Valsartan/hydrochlorothiazide Combix 320 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan/Hydrochlorothiazide Combix 320 mg/12.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms of illness as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, resulting in increased blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine output, which also lowers blood pressure.

Valsartan/Hydrochlorothiazide Combix is used to treat high blood pressure that is not adequately controlled with either component used alone.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications.

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

Do not take Valsartan/Hydrochlorothiazide Combix

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide-derived substances (chemically related to hydrochlorothiazide), or to any of the other components of Valsartan/Hydrochlorothiazide Combix,
• This medicine contains soya lecithin. It must not be used if you are allergic to peanuts or soya.
• Valsartan/hydrochlorothiazide if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section),
• if you have severe liver disease,
• if you have severe kidney disease,
• if you are unable to pass urine,
• if you are undergoing dialysis,
• if you have abnormally low levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment,
• if you have gout.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Valsartan/Hydrochlorothiazide Combix

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary

• if you have low levels of potassium in your blood

• if you experience severe diarrhoea or vomiting

• if you are taking high doses of a diuretic

• if you have severe heart disease

• if you have renal artery stenosis (narrowing of the kidney artery)

• if you have recently undergone a kidney transplant

• if you have hyperaldosteronism, a condition 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 develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease)

• if you have diabetes, gout, or high cholesterol or lipid levels in your blood

• if you have previously experienced an allergic reaction when using another medicine of this class for lowering 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 hypertension (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 exposure to sunlight and UV rays while taking Valsartan/Hydrochlorothiazide Combix.

• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking Valsartan/Hydrochlorothiazide Combix.

• If you have previously had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide, seek medical attention immediately.

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

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

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

Valsartan/hydrochlorothiazide may cause increased skin sensitivity to sunlight.

Use in children and adolescents

The use of Valsartan/hydrochlorothiazide is not recommended in children and adolescents (under 18 years of age).

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Valsartan/Hydrochlorothiazide Combix is not recommended during early pregnancy (first 3 months), and must in no case be administered from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).

Use in athletes:

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

Interaction of Valsartan/Hydrochlorothiazide Combix with other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

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

• lithium, a medicine used to treat certain psychiatric conditions
• medicines that may affect or be affected by potassium levels, such as digoxin, a medicine for controlling heart rhythm, and some antipsychotic medicines
• medicines that may increase potassium levels, such as potassium-sparing medicines and heparin
• medicines that may reduce potassium levels in the blood, such as corticosteroids, certain laxatives
• diuretics (water tablets), medicines for treating gout such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for treating diabetes (oral antidiabetics or insulin)
• other blood pressure-lowering medicines, such as beta-blockers or methyldopa, an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Valsartan/Hydrochlorothiazide Combix” and “Warnings and precautions”)
• medicines that constrict your blood vessels or stimulate your heart, such as noradrenaline or adrenaline
• medicines to increase blood sugar levels, such as diazoxide
• cancer treatment medicines, such as methotrexate or cyclophosphamide
• pain medicines
• 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 transplant rejection
• certain antibiotics (tetracyclines), anaesthetics, and sedatives
• carbamazepine, a medicine used to treat seizures
• if you are taking

Valsartan/Hydrochlorothiazide Combix with food and drink

You may take Valsartan/hydrochlorothiazide with or without food.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

• You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Valsartan/Hydrochlorothiazide Combix before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. The use of Valsartan/Hydrochlorothiazide Combix is not recommended during early pregnancy, and must in no case be administered from the third month of pregnancy onwards, as it may cause severe harm to your baby when administered from that time.

• Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Valsartan/Hydrochlorothiazide Combix is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and use of machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, ensure you are aware of your response to the effects of Valsartan/hydrochlorothiazide. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide may rarely cause dizziness and affect concentration ability.

Important information about some of the components of Valsartan/Hydrochlorothiazide Combix

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains soya lecithin. It must not be used if you are allergic to peanuts or soya.

3. How to take Valsartán/Hidroclorotiazida Combix

Always take Valsartán/Hidroclorotiazida Combix exactly as your doctor has instructed. This will help you achieve the best results and reduce the risk of adverse effects. Consult your doctor or pharmacist if you have any doubts.

People with high blood pressure often do not notice any symptoms of the condition and frequently feel perfectly normal. This makes it very important to keep your doctor's appointments, even if you feel well.

Your doctor will tell you exactly how many tablets of valsartan/hydrochlorothiazide 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 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 may 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 your next dose, skip the missed dose.

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

If you stop taking Valsartán/Hidroclorotiazida Combix

If you discontinue treatment with valsartan/hydrochlorothiazide, your hypertension 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Valsartan/Hydrochlorothiazide Combix may cause adverse effects, although not everyone experiences them.

These adverse effects may occur with certain frequencies, defined as follows:

• Very common: affects more than 1 in 10 patients
• Common: affects 1 to 10 in 100 patients
• Uncommon: affects 1 to 10 in 1,000 patients
• Rare: affects 1 to 10 in 10,000 patients
• Very rare: affects less than 1 in 10,000 patients
• Frequency not known: cannot be estimated from available data

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

You should see your doctor immediately if you experience symptoms of angioedema, such as:

• swelling of the face, tongue, or pharynx,
• difficulty swallowing,
• hives and difficulty breathing.

Other adverse effects include:

Uncommon

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms such as thirst, dry mouth and tongue, reduced frequency of urination, dark-colored urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• 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 urine output
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, malaise, seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)
• 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, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

Adverse effects observed with valsartan or hydrochlorothiazide separately, but not observed with the combination:

Valsartan:

Uncommon

• sensation of spinning
• abdominal pain

Very rare

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

Frequency not known

• skin rash with or without itching, accompanied by any of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
• low platelet count (sometimes with bleeding or bruising more frequent than usual)
• high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling mainly of the face and throat; skin rash; itching
• elevated liver function test values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• renal failure

Hydrochlorothiazide:

Common

• itchy skin rash and other types of skin eruptions
• decreased appetite
• mild nausea and vomiting
• dizziness, dizziness upon standing
• impotence

Rare

• skin swelling and blisters (due to increased sensitivity to sunlight)
• constipation and stomach or intestinal discomfort
• liver disorders (yellowing of the skin or eyes)
• irregular heartbeat
• headache
• sleep disturbances
• depression (feeling sad)
• low platelet count (sometimes with bleeding or bruising under the skin)

Very rare

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever

• skin itching or redness

• blisters on lips, eyes, or mouth

• skin peeling

• fever

• facial rash associated with joint pain

• muscle disorders

• fever (cutaneous lupus erythematosus)

• severe upper abdominal pain; absence or low levels of different types of blood cells

• severe allergic reactions

• difficulty breathing

• lung infection; shortness of breath

• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide, and if you develop dyspnea or severe breathing difficulty after taking Valsartan/Hydrochlorothiazide Combix, seek immediate medical attention.

Frequency not known

• skin and lip cancer (non-melanoma skin cancer)
• decreased vision or eye pain due to elevated 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán/Hidroclorotiazida Combix

Keep out of the reach and sight of children.

Blister packs: Do not store above 30 °C.

Do not use Valsartán/Hidroclorotiazida Combix 320 mg/12.5 mg tablets after the expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Do not use Valsartán/Hidroclorotiazida Combix if the packaging is damaged or shows any signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán/Hidroclorotiazida Combix

The active substances are valsartan and hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the pack

Valsartán/Hidroclorotiazida Combix 320 mg/12.5 mg is presented as film-coated tablets, pink in colour, oval-shaped, biconvex, with the inscription “V” on one side and “H” on the other.

Valsartán/Hidroclorotiazida Combix 320 mg/12.5 mg tablets are available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

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

Manufacturer

Actavis Limited
Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

or

Balkanpharma Dupnitsa AD
3, Samakovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This leaflet was approved in February 2025

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