Prospecto:information for the user

Amlodipino/valsartán Sandoz 5 mg/160 mg film-coated tablets

Amlodipino/valsartán Sandoz 10 mg/160 mg film-coated tablets

Read this prospectus carefully before starting to take this medicine,because 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 prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

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

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

2.What you need to knowbeforestarting totake Amlodipino/valsartán Sandoz

3.How to take Amlodipino/valsartán Sandoz

4.Possible adverse effects

5.Storage of Amlodipino/valsartán Sandoz

6.Contents of the package and additional information

Amlodipino/valsartán Sandoztablets contain two substances called amlodipino and valsartán. Both substances help control high blood pressure.

• Amlodipinobelongs to a group of substances called «calcium channel blockers». Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessel constriction.
• Valsartánbelongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to constrict, thereby increasing blood pressure. Valsartán acts by blocking the effect of angiotensin II.

This means that both substances help prevent blood vessel constriction. As a result, blood vessels relax and blood pressure decreases.

Amlodipino/valsartán Sandoz is used for the treatment of high blood pressure in adults whose blood pressure is not adequately controlled with amlodipino or valsartán alone.

Do not take Amlodipino/valsartán Sandoz:

• if you areallergic to amlodipineor to any other calcium channel blocker. This may include symptoms such as itching, skin redness, or difficulty breathing,
• if you areallergic to valsartanor to any of the other components of this medication (listed in section 6). If you think you may be allergic, inform your doctor before taking amlodipine/valsartan,
• if you havesevere liver problemsorbile duct problemssuch asbiliary cirrhosisorcholestasis,
• if you aremore than 3 months pregnant. (In any case, it is best to avoid taking this medication also at the beginning of your pregnancy, see Pregnancy section),
• if you have asevere decrease in blood pressure(hypotension),
• if you have anarrowing of the aortic valve(aortic stenosis) orcardiogenic shock(a situation in which your heart cannot supply enough blood to your body),
• if you haveheart failure after a heart attack,
• if you havediabetesorkidney failureand are being treated with a blood pressure medication that containsaliskiren.

Do not take amlodipine/valsartanand inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor before starting to take Amlodipino/valsartán Sandoz:

• if you have been sick (withvomitingordiarrhea),
• if you haveliver or kidney problems,
• if you have undergone akidney transplantor if you have been told that you have anarrowing of the kidney arteries,
• if you have adisease that affects the adrenal glandscalled “primary aldosteronism”,
• if you have hadheart failureor havehad a heart attack.

Follow your doctor's instructions to start the dosage carefully. Your doctor may also check your kidney function,

• if your doctor has told you that you have anarrowing of the heart valves(which is called “aortic or mitral stenosis”) or thatthe thickness of your heart muscle has increased abnormally(which is called “hypertrophic obstructive cardiomyopathy”),
• if you haveswelling, particularly in the face and throat, while taking other medications (including angiotensin-converting enzyme inhibitors).

If you have these symptoms,stop taking amlodipine/valsartanandcontact your doctor immediately.

You must never take amlodipine/valsartanagain,

• if you are taking any of the following medications used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACEI)(such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
• aliskiren.

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

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

Inform your doctor before taking amlodipine/valsartan if you are affected by any of the cases mentioned.

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

Children and adolescents

Amlodipine/valsartan is not recommended for use in children or adolescents (under 18 years of age).

Taking Amlodipino/valsartán Sandozwith other medications

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.You may need to adjust your dosage and/or take other precautions. In some cases, you may need to stop taking one of the medications. This applies especially to the medications listed below:

• anACEIoraliskiren(see also the information under the headings “Do not takeAmlodipino/valsartán Sandoz” and “Warnings and precautions”);
• diuretics(a type of medication that increases the amount of urine produced);
• lithium(a medication used to treat certain types of depression);
• potassium-sparing diureticsorpotassium supplements, orsubstitutes for salt that contain potassium, andother substancesthat may increase potassium levels;
• a certain type ofpain medicationcalled nonsteroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. Your doctor may also check your kidney function;
• anticonvulsants(e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• nitroglycerinandother nitrates, or other substances called “vasodilators”;
• medications used to treat HIV/AIDS(e.g., ritonavir, indinavir, nelfinavir);
• medications used to treat fungal infections(e.g., ketoconazole, itraconazole);
• antibiotics(such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil,diltiazem(heart medications);
• simvastatin(a medication used to control high cholesterol levels);
• dantrolene(in infusion for severe body temperature abnormalities);
• medications used to prevent rejection in a transplant(ciclosporin).

Taking Amlodipino/valsartán Sandoz with food and drinks

People taking amlodipine/valsartan 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 amlodipine, which may lead to unpredictable reductions in blood pressure.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or may be pregnant). Your doctor will usually advise you to stop taking amlodipine/valsartan before becoming pregnant or as soon as you become pregnant, and recommend taking another blood pressure medication instead. Amlodipine/valsartan is not recommended for use during the first 3 months of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Lactation

Inform your doctor if you are planning to breastfeed or are breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/valsartan is not recommended for use during this period, and your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication may cause dizziness. This may affect your ability to concentrate. Therefore, if you are unsure how this medication will affect you, do not drive, operate machinery, or perform other activities that require concentration.

Follow exactly the administration instructions for this medication as indicated 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 amlodipino/valsartán is one tablet per day.

• It is preferable to take the medication at the same time every day.
• Swallow the tablets with a glass of water.
• You can take amlodipino/valsartán with or without food. Do not take amlodipino/valsartán 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.

Amlodipino/valsartán Sandoz and advanced age (65 years or older)

Your doctor should exercise caution when increasing the dose.

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

If you take more Amlodipino/valsartán Sandoz than you should

If you have taken too many tablets of amlodipino/valsartán, or if someone else has taken your tablets, consult a doctor immediately.

If you have taken more amlodipino/valsartán 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 Sandoz

If you forget to take 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, do not take the missed dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Amlodipino/valsartán Sandoz

Stopping your treatment with amlodipino/valsartán may cause your condition to worsen. Do not stop taking your medication unless your doctor tells you to.

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

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

A few patients have experienced these serious side effects(which can affect up to 1 in 1,000 patients).Notify your doctor immediately if you notice any of the following:

• allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (dizziness, fainting).

Other possible side effects of amlodipine/valsartan

Frequent (can affect up to 1 in 10 patients)

• flu,
• stuffy nose, sore throat, and discomfort when swallowing,
• headache,
• swelling in the arms, hands, legs, ankles, or feet,
• fatigue,
• asthenia (weakness),
• redness and warmth of the face and/or neck.

Infrequent (can affect up to 1 in 100 patients)

• dizziness,
• nausea and abdominal pain,
• dry mouth,
• drowsiness, tingling, or numbness in the hands or feet,
• vertigo,
• rapid heart rate, including palpitations,
• dizziness when standing up,
• cough,
• diarrhea,
• constipation,
• skin rash, redness of the skin,
• inflammation of the joints, back pain,
• joint pain.

Rare (can affect up to 1 in 1,000 patients)

• sensation of anxiety,
• tinnitus (ringing in the ears),
• fainting,
• increased urine production or sensation of urgency to urinate,
• inability to achieve or maintain an erection,
• sensation of heaviness,
• low blood pressure with symptoms such as dizziness, fainting,
• excessive sweating,
• skin rash all over the body,
• itching,
• muscle spasms.

Notify your doctor if any of the above cases severely affect you.

Reported side effects with amlodipine or valsartan alone and not observed with amlodipine/valsartan or observed with a higher frequency than with amlodipine/valsartan:

Amlodipine

Consult your doctor immediately if you experience any of the following rare, severe side effects after taking this medicine:

• 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 causes severe difficulty breathing,
• severe skin reactions that include intense skin rash, blisters, redness of the skin, severe itching, peeling, and inflammation of the skin, Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions,
• heart attack, abnormal heart rhythm,
• pancreatitis, which can cause severe abdominal pain and back pain accompanied by a feeling of severe discomfort.

The following side effects have been reported. If any of these cause problems or last more than a week, consult your doctor.

Frequent (can affect up to 1 in 10 patients)

Dizziness, drowsiness, palpitations (feeling the heartbeat), hot flashes, swelling of the ankles (edema), abdominal pain, feeling unwell (nausea).

Infrequent (can affect up to 1 in 100 patients)

Mood changes, anxiety, depression, drowsiness, tremors, altered taste, fainting, loss of pain sensation, visual disturbances, visual deterioration, ringing in the ears; decreased blood pressure, nasal congestion and secretion caused by inflammation of the nasal mucosa (rhinitis), indigestion, vomiting (discomfort), hair loss, increased sweating, itching on the skin, skin discoloration, urinary disorders, increased need to urinate at night, increased frequency of urination, inability to achieve an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight gain or loss.

Rare (can affect up to 1 in 1,000 patients)

Confusion.

Very rare (can affect up to 1 in 10,000 patients)

Decreased white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising (damage to red blood cells), high blood sugar (hyperglycemia), inflammation of the gums, abdominal swelling (gastritis), abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests, increased muscle tension, inflammation of blood vessels often with skin eruptions, light sensitivity, disorders combining stiffness, tremors, and/or movement disorders.

Valsartan

Very rare (can affect up to 1 in 10,000 patients)

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency (cannot be estimated from available data)

Decreased red blood cell count, fever, sore throat or ulcers in the mouth due to infection, spontaneous bleeding or hematomas, increased potassium in the blood, abnormal liver function test results, decreased renal function, severely decreased renal function, swelling mainly of the face and throat, muscle pain, skin rash, purpura, fever, itching, allergic reaction, skin blisters (sign of a disease called bullous dermatitis).

Notify your doctor immediately if you experience any of the above cases.

Reporting 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 blister packafter CAD. 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 visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipine/valsartan Sandoz

• The active principles are amlodipine (as amlodipine besilate) and valsartan.

Each 5 mg/160 mg tablet contains 5 mg of amlodipine and 160 mg of valsartan.

Each 10 mg/160 mg tablet contains 10 mg of amlodipine and 160 mg of valsartan.

• The other components are:

5 mg/160 mg tablets: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000, and talc.

10 mg/160 mg tablets: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 4000, and talc.

Appearance of the product and contents of the package

Amlodipine/valsartan Sandoz 5 mg/160 mg are oval-shaped, dark yellow-coated tablets with beveled edges and marked with the inscription “NVR” on one face and “ECE” on the other.

Approximate dimensions: 14.2 mm x 5.7 mm.

Amlodipine/valsartan Sandoz 10 mg/160 mg are oval-shaped, light yellow-coated tablets with beveled edges and marked with the inscription “NVR” on one face and “UIC” on the other.

Approximate dimensions: 14.2 mm x 5.7 mm.

Amlodipine/valsartan Sandoz is available in packages containing 7, 14, 28, 30, 56, 90, 98, or 280 film-coated tablets, and in multiple packs of 4 boxes containing 70 film-coated tablets each, or 20 boxes containing 14 film-coated tablets each. All packages are available with standard blisters; the 56, 98, and 280 film-coated tablet packages are also available with perforated unit blisters.

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

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Novartis Farmaceutica S.A

Gran Vía Corts Catalanes, 764,

08013 Barcelona

Spain

Novartis Farma S.p.A.

Via Provinciale 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:

NetherlandsAmlodipine/Valsartan Sandoz 5 mg/160 mg, filmomhulde tabletten

Amlodipine/Valsartan Sandoz 10 mg/160 mg, filmomhulde tabletten

AustriaAmlodipin / Valsartan Sandoz - 5 mg/160 mg Filmtabletten

Amlodipin / Valsartan Sandoz - 10 mg/160 mg Filmtabletten

BelgiumAmlodipine/Valsartan Sandoz 5 mg/160 mg filmomhulde tabletten

Amlodipine/Valsartan Sandoz 10 mg/160 mg filmomhulde tabletten

Bulgaria?????????/???????????????5 mg/160 mg?????????????????

?????????/???????????????10 mg/160 mg?????????????????

Czech RepublicAmlodipin/Valsartan Sandoz 5 mg/160 mg

Amlodipin/Valsartan Sandoz 10 mg/160 mg

GermanyAmlodipin/Valsartan - 1 A Pharma 5mg/160 mg Filmtabletten

Amlodipin/Valsartan - 1 A Pharma 10 mg/160 mg Filmtabletten

EstoniaAmlodipine /Valsartan Sandoz

Amlodipine /Valsartan Sandoz

GreeceAmlodipine+Valsartan/Sandoz

FranceAMLODIPINE/VALSARTAN SANDOZ 5 mg/ 160 mg, comprimé pelliculé

AMLODIPINE/VALSARTAN SANDOZ 10 mg/ 160 mg, comprimé pelliculé

CroatiaAmlodipin/ valsartan Sandoz 5 mg/160 mg filmsko obložene tablete

Amlodipin/valsartan Sandoz 10 mg/160 mg filmom obložene tablete

HungaryAmlodipin/ Valsartan Sandoz 5 mg/160mg filmtabletta

Amlodipin/ Valsartan Sandoz 10 mg/160mg filmtabletta

IrelandAmlodipine/Valsartan Rowex 5 mg/160 mg, Film-coated tablets

Amlodipine/Valsartan Rowex 10 mg/160 mg, Filmcoated tablets

LithuaniaAmlodipine/Valsartan Sandoz 5 mg/160 mg apvalkotas tabletes

Amlodipine/Valsartan Sandoz 10 mg/160 mgapvalkotas tabletes

PolandAmlodipine + Valsartan Sandoz

Amlodipine + Valsartan Sandoz

PortugalAmlodipina + Valsartan Sandoz

RomaniaAMLODIPINA/VALSARTAN SANDOZ 5 mg/160 mg comprimate filmate

AMLODIPINA/VALSARTAN SANDOZ 10 mg/160 mg comprimate filmate

SloveniaAmlodipin/valsartan Lek 5 mg/160 mg filmsko obložene tablete

Amlodipin/valsartan Lek 10 mg/160 mg filmsko obložene tablete

SlovakiaAmlodipín/Valsartan Sandoz 5 mg/160 mg

Amlodipín/Valsartan Sandoz 10 mg/160 mg

Last review date of thisleaflet:February 2025

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