AMLODIPINE/VALSARTAN AUROVITAS 5 mg/160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine/Valsartan Aurovitas5 mg/160 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Amlodipine/Valsartan Aurovitas contains two active substances called amlodipine and valsartan. Both substances help to 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, which prevents the 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 makes the blood vessels narrow, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II.

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

Amlodipine/valsartan is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

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

Do not take Amlodipine/Valsartan Aurovitas:

• If you are allergic to amlodipine or any other calcium channel blocker. This may include itching, redness of the skin, or difficulty breathing.
• If you are allergic to valsartan or 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 problems such as biliary cirrhosis or cholestasis.
• If you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also at the start of your pregnancy, see section Pregnancy).
• If you have severe low blood pressure (hypotension).
• If you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation where your heart is unable to supply enough blood to your body).
• If you have heart failure after a heart attack.
• If you have diabetes or kidney problems and are being treated with a blood pressure lowering medicine containing aliskiren.

Do not take Amlodipine/Valsartan Aurovitas and inform your doctor if any of the above applies to you.

Warnings and precautions

Consult your doctor before taking Amlodipine/Valsartan Aurovitas:

• If you have been unwell (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 arteries to your kidneys.
• If you have a condition that affects your adrenal glands called “primary hyperaldosteronism”.
• If you have had heart failure or have had a heart attack. Follow your doctor's instructions carefully to start the dosage. 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 increased abnormally (called “hypertrophic cardiomyopathy”).
• If you have experienced swelling, particularly in the face and throat, while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking amlodipine/valsartan and contact your doctor immediately. Never take amlodipine/valsartan again.
• If you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. 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) in your blood at regular intervals.

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 Amlodipine/Valsartan Aurovitas”.

Tell your doctor before taking Amlodipine/Valsartan Aurovitas if any of the above applies to you.

Children and adolescents

Amlodipine/Valsartan Aurovitas is not recommended for use in children and adolescents (under 18 years).

Taking Amlodipine/Valsartan Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change your dose and/or take other precautions.

In some cases, you may need to stop taking one of the medicines. This is especially applicable to the medicines listed below:

• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Amlodipine/Valsartan Aurovitas” and “Warnings and precautions”);
• diuretics (a type of medicine that increases the amount of urine);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels;
• certain types of painkillers called non-steroidal 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;
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• medicines used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used to treat bacterial infections (e.g. rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (in infusion for severe body temperature abnormalities);
• tacrolimus (used to control the body's immune response allowing it to accept a transplanted organ);
• medicines used to protect against rejection in a transplant (cyclosporine).

Taking Amlodipine/Valsartan Aurovitas with food and drinks

People taking amlodipine/valsartan should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine/Valsartan Aurovitas.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking amlodipine/valsartan before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another blood pressure lowering medicine instead. Amlodipine/valsartan is not recommended during the first 3 months of pregnancy and should not be used after the third month of pregnancy as it may cause serious harm to your baby when used after this time.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding.

Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/valsartan is not recommended for use during breastfeeding. Your doctor may decide to prescribe a different treatment that is more suitable if you wish to breastfeed, especially for newborns or premature babies.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine may make you feel dizzy. This may affect your ability to concentrate. If you are unsure how this medicine will affect you, do not drive, use machines, or perform other activities that require concentration.

Amlodipine/Valsartan Aurovitas contains sodium

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

3. How to take Amlodipine/Valsartan Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. This will help you to get the best results and reduce the risk of side effects.

The usual dose of amlodipine/valsartan is one tablet per day.

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

Depending on your response to the treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

Amlodipine/Valsartan Aurovitas and elderly patients (65 years or older)

Your doctor should exercise caution when increasing your dose.

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

If you take more Amlodipine/Valsartan Aurovitas than you should

Fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

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

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

If you forget to take Amlodipine/Valsartan Aurovitas

If you forget to take this medicine, 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 forgotten doses.

If you stop taking Amlodipine/Valsartan Aurovitas

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

A few patients have experienced these serious side effects (may affect up to 1 in 1,000 patients).If you notice any of the following, tell 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 of fainting, dizziness).

Other possible side effects of amlodipine/valsartan:

Frequent (may affect up to 1 in 10 patients):flu; blocked nose, sore throat, and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles, or feet; tiredness; weakness; flushing and feeling of 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 of the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness when standing up; 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 anxious; ringing in the ears (tinnitus); fainting; increased urination or urgent need to urinate; inability to get or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, fainting; excessive sweating; skin rash all over the body, itching, muscle spasms.

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

Tell your doctor if you are seriously affected by any of the above.

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

Amlodipine

Consult your doctor immediately if you experience any of the following serious side effects, which are very rare, 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 that causes great difficulty breathing.
• Severe skin reactions including severe skin rash, blistering, or peeling of the skin, and inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heartbeat.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a feeling of being unwell.

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

Frequent (may affect up to 1 in 10 patients):dizziness, drowsiness; palpitations (feeling the heartbeat); flushing, 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, changes in taste, fainting, loss of pain sensation; visual disturbances, impaired vision; decreased blood pressure; runny nose/nasal congestion caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (nausea); hair loss, increased sweating, itching, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to get an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, 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 that can cause easy bruising or bleeding (damage to red blood cells); high blood sugar (hyperglycemia); gum inflammation, abdominal swelling (gastritis); abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, 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 that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from the available data):decrease in the number of red blood cells, fever, sore throat or mouth ulcers due to infection; spontaneous bleeding or bruising; high potassium levels 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, purple spots; fever; itching; allergic reaction, blistering skin disease (sign of a disease called bullous dermatitis).

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine/Valsartan Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Amlodipine/Valsartan Aurovitas

• The active ingredients are amlodipine and valsartan.

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

• The other ingredients are:

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

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

Appearance of the Product and Package Contents

Film-coated tablet, oval, biconvex, with a beveled edge, yellow, engraved with "J" on one side and "37" on the other side.

Amlodipine/Valsartan Aurovitas film-coated tablets are available in polyamide/aluminum/PVC-aluminum foil blisters containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 – Madrid

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Date of the Last Revision of this Leaflet:February 2025

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