Leaflet: information for the user

Valsartan/Hydrochlorothiazide Combix320 mg/12.5 mgfilm-coated tablets

Read this leaflet carefully before you start taking the medicinebecause 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 pharmacistor nurse.

-This medicine has been prescribedonlyfor you. Do not pass it on to others even if their symptoms are the sameas yours, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacisteven if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Valsartan/Hydrochlorothiazide Combix

3.How to take Valsartan/Hydrochlorothiazide Combix

4.Possible side effects

5.Storage of Valsartan/Hydrochlorothiazide Combix

6.Contents of the pack and additional information

Valsartan/Hidroclorotiazida Combixfilm-coated tablets contain two active ingredients known as valsartan and hidroclorotiazida. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medications known as “angiotensin II receptor antagonists” that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Valsartan acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hidroclorotiazidabelongs to a class of medications known as thiazide diuretics. Hidroclorotiazida increases diuresis, which also decreases blood pressure.

Valsartan/Hidroclorotiazida Combix is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not takeValsartán/Hidroclorotiazida Combix

• If you are allergic (hypersensitive) to valsartan, hidroclorotiazida, sulfonamide derivatives (chemical substances related to hidroclorotiazida) or any of the other components ofValsartán/Hidroclorotiazida Combix,
• This medication contains soy lecithin. Do not use if you are allergic to peanuts or soy.
• Valsartán/hidroclorotiazidaif you aremore than 3 months pregnant. (In any case, it is better to avoid taking this medication also at the beginning of your pregnancy-see Pregnancy section),
• If you have a severe liver disease,
• If you have a severe kidney disease,
• If you are unable to urinate,
• If you are undergoing dialysis,
• If you have low levels of potassium or sodium in your blood, or if your calcium levels in your blood are higher than normal despite treatment,
• If you have gout.
• If you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskirén.

If any of these situations affect you, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to takeValsartán/Hidroclorotiazida Combix

• If you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly control your potassium levels
• If you have low levels of potassium in your blood
• If you experience severe diarrhea or vomiting
• If you are taking high doses of a diuretic
• If you have a severe heart disease
• If you have a narrowing of the renal artery
• If you have recently undergone a kidney transplant
• If you have primary aldosteronisma disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartán/Hidroclorotiazida Combix is not recommended
• If you have kidney or liver disease
• If you have fever, skin rash and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease)
• If you have diabetes, gout, high levels of cholesterol or lipids in your blood
• If you have previously experienced an allergic reaction with the use of another medication of this class to reduce blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma
• 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.
• Aliskirén.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartán/Hidroclorotiazida Combix.
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking Valsartán/Hidroclorotiazida Combix.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you present dyspnea or severe difficulty breathing after taking Valsartán/Hidroclorotiazida, seek medical attention immediately.

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

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

See also the information under the heading “Do not take Valsartán/Hidroclorotiazida Combix”.

Valsartán/hidroclorotiazida may cause increased sensitivity to the sun.

Use in children and adolescents

It is not recommended to use Valsartán/hidroclorotiazida in children and adolescents (under 18 years).

If you are pregnant, if you suspect you may be pregnant or if you plan to become pregnant, inform your doctor. Generally, your doctor will advise you to stop takingValsartán/Hidroclorotiazida Combixbefore becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán/Hidroclorotiazida Combix is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that time.

Use in athletes:

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

Interaction ofValsartán/Hidroclorotiazida Combixwith other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

The effect of treatment with Valsartán/Hidroclorotiazida Combix may be altered if taken with certain medications.Possible modifications to your dose and/or other precautions may be necessary.o, in some cases, discontinue treatment with one of the medications. This is especially applicable to the following medications:

• Lithium, a medication used to treat certain types of psychiatric disorders
• Medications that may affect or be affected by potassium levels, such as digoxin, a medication to control heart rhythm, some antipsychotics
• Medications that may increase potassium levels, such as potassium-sparing medications, heparin
• Medications that may decrease potassium levels in the blood, such as corticosteroids, some laxatives
• Diuretics (medications to urinate), Medications to treat gout, such as allopurinol, vitamin D therapy and calcium supplements, medications to treat diabetes (oral antidiabetics or insulin)
• Other medications to reduce blood pressure, such as beta-blockers or methyldopa,an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskirén (see also the information under the headings “Do not take Valsartán/Hidroclorotiazida Combix” and “Warnings and precautions”).
• Medications that constrict your blood vessels or stimulate your heart, such as norepinephrine or adrenaline
• Medications to increase blood sugar levels, such as diazoxide
• Medications to treat cancer, such as methotrexate or cyclophosphamide
• Medications for pain
• Medications for arthritis
• Muscle relaxants, such as tubocurarine
• Anticholinergic medications, such as atropine or biperiden
• Amantadine (a medication to prevent flu)
• Colestiramine and colestipol (medications used to treat high levels of lipids in the blood)
• Ciclosporina, a medication used to prevent organ rejection
• Some antibiotics (tetracyclines), anesthetics and sedatives
• Carbamazepine, a medication used to treat seizures.
• If you are taking

Valsartán/Hidroclorotiazida Combixwith foods and beverages

You can take Valsartán/hidroclorotiazida with or without food.

Avoid taking alcohol until you have consulted your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

• You must inform your doctor if you are pregnant, if you suspect you may be pregnant or if you plan to become pregnant.Generally, your doctor will advise you to stop takingValsartán/Hidroclorotiazida Combixbefore becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán/Hidroclorotiazida Combix is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that time.

• Inform your doctor if you plan to initiate or are in a lactation periodsince it is notrecommended to administerValsartán/Hidroclorotiazida Combixto women during that period.Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially to newborns or premature babies.

Driving and operating machines

Before driving a vehicle, using tools or operating machines, or performing other activities that require concentration, make sure you know your reactions to the effects of Valsartán/hidroclorotiazida. Like many other medications used to treat high blood pressure, valsartán/hidroclorotiazida may cause, in rare cases, dizziness and affect concentration.

Important information about some of the components ofValsartán/Hidroclorotiazida Combix

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains soy lecithin. Do not use if you are allergic to peanuts or soy.

Always take Valsartán/Hidroclorotiazida Combix exactly as your doctor tells you to. This will help you get the best results and reduce the risk of side effects. Ask your doctor or pharmacist if you have any questions.

People with high blood pressure often do not notice any symptoms of the disease; many feel normal. This is why it is very important to attend your appointments with your doctor, even if you feel fine.

Your doctor will tell you exactly how many tablets of valsartán/hidroclorotiazida you should take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The usual dose of Valsartán/Hidroclorotiazida Combix is one tablet a day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can take Valsartán/Hidroclorotiazida Combix with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Combix than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

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

If you forget to take Valsartán/Hidroclorotiazida Combix

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Valsartán/Hidroclorotiazida Combix

If you stop taking Valsartán/hidroclorotiazida, your high blood pressure may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about using this product, ask your doctor or pharmacist.

Like all medicines, Valsartán/Hidroclorotiazida Combix can cause side effects, although not everyone will experience them.

These side effects may occur with certain frequencies, which are defined as follows:

• Very common: affects more than 1 in 10 patients
• Common: affects between 1 and 10 in 100 patients
• Uncommon: affects between 1 and 10 in 1,000 patients
• Rare: affects between 1 and 10 in 10,000 patients
• Very rare: affects less than 1 in 10,000 patients
• Unknown frequency: the frequency cannot be estimated from available data

Some side effects may be severe and require immediate medical attention:

You should visit your doctor immediately if you notice symptoms of angioedema, such as:

• Swelling in the face, tongue, or pharynx,
• Difficulty swallowing,
• Urticaria and difficulty breathing.

Other side effects include:

Uncommon

• Cough
• Low blood pressure
• Dizziness
• Dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine output, dark urine, dry skin)
• Muscle pain
• Fatigue
• Prickling or numbness
• Blurred vision
• Noises (e.g. ringing or buzzing) in the ears

Very rare

• Dizziness
• Diarrhea
• Joint pain

Unknown frequency

• Difficulty breathing
• Severe reduction in urine output
• Low sodium levels in the blood (sometimes with nausea, fatigue, confusion, discomfort, seizures)
• Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• Low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• Increased bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)
• Increased levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function)
• Increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)
• Syncope (fainting)

Side effects observed with valsartan or hydrochlorothiazide separately, but not observed with:

Valsartan:

Uncommon

• Sensation of rotation
• Abdominal pain

Very rare

• Intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency

• Rash with or without itching, accompanied by one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• Rash, red-purple spots, fever, itching (signs of blood vessel inflammation)
• Low platelet count (sometimes with bleeding or bruising more frequently than usual)
• High potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• Allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Elevation of liver function values
• Decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• Renal insufficiency

Hidroclorotiazida:

Common

• Rash with itching and other types of rash
• Loss of appetite
• Mild nausea and vomiting
• Dizziness, dizziness when standing up
• Impotence.

Rare

• Swelling and blisters on the skin (due to increased sensitivity to the sun)
• Constipation and stomach or intestinal discomfort Alterations of the liver (yellow skin or eyes)
• Irregular heartbeat
• Headache
• Sleep disturbances
• Depression
• Low platelet count (sometimes with bleeding or bruising under the skin)

Very rare

• Inflammation of blood vessels with symptoms such as rash, red-purple spots, fever
• Itching or redness of the skin
• Blisters on the lips, eyes, or mouth
• Peeling of the skin
• Fever
• Facial rash associated with joint pain
• Muscle disorders
• Fever (lupus erythematosus cutaneous)
• Severe pain in the upper stomach; absence or low levels of different types of blood cells
• Severe allergic reactions
• Difficulty breathing
• Pulmonary infection; shortness of breath
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Valsartán/Hidroclorotiazida, seek medical attention immediately.

Unknown frequency

• Skin cancer and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Blister Packs: Do not store at a temperature above 30 °C.

Do not useValsartán/Hidroclorotiazida Combix320 mg/12.5 mg tabletsafter the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not useValsartán/Hidroclorotiazida Combixif you observe that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment

Composition ofValsartán/Hidroclorotiazida Combix

The active principles are valsartán and hidroclorotiazida. Each tablet contains 320 mg of valsartán and 12.5 mg of hidroclorotiazida.

The other components are: microcrystalline cellulose (E460i), lactose monohydrate (lactose), sodium croscarmellose, povidone K29-K32, talc, magnesium stearate (E470b), anhydrous colloidal silica, polyvinyl alcohol alcohol, titanium dioxide (E171), macrogol 3350, soy lecithin (E322), iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and content of the packaging

Valsartán/Hidroclorotiazida Combix320 mg/12.5 mgis presented in the form of film-coated tablets,of pink color, oval, biconvex, with the inscription “V” on one face and “H” on the other.

Valsartán/Hidroclorotiazida Combix320 mg/12.5 mgtablets are available in blisters containing28tablets.

Holder of the marketing authorizationand responsible for the manufacturing

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for the manufacturing

Actavis Limited

Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

Balkanpharma Dupnitsa AD

3, Samakovsko Shosse Str.

2600 Dupnitsa

Bulgaria

This prospectus was approved inFebruary 2025

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/