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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amlodipine/Valsartan Aurovitas 5 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, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Amlodipine/Valsartan Aurovitas contains 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 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, 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 is lowered.

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 taking 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, skin redness, or difficulty breathing.

• If you are allergic to valsartan or any of the other components 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 severely 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 Aurovitas and inform your doctor if any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor before taking Amlodipine/Valsartan Aurovitas:

• If you have been unwell (with vomiting or diarrhoea).
• 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 disease affecting the adrenal glands called "primary hyperaldosteronism".
• If you have had heart failure or a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor 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 experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you get 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.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 conditions apply to you.

Children and adolescents

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

Taking Amlodipine/Valsartan Aurovitas with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use 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 especially applies to the following medicines:

• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan Aurovitas” and “Warnings and precautions”);
• diuretics (a type of medicine that increases urine production);
• 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 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 (e.g. rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (administered intravenously for serious disturbances in body temperature);
• tacrolimus (used to suppress the body's immune response to allow acceptance of a transplanted organ);
• medicines used to prevent transplant rejection (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 may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effects of Amlodipine/Valsartan Aurovitas.

Pregnancy, breast-feeding and fertility

Pregnancy

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

Breast-feeding

Inform your doctor if you are breast-feeding or plan to breast-feed.

It has been shown that amlodipine passes into breast milk in small amounts. Amlodipine/valsartan is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially if you have a newborn or premature infant.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine may make you feel dizzy, which 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.

Amlodipine/Valsartan Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Amlodipine/Valsartan Aurovitas

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in 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 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 Aurovitas with or without food. Do not take amlodipine/valsartan 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.

Amlodipine/Valsartan Aurovitas and elderly patients (65 years of age 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 Aurovitas than you should

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 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 a missed dose.

If you stop taking Amlodipine/Valsartan Aurovitas

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

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 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, tell your doctor immediately:

• allergic reaction with symptoms such as 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; nasal congestion, sore throat and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); flushing and sensation 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 in the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness upon standing; cough; diarrhoea; 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 urine output or urgent need to urinate; inability to achieve or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; rash all over the body, itching, muscle cramps.

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

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

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

Amlodipine

Contact your doctor immediately if you experience any of the following serious adverse 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 causing severe difficulty breathing.
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and skin inflammation, inflammation 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 strong feeling of malaise.

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 (oedema); abdominal pain, feeling of discomfort (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, blurred vision, tinnitus; low blood pressure; sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (nausea); 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 the breasts in men, pain, malaise, 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 white blood cell count, decrease in platelets which may cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycaemia); inflammation of the gums, 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, photosensitivity; disorders combining rigidity, tremor and/or movement disorders.

Valsartan

Very rare (may affect up to 1 in 10,000 people): Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (cannot be estimated from available data): decrease in red blood cell count, fever, sore throat or mouth ulcers due to infection; spontaneous skin bleeding or bruising; increased potassium levels 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, blistering skin disease (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 may also report them directly through 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 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 outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine/Valsartan Aurovitas

• The active substances 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), colloidal anhydrous silica, sodium carboxymethyl starch (type-A) (from 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 contents of the pack

Film-coated oval, biconvex tablet with bevelled edges, yellow in colour, engraved with "J" on one side and "37" on the other.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent review 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)