Prospecto: Information for the Patient

Amlodipino/Valsartán/Hidroclorotiazida Sandoz 5 mg/160 mg/12.5 mg Film-Coated Tablets

Amlodipino/Valsartán/Hidroclorotiazida Sandoz 10 mg/160 mg/12.5 mg Film-Coated Tablets

Amlodipino/Valsartán/Hidroclorotiazida Sandoz 5 mg/160 mg/25 mg Film-Coated Tablets

Amlodipino/Valsartán/Hidroclorotiazida Sandoz 10 mg/160 mg/25 mg Film-Coated Tablets

Amlodipino/Valsartán/Hidroclorotiazida Sandoz 10 mg/320 mg/25 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Amlodipino/Valsartán/Hidroclorotiazida Sandoz and for what it is used

2. What you need to know before starting to take Amlodipino/Valsartán/Hidroclorotiazida Sandoz

3. How to take Amlodipino/Valsartán/Hidroclorotiazida Sandoz

4. Possible adverse effects

5 Storage of Amlodipino/Valsartán/Hidroclorotiazida Sandoz

6. Contents of the package and additional information

Amlodipino/Valsartán/Hidroclorotiazida Sandoz contains three substances called amlodipino, valsartán and hidroclorotiazida. All these substances help control high blood pressure.

• Amlodipino belongs to a group of substances called «calcium channel antagonists». Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessels from narrowing.
• Valsartán belongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartán acts by blocking the effect of angiotensin II.
• Hidroclorotiazida belongs to a group of substances called «thiazide diuretics». Hidroclorotiazida increases urine production, which also decreases blood pressure.

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

Amlodipino/Valsartán/Hidroclorotiazida Sandoz is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipino, valsartán and hidroclorotiazida and who may benefit from taking a tablet that contains the three substances.

Do not takeAmlodipino/Valsartán/Hidroclorotiazida Sandoz

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

If you think you may be allergic, do not take Amlodipino/Valsartán/Hidroclorotiazida Sandoz and inform your doctor.

• if you have liver disease, destruction of the small bile ducts inside the liver (biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are undergoing 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 (crystals of uric acid in the joints).
• if you have severe low blood pressure (hypotension).
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation in which your heart cannot supply enough blood to the body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskiren.

Do not take Amlodipino/Valsartán/Hidroclorotiazida Sandoz and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAmlodipino/Valsartán/Hidroclorotiazida Sandoz

• if you have low levels of potassium or magnesium in the blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
• if you have low levels of sodium in the blood (with or without symptoms such as fatigue, confusion, muscle contractions, seizures).
• if you have high levels of calcium in the blood (with or without symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, and muscle contractions).
• if you have kidney problems, have undergone a kidney transplant, or if you have been told that you have a narrowing of the kidney arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, particularly if you have been prescribed the maximum dose of amlodipino/valsartán/hidroclorotiazida (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to start treatment carefully. Your doctor may also check your kidney function.
• if your doctor has told you that you have a narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (called "hypertrophic obstructive cardiomyopathy").
• if you have a condition called aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of amlodipino/valsartán/hidroclorotiazida is not recommended.
• if you have a disease called systemic lupus erythematosus (also known as "lupus" or "LES").
• if you have diabetes (high blood sugar levels).
• if you have high levels of cholesterol or triglycerides in the blood.
• if you experience skin reactions such as sunburn.
• if you have had an allergic reaction to other medications for high blood pressure 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 amlodipino/valsartán/hidroclorotiazida and contact your doctor immediately. You should never take amlodipino/valsartán/hidroclorotiazida again.
• if you experience dizziness and/or fainting during treatment with amlodipino/valsartán/hidroclorotiazida, inform your doctor as soon as possible.
• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye and may occur within a few hours to a week after taking amlodipino/valsartán/hidroclorotiazida. If left untreated, this can cause permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it.
• if you are taking any of the following medications used to treat high blood pressure:

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly 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. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking amlodipino/valsartán/hidroclorotiazida.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after takinghidroclorotiazidain the past. If you experience shortness of breath or severe difficulty breathing after taking amlodipino/valsartán/hidroclorotiazida, seek medical attention immediately.

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

See also the information under the heading “Do not take Amlodipino/Valsartán/Hidroclorotiazida Sandoz”.

Inform your doctor if you are affected by any of the cases mentioned.

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

Children and adolescents

Amlodipino/valsartán/hidroclorotiazida is not recommended for children or adolescents under 18 years old.

Older adults (65 years and older)

Amlodipino/valsartán/hidroclorotiazida 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 amlodipino, valsartán, and hidroclorotiazida. Your doctor should regularly check your blood pressure, particularly those who take the maximum dose of amlodipino/valsartán/hidroclorotiazida (10 mg/320 mg/25 mg).

Taking Amlodipino/Valsartán/Hidroclorotiazida Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medications. This is especially important if you are using any of the medications listed below:

Do not take with:

• lithium (a medication used to treat certain types of depression);
• medications or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin;
• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Amlodipino/Valsartán/Hidroclorotiazida Sandoz” and “Warnings and precautions”).

Use with caution with:

• alcohol, sleeping pills, and anesthetics (medications for patients undergoing surgery and other procedures);
• amantadine (treatment for Parkinson's disease, also used to treat or prevent certain diseases caused by viruses);
• anticholinergic medications (medications used to treat various disorders such as gastrointestinal upset, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• colestiramine, colestipol, or other resins (substances used mainly to treat high levels of lipids in the blood);
• simvastatin (a medication used to control high levels of cholesterol);
• ciclosporina (a medication used in transplants to prevent organ rejection or for other conditions, e.g., rheumatoid arthritis or atopic dermatitis);
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medications used to treat heart problems);
• verapamil, diltiazem (heart medications);
• iodinated contrast media (agents used in imaging tests);
• medications used to treat diabetes (oral medications such as metformin or insulin);
• medications used to treat gout, such as allopurinol;
• medications that may increase blood sugar levels (beta-blockers, diazoxide);
• medications that may induce "torsades de pointes" (irregular heart rhythm), such as antiarrhythmics (medications used to treat heart problems) and certain antipsychotics;
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptic medications;
• medications that may reduce the amount of potassium in the blood, such as diuretics, corticosteroids, laxatives, amphotericin B, or penicillin G;
• medications used to increase blood pressure, such as adrenaline or noradrenaline;
• medications used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medications used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medications used to treat inflammation and ulcers in the esophagus (carbenoxolone);
• medications used to relieve pain or inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors;
• muscle relaxants (medications used to relax muscles during surgery);
• nitroglycerin and other vasodilators;
• other medications used to treat high blood pressure, including methyldopa;
• rifampicin (used, e.g., to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (intravenous for severe temperature abnormalities);
• vitamin D and calcium salts.

Taking Amlodipino/Valsartán/Hidroclorotiazida Sandoz with food, drinks, and alcohol

People who have been prescribed amlodipino/valsartán/hidroclorotiazida should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipino, which may cause an unpredictable increase in the blood pressure-lowering effects of amlodipino/valsartán/hidroclorotiazida. Consult your doctor before drinking alcohol. Alcohol may significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and lactation

Pregnancy

You must inform your doctorif you are pregnant,if you suspect you may be pregnant or if you plan to become pregnant. Your doctor will usually advise you to stop taking amlodipino/valsartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another medication instead. Amlodipino/valsartán/hidroclorotiazida is not recommended to be taken at the beginning of pregnancy and should not be administered after the thirdmonth of pregnancy, as it may cause serious harm to your baby when administered from that point on.

Lactation

You must inform your doctorif you are orplan to initiate lactation. Amlodipino/valsartán/hidroclorotiazida is not recommended to be administered to women during this period. Your doctor may decide to administer another treatment if you want to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

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

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

The recommended dose of amlodipine/valsartan/hydrochlorothiazide is one tablet per 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.

Your doctor may suggest a higher or lower dose depending on your response to treatment.

Do not exceed the prescribed dose.

If you take more Amlodipino/Valsartán/Hidroclorotiazida Sandoz than you should

If you have taken more Amlodipino/Valsartán/Hidroclorotiazida Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological 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 that may develop up to 24-48 hours after ingestion.

If you forget to take Amlodipino/Valsartán/Hidroclorotiazida 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, only take the next tablet at the usual time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Amlodipino/Valsartán/Hidroclorotiazida Sandoz

Stopping your treatment with Amlodipino/Valsartán/Hidroclorotiazida Sandoz may cause your condition to worsen. Do not stop taking your medication unless your doctor tells you to.

Take this medication always, even if you feel well

People with high blood pressure often do not notice any symptoms of the disease. Many feel normal. It is very important that you take this medication exactly as your doctor tells you to, 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

As with any combination that contains three active principles, the side effects associated with each individual component cannot be excluded. The side effects reported with Amlodipino/Valsartán/Hidroclorotiazida Sandoz or any of its three active principles (amlodipino, valsartán, and hidroclorotiazida) are shown below and may occur with the use of Amlodipino/Valsartán/Hidroclorotiazida Sandoz.

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

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

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

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

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

• severe decrease in urine production (decreased renal function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that makes it difficult to breathe
• severe skin reactions that include intense skin rash, urticaria, redness of the skin all over the body, severe 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
• inflammation of the pancreas, which can cause severe abdominal and back pain accompanied by a feeling of great discomfort
• weakness, bruises, fever, and frequent infections
• stiffness
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Other side effects may include:

Frequent side effects (may affect more than 1 in 10 patients)

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

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

• drowsiness
• palpitations (feeling the heartbeat)
• angina
• 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
• skin rash and itching, and other types of rashes
• difficulty achieving or maintaining an erection

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

• rapid heartbeat
• sensation of spinning
• vision disorder
• stomach discomfort
• chest pain
• increase in urea, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• low potassium levels in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of the joints
• muscle cramps/weakness/pain
• pain in the limbs
• difficulty standing or walking 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
• trembling
• changes in mood
• anxiety
• depression
• drowsiness
• altered sense of taste
• fainting
• loss of pain sensation
• visual disturbances
• visual deterioration
• ringing in the ears
• runny nose/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 frequency of urination
• discomfort or enlargement of the breasts in men
• pain
• feeling of discomfort
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or hematoma under the skin)
• glucose in the urine
• high blood sugar
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders that may be accompanied by yellow skin and eyes, or dark-colored urine (hemolytic anemia)
• increased skin sensitivity to the sun
• purplish patches on the skin
• kidney disorders
• confusion

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

• decrease in white blood cell count
• decrease in platelet count in the blood that may cause unusual bruises or easy bleeding (damage to red blood cells)
• inflammation of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellow discoloration of the skin (jaundice)
• increase in liver enzymes that may affect some medical tests
• muscle tension
• inflammation of blood vessels often with skin eruptions
• light sensitivity
• disorders combining stiffness, trembling, and/or movement disorders
• fever, sore throat, or mouth ulcers, more frequent infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia, abnormal decrease in red blood cells due to rupture in blood vessels and other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper abdomen (inflammation of the pancreas)
• 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, red-purple patches, fever (vasculitis)
• severe skin disease that causes skin rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and the blisterafter CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

Do not usethis medicationif you observe that the packaging is damaged or shows signs of handling.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofAmlodipino/Valsartán/Hidroclorotiazida Sandoz 5mg/160mg/12,5mg film-coated tablets

• The active ingredients of Amlodipino/Valsartán/Hidroclorotiazida Sandoz are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each tablet contains 5mg of amlodipine (as amlodipine besilate), 160mg of valsartan and 12,5mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, titanium dioxide (E171).

Composition ofAmlodipino/Valsartán/Hidroclorotiazida Sandoz 10mg/160mg/12,5mg film-coated tablets

• The active ingredients of Amlodipino/Valsartán/Hidroclorotiazida Sandoz are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each tablet contains 10mg of amlodipine (as amlodipine besilate), 160mg of valsartan, and 12,5mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, titanium dioxide (E171).

Composition ofAmlodipino/Valsartán/Hidroclorotiazida Sandoz 5mg/160mg/25mg film-coated tablets

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

Composition ofAmlodipino/Valsartán/Hidroclorotiazida Sandoz 10mg/160mg/25mg film-coated tablets

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

Composition ofAmlodipino/Valsartán/Hidroclorotiazida Sandoz 10mg/320mg/25mg film-coated tablets

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

Appearance of the product and contents of the package

The film-coated tablets of Amlodipino/Valsartán/Hidroclorotiazida Sandoz 5mg/160mg/12,5mg film-coated tablets are white, oval-shaped, with «NVR» on one face and «VCL» on the other face.

Height: approximately 15 mm

Width: approximately 5,9 mm

The film-coated tablets of Amlodipino/Valsartán/Hidroclorotiazida Sandoz 10mg/160mg/12,5mg film-coated tablets are pale yellow, oval-shaped, with «NVR» on one face and «VDL» on the other face.

Height: approximately 15 mm

Width: approximately 5,9 mm

The film-coated tablets of Amlodipino/Valsartán/Hidroclorotiazida Sandoz 5mg/160mg/25mg film-coated tablets are yellow, oval-shaped, with «NVR» on one face and «VEL» on the other face.

Height: approximately 15 mm

Width: approximately 5,9 mm

The film-coated tablets of Amlodipino/Valsartán/Hidroclorotiazida Sandoz 10mg/160mg/25mg film-coated tablets are yellow-brown, oval-shaped, with «NVR» on one face and «VHL» on the other face.

Height: approximately 15 mm

Width: approximately 5,9 mm

The film-coated tablets of Amlodipino/Valsartán/Hidroclorotiazida Sandoz 10mg/320mg/25mg film-coated tablets are yellow-brown, oval-shaped, with «NVR» on one face and «VFL» on the other face.

Height: approximately 19 mm

Width: approximately 7,5 mm

Amlodipino/Valsartán/Hidroclorotiazida Sandoz is available in packages with PVC/PVDC-Alu blisters or with PVC/PVDC-Alu single-dose perforated blisters.

Amlodipino/Valsartán/Hidroclorotiazida Sandoz is available in packages with blisters containing 14, 28, 28x1, 30, 56, 56x1, 60, 90, 98, 98x1, 100, 280 or 280x1film-coated tablets, in multiple packages with 280film-coated tablets (with 4boxes, each containing 70x1film-coated tablets, or 20boxes, each containing 14film-coated tablets).

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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 with the following names:

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

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

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

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

Austria:Amlodipin/ Valsartan/ HCT Sandoz 5 mg/ 160 mg/ 12,5 mg - Filmtabletten

Amlodipin/ Valsartan/ HCT Sandoz 10 mg/160 mg/12,5 mg – Filmtabletten

Amlodipin/ Valsartan/ HCT Sandoz 5 mg/160 mg/25 mg - Filmtabletten

Amlodipin/ Valsartan/ HCT Sandoz HCT 10 mg/160 mg/25 mg – Filmtabletten

Amlodipin/ Valsartan/ HCT Sandoz 10 mg/320 mg/25 mg – Filmtabletten

Belgium:Amlodipin/Valsartan/HCT Sandoz 5mg/160mg/12,5mg film-coated tablets

Amlodipin/Valsartan/HCT Sandoz 10mg/160mg/12,5mg film-coated tablets

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

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

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

Croatia:Amlodipin/valsartan/hidroklorotiazid Sandoz 5 mg/160 mg/12,5 mg film-coated tablets

Amlodipin/valsartan/hidroklorotiazid Sandoz 10 mg/160 mg/12,5 mg film-coated tablets

Amlodipin/valsartan/hidroklorotiazid Sandoz 5 mg/160 mg/25 mg film-coated tablets

Amlodipin/valsartan/hidroklorotiazid Sandoz 10 mg/160 mg/25 mg film-coated tablets

Amlodipin/valsartan/hidroklorotiazid Sandoz 10 mg/320 mg/25 mg film-coated tablets

Finland:Amlodipin/Valsartan/Hydrochlorothiazide Sandoz 5 mg/160 mg/12,5 mg tablets, coated

Amlodipin/Valsartan/Hydrochlorothiazide Sandoz 10 mg/160 mg/12,5 mg tablets, coated

Amlodipin/Valsartan/Hydrochlorothiazide Sandoz 5 mg/160 mg/25 mg tablets, coated

Amlodipin/Valsartan/Hydrochlorothiazide Sandoz 10 mg/160 mg/25 mg tablets, coated

Amlodipin/Valsartan/Hydrochlorothiazide Sandoz 10 mg/320 mg/25 mg tablets, coated

Germany:Amlodipin/Valsartan - 1 A Pharma plus HCT 5 mg/160 mg/12,5 mg Filmtabletten

Amlodipin/Valsartan - 1 A Pharma plus HCT 10 mg/160 mg/12,5 mg Filmtabletten

Amlodipin/Valsartan - 1 A Pharma plus HCT 5 mg/160 mg/25 mg Filmtabletten

Amlodipin/Valsartan - 1 A Pharma plus HCT 10 mg/160 mg/25 mg Filmtabletten

Amlodipin/Valsartan - 1 A Pharma plus HCT 10 mg/320 mg/25 mg Filmtabletten

Greece:Amlodipine+Valsartan+Hydrochlorothiazide/Sandoz (5+160+12,5) mg coated tablets

Amlodipine+Valsartan+Hydrochlorothiazide/Sandoz (10+160+12,5) mg coated tablets

Amlodipine+Valsartan+Hydrochlorothiazide/Sandoz (5+160+25) mg coated tablets

Amlodipine+Valsartan+Hydrochlorothiazide/Sandoz (10+160+25) mg coated tablets

Amlodipine+Valsartan+Hydrochlorothiazide/Sandoz (10+320+25) mg coated tablets

Hungary:Amlodipin/Valsartan/HCT Sandoz 5 mg/160 mg/12,5 mg filmtabletta

Amlodipin/Valsartan/HCT Sandoz 10 mg/160 mg/12,5 mg filmtabletta

Amlodipin/Valsartan/HCT Sandoz 5 mg/160 mg/25 mg filmtabletta

Amlodipin/Valsartan/HCT Sandoz 10 mg/160 mg/25 mg filmtabletta

Amlodipin/Valsartan/HCT Sandoz 10 mg/320 mg/25 mg filmtabletta

Ireland:Amlodipine/Valsartan/ Hydrochlorothiazide Rowex5 mg/160 mg/12.5 mg Film-coated tablets

Amlodipine/Valsartan/ Hydrochlorothiazide Rowex 10 mg/160 mg/12.5 mg Film-coated tablets

Amlodipine/Valsartan/ Hydrochlorothiazide Rowex 5 mg/160 mg/25 mg Film-coated tablets

Amlodipine/Valsartan/ Hydrochlorothiazide Rowex 10 mg/160 mg/25 mg Film-coated tablets

Amlodipine/Valsartan/ Hydrochlorothiazide Rowex 10 mg/320/25 mg Film-coated tablets

Lithuania:Amlodipine/Valsartan/ Hydrochlorothiazide Sandoz 5 mg/160 mg/12,5 mg coated tablets

Amlodipine/Valsartan/ Hydrochlorothiazide Sandoz 10 mg/160 mg/12,5 mg coated tablets

Amlodipine/Valsartan/ Hydrochlorothiazide Sandoz 5 mg/160 mg/ 25 mg coated tablets

Amlodipine/Valsartan/ Hydrochlorothiazide Sandoz 10 mg/160 mg/25 mg coated tablets

Amlodipine/Valsartan/ Hydrochlorothiazide Sandoz 10 mg/320 mg/25 mg coated tablets

Last revision date of thisleaflet:February 2025

The detailed and updated information of thismedicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/