AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE SANDOZ 5 mg/160 mg/12.5 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the patient

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 5 mg/160 mg/12.5 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 10 mg/160 mg/12.5 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 5 mg/160 mg/25 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 10 mg/160 mg/25 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 10 mg/320 mg/25 mg film-coated tablets EFG

Read the entire leaflet carefully before you start 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Amlodipine/Valsartan/Hydrochlorothiazide Sandoz is and what it is used for
2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz
3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz
4. Possible side effects

5 Storage of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

1. Contents of the pack and other information

1. What Amlodipine/Valsartan/Hydrochlorothiazide Sandoz is and what it is used for

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz contains three active substances called amlodipine, valsartan, and hydrochlorothiazide. All these substances help to control high blood pressure.

• Amlodipine belongs to a group of substances called "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing.
• Valsartan belongs to a group of substances called "angiotensin II receptor antagonists". Angiotensin II is produced by the body and causes the blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances called "thiazide diuretics". Hydrochlorothiazide increases urine production, which also lowers blood pressure.

As a result of the three mechanisms, the blood vessels relax and blood pressure decreases.

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan, and hydrochlorothiazide, and who can benefit from taking a single tablet containing the three substances.

2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

Do not takeAmlodipine/Valsartan/Hydrochlorothiazide Sandoz

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking amlodipine/valsartan/hydrochlorothiazide also at the beginning of your pregnancy – see section Pregnancy).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medications (medications used to treat chest or urinary tract infections) or to any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, do not take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz and inform your doctor.

• if you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are on dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels in the blood.
• if your blood calcium levels are too high despite treatment to reduce calcium levels in the blood.
• if you have gout (uric acid crystals in the joints).
• if you have severe low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation where your heart cannot supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz and inform your doctor if any of the above applies to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

• if you have low potassium or magnesium levels in your blood (with or without symptoms such as muscle weakness, muscle spasms, irregular heartbeat).
• if you have low sodium levels in your blood (with or without symptoms such as fatigue, confusion, muscle contractions, convulsions).
• if you have high calcium levels in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and muscle contractions).
• if you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the arteries to the kidney.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, in particular if you have been prescribed the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to start taking the medication carefully. Your doctor may also check your kidney function.
• if your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (called "hypertrophic cardiomyopathy").
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of amlodipine/valsartan/hydrochlorothiazide is not recommended.
• if you have a disease called systemic lupus erythematosus (also known as "lupus" or "SLE").
• if you have diabetes (high blood sugar levels).
• if you have high cholesterol or triglyceride levels in your blood.
• if you experience skin reactions such as rash after sun exposure.
• if you have had an allergic reaction to other blood pressure-lowering medications or diuretics, especially if you have asthma and allergies.
• if you have been ill (with vomiting or diarrhea).
• if you have experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking amlodipine/valsartan/hydrochlorothiazide and contact your doctor immediately. You should never take amlodipine/valsartan/hydrochlorothiazide again.
• if you experience dizziness and/or fainting during treatment with amlodipine/valsartan/hydrochlorothiazide, inform your doctor as soon as possible.
• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and can occur within a few hours to a week after taking amlodipine/valsartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.
• if you are taking any of the following medications used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking amlodipine/valsartan/hydrochlorothiazide.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking amlodipine/valsartan/hydrochlorothiazide, seek medical attention immediately.

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in regular blood tests.

See also the information under the heading “Do not take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz”.

Tell your doctor if any of the above applies to you.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking amlodipine/valsartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking amlodipine/valsartan/hydrochlorothiazide on your own.

Children and adolescents

The use of amlodipine/valsartan/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Elderly (65 years and older)

Amlodipine/valsartan/hydrochlorothiazide can be used in people 65 years and older at the same dose as used in other adults and in the same way as they have already taken the three substances called amlodipine, valsartan, and hydrochlorothiazide. The blood pressure of elderly patients should be monitored periodically, especially those taking the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).

Other medicines andAmlodipine/Valsartan/Hydrochlorothiazide Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important if you are using any of the following medicines:

Do not take with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz” and “Warnings and precautions”).

Use with caution with:

• alcohol, sleeping pills, and anesthetics (medicines for patients undergoing surgery and other procedures);
• amantadine (treatment for Parkinson's disease, also used for treatment or prevention of certain viral diseases);
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsant and mood-stabilizing medicines used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances used primarily to treat high lipid levels in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in transplants to prevent organ rejection or for other conditions, e.g., rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• verapamil, diltiazem (heart medicines);
• iodinated contrast media (agents used in imaging procedures);
• medicines to treat diabetes (oral medicines such as metformin or insulins);
• medicines to treat gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may induce "torsades de pointes" (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce potassium levels in the blood, such as diuretics (medicines to urinate), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines to increase blood pressure, such as adrenaline or noradrenaline;
• medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat inflammation and ulceration of the esophagus (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines to relax muscles used during operations);
• nitroglycerin and other nitrates, or other substances called "vasodilators";
• other medicines used to treat high blood pressure, including methyldopa;
• rifampicin (used, e.g., to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (in infusion for severe body temperature abnormalities);
• tacrolimus (used to control the body's immune response, allowing it to accept a transplanted organ);
• vitamin D and calcium salts.

Taking Amlodipine/Valsartan/Hydrochlorothiazide Sandozwith food, drinks, and alcohol

People who have been prescribed amlodipine/valsartan/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effects of amlodipine/valsartan/hydrochlorothiazide. Consult your doctor before drinking alcohol. Alcohol can greatly lower your blood pressure and/or increase the possibility of dizziness or fainting.

Pregnancy andbreast-feeding

Pregnancy

You must tell your doctorif you are pregnant, if you think you may be pregnant, or if you are planning to become pregnant. Your doctor will normally advise you to stop taking amlodipine/valsartan/hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take a different medicine instead. Amlodipine/valsartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy and must not be taken after the first trimester, as it may cause serious harm to your baby.

Breast-feeding

Tell your doctorif you are breast-feeding or about to start breast-feeding. It has been shown that amlodipine passes into breast milk in small amounts. Amlodipine/valsartan/hydrochlorothiazide is not recommended for women during breast-feeding. Your doctor may decide to prescribe a different treatment if you want to breast-feed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine may make you feel dizzy, sleepy, nauseous, or have a headache. If you experience these symptoms, do not drive or use tools or machines.

3. How to Take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again. This will help you achieve the best results and reduce the risk of adverse effects.

The recommended dose of amlodipine/valsartan/hydrochlorothiazide is one tabletper day.

• It is preferable to take the tablet at the same time every day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You can take amlodipine/valsartan/hydrochlorothiazide with or without food. Do not take amlodipine/valsartan/hydrochlorothiazide with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

If you take more Amlodipine/Valsartan/Hydrochlorothiazide Sandoz than you should

If you have taken more Amlodipine/Valsartan/Hydrochlorothiazide Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

If you forget to take a dose of this medication, take it as soon as you remember. Then take the next dose at the usual time. However, if it is almost time for the next dose, you should only take the next tablet at the usual time. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

Interrupting your treatment with Amlodipine/Valsartan/Hydrochlorothiazide Sandoz may cause your disease to worsen. Do not stop taking your medication unless your doctor tells you to.

Always take this medication, even if you feel well

People with high blood pressure often do not notice any signs of the disease. Many feel normal. It is very important that you take this medication exactly as your doctor says to get the best results and reduce the risk of adverse effects. Keep your appointments with your doctor, even if you feel well.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

As with any combination that contains three active principles, the adverse effects associated with each individual component cannot be excluded. The adverse effects reported with Amlodipine/Valsartan/Hydrochlorothiazide Sandoz or any of its three active principles (amlodipine, valsartan, and hydrochlorothiazide) are shown below and may occur with the use of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz.

Some adverse effects can be serious and require immediate medical attention.

Consult your doctor immediately if you experience any of the following serious adverse effects after taking this medication.

Frequent adverse effects (may affect up to 1 in 10 patients)

• dizziness
• low blood pressure (feeling of fainting, dizziness, sudden loss of consciousness)

Infrequent adverse effects (may affect up to 1 in 100 patients)

• severe decrease in urine production (decreased renal function)

Rare adverse effects (may affect up to 1 in 1,000 patients)

• spontaneous bleeding
• irregular heartbeat
• liver disorder

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• acute difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion)
• sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that causes great difficulty breathing
• severe skin reactions that include intense rash, hives, redness of the skin all over the body, significant itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• pancreatitis, which can cause severe abdominal and back pain accompanied by a great feeling of discomfort
• weakness, bruising, fever, and frequent infections
• stiffness
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Other adverse effects may include:

Very frequent adverse effects (may affect more than 1 in 10 patients)

• low potassium levels in the blood
• increased lipids in the blood

Frequent adverse effects (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeat)
• hot flashes
• swelling of the ankles (edema)
• abdominal pain
• discomfort in the stomach after eating
• fatigue
• headache
• frequent urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, fainting when standing up
• decreased appetite
• nausea and vomiting
• rash and itching of the skin and other types of rashes
• inability to achieve or maintain an erection

Infrequent adverse effects (may affect up to 1 in 100 patients)

• rapid heartbeat
• feeling that everything is spinning around
• vision disorder
• stomach discomfort
• chest pain
• increased urea, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• decreased potassium in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of the joints
• cramps/weakness/pain in the muscles
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• redness of the skin
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• ringing in the ears
• sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching of the skin
• skin discoloration
• urination disorder
• increased need to urinate at night
• increased number of times urinating
• discomfort or enlargement of the breasts in men
• pain
• feeling of discomfort
• weight loss

Rare adverse effects (may affect up to 1 in 1,000 patients)

• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• sugar in the urine
• high blood sugar levels
• worsening of diabetic metabolic condition
• abdominal discomfort
• constipation
• liver disorders that may present with yellowing of the skin and eyes or darkening of the urine (hemolytic anemia)
• increased sensitivity of the skin to the sun
• purplish spots on the skin
• kidney disorders
• confusion

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• decrease in the number of white blood cells
• decrease in blood platelets that can cause unusual bruising or easy bleeding (damage to red blood cells)
• inflammation of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• increase in liver enzymes that can affect some medical tests
• increase in muscle tension
• inflammation of blood vessels often with skin rashes
• sensitivity to light
• disorders combining stiffness, tremor, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal decrease due to rupture of red blood cells both in blood vessels and in other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
• severe skin disease that causes rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)

Adverse effects of unknown frequency (cannot be estimated from available data)

• alteration of kidney function test results in blood, increased potassium in the blood, low red blood cell count
• abnormal red blood cell count
• low levels of a certain type of white blood cell and platelets in the blood
• increased creatinine in the blood
• abnormal liver function test
• significant decrease in urine production
• inflammation of blood vessels
• weakness, bruising, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of kidney disorder or kidney failure)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a disease called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep in the original packaging to protect it from moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of tampering.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAmlodipine/Valsartan/Hydrochlorothiazide Sandoz 5mg/160mg/12.5mg film-coated tablets

• The active ingredients of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
• The other ingredients are microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, and titanium dioxide (E171).

Composition ofAmlodipine/Valsartan/Hydrochlorothiazide Sandoz 10mg/160mg/12.5mg film-coated tablets

• The active ingredients of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
• The other ingredients are microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Composition ofAmlodipine/Valsartan/Hydrochlorothiazide Sandoz 5mg/160mg/25mg film-coated tablets

• The active ingredients of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
• The other ingredients are microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Composition ofAmlodipine/Valsartan/Hydrochlorothiazide Sandoz 10mg/160mg/25mg film-coated tablets

• The active ingredients of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
• The other ingredients are microcrystalline cellulose; crospovidone (type A); colloidal anhydrous silica, magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, and yellow iron oxide (E172).

Composition ofAmlodipine/Valsartan/Hydrochlorothiazide Sandoz 10mg/320mg/25mg film-coated tablets

• The active ingredients of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan, and 25 mg of hydrochlorothiazide.
• The other ingredients are microcrystalline cellulose; crospovidone (type A); colloidal anhydrous silica, magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, and yellow iron oxide (E172).

Product Appearance and Package Contents

The Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with "NVR" on one side and "VCL" on the other side.

Height: approximately 15 mm

Width: approximately 5.9 mm

The Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with "NVR" on one side and "VDL" on the other side.

Height: approximately 15 mm

Width: approximately 5.9 mm

The Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with "NVR" on one side and "VEL" on the other side.

Height: approximately 15 mm

Width: approximately 5.9 mm

The Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 10 mg/160 mg/25 mg film-coated tablets are yellow-brown, oval tablets with "NVR" on one side and "VHL" on the other side.

Height: approximately 15 mm

Width: approximately 5.9 mm

The Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 10 mg/320 mg/25 mg film-coated tablets are yellow-brown, oval tablets with "NVR" on one side and "VFL" on the other side.

Height: approximately 19 mm

Width: approximately 7.5 mm

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz is available in blister packs of PVC/PVDC-Alu or in perforated unit dose blister packs of PVC/PVDC-Alu.

Amlodipine/Valsartan/Hydrochlorothiazide Sandoz is available in blister packs containing 14, 28, 28x1, 30, 56, 56x1, 60, 90, 98, 98x1, 100, 280, or 280x1 film-coated tablets, in multiple packs with 280 tablets (with 4 boxes, each containing 70x1 tablets, or 20 boxes, each containing 14 tablets).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, Sachsen-Anhalt

39179 Barleben

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg, Bayern

Germany

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Farma S.p.A.

Via Proviniciale Schito 131

80058 Torre Annunziata (NA)

Italy

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

Netherlands: Amlodipine besylate/Valsartan/HCT Sandoz 5 mg/160 mg/12.5 mg film-coated tablets Amlodipine besylate/Valsartan/HCT Sandoz 10 mg/160 mg/12.5 mg film-coated tablets

Amlodipine besylate/Valsartan/HCT Sandoz 5 mg/160 mg/25 mg film-coated tablets

Amlodipine besylate/Valsartan/HCT Sandoz 10 mg/160 mg/25 mg film-coated tablets

Amlodipine besylate/Valsartan/HCT Sandoz 10 mg/320 mg/25 mg film-coated tablets

Austria: Amlodipine/Valsartan/HCT Sandoz 5 mg/160 mg/12.5 mg - film-coated tablets

Amlodipine/Valsartan/HCT Sandoz 10 mg/160 mg/12.5 mg – film-coated tablets

Amlodipine/Valsartan/HCT Sandoz 5 mg/160 mg/25 mg - film-coated tablets

Amlodipine/Valsartan/HCT Sandoz HCT 10 mg/160 mg/25 mg – film-coated tablets

Amlodipine/Valsartan/HCT Sandoz 10 mg/320 mg/25 mg – film-coated tablets

Germany: Amlodipine/Valsartan/HCT - 1 A Pharma 5 mg/160 mg/12.5 mg film-coated tablets

Amlodipine/Valsartan/HCT - 1 A Pharma 10 mg/160 mg/12.5 mg film-coated tablets

Amlodipine/Valsartan/HCT - 1 A Pharma 5 mg/160 mg/25 mg film-coated tablets

Amlodipine/Valsartan/HCT - 1 A Pharma 10 mg/160 mg/25 mg film-coated tablets

Amlodipine/Valsartan/HCT - 1 A Pharma 10 mg/320 mg/25 mg film-coated tablets

Hungary: Amlodipine/Valsartan/HCT Sandoz 5 mg/160 mg/12.5 mg film-coated tablets

Amlodipine/Valsartan/HCT Sandoz 10 mg/160 mg/12.5 mg film-coated tablets

Amlodipine/Valsartan/HCT Sandoz 5 mg/160 mg/25 mg film-coated tablets

Amlodipine/Valsartan/HCT Sandoz 10 mg/160 mg/25 mg film-coated tablets

Amlodipine/Valsartan/HCT Sandoz 10 mg/320 mg/25 mg film-coated tablets

Date of the last revision of thisleaflet:June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/