Prospect: information for the patient

Amlodipino/Valsartán Stada 5 mg/160 mg film-coated tablets EFG

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

• Keep this prospect, 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 must not give it to other people 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 prospect. 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 increasing 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 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 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 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 Amlodipino/Valsartán Stada and contact your doctor immediately. Never take Amlodipino/Valsartán Stada 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) 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 muscle disorders);
• 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 can 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 can 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 achieve 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 doubts 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 Interrupt Treatment with 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 doubts 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 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, drowsiness).

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):

• anxiety sensation
• tinnitus (ringing in the ears)
• syncope (fainting)
• increased urine production or urgent need to urinate
• difficulty achieving or maintaining an erection
• heaviness sensation
• low blood pressure with symptoms such as dizziness, drowsiness
• 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 serious 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 increase
• 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 with 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, purpura
• fever
• itching
• allergic reaction, blistering skin disease (sign of a disease called bullous dermatitis).

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 the Vigilance of Medicinal Products 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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipino/Valsartán Stada

• The active ingredients are amlodipine (as amlodipine besilate) 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, povidone, pregelatinized maize starch, anhydrous colloidal silica, crospovidone, sodium starch glycolate, magnesium stearate.

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

Appearance of the product and contents of the package

Amlodipino/Valsartán Stada 5 mg/160 mg are film-coated, dark yellow, oval, biconvex tablets.

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

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) España

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Alemania

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Irlanda

or

STADA M&D SRL

Str. Trascaului, nr 10,

Municipiul Turda,

Judet Cluj 401135,

Rumanía

This medicinal product is authorized in the member states of the European Economic Area with the following names:

AustriaAmlodipin/Valsartan STADA 5 mg/160 mg Filmtabletten

BélgicaAmlodipine/Valsartan EG 5 mg/160 mg filmomhulde tabletten

AlemaniaAmlodipin/Valsartan AL 5 mg/160 mg Filmtabletten

DinamarcaAmlodipin/Valsartan STADA 5 mg/160 mg

EspañaAmlodipino/Valsartán STADA 5 mg/160 mg comprimidos recubiertos con película EFG

FinlandiaAmlodipin/Valsartan STADA 5/160 mg kalvopäällysteiset tabletit

FranciaAMLODIPINE/VALSARTAN EG 5/160 mg, comprimé pelliculé

IrlandaAmlodipine/Valsartan Clonmel 5 mg/160 mg film-coated tablets

ItaliaAmlodipina e Valsartan EG 5 mg/160 mg

LuxemburgoAmlodipine/Valsartan EG 5 mg/160 mgcomprimés pelliculés

Países BajosAmlodipine/Valsartan CF 5/160 mg, filmomhulde tabletten

PoloniaAmlodypina + Valsartan STADA

PortugalAmlodipina + Valsartan Ciclum 5/160 mg

RumaniaAmlodipina/Valsartan STADA 5/160 mg, comprimate filmate

SueciaAmlodipin/Valsartan STADA 5/160 mg, filmdragerad tablett

EsloveniaAmlodipin/valsartan STADA 5 mg/160 mg filmsko obložene tablete

Date of the last review of this leaflet:February 2025

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