Amlodipine/valsartan/hydrochlorothiazide Combix 10 mg/160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

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

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

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

amlodipine/valsartan/hydrochlorothiazide

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Amlodipine/Valsartan/Hydrochlorothiazide Combix tablets contain 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, thereby 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 Combix is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide separately, and who may benefit from taking a single tablet containing the three substances.

2. What you need to know before taking Amlodipine/Valsartan/Hydrochlorothiazide Combix

Do not take Amlodipine/Valsartan/Hydrochlorothiazide Combix

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine also during early pregnancy – see Pregnancy section).
• 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 components of this medicine (listed in section 6).

If you think you may be allergic, do not take this medicine and inform your doctor.

• if you have liver disease, destruction of the small bile ducts within the liver (primary biliary cirrhosis) leading to bile accumulation 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 Amlodipine/Valsartan/Hydrochlorothiazide Combix and inform your doctor if any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine

• 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 twitching, and muscle weakness).

• if you have kidney problems, have had a kidney transplant, or have been told you have 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 Amlodipine/Valsartan/Hydrochlorothiazide Combix (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 check your kidney function.

• if your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or abnormal thickening of your heart muscle (called "hypertrophic obstructive cardiomyopathy").

• if you have hyperaldosteronism. A condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of this medicine is not recommended.

• if you have systemic lupus erythematosus (also known as "lupus" or "SLE").

• if you have diabetes (high blood sugar).

• 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 develop swelling, particularly in the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking this medicine and contact your doctor immediately. You must never take this medicine again.

• if you experience dizziness and/or fainting during treatment with this medicine, inform your doctor as soon as possible.

• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking this medicine. If left untreated, this may lead to permanent vision loss. You may be at higher risk of developing this if you previously had an allergy to penicillin or sulfonamides.

• if you are taking any of the following medicines for high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV rays while taking this medicine.

• if you have had respiratory 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 Combix, see your doctor immediately.

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

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 monotherapy without medical advice.

See also information under the heading “Do not take Amlodipine/Valsartan/Hydrochlorothiazide Combix”.

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

Children and adolescents

Use of this medicine is not recommended in children and adolescents under 18 years of age.

Elderly people (65 years and older)

This medicine can be used in people aged 65 years and older at the same dose as in other adults, and in the same way as they would have 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 Combix (10 mg/320 mg/25 mg).

Taking Amlodipine/Valsartan/Hydrochlorothiazide Combix with other medicines

Tell 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 other 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:

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 Amlodipine/Valsartan/Hydrochlorothiazide Combix” and “Warnings and precautions”).

Should be used 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 to treat or prevent certain viral illnesses);
• 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);
• anticonvulsants and mood stabilizers 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);
• cyclosporine (a medicine used in organ transplantation 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 diabetes (oral medicines such as metformin or insulin);
• medicines for gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (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 esophageal inflammation and ulceration (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, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (intravenous use for severe body temperature abnormalities);
• tacrolimus (used to control the body’s immune response, allowing acceptance of transplanted organs);
• vitamin D and calcium salts.

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

People prescribed this medicine 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 cause an unpredictable increase in the blood pressure-lowering effect of this medicine. 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 before using this medicine. Generally, your doctor will advise you to stop taking this medicine before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Use of this medicine is not recommended during early pregnancy, and in no case should it be administered from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. Administration of this medicine is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if the infant is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

As with other 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 lead to a positive result in doping tests.

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Combix

Follow exactly the administration instructions for this medicine as 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 usual dose of Amlodipine/Valsartan/Hydrochlorothiazide Combix is one tablet daily.

• It is best to take the tablet at the same time each day. The optimal time is in the morning.
• Swallow the tablet whole with a glass of water.
• You may take this medicine with or without food. Do not take this medicine with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may recommend a higher or lower dose.

Do not exceed the prescribed dose.

If you take more Amlodipine/Valsartan/Hydrochlorothiazide Combix than you should

If you have accidentally taken too many tablets of this medicine, contact your doctor immediately. You may require medical attention.

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

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.

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide Combix

If you forget to take a dose of this medicine, take it as soon as you remember, and then take the next dose at your usual time. If it is almost time for your next dose, you should only take the next tablet at the usual time. Do not take a double dose (two tablets at once) to make up for missed doses.

If you stop taking Amlodipine/Valsartan/Hydrochlorothiazide Combix

Stopping your treatment with this medicine may cause your condition to worsen. Do not stop taking the 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 their condition. Many feel fine. It is very important that you take this medicine exactly as prescribed by your doctor to achieve the best results and reduce the risk of adverse effects. Continue attending 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 ruled out. The adverse effects observed with this medicine or one 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, after taking this medicine, you experience any of the following serious adverse effects:

Common (may affect up to 1 in 10 patients):

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

Uncommon (may affect up to 1 in 100 patients):

• decreased urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• sudden whistling sound when breathing (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 severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)
• heart attack
• inflammation of the pancreas that may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise
• weakness, bruising, fever, and frequent infections
• stiffness

Other adverse effects may include:

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

• low blood potassium levels
• increased blood lipids

Common (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
• high blood uric acid levels
• low blood magnesium levels
• low blood sodium levels
• dizziness, dizziness upon standing
• decreased appetite
• nausea and vomiting
• itchy rash and other types of rash
• inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 patients)

• rapid heartbeat
• sensation of spinning
• vision disorder
• 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 taste sensation
• back pain
• joint swelling
• muscle cramps/weakness/muscle pain
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness upon standing or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden and 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
• 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 of malaise
• weight loss

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

• low blood platelet count (sometimes with bleeding or bruising under the skin)
• sugar in 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
• purpuric skin spots
• kidney disorders
• confusion

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

• decreased number of white blood cells in the blood
• decreased blood platelets which may cause unusual bruising or easy bleeding (damage to red blood cells)
• gum inflammation
• 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 with 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 decrease due to rupture of red blood cells in blood vessels and other body parts)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper abdomen (pancreatic inflammation)
• 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 causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• abnormal 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 the blood
• increased blood creatinine
• 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 intraocular 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 kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Amlodipine/Valsartan/Hydrochlorothiazide Combix

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Do not use any packaging that is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be returned to the SIGRE point at your pharmacy. If you are unsure, 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

The active substances in Amlodipine/Valsartan/Hydrochlorothiazide are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide.

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

Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

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

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

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

Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 25 mg of hydrochlorothiazide.

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

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 25 mg of hydrochlorothiazide.

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

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 320 mg of valsartan and 25 mg of hydrochlorothiazide.

The other components are:

Microcrystalline cellulose
Crospovidone
Colloidal silicon dioxide
Magnesium stearate
Hypromellose 6 cPs
Macrogol 4000
Talc
Titanium dioxide (E171) (only in 5 mg/160 mg/12.5 mg film-coated tablets, 10 mg/160 mg/12.5 mg film-coated tablets, 5 mg/160 mg/25 mg tablets)
Red iron oxide (E172) (only in 10 mg/160 mg/12.5 mg film-coated tablets)
Yellow iron oxide (E172) (only in 10 mg/160 mg/12.5 mg film-coated tablets, 5 mg/160 mg/25 mg film-coated tablets, 10 mg/160 mg/25 mg film-coated tablets, 10 mg/320 mg/25 mg film-coated tablets)

Appearance of the product and contents of the pack

Amlodipine/Valsartan/Hydrochlorothiazide Combix 5 mg/160 mg/12.5 mg film-coated tablets EFG are biconvex, oval, white tablets, marked with “T23” on one side and smooth on the other.

Amlodipine/Valsartan/Hydrochlorothiazide Combix 5 mg/160 mg/25 mg film-coated tablets EFG are biconvex, oval, yellow tablets, marked with “T25” on one side and smooth on the other.

Amlodipine/Valsartan/Hydrochlorothiazide Combix 10 mg/160 mg/12.5 mg film-coated tablets EFG are biconvex, oval, pale yellow tablets, marked with “C96” on one side and smooth on the other.

Amlodipine/Valsartan/Hydrochlorothiazide Combix 10 mg/160 mg/25 mg film-coated tablets EFG are biconvex, oval, brown-yellow tablets, marked with “C97” on one side and smooth on the other.

Amlodipine/Valsartan/Hydrochlorothiazide Combix 10 mg/320 mg/25 mg film-coated tablets EFG are biconvex, oval, brown-yellow tablets, marked with “T98” on one side and smooth on the other.

Available pack sizes: boxes with 14, 28, 56 and 98 film-coated tablets in blister packs.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.
C/ Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain

Manufacturer

Synoptis Industrial Sp. z o.o
ul. Rabowicka 15, Swarzedz,
62-020, Poland

or

Focus Care Pharmaceuticals B.V.
Westzijde 416, 1506 GM Zaandam
The Netherlands

or

Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nuremberg
Germany

or

Laboratori FUNDACIO DAU,
C/ De la letra C, 12-14,
Poligono Industrial de la Zona Franca,
08040 Barcelona,
Spain

Date of latest revision of the package leaflet: December 2025

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