Valsartan/hydrochlorothiazide Sandoz 160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartan/Hydrochlorothiazide Sandoz 80 mg/12.5 mg film-coated tablets EFG

Valsartan/Hydrochlorothiazide Sandoz 160 mg/12.5 mg film-coated tablets EFG

Valsartan/Hydrochlorothiazide Sandoz 160 mg/25 mg film-coated tablets EFG

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

Valsartan/Hydrochlorothiazide Sandoz 320 mg/25 mg film-coated tablets EFG

Valsartan/hydrochlorothiazide

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you get any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Valsartan/Hydrochlorothiazide Sandoz 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, leading to 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 production, which also lowers blood pressure.

Valsartan/hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with a single component.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead 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 conditions.

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

Do not take Valsartán/Hidroclorotiazida Sandoz

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide 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 (it is best to avoid taking Valsartán/Hidroclorotiazida Sandoz, even in early pregnancy – see Pregnancy section),
• if you have severe liver disease, destruction of the small bile ducts in the liver (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 treatment with an artificial kidney,
• if you have abnormally low levels of potassium or sodium in your blood, or if your blood calcium levels remain high 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

Consult your doctor or pharmacist before taking Valsartán/Hidroclorotiazida Sandoz

• if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, 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 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 heart failure or have recently had a heart attack. Follow your doctor’s instructions carefully regarding the initial dose. Your doctor may also monitor your kidney function,
• if you have narrowing of the artery supplying 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, valsartan/hydrochlorothiazide is not recommended,
• if you have kidney or liver disease,
• if you have previously experienced swelling, mainly of the tongue and face, while taking other medicines (including ACE inhibitors). If you develop these symptoms, stop taking valsartan/hydrochlorothiazide and contact your doctor immediately. Do not restart valsartan/hydrochlorothiazide. See also section 4, “Possible side effects”,
• if you develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, 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 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 from hours to weeks after taking valsartan/hydrochlorothiazide. This may lead to vision loss if untreated. If you have previously been allergic to sulfonamides or penicillin, you may be at higher risk,
• it may cause increased skin sensitivity to sunlight,
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancers. Protect your skin from sun exposure and UV rays while taking Valsartán/Hidroclorotiazida Sandoz,
• if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulty after taking valsartan/hydrochlorothiazide, seek medical attention immediately,
• if you are taking any of the following medicines used to treat hypertension (high blood pressure):
  • an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
  • aliskiren.

If any of these situations apply to you, consult your doctor.

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

See also the information under the heading “Do not take Valsartán/Hidroclorotiazida Sandoz”.

Consult your doctor if you think you are (or might become) pregnant.

The use of valsartan/hydrochlorothiazide is not recommended at the beginning of pregnancy and must not be administered from the third month of pregnancy onward, as it may cause serious harm to your baby (see Pregnancy section).

Contact 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.

Children and adolescents

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

Other medicines and Valsartán/Hidroclorotiazida Sandoz

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 valsartan/hydrochlorothiazide may be altered when taken with certain medicines. Your doctor may need to adjust your dose and/or take other precautions or, in some cases, discontinue one of the treatments. This particularly applies to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders,
• medicines 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, corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G,
• certain antibiotics (rifampicin group) or antiretroviral medicines used to treat HIV/AIDS infection (ritonavir). These medicines may enhance the effect of valsartan/hydrochlorothiazide,
• medicines that may cause “torsades de pointes” (an irregular heart rhythm), such as antiarrhythmics (medicines used to treat heart problems) and certain 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 (oral antidiabetics such as metformin or insulin),
• other blood pressure-lowering medicines, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under “Do not take Valsartán/Hidroclorotiazida Sandoz” and “Warnings and precautions”),
• medicines that may increase your 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 inhibitors (COX-2 inhibitors) and more than 3 grams of acetylsalicylic acid per day,
• muscle relaxants, such as tubocurarine,
• anticholinergic medicines (used to treat various disorders such as intestinal cramps, urinary bladder spasm, asthma, dizziness, muscle spasms, Parkinson’s disease, and as an aid in anesthesia),
• amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral infections),
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels),
• cyclosporine, a medicine used to prevent rejection of transplanted organs,
• alcohol, sedatives, and anesthetics (medicines with sedative or analgesic effects, used, for example, during surgery),
• iodinated contrast agents (used in imaging procedures).

Valsartán/Hidroclorotiazida Sandoz with food, drinks, and alcohol

You may take valsartan/hydrochlorothiazide 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 and breastfeeding

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

You must inform your doctor if you suspect you are (or might be) pregnant.

Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment.

Valsartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

Inform your doctor if you are planning to breastfeed or are already breastfeeding.

Valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

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

3. How to take Valsartan/Hydrochlorothiazide Sandoz

Always take this medicine exactly as prescribed by your doctor. 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 experience any symptoms and may feel perfectly normal. This makes it very important to keep your appointments with your doctor, even if you feel well.

Your doctor will tell you exactly how many tablets of valsartan/hydrochlorothiazide you should take. Depending on your response to treatment, your doctor may decide to adjust the dose upwards or downwards.

• The recommended dose of Valsartan/Hydrochlorothiazide Sandoz is one tablet daily.
• 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 valsartan/hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Sandoz than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan/Hydrochlorothiazide Sandoz

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 Valsartan/Hydrochlorothiazide Sandoz

If you stop treatment with Valsartan/Hydrochlorothiazide Sandoz, your hypertension 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 everyone will experience them.

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

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

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

You should contact your doctor immediately if you experience acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion); this is a very rare adverse reaction (may affect up to 1 in 10,000 people).

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

Other possible adverse effects:

Uncommon, affecting 1 to 10 in 1,000 patients

• 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, affecting fewer than 1 in 10,000 patients

• dizziness,
• diarrhoea,
• joint pain.

Frequency not known, according to available data

• difficulty breathing,
• significant decrease in urine output,
• low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps, and/or seizures in severe cases),
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, or 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 products containing valsartan or hydrochlorothiazide separately:

Valsartan

Uncommon, affecting 1 to 10 in 1,000 patients

• sensation of spinning,
• abdominal pain.

Very rare, affecting fewer than 1 in 10,000 patients

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

Frequency not known, according to available data

• blisters on the skin (symptom of bullous dermatitis),
• 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 bleeding or bruising more frequently 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 cause anemia),
• renal failure,
• low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps, and/or seizures in severe cases).

Hydrochlorothiazide

Very common, affecting more than 1 in 10 patients

• low potassium levels in the blood,
• increased blood lipids.

Common, affecting more than 1 in 100 patients

• 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, affecting 1 in 10,000 patients

• swelling and blisters on the skin (due to increased sensitivity to sunlight),
• high calcium levels in the blood,
• high blood sugar levels,
• sugar in the urine,
• worsening of diabetic metabolic state,
• constipation, diarrhoea, stomach or intestinal discomfort, liver disorders which may occur together 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,
• visual disturbances.

Very rare, affecting fewer than 1 in 10,000 patients

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis),
• rash, itching, redness of the skin, difficulty breathing or swallowing, dizziness (hypersensitivity reactions),
• severe skin disease causing 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 (respiratory distress including pneumonitis and pulmonary edema),
• fever, sore throat, more frequent infections (agranulocytosis),
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia),
• fever, sore throat or mouth ulcers due to infections (leucopenia),
• confusion, fatigue, cramps and muscle spasms, rapid breathing (hypochloremic alkalosis).

Frequency not known, according to available data

• weakness, bruising, and frequent infections (aplastic anemia),
• severely reduced urine production (possible signs of kidney disorder or kidney failure),
• decreased vision or eye pain due to high pressure (possible symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or angle-closure glaucoma),
• rash, redness of the skin, blisters on the lips, eyes or mouth, fever (possible symptom of erythema multiforme),
• muscle spasm,
• fever (pyrexia),
• weakness (asthenia),
• skin and lip cancer (non-melanoma skin cancer).

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán/Hidroclorotiazida Sandoz

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Do not use Valsartán/Hidroclorotiazida Sandoz if you notice that the packaging is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection 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 Valsartan/Hydrochlorothiazide Sandoz

Valsartan/Hydrochlorothiazide Sandoz 80 mg/12.5 mg

The active substances are valsartan and hydrochlorothiazide. Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate and colloidal anhydrous silica.

Coating

hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).

Valsartan/Hydrochlorothiazide Sandoz 160 mg/12.5 mg

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

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate and colloidal anhydrous silica.

Coating

hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172).

Valsartan/Hydrochlorothiazide Sandoz 160 mg/25 mg

The active substances are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate and colloidal anhydrous silica.
Coating

hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

Valsartan/Hydrochlorothiazide Sandoz 320 mg/12.5 mg

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

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate and colloidal anhydrous silica.
Coating

hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).

Valsartan/Hydrochlorothiazide Sandoz 320 mg/25 mg

The active substances are valsartan and hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.

The other components are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate and colloidal anhydrous silica.
Coating

hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Valsartan/Hydrochlorothiazide Sandoz 80 mg/12.5 mg

Film-coated tablet, light orange in colour, oval-shaped, slightly convex, with an engraved mark (imprint) reading “HGH” on one side and “CG” on the other.

Valsartan/Hydrochlorothiazide Sandoz 160 mg/12.5 mg

Film-coated tablet, dark red in colour, oval-shaped, slightly convex, with an engraved mark (imprint) reading “HHH” on one side and “CG” on the other.

Valsartan/Hydrochlorothiazide Sandoz 160 mg/25 mg

Film-coated tablet, dark orange in colour, oval-shaped, slightly convex, with an engraved mark (imprint) reading “HXH” on one side and “NVR” on the other.

Valsartan/Hydrochlorothiazide Sandoz 320 mg/12.5 mg

Film-coated tablet, pink in colour, oval-shaped with bevelled edges, with an engraved mark (imprint) reading “NVR” on one side and “HIL” on the other.

Valsartan/Hydrochlorothiazide Sandoz 320 mg/25 mg

Film-coated tablet, yellow in colour, oval-shaped with bevelled edges, with an engraved mark (imprint) reading “NVR” on one side and “CTI” on the other.

Pack sizes:

Available in packs containing 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100 or 280 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Salutas Pharma GmbH
Ott-von-Guericke-Allee 1
39179 Barleben
Germany

OR

LEK S.A.
Ul. Domaniewska 50 C
02-672 Warszawa
Poland

OR

Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana
Slovenia

OR

Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia

OR

LEK, S.A.
Ul Podlipie, 16
Strykow
PL95-010
Poland

OR

NOVARTIS FARMA S.P.A.
Via Provinciale Schito 131
Torre Annunziata
80058 Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Sweden: Valsartan/Hydrochlorothiazide Sandoz

Austria: Valsartan/HCT Sandoz 80 mg/12.5 mg – Filmtabletten
Valsartan/HCT Sandoz 160 mg/12.5 mg – Filmtabletten
Valsartan/HCT Sandoz 160 mg/25 mg – Filmtabletten
Valsartan/HCT Sandoz 320 mg/12.5 mg – Filmtabletten
Valsartan/HCT Sandoz 320 mg/25 mg – Filmtabletten

Belgium: Co-Valsartan Sandoz 80 mg / 12.5 mg filmomhulde tabletten
Co-Valsartan Sandoz 160 mg / 12.5 mg filmomhulde tabletten
Co-Valsartan Sandoz 160 mg / 25 mg filmomhulde tabletten
Co-Valsartan Sandoz 320 mg / 12.5 mg filmomhulde tabletten
Co-Valsartan Sandoz 320 mg / 25 mg filmomhulde tabletten

Bulgaria: Suvartar H

Cyprus: Valsartan Hydrochlorothiazid Sandoz 80 mg/12.5 mg
Valsartan Hydrochlorothiazid Sandoz 160 mg/12.5 mg
Valsartan Hydrochlorothiazid Sandoz 160 mg/25 mg
Valsartan Hydrochlorothiazid Sandoz 320 mg/12.5 mg
Valsartan Hydrochlorothiazid Sandoz 320 mg/25 mg

Czech Republic: Valsartan/Hydrochlorothiazid Sandoz 80 mg/12.5 mg
Valsartan/Hydrochlorothiazid Sandoz 160 mg/12.5 mg
Valsartan/Hydrochlorothiazid Sandoz 160 mg/25 mg
Valsartan/Hydrochlorothiazid Sandoz 320 mg/12.5 mg
Valsartan/Hydrochlorothiazid Sandoz 320 mg/25 mg

Germany: Valsartan HCT Sandoz 80 mg/12.5 mg Filmtabletten
Valsartan HCT Sandoz 160 mg/12.5 mg Filmtabletten
Valsartan HCT Sandoz 160 mg/25 mg Filmtabletten
Valsartan HCT Sandoz 320 mg/12.5 mg Filmtabletten
Valsartan HCT Sandoz 320 mg/25 mg Filmtabletten

Denmark: Valsartan Hydrochlorthiazid Sandoz

Estonia: Valsartan HCT Sandoz 80 mg/12.5 mg
Valsartan HCT Sandoz 160 mg/12.5 mg
Valsartan HCT Sandoz 160 mg/25 mg
Valsartan HCT Sandoz 320 mg/12.5 mg
Valsartan HCT Sandoz 320 mg/25 mg

Greece: Valsartan HCT/Sandoz

Spain: Valsartan Hidrocloritiazida Sandoz 80/12.5 mg comprimidos recubiertos con película EFG
Valsartan Hidrocloritiazida Sandoz 160/12.5 mg comprimidos recubiertos con película EFG
Valsartan Hidrocloritiazida Sandoz 160/25 mg comprimidos recubiertos con película EFG
Valsartan Hidrocloritiazida Sandoz 320/12.5 mg comprimidos recubiertos con película EFG
Valsartan Hidrocloritiazida Sandoz 320/25 mg comprimidos recubiertos con película EFG

Date of the latest 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/