Leaflet: information for the user

Amlodipine/Valsartan Aurovitas5 mg/160 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1. What isAmlodipine/Valsartan Aurovitasand what it is used for

2. What you need to know before starting totake Amlodipine/Valsartan Aurovitas

3. How to takeAmlodipine/Valsartan Aurovitas

4. Possible side effects

5. Storage ofAmlodipine/Valsartan Aurovitas

6. Contents of the pack and additional information

Amlodipino/Valsartán Aurovitas contains two substances called amlodipino and valsartán. Both substances help control high blood pressure.

• Amlodipino belongs to a group of substances called «calcium channel blockers». Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessel constriction.
• Valsartán belongs 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 is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipino or valsartán alone.

Do not take Amlodipino/Valsartán Aurovitas:

• If you are allergic to amlodipine or any other calcium channel blocker. This may include symptoms such as itching, skin redness, or difficulty breathing.
• If you are allergic to valsartan or 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 have severe liver problems or bile duct problems such as biliary cirrhosis or cholestasis.
• If you are more 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 a severe decrease in 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 your body).
• If you have heart failure after a heart attack.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor before taking Amlodipino/Valsartán Aurovitas:

• If you have been sick (with vomiting or diarrhea).
• If you have liver or kidney problems.
• If you have had a kidney transplant or if you have been told that you have a narrowing of the kidney arteries.
• If you have a condition that affects the adrenal glands called "primary hyperaldosteronism".
• If you have had heart failure or have had a heart attack. Follow your doctor's instructions to start taking the medication carefully. Your doctor may also check your kidney function.
• If your doctor has told you that you have 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 experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking amlodipine/valsartan and contact your doctor immediately. You should never take amlodipine/valsartan again.
• If you are taking any of the following medications used to treat high blood pressure:
• An ACE inhibitor (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 (such as potassium) regularly.

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.

See also the information under the heading "Do not take Amlodipino/Valsartán Aurovitas".

Inform your doctor before taking Amlodipino/Valsartán Aurovitas if you are affected by any of the cases mentioned.

Children and adolescents

Amlodipino/Valsartán Aurovitas is not recommended for use in children or adolescents (under 18 years old).

Taking Amlodipino/Valsartán Aurovitas with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 applies especially to the medications listed below:

• An ACE inhibitor or aliskiren (see also the information under the headings "Do not take Amlodipino/Valsartán Aurovitas" and "Warnings and precautions");
• Diuretics (a type of medication that increases urine production);
• Lithium (a medication used to treat certain types of depression);
• Diuretics that save potassium, potassium supplements, salt substitutes that contain potassium, and other substances that may increase potassium levels;
• A certain type of pain medication called nonsteroidal anti-inflammatory drugs (NSAIDs) or selective COX-2 inhibitors. Your doctor may also check your kidney function;
• Anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• Nitroglycerin and other 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);
• Medications used to treat bacterial infections (e.g. rifampicin, erythromycin, clarithromycin, telithromycin);
• Verapamil, diltiazem (heart medications);
• Simvastatin (a medication used to control high cholesterol levels);
• Dantrolene (for severe temperature abnormalities);
• Tacrolimus (used to control the body's immune response to allow it to accept the transplanted organ);
• Medications used to protect against rejection in a transplant (cyclosporin).

Taking Amlodipino/Valsartán Aurovitas 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, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant.If you are pregnant, your doctor will usually advise you to stop taking amlodipine/valsartan as soon as possible and recommend an alternative antihypertensive medication.Amlodipine/valsartan should not be used 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.

Breastfeeding

Inform your doctor if you plan to start 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. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication may cause dizziness, which 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.

Amlodipino /Valsartán Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

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

The usual 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 Aurovitas 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 Aurovitas and Older Adults (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 Aurovitas Than You Should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Amlodipino/Valsartán Aurovitas

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 Aurovitas

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

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.

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); flushing and sensation of heat in the face and/or neck.

Infrequent (can affect up to 1 in 100 patients):dizziness; nausea and abdominal pain; dry mouth; somnolence, tingling, or numbness in the hands or feet; vertigo, rapid heartbeats including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; joint inflammation, back pain; joint pain.

Rare (can affect up to 1 in 1,000 patients):sensation of anxiety; ringing in the ears (tinnitus); 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.

Very rare (can affect up to 1 in 10,000 people):intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Side effects reported with amlodipine or valsartan alone and not observed with Amlodipino/Valsartán Aurovitas or observed with a higher frequency than with Amlodipino/Valsartán Aurovitas:

Amlodipine

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

• Sudden hissing sounds while breathing (sudden sibilance), chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes great difficulty breathing.
• Severe skin reactions that include intense skin rash, blisters, redness of the skin all over the body, severe itching, blister formation, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heart rhythm.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by great 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, somnolence; palpitations (feeling the heartbeat); hot flashes, swelling of the ankles (edema); abdominal pain, discomfort (nausea).

Infrequent (can affect up to 1 in 100 patients):mood changes, anxiety, depression, somnolence, tremor, taste alterations, fainting; visual disturbances, visual deterioration, ringing in the ears; decreased blood pressure; nasal congestion/secreting nasal discharge caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (discomfort); hair loss, increased sweating, itching skin, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or breast enlargement in men, pain, discomfort, 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 bruises (damage to red blood cells); high blood sugar (hyperglycemia); inflammation of the gums, abdominal swelling (gastritis); abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests; muscle tension; inflammation of blood vessels often with skin eruptions, light sensitivity; disorders combining stiffness, tremor, and/or movement disorders.

Valsartan

Very rare (can affect up to 1 in 10,000 people):Intestinal angioedema: swelling in the intestine with 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 mouth ulcers due to infection; spontaneous bleeding or skin hematomas; increased potassium in the blood; abnormal liver function test results; decreased kidney function and severely decreased kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, red purpura spots; fever; itching; allergic reaction, blistering skin disease (sign of a disease called dermatitis bullosa).

Notify your doctor immediately if you experience any of the mentioned 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 the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipino/Valsartán Aurovitas

• The active principles are amlodipine and valsartan.

Each tablet contains 5 mg of amlodipine (as amlodipine besilate) and 160 mg of valsartan.

• The other components are:

Tablet core:microcrystalline cellulose(grade-101),anhydrous colloidal silica, sodium carboxymethylcellulose (type-A) (from potato), povidone(K-30),pregelatinized cornstarch, magnesium stearate.

Tablet coating:hypromellose 2910 (E464), titanium dioxide (E 171), talc, macrogol, yellow iron oxide (E 172).

Appearance of the product and contents of the packaging

Yellow, oval-shaped, biconvex, beveled-edge tablet with a film coating, marked with«J»on one face and«37»on the other face.

Amlodipino/Valsartán Aurovitas film-coated tablets are available in blisters of polyamide/aluminium/PVC-aluminium laminate containing 28 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 – Madrid

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Last review date of this leaflet:February 2025

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