AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE TECNIGEN 10 mg/320 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 5 mg/160 mg/12.5 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/160 mg/12.5 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 5 mg/160 mg/25 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/160 mg/25 mg film-coated tablets EFG

Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/320 mg/25 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 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/Hydrochlorothiazide TecniGen and what is it used for
2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide TecniGen
3. How to take Amlodipine/Valsartan/Hydrochlorothiazide TecniGen
4. Possible side effects

5 Storage of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen

1. Package contents and further information

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

This medicine contains three active substances called amlodipine, valsartan, and hydrochlorothiazide. All these 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 makes the blood vessels narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances called "thiazide diuretics".

Hydrochlorothiazide increases urine production, which also reduces blood pressure.

As a result of the three mechanisms, the blood vessels relax and blood pressure decreases.

Amlodipine/Valsartan/Hydrochlorothiazide is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan, and hydrochlorothiazide, and who can benefit from taking a single tablet that contains the three substances.

2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide TecniGen

Do not take Amlodipine/Valsartan/Hydrochlorothiazide TecniGen:

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking amlodipine/valsartan/hydrochlorothiazide also at the start of your pregnancy – see section Pregnancy).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medications (medications used to treat chest or urinary tract infections) or to any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, do not take amlodipine/valsartan/hydrochlorothiazide and inform your doctor.

• if you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are on dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels in the blood.
• if your blood calcium levels are too high despite treatment to reduce calcium levels in the blood.
• if you have gout (uric acid crystals in the joints).
• 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 that contains aliskiren.

Do not take Amlodipine/Valsartan/Hydrochlorothiazide TecniGen and inform your doctor if any of the above applies to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipine/valsartan/hydrochlorothiazide

• if you have low potassium or magnesium levels in your blood (with or without symptoms such as muscle weakness, muscle spasms, irregular heartbeat).
• if you have low sodium levels in your blood (with or without symptoms such as fatigue, confusion, muscle contractions, convulsions).
• if you have high calcium levels in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and muscle contractions).
• if you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the arteries to the kidneys.
• if you have liver problems.
• if you have or have had heart failure or coronary heart disease, in particular if you have been prescribed the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).
• if you 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 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 aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of amlodipine/valsartan/hydrochlorothiazide is not recommended.
• if you have a disease called systemic lupus erythematosus (also known as "lupus" or "SLE").
• if you have diabetes (high blood sugar levels).
• if you have high cholesterol or triglyceride levels in your blood.
• if you experience skin reactions such as rash after sun exposure.
• if you have had an allergic reaction to other blood pressure-lowering medications or diuretics, especially if you have asthma and allergies.
• if you have been ill (with vomiting or diarrhea).
• 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/hydrochlorothiazide and contact your doctor immediately.

You should never take amlodipine/valsartan/hydrochlorothiazide again.

• if you experience dizziness and/or fainting during treatment with amlodipine/valsartan/hydrochlorothiazide, inform your doctor as soon as possible.
• if you experience a decrease in vision or eye pain. These can be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to a week after taking amlodipine/valsartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss.
• if you are taking any of the following medications used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking amlodipine/valsartan/hydrochlorothiazide.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking amlodipine/valsartan/hydrochlorothiazide, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking amlodipine/valsartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking amlodipine/valsartan/hydrochlorothiazide 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/Hydrochlorothiazide TecniGen”.

Tell your doctor if any of the above applies to you.

Children and adolescents

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

Older adults (65 years and over)

Amlodipine/valsartan/hydrochlorothiazide can be used in people 65 years and older at the same dose as used in other adults and in the same way as they have already taken the three substances called amlodipine, valsartan, and hydrochlorothiazide. Blood pressure should be checked regularly in older adult patients, particularly those taking the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).

Taking Amlodipine/Valsartan/Hydrochlorothiazide TecniGen with other medications

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

Do not take with:

• lithium (a medication used to treat certain types of depression);
• medications or substances that may increase potassium levels in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin;
• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Amlodipine/Valsartan/Hydrochlorothiazide TecniGen” and “Warnings and precautions”).

Use with caution with:

• alcohol, sleeping pills, and anesthetics (medications for patients undergoing surgery and other procedures);
• amantadine (treatment for Parkinson's disease, also used for treatment or prevention of certain viral diseases);
• anticholinergic medications (medications used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsant medications and mood stabilizers used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances used primarily to treat high lipid levels in the blood);
• simvastatin (a medication used to control high cholesterol levels);
• cyclosporine (a medication used in transplants to prevent organ rejection or for other conditions, e.g., rheumatoid arthritis or atopic dermatitis);
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medications used to treat heart problems);
• verapamil, diltiazem (heart medications);
• iodinated contrast media (agents used in imaging tests);
• medications for treating diabetes (oral medications such as metformin or insulins);
• medications for treating gout, such as allopurinol;
• medications that may increase blood sugar levels (beta-blockers, diazoxide);
• medications that may induce "torsades de pointes" (irregular heartbeat), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics;
• medications that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medications that may reduce potassium levels in the blood, such as diuretics (medications that increase urine production), corticosteroids, laxatives, amphotericin, or penicillin G;
• medications used to increase blood pressure, such as adrenaline or noradrenaline;
• 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 inflammation and ulcers of the esophagus (carbenoxolone);
• medications used to relieve pain or inflammation, especially non-steroidal anti-inflammatory medications (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medications used to relax muscles during surgery);
• nitroglycerin and other nitrates, or other substances called "vasodilators";
• other medications used to treat high blood pressure, including methyldopa;
• rifampicin (used, e.g., to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (in infusion for severe body temperature abnormalities);
• vitamin D and calcium salts.

Taking Amlodipine/Valsartan/Hydrochlorothiazide TecniGen with food, drinks, and alcohol

People who have been prescribed amlodipine/valsartan/hydrochlorothiazide 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 effects of amlodipine/valsartan/hydrochlorothiazide. Consult your doctor before drinking alcohol. Alcohol can significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. In general, your doctor will advise you to stop taking amlodipine/valsartan/hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and recommend that you take another blood pressure-lowering medication instead. Amlodipine/valsartan/hydrochlorothiazide is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it can cause serious harm to your baby when taken from that time on.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. Therefore, you should inform your doctor before taking this medication if you are breastfeeding or plan to start breastfeeding. Amlodipine/valsartan/hydrochlorothiazide is not recommended for use in breastfeeding women. Your doctor may decide to prescribe you a different treatment if you want to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

Like all medications used to treat high blood pressure, this medication may make you feel dizzy, drowsy, nauseous, or have a headache. If you experience these symptoms, do not drive or use tools or machines.

Use in athletes:

This medication contains hydrochlorothiazide, which may produce a positive result in doping tests.

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide TecniGen

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again. This will help you get the best results and reduce the risk of adverse effects.

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

• It is preferable to take the tablet at the same time every day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You can take amlodipine/valsartan/hydrochlorothiazide with or without food. Do not take amlodipine/valsartan/hydrochlorothiazide 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.

If you take more Amlodipine/Valsartan/Hydrochlorothiazide TecniGen than 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 can develop up to 24-48 hours after ingestion.

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide TecniGen

If you forget to take a dose of 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, only take the next tablet at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Amlodipine/Valsartan/Hydrochlorothiazide TecniGen

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

Always take this medication, even if you feel well

People with high blood pressure often do not notice any signs of the disease. Many feel normal. It is very important that you take this medication exactly as your doctor says to get the best results and reduce the risk of adverse effects. Keep your appointments with your doctor, even if you feel well.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

As with any combination containing three active ingredients, the side effects associated with each individual component cannot be excluded. The side effects reported with amlodipine/valsartan/hydrochlorothiazide or any of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are shown below and may occur with the use of this medication.

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

Consult your doctor immediately if you experience any of the following serious side effects after taking this medication.

Common side effects (may affect up to 1 in 10 patients)

• dizziness
• low blood pressure (feeling of fainting, dizziness, sudden loss of consciousness)

Uncommon side effects (may affect up to 1 in 100 patients)

• severe decrease in urine production (decreased renal function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• 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 that include intense skin rash, hives, redness of the skin all over the body, important 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
• pancreas inflammation, which can cause severe abdominal and back pain accompanied by a great feeling of discomfort
• weakness, bruising, fever, and frequent infections
• stiffness
• acute difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion)
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Other side effects may include:

Very common side effects (may affect more than 1 in 10 patients)

• low potassium levels in the blood
• increased lipids in the blood

Common side effects (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeat)
• hot flashes
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, fainting when standing up
• decreased appetite
• nausea and vomiting
• skin rash and itching and other types of rashes
• inability to achieve or maintain an erection

Uncommon side effects (may affect up to 1 in 100 patients)

• rapid heartbeat
• feeling that everything is spinning around
• vision disorder
• stomach discomfort
• chest pain
• increased urea, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• decreased potassium in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• joint swelling
• muscle cramps/weakness/pain
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• altered taste
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• ringing in the ears
• sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of intestinal habits
• indigestion
• hair loss
• skin itching
• skin discoloration
• urination disorder
• increased need to urinate at night
• increased number of times urinating
• discomfort or increase in breast size in men
• pain
• feeling of discomfort
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• sugar in the urine
• high sugar levels in the blood
• worsening of diabetic metabolic condition
• abdominal discomfort
• constipation
• liver alterations that may present with yellowish skin and eyes or dark urine color (hemolytic anemia)
• increased sensitivity of the skin to the sun
• purplish spots on the skin
• kidney alterations
• confusion

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

• decrease in the number of white blood cells
• decrease in blood platelets that can cause unusual bruising or bleeding (damage to red blood cells)
• gum inflammation
• abdominal swelling (gastritis)
• liver inflammation (hepatitis)
• yellowish color of the skin (jaundice)
• increase in liver enzymes that can have an effect on some medical tests
• increase in muscle tension
• inflammation of blood vessels often with skin rashes
• sensitivity to light
• disorders combining stiffness, tremor, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal decrease due to rupture of red blood cells both in blood vessels and in other parts of the body)
• confusion, fatigue, muscle contractions, and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper part of the stomach (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
• severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)

Side effects of unknown frequency (cannot be estimated from available data)

• alteration of kidney function test results in blood, increased potassium in the blood, low red blood cell count
• abnormal red blood cell count
• low levels of a certain type of white blood cells and platelets in the blood
• increased creatinine in the blood
• abnormal liver function test
• significant decrease in urine production
• inflammation of blood vessels
• weakness, bruising, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of kidney disorder or kidney failure)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a disease called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects

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

5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen

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.

This medication does not require special storage conditions.

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

Medications 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 will help protect the environment.

6. Package contents and additional information

Composition of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 5 mg/160 mg/12.5 mg

• The active ingredients are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E-171).

Composition of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/160 mg/12.5 mg

• The active ingredients are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172).

Composition of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 5 mg/160 mg/25 mg

• The active ingredients are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E-171), yellow iron oxide (E-172).

Composition of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/160 mg/25 mg

• The active ingredients are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose; crospovidone (type A); anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, yellow iron oxide (E-172).

Composition of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/320 mg/25 mg

• The active ingredients are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan, and 25 mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose; crospovidone (type A); anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, yellow iron oxide (E-172).

Appearance of the product and package contents

The tablets of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 5 mg/160 mg/12.5 mg are film-coated white, oval, biconvex tablets with the engraving "T23" on one face and smooth on the other.

Height: approximately 15.1 mm, Width: approximately 7.1 mm

The tablets of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/160 mg/12.5 mg are film-coated pale yellow, oval, biconvex tablets with the engraving "C96" on one face and smooth on the other.

Height: approximately 15.6 mm, Width: approximately 6.6 mm

The tablets of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 5 mg/160 mg/25 mg are film-coated yellow, oval, biconvex tablets with the engraving "T25" on one face and smooth on the other.

Height: approximately 15.1 mm, Width: approximately 7.1 mm

The tablets of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/160 mg/25 mg are film-coated yellow-brown, oval, biconvex tablets with the engraving "C97" on one face and smooth on the other.

Height: approximately 15.6 mm, Width: approximately 6.6 mm

The tablets of Amlodipine/Valsartan/Hydrochlorothiazide TecniGen 10 mg/320 mg/25 mg are film-coated yellow-brown, oval, biconvex tablets with the engraving "T98" on one face and smooth on the other.

Height: approximately 19.2 mm, Width: approximately 7.7 mm

Amlodipine/Valsartan/Hydrochlorothiazide TecniGen is available in OPA/AL/PVC blister packs and aluminum foil that contain 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

Portugal

Date of the last revision of this leaflet:February 2025.

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