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

Introduction

Package Leaflet: Information for the Patient

Amlodipine/Valsartan Stada 5 mg/160 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Amlodipine/Valsartan Stada is and what it is used for
2. What you need to know before taking Amlodipine/Valsartan Stada
3. How to take Amlodipine/Valsartan Stada
4. Possible side effects
5. Storage of Amlodipine/Valsartan Stada
6. Package Contents and Additional Information

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

Amlodipine/Valsartan Stada tablets contain two active substances called amlodipineand valsartan. 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 the blood vessels from narrowing.
• Valsartan belongs to a group of substances called "angiotensin II receptor antagonists". Angiotensin II is produced by the body and causes blood vessels to narrow, thereby 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 decreases.

Amlodipine/Valsartan Stada 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 Stada

Do not take Amlodipine/Valsartan Stada

• 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 ingredients of this medication (listed in section 6). If you think you may be allergic, inform your doctor before taking Amlodipine/Valsartan Stada.
• if you have severe liver problems or biliary problems such as biliary cirrhosis or cholestasis.
• if you are pregnant for more than 3 months. (It is also best to avoid taking Amlodipine/Valsartan Stada 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 cannot 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 medication that contains aliskiren.

Do not take Amlodipine/Valsartan Stada and inform your doctor if any of the above cases apply to you.

Warnings and Precautions

Consult your doctor before starting to take Amlodipine/Valsartan Stada:

• if you have been ill (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 of the kidney.
• if you have a disease 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 carefully start the dosage. Your doctor may also check your kidney function.
• if your doctor has informed 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 medications (including ACE inhibitors). If you have these symptoms, stop taking Amlodipine/Valsartan Stada and contact your doctor immediately. You should never take Amlodipine/Valsartan Stada again.
• if you are taking any of the following medications 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 monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.

See also the information under the heading "Do not take Amlodipine/Valsartan 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.

Tell your doctor before taking Amlodipine/Valsartan Stada if any of the above cases apply to you.

Children and Adolescents

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

Other Medications and Amlodipine/Valsartan Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. 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 is especially applicable to the medications listed below:

• ACE inhibitors or aliskiren (see also the information under the headings "Do not take Amlodipine/Valsartan 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 that contain potassium, and other substances that may increase potassium levels;
• a certain type of pain medication called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. Your doctor may also monitor your kidney function;
• anticonvulsant agents (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 (in infusion for severe body temperature abnormalities);
• medications used to protect against rejection in a transplant (cyclosporine).

Taking Amlodipine/Valsartan Stada with Food and Drinks

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 generally advise you to stop taking Amlodipine/Valsartan Stada before becoming pregnant or as soon as you become pregnant, and recommend taking another blood pressure medication instead. Amlodipine/Valsartan Stada is not recommended during the first trimester of pregnancy (first 3 months) and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

It has been shown that amlodipine, one of the two active substances in Amlodipine/Valsartan Stada, passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, inform your doctor before taking Amlodipine/Valsartan Stada. Amlodipine/Valsartan Stada is not recommended for women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and Using Machines

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, use machines, or perform other activities that require concentration.

Amlodipine/Valsartan Stada Contains Sodium

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

3. How to Take Amlodipine/Valsartan Stada

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor again. This will help you get the best results and reduce the risk of side effects.

The usual dose of Amlodipine/Valsartan Stada is one tablet per day.

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

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

Do not exceed the prescribed dose.

Amlodipine/Valsartan Stada and Elderly Patients (65 years or older)

Your doctor should exercise caution when increasing your dose.

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

If You Take More Amlodipine/Valsartan Stada Than You Should

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

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

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

If You Forget to Take Amlodipine/Valsartan 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 missed doses.

If You Stop Taking Amlodipine/Valsartan Stada

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

A few patients have experienced these serious adverse effects (may affect up to 1 in 1,000 people). If you notice any of the following, inform 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 adverse effects of Amlodipine/Valsartan Stada:

Frequent (may 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 warming of the face and/or neck

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

• dizziness
• nausea and abdominal pain
• dry mouth
• drowsiness, tingling or numbness of 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 (may affect up to 1 in 1,000 people):

• feeling of anxiety
• ringing in the ears (tinnitus)
• fainting
• increased urine output or urgent need to urinate
• inability to achieve or maintain an erection
• feeling of heaviness
• low blood pressure with symptoms such as dizziness, lightheadedness
• excessive sweating
• skin rash all over the body, itching, muscle spasms

Tell your doctor if you are severely affected by any of the mentioned cases.

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

Amlodipine

Consult 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 that causes great difficulty breathing
• severe skin reactions including intense skin rash, hives, redness of the skin all over the body, significant itching, blistering, peeling and skin inflammation, inflammation of the mucous membranes (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 a great feeling of discomfort

The following adverse 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 people):

• dizziness, drowsiness
• palpitations (feeling heartbeats)
• hot flashes, swelling of the ankles (edema)
• abdominal pain, feeling of discomfort (nausea)

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

• mood changes, anxiety, depression, drowsiness, tremors, taste disturbances, fainting, loss of pain sensation
• visual disturbances, visual impairment, ringing in the ears
• decreased blood pressure
• sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• indigestion, vomiting (discomfort)
• hair loss, increased sweating, itching of the skin, skin discoloration
• urination disorder, increased need to urinate at night, increased number of times urinating
• inability to achieve an erection, discomfort or enlargement of the breasts in men, pain, feeling of discomfort, muscle pain, muscle cramps
• weight gain or weight loss

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

• confusion

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

• decrease in the number of white blood cells, decrease in blood platelets that can cause easy bleeding or unusual bruising (red blood cell damage)
• 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
• increased muscle tension
• inflammation of blood vessels often with skin rashes, sensitivity to light
• disorders combining stiffness, tremors and/or movement disorders

Valsartán

Very rare (may 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 not known (frequency cannot be estimated from available data):

• decrease in the number of red blood cells, fever, sore throat or mouth ulcers due to infections
• 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, purplish red spots
• fever
• itching
• allergic reaction, blistering skin disease (sign of a disease called bullous dermatitis)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Amlodipine/Valsartan Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Amlodipine/Valsartan Stada

• The active ingredients are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
• The other ingredients are:

Core of the tablet:microcrystalline cellulose, povidone, pregelatinized corn 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 package contents

Amlodipine/Valsartan Stada 5 mg/160 mg are film-coated tablets, dark yellow in color, oval and biconvex.

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Amlodipin/Valsartan STADA 5 mg/160 mg Filmtabletten

Belgium Amlodipine/Valsartan EG 5 mg/160 mg film-coated tablets

Germany Amlodipin/Valsartan AL 5 mg/160 mg Filmtabletten

Denmark Amlodipin/Valsartan STADA 5 mg/160 mg

Spain Amlodipino/Valsartán STADA 5 mg/160 mg film-coated tablets EFG

Finland Amlodipin/Valsartan STADA 5/160 mg film-coated tablets

France AMLODIPINE/VALSARTAN EG 5/160 mg, film-coated tablet

Ireland Amlodipine/Valsartan Clonmel 5 mg/160 mg film-coated tablets

Italy Amlodipina e Valsartan EG 5 mg/160 mg

Luxembourg Amlodipine/Valsartan EG 5 mg/160 mg film-coated tablets

Netherlands Amlodipine/Valsartan CF 5/160 mg, film-coated tablets

Poland Amlodypina + Valsartan STADA

Portugal Amlodipina + Valsartan Ciclum 5/160 mg

Romania Amlodipina/Valsartan STADA 5/160 mg, film-coated tablets

Sweden Amlodipin/Valsartan STADA 5/160 mg, film-coated tablet

Slovenia Amlodipin/valsartan STADA 5 mg/160 mg film-coated tablets

Date of the last revision of this leaflet:February 2025

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