Package Leaflet: Information for the User

Amlodipino/Valsartán Tevagen 5 mg/160 mg Film-Coated Tablets

Read this 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, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is Amlodipino/Valsartán Tevagen and what is it used for

2. What you need to know before you start taking Amlodipino/Valsartán Tevagen

3. How to take Amlodipino/Valsartán Tevagen

4. Possible side effects

5. Storage of Amlodipino/Valsartán Tevagen

6. Contents of the pack and additional information

Amlodipino/Valsartán Tevagencontains two substances called amlodipine and valsartan. Both substanceshelp 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 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 to prevent blood vessel constriction. As a result, blood vessels relax and blood pressure decreases.

Amlodipino/Valsartán Tevagenis 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 Tevagen

• if you are allergic to amlodipino or any other calcium channel blocker. This may include symptoms such as itching, skin redness, or difficulty breathing.

• if you are allergic to valsartán or any of the other components of this medication (listed in section 6). If you think you may be allergic, inform your doctor before taking amlodipino/valsartán.

• if you have severe liver problems or bile duct 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 medication 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 medication to lower blood pressure that contains aliskireno.

Do not take amlodipino/valsartán and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor before starting to take amlodipino/valsartán:

• if you have been ill (with vomiting or diarrhea).

• if you have liver or kidney problems.

• if you have undergone a kidney transplant or if you have been told that you have a narrowing of the kidney arteries.

• 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 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 and contact your doctor immediately. You should never take amlodipino/valsartán again.

• if you are taking any of the following medications used to treat high blood pressure:

Your doctor may monitor 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 Tevagen”.

Inform your doctor before taking amlodipino/valsartánif you are affected by any of the cases mentioned.

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

Children and adolescents

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

Taking Amlodipino/Valsartán Tevagen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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:

• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Amlodipino/Valsartán Tevagen” and “Warnings and precautions”);

• diuretics (a type of medication that increases urine production);

• litium (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;

• certain types of pain medications called nonsteroidal anti-inflammatory drugs (NSAIDs) or selective 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";

• 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 (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 (ciclosporina).

• rifampicin, erythromycin, clarithromycin (antibiotics)

Taking Amlodipino/Valsartán Tevagen with food and drinks

People taking amlodipino/valsartán should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipino, which may lead to unpredictable reductions in the blood pressure-lowering effects of amlodipino/valsartán.

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 or pharmacist before using this medication,

Pregnancy

Generally, your doctor will advise you to stop taking amlodipino/valsartán before becoming pregnant or as soon as you become pregnantand recommend taking another antihypertensive medication instead. Amlodipino/valsartán is not recommended for use at the beginning of pregnancy (first 3 months) 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

Amlodipino has been shown to pass into breast milk in small amounts.Amlodipino/valsartán is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication may cause dizziness, 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 Tevagen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; 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 normal dose of amlodipino/valsartán 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 with or without food. Do not take amlodipino/valsartán 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 Tevagenand 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 MoreAmlodipino/Valsartán Tevagenthan You Should

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

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

If You Forget to TakeAmlodipino/Valsartán Tevagen

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 TakingAmlodipino/Valsartán Tevagen

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

Like all medications, amlodipine/valsartan 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 in1,000 patients).Notify your doctor immediately if you experience any of the following:

Allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (dizziness, fainting).

Other possible side effects of amlodipine/valsartan:

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

Infrequent (can affect up to 1 in 100 patients):Dizziness; nausea and abdominal pain;dry mouth; drowsiness, numbness, or tingling in 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 (can affect up to 1 in 1,000 patients):Feeling of anxiety; ringing in the ears(tinnitus); fainting; increased urine production or feeling of urgency to urinate; inability to achieve or maintain 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 amlodipine/valsartan or observed with a higher frequency than with amlodipine/valsartan:

Amlodipine

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

• Sudden hissing sounds while breathing (sudden sibilance), 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 that include intense skin rash, blisters, redness of the skin all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of 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 great 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 patients):Dizziness, somnolence; palpitations (feelingthe heartbeat); hot flashes, swelling of the ankles (edema); abdominal pain, feeling of discomfort (nausea).

Infrequent (can affect up to 1 in 100 patients):Changes in mood, anxiety,depression, somnolence, tremor, alterations in taste, fainting, loss of sensation of pain; visual disturbances, visual deterioration, ringing in the ears; decreased blood pressure; runny nose/secretion caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (discomfort); hair loss, increased sweating, itching in the skin, 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, feeling of discomfort, muscle pain, muscle cramps; weight gain or loss.

Rare (can affect up to 1 in 1,000 patients):Confusion.

Very rare (can affect up to 1 in 10,000 patients):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), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests; increased muscle tension; inflammation of blood vessels often with skin eruptions, sensitivity to light; disorders combining stiffness, tremor, and/or movement disorders.

Valsartan

Very rare:Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

Decreased red blood cell count, fever, sore throat or ulcers in the mouth due to infection; spontaneous bleeding or skin hematomas; 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).

Notify your doctor immediately if you experience any of the mentioned cases.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 of

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 medication.

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 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 manipulation.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipino/Valsartán Tevagen

-The active ingredients ofAmlodipino/Valsartán Tevagenare amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.

-The other components are microcrystalline cellulose (type 101 and 102), povidone, sodium croscarmellose, talc, and magnesium stearate (core of the tablet) and hypromellose; macrogol 400; titanium dioxide (E171) and iron oxide yellow (E172) (coating).

Appearance of the product and contents of the packaging

The tablets of Amlodipino/Valsartán Tevagen5 mg/160 mg are coated tablets, oval, biconvex, yellow in color with the imprint «2» on one face and «LD» on the other face.

Amlodipino/Valsartán Tevagenis presented in packaging that contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for manufacturing

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 holder of the marketing authorization:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Last review date of this leaflet: January 2025

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

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the carton. 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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