AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE COMBIX 5 mg/160 mg/25 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 medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. Contents of the pack and further information

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

Amlodipine/Valsartan/Hydrochlorothiazide Combix film-coated tablets contain three active substances called amlodipine, valsartan, and hydrochlorothiazide. All these substances help to 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, which prevents the blood vessels from narrowing.
• Valsartan belongs to a group of substances known as "angiotensin II receptor blockers". Angiotensin II is produced by the body and causes the blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the action 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, the 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 more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine also at the start of your pregnancy - see section Pregnancy).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medicines (medicines used to treat chest or urinary tract infections), or any of the other ingredients 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 (biliary cirrhosis) leading to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are on dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase blood potassium or sodium levels.
• 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 situation where your heart is unable to supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• if you have low blood potassium or magnesium levels (with or without symptoms such as muscle weakness, muscle spasms, irregular heartbeat).
• if you have low blood sodium levels (with or without symptoms such as tiredness, confusion, muscle contractions, convulsions).
• if you have high blood calcium levels (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 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, in particular 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 start taking the medicine carefully. Your doctor may also check your kidney function.
• if your doctor has told you that you have 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 have aldosteronism, a disease in which the adrenal glands produce too much of the hormone aldosterone. In this case, the use of this medicine 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 the blood.
• if you experience skin reactions such as a rash after exposure to the sun.
• if you have had an allergic reaction to other blood pressure-lowering medicines or diuretics, especially if you have asthma and allergies.
• if you have been ill (with vomiting or diarrhea).
• if you have experienced swelling, particularly in the face and throat, while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking this medicine and contact your doctor immediately. You should 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 an increase in pressure in the eye, and can occur within hours to weeks after taking this medicine. If left untreated, this can lead to permanent vision loss. 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 medicines used to treat high blood pressure:

• an 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, in particular 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 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 experience shortness of breath or severe difficulty breathing after taking Amlodipine/Valsartan/Hydrochlorothiazide Combix, seek medical attention immediately.

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

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

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

Children and adolescents

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

Older people (65 years and over)

This medicine 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 older patients should be monitored regularly, particularly those taking the maximum dose of Amlodipine/Valsartan/Hydrochlorothiazide Combix (10 mg/320 mg/25 mg).

Using Amlodipine/Valsartan/Hydrochlorothiazide Combix with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to change your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important if you are using any of the following medicines:

Do not take 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 salt substitutes that contain potassium, potassium-sparing medicines, 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 (medicines for patients who are going to have an operation and other procedures);
• amantadine (treatment for Parkinson's disease, also used to treat or prevent certain viral diseases);
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsant medicines and mood stabilizers used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances used mainly to treat high lipid levels in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in transplants 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 media (agents used in imaging procedures);
• medicines for treating diabetes (oral medicines such as metformin or insulins);
• medicines for treating gout, such as allopurinol;
• medicines that can increase blood sugar levels (beta-blockers,

diazoxide);

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

• medicines that can reduce blood sodium levels, such as antidepressants,

antipsychotics, antiepileptics;

• medicines that can reduce blood potassium levels, such as diuretics (medicines that increase urine production), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines used 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 to treat inflammation and ulcers of the esophagus (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines used to relax muscles during operations);
• 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 (in infusion for severe body temperature abnormalities);
• vitamin D and calcium salts.

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

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

This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of this medicine. Consult your doctor before drinking alcohol. Alcohol can 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 doctorbefore taking this medicine. Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another blood pressure-lowering medicine instead. This medicine is not recommended during the first trimester of pregnancy and should not be used 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 already breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts. This medicine is not recommended for women during breastfeeding. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

As with other medicines used to treat high blood pressure, this medicine may make you feel dizzy, sleepy, nauseous, or give you a headache. If you experience these symptoms, do not drive or use tools or machines.

Use in athletes

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

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Combix

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

The normal dose of Amlodipine/Valsartan/Hydrochlorothiazide Combix is one tabletper day.

• 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 can accumulate in the lungs (pulmonary edema) causing difficulty breathing, which 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 forgotten doses.

If you interrupt treatment withAmlodipine/Valsartan/Hydrochlorothiazide Combix

Stopping your treatment with this medication may cause your illness 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 containing 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 can 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, significant 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 common (may affect more than 1 in 10 patients)

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

Common (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeat)
• hot flashes
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, 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
• swelling of the joints
• 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
• runny nose/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 bruising under the skin)
• sugar in the urine
• high blood sugar levels
• 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 can have an effect on some medical tests
• increase in muscle tension
• inflammation of blood vessels often with skin rashes
• sensitivity to light
• disorders combining stiffness, tremor, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal decrease due to rupture of red blood cells both in blood vessels and in other parts of the body)
• confusion, fatigue, muscle contractions, and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper part of the stomach (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 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 the 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 Healthcare 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 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 way, you 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 components 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, yellow-brown, 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, yellow-brown, 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.

Badajoz Street 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Synoptis Industrial Sp. z o.o.

Rabowicka Street 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,

De la letra C Street, 12-14,

Zona Franca Industrial Park,

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 Healthcare Products (AEMPS) (http://www.aemps.gob.es/)