Valsacombi film-coated tablets (valsartan + hydrochlorothiazide) – combination for high blood pressure, strengths 80/12.5 to 320/25 mg

Valsacombi contains two active substances that lower blood pressure together: valsartan, an angiotensin II receptor antagonist that relaxes blood vessels, and hydrochlorothiazide, a thiazide diuretic ("water tablet") that increases urine output.

In Serbia it is authorised as film-coated tablets in the strengths 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg, manufactured by KRKA d.d., Novo mesto (Slovenia); the marketing authorisation holder is KRKA-FARMA d.o.o. Beograd. It is a prescription-only medicine.

What is Valsacombi used for and how should it be taken?

Key facts about the medicine

What is Valsacombi used for?

According to the patient leaflet, Valsacombi is used to treat high blood pressure (hypertension) that cannot be adequately controlled by one medicine alone (valsartan or hydrochlorothiazide). The medicine is intended for adults.

Lowering blood pressure to normal values reduces the risk of stroke, heart attack and heart or kidney failure.

How is it taken and dosed?

• The usual dose is one tablet daily; the doctor chooses the strength according to the response to treatment.
• Take the medicine at the same time every day, preferably in the morning, with or without food, and swallow the tablet with a glass of water.
• Do not change the dose or stop treatment without consulting your doctor.

This is the general dosage from the leaflet – the exact strength and dose are set by the doctor.

Special patient groups

• Children and adolescents under 18: use is not recommended.
• Impaired kidney function: no dose adjustment at GFR ≥ 30 mL/min, with periodic checks of potassium, creatinine and uric acid; severe impairment (GFR < 30 mL/min), anuria and dialysis are contraindications.
• Impaired liver function: in mild to moderate impairment without cholestasis the valsartan dose should not exceed 80 mg; severe impairment, biliary cirrhosis and cholestasis are contraindications.

Contraindications – when the medicine must not be used

• allergy to valsartan, hydrochlorothiazide, sulphonamide derivatives or any of the excipients
• pregnancy beyond 3 months (avoid also in early pregnancy)
• severe liver disease, biliary cirrhosis and cholestasis
• severe kidney disease, anuria, dialysis
• low blood potassium or sodium, or high calcium despite treatment
• gout
• diabetes or impaired kidney function with concomitant aliskiren

Warnings and precautions

• Medicines or products that raise potassium, low potassium, diarrhoea or severe vomiting, high-dose diuretics – electrolyte monitoring is needed.
• Serious heart disease, heart failure or previous heart attack, renal artery narrowing, kidney transplantation, hyperaldosteronism, liver or kidney disease.
• History of angioedema (including with ACE inhibitors) – if it occurs during treatment, stop immediately and never take the medicine again.
• Systemic lupus, diabetes, gout, high cholesterol or triglycerides, allergy or asthma.
• Decreased vision or eye pain (choroidal effusion or acute angle-closure glaucoma) may occur hours to weeks after starting treatment – higher risk with a history of penicillin or sulphonamide allergy.
• Increased skin sensitivity to the sun; history of skin cancer or a new skin lesion – hydrochlorothiazide may increase the risk of non-melanoma skin and lip cancer.
• Breathing or lung problems after hydrochlorothiazide in the past; abdominal pain, nausea, vomiting or diarrhoea after taking the medicine – talk to your doctor.
• Concomitant ACE inhibitor or aliskiren – only under medical supervision. Contains lactose.

Interactions with other medicines, food and drink

• Lithium; potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, heparin.
• Medicines that lower potassium (other diuretics, corticosteroids, laxatives, carbenoxolone, amphotericin, penicillin G); medicines that can cause "torsades de pointes" (antiarrhythmics, some antipsychotics); digoxin.
• Medicines that lower sodium (antidepressants, antipsychotics, antiepileptics); gout medicines (allopurinol, probenecid, sulfinpyrazone); therapeutic vitamin D and calcium supplements.
• Diabetes medicines (metformin, insulin), other blood pressure medicines, noradrenaline and adrenaline, diazoxide, beta blockers.
• NSAIDs, including COX-2 inhibitors and acetylsalicylic acid above 3 g; rifampicin, ciclosporin, ritonavir; cytotoxic medicines (methotrexate, cyclophosphamide); colestyramine and colestipol; anticholinergics, amantadine, tubocurarine; iodinated contrast agents.
• Alcohol, sedatives and anaesthetics – more pronounced fall in blood pressure; avoid alcohol until you have talked to your doctor.

Pregnancy and breast-feeding

Valsacombi is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby; before a planned pregnancy the doctor will prescribe another medicine. It is also not recommended during breast-feeding, especially of a newborn or premature baby.

Driving and using machines

The effect on the ability to drive has not been studied; bear in mind that dizziness or tiredness may occasionally occur.

Possible side effects

• Uncommon: cough, low blood pressure, light-headedness, dehydration (thirst, dry mouth, infrequent urination, dark urine), muscle pain, tiredness, tingling, blurred vision, ringing in the ears.
• Very rare: dizziness, diarrhoea, joint pain.
• Not known: difficulty breathing, markedly reduced urine output, low blood sodium or potassium, low white blood cells, increased bilirubin, urea, creatinine and uric acid, fainting.
• Hydrochlorothiazide: very common low potassium and increased blood lipids; common low sodium and magnesium, high uric acid, rash, reduced appetite, nausea, dizziness on standing, erectile dysfunction; rare sun sensitivity with blistering, high calcium and blood sugar, rhythm disorders, depression; not known skin and lip cancer (non-melanoma).
• Valsartan: intestinal angioedema (very rare), skin blistering, vasculitis, high potassium, kidney failure.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: if you feel dizzy or faint, lie down and contact your doctor, pharmacist or hospital at once.
• Missed dose: take it as soon as possible; if it is nearly time for the next dose, skip the missed one. Do not take a double dose.
• Stopping treatment: may worsen your condition – do not stop without medical advice.

Related information

For home blood pressure monitoring during treatment, see also the Blood pressure monitors category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substances: valsartan and hydrochlorothiazide in the strengths listed.
• Excipients – core: microcrystalline cellulose; lactose monohydrate; magnesium stearate; croscarmellose sodium; povidone; colloidal anhydrous silica. Coating: hypromellose, titanium dioxide (E171), macrogol 4000, iron oxides (E172) – colour depends on strength.
• Pack: carton with 2 blisters of 14 (28) or, for strengths up to 160 mg, of 15 film-coated tablets (30).
• Marketing authorisation holder: KRKA-FARMA D.O.O. BEOGRAD, Jurija Gagarina 26/V/II, Belgrade. Manufacturer: KRKA, D.D., NOVO MESTO, Šmarješka cesta 6, Novo mesto, Slovenia.

Storage

• Store below 30 °C in the original package to protect from moisture and light.
• Keep out of the sight and reach of children. Do not use after the expiry date.

Frequently asked questions

When should Valsacombi be taken – morning or evening?

The leaflet advises taking it at the same time every day, preferably in the morning, with or without food. The usual dose is one tablet daily.

Why is sun protection needed with Valsacombi?

Hydrochlorothiazide increases skin sensitivity to the sun, and long-term high-dose use may increase the risk of non-melanoma skin and lip cancer. The skin should therefore be protected from sun and UV light, and any new skin change shown to the doctor.

Can people with gout use Valsacombi?

No. Gout is a contraindication because hydrochlorothiazide can increase blood uric acid.

How do the Valsacombi strengths differ?

The strengths differ in the amount of valsartan (80, 160 or 320 mg) and hydrochlorothiazide (12.5 or 25 mg). The doctor chooses the strength based on blood pressure and response to treatment; it should not be changed on your own.

Sources

• ALIMS – Summary of Product Characteristics Valsacombi®, 80/12.5 mg, 160/12.5 mg and 160/25 mg, film-coated tablets (Serbian)
• ALIMS – Patient leaflet Valsacombi®, 80/12.5 mg, 160/12.5 mg and 160/25 mg, film-coated tablets (May 2026, Serbian)
• ALIMS – Summary of Product Characteristics Valsacombi®, 320/12.5 mg and 320/25 mg, film-coated tablets (Serbian)
• ALIMS – Patient leaflet Valsacombi®, 320/12.5 mg and 320/25 mg, film-coated tablets (Serbian)

Sources checked on: 25 October 2026.