Prospect: information for the user

Amlodipino/valsartán TecniGen 5 mg/160 mg film-coated tablets

Amlodipino/valsartán TecniGen 10 mg/160 mg film-coated tablets

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 questions, consult your doctor or pharmacist.

• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

This medication contains two substances called amlodipino and valsartán. Both substances help control high blood pressure.

• Amlodipinobelongs to a group of substances called «calcium channel blockers». Amlodipino prevents calcium from entering the blood vessel wall, preventing blood vessel constriction.
• Valsartánbelongs 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. Valsartán 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 is used for the treatment of high blood pressure in adults whose blood pressure is not adequately controlled with amlodipino or valsartán alone.

Do not take Amlodipino/valsartán TecniGen

• if you are allergic to amlodipino or any other calcium channel blocker,

If you think you may be allergic, inform your doctor before taking amlodipino/valsartán. This may include symptoms such as itching, skin redness, or difficulty breathing.

• 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 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 containing 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 sick (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 (which is called “aortic or mitral stenosis”) or that the thickness of your heart muscle has increased abnormally (which is 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 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:
• • an angiotensin-converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • Aliskireno

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 in monotherapy.

Your doctor may regularly check your kidney function, blood pressure, and electrolyte levels (e.g. potassium) through blood tests.

See also the information under the heading “Do not take Amlodipino/valsartán TecniGen”.

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

Children and adolescents

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

Other medications and Amlodipino/valsartán TecniGen

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:

• an ACEI or aliskireno (see also the information under the headings “Do not take Amlodipino/valsartán TecniGen” and “Warnings and precautions”);
• diuretics (a type of medication that increases the amount of urine produced);
• 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 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);
• antibiotics (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medications);
• simvastatin (a medication used to control high cholesterol levels);
• dantrolene (for severe abnormalities of body temperature);
• medications used to prevent rejection in a transplant (ciclosporina).

Taking Amlodipino/valsartán TecniGen with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking amlodipino/valsartán before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Amlodipino/valsartán is not recommended for use during the first 3 months of pregnancy and should not be administered at all from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding. It has been shown that amlodipino passes into breast milk in small amounts. Amlodipino/valsartán is not recommended for use during this period, and your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

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

Driving and operating machinery

This medication may make you feel dizzy. This 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.

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 recommended 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 TecniGen and Advanced Age (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 TecniGen Than You Should

If you have taken too many tablets of amlodipino/valsartán, 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 or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Amlodipino/valsartán TecniGen

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 TecniGen

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 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 patients).Notify your doctor immediately if you notice 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 (feeling faint, dizziness).

Other possible side effects of amlodipine/valsartan

Frequent (can affect up to 1 in 10 patients)

• flu,
• stuffy nose, sore throat, and discomfort swallowing,
• headache,
• swelling in the arms, hands, legs, ankles, or feet,
• fatigue,
• weakness,
• reddening and warming of the face and/or neck.

Rare (can affect up to 1 in 100 patients)

• 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, redness of the skin,
• inflammation of the joints, back pain,
• joint pain.

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

• feeling of anxiety,
• tinnitus (ringing in the ears),
• syncope,
• increased urine production or feeling of urgency 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 above cases severely affect you.

The 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

Notify your doctor immediately if you experience any of the following rare, severe side effects after taking this medicine:

• abrupt 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 the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions,
• heart attack, abnormal heartbeat,
• inflammation of the pancreas, which 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, drowsiness, palpitations (feeling the heartbeat), hot flashes, swelling of the ankles (edema), abdominal pain, feeling unwell (nausea).

Rare (can affect up to 1 in 100 patients)

Mood changes, anxiety, depression, drowsiness, tremors, altered taste, fainting, loss of sensation of pain, visual disturbances, visual deterioration, ringing in the ears; decreased blood pressure, nasal congestion or secretion caused by inflammation of the nasal mucosa (rhinitis), indigestion, vomiting (discomfort), hair loss, increased sweating, itching on 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 unwell, 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, inflammation of the liver (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, light sensitivity, disorders combining stiffness, tremors, and/or movement disorders.

Valsartan

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

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

Unknown frequency (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 skin bleeding or hematomas, increased potassium in the blood, abnormal liver function test results, severely decreased kidney function, primarily facial and throat swelling, muscle pain, skin rash, purpura, fever, itching, allergic reaction, blistering skin disease (sign of a disease called dermatitis bullosa).

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the 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.

This medication does not require special conditions for conservation.

Do not use this medication if you observe visible signs of deterioration.

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

Composition of Amlodipino/valsartán TecniGen

• The active principles are amlodipine (as amlodipine besylate) and valsartan.

Each 5 mg/160 mg tablet contains 5 mg of amlodipine and 160 mg of valsartan. Each 10 mg/160 mg tablet contains 10 mg of amlodipine and 160 mg of valsartan.

• The other components are:

5 mg/160 mg tablets: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E-171), yellow iron oxide (E-172).

10 mg/160 mg tablets: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, yellow iron oxide (E-172), red iron oxide (E-172)

Appearance of the product and contents of the packaging

Amlodipino/valsartán TecniGen 5 mg/160 mg are dark yellow-coated, oval, biconvex tablets, with the mark “C94” on one face and flat on the other.

Height: approximately 15.6 mm. Width: approximately 6.6 mm

Amlodipino/valsartán TecniGen 10 mg/160 mg are light yellow-coated, oval, biconvex tablets, with the mark “C95” on one face and flat on the other.

Height: approximately 15.6 mm. Width: approximately 6.6 mm

Packaging sizes: 28 tablets

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Tecnimede - Sociedade Tecnico-medicinal, S.a.

Quinta da Cerca, Caixaria

2565-187 Dois Portos, Lisboa

Portugal

Last review date of this leaflet:February 2025

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