Valotensix Plus 5 mg/160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package Leaflet: Information for the Patient

Valotensix Plus 5 mg/160 mg/12.5 mg film-coated tablets EFG

Valotensix Plus 10 mg/160 mg/12.5 mg film-coated tablets EFG

Valotensix Plus 5 mg/160 mg/25 mg film-coated tablets EFG

Valotensix Plus 10 mg/160 mg/25 mg film-coated tablets EFG

Valotensix Plus 10 mg/320 mg/25 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Valotensix Plus is and what it is used for
2. What you need to know before taking Valotensix Plus
3. How to take Valotensix Plus
4. Possible side effects
5. How to store Valotensix Plus
6. Contents of the pack and other information

1. What is Valotensix Plus and what is it used for?

This medicine contains three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help control high blood pressure.

• Amlodipine belongs to a group of substances known as «calcium channel blockers». Amlodipine prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing.
• Valsartan belongs to a group of substances known as «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thus increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances known as «thiazide diuretics».

Hydrochlorothiazide increases urine production, which also lowers blood pressure.

As a result of these three mechanisms, 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 may benefit from taking a single tablet containing the three substances.

2. What you need to know before starting Valotensix Plus

Do not take Valotensix Plus:

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking amlodipine/valsartan/hydrochlorothiazide also at the beginning of your pregnancy – see section Pregnancy).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medicines (medicines 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 (primary biliary cirrhosis), leading to accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or 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 blood calcium levels.
• 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 condition in which your heart cannot supply enough blood to the body).
• if you have heart failure following a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Valotensix Plus and inform your doctor if any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting amlodipine/valsartan/hydrochlorothiazide

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).
• if you have low levels of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, seizures).
• if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and muscle twitching).
• 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 artery disease, particularly 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 carefully when starting treatment. Your doctor may also monitor 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 abnormally increased (called "obstructive hypertrophic cardiomyopathy").
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, 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 exposure to sunlight.
• if you have had an allergic reaction to other high blood pressure medicines or diuretics, especially if you have asthma and allergies.
• if you have been ill (with vomiting or diarrhea).
• if you experience swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme [ACE] inhibitors). If you have these symptoms, stop taking amlodipine/valsartan/hydrochlorothiazide and contact your doctor immediately.

You must 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 vision changes or eye pain. These may be symptoms of fluid buildup in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking amlodipine/valsartan/hydrochlorothiazide. If left untreated, this may lead to permanent vision loss.
• if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 exposure to sunlight and UV rays while taking amlodipine/valsartan/hydrochlorothiazide.
• if you have had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking amlodipine/valsartan/hydrochlorothiazide, seek medical attention immediately.

Contact 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 monotherapy on your own.

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

See also the information under the heading “Do not take Valotensix Plus.”

Inform your doctor if any of the above conditions apply to you.

Children and adolescents

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

Elderly (65 years and older)

Amlodipine/valsartan/hydrochlorothiazide can be used in patients aged 65 years and older at the same dose as in other adults, and in the same manner as they have previously taken the three individual substances amlodipine, valsartan, and hydrochlorothiazide. Blood pressure should be monitored periodically in elderly patients, particularly those taking the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).

Taking Valotensix Plus with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust your dose and/or take additional precautions.

In some cases, you may need to stop taking one of the medicines. This is especially important if you are taking any of the following medicines:

Do not take together with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Valotensix Plus” and “Warnings and precautions”).

Use with caution with:

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

Taking Valotensix Plus with food, drinks, and alcohol

Patients prescribed amlodipine/valsartan/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of amlodipine/valsartan/hydrochlorothiazide. Consult your doctor before drinking alcohol. Alcohol may greatly 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 medicine. Your doctor will generally advise you to stop taking amlodipine/valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Amlodipine/valsartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. Therefore, inform your doctor if you are breastfeeding or planning to breastfeed. Amlodipine/valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Like all medicines used to treat high blood pressure, this medicine may make you feel dizzy, drowsy, nauseous, or give you a headache. If you experience these symptoms, do not drive or operate tools or machinery.

Use in athletes:

This medicine contains hydrochlorothiazide, which may result in a positive test in doping controls.

3. How to take Valotensix Plus

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor again. This will help you achieve the best results and reduce the risk of adverse effects.

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

• It is preferable to take the tablet at the same time each day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You may 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 Valotensix Plus than you should

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

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

If you forget to take Valotensix Plus

If you forget to take a dose of this medicine, take it as soon as you remember. Then take the next dose at your usual time. However, if it is almost time for your next dose, you should only take the next tablet at your usual time. Do not take a double dose to make up for missed doses.

If you stop taking Valotensix Plus

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

Always take this medicine, even if you feel well

People with high blood pressure often do not notice any symptoms of the disease. Many feel completely normal. It is very important that you take this medicine exactly as directed by your doctor to achieve the best results and reduce the risk of adverse effects. Keep your doctor's appointments, even if you feel well.

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

4. Possible adverse effects

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

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

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

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

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

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

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

• severe decrease in urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

Very rare adverse 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 causing severe difficulty breathing
• severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• inflammation of the pancreas, which may cause severe abdominal and back pain accompanied by a strong feeling of malaise
• weakness, bruising, fever and frequent infections
• stiffness
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion)
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Other adverse effects may include:

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

• low blood potassium levels
• increased blood lipids

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

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

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

• rapid heartbeat
• sensation of spinning (vertigo)
• vision disorders
• stomach discomfort
• chest pain
• increased blood urea nitrogen, creatinine and uric acid levels
• high blood calcium, lipid or sodium levels
• decreased blood potassium levels
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of joints
• muscle cramps/weakness/muscle pain
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness upon standing or after exercise
• low energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden transient loss of consciousness
• low blood pressure upon standing
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness and pain along a vein
• redness of the skin
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• ringing in the ears (tinnitus)
• sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• changes in bowel habits
• indigestion
• hair loss
• skin itching
• skin discoloration
• urinary disorders
• increased need to urinate at night
• increased frequency of urination
• discomfort or enlargement of the breasts in men
• pain
• feeling unwell
• weight loss

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

• low blood platelet count (sometimes with bleeding or bruising under the skin)
• sugar in the urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders which may present with yellowing of the skin and eyes or dark-colored urine (hemolytic anemia)
• increased sensitivity of the skin to sunlight
• purplish spots on the skin
• kidney disorders
• confusion

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

• decreased number of white blood cells
• decreased blood platelets which may cause unusual bruising or easy bleeding (damage to red blood cells)
• inflammation of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowish discoloration of the skin (jaundice)
• increased liver enzymes which may affect certain medical tests
• increased muscle tension
• inflammation of blood vessels often accompanied by skin rashes
• light sensitivity
• 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 breakdown of red blood cells both in blood vessels and other parts of the body)
• confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloremic alkalosis)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)

Adverse effects with unknown frequency (cannot be estimated from available data)

• alteration in blood test results for kidney function, increased blood potassium levels, low red blood cell count
• abnormal red blood cell count
• low levels of certain types of white blood cells and platelets in blood
• increased blood creatinine
• abnormal liver function test
• marked decrease in urine production
• inflammation of blood vessels
• weakness, bruising and frequent infections (aplastic anemia)
• decreased vision or eye pain due to elevated 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 causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a condition called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valotensix Plus

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valotensix Plus 5 mg/160 mg/12.5 mg

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

Composition of Valotensix Plus 10 mg/160 mg/12.5 mg

• The active substances are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each tablet contains 10 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• Other components: 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 Valotensix Plus 5 mg/160 mg/25 mg

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

Composition of Valotensix Plus 10 mg/160 mg/25 mg

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

Composition of Valotensix Plus 10 mg/320 mg/25 mg

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

Presentation of the product and contents of the pack

Valotensix Plus 5 mg/160 mg/12.5 mg tablets are film-coated white, oval, biconvex tablets, engraved with "T23" on one side and smooth on the other.

Height: approximately 15.1 mm, Width: approximately 7.1 mm.

Valotensix Plus 10 mg/160 mg/12.5 mg tablets are film-coated pale yellow, oval, biconvex tablets, engraved with "C96" on one side and smooth on the other.

Height: approximately 15.6 mm, Width: approximately 6.6 mm.

Valotensix Plus 5 mg/160 mg/25 mg tablets are film-coated yellow, oval, biconvex tablets, engraved with "T25" on one side and smooth on the other.

Height: approximately 15.1 mm, Width: approximately 7.1 mm.

Valotensix Plus 10 mg/160 mg/25 mg tablets are film-coated yellow-brown, oval, biconvex tablets, engraved with "C97" on one side and smooth on the other.

Height: approximately 15.6 mm, Width: approximately 6.6 mm.

Valotensix Plus 10 mg/320 mg/25 mg tablets are film-coated yellow-brown, oval, biconvex tablets, engraved with "T98" on one side and smooth on the other.

Height: approximately 19.2 mm, Width: approximately 7.7 mm.

Valotensix Plus is available in packs with OPA/AL/PVC blisters and aluminum foil containing 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 most recent revision of this leaflet: February 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/