Package Insert: Information for the Patient

Amlodipino/Valsartán Stada 10 mg/160 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

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

1. What isAmlodipino/Valsartán Stadaand for what it is used

2. What you need to know before starting to takeAmlodipino/Valsartán Stada

3. How to takeAmlodipino/Valsartán Stada

4. Possible adverse effects

5. Storage ofAmlodipino/Valsartán Stada

6. Contents of the package and additional information

Amlodipino/Valsartán Stadatablets contain two substances calledamlodipineandvalsartan. Both substances help control high blood pressure.

• Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, which prevents blood vessel constriction.
• Valsartan 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 raising blood pressure. Valsartan 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 Stadais used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

Do not take Amlodipino/Valsartán Stada

• 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 takingAmlodipino/Valsartán Stada.
• if you have severe liver problems or bile duct problems such as biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant. (It is best to avoid taking Amlodipino/Valsartán Stada 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 blood pressure medication that contains aliskiren.

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

Warnings and precautions

Consult your doctor before starting to takeAmlodipino/Valsartán Stada:

• 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 your 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 angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking Amlodipino/Valsartán Stada and contact your doctor immediately. You should never take Amlodipino/Valsartán Stada again.
• if you are taking any of the following medications used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (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) at regular intervals.

See also the information under the heading “Do not take Amlodipino/Valsartán Stada”.

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.

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

Children and adolescents

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

Other medications and Amlodipino/Valsartán Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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:

• ACE inhibitors or aliskiren (see also the information under the headings “Do not take Amlodipino/Valsartán Stada” and “Warnings and precautions”);
• diuretics (a type of medication that increases urine production);
• lithium (a medication used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing 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 (antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medications);
• simvastatin (a medication used to control high cholesterol levels);
• dantrolene (for severe temperature abnormalities);
• medications used to prevent rejection in a transplant (ciclosporin).

Taking Amlodipino/Valsartán Stada with food and drinks

People taking Amlodipino/Valsartán Stada should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase the levels of the active ingredient amlodipine in the blood, which may cause unpredictable reductions in blood pressure.

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Amlodipino/Valsartán Stada before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Amlodipino/Valsartán Stada 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.

Breastfeeding

It has been shown that amlodipine, one of the two active substances in Amlodipino/Valsartán Stada, passes into breast milk in small amounts. If you are breastfeeding or plan to breastfeed, inform your doctor before taking Amlodipino/Valsartán Stada. Amlodipino/Valsartán Stada 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.

Driving and operating machinery

This medication may make you feel dizzy, 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 Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol); that is, it is essentially “sodium-free”.

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 usual dose of Amlodipino/Valsartán Stada 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 Stada with or without food. Do not take Amlodipino/Valsartán Stada 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 Stada 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 Stada Than You Should

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

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

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

If You Forget to Take Amlodipino/Valsartán Stada

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 Stop Taking Amlodipino/Valsartán Stada

Stopping your treatment with Amlodipino/Valsartán Stada 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 severe and require immediate medical attention:

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

Allergic reaction with symptoms such as skin rash, itching, facial swelling, lip or tongue swelling, difficulty breathing, low blood pressure (dizziness, fainting).

Other possible side effects of Amlodipino/Valsartán Stada:

Frequent (can affect up to 1 in 10 people):

• 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 people):

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

Rare (can affect up to 1 in 1,000 people):

• feeling of anxiety
• tinnitus (ringing in the ears)
• fainting
• increased urine production or feeling of urgent need to urinate
• difficulty achieving or maintaining 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

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 Stada or observed with a higher frequency than with Amlodipino/Valsartán Stada:

Amlodipino

Consult your doctor immediately if you experience any of the following severe side effects, which are very rare, 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, hives, skin redness all over the body, severe itching, blistering, peeling, skin inflammation, mucous membrane inflammation (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 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 people):

• dizziness, drowsiness
• palpitations (feeling the heartbeat)
• angina, swelling of the ankles (edema)
• abdominal pain, nausea

Infrequent (can affect up to 1 in 100 people):

• mood changes, anxiety, depression, drowsiness, tremors, altered taste, fainting, loss of pain sensation
• visual disturbances, visual deterioration, ringing in the ears
• low blood pressure
• runny nose/nasal secretion caused by nasal mucosa inflammation (rhinitis)
• indigestion, vomiting (discomfort)
• hair loss, increased sweating, itching skin, skin discoloration
• urinary disorders, increased need to urinate at night, increased frequency of urination
• difficulty achieving an erection, breast tenderness in men, pain, discomfort, muscle pain, muscle cramps
• weight gain or loss

Rare (can affect up to 1 in 1,000 people):

• confusion

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

• 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, liver inflammation (hepatitis), yellow skin discoloration (jaundice), increased liver enzymes that can affect some medical tests
• muscle tension
• inflammation of blood vessels often with skin eruptions, light sensitivity
• movement disorders combining stiffness, tremors, and/or movement disorders

Valsartán

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

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

Frequency unknown (the frequency cannot be estimated from available data):

• decreased red blood cell count, fever, sore throat, or mouth ulcers due to infections
• spontaneous skin or subcutaneous bleeding
• 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).

Consult 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 prospectus. You can also report them directly through the Spanish System for 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 box and the blister pack after “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.

Medications should not be disposed of through drains or in the trash. Dispose of the containers 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 containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipino/Valsartán Stada

• The active ingredients are amlodipino (as amlodipino besilato) and valsartán. Each tablet contains 10 mg of amlodipino (as amlodipino besilato) and 160 mg of valsartán.
• The other components are:

Core of the tablet:microcrystalline cellulose, povidone, pregelatinized cornstarch, anhydrous colloidal silica, crospovidone, sodium starch glycolate, magnesium stearate.

Coating:hypromellose, titanium dioxide (E171), yellow iron oxide (E172), talc, macrogol

Appearance of the product and contents of the package

Amlodipino/Valsartán Stada 10 mg/160 mg are film-coated tablets, yellowish in color, oval-shaped, and biconvex.

The film-coated tablets are presented in blister packs with a transparent PVC/TE/PVdC laminate and an aluminum laminate with 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, or 100 film-coated tablets.

The film-coated tablets are presented in single-dose blister packs with a transparent PVC/TE/PVdC laminate and an aluminum laminate with 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, or 100 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului, nr 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

AustriaAmlodipin/Valsartan STADA 10 mg/160 mg Filmtabletten

BelgiumAmlodipine/Valsartan EG 10 mg/160 mg filmomhulde tabletten

GermanyAmlodipin/Valsartan AL 10 mg/160 mg Filmtabletten

DenmarkAmlodipin/Valsartan STADA 10 mg/160 mg

SpainAmlodipino/Valsartán STADA 10 mg/160 mg comprimidos recubiertos con película EFG

FinlandAmlodipin/Valsartan STADA 10/160 mg kalvopäällysteiset tabletit

FranceAMLODIPINE/VALSARTAN EG 10/160 mg, comprimé pelliculé

IrelandAmlodipine/Valsartan Clonmel 10 mg/160 mg film-coated tablets

ItalyAmlodipina e Valsartan EG 10 mg/160 mg

LuxembourgAmlodipine/Valsartan EG 10 mg/160 mgcomprimés pelliculés

NetherlandsAmlodipine/Valsartan CF 10/160 mg, filmomhulde tabletten

PolandAmlodypina + Valsartan STADA

PortugalAmlodipina + Valsartan Ciclum 10/160 mg

RomaniaAmlodipina/Valsartan STADA 10/160 mg, comprimate filmate

SwedenAmlodipin/Valsartan STADA 10/160 mg, filmdragerad tablett

SloveniaAmlodipin/valsartan STADA 10 mg/160 mg filmsko obložene tablete

Last review date of this leaflet:February 2025

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.