Candesartan cilexetil + amlodipine + hct sandoz

Package leaflet: Information for the user

Candesartan cilexetil + Amlodipine + HCT Sandoz, 16 mg + 5 mg + 12.5 mg, hard capsules
Candesartan cilexetil + Amlodipine + HCT Sandoz, 16 mg + 10 mg + 12.5 mg, hard capsules
Candesartanum cilexetili + Amlodipinum + Hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Contents of the leaflet

1. What Candesartan cilexetil + Amlodipine + HCT Sandoz is and what it is used for
2. What you need to know before taking Candesartan cilexetil + Amlodipine + HCT Sandoz
3. How to take Candesartan cilexetil + Amlodipine + HCT Sandoz
4. Possible side effects
5. How to store Candesartan cilexetil + Amlodipine + HCT Sandoz
6. Contents of the pack and other information

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

The name of the medicine is Candesartan cilexetil + Amlodipine + HCT Sandoz. It is used in adults
for the treatment of high blood pressure (hypertension). 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 causes blood vessels to relax and widen, which helps lower blood pressure.
Amlodipine belongs to a group of substances called calcium antagonists. It 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 eliminate water and salts (e.g. sodium) through urine, which helps reduce blood pressure.
The action of these substances contributes to lowering blood pressure.
Candesartan cilexetil + Amlodipine + HCT Sandoz may be used in the treatment of high
blood pressure (hypertension) in adult patients whose blood pressure is adequately controlled with separate products taken simultaneously at the same doses as in this combination, but in the form of separate tablets.

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

Do not take Candesartan cilexetil + Amlodipine + HCT Sandoz if:

• you are allergic to candesartan, amlodipine, hydrochlorothiazide, dihydropyridine derivatives, sulphonamide medicines, 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 + HCT Sandoz or are unsure whether this applies to you, please talk to your doctor before taking Candesartan cilexetil + Amlodipine + HCT Sandoz.
• you have severe kidney problems
• you are unable to produce urine (anuria)
• you have diabetes or kidney problems and are taking 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
• if you have gout
• you are more than 3 months pregnant
• you have severe liver disease with cholestasis (impaired bile secretion or blocked bile flow from the gallbladder) or without cholestasis
• you have poor blood flow to tissues, manifested by low blood pressure, slow pulse, rapid heartbeat, or shock (including cardiogenic shock)
• you have very low blood pressure
• blood flow from your heart is slowed or blocked. This may occur if a blood vessel or heart valve carrying blood away from the heart is narrowed (aortic stenosis)
• you have low cardiac output after a heart attack (acute myocardial infarction).

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

Warnings and precautions

Before starting to take Candesartan cilexetil + Amlodipine + HCT Sandoz, 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 due to diabetes
• aliskiren
• an ACE inhibitor together with a medicine belonging to the group of medicines known as mineralocorticoid receptor antagonists (MRA). These medicines are used in the treatment of heart failure (see "Other medicines and Candesartan cilexetil + Amlodipine + HCT Sandoz").

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.

See also the information under the section "Do not take Candesartan cilexetil + Amlodipine + HCT Sandoz".

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

• kidney problems, or if you have had a kidney transplant or are undergoing dialysis

• liver disease

• history of 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)

• if you have previously had skin cancer or if you develop an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). While taking Candesartan cilexetil + Amlodipine + HCT Sandoz, protect your skin from 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 problems

• diabetes

• systemic lupus erythematosus (an autoimmune disease)

• allergy or asthma

• skin reactions such as sunburn or rash after sun exposure or use of tanning beds

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

• diarrhoea that is severe, persistent, and causes significant weight loss. Your doctor may assess your symptoms and decide whether to continue treatment with blood pressure medicines.
• blurred vision or eye pain. These may be symptoms 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 weeks after taking Candesartan cilexetil + Amlodipine + HCT Sandoz, and if untreated, may lead to permanent vision loss. The risk of developing such disorders may be higher in patients who previously had an allergy to penicillin or sulphonamides.
• if you previously experienced breathing problems or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Candesartan cilexetil + Amlodipine + HCT Sandoz, seek medical help immediately.

If you are undergoing surgery, inform your doctor or dentist that you are taking Candesartan cilexetil + Amlodipine + HCT Sandoz. This is because Candesartan cilexetil + Amlodipine + HCT Sandoz, in combination with certain anaesthetics, may cause excessive lowering of blood pressure.

As with any blood pressure-lowering medicine, excessive lowering of blood pressure may lead to heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Candesartan cilexetil + Amlodipine + HCT Sandoz may increase blood levels of cholesterol and uric acid (a cause of gout – painful joint swelling). Your doctor may order blood tests to monitor this.

Candesartan cilexetil + Amlodipine + HCT Sandoz may alter blood levels of certain chemicals called electrolytes. Your doctor may want to periodically perform blood tests to check electrolyte levels. Symptoms of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling weak, drowsiness, fatigue, sleepiness or restlessness, nausea, vomiting, reduced need to pass urine, rapid heartbeat. Tell your doctor if you experience any of these symptoms.

If parathyroid function tests are planned, you should stop taking Candesartan cilexetil + Amlodipine + HCT Sandoz before the tests.

Tell your doctor if you suspect you are pregnant (or could become pregnant). Taking Candesartan cilexetil + Amlodipine + HCT Sandoz is not recommended during early pregnancy and is contraindicated after the third month of pregnancy, as its use during this time may cause severe harm to the unborn child (see section "Pregnancy and breastfeeding").

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

Children and adolescents

Candesartan cilexetil + Amlodipine + HCT Sandoz is not recommended for use in children and adolescents under 18 years of age.

Candesartan cilexetil + Amlodipine + HCT Sandoz 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 they may enhance the effect of Candesartan cilexetil + Amlodipine + HCT Sandoz. Your doctor may adjust the dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren, refer to the information under the headings "Do not take Candesartan cilexetil + Amlodipine + HCT Sandoz:" and "Warnings and precautions".
• an ACE inhibitor together with certain other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (e.g. spironolactone, eplerenone)
• lithium (a medicine used to treat mood disorders and certain types of depression). Concomitant use with Candesartan cilexetil + Amlodipine + HCT Sandoz may increase lithium toxicity. If lithium treatment is necessary, your doctor will measure its blood concentration.
• antiepileptic medicines such as carbamazepine (medicines for epilepsy and seizures)
• 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 improve food movement through the stomach and intestines
• difemanil, used to treat slow heart rate or reduce sweating
• halofantrine, used to treat malaria
• intravenous vinpocetine, a medicine used to improve circulation in the nervous system
• amantadine, used to treat Parkinson's disease
• potassium supplements, potassium-containing salt substitutes, diuretics (water tablets), heparin (used to thin the blood and prevent 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 Sandoz may alter blood potassium levels
• trimethoprim in combination with sulfamethoxazole (a combination of antibiotics)
• non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including joint inflammation) used together with Candesartan cilexetil + Amlodipine + HCT Sandoz may increase the risk of kidney failure. The effect of Candesartan cilexetil + Amlodipine + HCT Sandoz may be weakened by NSAIDs. High doses of salicylates may enhance toxic effects on the central nervous system.
• sleeping pills, sedatives, and antidepressants, as using these together with Candesartan cilexetil + Amlodipine + HCT Sandoz may cause a sudden drop in blood pressure upon standing
• colesevelam hydrochloride, a cholesterol-lowering medicine, as the effect of Candesartan cilexetil + Amlodipine + HCT Sandoz may be reduced. Your doctor may recommend taking Candesartan cilexetil + Amlodipine + HCT Sandoz at least 4 hours before colesevelam hydrochloride.
• certain medicines that neutralize stomach acid (medicines for indigestion or heartburn), as the effect of Candesartan cilexetil + Amlodipine + HCT Sandoz 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 in severe temperature disorders)
• simvastatin, used to lower blood cholesterol and fat (triglyceride) levels
• medicines used to control the body's immune response (such as tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), allowing the body to accept a transplanted organ
• medicines used to treat certain mental 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 Sandoz may affect the action of these medicines
• medicines used to treat heart rhythm disorders, e.g. 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 that increase blood pressure (e.g. 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 that lower blood fat levels, such as cholestyramine and colestipol
• medicines that lower blood sugar levels, such as metformin or insulin.

Taking Candesartan cilexetil + Amlodipine + HCT Sandoz with food, drink, and alcohol

Candesartan cilexetil + Amlodipine + HCT Sandoz can be taken with or without food.
Do not eat grapefruit or drink grapefruit juice while taking Candesartan cilexetil + Amlodipine + HCT Sandoz, as this may increase blood levels of one of the active substances in the medicine – amlodipine. This may lead to unpredictable intensification of the blood pressure-lowering effect of Candesartan cilexetil + Amlodipine + HCT Sandoz.
Exercise caution when consuming alcohol while taking Candesartan cilexetil + Amlodipine + HCT Sandoz, as some people may experience fainting or dizziness. In such cases, do not drink alcohol.

Elderly patients

For patients over 65 years of age, your doctor will regularly monitor blood pressure with each dose increase to ensure that blood pressure does not become too low.

Pregnancy, breastfeeding, and effects on fertility

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

Pregnancy

Your doctor will usually advise you to stop taking Candesartan cilexetil + Amlodipine + HCT Sandoz before becoming pregnant or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Candesartan cilexetil + Amlodipine + HCT Sandoz 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 being treated with Candesartan cilexetil + Amlodipine + HCT Sandoz, inform your doctor immediately and schedule an appointment.

Breastfeeding

It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. If you are breastfeeding or plan to start breastfeeding, you must inform your doctor before taking Candesartan cilexetil + Amlodipine + HCT Sandoz. Your doctor may decide on an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or premature.

Fertility

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

Driving and using machines

Treatment for high blood pressure may cause drowsiness, nausea, dizziness, or headache. Do not drive or operate machinery if you experience these symptoms. Consult your doctor.

Candesartan cilexetil + Amlodipine + HCT Sandoz contains lactose

If you have previously been diagnosed with an intolerance to certain sugars, you should contact your doctor before taking this medicine.

Candesartan cilexetil + Amlodipine + HCT Sandoz contains sunset yellow (E 110) and azorubine (E 122)

The medicine may cause allergic reactions.

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

This medicine should always be taken 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 may be taken with or without food. Swallow the capsule whole with a small amount of liquid (e.g. a glass of water). Do not chew the capsule. Do not take the capsule with grapefruit juice or grapefruit.
• For best results, take the daily dose at the same time each day, for example with breakfast.

Use in children and adolescents
The use of Candesartan cilexetil + Amlodipine + HCT Sandoz is not recommended in children and adolescents under 18 years of age. Safety and efficacy have not been established in this patient group.

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

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

Hepatic function impairment
In patients with impaired liver function, careful monitoring of blood pressure and renal function is recommended. Candesartan cilexetil + Amlodipine + HCT Sandoz is contraindicated in patients with severe hepatic impairment.

If you take more Candesartan cilexetil + Amlodipine + HCT Sandoz than you should
Taking more capsules than recommended may lead to 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 within 24–48 hours after taking the medicine.
If you or a child accidentally take more capsules than recommended, seek immediate medical advice from your doctor or the nearest emergency department and bring the medicine pack or this leaflet with you.

If you forget to take Candesartan cilexetil + Amlodipine + HCT Sandoz
If you miss a dose, take your usual dose the next day.
Do not take a double dose to make up for the missed capsule.

Stopping Candesartan cilexetil + Amlodipine + HCT Sandoz
It is important to continue taking Candesartan cilexetil + Amlodipine + HCT Sandoz unless your doctor advises otherwise.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You must stop taking Candesartan cilexetil + Amlodipine + HCT Sandoz and immediately contact your doctor if any of the following severe adverse effects occur:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat, significantly impairing breathing
• severe skin reactions, including intense rash, hives, redness of the skin over the entire body, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• myocardial infarction, heart rhythm disturbances
• pancreatitis, which may cause severe abdominal and back pain and general malaise
• Candesartan cilexetil + Amlodipine + HCT Sandoz may cause a reduction in white blood cell count. This may lead to reduced resistance to infections, fatigue, infection, or fever. In such cases, contact your doctor. Your doctor may periodically perform blood tests to check whether Candesartan cilexetil + Amlodipine + HCT Sandoz affects the patient's blood composition (agranulocytosis).
• sudden severe eye pain, redness of the eyes, visual disturbances or blurred vision, halos around light sources, accompanied by nausea and (or) vomiting. These may be symptoms of fluid retention in the eye (between the choroid and retina) or an acute attack of narrow-angle glaucoma, which may occur when intraocular pressure rises rapidly. Immediate treatment is necessary to relieve symptoms and prevent permanent vision loss (serious visual impairment).

Candesartan cilexetil + Amlodipine + HCT Sandoz is a combination of three active substances.
The following information refers to adverse effects known for each of them.
Adverse effects have been classified as very common, common, uncommon, rare, very rare, and frequency not known, to give patients an idea of how many people may be affected.
Very common (may affect more than 1 in 10 people):

• oedema (fluid retention)

Common (may affect up to 1 in 10 people):

• hypokalaemia (reduced potassium levels in blood), especially with high doses
• increased lipid levels in serum
• respiratory tract infections
• increased blood sugar levels (hyperglycaemia)
• increased uric acid levels (hyperuricaemia)
• 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
• bowel rhythm disturbances, constipation, diarrhoea
• rash, urticaria
• ankle swelling
• muscle cramps
• fatigue, weakness

Uncommon (may affect up to 1 in 100 people):

• depression, mood changes (including anxiety), insomnia
• tremor
• vomiting
• dysgeusia (altered taste perception)
• fainting
• hypoaesthesia, paraesthesia (sensory disturbances)
• tinnitus
• arrhythmia (including slow heart rate - bradycardia)
• rapid heartbeat (ventricular tachycardia) and irregular heartbeat (atrial fibrillation)
• hypotension (low blood pressure), orthostatic hypotension (low blood pressure, which may be worsened by alcohol consumption, anaesthetics or sedatives)
• hypomagnesaemia (reduced magnesium levels in blood), hypercalcaemia (increased calcium levels in blood), hypochloraemic alkalosis (acid-base imbalance due to reduced chloride levels), hypophosphataemia (reduced phosphate levels in blood)
• hyponatraemia (low sodium levels in blood)
• cough
• nasal mucosal inflammation
• dry mouth
• hair loss, increased sweating, skin itching, red skin spots, skin discoloration
• malaise
• chest pain, back pain
• joint pain
• myalgia (muscle pain)
• urinary disorders, nocturia (frequent urination at night), increased frequency of urination
• impotence, discomfort or breast enlargement in men, inability to achieve 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 skin bleeding (purpura)
• breathlessness with accompanying cough and fatigue or coughing up blood
• vasculitis with symptoms such as rash, purple-red skin spots, fever
• gastrointestinal disorders
• pancreatitis
• disorientation
• sleep disorders
• jaundice (yellowish or greenish discoloration of the skin and whites of the eyes)
• kidney failure and kidney function disorders
• 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 haematopoietic activity of the bone marrow)
• severe breathlessness
• red spots and blisters on the skin resembling a red "bull's eye" or "target lesion", fatigue, fever, joint pain or swelling, and kidney problems – these are the most common symptoms of a disease called systemic lupus erythematosus
• rash with red, non-itchy, scaly patches
• haemolytic anaemia
• allergic reactions
• vasculitis (inflammatory condition and damage to blood vessels)
• high potassium levels
• increased muscle tone
• 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 diarrhoea

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

• aplastic anaemia (a condition in which bone marrow and haematopoietic stem cells are damaged)
• extrapyramidal disorders (clinical syndromes with excessive or deficient voluntary and involuntary movements, unrelated to weakness or spasticity)
• acute kidney failure
• skin and lip cancer (non-melanoma skin cancer)

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

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

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater. 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 + HCT Sandoz contains
The active substances in the medicine are:
Candesartan cilexetil + Amlodipine + HCT Sandoz, 16 mg + 5 mg + 12.5 mg, hard capsule
Each hard capsule contains 16 mg of candesartan cilexetil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
Candesartan cilexetil + Amlodipine + HCT Sandoz, 16 mg + 10 mg + 12.5 mg, hard capsule
Each hard capsule contains 16 mg of candesartan cilexetil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Other components are:
Capsule contents:
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: sunset yellow FCF (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), sunset yellow FCF (E 110), titanium dioxide (E 171), gelatin

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

What Candesartan cilexetil + Amlodipine + HCT Sandoz looks like and contents of the pack
Candesartan cilexetil + Amlodipine + HCT Sandoz, 16 mg + 5 mg + 12.5 mg, hard capsules
A hard, gelatin capsule, size "0", with a white body printed in black with "1", and an orange cap printed in black with "CAH", filled with white to off-white powder.

Candesartan cilexetil + Amlodipine + HCT Sandoz, 16 mg + 10 mg + 12.5 mg, hard capsules
A hard, gelatin capsule, size "0", with a white body printed in black with "2", and a red cap printed in black with "CAH", filled with white to off-white powder.

Available in packs of 30 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00

Manufacturers
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana, Slovenia
Adamed Pharma S.A.
ul. Marsz. Józefa Piłsudskiego 5
95-200 Pabianice, Poland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00

This medicine is authorised in the countries of the European Economic Area under the following names:
Poland: Candesartan cilexetil + Amlodipine + HCT Sandoz
Germany: CandeAmlo HEXAL plus HCT 16 mg/5 mg/12.5 mg Hartkapseln
CandeAmlo HEXAL plus HCT 16 mg/10 mg/12.5 mg Hartkapseln
Portugal: Candesartan + Amlodipina + Hidroclorotiazida Sandoz
Slovenia: Amcandin HCT 16 mg/5 mg/12.5 mg trde kapsule
Amcandin HCT 16 mg/10 mg/12.5 mg trde kapsule