Candesartan Cilexetil + Amlodipine + Hidrohlorothiazide Adamed

PATIENT INFORMATION LEAFLET

Enclosed patient information leaflet

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

Candesartan cilexetil+Amlodipine+Hydrochlorothiazide

You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, please 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, please inform your doctor. See section 4.

Table of contents of the leaflet

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

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

Whatitisusedfor
The name of this 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.
They work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes blood vessels to relax and widen, which helps to lower blood pressure.
• Amlodipine, which belongs to a group of medicines called calcium channel blockers, also causes blood vessels to relax, making it easier for blood to flow through them.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (water pills). It helps the body get rid of excess water and salt (sodium) in the urine, which helps to lower blood pressure. The action of these substances helps to lower blood pressure. Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed can be used to treat high blood pressure in adult patients whose blood pressure is adequately controlled with the individual products given simultaneously at the same doses as in the combination product.

2. Important information before taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed

When not to take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed:

• if you are allergic to candesartan, amlodipine, hydrochlorothiazide, dihydropyridines, 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 if you are unsure, you should discuss this with your doctor before taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed.
• 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 potassium or sodium levels in your blood, or high calcium levels in your blood, which have not improved with treatment.
• if you have gout.
• if you are pregnant for more than 3 months.
• if you have severe liver disease with cholestasis or without cholestasis (disorders of bile secretion or blockage of bile flow from the gallbladder).
• if you have poor blood circulation to the tissues, with symptoms such as low blood pressure, low pulse, rapid heartbeat, or shock (including cardiogenic shock).
• if you have very low blood pressure.
• if blood flow from the heart is slowed down or blocked. This can happen when the blood vessel or valve carrying blood from the heart becomes narrowed (aortic stenosis).
• If you have had a heart attack with a reduced heart pumping function (acute myocardial infarction with a reduced left ventricular ejection fraction). You should not take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed if any of the above applies to you.

Warnings and precautions

Before taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, you should discuss this with your doctor, pharmacist, or nurse.

Youmusttellyourdoctorif you are taking any of the following medicines for high blood pressure:

• An ACE inhibitor (such as enalapril, lisinopril, ramipril), especially in patients with kidney problems related to diabetes.
• Aliskiren.
• An ACE inhibitor and a medicine belonging to a group of medicines called mineralocorticoid receptor antagonists (MRAs) at the same time. These medicines are used to treat heart failure (see "Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed and other medicines"). Your doctor may regularly check your kidney function, blood pressure, and the levels of electrolytes (such as potassium) in your blood. See also the information under "When not to take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed" and "Warnings and precautions". Youmustcontactyourdoctorif you have any of the following health problems:
• Kidney problems, kidney transplant, or dialysis.
• Liver disease.
• Previous heart attack or stroke
• Hardening of the arteries in the heart or brain
• Heart failure or problems with heart valves or heart muscle.
• Very high blood pressure (hypertensive crisis)
• Appearance of skin cancer or unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially long-term and with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, you should protect your skin from sun exposure and UV radiation.
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or a low-sodium diet.
• High potassium levels in the blood.
• Adrenal gland problems.
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergies or asthma.
• Skin reactions, such as sunburn or rash after sun exposure or using a sunbed.

Youmustcontactyourdoctorif you experience any of the following symptoms:

• Severe, persistent diarrhea causing significant weight loss. Your doctor may assess your symptoms and decide how to continue treatment with the blood pressure-lowering medicine.
• Blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (acute angle-closure glaucoma), which can occur within a few hours to a week after taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. If left untreated, they can lead to permanent vision loss. The risk of developing these disorders may be higher in patients who have previously been allergic to penicillin or sulfonamides.
• If you have had breathing or lung problems in the past (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, you should see your doctor immediately.

If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, you should 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 planning to have surgery, you should tell your doctor or dentist that you are taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. This is because Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, in combination with certain anesthetics, may cause a significant drop in blood pressure.
As with other blood pressure-lowering medicines, excessive lowering of blood pressure may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may increase cholesterol and uric acid levels in the blood (a cause of gout - a painful swelling of the joints). Your doctor may order blood tests.
This medicine may cause changes in the levels of certain chemicals in the blood, called electrolytes. Your doctor may order periodic blood tests to check the levels of these substances. Symptoms of electrolyte changes include: thirst, dry mouth, muscle cramps or spasms, muscle weakness, low blood pressure (hypotension), feeling of weakness, drowsiness, fatigue, or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Youmusttellyourdoctorifyounoticesuchsymptoms.
If you are going to have a parathyroid function test, you should stop taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed before the test.
If you are pregnant or think you may be pregnant (or plan to become pregnant), you should not take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed in early pregnancy and must not take it after the 3rd month of pregnancy, as it may cause serious harm to your baby (see section "Pregnancy and breastfeeding").

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed and other medicines

You should tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take, i.e.

• Other blood pressure-lowering medicines, as the effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may be increased. Your doctor may change the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also the information under "When not to take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed" and "Warnings and precautions").
• An ACE inhibitor and certain other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone).
• Lithium (a medicine used to treat mood swings and certain types of depression), taken with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, may show increased toxicity. If you need to take lithium, your doctor will check your lithium levels in the blood.
• Antiepileptic medicines, such as carbamazepine (antiepileptic and anticonvulsant medicines).
• Diltiazem, verapamil, used to treat irregular heart rhythms and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, used to treat tuberculosis and other infections.
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression.
• Cisapride, used to stimulate stomach and intestinal movement.
• Difemanil, used to treat slow heartbeat or to reduce sweating.
• Halofantrine, used to treat malaria.
• Vinca alkaloids (given intravenously) used to improve blood flow to the nervous system.
• Amantadine, used to treat Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, diuretics, heparin (to thin the blood and prevent blood clots),
• Laxatives,
• Steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth ulcers and stomach ulcers), penicillin - an antibiotic). Taking these medicines with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may change potassium levels in the blood.
• Trimethoprim/sulfamethoxazole (a combination of antibiotics).
• Non-steroidal anti-inflammatory medicines (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, may increase the risk of kidney failure. NSAIDs may weaken the effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. With high doses of salicylates, there may be an increased toxic effect on the central nervous system.
• Sleeping medicines, sedatives, and antidepressants, as taking these medicines with Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may cause a sudden drop in blood pressure when changing position from sitting to standing.
• Cholestyramine, a medicine used to lower cholesterol levels in the blood, as it may reduce the effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. Your doctor may recommend taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed at least 4 hours before cholestyramine.
• Certain antacids (medicines used to neutralize stomach acid), as they may slightly reduce the effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and bipiperiden.
• Calcium supplements.
• Dantrolene (an intravenous medicine used to treat severe body temperature disorders).
• Simvastatin, used to lower cholesterol and fat levels in the blood.
• Medicines used to control the body's immune response (such as tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which allow the body to accept a transplanted organ.
• Medicines used to treat certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Medicines used to treat low blood sugar (such as diazoxide) or high blood pressure (such as beta-blockers, methyldopa), as Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may affect the action of these medicines.
• Medicines used to treat irregular heart rhythms, such as dofetilide or ibutilide.
• Medicines used to treat HIV/AIDS infection (such as ritonavir, indinavir, nelfinavir).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, amphotericin).
• Medicines used to treat heart conditions, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis glycosides.
• Medicines used to treat cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Medicines that increase blood pressure (such as noradrenaline) and slow the heart rate.
• Medicines used to treat infections, such as antibiotics called tetracyclines or sparfloxacin, and pentamidine.
• Medicines used to treat seasonal allergic reactions, such as mizolastine or terfenadine.
• Medicines used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Medicines used to lower fat levels in the blood, such as cholestyramine and colestipol.
• Medicines used to lower blood sugar levels, 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 eat grapefruits. Grapefruits and grapefruit juice may increase the levels of the active substance amlodipine in the blood, which may cause unpredictable enhancement of the blood pressure-lowering effect of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed.
When taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, you should be cautious when drinking alcohol, as some people may feel weak or dizzy. In such cases, you should not drink alcohol.

Elderly patients

In patients over 65 years of age, the doctor will regularly check blood pressure after each dose increase to ensure that it has not been excessively lowered.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor before taking this medicine.
Pregnancy
Usually, your doctor will advise you to stop taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed before planned pregnancy or as soon as you find out you are pregnant, and will prescribe a different medicine instead of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed. You should not take Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed during pregnancy and should not take it after the 3rd month of pregnancy, as it may have very harmful effects on your baby.
If you become pregnant while taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, you should inform your doctor immediately and have a consultation with him.
Breastfeeding
Amlodipine and hydrochlorothiazide have been shown to pass into breast milk in small amounts. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed, and your doctor may choose a different treatment for you if you want to breastfeed, especially if your baby is a newborn or premature.
Fertility
Clinical data on the potential effects of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed on fertility are insufficient.

Driving and using machines

During treatment for high blood pressure, you may experience drowsiness, nausea, or dizziness, or headache. If you experience any of these symptoms, you should not drive or operate machinery. You should consult your doctor.

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed contains azorubine (E122) and yellow-orange (E110)

They may cause allergic reactions.

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

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.

• The recommended dose is one capsule of the strength prescribed by your doctor per day.
• The capsule can be taken with or without food. The capsule should be swallowed with a liquid (such as a glass of water). The capsule should not be chewed. Do not take the capsule with grapefruit juice or grapefruits.
• It is recommended to take the daily dose at the same time each day, for example, at breakfast time.

Childrenandadolescents:
Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed should not be used in children and adolescents under 18 years of age, as the safety and efficacy of this medicine in this age group have not been established.
Elderlypatients:
Special care should be taken in elderly patients due to their susceptibility to disturbances in electrolyte balance.
Kidneyproblems:
When taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed in patients with mild or moderate kidney problems, it is recommended to periodically check kidney function. Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed should not be used in patients with severe kidney problems.
Liverproblems:
It is recommended to carefully monitor blood pressure and kidney function in patients with liver problems. Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed should not be used in patients with severe liver problems.

What to do if you take more Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed than you should

than you should

If you take more capsules than you should, you may experience low blood pressure with symptoms such as dizziness, rapid or slow heartbeat.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may occur 24-48 hours after taking the medicine.
If you take more capsules than you should, or if a child accidentally swallows several capsules, you should immediately see a doctor or go to the nearest emergency room, taking the medicine packaging or this leaflet with you.
IfyouforgettotakeCandesartanCilexetil+Amlodipine+HydrochlorothiazideAdamed
If you miss a dose, take your normal dose the next day at the usual time. Do not take a double dose to make up for a missed dose.
IfyoustoptakingCandesartanCilexetil+Amlodipine+HydrochlorothiazideAdamed
It is important to continue taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed unless your doctor tells you to stop. If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed and immediatelysee a doctor if you experience any of the following serious side effects after taking this medicine :

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat, causing severe breathing difficulties
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular heartbeat
• Pancreatitis, which can cause severe abdominal and back pain, accompanied by a general feeling of being unwell
• Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed may cause a decrease in the number of white blood cells. This may lead to an increased risk of infections and you may notice fatigue, infection, or fever. In such cases, you should contact your doctor. Your doctor may order periodic blood tests to check if Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed has affected your blood composition (agranulocytosis).
• Sudden severe eye pain, redness of the eyes, vision disturbances, or blurred vision, and seeing halos around light sources, accompanied by nausea/vomiting. This may be a sign of fluid accumulation in the eye (choroidal effusion) or acute angle-closure glaucoma, which can occur with a sudden increase in eye pressure. Immediate treatment is necessary to alleviate symptoms and prevent permanent vision loss (severe vision disturbances).

Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed is a combination of three active substances. The following side effects are known for each of them separately.
To give you an idea of how often side effects may occur, they are listed as: very common, common, uncommon, rare, very rare, and not known.

Very common (may affect more than 1 in 10 people)

• Edema (fluid retention).

Common (may affect up to 1 in 10 people)

• Hypokalemia (low potassium levels in the blood), especially with high doses,
• Increased lipid levels in the blood,
• Respiratory tract infection,
• Hyperglycemia (high blood sugar),
• Hyperuricemia (high uric acid levels),
• Drowsiness,
• Dizziness, vertigo, headache,
• Vision disturbances (including double vision),
• Palpitations (irregular heartbeat),
• Flushing (including feeling hot),
• Shortness of breath,
• Abdominal pain, nausea, vomiting,
• Changes in bowel movements, constipation, diarrhea,
• Rash, hives,
• Swelling of the ankles,
• Muscle cramps,
• Feeling tired, weak,

Uncommon (may affect up to 1 in 100 people)

• Depression, mood changes (including anxiety), insomnia,
• Tremors,
• Vomiting,
• Taste disturbances,
• Fainting,
• Numbness, paresthesia (abnormal sensations),
• Tinnitus,
• Heart rhythm disturbances (including slow heartbeat (bradycardia)),
• Rapid heartbeat (ventricular tachycardia) and irregular heartbeat (atrial fibrillation),
• Low blood pressure (hypotension), orthostatic hypotension (low blood pressure when standing up, which may be increased by consuming alcohol, taking anesthetics, or sedatives),
• Low magnesium levels in the blood, high calcium levels in the blood, acid-base balance disturbances with low chloride levels, low phosphate levels in the blood, low sodium levels in the blood,
• Cough,
• Rhinitis,
• Dry mouth,
• Hair loss, excessive sweating, itching, red spots on the skin, skin discoloration,
• General feeling of being unwell,
• Chest pain, pain, back pain,
• Joint pain,
• Muscle pain,
• Urination disturbances, nocturia, increased urination frequency,
• Impotence, discomfort in the breast area or breast enlargement in men, inability to achieve an erection,
• Decreased appetite,
• Weight gain or weight loss,
• Photosensitivity reactions.

Rare (may affect up to 1 in 1,000 people)

• Thrombocytopenia (abnormally low platelet count), sometimes with bleeding into the skin (purpura),
• Shortness of breath with cough and feeling tired or coughing up blood
• Vasculitis with symptoms such as rash, purple spots on the skin, fever
• Gastrointestinal disturbances,
• Pancreatitis
• Confusion,
• Sleep disturbances,
• Jaundice, yellowing of the skin and whites of the eyes (yellow or greenish discoloration of the skin and eyes),
• Kidney failure or kidney problems,
• Fever,

Very rare (may affect up to 1 in 10,000 people)

• Blood disorders, such as neutropenia (low neutrophil count, a type of white blood cell),
• Suppression of bone marrow function (reduced blood cell production in the bone marrow),
• Severe shortness of breath
• Red spots and blisters on the skin, resembling a target, fatigue, fever, joint pain or kidney problems - the most common symptoms of a condition called lupus erythematosus.
• Rash with red, non-itchy, flaky patches
• Hemolytic anemia,
• 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 diarrhea,
• Gingival hyperplasia,
• Increased liver enzyme activity, liver problems, hepatitis.

Not known (cannot be estimated from the available data)

• Aplastic anemia (a condition in which the bone marrow is damaged and the blood cell-producing cells are destroyed),
• Extrapyramidal disorders (clinical syndromes characterized by excessive movement or a small amount of voluntary and involuntary movements, not related to weakness or spasticity),
• Acute kidney failure,
• Skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor.
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 Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Exp". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed contains

The active substances of this 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 ingredients are:
Filler: lactose monohydrate, corn starch, hydroxypropyl cellulose, calcium carboxymethylcellulose, macrogol (type 8000), 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

Ink: shellac, iron oxide black (E 172), propylene glycol, concentrated ammonia, 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
The capsule is a hard, size "0" gelatin capsule; the body is white with black printing "1", the cap is orange with black printing "CAH", filled with a white or off-white powder of Candesartan Cilexetil + Amlodipine + Hydrochlorothiazide Adamed 16 mg+10 mg+12.5 mg hard capsules
The capsule is a hard, size "0" gelatin capsule; the body is white with black printing "2", the cap is red with black printing "CAH", filled with a white or off-white powder
Available in packs of 7, 10, 28, 30, 60, 90, and 100 hard capsules.
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
tel.: +48 22 732 77 00

Manufacturer

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

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

This medicinal product is approved 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

Date of last revision of the leaflet: January 2025