Valsartan/hydrochlorothiazide Pharma Combix 80 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartan/Hydrochlorothiazide Pharma Combix 80 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms 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 Pharma Combix is and what it is used for.
2. What you need to know before taking Valsartan/Hydrochlorothiazide Pharma Combix.
3. How to take Valsartan/Hydrochlorothiazide Pharma Combix.
4. Possible side effects.
5. How to store Valsartan/Hydrochlorothiazide Pharma Combix.
6. Contents of the pack and other information.

1. What Valsartán/Hidroclorotiazida Pharma Combix is and what it is used for

Valsartán/Hidroclorotiazida Pharma 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 helps lower blood pressure.

Valsartán/Hidroclorotiazida is used to treat high blood pressure that is not adequately controlled with either component 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, and may lead to 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 complications.

2. What you need to know before taking Valsartán/Hidroclorotiazida Pharma Combix

Do not take Valsartán/Hidroclorotiazida Pharma Combix

• if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or any of the other components of this medicine (listed in section 6).
• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also during early pregnancy – see section Pregnancy, breastfeeding and fertility).
• if you have severe liver disease, destruction of the small bile ducts in the liver (primary biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
• if you have severe kidney disease.
• if you are unable to produce urine (anuria).
• 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 impairment 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

Talk to your doctor or pharmacist before taking Valsartán/Hidroclorotiazida Pharma 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 your potassium levels.

• if you have low blood potassium levels.

• 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 heart failure or have had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.

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

• 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, Valsartán/Hidroclorotiazida is not recommended.

• if you have kidney or liver disease.

• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking Valsartán/Hidroclorotiazida, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.

• 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 triglyceride levels in your blood.

• if you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.

• if you experience vision loss 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 from several hours to one week after taking Valsartán/Hidroclorotiazida. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergic reaction to penicillin or sulphonamides.

• it may cause increased skin sensitivity to sunlight.

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

  • 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 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 non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking Valsartán/Hidroclorotiazida Pharma Combix.

• if you have previously experienced breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Valsartán/Hidroclorotiazida, 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 without medical advice.

See also the information under the heading “Do not take Valsartán/Hidroclorotiazida Pharma Combix”. If any of these situations apply to you, consult your doctor.

The use of Valsartán/Hidroclorotiazida 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, inform your doctor. Use of Valsartán/Hidroclorotiazida is not recommended during early pregnancy (first 3 months) and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby. See section Pregnancy, breastfeeding and fertility.

Taking Valsartán/Hidroclorotiazida with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment with Valsartán/Hidroclorotiazida may be altered when 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 particularly important for 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 used to control heart rhythm, and some antipsychotics
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
• medicines that may decrease blood potassium levels, such as diuretics (medicines to increase urine production), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Valsartán/Hidroclorotiazida
• medicines that may cause "torsades de pointes" (irregular heartbeats), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, and antiepileptics
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines used to treat diabetes (insulin or oral antidiabetics such as metformin)
• other blood pressure-lowering medicines including methyldopa, an angiotensin-converting enzyme inhibitor (ACE inhibitor), or aliskiren (see also information under the headings “Do not take Valsartán/Hidroclorotiazida Pharma Combix” and “Warnings and precautions”)
• medicines that may increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (medicines used to treat heart problems)
• medicines that may increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medicines such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, and acetylsalicylic acid at doses exceeding 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines (used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anaesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases)
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)
• cyclosporine, a medicine used to prevent rejection of transplanted organs
• alcohol, sleeping pills, and anaesthetics (medicines with sedative or pain-relieving effects, used, for example, during surgery)
• iodinated contrast media (used in diagnostic imaging procedures)

Taking Valsartán/Hidroclorotiazida Pharma Combix with food, drinks, and alcohol

You may take Valsartán/Hidroclorotiazida with or without food.

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Valsartán/Hidroclorotiazida before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Use of Valsartán/Hidroclorotiazida is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when administered from that point.

• Inform your doctor if you are planning to start or are currently breastfeeding, as Valsartán/Hidroclorotiazida is not recommended for women during this period. Your doctor may choose a more suitable treatment if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

Before driving, operating tools, or handling machinery, or engaging in other activities requiring concentration, make sure you are aware of how Valsartán/Hidroclorotiazida affects you. Like many other medicines used to treat high blood pressure, Valsartán/Hidroclorotiazida may rarely cause dizziness and affect your ability to concentrate.

Use in athletes

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

3. How to take Valsartán/Hidroclorotiazida Pharma Combix

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

People with high blood pressure often do not experience any symptoms and may feel perfectly 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 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 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 with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Pharma 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartán/Hidroclorotiazida Pharma 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 Pharma Combix

If you stop your treatment with Valsartán/Hidroclorotiazida, your high blood pressure may worsen. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

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

• very common: may affect more than 1 in 10 people
• common: may affect up to 1 in 10 people
• uncommon: may affect up to 1 in 100 people
• rare: may affect up to 1 in 1,000 people
• very rare: may affect up to 1 in 10,000 people
• frequency not known: frequency cannot be estimated from the 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.

If you experience any of these symptoms, stop taking Valsartan/Hydrochlorothiazide and contact your doctor immediately (see also section 2 “Warnings and precautions”).

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
• severely decreased urine output
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or 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)

The following adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

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, together with one or more 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 increased bleeding or bruising)
• 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
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)

Hydrochlorothiazide

Very common

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

Common

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rash and other types of skin rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain an erection

Rare

• skin swelling and blisters (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic status
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders which may occur with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

Very rare

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• serious skin disease causing skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulties including pneumonitis and pulmonary edema)
• fever, sore throat, increased frequency of infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloremic alkalosis)
• acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)

Frequency not known

• weakness, bruising, and frequent infections (aplastic anemia)
• markedly decreased urine production (possible signs of kidney impairment or kidney failure)
• vision loss 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)
• skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effect, talk to 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 Valsartan/Hydrochlorothiazide Pharma Combix

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan/Hydrochlorothiazide Pharma Combix

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components are: crospovidone, microcrystalline cellulose (E460i), anhydrous colloidal silica (E551), hypromellose (E464), anhydrous calcium hydrogen phosphate (E341i), and magnesium stearate (E470b).
• The tablet coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the pack

Pink, oval, biconvex, film-coated tablets with bevelled edges, smooth on both sides.

Aluminium-aluminium blisters.

Valsartan/Hydrochlorothiazide Pharma Combix 80 mg/12.5 mg is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

Zydus France
Zac Les Hautes Pâtures
Parc d'Activités des Pleupliers
25 rue des Pleupliers
92000 Nanterre
France

or

Centre Spécialités Pharmaceutiques
ZAC des Suzots
35 rue de la Chapelle
63450 Saint Amant Tallende
France

Date of the most recent revision of this leaflet: February 2025

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