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

Introduction

Package Leaflet: Information for the User

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

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

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Amlodipine/Valsartan Tevagen contains two active substances called amlodipine and valsartan. Both substances help to 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 the blood vessels to narrow, thereby increasing 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 blood pressure decreases.

Amlodipine/Valsartan Tevagen 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 Tevagen

Do not take Amlodipine/Valsartan Tevagen

• 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 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 best to avoid taking this medicine during the start of your pregnancy, see section Pregnancy).

• if you have severe low blood pressure (hypotension).

• if you have a 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-lowering medicine that contains aliskiren.

Do not take amlodipine/valsartan and inform your doctor if any of the above applies to you.

Warnings and Precautions

Consult your doctor before starting to take amlodipine/valsartan:

• 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 that you have a narrowing of the arteries to 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 a 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), especially 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.

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

Tell your doctor before taking amlodipine/valsartanif any of the above applies to you.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Amlodipine/Valsartan Tevagen. Your doctor will decide whether to continue treatment. Do not stop taking Amlodipine/Valsartan Tevagen on your own.

Children and Adolescents

The use of amlodipine/valsartan is not recommended in children and adolescents (under 18 years of age).

Taking Amlodipine/Valsartan Tevagen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 Tevagen" 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 that contain 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 (such as 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);

• medicines used to prevent rejection in a transplant (cyclosporine).

• rifampicin, erythromycin, clarithromycin (antibiotics)
• tacrolimus (used to control the body's immune response to allow it to accept a transplanted organ);

Taking Amlodipine/Valsartan Tevagen 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.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Normally, your doctor will advise you to stop taking amlodipine/valsartan before you become pregnant or as soon as you find out you are pregnantand will recommend that you take a different blood pressure-lowering medicine instead. Amlodipine/valsartan should not be used during the first 3 months of pregnancy and should not be used at all after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts.Amlodipine/valsartan should not be used during breastfeeding. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially if you are breastfeeding newborns or premature babies.

Ask your doctor or pharmacist for advice 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 Tevagen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Amlodipine/Valsartan Tevagen

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

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

• It is best to take the medicine at the same time each day.

• Swallow the tablets with a glass of water.

• You can take amlodipine/valsartan 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 Tevagenand the Elderly (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 moreAmlodipine/Valsartan Tevagenthan you should

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

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

If you forget to takeAmlodipine/Valsartan Tevagen

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 missed doses.

If you stop takingAmlodipine/Valsartan Tevagen

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

4. Possible Adverse Effects

Like all medicines, amlodipine/valsartan 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 inevery 1,000 patients).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/valsartán:

Frequent (may affect up to 1 in 10 patients):Flu; stuffy nose, sore throat, and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles, or feet; fatigue; asthenia (weakness); flushing and warming of the face and/or neck.

Infrequent (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 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/valsartánor observed with a higher frequency than with amlodipine/valsartán:

Amlodipine

Consult your doctor immediately if you experience any of the following serious adverse effects, which are very rare after taking this medication:

• Sudden wheezing when breathing (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 inflammation of the skin, 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 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 patients):Dizziness, drowsiness; palpitations (feeling the heartbeat); hot flashes, swelling of the ankles (edema); abdominal pain, feeling of discomfort (nausea).

Infrequent (may affect up to 1 in 100 patients):Mood changes, anxiety, depression, drowsiness, tremors, taste disturbances, fainting, loss of pain sensation; visual disturbances, vision impairment, ringing in the ears; decreased blood pressure; nasal congestion/caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (discomfort); hair loss, increased sweating, itching of the skin, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or breast enlargement in men, pain, feeling of discomfort, 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):Decreased white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising (red blood cell damage); high blood sugar (hyperglycemia); gum inflammation, 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: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):

Decreased red blood cell count, fever, sore throat, or mouth ulcers due to infection; spontaneous bleeding or bruising; increased potassium in the blood; abnormal liver function test results; decreased renal function and severely decreased renal 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.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. 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 medication.

5. Storage of Amlodipine/Valsartán Tevagen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Do not use this medication if you observe that the packaging is damaged or shows signs of tampering.

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

6. Package Contents and Additional Information

Composition of Amlodipine/Valsartán Tevagen

• The active ingredients of Amlodipine/Valsartán Tevagen are amlodipine (as amlodipine besylate) and valsartán. Each tablet contains 5 mg of amlodipine and 160 mg of valsartán.
• The other components are microcrystalline cellulose (type 101 and 102), povidone, sodium croscarmellose, talc, and magnesium stearate (tablet core) and hypromellose; macrogol 400; titanium dioxide (E171) and yellow iron oxide (E172) (coating).

Appearance of the Product and Package Contents

The tablets of Amlodipine/Valsartán Tevagen 5 mg/160 mg are film-coated, oval, biconvex, yellow in color with the imprint "2" on one side and "LD" on the other side.

Amlodipine/Valsartán Tevagen is available in packages containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

Balkanpharma Dupnitza AD.

3 Samokovsko Shosse Street

Dupnitsa, 2600

Bulgaria

Actavis Ltd.

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this prospectus: June 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82053/P_82053.html

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