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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Amlodipine/valsartan Sandoz 10 mg/160 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. 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 give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

1. What Amlodipine/valsartan Sandoz is and what it is used for
2. What you need to know before taking Amlodipine/valsartan Sandoz
3. How to take Amlodipine/valsartan Sandoz
4. Possible side effects
5. How to store Amlodipine/valsartan Sandoz
6. Contents of the pack and other information

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

Amlodipine/Valsartan Sandoz tablets contain two substances called amlodipine and valsartan. Both 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 the narrowing of blood vessels.
• 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, thus increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.

This means that both substances help prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Amlodipine/Valsartan Sandoz is used for the treatment of high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

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

Do not take Amlodipine/valsartan Sandoz

• if you are allergic to amlodipine or to any other calcium channel blocker. This may include itching, skin redness, or difficulty breathing,
• if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking amlodipine/valsartan,
• if you have severe liver problems or biliary disorders such as primary biliary cirrhosis or cholestasis,
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy; see Pregnancy section),
• 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 after a heart attack,
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take amlodipine/valsartan and inform your doctor if any of the above apply to you.

Warnings and precautions

Talk to your doctor before starting Amlodipine/valsartan Sandoz:

• if you have been ill (with vomiting or diarrhea),
• if you have liver or kidney problems,
• if you have had a kidney transplant or have been told you have narrowing of the kidney arteries,
• if you have an adrenal gland disorder called “primary hyperaldosteronism”,
• if you have had heart failure or have had a heart attack.

Follow your doctor’s instructions carefully when 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 that the thickness of your heart muscle has abnormally increased (called “obstructive hypertrophic cardiomyopathy”),
• if you have experienced swelling, especially of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors).

If you have these symptoms, stop taking amlodipine/valsartan and contact your doctor immediately. You must never take amlodipine/valsartan again.

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

Talk to your doctor if you develop 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.

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 Sandoz”.

Inform your doctor before taking amlodipine/valsartan if any of the above conditions apply to you.

Children and adolescents

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

Other medicines and Amlodipine/valsartan Sandoz

Tell 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 for the following medicines:

• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Amlodipine/valsartan Sandoz” and “Warnings and precautions”);
• diuretics (a type of medicine that increases the amount of urine produced);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, and other substances that can increase potassium levels;
• certain types of pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also monitor your kidney function;
• anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John’s wort;
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (administered intravenously for serious body temperature abnormalities);
• tacrolimus (used to control the body’s immune response, allowing acceptance of a transplanted organ);
• medicines used to prevent transplant rejection (cyclosporine).

Taking Amlodipine/valsartan Sandoz with food and drink

People taking amlodipine/valsartan should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effects of amlodipine/valsartan.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant (or think you might be). Your doctor will usually advise you to stop taking amlodipine/valsartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative antihypertensive medicine. Amlodipine/valsartan is not recommended during early pregnancy (first 3 months), and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. It has been shown that amlodipine passes into breast milk in small amounts. Amlodipine/valsartan is not recommended for women during this period, and your doctor may choose a treatment more suitable if you wish to breastfeed, especially if your baby is a newborn or premature.

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

Driving and using machines

This medicine may make you feel dizzy. This could affect your ability to concentrate. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any activities requiring concentration.

3. How to take Amlodipine/valsartan Sandoz

Follow exactly the instructions for using this medicine given by your doctor. 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 is one tablet daily.

• It is preferable to take the medicine at the same time each day.
• Swallow the tablets with a glass of water.
• You may take amlodipine/valsartan with or without food. Do not take amlodipine/valsartan 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.

Amlodipine/valsartan Sandoz in elderly patients (aged 65 years or older)

Your doctor should exercise caution when increasing your dose.

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

If you take more Amlodipine/valsartan Sandoz than you should

If you have taken too many amlodipine/valsartan tablets, or if someone else has taken your tablets, contact a doctor immediately.

If you have taken more amlodipine/valsartan than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Amlodipine/valsartan Sandoz

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

If you stop taking Amlodipine/valsartan Sandoz

Stopping your treatment with amlodipine/valsartan may cause your condition to worsen. Do not stop taking this medicine unless your doctor tells you to.

4. Possible adverse effects

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

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

A small number of patients have experienced these serious adverse effects (may affect up to 1 in 1,000 patients). If you notice any of the following, contact your doctor immediately:

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

Other possible adverse effects of amlodipine/valsartan:

Common (may affect up to 1 in 10 patients)

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

Uncommon (may 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 heartbeat including palpitations,
• dizziness upon standing,
• cough,
• diarrhea,
• constipation,
• skin rash, redness of the skin,
• joint inflammation, back pain,
• joint pain.

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

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

Tell your doctor if any of the above affect you severely.

Adverse effects reported with amlodipine or valsartan alone, not observed with amlodipine/valsartan or observed with higher frequency than with amlodipine/valsartan:

Amlodipine

Contact your doctor immediately if you experience any of the following very rare, serious adverse effects after taking this medicine:

• 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, severe itching, blistering, peeling and skin inflammation, swelling of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions,
• heart attack, irregular heartbeat,
• inflammation of the pancreas, which may cause severe abdominal pain and back pain accompanied by a general feeling of illness.

The following adverse effects have been reported. If any of these cause problems or last longer than one week, consult your doctor.

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

Mood changes, anxiety, depression, drowsiness, tremor, taste disturbances, fainting, loss of pain sensation, visual disturbances, worsening of vision, ringing in the ears; low blood pressure, sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis), indigestion, vomiting (feeling unwell), hair loss, increased sweating, skin itching, skin discoloration, urinary disorders, increased need to urinate at night, increased frequency of urination, inability to achieve an erection, discomfort or enlargement of breasts in men, pain, discomfort, muscle pain, muscle cramps; weight gain or weight loss.

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

Confusion.

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

Decrease in the number of white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells), high blood sugar (hyperglycemia), gum inflammation, abdominal swelling (gastritis), abnormal liver function, inflammation of the liver (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, sensitivity to light, disorders combining stiffness, tremor and/or movement disorders.

Valsartan

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

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

Frequency not known (cannot be estimated from available data)

Decrease in the number of red blood cells, fever, sore throat or mouth ulcers due to infection, spontaneous bleeding or bruising, increased potassium in blood, abnormal liver function tests, reduced kidney function and severely reduced kidney function, swelling mainly of the face and throat, muscle pain, skin rash, purplish red spots, fever, itching, allergic reaction, blisters on the skin (sign of a condition called bullous dermatitis).

If you experience any of the above, contact your doctor immediately.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 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. 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 any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine/valsartan Sandoz

• The active substances are amlodipine (as amlodipine besylate) and valsartan.

Each 5 mg/160 mg film-coated tablet contains 5 mg of amlodipine and 160 mg of valsartan.
Each 10 mg/160 mg film-coated tablet contains 10 mg of amlodipine and 160 mg of valsartan.

• The other components are:

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

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

Nature of the product and pack contents

Amlodipine/valsartan Sandoz 5 mg/160 mg are oval, dark yellow, film-coated tablets with bevelled edges, marked with the code “NVR” on one side and “ECE” on the other.
Approximate dimensions: 14.2 mm x 5.7 mm.

Amlodipine/valsartan Sandoz 10 mg/160 mg are oval, light yellow, film-coated tablets with bevelled edges, marked with the code “NVR” on one side and “UIC” on the other.
Approximate dimensions: 14.2 mm x 5.7 mm.

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

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

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
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 medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Amlodipine/Valsartan Sandoz 5 mg/160 mg, filmomhulde tabletten
Amlodipine/Valsartan Sandoz 10 mg/160 mg, filmomhulde tabletten

Austria: Amlodipin / Valsartan Sandoz - 5 mg/160 mg Filmtabletten
Amlodipin / Valsartan Sandoz - 10 mg/160 mg Filmtabletten

Belgium: Amlodipine/Valsartan Sandoz 5 mg/160 mg filmomhulde tabletten
Amlodipine/Valsartan Sandoz 10 mg/160 mg filmomhulde tabletten

Bulgaria: Амлодипин/Валсартан Сандоз 5 mg/160 mg филмови таблети
Амлодипин/Валсартан Сандоз 10 mg/160 mg филмови таблети

Czech Republic: Amlodipin/Valsartan Sandoz 5 mg/160 mg
Amlodipin/Valsartan Sandoz 10 mg/160 mg

Germany: Amlodipin/Valsartan - 1 A Pharma 5 mg/160 mg Filmtabletten
Amlodipin/Valsartan - 1 A Pharma 10 mg/160 mg Filmtabletten

Estonia: Amlodipine /Valsartan Sandoz
Amlodipine /Valsartan Sandoz

Greece: Amlodipine+Valsartan/Sandoz

France: AMLODIPINE/VALSARTAN SANDOZ 5 mg/160 mg, comprimé pelliculé
AMLODIPINE/VALSARTAN SANDOZ 10 mg/160 mg, comprimé pelliculé

Croatia: Amlodipin/valsartan Sandoz 5 mg/160 mg filmsko obložene tablete
Amlodipin/valsartan Sandoz 10 mg/160 mg filmsko obložene tablete

Hungary: Amlodipin/Valsartan Sandoz 5 mg/160 mg filmtabletta
Amlodipin/Valsartan Sandoz 10 mg/160 mg filmtabletta

Ireland: Amlodipine/Valsartan Rowex 5 mg/160 mg, Film-coated tablets
Amlodipine/Valsartan Rowex 10 mg/160 mg, Film-coated tablets

Latvia: Amlodipine/Valsartan Sandoz 5 mg/160 mg apvalkotas tabletes
Amlodipine/Valsartan Sandoz 10 mg/160 mg apvalkotas tabletes

Poland: Amlodipine + Valsartan Sandoz
Amlodipine + Valsartan Sandoz

Portugal: Amlodipina + Valsartan Sandoz

Romania: AMLODIPINA/VALSARTAN SANDOZ 5 mg/160 mg comprimate filmate
AMLODIPINA/VALSARTAN SANDOZ 10 mg/160 mg comprimate filmate

Slovenia: Amlodipin/valsartan Lek 5 mg/160 mg filmsko obložene tablete
Amlodipin/valsartan Lek 10 mg/160 mg filmsko obložene tablete

Slovakia: Amlodipín/Valsartan Sandoz 5 mg/160 mg
Amlodipín/Valsartan Sandoz 10 mg/160 mg

Date of the most recent review of this summary: May 2025

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