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 your medicine is Candesartan Cilexetil + Amlodipine + HCT Sandoz. It is used in adults to treat high blood pressure (hypertension). The medicine contains three active substances: candesartan cilexetil, amlodipine besylate, and hydrochlorothiazide. They work together to lower your blood pressure.

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 used to treat high blood pressure
• if you have low potassium or sodium levels, or high calcium levels in your blood that 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 a reduced blood flow to the tissues, which may cause low blood pressure, low pulse, fast heartbeat, or shock (including cardiogenic shock)
• if you have very low blood pressure
• if the 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)

If any of the above applies to you, do not take Candesartan Cilexetil + Amlodipine + HCT Sandoz.

Warnings and precautions

Before taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, talk to your doctor, pharmacist, or nurse.

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

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems caused by diabetes
• aliskiren
• an ACE inhibitor and a medicine called a mineralocorticoid receptor antagonist (MRA), used to treat heart failure

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 having dialysis
• liver disease
• heart attack or stroke
• coronary heart disease or cerebral vascular disease
• heart failure or problems with your heart valves or heart muscle
• very high blood pressure (hypertensive crisis)
• if you have ever had a tumor of the adrenal gland (pheochromocytoma)
• if you have ever had a low blood cell count (e.g., anemia)

During treatment with Candesartan Cilexetil + Amlodipine + HCT Sandoz, you should protect your skin from the sun and UV radiation.

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

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

• diarrhea that is severe, persistent, and causes significant weight loss. Your doctor may assess your symptoms and decide whether to continue your blood pressure medication.
• blurred vision or eye pain. These can be symptoms of fluid accumulation in the eye (choroidal effusion) or increased pressure in the eye, which can occur within hours to weeks after taking Candesartan Cilexetil + Amlodipine + HCT Sandoz and can lead to permanent vision loss if left untreated.
• if you have had breathing or lung problems after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, seek medical help immediately.

Before surgery, tell your doctor or dentist that you are taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, as it may cause a drop in blood pressure when combined with certain anesthetics.

As with any blood pressure medicine, low blood pressure can occur, which may lead to a heart attack or stroke. Your doctor will monitor your blood pressure closely.

Candesartan Cilexetil + Amlodipine + HCT Sandoz may increase your cholesterol and uric acid levels in the blood. Your doctor may perform blood tests to monitor this.

Candesartan Cilexetil + Amlodipine + HCT Sandoz may change the levels of certain substances in your blood called electrolytes. Your doctor may perform blood tests to check your electrolyte levels from time to time. Symptoms of electrolyte changes include thirst, dry mouth, muscle pain or cramps, fatigue, low blood pressure, weakness, lethargy, sleepiness, or restlessness, nausea, vomiting, decreased urine production, and rapid heartbeat.

Tell your doctor if you experience any of these symptoms.

If you need to have a parathyroid function test, stop taking Candesartan Cilexetil + Amlodipine + HCT Sandoz before the test.

Tell your doctorif you think you might be pregnant or are planning to become pregnant.

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.

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, talk to your doctor. Your doctor will decide whether to continue your treatment.

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 or pharmacist about all the medicines you are taking, have recently taken, or might take, including:

• other blood pressure medicines, as they may increase the effect of Candesartan Cilexetil + Amlodipine + HCT Sandoz. Your doctor may adjust your dose and/or take other precautions.
• lithium (a medicine used to treat mood swings and depression), as taking it with Candesartan Cilexetil + Amlodipine + HCT Sandoz may increase lithium toxicity.
• certain anti-seizure medicines, such as carbamazepine
• certain heart rhythm medicines, such as diltiazem, verapamil
• certain antibiotics, such as rifampicin, erythromycin, clarithromycin
• St. John's Wort (a herbal medicine used to treat depression)
• cisapride (a medicine used to improve the movement of food in the stomach and intestines)
• certain medicines used to treat irregular heartbeat, such as dofetilide or ibutilide
• certain medicines used to treat HIV/AIDS, such as ritonavir, indinavir, nelfinavir
• certain medicines used to treat fungal infections, such as ketoconazole, itraconazole, amphotericin
• certain medicines used to treat heart conditions, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil
• certain medicines used to treat cancer, such as amifostine, cyclophosphamide, methotrexate
• medicines that increase blood pressure (e.g., noradrenaline) and slow the heart rate
• certain antibiotics, such as tetracyclines or sparfloxacin, and pentamidine
• medicines used to treat seasonal allergies, such as mizolastine or terfenadine
• medicines used to treat gout, such as probenecid, sulfinpyrazone, allopurinol
• medicines used to lower cholesterol, such as colestyramine or colestipol
• medicines used to lower blood sugar, 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 amlodipine in your blood, leading to unpredictable and increased effects of the medicine.

Be cautious when consuming alcohol while taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, as some people may experience dizziness or lightheadedness.

Elderly

In patients over 65 years of age, your doctor will monitor your blood pressure closely when increasing the dose.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

If you become pregnant while taking Candesartan Cilexetil + Amlodipine + HCT Sandoz, inform 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 effects of Candesartan Cilexetil + Amlodipine + HCT Sandoz on fertility.

Driving and using machines

During treatment with Candesartan Cilexetil + Amlodipine + HCT Sandoz, you may experience drowsiness, nausea, dizziness, or headache. Do not drive or operate machinery if you experience these symptoms.

Ask your doctor for advice.

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)

This 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 or pharmacist if you are not sure.

• The recommended dose is one capsule per day, as prescribed by your doctor.
• Swallow the capsule with a glass of water. Do not chew the capsule. Do not take the capsule with grapefruit juice.
• Try to take your dose at the same time each day, e.g., with breakfast.

Use in 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 Candesartan Cilexetil + Amlodipine + HCT Sandoz in this age group have not been established.

Elderly

Special care is needed when taking Candesartan Cilexetil + Amlodipine + HCT Sandoz in elderly patients due to the risk of electrolyte disturbances.

Renal impairment

When taking Candesartan Cilexetil + Amlodipine + HCT Sandoz in patients with mild to moderate kidney problems, your doctor may monitor your kidney function regularly. Candesartan Cilexetil + Amlodipine + HCT Sandoz is contraindicated in patients with severe kidney problems.

Hepatic impairment

In patients with liver problems, your doctor may monitor your blood pressure and kidney function closely. 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 you should, you may experience low blood pressure with symptoms such as dizziness, fast or slow heartbeat.

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

If you have taken more capsules than you should or if a child has taken some, contact your doctor or go to the nearest hospital casualty department immediately, taking this leaflet and any remaining capsules 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.

If you stop taking 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Candesartan Cilexetil + Amlodipine + HCT Sandoz 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 or throat, which may cause difficulty breathing
• severe skin reactions, including intense rash, itching, or hives, blistering of the skin, mouth, eyes, or genitals
• heart attack or irregular heartbeat
• pancreatitis, which may cause severe stomach pain and discomfort
• Candesartan Cilexetil + Amlodipine + HCT Sandoz may cause a decrease in white blood cell count. You may experience decreased immunity to infections, fatigue, infection, or fever. Contact your doctor if you experience any of these symptoms.
• sudden, severe eye pain, redness of the eye, vision changes, or seeing halos around lights, with nausea and/or vomiting. These can be symptoms of fluid accumulation in the eye or increased pressure in the eye, which can occur within hours to weeks after taking Candesartan Cilexetil + Amlodipine + HCT Sandoz and can lead to permanent vision loss if left untreated.

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

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), especially with high doses
• increased lipid levels in the blood
• respiratory tract infections
• increased blood sugar levels (hyperglycemia)
• increased uric acid levels in the blood (hyperuricemia)
• drowsiness
• dizziness or lightheadedness, headache
• vision disturbances (including double vision)
• irregular heartbeat (palpitations)
• flushing
• shortness of breath
• abdominal pain, nausea, vomiting
• gastrointestinal disturbances, constipation, diarrhea
• skin rash, itching
• edema of the ankles
• muscle cramps
• fatigue, weakness

Uncommon (may affect up to 1 in 100 people)

• depression, mood changes (including anxiety), insomnia
• tremors
• vomiting
• disturbances of taste (dysgeusia)
• syncope (fainting)
• paresthesia (tingling or numbness)
• tinnitus (ringing in the ears)
• arrhythmia (including slow heart rate - bradycardia)
• hypotension (low blood pressure), orthostatic hypotension (low blood pressure when standing up),
• hypomagnesemia (low magnesium levels), hypercalcemia (high calcium levels), hypochloremic alkalosis (a condition where the blood becomes too alkaline), hypophosphatemia (low phosphate levels)
• hyponatremia (low sodium levels)
• cough
• rhinitis (inflammation of the nasal passages)
• dry mouth
• hair loss, increased sweating, itching, redness, or discoloration of the skin
• general malaise
• chest pain, back pain
• arthralgia (joint pain)
• myalgia (muscle pain)
• urinary disturbances, nocturia (frequent urination at night), increased urine production
• impotence, discomfort or enlargement of the breasts in men, erectile dysfunction
• decreased appetite
• weight gain or loss
• photosensitivity reactions

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

• thrombocytopenia (low platelet count), sometimes with bleeding under the skin (purpura)
• shortness of breath with cough and fatigue or weight loss
• vasculitis (inflammation of blood vessels) with symptoms such as rash, purpura, or fever
• gastrointestinal disturbances
• pancreatitis
• confusion
• sleep disturbances
• jaundice (yellowing of the skin and eyes)
• kidney problems or kidney failure
• fever

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

• blood disorders, such as neutropenia (low white blood cell count), agranulocytosis (a potentially life-threatening reduction in white blood cells)
• bone marrow failure (a condition where the bone marrow does not produce enough blood cells)
• severe shortness of breath
• red or purple spots on the skin, fever, joint pain or swelling, and kidney problems - these can be symptoms of a condition called systemic lupus erythematosus
• skin rash with red, non-itchy, scaly patches
• hemolytic anemia (a condition where red blood cells are destroyed faster than they can be made)
• allergic reactions
• vasculitis (inflammation of blood vessels)
• high potassium levels in the blood
• increased muscle tone
• peripheral neuropathy (nerve damage)
• gastritis (inflammation of the stomach lining)
• gingival hyperplasia (overgrowth of gum tissue)
• increased liver enzymes, liver problems, or liver failure
• intestinal angioedema (swelling of the intestines)

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

• aplastic anemia (a condition where the bone marrow does not produce enough blood cells)
• extrapyramidal disorders (a group of disorders that affect movement, including Parkinson's disease)
• acute kidney failure
• skin cancer or lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experience any side effects, tell your doctor. You can also report side effects directly via the national reporting system.

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

Do not store above 30°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 capsules

Each hard capsule contains 16 mg candesartan cilexetil, 5 mg amlodipine (as amlodipine besylate), and 12.5 mg hydrochlorothiazide.

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

Each hard capsule contains 16 mg candesartan cilexetil, 10 mg amlodipine (as amlodipine besylate), and 12.5 mg hydrochlorothiazide.

The other ingredients are:

Filler:

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

Cap:

(16 mg + 5 mg + 12.5 mg):

• body: titanium dioxide (E 171), gelatin
• cap: orange yellow S (E 110), titanium dioxide (E 171), gelatin

(16 mg + 10 mg + 12.5 mg):

• body: titanium dioxide (E 171), gelatin
• cap: azorubine (E 122), orange yellow S (E 110), titanium dioxide (E 171), gelatin

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

Hard gelatin capsule, size 0, with a white body and black ink "1", and an orange cap with black ink "CAH", filled with a white to off-white powder.

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

Hard gelatin capsule, size 0, with a white body and black ink "2", and a red cap with black ink "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 Warszawa

tel. 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 further 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 Warszawa

tel. 22 209 70 00

Candesartan Cilexetil + Amlodipine + HCT Sandoz 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