Valsartore Comp (Valsartan/Hydrochlorothiazide)
Combination antihypertensive – angiotensin II receptor blocker + thiazide diuretic
Valsartore Comp is a prescription combination medicine containing valsartan and hydrochlorothiazide. It is used to treat high blood pressure (hypertension) when a single medicine alone does not provide sufficient blood pressure control. Valsartan relaxes blood vessels while hydrochlorothiazide helps the body eliminate excess water and salt, and together they lower blood pressure more effectively than either drug alone.
Quick Facts
Key Takeaways
- Valsartore Comp combines two blood-pressure-lowering mechanisms – an ARB and a diuretic – for patients whose hypertension is not controlled by one drug alone.
- It is taken once daily, with or without food, and should be swallowed whole with water at the same time each morning.
- The medicine must not be used during the last 6 months of pregnancy and should be avoided throughout pregnancy when possible.
- Regular blood tests may be needed to monitor potassium, sodium, kidney function, and uric acid levels during treatment.
- Common side effects include low potassium, elevated blood lipids, dizziness, and cough – contact your doctor if you experience swelling of the face, tongue, or throat.
What Is Valsartore Comp and What Is It Used For?
Valsartore Comp film-coated tablets contain two active substances that work together to control high blood pressure. Valsartan belongs to a class of medicines called angiotensin II receptor blockers (ARBs). Angiotensin II is a naturally occurring hormone that causes blood vessels to constrict, which raises blood pressure. Valsartan works by blocking the effect of angiotensin II at its receptor, allowing blood vessels to relax and widen, which lowers blood pressure.
Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics, sometimes called “water pills.” It works by acting on the kidneys to increase the excretion of sodium and water in the urine. This reduces the volume of fluid in the bloodstream, which in turn lowers the pressure within the blood vessels. The diuretic effect also has a mild direct vasodilatory action on the arterioles over time.
The combination of these two complementary mechanisms provides more effective blood pressure reduction than either medicine alone. Clinical trials, including the landmark VALUE trial (Valsartan Antihypertensive Long-term Use Evaluation), have demonstrated that valsartan-based regimens provide effective cardiovascular protection in hypertensive patients. The European Society of Cardiology (ESC) and European Society of Hypertension (ESH) 2023 guidelines recommend combination therapy as first-line treatment for most patients with hypertension, as achieving blood pressure targets with monotherapy is often insufficient.
Untreated high blood pressure increases the workload on the heart and blood vessels. Over time, this can damage blood vessels in the brain, heart, and kidneys, potentially leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Reducing blood pressure to normal levels significantly decreases the risk of these serious cardiovascular events. According to the World Health Organization (WHO), hypertension is the leading modifiable risk factor for cardiovascular disease and premature death worldwide.
Valsartore Comp is typically prescribed when a patient has already tried a single blood pressure medication (monotherapy) without achieving adequate blood pressure control, or as initial therapy in patients whose blood pressure is significantly elevated and who are likely to need more than one medicine to reach their target. The decision to use combination therapy is made by the prescribing physician based on the individual patient’s blood pressure readings, cardiovascular risk profile, and overall health status.
What Should You Know Before Taking Valsartore Comp?
Contraindications
Do not take Valsartore Comp if any of the following apply to you:
- You are allergic to valsartan, hydrochlorothiazide, sulphonamide-derived substances, or any other ingredient in this medicine.
- You are more than 3 months pregnant (it is also best to avoid Valsartore Comp in early pregnancy).
- You have severe liver disease or destruction of the small bile ducts (biliary cirrhosis) leading to bile build-up (cholestasis).
- You have severe kidney disease or are unable to produce urine (anuria).
- You are being treated with an artificial kidney (dialysis).
- Your blood potassium or sodium levels are lower than normal, or your blood calcium level is higher than normal despite treatment.
- You have gout.
- You have diabetes or impaired kidney function and are being treated with aliskiren (a blood-pressure-lowering medicine).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Valsartore Comp if any of the following conditions apply to you. Your doctor may need to adjust your dose, run additional tests, or prescribe an alternative medicine:
- You are taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels (e.g. heparin). Your doctor may need to check your blood potassium regularly.
- You have low potassium levels in the blood.
- You have diarrhoea or severe vomiting, as these can cause significant fluid and electrolyte loss.
- You are taking high doses of diuretics (water tablets).
- You have serious heart disease, heart failure, or have had a heart attack.
- You have narrowing of the arteries leading to the kidneys (renal artery stenosis).
- You have recently had a kidney transplant.
- You have hyperaldosteronism (a condition in which your adrenal glands produce too much of the hormone aldosterone).
- You have liver or kidney disease.
- You have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema. If these symptoms occur while taking Valsartore Comp, stop immediately and never take it again.
- You have diabetes, gout, high cholesterol, or high triglyceride levels.
- You experience vision impairment or eye pain, which could be symptoms of fluid accumulation in the eye or acute angle-closure glaucoma.
- You have previously had skin cancer or develop an unexpected skin change during treatment. Hydrochlorothiazide, particularly with long-term use at high doses, may increase the risk of non-melanoma skin cancer. Protect your skin from sun and UV exposure.
- You have previously had breathing or lung problems after taking hydrochlorothiazide. Seek immediate medical attention if you develop severe breathlessness after taking Valsartore Comp.
Your doctor may need to check your kidney function, blood pressure, and levels of electrolytes (such as potassium and sodium) in your blood at regular intervals during treatment. This is particularly important during the first few weeks of therapy and whenever your dose is changed.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, speak to your doctor before taking this medicine. Your doctor will normally advise you to stop taking Valsartore Comp before you become pregnant, or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartore Comp must not be used during the last 6 months of pregnancy, as it may cause serious harm to the unborn baby. It should also be avoided during the first trimester.
Tell your doctor if you are breastfeeding or about to start breastfeeding. Valsartore Comp is not recommended during breastfeeding, and your doctor may choose an alternative treatment, especially if your baby is a newborn or premature.
Children and Adolescents
The use of Valsartore Comp in children and adolescents under 18 years of age is not recommended. There is insufficient evidence regarding safety and efficacy in this age group, and alternative antihypertensive strategies should be considered by the treating paediatrician.
Driving and Operating Machinery
Before driving, using tools, or performing activities that require concentration, make sure you know how Valsartore Comp affects you. Like many blood pressure medicines, Valsartore Comp can occasionally cause dizziness or impair concentration, particularly at the start of treatment or when the dose is increased. If you experience these effects, do not drive or operate heavy machinery until they resolve.
How Does Valsartore Comp Interact with Other Drugs?
The therapeutic effect of Valsartore Comp can be altered when taken with certain other medicines. In some cases, dose adjustments or additional monitoring may be necessary. In other cases, one of the medicines may need to be stopped. It is essential to tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including over-the-counter medicines and herbal supplements.
Major Interactions
The following interactions are considered clinically significant and require close medical supervision or avoidance:
| Drug / Class | Effect | Clinical Action |
|---|---|---|
| Lithium | Increased lithium toxicity risk; reduced renal clearance | Avoid combination or monitor lithium levels closely |
| Aliskiren | Dual RAAS blockade; increased risk of hypotension, hyperkalaemia, renal impairment | Contraindicated in diabetic patients; avoid in renal impairment |
| ACE inhibitors (e.g. enalapril, lisinopril, ramipril) | Dual RAAS blockade; increased adverse events | Avoid combination; especially in diabetic nephropathy |
| NSAIDs (e.g. ibuprofen, diclofenac, celecoxib) | Reduced antihypertensive effect; increased renal impairment risk | Monitor kidney function and blood pressure |
| Potassium supplements / potassium-sparing diuretics | Risk of hyperkalaemia | Monitor serum potassium regularly |
| Digoxin | Diuretic-induced hypokalaemia increases digoxin toxicity risk | Monitor potassium levels and digoxin concentrations |
Other Notable Interactions
The following medicines may also interact with Valsartore Comp and may require dose adjustments or additional monitoring:
- Diabetes medicines (insulin, metformin, sulphonylureas) – hydrochlorothiazide may raise blood sugar, potentially requiring dose adjustment of diabetes medicines.
- Corticosteroids and laxatives – may further deplete potassium when used with hydrochlorothiazide.
- Cyclosporine – increased risk of hyperkalaemia and gout when combined with valsartan/HCTZ.
- Ritonavir – may increase the effect of Valsartore Comp.
- Rifampicin-group antibiotics – may alter the effect of Valsartore Comp.
- Cholestyramine and colestipol – may reduce absorption of hydrochlorothiazide; take Valsartore Comp at least 1 hour before or 4 hours after these resins.
- Medicines that can cause torsades de pointes (certain antiarrhythmics, some antipsychotics) – electrolyte imbalances from hydrochlorothiazide may increase the risk of dangerous heart rhythm disturbances.
- Noradrenaline and adrenaline – the blood-pressure-raising effect may be reduced.
- Methotrexate and cyclophosphamide – hydrochlorothiazide may reduce renal clearance of cytotoxic agents, increasing toxicity.
- Alcohol, sedatives, and anaesthetics – may enhance the blood-pressure-lowering effect, increasing the risk of dizziness or fainting.
- Iodinated contrast media – increased risk of acute kidney injury in patients taking diuretics; ensure adequate hydration before imaging procedures.
- Vitamin D and calcium supplements – hydrochlorothiazide can reduce calcium excretion, potentially raising blood calcium levels.
You can take Valsartore Comp with or without meals. Avoid alcohol until you have spoken with your doctor, as alcohol can further lower blood pressure and increase the risk of dizziness or fainting.
What Is the Correct Dosage of Valsartore Comp?
Always take this medicine exactly as your doctor has told you. People with high blood pressure often have no noticeable symptoms, so it is important to keep all scheduled appointments even if you feel well. Your doctor will tell you which strength of Valsartore Comp tablet to take, and depending on your response, may adjust the dose up or down.
Adults
Standard Dosing
The usual dose is one tablet once daily. Take the tablet at the same time each day, usually in the morning. Swallow it whole with a glass of water. Valsartore Comp can be taken with or without food.
| Strength | Valsartan | Hydrochlorothiazide | Typical Use |
|---|---|---|---|
| 80/12.5 mg | 80 mg | 12.5 mg | Starting dose / mild hypertension |
| 160/12.5 mg | 160 mg | 12.5 mg | Moderate hypertension / dose escalation |
| 160/25 mg | 160 mg | 25 mg | Maximum strength / insufficient response at lower doses |
Elderly Patients
No specific dose adjustment is routinely required for elderly patients. However, doctors typically start with the lowest available strength and titrate cautiously, as older adults may be more susceptible to the blood-pressure-lowering effects, electrolyte disturbances, and dehydration. Kidney function should be assessed before starting and monitored during treatment.
Children and Adolescents
Valsartore Comp is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy in this population.
Missed Dose
Take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten tablet.
Overdose
If you take too much Valsartore Comp, or if a child accidentally swallows the medicine, contact your doctor, hospital, or poison control centre immediately. An overdose may cause severe dizziness, fainting, and dangerously low blood pressure. If you feel severely dizzy or faint, lie down and seek medical help at once. Symptoms of overdose may also include excessive dehydration and electrolyte imbalances.
Stopping Treatment
Do not stop taking Valsartore Comp without consulting your doctor. If you stop treatment abruptly, your blood pressure may rise again, increasing your risk of cardiovascular complications. Your doctor will advise you on how to safely discontinue treatment if necessary, which may involve gradually switching to an alternative medication.
What Are the Side Effects of Valsartore Comp?
- Swelling of the face, tongue, or throat (angioedema)
- Difficulty swallowing or breathing
- Hives combined with breathing difficulty
- Severe skin rash with blistering, redness, or peeling (toxic epidermal necrolysis)
- Vision deterioration or eye pain (possible glaucoma or choroidal effusion)
- Fever, sore throat, frequent infections (agranulocytosis)
- Severe breathlessness with fever, weakness, and confusion (acute respiratory distress)
The frequency of side effects is classified according to international convention. Below is an overview of reported side effects for the combination and its individual components:
Valsartan/Hydrochlorothiazide Combination
Uncommon
May affect up to 1 in 100 people
- Cough
- Low blood pressure
- Dizziness, lightheadedness
- Dehydration (thirst, dry mouth, dark urine)
- Muscle pain
- Fatigue
- Tingling and numbness
- Blurred vision
- Buzzing or ringing in the ears
Very Rare
May affect up to 1 in 10,000 people
- Vertigo
- Diarrhoea
- Joint pain
Additional side effects reported with unknown frequency for the combination include breathing difficulties, significantly reduced urine output, low sodium (which may cause fatigue, confusion, or seizures in severe cases), low potassium (sometimes with muscle weakness or abnormal heart rhythm), low white blood cell count, elevated bilirubin (which may cause yellowing of the skin and eyes), elevated urea nitrogen and creatinine (suggesting reduced kidney function), elevated uric acid, and fainting.
Hydrochlorothiazide Component
Very Common
May affect more than 1 in 10 people
- Low potassium level in the blood
- Elevated blood lipid levels
Common
May affect up to 1 in 10 people
- Low sodium level in the blood
- Low magnesium level in the blood
- High uric acid level in the blood
- Itchy rash and other skin rashes
- Decreased appetite
- Mild nausea and vomiting
- Dizziness, fainting on standing up
- Erectile dysfunction
Rare
May affect up to 1 in 1,000 people
- Photosensitivity (skin blistering with sun exposure)
- High calcium level in the blood
- High blood sugar level
- Constipation, diarrhoea, stomach discomfort
- Irregular heartbeat
- Headache, sleep disturbance
- Depressed mood
- Low platelet count
- Visual disturbances
Very Rare
May affect up to 1 in 10,000 people
- Vasculitis (inflammation of blood vessels with rash, purple spots, fever)
- Hypersensitivity reactions (rash, hives, breathing difficulty, dizziness)
- Cutaneous lupus erythematosus (facial rash, joint pain, fever)
- Pancreatitis (severe upper abdominal pain)
- Pneumonitis (breathing difficulty with fever, cough, wheezing)
- Haemolytic anaemia (pale skin, fatigue, dark urine)
Valsartan Component
Uncommon
May affect up to 1 in 100 people
- Sensation of spinning (vertigo)
- Abdominal pain
Very Rare / Frequency Not Known
Reported in post-marketing surveillance
- Intestinal angioedema (abdominal pain, nausea, vomiting, diarrhoea)
- Skin blistering (bullous dermatitis)
- Rash with fever, joint pain, swollen lymph nodes
- Purple-red spots, fever, itching (vasculitis)
- Low platelet count (unusual bleeding or bruising)
- High potassium levels (muscle cramps, abnormal heart rhythm)
- Allergic reactions (rash, itching, hives, difficulty breathing)
- Elevated liver function values
- Decreased haemoglobin (anaemia)
- Kidney failure
Long-term use of hydrochlorothiazide, particularly at high doses, has been associated with an increased risk of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) of the skin and lips. Protect your skin from sunlight and UV rays during treatment, and report any new or changing skin lesions to your doctor promptly.
If you experience any side effects, including those not listed above, talk to your doctor or pharmacist. You can also report side effects directly to your national medicines regulatory authority. By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Valsartore Comp?
Keep this medicine out of the sight and reach of children at all times. Store the tablets at a temperature not exceeding 30°C (86°F). Do not use the tablets after the expiry date stated on the packaging – the expiry date refers to the last day of that month. Do not use any packaging that is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment and prevent accidental exposure.
What Does Valsartore Comp Contain?
Active Substances
| Strength | Valsartan | Hydrochlorothiazide | Appearance |
|---|---|---|---|
| 80/12.5 mg | 80 mg | 12.5 mg | Pink, oblong, biconvex |
| 160/12.5 mg | 160 mg | 12.5 mg | Brown, oblong, biconvex |
| 160/25 mg | 160 mg | 25 mg | Orange, oblong, biconvex |
Inactive Ingredients (Excipients)
Tablet core: lactose monohydrate, cellulose powder, hypromellose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Film coating: hypromellose, macrogol 8000, titanium dioxide (E171), talc, red iron oxide (E172). Some strengths also contain yellow iron oxide (E172) and black iron oxide (E172).
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially “sodium-free.”
Packaging
Valsartore Comp is available in blister packs containing 10, 14, 28, 30, 50, 56, 90, 98, or 100 tablets. Not all pack sizes may be marketed in every country.
Marketing authorisation holder: STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany.
Frequently Asked Questions
Valsartore Comp is used to treat high blood pressure (hypertension) when blood pressure cannot be adequately controlled with a single active substance alone. It contains two complementary medicines: valsartan (an angiotensin II receptor blocker) and hydrochlorothiazide (a thiazide diuretic). Together they lower blood pressure more effectively than either component alone, reducing the risk of stroke, heart attack, and kidney disease.
The most common side effects relate to the hydrochlorothiazide component and include low potassium levels in the blood and elevated blood lipid levels (occurring in more than 1 in 10 people). Other common effects include low sodium, low magnesium, itchy rash, decreased appetite, nausea, dizziness, and erectile dysfunction. Most side effects are mild and manageable with medical supervision.
No. Valsartore Comp must not be used during the last 6 months of pregnancy, as it can cause serious harm to the unborn baby, including kidney damage and low amniotic fluid. It should also be avoided during the first trimester. If you become pregnant while taking Valsartore Comp, contact your doctor immediately so they can prescribe a safer alternative such as methyldopa, labetalol, or nifedipine.
Take one tablet once daily at the same time each day, usually in the morning. Swallow the tablet whole with a glass of water. You can take it with or without food. Do not change the dose or stop treatment without your doctor’s advice, even if you feel well – high blood pressure often causes no symptoms.
Take the missed dose as soon as you remember. If it is nearly time for your next dose, skip the missed one and take your next dose at the usual time. Never take two tablets at once to make up for a missed dose. If you frequently forget your medicine, consider setting a daily alarm or using a pill organiser.
You should avoid alcohol while taking Valsartore Comp unless your doctor says otherwise. Alcohol can further lower your blood pressure, which may increase the risk of dizziness, lightheadedness, or fainting, especially when standing up from a sitting or lying position. If you do choose to drink, do so in moderation and be aware of these enhanced effects.
References
- Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal. 2018;39(33):3021–3104. Updated 2023. doi:10.1093/eurheartj/ehy339
- Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. Journal of the American College of Cardiology. 2018;71(19):e127–e248.
- Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. The Lancet. 2004;363(9426):2022–2031.
- World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. Geneva: WHO; 2021.
- National Institute for Health and Care Excellence (NICE). Hypertension in adults: diagnosis and management. NICE guideline [NG136]. Updated 2022.
- European Medicines Agency (EMA). Valsartan/Hydrochlorothiazide: Summary of Product Characteristics. Available at: ema.europa.eu.
- British National Formulary (BNF). Valsartan with hydrochlorothiazide. Available at: bnf.nice.org.uk.
- Sica DA. Combination angiotensin-receptor blocker/hydrochlorothiazide: optimizing outcomes in hypertension management. Drugs. 2006;66(4):443–458.
Medical Editorial Team
This article has been reviewed by the iMedic Medical Editorial Team, comprising board-certified physicians specialising in cardiology, clinical pharmacology, and internal medicine, in accordance with international guidelines from ESC/ESH, AHA/ACC, WHO, and NICE.
All medical claims are supported by Level 1A evidence from systematic reviews and randomised controlled trials. Content follows the GRADE evidence framework and is free from commercial funding or pharmaceutical sponsorship.
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