Prospect: information for the patient

Amlodipino/Valsartán/Hidroclorotiazida TecniGen 5 mg/160 mg/12,5 mg film-coated tablets

Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/160 mg/12,5 mg film-coated tablets

Amlodipino/Valsartán/Hidroclorotiazida TecniGen 5 mg/160 mg/25 mg film-coated tablets

Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/160 mg/25 mg film-coated tablets

Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/320 mg/25 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 only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

5Storage of Amlodipino/Valsartán/Hidroclorotiazida TecniGen

6.Contents of the package and additional information

This medication contains three substances called amlodipino, valsartán and hidroclorotiazida. All these substances help control high blood pressure.

• Amlodipino belongs to a group of substances called «calcium channel blockers». Amlodipino prevents calcium from entering the blood vessel wall, which prevents blood vessels from narrowing.
• Valsartán belongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartán acts by blocking the effect of angiotensin II.
• Hidroclorotiazida belongs to a group of substances called «thiazide diuretics».

Hidroclorotiazida increases urine production, which also lowers blood pressure.

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

Amlodipino/Valsartán/Hidroclorotiazida is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipino, valsartán and hidroclorotiazida and who may benefit from taking a tablet that contains the three substances.

Do not take Amlodipino/Valsartán/Hidroclorotiazida TecniGen:

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking amlodipino/valsartán/hidroclorotiazida also at the beginning of your pregnancy – see Pregnancy section).
• if you are allergic to amlodipino or to any other calcium channel blocker, valsartán, hidroclorotiazida, sulfonamide-derived medications (medications used to treat chest or urinary tract infections) or to any of the other components of this medication (included in section 6).

If you think you may be allergic, do not take amlodipino/valsartán/hidroclorotiazida and inform your doctor.

• if you have liver disease, destruction of the small bile ducts inside 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 undergoing 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 (crystals of uric acid in the joints).
• if you have severe low 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 the body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskiren.

Do not take Amlodipino/Valsartán/Hidroclorotiazida TecniGen and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipino/valsartán/hidroclorotiazida

• if you have low levels of potassium or magnesium in the blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
• if you have low levels of sodium in the blood (with or without symptoms such as fatigue, confusion, muscle contractions, seizures).
• if you have high levels of calcium in the 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 undergone a kidney transplant, or if you have been told that you have a narrowing of the kidney arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, particularly if you have been prescribed the maximum dose of amlodipino/valsartán/hidroclorotiazida (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to start treatment carefully. Your doctor may also check your renal function.
• if your doctor has told you that you have a narrowing of the heart valves (called "aortic or mitral stenosis") or that your heart muscle has become abnormally thickened (called "hypertrophic obstructive cardiomyopathy").
• if you have a condition called aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of amlodipino/valsartán/hidroclorotiazida is not recommended.
• if you have a disease called systemic lupus erythematosus (also known as "lupus" or "LES").
• if you have diabetes (high blood sugar levels).
• if you have high levels of cholesterol or triglycerides in the blood.
• if you experience skin reactions such as sunburn after exposure to the sun.
• if you have had an allergic reaction to other medications for high blood pressure or diuretics, especially if you have asthma and allergies.
• if you have been sick (with vomiting or diarrhea).
• 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/hidroclorotiazida and contact your doctor immediately.

You should never take amlodipino/valsartán/hidroclorotiazida again.

• if you experience dizziness and/or fainting during treatment with amlodipino/valsartán/hidroclorotiazida, inform your doctor as soon as possible.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye and can occur within a few hours to a week after taking amlodipino/valsartán/hidroclorotiazida. 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. The treatment with hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking amlodipino/valsartán/hidroclorotiazida.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking amlodipino/valsartán/hidroclorotiazida, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking amlodipino/valsartán/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking amlodipino/valsartán/hidroclorotiazida in monotherapy.

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

See also the information under the heading "Do not take Amlodipino/Valsartán/Hidroclorotiazida TecniGen".

Inform your doctor if you are affected by any of the cases mentioned.

Children and adolescents

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

Older adults (65 years and older)

Amlodipino/valsartán/hidroclorotiazida 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 amlodipino, valsartán, and hidroclorotiazida. Renal pressure should be checked regularly in elderly patients, particularly those taking the maximum dose of amlodipino/valsartán/hidroclorotiazida (10 mg/320 mg/25 mg).

Use of Amlodipino/Valsartán/Hidroclorotiazida TecniGen with other medications

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 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 the amount of potassium 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 Amlodipino/Valsartán/Hidroclorotiazida 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 to treat or prevent certain diseases caused by viruses);
• anticholinergic medications (medications used to treat various disorders such as gastrointestinal upset, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• colestiramine, colestipol, or other resins (substances used mainly to treat high levels of lipids in the blood);
• simvastatin (a medication used to control high cholesterol levels);
• ciclosporina (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);
• contrast agents and iodinated substances (agents used in imaging tests);
• medications used to treat diabetes (oral medications such as metformin or insulin);
• medications used to treat gout, such as allopurinol;
• medications that may increase blood sugar levels (beta-blockers, diazoxide);
• medications that may induce "torsades de pointes" (irregular heart rhythm), such as antiarrhythmics (medications used to treat heart problems) and certain antipsychotics;
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptic medications;
• medications that may reduce the amount of potassium in the blood, such as diuretics (medications for urination), corticosteroids, laxatives, amphotericin B, 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 esophageal inflammation and ulcers (carbenoxolone);
• medications used to relieve pain or inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors;
• muscle relaxants (medications used to relax muscles during surgery);
• nitroglycerin and other 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.

Use of Amlodipino/Valsartán/Hidroclorotiazida TecniGen with food, drinks, and alcohol

People who have been prescribed amlodipino/valsartán/hidroclorotiazida 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/hidroclorotiazida. Consult your doctor before drinking alcohol. Alcohol may significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

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. Your doctor will usually advise you to stop taking amlodipino/valsartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Amlodipino/valsartán/hidroclorotiazida is not recommended to be taken at the beginning of pregnancy 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. Therefore, inform your doctor before taking this medication if you are or plan to start breastfeeding.Amlodipino/valsartán/hidroclorotiazida is not recommended to be administered to women during this period. Your doctor may decide to administer another 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 operating machinery

As with all medications used to treat high blood pressure, this medication may cause you to feel dizzy, drowsy, nauseous, or experience headaches. If you experience these symptoms, do not drive or operate tools or machines.

Use in athletes:

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

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 recommended dose of amlodipino/valsartán/hidroclorotiazida 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 amlodipino/valsartán/hidroclorotiazida with or without food. Do not take amlodipino/valsartán/hidroclorotiazida 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 Amlodipino/Valsartán/Hidroclorotiazida TecniGen than you should

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.

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 take Amlodipino/Valsartán/Hidroclorotiazida 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 the missed doses.

If you interrupt treatment with Amlodipino/Valsartán/Hidroclorotiazida TecniGen

Stopping your treatment with amlodipino/valsartán/hidroclorotiazida 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 tells you to obtain 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

As with any combination that contains three active principles, the side effects associated with each individual component cannot be excluded. The side effects reported with amlodipino/valsartán/hidroclorotiazida or any of its three active principles (amlodipino, valsartán, and hidroclorotiazida) are listed below and may occur with the use of this medicine.

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

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

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

• dizziness
• low blood pressure (sensation 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 onset of wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that causes severe difficulty breathing
• severe skin reactions that include intense skin rash, urticaria, skin redness all over the body, significant itching, blistering, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• pancreatitis, which can cause severe abdominal and back pain accompanied by a feeling of great discomfort
• weakness, bruises, fever, and frequent infections
• stiffness
• acute respiratory difficulty (the signs include severe breathing difficulty, fever, weakness, and confusion)
• Angioedema intestinal: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Other side effects may include:

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

• low potassium levels in the blood
• increased blood lipids

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

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

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

• rapid heartbeat
• sensation that everything is spinning
• vision disorder
• stomach discomfort
• chest pain
• increase in urea, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• low potassium levels in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of the joints
• muscle cramps/weakness/pain
• pain in the extremities
• difficulty standing or walking normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• irritation of the throat
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• trembling
• mood changes
• anxiety
• depression
• drowsiness
• altered sense of taste
• fainting
• loss of pain sensation
• visual disturbances
• visual deterioration
• ringing in the ears
• runny nose and nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching of the skin
• skin discoloration
• urinary disorders
• increased need to urinate at night
• increased frequency of urination
• breast discomfort or enlargement in men
• pain
• 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 hematoma under the skin)
• azoturia
• high blood sugar
• emergence of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders that may be accompanied by yellow skin and eyes, or dark-colored urine (hemolytic anemia)
• increased skin sensitivity to the sun
• purpuric spots on the skin
• kidney disorders
• confusion

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

• decrease in white blood cell count
• decrease in platelet count in the blood that may cause unusual bruises or easy bleeding (damage to red blood cells)
• gingivitis
• abdominal swelling (gastritis)
• hepatitis
• yellow discoloration of the skin (jaundice)
• increase in liver enzymes that may affect some medical tests
• muscle tension
• inflammation of blood vessels often with skin eruptions
• light sensitivity
• movement disorders combining stiffness, trembling, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• paleness, fatigue, shortness of breath, dark-colored urine (hemolytic anemia, abnormal decrease in red blood cells due to rupture in blood vessels or other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper abdomen (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, red-purple 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 renal function in blood, increase in potassium in the blood, low red blood cell count
• abnormal red blood cell count
• low count of a certain type of white blood cell and platelets in the blood
• increase in creatinine in the blood
• abnormal liver function test
• important decrease in urine production
• inflammation of blood vessels
• weakness, bruises, and frequent infections (aplastic anemia)
• decrease in vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of renal dysfunction or renal insufficiency)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• muscle spasms
• fever (pyrexia)
• bullous dermatitis (sign of a disease called dermatitis bullosa)
• skin cancer 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 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 that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you do not need at the SIGREdisposal point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you do not need. In this way, you will help protect the environment.

Composition of Amlodipino/Valsartán/Hidroclorotiazida TecniGen 5 mg/160 mg/12,5 mg

• The active principles are amlodipino (as amlodipino besilato), valsartán and hidroclorotiazida. Each tablet contains 5 mg of amlodipino (as amlodipino besilato), 160 mg of valsartán and 12,5 mg of hidroclorotiazida.
• The other components are microcrystalline cellulose, crospovidona (type A), anhydrous colloidal silica, magnesium stearate, hypromelosa, macrogol, talco, titanium dioxide (E-171).

Composition of Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/160 mg/12,5 mg

• The active principles are amlodipino (as amlodipino besilato), valsartán and hidroclorotiazida. Each tablet contains 10 mg of amlodipino (as amlodipino besilato), 160 mg of valsartán, and 12,5 mg of hidroclorotiazida.
• The other components are microcrystalline cellulose, crospovidona (type A), anhydrous colloidal silica, magnesium stearate, hypromelosa, macrogol, talco, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172).

Composition of Amlodipino/Valsartán/Hidroclorotiazida TecniGen 5 mg/160 mg/25 mg

• The active principles are amlodipino (as amlodipino besilato), valsartán and hidroclorotiazida. Each tablet contains 5 mg of amlodipino (as amlodipino besilato), 160 mg of valsartán and 25 mg of hidroclorotiazida.
• The other components are microcrystalline cellulose, crospovidona (type A), anhydrous colloidal silica, magnesium stearate, hypromelosa, macrogol, talco, titanium dioxide (E-171), yellow iron oxide (E-172).

Composition of Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/160 mg/25 mg

• The active principles are amlodipino (as amlodipino besilato), valsartán and hidroclorotiazida. Each tablet contains 10 mg of amlodipino (as amlodipino besilato), 160 mg of valsartán, and 25 mg of hidroclorotiazida.
• The other components are microcrystalline cellulose; crospovidona (type A); anhydrous colloidal silica, magnesium stearate, hypromelosa, macrogol, talco, yellow iron oxide (E-172).

Composition of Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/320 mg/25 mg

• The active principles are amlodipino (as amlodipino besilato), valsartán and hidroclorotiazida. Each tablet contains 10 mg of amlodipino (as amlodipino besilato), 320 mg of valsartán, and 25 mg of hidroclorotiazida.
• The other components are microcrystalline cellulose; crospovidona (type A); anhydrous colloidal silica, magnesium stearate, hypromelosa, macrogol, talco, yellow iron oxide (E-172).

Appearance of the product and contents of the package

The Amlodipino/Valsartán/Hidroclorotiazida TecniGen 5 mg/160 mg/12,5 mg tablets are white-coated, oval, biconvex tablets with the imprint «T23» on one face and smooth on the other.

Height: approximately 15.1 mm, Width: approximately 7.1 mm

The Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/160 mg/12,5 mg tablets are pale yellow-coated, oval, biconvex tablets with the imprint «C96» on one face and smooth on the other.

Height: approximately 15.6 mm, Width: approximately 6.6 mm

The Amlodipino/Valsartán/Hidroclorotiazida TecniGen 5 mg/160 mg/25 mg tablets are yellow-coated, oval, biconvex tablets with the imprint «T25» on one face and smooth on the other.

Height: approximately 15.1 mm, Width: approximately 7.1 mm

The Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/160 mg/25 mg tablets are yellow-brown-coated, oval, biconvex tablets with the imprint «C97» on one face and smooth on the other.

Height: approximately 15.6 mm, Width: approximately 6.6 mm

The Amlodipino/Valsartán/Hidroclorotiazida TecniGen 10 mg/320 mg/25 mg tablets are yellow-brown-coated, oval, biconvex tablets with the imprint «T98» on one face and smooth on the other.

Height: approximately 19.2 mm, Width: approximately 7.7 mm

Amlodipino/Valsartán/Hidroclorotiazida TecniGen is available in packages with OPA/AL/PVC blisters and aluminum foil containing 28 tablets.

Marketing authorization holder and responsible for manufacturing

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

Responsible for manufacturing

Tecnimede - Sociedade Tecnico-medicinal, S.a.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Last review date of this leaflet:February 2025.

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