Candesartan cilexetil + Amlodipine + Hct +pharma

Leaflet attached to the packaging: patient information

Candesartan cilexetil + Amlodipine + HCT+pharma, 16 mg + 5 mg + 12.5 mg, hard capsules
Candesartan cilexetil + Amlodipine + HCT+pharma, 16 mg + 10 mg + 12.5 mg, hard capsules
Candesartanum cilexetili + Amlodipinum + Hydrochlorothiazidum

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Candesartan cilexetil + Amlodipine + HCT +pharmaand what is it used for
• 2. Important information before taking Candesartan cilexetil + Amlodipine + HCT +pharma
• 3. How to take Candesartan cilexetil + Amlodipine + HCT +pharma
• 4. Possible side effects
• 5. How to store Candesartan cilexetil + Amlodipine + HCT +pharma
• 6. Contents of the packaging and other information

1.

What is Candesartan cilexetil + Amlodipine + HCT+pharmaand what is it used for
The name of the medicine is Candesartan cilexetil + Amlodipine + HCT +pharma. It is used to treat
high blood pressure (hypertension) in adult patients. The medicine 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. Its action is to relax and dilate blood vessels, which helps to lower blood pressure.
• Amlodipine, which belongs to a group of medicines called calcium antagonists, works by relaxing blood vessels, making it easier for blood to flow through them.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (water pills). It helps to remove water and salt, such as sodium, from the body in the urine. This helps to lower blood pressure. The action of these substances contributes to lowering blood pressure.

Candesartan cilexetil + Amlodipine + HCT +pharmamay be used to treat high blood pressure in adult
patients who have achieved adequate blood pressure control with single-agent therapy at the same
doses as in this combination, but in the form of separate tablets.

2. Important information before taking Candesartan cilexetil + Amlodipine + HCT

+pharma
Do not take Candesartan cilexetil + Amlodipine + HCT+pharmaif:

• 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 have been diagnosed with an allergy to the ingredients of Candesartan cilexetil + Amlodipine + HCT +pharmaor you are not sure if this situation applies to you, you should consult your doctor before taking Candesartan cilexetil + Amlodipine + HCT +pharma.

if you have severe kidney problems

• you are unable to produce urine (anuria)
• you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren
• you have low levels of potassium or sodium, or high levels of calcium in the blood that do not improve with treatment
• you have gout
• you are pregnant for more than 3 months
• you have severe liver problems with cholestasis or without cholestasis (disrupted bile secretion or blockage of bile flow from the gallbladder)
• you have poor tissue perfusion with symptoms such as low blood pressure, slow pulse, rapid heartbeat, or shock (including cardiogenic shock)
• you have very low blood pressure
• blood flow from the heart is slow or blocked. This can happen if a blood vessel or valve that carries blood from the heart becomes narrowed (aortic stenosis)
• you have a small cardiac output after a heart attack (acute myocardial infarction) Do not take Candesartan cilexetil + Amlodipine + HCT +pharmaif any of the above situations apply to you.

Warnings and precautions Before taking Candesartan cilexetil + Amlodipine + HCT+pharma, you should

discuss it with your doctor, pharmacist, or nurse.
Tell your doctorif you are taking any of the following medicines for high blood pressure:

• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney disease related to diabetes
• aliskiren
• an ACE inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRAs, English: mineralocorticoid receptors antagonists). These medicines are used to treat heart failure (see "Candesartan cilexetil + Amlodipine + HCT +pharmaand other medicines")

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also the section "When not to take Candesartan cilexetil + Amlodipine + HCT +pharma".
Tell your doctorif you have any of the following health problems:

• kidney problems or kidney transplant, or if you are on dialysis
• liver problems
• previous heart attack or stroke
• coronary artery disease or cerebral artery disease
• heart failure or problems with heart valves or heart muscle
• you have had a significant increase in blood pressure (hypertensive crisis)
• cancer of the skin or if you have had an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use of 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 + HCT +pharma, you should protect your skin from sun exposure and UV radiation.
• severe vomiting, diarrhea, treatment with high doses of diuretics (water pills), or a low-salt diet
• high levels of potassium 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

You should contact your doctorif you experience any of the following symptoms:

• diarrhea that is severe, persistent, and causes significant weight loss. Your doctor may assess the symptoms and decide how to continue treating high blood pressure
• blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (severe eye disorder) or increased pressure in the eye, which can occur from a few hours to a week after taking Candesartan cilexetil + Amlodipine + HCT +pharma. This can lead to permanent vision loss if left untreated. If you have previously been allergic to penicillin or sulfonamides, you may be more prone to developing this condition.
• you have had breathing or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartan cilexetil + Amlodipine + HCT +pharma, you should seek medical help immediately.

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Candesartan cilexetil + Amlodipine + HCT +pharma, you should discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Candesartan cilexetil + Amlodipine + HCT +pharmaon your own.
If you are scheduled for surgery, you should inform your doctor or dentist that you are taking Candesartan cilexetil + Amlodipine + HCT +pharma, as the simultaneous administration of certain anesthetics may cause excessive lowering of blood pressure.
As with any blood pressure-lowering medicine, excessive lowering of blood pressure can lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.
Candesartan cilexetil + Amlodipine + HCT +pharmamay cause an increase in cholesterol and uric acid levels in the blood (which can cause gout - painful joint swelling). Your doctor may order regular blood tests.
The medicine may change the levels of certain chemicals in the blood called electrolytes. Your doctor will likely periodically order blood tests to check electrolyte levels. Symptoms of changes in electrolyte levels include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling of weakness, lethargy, fatigue, drowsiness, or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. If you experience such symptoms, you should tell your doctor.
If you are going to have parathyroid function tests, you should stop taking Candesartan cilexetil + Amlodipine + HCT +pharmabefore the tests.
If you think you may be pregnant (or may become pregnant), you should tell your doctor.
Candesartan cilexetil + Amlodipine + HCT +pharmais not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to the fetus if taken during this period.

Children and adolescents

The use of Candesartan cilexetil + Amlodipine + HCT +pharmais not recommended in children and adolescents under 18 years of age.
Candesartan cilexetil + Amlodipine + HCT+pharmaand other medicines
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including:

• other medicines used to lower blood pressure, as the effect of Candesartan cilexetil + Amlodipine + HCT +pharmamay be enhanced. Your doctor may change the dose and/or take other precautions:
• if you are taking an ACE inhibitor or aliskiren (see also the information in the section "When not to take Candesartan cilexetil + Amlodipine + HCT +pharmaand "Warnings and precautions").
• ACE inhibitor in combination with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone)
• lithium (a medicine used to treat mental disorders and certain types of depression). Concomitant use with Candesartan cilexetil + Amlodipine + HCT +pharmamay increase lithium toxicity. If lithium is necessary, your doctor will check its level in the blood.
• antiepileptic medicines, such as carbamazepine (medicines used to treat epilepsy and seizures)
• diltiazem, verapamil (used to treat arrhythmias 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 increase the movement of food in the stomach and intestines)
• difemanil (used to treat slow heartbeat or increased sweating)
• halofantrine (used to treat malaria)
• iv vincamine (used to improve blood circulation in the nervous system)
• amantadine (used to treat Parkinson's disease)
• potassium supplements, salt substitutes containing potassium, diuretics (water pills), heparin (a blood thinner that prevents blood clots)
• laxatives
• corticosteroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), penicillin (an antibiotic) - concomitant use of these medicines and Candesartan cilexetil + Amlodipine + HCT +pharmamay 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), used concomitantly with Candesartan cilexetil + Amlodipine + HCT +pharma, may increase the risk of kidney failure. The effect of Candesartan cilexetil + Amlodipine + HCT +pharmamay be weakened by NSAIDs. With high doses of salicylates, there may be an increased risk of toxic effects on the central nervous system.
• sleeping medicines, sedatives, and antidepressants, as taking these medicines with Candesartan cilexetil + Amlodipine + HCT +pharmamay cause a sudden drop in blood pressure when standing up
• cholesterol-lowering medicines, such as colestyramine, as they may reduce the effect of Candesartan cilexetil + Amlodipine + HCT +pharma. Your doctor may recommend taking Candesartan cilexetil + Amlodipine + HCT +pharmaat least 4 hours before taking colestyramine.
• certain antacids (medicines that neutralize stomach acid), as the effect of Candesartan cilexetil + Amlodipine + HCT +pharmamay be slightly reduced
• certain muscle relaxants, such as baclofen and tubocurarine
• anticholinergic medicines, such as atropine and bipiperidine
• calcium supplements
• dantrolene (given by infusion in case of severe temperature regulation 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 tiorydazine, chlorpromazine, levomepromazine, trifluoperazine, cyanemazine, 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 + HCT +pharmamay affect the action of these medicines
• medicines used to treat arrhythmias, 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 conditions, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis
• medicines used to treat cancer, such as amifostine, cyclophosphamide, or methotrexate
• medicines used to increase blood pressure (such as noradrenaline) and slow 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 colestyramine and colestipol
• medicines used to lower blood sugar levels, such as metformin or insulin

Candesartan cilexetil + Amlodipine + HCT+pharmawith food, drink, and alcohol
Candesartan cilexetil + Amlodipine + HCT +pharmacan be taken with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Candesartan cilexetil + Amlodipine + HCT +pharma. Grapefruit and grapefruit juice may increase the levels of one of the active substances of the medicine - amlodipine - in the blood, which may cause unpredictable enhancement of the blood pressure-lowering effect of Candesartan cilexetil + Amlodipine + HCT +pharma.
Be careful when consuming alcohol while taking Candesartan cilexetil + Amlodipine + HCT +pharma, as it may cause dizziness or lightheadedness in some people. If you experience such symptoms, do 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 the blood pressure is not too low.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor before taking this medicine.
Pregnancy
Your doctor will usually advise you to stop taking Candesartan cilexetil + Amlodipine + HCT +pharmabefore planned pregnancy or immediately after confirmation of pregnancy and recommend taking a different medicine instead of Candesartan cilexetil + Amlodipine + HCT +pharma.
Candesartan cilexetil + Amlodipine + HCT +pharmashould not be taken during pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken during this period.
If you become pregnant while being treated with Candesartan cilexetil + Amlodipine + HCT +pharma, you should immediately inform your doctor and schedule a visit.
Breastfeeding
It has been shown that amlodipine and hydrochlorothiazide pass into human milk in small amounts. If you are breastfeeding or plan to breastfeed, you should tell your doctor before taking Candesartan cilexetil + Amlodipine + HCT +pharma. Your doctor may choose a different treatment, especially if you are breastfeeding a newborn or premature baby.
Fertility
Clinical data on the potential impact of Candesartan cilexetil + Amlodipine + HCT +pharmaon fertility are insufficient.

Driving and using machines

During treatment for high blood pressure, you may feel drowsy, unwell, dizzy, or have a headache. If you experience such symptoms, do not drive or operate machinery. Ask your doctor for advice.

Candesartan cilexetil + Amlodipine + HCT+pharmacontains lactose
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
Candesartan cilexetil + Amlodipine + HCT+pharmacontains sunset yellow FCF (E 110)
and azorubine (E 122)
The medicine may cause allergic reactions.

3.

How to take Candesartan cilexetil + Amlodipine + HCT+pharma
This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.

• The recommended dose of Candesartan cilexetil + Amlodipine + HCT +pharmais one capsule once a day.
• The capsule can be taken with or without food. It should be swallowed with a small amount of liquid (e.g., a glass of water). The capsules should not be chewed. The capsules should not be taken with grapefruit juice.
• If possible, the recommended dose should be taken daily at the same time, for example, at breakfast time.

Children and adolescents

The use of Candesartan cilexetil + Amlodipine + HCT +pharmais not recommended in children and adolescents under 18 years of age, as its safety and efficacy have not been established.
Elderly patients
Particular caution should be exercised in elderly patients due to their susceptibility to electrolyte disturbances.
Kidney problems
When taking Candesartan cilexetil + Amlodipine + HCT +pharmain patients with mild to moderate kidney problems, it is recommended to periodically monitor kidney function. Candesartan cilexetil + Amlodipine + HCT +pharmais contraindicated in patients with severe kidney problems.
Liver problems
In patients with liver problems, it is recommended to carefully monitor blood pressure and kidney function. Candesartan cilexetil + Amlodipine + HCT +pharmais contraindicated in patients with severe liver problems.

Taking a higher dose of Candesartan cilexetil + Amlodipine + HCT +pharmathan recommended

If you take more capsules than recommended, 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 can occur up to 24-48 hours after taking the medicine.
If you take more capsules than recommended or if a child accidentally swallows them, you should immediately consult a doctor or the nearest emergency department and bring the packaging or this leaflet with you.
Missing a dose of Candesartan cilexetil + Amlodipine + HCT+pharma
If you miss a dose, you should take the usual dose the next day at the usual time. Do not take a double dose to make up for the missed dose.
Stopping treatment with Candesartan cilexetil + Amlodipine + HCT+pharma
It is important to continue taking Candesartan cilexetil + Amlodipine + HCT +pharmaunless your doctor tells you to stop. If you have any further questions about taking this medicine, you should ask your doctor.

4. Possible side effects

Like all medicines, Candesartan cilexetil + Amlodipine + HCT +pharmacan cause side effects, although not everybody gets them.
You should immediatelystop taking Candesartan cilexetil + Amlodipine + HCT +pharmaand seek medical helpif you experience any of the following serious side effects:

• sudden, wheezing breathing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat, causing severe difficulty breathing
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and skin swelling, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack, arrhythmias
• pancreatitis, which can cause severe abdominal and back pain, with very poor general condition
• Candesartan cilexetil + Amlodipine + HCT +pharmamay cause a decrease in white blood cell count. Your resistance to infections may be reduced, and you may notice symptoms such as fatigue, infection, or fever. You should contact your doctor. Your doctor may order periodic blood tests to check if Candesartan cilexetil + Amlodipine + HCT +pharmais affecting your blood count (agranulocytosis).
• sudden severe eye pain, redness of the eyes, vision disturbances, or blurred vision, along with nausea and/or vomiting. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or acute angle-closure glaucoma, which can occur if eye pressure suddenly increases. Immediate treatment is necessary to alleviate symptoms and prevent permanent vision loss (severe vision disturbances).

Candesartan cilexetil + Amlodipine + HCT +pharmaconsists of three active substances. The following information is provided about side effects that are known for each of them individually.
To give you an idea of how often side effects may occur, they are listed 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)

• hypokalemia (low potassium levels in the blood), especially with high doses
• increased lipid levels in the blood
• respiratory tract infections
• increased blood sugar levels (hyperglycemia)
• increased uric acid levels (hyperuricemia)
• drowsiness
• dizziness or lightheadedness, headache
• vision disturbances (including double vision)
• palpitations (irregular heartbeat)
• redness of the skin with a feeling of warmth
• shortness of breath
• abdominal pain, nausea, vomiting
• changes in bowel movements, constipation, diarrhea
• rash, hives
• swelling of the ankles
• muscle cramps
• fatigue, weakness

Uncommon (may affect up to 1 in 100 people)

• depression, mood changes (including anxiety), insomnia
• tremors
• vomiting
• disturbance of taste (dysgeusia)
• fainting
• numbness, paresthesia (abnormal sensation)
• ringing in the ears
• arrhythmias (including slow heartbeat - bradycardia)
• rapid heartbeat (ventricular tachycardia) and irregular heartbeat (atrial fibrillation)
• low blood pressure (hypotension), orthostatic hypotension (low blood pressure that may increase after consuming alcohol, taking anesthetics, or using sedatives)
• hypomagnesemia (low magnesium levels in the blood), hypophosphatemia (low phosphate levels in the blood), hypercalcemia (high calcium levels in the blood), hypochloremic alkalosis (acid-base imbalance caused by high chloride levels in the blood), hyponatremia (low sodium levels in the blood)
• cough
• nasal congestion
• dry mouth
• hair loss, excessive sweating, itching, redness of the skin, skin discoloration
• malaise
• chest pain, pain, back pain
• joint pain
• muscle pain
• urination disorders, increased need to urinate at night, increased frequency of urination
• impotence, discomfort, or breast enlargement in men, inability to achieve an erection
• decreased appetite
• weight gain or loss
• increased sensitivity to sunlight

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 fatigue or coughing up blood
• vasculitis with symptoms such as rash, purple or red spots on the skin, fever
• gastrointestinal disorders
• pancreatitis
• disorientation
• sleep disturbances
• cholestatic jaundice, jaundice (yellowing or greenish discoloration of the skin and whites of the eyes)
• kidney failure or kidney problems
• fever

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

• blood disorders, such as neutropenia (reduced neutrophil count, a type of white blood cell)
• bone marrow depression (reduced bone marrow activity)
• severe shortness of breath
• red spots and blisters on the skin resembling a "target" or "bull's eye", fatigue, fever, joint pain or kidney problems - the most common symptoms of a condition called lupus erythematosus
• rash with red, non-itchy, peeling spots
• hemolytic anemia
• allergic reactions
• vasculitis (inflammation and damage to blood vessels)
• high potassium levels
• increased muscle tone
• peripheral neuropathy
• gastritis
• gingival hyperplasia
• increased liver enzyme activity, liver problems, hepatitis
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (frequency cannot be estimated from available data)

• aplastic anemia (a condition in which the bone marrow is damaged and bone marrow stem cells are depleted)
• extrapyramidal disorders (clinical syndromes with excessive or inadequate voluntary and involuntary movements, not related to weakness or spasticity)
• acute kidney failure
• skin cancer and lip cancer (non-melanoma skin cancer)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +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 or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store Candesartan cilexetil + Amlodipine + HCT+pharma
Do not store above 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Candesartan cilexetil + Amlodipine + HCT+pharmacontains
The active substances of the medicine are:
Candesartan cilexetil + Amlodipine + HCT +pharma, 16 mg + 5 mg + 12.5 mg
One capsule contains 16 mg of candesartan cilexetil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
Candesartan cilexetil + Amlodipine + HCT +pharma, 16 mg + 10 mg + 12.5 mg
One capsule contains 16 mg of candesartan cilexetil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
The other ingredients are:
capsule filling:lactose monohydrate, cornstarch, hydroxypropyl cellulose, calcium carmellose, macrogol (type 8000), cornstarch, magnesium stearate
body:titanium dioxide (E 171), gelatin
lid:azorubine (E 122) (only 16 mg + 10 mg + 12.5 mg dose), sunset yellow FCF (E 110), titanium dioxide (E 171), gelatin
ink:shellac, iron oxide black (E 172), propylene glycol, ammonia solution, concentrated, potassium hydroxide
What Candesartan cilexetil + Amlodipine + HCT+pharmalooks like and contents of the pack
Candesartan cilexetil + Amlodipine + HCT +pharma, 16 mg + 5 mg + 12.5 mg
Hard gelatin capsule, size "0", consisting of a white body with black printing "1" and an orange lid with black printing "CAH", filled with a white to off-white powder.
Candesartan cilexetil + Amlodipine + HCT +pharma, 16 mg + 10 mg + 12.5 mg
Hard gelatin capsule, size "0", consisting of a white body with black printing "2" and a red lid with black printing "CAH", filled with a white to off-white powder.
Pack size: 30 hard capsules.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer

Adamed Pharma S.A.
ul. Marsz. Józefa Piłsudskiego 5
95-200 Pabianice
Poland

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

Poland Candesartan cilexetil + Amlodipine + HCT +pharma
Austria
Candesartan/Amlodipin/HCT +pharma 16mg/5mg/12,5mg Hartkapseln
Candesartan/Amlodipin/HCT +pharma 16mg/10mg/12,5mg Hartkapseln
To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder in Poland:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: krakow@pluspharma.eu
Date of last revision of the leaflet:January 2025