines"). Your doctor may regularly monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood. See also the information under the heading "Do not take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed".

Contact your doctor if you have any of the following health problems:

Kidney problems, kidney transplant, or dialysis.
Liver disease.
Previous heart attack or stroke.
Atherosclerosis of the coronary or cerebral arteries.
Heart failure or problems with heart valves or heart muscle.
Very high blood pressure (hypertensive crisis).
Skin cancer or unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially long-term and at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). While taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, protect your skin from exposure to sunlight and UV rays.
Severe vomiting, diarrhoea, treatment with high doses of diuretics (water tablets), or a low-sodium diet.
High potassium levels in the blood.
Adrenal gland disorders.
Diabetes.
Systemic lupus erythematosus (an autoimmune disease).
Allergies or asthma.
Skin reactions such as sunburn or rash after sun exposure or using a sunbed.

Contact your doctor if you experience any of the following symptoms:

Severe, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to continue treatment with blood pressure-lowering medicines.
Blurred vision or eye pain. These may be signs 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 from a few hours to a week after taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. If left untreated, they may lead to permanent vision loss. The risk of such disorders may be higher in patients who previously had an allergic reaction to penicillin or sulfonamides.
If you previously had breathing problems or lung issues (including pneumonia or fluid in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, seek medical help immediately.

If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed on your own. If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. This medicine, in combination with certain anaesthetics, may cause excessive lowering of blood pressure. As with other blood pressure-lowering medicines, excessive reduction in blood pressure may lead to heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure. Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may increase blood levels of cholesterol and uric acid (a cause of gout – painful joint swelling). Your doctor may order blood tests. This medicine may cause changes in certain chemicals in the blood called electrolytes. Your doctor may order periodic blood tests to monitor these substances. Symptoms of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling weak, drowsiness, fatigue, sleepiness, restlessness, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if you notice any of these symptoms. If you are scheduled for parathyroid function tests, you should stop taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed before the tests. If you think you are pregnant (or might become pregnant), it is not recommended to take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed in early pregnancy, and it must not be used after the 3rd month of pregnancy, as it may cause severe harm to the unborn child (see section "Pregnancy and breastfeeding").

Children and adolescents
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed is not recommended for use in children and adolescents under 18 years of age.

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take, including:

Other blood pressure-lowering medicines, as the effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may be enhanced. Your doctor may adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed" and "Warnings and precautions").
An ACE inhibitor together with certain other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).
Lithium (a medicine used to treat mood disorders and certain types of depression), when taken together with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, may show increased toxicity. If you must take lithium, your doctor will monitor lithium levels in your blood.
Antiepileptic medicines such as carbamazepine (antiepileptic and anticonvulsant medicines).
Diltiazem, verapamil, used for heart rhythm disorders and high blood pressure.
Rifampicin, erythromycin, clarithromycin, used to treat tuberculosis and other infections.
St John's wort (Hypericum perforatum), a herbal remedy used to treat depression.
Cisapride, used to stimulate gastric and intestinal motility.
Difemanil, used to treat slow heart rate or to reduce sweating.
Halofantrine, used to treat malaria.
Vinpocetine (given intravenously) used to improve blood flow in the nervous system.
Amantadine, used in Parkinson's disease.
Potassium supplements, potassium-containing salt substitutes, diuretics (water tablets), heparin (to thin the blood and prevent blood clots).
Laxatives.
Steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth ulcers and gastric ulcers), penicillin (an antibiotic). Taking these medicines together with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may alter potassium levels in the blood.
Trimethoprim/sulfamethoxazole (a combination of antibiotics).
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other signs of inflammation, including joint inflammation), when taken together with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, may increase the risk of kidney failure. NSAIDs may reduce the effectiveness of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. High doses of salicylates may enhance toxic effects on the central nervous system.
Sleeping pills, sedatives, and antidepressants, as taking these together with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may cause a sudden drop in blood pressure when changing position from sitting to standing.
Colesevelam hydrochloride, a cholesterol-lowering medicine, as it may reduce the effectiveness of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. Your doctor may recommend taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed at least 4 hours before colesevelam hydrochloride.
Some medicines that neutralize stomach acid (antacids or remedies for indigestion or heartburn), as they may slightly reduce the effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed.
Some muscle relaxants such as baclofen and tubocurarine.
Anticholinergic medicines such as atropine and biperiden.
Calcium supplements.
Dantrolene (an infusion used in severe temperature disorders).
Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
Medicines used to control the body's immune response (e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), allowing the body to accept a transplanted organ.
Medicines used to treat certain psychiatric disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
Medicines used to treat low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), as Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may affect their action.
Medicines used to treat heart rhythm disorders, such as dofetilide or ibutilide.
Medicines used to treat HIV/AIDS infection (e.g., ritonavir, indinavir, nelfinavir).
Medicines used to treat fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
Medicines used to treat heart disease, e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis glycosides.
Medicines used to treat cancer, e.g., amifostine, cyclophosphamide, or methotrexate.
Medicines that increase blood pressure (e.g., noradrenaline) and slow heart rate.
Medicines used to treat infections, e.g., antibiotics called tetracyclines or sparfloxacin, and pentamidine.
Medicines used to treat seasonal allergies, e.g., mizolastine or terfenadine.
Medicines used to treat gout, e.g., probenecid, sulfinpyrazone, and allopurinol.
Medicines that lower blood fat levels, e.g., cholestyramine and colestipol.
Medicines that lower blood sugar, such as metformin or insulin.

Taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed with food, drink, and alcohol
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed can be taken with or without food.
Patients taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed should not consume grapefruit juice or grapefruits. Grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could unpredictably enhance the hypotensive effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed.
Exercise caution when drinking alcohol while taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, as some people may feel unwell or experience dizziness. In such cases, do not drink alcohol.

Elderly patients
In patients over 65 years of age, your doctor will regularly monitor blood pressure after each dose increase to ensure it is not excessively lowered.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.

Pregnancy
Usually, your doctor will advise stopping Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed should not be used during pregnancy and must not be used after the 3rd month of pregnancy, as it may have very harmful effects on the unborn child.
If you become pregnant while being treated with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, inform your doctor immediately and schedule a consultation.

Breastfeeding
It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. Your doctor may choose another treatment, especially if the baby is a newborn or premature.

Fertility
Clinical data on the potential effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed on fertility are insufficient.

Driving and operating machinery
During treatment for high blood pressure, you may experience drowsiness, nausea, dizziness, or headache. If you experience any of these symptoms, do not drive or operate machinery. Consult your doctor.

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed contains azorubine (E122) and sunset yellow (E110)
These may cause allergic reactions.

3. How to use Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.

The recommended dose is one capsule per day, as indicated by your doctor.
The capsule can be taken independently of meals. Swallow the capsule whole with liquid (for example, a glass of water). Do not chew the capsules. Do not take the capsule with grapefruit juice or grapefruit.
Whenever possible, take the daily dose at the same time each day, for example at breakfast time.

Children and adolescents:
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy have not been established in this population.

Elderly patients:
Particular caution should be exercised in elderly patients due to their susceptibility to electrolyte imbalances.

Renal function disorders:
When using Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed in patients with mild to moderate renal impairment, periodic monitoring of renal function is recommended. Use of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed is contraindicated in patients with severe renal impairment.

Hepatic function disorders:
Careful monitoring of blood pressure and renal function is recommended in patients with hepatic impairment. Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed is contraindicated in patients with severe hepatic impairment.

Overdose of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed
If more capsules than recommended are taken, a drop in blood pressure may occur, with symptoms such as dizziness, rapid or slow heartbeat. Excess fluid may accumulate in the lungs (pulmonary oedema), causing breathlessness, which may develop within 24–48 hours after taking the medicine.

If more than the recommended number of capsules is taken, or if a child accidentally swallows several capsules, seek immediate medical advice from a doctor or the nearest emergency department, taking the medicine packaging or this leaflet with you.

Missed dose of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed
If a dose is missed, take the next dose at the usual time and in the usual amount. Do not take a double dose to make up for a missed dose.

Stopping Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed
It is important to continue taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed unless your doctor advises otherwise.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed should be discontinued and
immediately consult a doctor if any of the following serious adverse reactions occur after taking this medicine:

sudden wheezing, chest pain, breathlessness or difficulty breathing
swelling of the eyelids, face or lips
swelling of the tongue and throat, causing significant breathing difficulties
severe skin reactions, including intense skin rash, urticaria, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
heart attack, irregular heartbeat
pancreatitis, which may cause severe abdominal and back pain accompanied by a general feeling of being unwell
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may cause a decrease in white blood cell count. This may reduce immunity to infections, and the patient may experience fatigue, infections or fever. In such a case, contact a doctor. The doctor may recommend periodic blood tests to monitor whether Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed has affected the patient's blood composition (agranulocytosis).
sudden severe eye pain, redness of the eyes, visual disturbances or blurred vision, and seeing halos around light sources, accompanied by nausea/vomiting. This may be a sign of fluid retention in the eye (between choroid and retina) or acute angle-closure glaucoma, which may occur due to a sudden increase in intraocular fluid pressure. Immediate treatment is required to relieve symptoms and prevent permanent vision loss (severe visual disturbances).

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed is a combination of three active substances. The adverse reactions listed below are those known for each substance individually. To provide an indication of how many patients may be affected, the reactions are categorized as very common, common, uncommon, rare, very rare, and frequency not known.
Very common (may affect more than 1 in 10 people)

Edema (fluid retention).

Common (may affect up to 1 in 10 people)

Hypokalaemia (reduced potassium levels in blood), particularly with high doses,
Increased lipid levels in blood serum,
Respiratory tract infection,
Hyperglycaemia (increased blood sugar),
Hyperuricaemia (increased uric acid levels),
Drowsiness,
Dizziness, vertigo, headache,
Visual disturbances (including double vision),
Palpitations (irregular heartbeat),
Skin redness, including sensation of warmth,
Dyspnoea,
Abdominal pain, indigestion, nausea,
Changes in bowel habits, constipation, diarrhoea,
Rash, urticaria,
Ankle swelling,
Muscle cramps,
Feeling of fatigue, weakness,

Uncommon (may affect up to 1 in 100 people)

Depression, mood changes (including anxiety), insomnia,
Tremor,
Vomiting,
Taste disturbances,
Fainting,
Hypoaesthesia, paraesthesia (abnormal sensations),
Tinnitus,
Heart rhythm disorders (including slow heartbeat (bradycardia)),
Accelerated heartbeat (ventricular tachycardia) and irregular heartbeat (atrial fibrillation),
Hypotension (low blood pressure), orthostatic hypotension (low blood pressure, which may be increased by alcohol consumption, anaesthetics or sedatives),
Hypomagnesaemia, hypercalcaemia, acid-base imbalance with chloride deficiency, decreased phosphate levels in blood, hyponatraemia,
Cough,
Rhinitis,
Dry mouth,
Alopecia, excessive sweating, skin itching, red skin spots, skin discoloration,
Malaise,
Chest pain, pain, back pain,
Joint pain,
Muscle pain,
Urinary disorders, nocturia, increased frequency of urination,
Impotence, discomfort in the breast area or breast enlargement in men, inability to achieve erection,
Decreased appetite,
Increase or decrease in body weight,
Photosensitivity reactions.

Rare (may affect up to 1 in 1000 people)

Thrombocytopenia (abnormally low platelet count), sometimes with skin bleeding (purpura),
Dyspnoea with cough and fatigue or coughing up blood
Vasculitis (inflammation of blood vessels) with symptoms such as rash, purple-red skin spots, fever
Gastrointestinal disorders,
Pancreatitis
Confusion,
Sleep disorders,
Jaundice, yellowing of the skin (yellow or greenish discoloration of skin and whites of the eyes),
Kidney failure and kidney function disorders,
Fever,

Very rare (may affect less than 1 in 10,000 people)

Blood disorders such as neutropenia (reduced neutrophil count, a type of white blood cell),
Bone marrow suppression (impaired bone marrow haematopoietic function),
Severe dyspnoea
Red spots and blisters on the skin resembling target lesions, fatigue, fever, joint pain or swelling and kidney problems – most common symptoms of a disease called systemic lupus erythematosus.
Rash with red, non-itchy, scaly lesions
Haemolytic anaemia,
Allergic reactions,
Vasculitis (inflammation and destruction of blood vessels),
High potassium levels,
Increased muscle tone,
Peripheral neuropathy,
Gastritis,
Intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
Gingival hyperplasia,
Increased liver enzyme activity, liver function disorders, hepatitis.

Frequency not known (cannot be estimated from available data)

Aplastic anaemia (a disease in which bone marrow and haematopoietic stem cells are damaged),
Extrapyramidal disorders (clinical syndromes characterized by excessive movement or reduced voluntary and involuntary movements, unrelated to weakness or spasticity),
Acute kidney failure,
Skin and lip cancer (non-melanoma skin cancer). Reporting of adverse reactions If any adverse reactions occur in a patient, including any adverse reactions not listed in this leaflet, inform a doctor. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps gather additional information on the safety of the medicine.

5. How to store Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed

Do not store above 30°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging after the abbreviation "Exp". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What the medicine Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed contains
The active substances of the medicine are:
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, 16 mg+5 mg+12.5 mg, hard capsules
The active substances in one capsule are: 16 mg of candesartan cilexetil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed 16 mg+10 mg+12.5 mg hard capsules
The active substances in one capsule are: 16 mg of candesartan cilexetil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Other components are:
Capsule filling: Monohydrate lactose, corn starch, hydroxypropylcellulose, calcium carmellose, polyethylene glycol (type 8000), pregelatinized corn starch, magnesium stearate
Capsule shell (16 mg+5 mg+12.5 mg):

Body: Titanium dioxide (E 171), gelatin
Cap: Orange yellow (E 110), titanium dioxide (E 171), gelatin

Capsule shell (16 mg+10 mg+12.5 mg):

Body: Titanium dioxide (E 171), gelatin
Cap: Azorubine (E 122), orange yellow (E 110), titanium dioxide (E 171), gelatin

Printing ink: Shellac, iron oxide black (E 172), propylene glycol, concentrated ammonium hydroxide, potassium hydroxide.

What Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed looks like and contents of the pack
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed 16 mg+5 mg+12.5 mg hard capsules
Hard gelatin capsule, size "0"; white body with black print "1", orange cap with black print "CAH", filled with white or almost white powder.
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed 16 mg+10 mg+12.5 mg hard capsules
Hard gelatin capsule, size "0"; white body with black print "2", red cap with black print "CAH", filled with white or almost white powder.
Available in packs containing 7, 10, 28, 30, 60, 90 and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

This medicinal product is authorised in the European Economic Area countries under the following names:
Greece: CARDITRAT PLUS
Italy: LODICAND HCTZ
Portugal: Candesartan cilexetil/Amlodipine/Hydrochlorothiazide Adamed
Croatia: Kandesartancileksetil/amlodipin/hidroklorotiazid Adamed