Candesartan cilexetil + Amlodipine + Hct Sandoz

Patient Information Leaflet: Candesartan Cilexetil + Amlodipine + HCT Sandoz

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
Candesartan Cilexetil+Amlodipine + Hydrochlorothiazide

Read the patient information leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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, tell your doctor. See section 4.

Contents of the pack

• 1. What Candesartan Cilexetil + Amlodipine + HCT Sandoz is and what it is used for
• 2. Important information 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 adult patients to treat 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 to lower blood pressure.

Amlodipine belongs to a group of substances called calcium channel blockers. It works by relaxing blood vessels, making it easier for blood to flow through them.

Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body get rid of excess water and salt (such as sodium) in the urine, which helps to lower blood pressure.

The combination of these substances helps to lower blood pressure.

Candesartan Cilexetil + Amlodipine + HCT Sandoz can be used to treat high blood pressure in adult patients whose blood pressure is adequately controlled with the individual components given simultaneously at the same dose level as in the combination.

2. Important information before taking Candesartan Cilexetil + Amlodipine + HCT Sandoz

When not to take Candesartan Cilexetil + Amlodipine + HCT Sandoz

• if you are allergic to candesartan, amlodipine, hydrochlorothiazide, dihydropyridines, sulfonamides, or any of the other ingredients of this medicine
• if you have severe kidney problems
• if you have no urine production (anuria)
• if you have diabetes or kidney problems and are taking aliskiren, a medicine that lowers blood pressure
• if you have low levels of potassium or sodium, or high levels of calcium in your blood, which do not improve with treatment
• if you have gout
• if you are pregnant for more than 3 months
• if you have severe liver disease with cholestasis (a condition where bile flow is reduced or blocked) or without cholestasis
• if you have poor blood flow to your organs, which can cause low blood pressure, low pulse, fast heartbeat, or shock (including cardiogenic shock)
• if you have very low blood pressure
• if blood flow from your heart is slowed down or blocked. This can happen if the blood vessel or valve that carries blood from your heart becomes narrowed (aortic stenosis)
• if you have a small heart output after a heart attack (acute myocardial infarction)

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

Warnings and precautions

Before taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, talk to your doctor

Tell your doctorif you are taking any of the following medicines for high blood pressure:

• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems caused by diabetes
• aliskiren
• ACE inhibitors and mineralocorticoid receptor antagonists (MRAs) at the same time. These medicines are used to treat heart failure (see "Other medicines and Candesartan Cilexetil + Amlodipine + HCT Sandoz").

Your doctor may check your kidney function, blood pressure, and electrolyte levels regularly.

Tell your doctorif you have any of the following health problems:

• kidney problems or have had a kidney transplant or are on dialysis
• liver disease
• heart attack or stroke in the past
• hardening of the arteries (atherosclerosis) in the heart or brain
• heart failure or problems with heart valves or heart muscle
• very high blood pressure (hypertensive crisis)
• in the past, you have had cancer or if you have had an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, 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 the sun and UV radiation

If you experience any of the following symptoms, contact your doctor:

• severe diarrhea, vomiting, or taking high doses of diuretics (water pills) or following a low-salt diet
• high levels of potassium in the blood
• adrenal gland problems
• diabetes
• systemic lupus erythematosus (an autoimmune disease)
• allergy or asthma
• skin reactions, such as sunburn or rash after being in the sun or using a sunbed

If you are going to have surgery, tell your doctor or dentist that you are taking Candesartan Cilexetil + Amlodipine + HCT Sandoz. This is because the medicine, in combination with some anesthetics, may cause a drop in blood pressure.

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

Candesartan Cilexetil + Amlodipine + HCT Sandoz may increase cholesterol and uric acid levels in the blood (which can cause gout, a painful swelling of the joints). Your doctor may order blood tests to monitor this.

Candesartan Cilexetil + Amlodipine + HCT Sandoz may change the levels of certain substances in your blood called electrolytes. Your doctor will likely want to do blood tests from time to time to check the levels of these substances.

Symptoms of changes in electrolyte levels include: thirst, dry mouth, muscle cramps, muscle weakness, low blood pressure (hypotension), feeling weak, tiredness, sleepiness, or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you experience these symptoms.

If you are going to have a test to check your parathyroid gland function, stop taking Candesartan Cilexetil + Amlodipine + HCT Sandoz before the test.

Tell your doctorif you think you might be pregnant or are planning to have a baby.

Taking Candesartan Cilexetil + Amlodipine + HCT Sandoz is not recommended during early pregnancy and is contraindicated after the third month of pregnancy, as it may cause serious harm to the baby (see "Pregnancy and breastfeeding").

If you experience stomach pain, nausea, vomiting, or diarrhea after taking the medicine, discuss this with your doctor. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan Cilexetil + Amlodipine + HCT Sandoz without consulting your doctor.

Children and adolescents

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

Candesartan Cilexetil + Amlodipine + HCT Sandoz with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take, including:

• other blood pressure-lowering medicines, as they may increase the effect of Candesartan Cilexetil + Amlodipine + HCT Sandoz. Your doctor may change the dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren, see the information under "Do not take Candesartan Cilexetil + Amlodipine + HCT Sandoz" and "Warnings and precautions".
• ACE inhibitors and mineralocorticoid receptor antagonists (MRAs) at the same time
• lithium (a medicine used to treat mood swings and some types of depression). Taking lithium with Candesartan Cilexetil + Amlodipine + HCT Sandoz may increase lithium toxicity. If lithium is taken, your doctor will monitor its levels in your blood
• antiepileptic medicines, such as carbamazepine (medicines for epilepsy and seizures)
• verapamil, diltiazem, 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 improve the movement of food in the stomach and intestines
• difemanil, used to treat slow heart rate or excessive sweating
• halofantrine, used to treat malaria
• iv vincamine, a medicine used to improve blood circulation in the nervous system
• amantadine, used to treat Parkinson's disease
• potassium supplements, salt substitutes containing potassium, diuretics, heparin (used to thin the blood and prevent clots),
• laxatives
• corticosteroids, adrenocorticotropic hormone (ACTH), carbenoxolone (used to treat mouth and stomach ulcers), penicillin (an antibiotic),
• trimethoprim in combination with 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 at the same time as Candesartan Cilexetil + Amlodipine + HCT Sandoz may increase the risk of kidney problems. The effect of Candesartan Cilexetil + Amlodipine + HCT Sandoz may be reduced by NSAIDs. High doses of salicylates may increase the toxic effect on the central nervous system
• sedatives, tranquilizers, and antidepressant medicines, as taking them with Candesartan Cilexetil + Amlodipine + HCT Sandoz may cause a sudden drop in blood pressure when standing up
• colesevelam hydrochloride, a medicine used to lower cholesterol levels in the blood, 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 taking colesevelam hydrochloride
• certain antacids (medicines used to neutralize stomach acid), 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 bipiperiden
• 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 cyclosporin, 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 Sandoz 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 (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 that increase blood pressure (e.g., noradrenaline) and slow the heart rate
• medicines used to treat infections, such as tetracycline antibiotics 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, or allopurinol
• medicines used to lower fat levels in the blood, such as colestyramine or colestipol
• medicines used to 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 grapefruits or drink grapefruit juice while taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, as it may increase the levels of one of the active substances (amlodipine) in the blood, leading to unpredictable and increased effects of the medicine on lowering blood pressure.

Be cautious when consuming alcohol while taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, as some people may experience dizziness or lightheadedness. In such cases, do not drink alcohol.

Elderly

In patients over 65 years of age, the doctor will regularly check blood pressure when increasing the dose 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Your doctor will usually advise you to stop taking Candesartan Cilexetil + Amlodipine + HCT Sandoz before you become pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead. Candesartan Cilexetil + Amlodipine + HCT Sandoz should not be taken during pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby.

If you become pregnant while taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, tell your doctor immediately.

Breastfeeding

Amlodipine and hydrochlorothiazide have been shown to pass into breast milk in small amounts. If you are breastfeeding or plan to breastfeed, tell your doctor before taking Candesartan Cilexetil + Amlodipine + HCT Sandoz. Your doctor may decide on a different treatment if you want to breastfeed, especially if your baby is newborn or premature.

Fertility

There is limited clinical data on the potential effects of Candesartan Cilexetil + Amlodipine + HCT Sandoz on fertility.

Driving and using machines

While taking Candesartan Cilexetil + Amlodipine + HCT Sandoz for high blood pressure, you may experience 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 been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

The medicine may cause allergic reactions.

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

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

• The recommended dose is one capsule per day, at the strength prescribed by your doctor.
• Swallow the capsule 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 grapefruits.
• Try to take your daily dose at the same time each day, e.g., in the morning.

Children and adolescents

Candesartan Cilexetil + Amlodipine + HCT Sandoz is not recommended for children and adolescents under 18 years of age. The safety and efficacy of the medicine in this age group have not been established.

Elderly

Special care should be taken in elderly patients due to their susceptibility to electrolyte disturbances.

Kidney problems

When taking Candesartan Cilexetil + Amlodipine + HCT Sandoz in patients with mild to moderate kidney problems, it is recommended to regularly check kidney function. Candesartan Cilexetil + Amlodipine + HCT Sandoz is contraindicated in patients with severe kidney problems.

Liver problems

In patients with liver problems, it is recommended to closely monitor blood pressure and kidney function. Candesartan Cilexetil + Amlodipine + HCT Sandoz is contraindicated in patients with severe liver problems.

If you take more Candesartan Cilexetil + Amlodipine + HCT Sandoz than you should

If you have taken more capsules than prescribed, you may experience low blood pressure with symptoms such as dizziness, fast or slow heartbeat.

Fluid may accumulate in the lungs, causing shortness of breath, which may occur 24-48 hours after taking the medicine.

If you have taken more capsules than prescribed or if a child has accidentally swallowed a capsule, go to your doctor or the nearest emergency department immediately and take the medicine pack or this leaflet with you.

If you forget to take Candesartan Cilexetil + Amlodipine + HCT Sandoz

Take your normal dose the next day. Do not take a double dose to make up for a forgotten capsule.

Stopping treatment with Candesartan Cilexetil + Amlodipine + HCT Sandoz

It is important to continue taking Candesartan Cilexetil + Amlodipine + HCT Sandoz 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.

Stop taking Candesartan Cilexetil + Amlodipine + HCT Sandoz and contact your doctor immediatelyif you experience any of the following serious side effects:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat, which can cause difficulty breathing
• severe skin reactions, including intense 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 heart rhythms
• pancreatitis, which can cause severe stomach and back pain and very poor general health
• Candesartan Cilexetil + Amlodipine + HCT Sandoz may cause a decrease in the number of white blood cells. You may experience decreased resistance to infection and fatigue, infection, or fever. In such cases, contact your doctor. Your doctor may perform blood tests from time to time to check if Candesartan Cilexetil + Amlodipine + HCT Sandoz is affecting your blood (agranulocytosis)
• sudden severe eye pain, redness of the eyes, vision disturbances, and halos around light sources, accompanied by nausea and/or vomiting. These may be symptoms of fluid accumulation in the eye (between the iris and the cornea) or a sudden increase in pressure in the eye (angle-closure glaucoma), which requires immediate treatment to alleviate symptoms and prevent permanent vision loss (serious vision problems)

Candesartan Cilexetil + Amlodipine + HCT Sandoz is a combination of three active substances. The following information is about side effects known for each of them.

Side effects are classified as very common, common, uncommon, rare, very rare, and not known, to give you an idea of how often they may occur.

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 when taking 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
• stomach pain, nausea, vomiting
• disturbances 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 in taste (dysgeusia)
• fainting
• numbness, paresthesia (abnormal sensations)
• ringing in the ears (tinnitus)
• irregular heartbeat (including slow heart rate - bradycardia)
• fast heartbeat (ventricular tachycardia) and irregular heartbeat (atrial fibrillation)
• low blood pressure (hypotension), orthostatic hypotension (low blood pressure that may be worsened by alcohol, anesthetics, or sedatives)
• low levels of magnesium, high levels of calcium, acid-base imbalance (a condition where the body has either too much or too little acid), low levels of phosphate
• low levels of sodium in the blood (hyponatremia)
• cough
• nasal inflammation
• dry mouth
• hair loss, increased sweating, itching, skin redness, skin discoloration
• general malaise
• chest pain, back pain
• joint pain
• muscle pain (myalgia)
• urination disturbances, nocturia (frequent urination at night), increased frequency of urination
• impotence, discomfort or enlargement of the breasts in men, inability to achieve an erection
• decreased appetite
• weight gain or loss
• reactions to sunlight

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

• low platelet count (thrombocytopenia), sometimes with bleeding under the skin (purpura)
• shortness of breath with a cough and fatigue or feeling unwell
• inflammation of blood vessels with symptoms such as rash, purple spots on the skin, fever
• gastrointestinal disturbances
• pancreatitis
• confusion
• sleep disturbances
• jaundice (yellowing 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 levels of neutrophils, a type of white blood cell),
• bone marrow depression (reduced activity of the bone marrow)
• severe shortness of breath
• red spots and blisters on the skin, looking like a "bull's eye", fatigue, fever, joint pain or kidney problems - these are the most common symptoms of a condition called lupus erythematosus
• rash with red, non-itchy, flaky patches
• hemolytic anemia
• allergic reactions
• inflammation of blood vessels (vasculitis),
• high levels of potassium in the blood
• increased muscle tone
• peripheral neuropathy
• gastritis
• gum overgrowth
• increased liver enzymes, liver problems, liver inflammation
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Not known (frequency cannot be estimated from the available data)

• aplastic anemia (a condition where the bone marrow is damaged and cannot produce blood cells)
• extrapyramidal disorders (a group of neurological disorders that affect movement and coordination)
• acute kidney failure
• skin and lip cancer (non-melanoma skin cancer)

Reporting side effects

If you experience any side effects, tell your doctor. Side effects can also be reported to the national reporting system via the internet at https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this 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 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 + HCT Sandoz contains

The active substances 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.

The other ingredients are:

Filler:

lactose monohydrate, corn starch, hydroxypropyl cellulose, calcium carmellose, macrogol (type 8000), corn starch, magnesium stearate.

Cap and body of the capsule (16 mg + 5 mg + 12.5 mg):

• Body: titanium dioxide (E 171), gelatin
• Cap: sunset yellow FCF (E 110), titanium dioxide (E 171), gelatin

Cap and body of the capsule (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

Ink:

shellac, iron oxide black (E 172), propylene glycol, concentrated ammonia solution, 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

The hard gelatin capsule, size "0", has a white body with a black imprint "1" and an orange cap with a black imprint "CAH", filled with a white to off-white powder.

Candesartan Cilexetil + Amlodipine + HCT Sandoz, 16 mg + 10 mg + 12.5 mg, hard capsules

The hard gelatin capsule, size "0", has a white body with a black imprint "2" and a red cap with a black imprint "CAH", filled with a white to off-white powder.

Available in packs of 30 or 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

Phone: +48 22 209 70 00

Manufacturer:

Lek Pharmaceuticals d.d.

Verovskova Ulica 57

1526 Ljubljana, Slovenia

Adamed Pharma S.A.

ul. Marsz. Józefa Pilsudskiego 5

95-200 Pabianice, Poland

For more information on this medicine, contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

Phone: +48 22 209 70 00

This medicine is authorized in the Member States 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

Date of last revision of the leaflet:01/2025