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

Introduction

Package Leaflet: Information for the User

Valsartan/Hydrochlorothiazide Combix160 mg/12.5 mg

film-coated tablets EFG

valsartan and hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the pack and other information:

1. What is Valsartan/Hydrochlorothiazide Combix and what is it used for
2. Before taking Valsartan/Hydrochlorothiazide Combix
3. How to take Valsartan/Hydrochlorothiazide Combix
4. Possible side effects
5. Storage of Valsartan/Hydrochlorothiazide Combix
6. Further information

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

Valsartan/Hydrochlorothiazide Combix film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines 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 narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also decreases blood pressure.

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

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

2. Before taking Valsartan/Hydrochlorothiazide Combix

Do not takeValsartan/Hydrochlorothiazide Combix

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the other components of Valsartan/Hydrochlorothiazide Combix.
• This medicine contains soy lecithin. It should not be used in case of peanut or soy allergy.
• if you are pregnant for more than 3months. (In any case, it is best to avoid taking this medicine also at the beginning of your pregnancy – see section Pregnancy and lactation).
• if you have severeliver disease.
• if you have severekidney disease.
• if you are unable to urinate.
• if you are undergoing dialysis.
• if you have low potassium or sodium levels in your blood, or if your blood calcium levels are higher than normal despite treatment.
• if you have gout.
• this medicine contains soy oil. It should not be used in case of soy allergy.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of these situations apply to you, do not take this medicine and consult your doctor.

Be particularly cautious withValsartan/Hydrochlorothiazide Combix

• if you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels.

• if you have low potassium levels in your blood.
• if you experience severe diarrhea or vomiting.
• if you are taking high doses of a diuretic.
• if you have severe heart disease.
• if you have narrowing of the kidney artery.
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartan/Hydrochlorothiazide Combix is not recommended.
• if you have kidney or liver disease.
• if you have fever, skin rash, and joint pain, which can be signs of systemic lupus erythematosus (a known autoimmune disease).
• if you have diabetes, gout, high cholesterol, or lipid levels in your blood.
• if you have previously had an allergic reaction with the use of another medicine of this class to lower blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.

• if you are taking any of the following medicines 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, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide Combix.
• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and can occur within a few hours to a week after taking Valsartan/Hydrochlorothiazide Combix.
• 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 shortness of breath or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide Combix, seek medical attention immediately.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking valsartan/hydrochlorothiazide on your own.

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

Valsartan/Hydrochlorothiazide Combix is not recommended for use in children and adolescents (under 18 years of age).

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Valsartan/Hydrochlorothiazide Combix is not recommended during the first trimester of pregnancy, and in any case, should not be administered after the third month of pregnancy as it may cause serious harm to your baby, see section Pregnancy and lactation.

Valsartan/hydrochlorothiazide may increase your skin's sensitivity to the sun.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription. Your doctor may need to adjust your dose and/or take other precautions.

The effect of treatment with Valsartan/Hydrochlorothiazide Combix may be altered if taken with certain medicines. Your doctor may need to adjust your dose and/or take other precautions or, in some cases, stop treatment with one of the medicines. This is especially applicable to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders.
• medicines that may affect or be affected by potassium levels, such as digoxin, a medicine to control heart rhythm, and some antipsychotic medicines.
• medicines that may increase the amount of potassium in your blood, such as potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, and heparin.
• medicines that may decrease the amount of potassium in your blood, such as corticosteroids and some laxatives.
• diuretics (medicines to increase urine production), medicines to treat gout, such as allopurinol, therapeutic vitamin D, and calcium supplements, and medicines to treat diabetes (oral antidiabetics or insulin).
• other medicines to lower blood pressure, such as beta-blockers or methyldopa, an angiotensin-converting enzyme inhibitor (ACE inhibitor), or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide Combix” and “Be particularly cautious with Valsartan/Hydrochlorothiazide Combix”).
• medicines that constrict your blood vessels or stimulate your heart, such as noradrenaline or adrenaline.
• medicines to increase blood sugar levels, such as diazoxide.
• medicines to treat cancer, such as methotrexate or cyclophosphamide.
• medicines for pain.
• medicines for arthritis.
• muscle relaxants, such as tubocurarine.
• anticholinergic medicines, such as atropine or biperiden.
• amantadine (a medicine to prevent influenza).
• cholestyramine and colestipol (medicines used to treat high lipid levels in the blood).
• cyclosporine, a medicine used to prevent organ rejection after transplantation.
• certain antibiotics (tetracyclines), anesthetics, and sedatives.
• carbamazepine, a medicine used to treat seizures.

TakingValsartan/Hydrochlorothiazide Combixwith food and drink

You can take Valsartan/Hydrochlorothiazide Combix with or without food.

Avoid drinking 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 medicine.

• You must inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.Your doctor will normally advise you to stop taking Valsartan/Hydrochlorothiazide Combix 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. Valsartan/Hydrochlorothiazide Combix is not recommended during the first trimester of pregnancy, and in any case, should not be administered after the third month of pregnancy as it may cause serious harm to your baby.

• Tell your doctor if you are about to start or are breastfeeding, as Valsartan/Hydrochlorothiazide Combix is not recommended for women during this period. Your doctor may decide to prescribe a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know how Valsartan/Hydrochlorothiazide Combix affects you. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide Combix can cause dizziness and affect your ability to concentrate.

Important information about some of the ingredients ofValsartan/Hydrochlorothiazide Combix

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking the medicine.

This medicine contains soy lecithin. It should not be used in case of peanut or soy allergy.

This medicine may cause allergic reactions because it contains orange yellow S (E110). It can trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Valsartan/Hydrochlorothiazide Combix

Always take Valsartan/Hydrochlorothiazide Combix exactly as your doctor has told you. This will help you to get the best results and reduce the risk of side effects. If you are unsure, ask your doctor or pharmacist.

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

Your doctor will tell you exactly how many Valsartan/Hydrochlorothiazide Combix tablets to take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

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

If you take moreValsartan/Hydrochlorothiazide Combixthan you should

If you notice a strong 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeValsartan/Hydrochlorothiazide Combix

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

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

If you stop takingValsartan/Hydrochlorothiazide Combix

If you stop treatment with Valsartan/Hydrochlorothiazide Combix, your high blood pressure may worsen. Do not stop taking the medicine unless your doctor tells you to.

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

4. Possible Adverse Effects

Like all medicines, Valsartan/Hydrochlorothiazide Combix can cause adverse effects, although not all people suffer from them.

These adverse effects may occur with certain frequencies, which are defined below:

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

Some adverse effects can be serious 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
• Hives and difficulty breathing

Other adverse effects include:

Uncommon

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

Very rare

• Dizziness
• Diarrhea
• Joint pain

Frequency not known

• Difficulty breathing
• Severe decrease in diuresis
• Low sodium levels in the blood (sometimes with nausea, fatigue, confusion, discomfort, convulsions)
• Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• Low white blood cell count (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 nitrogen and creatinine levels 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)

Adverse effects observed with valsartan or hydrochlorothiazide alone, but not observed with Valsartan/Hydrochlorothiazide Combix:

Valsartan

Uncommon

• Feeling of rotation

• Abdominal pain

Very rare

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

Frequency not known

• Rash with or without itching along with some of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or symptoms similar to those of the flu
• Rash, red-purple spots, fever, itching (symptoms 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, hives, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Elevation of liver function values
• Decrease in hemoglobin levels and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia)
• Kidney failure

Hydrochlorothiazide

Common

• Rash with itching and other types of rash
• Decreased 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, liver changes (yellowing of the skin or eyes)
• Irregular heartbeat
• Headache
• Sleep disturbances
• Sadness (depression)
• Low platelet count (sometimes accompanied by bleeding or bruising under the skin)

Very rare

• Vasculitis 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 (cutaneous lupus erythematosus)
• Severe pain in the upper abdomen; absence or low levels of different types of blood cells
• Severe allergic reactions
• Difficulty breathing
• Lung infection; lack of breath
• Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion)

Frequency not known

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

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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Combix

• Keep out of the reach and sight of children.
• Do not use Valsartan/Hydrochlorothiazide Combix after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.
• Blister packs: Do not store at a temperature above 30 °C.

• Do not use Valsartan/Hydrochlorothiazide Combix if you notice that the packaging is damaged or shows signs of deterioration.
• Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Valsartan/Hydrochlorothiazide Combix

The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other components are: microcrystalline cellulose (E460i), lactose monohydrate (lactose), sodium croscarmellose, povidone K29-K32, talc, magnesium stearate (E470b), anhydrous colloidal silica, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, soy lecithin (E322), red iron oxide (E172), and orange yellow S (E110).

Appearance of the Product and Packaging Content

Valsartan/Hydrochlorothiazide Combix 160 mg/12.5 mg is presented in the form of film-coated tablets, red in color, oval, biconvex, with the inscription "V" on one face and "H" on the other.

Valsartan/Hydrochlorothiazide Combix 160 mg/12.5 mg tablets are available in blister packs containing 28 tablets.

Marketing Authorization Holder

Combix Laboratories, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Actavis Limited

Bulebel Industrial Estate

Zejtun

Malta

or

Balkanpharma Dupnitsa AD

3, Samakovsko Shosse Str.

2600 Dupnitsa

Bulgaria

This prospectus was approved in February 2025

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