AMLODIPINE/VALSARTAN TECNIGEN 10 mg/160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine/Valsartan TecniGen 5 mg/160 mg film-coated tablets EFG

Amlodipine/Valsartan TecniGen 10 mg/160 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack

1. What Amlodipine/Valsartan TecniGen is and what it is used for
2. What you need to know before you take Amlodipine/Valsartan TecniGen
3. How to take Amlodipine/Valsartan TecniGen
4. Possible side effects
5. Storage of Amlodipine/Valsartan TecniGen
6. Contents of the pack and other information

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

This medicine contains two active substances called amlodipine and valsartan. Both substances help to control high blood pressure.

• Amlodipinebelongs 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.
• Valsartanbelongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and makes the blood vessels narrow, which increases 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 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 you take Amlodipine/Valsartan TecniGen

Do not take Amlodipine/Valsartan TecniGen

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

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. This can include itching, skin rash, or difficulty breathing

• 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 better to avoid taking this medicine also 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-lowering medicine containing 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 you have narrowing of the arteries to your kidneys,
• 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 for carefully starting the dosage. Your doctor may also check your kidney function,

• if your doctor has told you that you have narrowing of the heart valves (so-called «aortic or mitral stenosis») or that the thickness of your heart muscle has increased abnormally (so-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 (high blood pressure):
• • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • Aliskiren

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.

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

See also the information under the heading «Do not take Amlodipine/Valsartan TecniGen».

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

Children and adolescents

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

Other medicines and Amlodipine/Valsartan TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 true for the medicines listed below:

• an ACE inhibitor or aliskiren (see also the information under the headings «Do not take Amlodipine/Valsartan TecniGen» and «Warnings and precautions»);
• diuretics (a type of medicine that increases the amount of urine produced);
• lithium (a medicine 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 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);
• antibiotics (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 protect against rejection in a transplant (cyclosporine).

Taking Amlodipine/Valsartan TecniGen with food and drink

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

Pregnancy

You should inform your doctor if you are pregnant or think you might be pregnant or if you are planning to become pregnant. Your doctor will normally advise you to stop taking amlodipine/valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine to treat your high blood pressure. Amlodipine/valsartan is not recommended during the first 3 months of pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to your baby when administered after this period.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. Amlodipine/valsartan is not recommended for use during breastfeeding and your doctor may decide to give you a different treatment, especially if you are breastfeeding a newborn or premature baby.

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.

Driving and using machines

This medicine may make you feel dizzy. This can affect your ability to concentrate. Therefore, if you are unsure how this medicine will affect you, do not drive, use machines, or perform other activities that require concentration.

3. How to take Amlodipine/Valsartan TecniGen

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor. This will help you to get the best results and reduce the risk of side effects.

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

• It is preferable 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 treatment, your doctor may suggest a higher or lower dose. Do not exceed the prescribed dose.

Amlodipine/Valsartan TecniGen and advanced age (65 years or older)

Your doctor should exercise caution when increasing your dose.

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

If you take more Amlodipine/Valsartan TecniGen than you should

If you have taken too many tablets of amlodipine/valsartan, or if someone else has taken your tablets, contact a doctor immediately.

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

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

If you forget to take Amlodipine/Valsartan TecniGen

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 forgotten doses.

If you stop taking Amlodipine/Valsartan TecniGen

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

A few patients have experienced these serious side effects (may affect up to 1 in 1,000 patients). If you notice any of the following, tell 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 side effects of amlodipine/valsartan

Common (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,
• weakness (asthenia),
• flushing and warmth of the face and/or neck.

Uncommon (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 anxious,
• ringing in the ears (tinnitus),
• fainting,
• increased urine production or urgent need to urinate,
• inability to get or maintain an erection,
• feeling heavy,
• 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 affected by any of the above.

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 very rare, serious side effects 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, which can cause great difficulty breathing,
• severe skin reactions including intense skin rash, hives, 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 a feeling of being very unwell.

The following side effects have been reported. If any of these cause problems or last more than a week, consult your doctor.

Common (may affect up to 1 in 10 patients)

Dizziness, drowsiness, palpitations (feeling your heartbeat), flushing, swelling of the ankles (edema), abdominal pain, feeling unwell (nausea).

Uncommon (may affect up to 1 in 100 patients)

Mood changes, anxiety, depression, drowsiness, tremor, changes in taste, fainting, loss of pain sensation, visual disturbances, impaired vision, ringing in the ears; low blood pressure, runny nose/nasal congestion caused by inflammation of the nasal mucosa (rhinitis), indigestion, vomiting (nausea), hair loss, increased sweating, itching of the skin, discoloration of the skin, urinary disorders, increased need to urinate at night, increased number of times of urination, inability to get an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain; muscle cramps.

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

Confusion.

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

Decrease in the number of white blood cells, decrease in blood platelets that can cause easy bruising or bleeding (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 rash, sensitivity to light, disorders combining stiffness, tremor, and/or movement disorders.

Valsartan

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

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

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

Decrease in the number of red blood cells, fever, sore throat or mouth ulcers due to infection, 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, purple spots, fever, itching, allergic reaction, blistering skin disease (sign of a disease called bullous dermatitis).

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

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine/valsartan TecniGen

Keep this medicine out of the sight and reach of children.

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

This medicine does not require special storage conditions.

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

Medicines should not be thrown away via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of 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 TecniGen

• The active ingredients 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 Package Contents

Amlodipine/valsartan TecniGen 5 mg/160 mg are film-coated tablets of dark yellow color, oval, biconvex, with the mark "C94" on one face and flat on the other.

Height: approximately 15.6 mm. Width: approximately 6.6 mm

Amlodipine/valsartan TecniGen 10 mg/160 mg are film-coated tablets of light yellow color, oval, biconvex, with the mark "C95" on one face and flat on the other.

Height: approximately 15.6 mm. Width: approximately 6.6 mm

Package sizes: 28 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid)

Spain

Manufacturer

Tecnimede - Sociedade Tecnico-medicinal, S.a.

Quinta da Cerca, Caixaria

2565-187 Dois Portos, Lisboa

Portugal

Date of the Last Revision of this Prospectus: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/