AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE COMBIX 10 mg/160 mg/12.5 mg FILM-COATED TABLETS

Introduction

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 starting to take this medication, as it contains important information for you.

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

Contents of the leaflet

1. What is Amlodipine/Valsartan/Hydrochlorothiazide Combix and what is it 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 Preservation of Amlodipine/Valsartan/Hydrochlorothiazide Combix

1. Package contents and additional information

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

Amlodipine/Valsartan/Hydrochlorothiazide Combix film-coated tablets contain three substances called amlodipine, valsartan, and hydrochlorothiazide. All these substances help 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 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 the 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 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 pregnant for more than 3 months. (In any case, it is recommended to avoid taking this medication 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 medications (medications used to treat chest or urinary tract infections), or any of the other components of this medication (listed in section 6).

If you think you may be allergic, do not take this medication 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 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 (uric acid crystals 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 failure and are being treated with a blood pressure medication that contains aliskiren.

Do not take Amlodipine/Valsartan/Hydrochlorothiazide Combixand 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 this medication

• if you have low potassium or magnesium levels in the blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
• if you have low sodium levels in the blood (with or without symptoms such as fatigue, confusion, muscle contractions, convulsions).
• if you have high calcium levels in the blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle contractions, and muscle weakness).
• if you have kidney problems, have undergone a kidney transplant, or have been informed that you have a narrowing of the arteries of the kidney.
• 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 to carefully start dosing. Your doctor may also check your kidney function.
• if your doctor has informed you that you have a narrowing of the heart valves (so-called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (so-called "hypertrophic cardiomyopathy").
• if you suffer from aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of this medication is not recommended.
• if you suffer from 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 the blood.
• if you experience skin reactions such as rash after sun exposure.
• if you have had an allergic reaction to other blood pressure medications or diuretics, especially if you suffer from 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 this medication and contact your doctor immediately. You should never take this medication again.
• if you experience dizziness and/or fainting during treatment with this medication, 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 an increase in pressure in the eye and can occur between hours and weeks after taking this medication. If left untreated, this can cause permanent vision impairment. You may be at greater risk of developing this if you have previously had an allergy to penicillin or sulfonamides.
• 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking this medication.
• 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 Combix, seek medical attention immediately.

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

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

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

Children and adolescents

The use of this medication is not recommended in children and adolescents under 18 years of age.

Elderly people (65 years and older)

This medication 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. The blood pressure of elderly patients should be monitored periodically, particularly those taking the maximum dose of Amlodipine/Valsartan/Hydrochlorothiazide Combix (10 mg/320 mg/25 mg).

Use of Amlodipine/Valsartan/Hydrochlorothiazide Combix with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. Your doctor may need to modify 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 Combix" and "Warnings and precautions").

Should be used with caution with:

• alcohol, sleeping pills, and anesthetics (medications for patients who are going to undergo surgery and other procedures);
• amantadine (treatment for Parkinson's disease, also used to treat or prevent 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 procedures);
• medications for treating diabetes (oral medications such as metformin or insulins);
• medications for treating gout, such as allopurinol;
• medications that can increase blood sugar levels (beta-blockers,

diazoxide);

• medications that can induce "torsades de pointes"(irregular heartbeat), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics;

• medications that can reduce sodium levels in the blood, such as antidepressants,

antipsychotics, antiepileptics;

• medications that can 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, for example, to treat tuberculosis), erythromycin, clarithromycin

(antibiotics);

• St. John's Wort;
• dantrolene (in infusion for severe body temperature anomalies);
• vitamin D and calcium salts.

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

People who have been prescribed this medication should not consume grapefruit or grapefruit juice.

This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effects of this medication. 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 doctorbefore using this medication. Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you become pregnant and recommend taking another anti-hypertensive medication instead. This medication is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctorif you are about to start or are breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. This medication is not recommended for women during breastfeeding. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

As with other 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 hydrochlorothiazidewhich may produce a positive result in doping tests

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Combix

Follow exactly the administration instructions of this medication 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 normal dose of Amlodipine/Valsartan/Hydrochlorothiazide Combix is one tabletper day.

• It is best 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 this medication with or without food. Do not take this medication 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 moreAmlodipine/Valsartan/Hydrochlorothiazide Combixthan you should

If you have accidentally taken too many tablets of this medication, consult your doctor immediately. You may need medical attention.

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

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

If you forget to takeAmlodipine/Valsartan/Hydrochlorothiazide Combix

If you forget to take a dose of this medication, take it as soon as you remember and then take the next dose at the usual time. If it is almost time for the next dose, only take the next tablet at the usual time. Do nottake a double dose (two tablets at the same time) to make up for missed doses.

If you interrupt treatment withAmlodipine/Valsartan/Hydrochlorothiazide Combix

Interrupting your treatment with this medication may cause your disease to worsen. Do not stop taking the medication unless your doctor tells you to.

Always take this medication, even if you feel well

Hypertensive people often do not notice any symptoms of their problem. Many feel well. It is very important that you take this medication exactly as your doctor has indicated 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.

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

As with any combination that contains three active ingredients, the adverse effects associated with each individual component cannot be excluded. The adverse effects observed with this medication or one of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur with the use of this medication.

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

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

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

• dizziness
• low blood pressure (feeling of fainting, 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 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 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
• inflammation of the pancreas that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort
• weakness, bruising, fever, and frequent infections
• stiffness
• difficulty breathing (the signs include severe difficulty breathing, fever, weakness, and confusion).

Other adverse effects may include:

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

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

Frequent (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeats)
• 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, dizziness when standing up
• 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
• 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
• cramps/weakness/pain in the muscles
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercising
• 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
• redness of the skin
• 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 bowel habits
• indigestion
• hair loss
• itching of the skin
• 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 (may affect up to 1 in 1,000 patients)

• low platelet count in the blood (sometimes with bleeding or hematoma under the skin)
• sugar in the urine
• high sugar levels in the blood
• worsening of diabetic metabolic condition
• abdominal discomfort
• constipation
• liver disorders 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 disorders
• confusion

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

• decrease in the number of white blood cells in the blood
• decrease in blood platelets that can cause unusual bruising or easy bleeding (damage to red blood cells)
• inflammation of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowish color of the skin (jaundice)
• increase in liver enzymes that may 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 (inflammation of the pancreas)
• 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, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)

Frequency not known (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 eye 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, peeling of the skin, 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide Combix

Keep this medication out of sight and reach of children.

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

Do not store at a temperature above 30°C

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

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection 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

The active ingredients of Amlodipine/Valsartan/Hydrochlorothiazide are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide.

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

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

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

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

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

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

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

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

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

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

The other ingredients are:

Microcrystalline cellulose

Crospovidone

Colloidal silicon dioxide

Magnesium stearate

Hypromellose 6 cPs

Macrogol 4000

Talc

Titanium dioxide (E171) (only 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 only)

Red iron oxide (E172) (only 10 mg/160 mg/12.5 mg film-coated tablets)

Yellow iron oxide (E172) (only 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 package contents

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

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

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

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

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

The following formats are available: boxes with blisters of 14, 28, 56, and 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Combix Laboratories, 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

Netherlands

or

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

or

Laboratori FUNDACIO DAU,

C/ De la letra C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spain

Date of the last revision of thisleaflet:January 2022

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/)