Candesartan cilexetil + amlodipine + hct +pharma: detailed information

Package leaflet: Information for the patient

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
Please 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, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Candesartan cilexetil + Amlodipine + HCT +pharma is and what it is used for

The name of the medicine is Candesartan cilexetil + Amlodipine + HCT +pharma. It is used in the treatment of 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. It works by relaxing and widening blood vessels, which helps lower blood pressure.
Amlodipine, which belongs to a group of medicines called calcium channel blockers, works by relaxing blood vessels, allowing blood to flow more easily.
Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps the body get rid of excess water and salts, such as sodium, through urine. This helps reduce blood pressure. The combined action of these substances contributes to lowering blood pressure.

Candesartan cilexetil + Amlodipine + HCT +pharma may be used in the treatment of high blood pressure (hypertension) in adult patients who have previously been adequately controlled with the individual medicines given simultaneously at the same doses as in this combination, but as separate tablets.

2. What you need to know before taking Candesartan cilexetil + Amlodipine + HCT +pharma

Do not take Candesartan cilexetil + Amlodipine + HCT +pharma 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 have previously experienced an allergic reaction to any component of Candesartan cilexetil + Amlodipine + HCT +pharma, or if you are unsure whether this applies to you, please consult your doctor before taking this medicine.
You have severe kidney function impairment
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 persistently 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 more than 3 months pregnant
You have severe liver function impairment with or without cholestasis (impaired bile secretion or blocked bile flow from the gallbladder)
You have poor tissue perfusion with symptoms such as low blood pressure, slow heart rate, rapid heartbeat, or shock (including cardiogenic shock)
You have very low blood pressure
Blood flow from the heart is slow or blocked. This may occur if blood vessels or heart valves carrying blood away from the heart are narrowed (aortic stenosis)
You have low cardiac output following a heart attack (acute myocardial infarction)

Do not take Candesartan cilexetil + Amlodipine + HCT +pharma if any of the above conditions apply to you.

Warnings and precautions
Before starting treatment with Candesartan cilexetil + Amlodipine + HCT +pharma, please 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 disease related to diabetes
Aliskiren
An ACE inhibitor together with a medicine belonging to a class known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see section "Candesartan cilexetil + Amlodipine + HCT +pharma and other medicines")

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g., potassium). See also the section "When not to take Candesartan cilexetil + Amlodipine + HCT +pharma".

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

Impaired kidney function, kidney transplant, or if you are on dialysis
Impaired liver function
Previous heart attack or stroke
Atherosclerosis of the coronary or cerebral arteries
Heart failure or problems with heart valves or heart muscle
A very high increase in blood pressure (hypertensive crisis)
Skin cancer or if you develop unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially long-term use of high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). While taking Candesartan cilexetil + Amlodipine + HCT +pharma, protect your skin from exposure to sunlight and UV radiation.
Severe vomiting, diarrhoea, treatment with high doses of diuretics (water tablets), or a low-salt 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 use of a sunbed

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

Diarrhoea that is severe, persistent, and causes significant weight loss. Your doctor will assess your symptoms and decide how to continue treatment for high blood pressure.
Impaired vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure, which may occur from several hours to a week after taking Candesartan cilexetil + Amlodipine + HCT +pharma. This may lead to permanent vision loss if untreated. If you have previously had an allergic reaction to penicillin or sulfonamides, you may be at higher risk of developing this condition.
You have breathing or lung problems (including pneumonia 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, seek immediate medical help.

If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Candesartan cilexetil + Amlodipine + HCT +pharma, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Candesartan cilexetil + Amlodipine + HCT +pharma on your own.

If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartan cilexetil + Amlodipine + HCT +pharma, as concomitant use of certain anaesthetics may cause excessive drop in blood pressure.

As with any medicine that lowers blood pressure, an excessive drop in blood pressure may lead to heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Candesartan cilexetil + Amlodipine + HCT +pharma may cause increased levels of cholesterol and uric acid in the blood (which causes gout – painful joint swelling). Your doctor may order blood tests to monitor these levels.

The medicine may alter levels of certain chemicals in the blood called electrolytes. Your doctor will likely recommend periodic blood tests to check electrolyte levels. Symptoms of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), weakness, drowsiness, tiredness, sleepiness, restlessness, nausea, vomiting, reduced need to pass urine, rapid heartbeat. If you experience such symptoms, tell your doctor.

If you are scheduled for parathyroid function tests, you should stop taking Candesartan cilexetil + Amlodipine + HCT +pharma before the test.

Tell your doctor if you suspect you are pregnant (or might become pregnant). Candesartan cilexetil + Amlodipine + HCT +pharma is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause severe harm to the unborn baby (see section "Pregnancy and breastfeeding").

Children and adolescents
The use of Candesartan cilexetil + Amlodipine + HCT +pharma is not recommended in children and adolescents under 18 years of age.

Candesartan cilexetil + Amlodipine + HCT +pharma and other medicines
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 +pharma may be enhanced. Your doctor may adjust the dose and/or take additional precautions:
- If you are taking an ACE inhibitor or aliskiren (see also information in section "When not to take Candesartan cilexetil + Amlodipine + HCT +pharma" and "Warnings and precautions").
An ACE inhibitor in combination with certain other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone)
Lithium (a medicine used for psychiatric disorders and certain types of depression). Concomitant use with Candesartan cilexetil + Amlodipine + HCT +pharma may increase lithium toxicity. If lithium treatment is necessary, your doctor will monitor its blood levels.
Antiepileptic medicines such as carbamazepine (medicines used to treat epilepsy and seizures)
Diltiazem, verapamil (used to treat 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 medicine used to treat depression)
Cisapride (used to increase gastrointestinal motility)
Disopyramide (used to treat slow heart rate or reduce sweating)
Halofantrine (used to treat malaria)
Intravenous vinpocetine (used to improve nervous system circulation)
Amantadine (used in Parkinson's disease)
Potassium supplements, potassium-containing salt substitutes, diuretics (water tablets), heparin (a blood thinner used to prevent blood clots)
Laxatives
Steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), penicillin (an antibiotic) – concomitant use of these medicines with Candesartan cilexetil + Amlodipine + HCT +pharma may alter blood potassium levels
Trimethoprim/sulfamethoxazole (a combination of antibiotics)
Non-steroidal anti-inflammatory drugs (NSAIDs – medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used together with Candesartan cilexetil + Amlodipine + HCT +pharma, may increase the risk of kidney failure. The effect of Candesartan cilexetil + Amlodipine + HCT +pharma may be reduced by NSAIDs. High doses of salicylates may increase central nervous system toxicity.
Sleeping pills, sedatives, and antidepressants, as taking these together with Candesartan cilexetil + Amlodipine + HCT +pharma may cause a sudden drop in blood pressure upon standing
Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels), as it may reduce the effect of Candesartan cilexetil + Amlodipine + HCT +pharma. Your doctor may recommend taking Candesartan cilexetil + Amlodipine + HCT +pharma at least 4 hours before taking colesevelam hydrochloride.
Certain antacids (medicines for indigestion or heartburn), as the effect of Candesartan cilexetil + Amlodipine + HCT +pharma may be slightly reduced
Certain muscle relaxants such as baclofen and tubocurarine
Anticholinergic medicines such as atropine and biperiden
Calcium supplements
Dantrolene (administered by infusion for severe body temperature disorders)
Simvastatin (used to reduce 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), which help the body 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 + HCT +pharma 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 diseases, 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 (e.g., noradrenaline) and slow heart rate
Medicines used to treat infections, such as: antibiotics known as 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 blood fat levels, such as: cholestyramine and colestipol
Medicines used to lower blood sugar levels, such as: metformin or insulin

Candesartan cilexetil + Amlodipine + HCT +pharma with food, drink, and alcohol
Candesartan cilexetil + Amlodipine + HCT +pharma may be taken with or without food.
Do not drink grapefruit juice or consume grapefruit while taking Candesartan cilexetil + Amlodipine + HCT +pharma. Grapefruit and grapefruit juice may increase blood levels of one of the active substances in the medicine – amlodipine – which could lead to unpredictable intensification of the blood pressure-lowering effect of Candesartan cilexetil + Amlodipine + HCT +pharma.
Exercise caution when consuming alcohol while taking Candesartan cilexetil + Amlodipine + HCT +pharma, as dizziness or fainting may occur in some people. If such symptoms occur, avoid alcohol.

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

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
Your doctor will usually advise stopping treatment with Candesartan cilexetil + Amlodipine + HCT +pharma before planning pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine.
Candesartan cilexetil + Amlodipine + HCT +pharma should not be used during pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child if used during this period.
If you become pregnant while taking Candesartan cilexetil + Amlodipine + HCT +pharma, inform your doctor immediately and arrange a medical visit.

Breastfeeding
It has been shown that amlodipine and hydrochlorothiazide pass into human milk in small amounts. If you are breastfeeding or planning to breastfeed, inform your doctor before starting Candesartan cilexetil + Amlodipine + HCT +pharma, as your doctor may choose an alternative treatment, especially if breastfeeding a newborn or premature infant.

Fertility
Clinical data on the potential effect of Candesartan cilexetil + Amlodipine + HCT +pharma on fertility are insufficient.

Driving and using machines
During treatment for high blood pressure, you may experience drowsiness, malaise, dizziness, or headache. If you experience such symptoms, do not drive or operate machinery. Consult your doctor for advice.

Candesartan cilexetil + Amlodipine + HCT +pharma contains lactose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Candesartan cilexetil + Amlodipine + HCT +pharma contains sunset yellow FCF (E 110) and azorubine (E 122)
This medicine may cause allergic reactions.

3. How to take Candesartan cilexetil + Amlodipine + HCT +pharma

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

The recommended dose of Candesartan cilexetil + Amlodipine + HCT +pharma is one capsule once daily.
The capsule may be taken with food or independently of meals. Swallow it with a small amount of liquid (e.g., a glass of water). Do not chew the capsules. Do not take the capsules together with grapefruit juice or grapefruit.
If possible, take the recommended dose at the same time each day, for example, with breakfast.

Children and adolescents
The use of Candesartan cilexetil + Amlodipine + HCT +pharma is not recommended in children and adolescents under 18 years of age, as its safety and efficacy have not been established.

Elderly patients
Exercise particular caution in elderly patients due to their susceptibility to electrolyte imbalance.

Impaired kidney function
When using Candesartan cilexetil + Amlodipine + HCT +pharma in patients with mild to moderate kidney function impairment, periodic monitoring of kidney function is recommended. Candesartan cilexetil + Amlodipine + HCT +pharma is contraindicated in patients with severe kidney function impairment.

Impaired liver function
In patients with impaired liver function, careful monitoring of blood pressure and kidney function is recommended. Candesartan cilexetil + Amlodipine + HCT +pharma is contraindicated in patients with severe liver function impairment.

Taking more than the recommended dose of Candesartan cilexetil + Amlodipine + HCT +pharma
If you take more capsules than recommended, low blood pressure may occur, with symptoms such as dizziness, rapid or slow heartbeat. Excess fluid may accumulate in the lungs (pulmonary oedema), causing shortness of breath, which may occur within 24–48 hours after ingestion.
If you take more capsules than recommended or if a child accidentally swallows the medicine, seek immediate medical help at your doctor's office or the nearest emergency department. Bring the medicine packaging or this leaflet with you.

Missing a dose of Candesartan cilexetil + Amlodipine + HCT +pharma
If you miss a dose, take your usual dose the next day at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Candesartan cilexetil + Amlodipine + HCT +pharma
It is important to continue taking Candesartan cilexetil + Amlodipine + HCT +pharma unless your doctor advises stopping. If you have any further questions about using this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Immediately discontinue use of Candesartan cilexetil + Amlodipine + HCT +pharma
and seek urgent medical help if the patient experiences any of the following
severe adverse reactions:

sudden, wheezing breath, chest pain, shortness of breath, or difficulty breathing
eyelid, facial, or lip swelling
swelling of the tongue and throat causing severe breathing difficulties
severe skin reactions, including intense skin rash, urticaria, generalized redness of the skin, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
heart attack, cardiac arrhythmias
pancreatitis, which may cause severe abdominal and back pain accompanied by a very poor general condition
Candesartan cilexetil + Amlodipine + HCT +pharma may reduce the number of white blood cells. The patient's resistance to infections may decrease, and symptoms such as fatigue, infection, or fever may occur. In such cases, contact a doctor. The doctor may order periodic blood tests to monitor whether Candesartan cilexetil + Amlodipine + HCT +pharma affects blood composition (agranulocytosis).
sudden, severe eye pain, eye redness, visual disturbances or blurred vision, and halos around light sources, accompanied by nausea and/or vomiting. These may be symptoms of fluid accumulation in the eye (between choroid and retina) or acute angle-closure glaucoma, which may occur when intraocular pressure rises rapidly. Immediate treatment is necessary to relieve symptoms and prevent permanent vision loss (severe visual disturbances).

Candesartan cilexetil + Amlodipine + HCT +pharma contains three active substances. Below
are listed adverse reactions known for each of them individually.
To inform the patient about how frequently adverse reactions may occur, they are categorized as:
very common, common, uncommon, rare, very rare, and frequency not known.

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

swelling (fluid retention)

Common (may occur in up to 1 in 10 people)

hypokalemia (reduced potassium levels in blood), especially with high doses
increased serum lipid levels
respiratory tract infections
increased blood sugar (hyperglycemia)
increased uric acid levels (hyperuricemia)
drowsiness
dizziness/vertigo, headache
visual disturbances (including double vision)
palpitations (irregular heartbeat)
skin redness with sensation of warmth
shortness of breath
abdominal pain, indigestion, nausea
changes in bowel rhythm, constipation, diarrhea
rash, urticaria
ankle swelling
muscle cramps
fatigue, weakness

Uncommon (may occur in up to 1 in 100 people)

depression, mood changes (including anxiety), insomnia
tremor
vomiting
dysgeusia (altered taste sensation)
fainting
hypoesthesia, paresthesia (abnormal sensation)
tinnitus
cardiac arrhythmias (including slow heartbeat – bradycardia)
rapid heartbeat (ventricular tachycardia) and irregular heartbeat (atrial fibrillation)
hypotension (low blood pressure), orthostatic hypotension (low blood pressure that may worsen after alcohol consumption, or when used concomitantly with anesthetics or sedatives)
hypomagnesemia (low magnesium levels in blood), hypophosphatemia (low phosphate levels in blood), hypercalcemia (high calcium levels in blood), hypochloremic alkalosis (acid-base imbalance due to high chloride levels in blood), hyponatremia (low sodium levels in blood)
cough
rhinitis
dry mouth
hair loss, excessive sweating, skin itching, red skin spots, skin discoloration
malaise
chest pain, pain, back pain
joint pain
muscle pain
urinary disorders, increased need to urinate at night, increased frequency of urination
impotence, discomfort or enlargement of breast glands in men, inability to achieve erection
decreased appetite
weight gain or weight loss
photosensitivity

Rare (may occur in up to 1 in 1000 people)

thrombocytopenia (abnormally low platelet count), sometimes with skin bleeding (purpura)
shortness of breath with cough and fatigue, or coughing up blood
vasculitis with symptoms such as: rash, purple-red skin spots, fever
gastrointestinal disorders
pancreatitis
disorientation
sleep disorders
cholestatic jaundice, jaundice (yellowish or greenish discoloration of skin and whites of the eyes)
renal failure and kidney function disorders
fever

Very rare (may occur in fewer than 1 in 10,000 people)

blood disorders such as neutropenia (reduced number of neutrophils, a type of white blood cell)
bone marrow depression (reduced hematopoietic activity in the bone marrow)
severe shortness of breath
red spots and blisters on the skin resembling a "target" or "bull's eye", fatigue, fever, joint pain or swelling, and kidney problems – most common symptoms of a disease called systemic lupus erythematosus
rash with red, non-itchy, scaling patches
hemolytic anemia
allergic reactions
vasculitis (inflammation and damage to blood vessels)
high potassium levels
increased muscle tension
peripheral neuropathy
gastric mucosal inflammation
gingival hyperplasia
increased liver enzyme activity, liver function disorders, hepatitis
angioedema of the intestine: intestinal swelling 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 bone marrow and hematopoietic stem cells are damaged)
extrapyramidal disorders (clinical syndromes with excessive movement or lack of 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 symptoms occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 181 C, 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 or its representative in Poland. Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Candesartan cilexetil + Amlodipine + HCT +pharma

Do not store above 30°C.
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Candesartan cilexetil + Amlodipine + HCT +pharma contains
The active substances of the medicinal product 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.

Other components:
Capsule filling: monohydrate lactose, maize starch, hydroxypropylcellulose, calcium carmellose, polyethylene glycol (type 8000), pregelatinized maize starch, magnesium stearate
Body: titanium dioxide (E 171), gelatin
Cap: azorubine (E 122) (only in the 16 mg + 10 mg + 12.5 mg strength), sunset 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 + HCT +pharma looks 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 print “1” and an orange cap with black print “CAH”, filled with 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 print “2” and a red cap with black print “CAH”, filled with 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 medicinal product is authorized in the European Economic Area countries 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

For further information about this medicinal product, please 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: [email protected]