Amlodipine/valsartan/hydrochlorothiazide Sandoz 5 mg/160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.

  • If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

4. Possible side effects

5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

6. 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 substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help control high blood pressure.

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

As a result of these three mechanisms, 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 may benefit from taking a single tablet containing the three substances.

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

Do not take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking amlodipine/valsartan/hydrochlorothiazide also during early pregnancy – see section Pregnancy).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other components 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 (primary biliary cirrhosis), leading to bile accumulation in the liver (cholestasis).
• if you have severe kidney problems or 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.
• if your blood calcium levels are too high despite treatment to reduce calcium levels.
• 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 condition in which your heart cannot supply enough blood to the body).
• if you have heart failure following a heart attack.
• if you have diabetes or kidney failure 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 conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).

• if you have low levels of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, seizures).

• if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and muscle cramps).

• if you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the kidney arteries.

• if you have liver problems.

• if you have or have had heart failure or coronary artery disease, especially 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 for carefully starting treatment. 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 abnormal thickening of your heart muscle (called “obstructive hypertrophic cardiomyopathy”).

• if you have hyperaldosteronism. A condition 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).

• 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 high blood pressure medicines or diuretics, especially if you have asthma and allergies.

• if you have been ill (with vomiting or diarrhea).

• if you experience swelling, particularly in the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking amlodipine/valsartan/hydrochlorothiazide and contact your doctor immediately. You must 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, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to one week after taking amlodipine/valsartan/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this condition.

• if you are taking any of the following medicines for high blood pressure (high blood pressure):

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

• aliskiren.

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip 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 develop shortness of breath or severe difficulty breathing after taking amlodipine/valsartan/hydrochlorothiazide, seek medical attention immediately.

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

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

Inform your doctor if any of the above conditions apply to you.

Talk to 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 aged 65 years and older at the same dose as in other adults and in the same way as they have previously taken the three active substances amlodipine, valsartan, and hydrochlorothiazide. Blood pressure should be monitored periodically in elderly patients, especially those taking the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).

Other medicines and Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 medicines. This is especially important if you are taking any of the following medicines:

Do not take together 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 potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz” and “Warnings and precautions”).

Should be used with caution with:

• alcohol, sleeping pills, and anesthetics (medicines for patients undergoing surgery or other procedures);
• amantadine (used to treat Parkinson’s disease, also used to treat or prevent certain viral infections);
• anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, urinary 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);
• cholestyramine, colestipol, or other resins (substances mainly used to treat high lipid levels in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in organ transplantation 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 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 cause “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 increase urination), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines to increase blood pressure, such as adrenaline or noradrenaline;
• medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used for inflammation and ulceration of the esophagus (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors);
• muscle relaxants (medicines used to relax muscles during surgery);
• 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 (intravenous use for severe body temperature abnormalities);
• tacrolimus (used to control the body’s immune response, allowing acceptance of a transplanted organ);
• vitamin D and calcium salts.

Taking Amlodipine/Valsartan/Hydrochlorothiazide Sandoz with food, drinks, and alcohol

People prescribed amlodipine/valsartan/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effects of amlodipine/valsartan/hydrochlorothiazide. Consult your doctor before drinking alcohol. Alcohol may significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking amlodipine/valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Amlodipine/valsartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/valsartan/hydrochlorothiazide is not recommended for use in women during this period. Your doctor may decide to prescribe an alternative treatment if you wish to breastfeed, 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, drowsy, nauseous, or cause headache. If you experience these symptoms, do not drive or operate tools or machinery.

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. If in 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 tablet per day.

• It is preferable to take the tablet at the same time each day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You may 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 recommend 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

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

If you stop taking Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

Stopping your treatment with Amlodipine/Valsartan/Hydrochlorothiazide Sandoz may cause your condition to worsen. Do not stop taking this medicine unless your doctor tells you to.

Keep taking this medicine, even if you feel well

People with high blood pressure often do not notice any symptoms of the disease. Many feel perfectly normal. It is very important that you take this medicine exactly as prescribed by your doctor to achieve 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.

As with any combination containing three active substances, adverse effects associated with each individual component cannot be excluded. The adverse effects reported with Amlodipine/Valsartan/Hydrochlorothiazide Sandoz or with any of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur during use of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz.

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

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

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

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

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

• severe decrease in urine production (reduced kidney 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 breathing difficulty (symptoms include severe shortness of breath, 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 causing severe difficulty breathing
• severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and inflammation of the skin, swelling of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• heart attack
• inflammation of the pancreas, which may cause severe abdominal and back pain accompanied by a strong feeling of malaise
• weakness, bruising, fever, and frequent infections
• stiffness
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Other adverse effects may include:

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

• low potassium levels in the blood
• increased blood lipids

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

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

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

• rapid heartbeat
• sensation of spinning (vertigo)
• vision disorders
• stomach discomfort
• chest pain
• increased blood urea nitrogen, creatinine, and uric acid
• high levels of calcium, lipids, or sodium in blood
• decreased potassium in blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered taste
• back pain
• joint swelling
• muscle cramps/weakness/muscle pain
• limb pain
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness upon standing or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure upon standing
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• tinnitus (ringing in the ears)
• sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• changes in bowel habits
• indigestion
• hair loss
• skin itching
• skin discoloration
• urinary disorders
• 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 adverse effects (may affect up to 1 in 1,000 patients)

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

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

• decreased number of white blood cells
• decreased blood platelets that may cause unusual bruising or easy bleeding (damage to red blood cells)
• gum inflammation
• abdominal swelling (gastritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• increased liver enzymes, which may affect certain medical tests
• increased muscle tension
• inflammation of blood vessels, often with skin rashes
• light sensitivity
• 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 destruction of red blood cells in blood vessels and other body parts)
• confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloremic alkalosis)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)

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

• changes in blood test results for kidney function, increased potassium in blood, low red blood cell count
• abnormal red blood cell count
• low levels of certain types of white blood cells and platelets in blood
• increased creatinine in blood
• abnormal liver function test
• marked decrease in urine production
• inflammation of blood vessels
• weakness, bruising, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to elevated 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 causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme)
• muscle spasms
• fever (pyrexia)
• blistering skin disease (sign of a condition 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP/CAD. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

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

• The active substances in Amlodipine/Valsartan/Hydrochlorothiazide Sandoz are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each tablet contains 5 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 12.5 mg 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 of Amlodipine/Valsartan/Hydrochlorothiazide Sandoz 10 mg/160 mg/12.5 mg film-coated tablets

• The active substances in Amlodipine/Valsartan/Hydrochlorothiazide Sandoz are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each tablet contains 10 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 12.5 mg 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), yellow iron oxide (E172), red iron oxide (E172).

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

• The active substances in Amlodipine/Valsartan/Hydrochlorothiazide Sandoz are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each tablet contains 5 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 25 mg 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), yellow iron oxide (E172).

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

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

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

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

Appearance of the product and contents of the pack

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

Height: approximately 15 mm
Width: approximately 5.9 mm

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

Height: approximately 15 mm
Width: approximately 5.9 mm

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

Height: approximately 15 mm
Width: approximately 5.9 mm

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

Height: approximately 15 mm
Width: approximately 5.9 mm

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

Height: approximately 19 mm
Width: approximately 7.5 mm

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

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
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 European Economic Area member states under the following names:

Netherlands:
Amlodipine besilaat/Valsartan/HCT Sandoz 5 mg/160 mg/12.5 mg filmomhulde tabletten
Amlodipine besilaat/Valsartan/HCT Sandoz 10 mg/160 mg/12.5 mg filmomhulde tabletten
Amlodipine besilaat/Valsartan/HCT Sandoz 5 mg/160 mg/25 mg filmomhulde tabletten
Amlodipine besilaat/Valsartan/HCT Sandoz 10 mg/160 mg/25 mg filmomhulde tabletten
Amlodipine besilaat/Valsartan/HCT Sandoz 10 mg/320 mg/25 mg filmomhulde tabletten

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

Germany:
Amlodipin/Valsartan/HCT - 1 A Pharma 5 mg/160 mg/12,5 mg Filmtabletten
Amlodipin/Valsartan/HCT - 1 A Pharma 10 mg/160 mg/12,5 mg Filmtabletten
Amlodipin/Valsartan/HCT - 1 A Pharma 5 mg/160 mg/25 mg Filmtabletten
Amlodipin/Valsartan/HCT - 1 A Pharma 10 mg/160 mg/25 mg Filmtabletten
Amlodipin/Valsartan/HCT - 1 A Pharma 10 mg/320 mg/25 mg Filmtabletten

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

Date of latest review of this leaflet: June 2025

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