VALSARTAN/HYDROCHLOROTHIAZIDE SANDOZ 160 mg/25 mg FILM-COATED TABLETS

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Valsartan/Hydrochlorothiazide Sandoz and what is it used for
2. What you need to know before you take Valsartan/Hydrochlorothiazide Sandoz
3. How to take Valsartan/Hydrochlorothiazide Sandoz
4. Possible side effects

5 Storage of Valsartan/Hydrochlorothiazide Sandoz

1. Contents of the pack and further information

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

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

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

Valsartan/Hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and can 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 disorders.

2. What you need to know before you take Valsartan/Hydrochlorothiazide Sandoz

Do not takeValsartan/Hydrochlorothiazide Sandoz

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6),

• if you are pregnant more than 3 months(it is better to avoid taking Valsartan/Hydrochlorothiazide Sandoz, also at the beginning of your pregnancy – see section Pregnancy),
• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis),
• if you have severe kidney disease,
• if you are unable to produce urine (anuria),
• if you are being treated with a kidney dialysis machine,
• if you have low potassium or sodium levels in your blood, or if your blood calcium levels are higher than normal despite treatment,
• if you have gout,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains 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 starting to take Valsartan/Hydrochlorothiazide Sandoz

• if you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly check 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 had a heart attack. Follow your doctor's instructions for the initial dose carefully. Your doctor may also check your kidney function,
• if you have narrowing of the kidney artery,
• if you have recently had a kidney transplant,
• if you have hyperaldosteronism. A disease 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 ever had swelling mainly of the tongue and face while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking valsartan/hydrochlorothiazide and contact your doctor immediately. Do not take valsartan/hydrochlorothiazide again. See also section 4, “Possible side effects”,
• if you have fever, rash, and joint pain, which can be signs of systemic lupus erythematosus (SLE, a known autoimmune disease),
• if you have diabetes, gout, high cholesterol or triglyceride levels in your blood,
• if you have previously had an allergic reaction with the use of another medicine in this class 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 pain in the eye. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and may occur from the first hours to weeks after taking valsartan/hydrochlorothiazide. This can lead to vision loss if left untreated. If you have previously been allergic to sulfonamides or penicillin, you may be at higher risk of developing it,
• it may cause an increased sensitivity of the skin to the sun,
• if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide Sandoz,
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking valsartan/hydrochlorothiazide, see your doctor immediately,
• if you are taking any of the following medicines used to treat high blood pressure (high blood pressure):
• • an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskiren.

If you are in any of these situations, consult your doctor.

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

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

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

Valsartan/hydrochlorothiazide is not recommended for use at the start of pregnancy and should not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section Pregnancy).

Consult 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 Valsartan/Hydrochlorothiazide Sandoz

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

The effect of treatment with valsartan/hydrochlorothiazide may be altered if taken with certain medicines. Your doctor may need to change your dose and/or take other precautions, or in some cases, stop treatment with one of the medicines. This is especially applicable to the following medicines:

• lithium, a medicine used to treat some types of psychiatric disorders,
• medicines that may increase the amount of potassium in your blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin,
• medicines that may decrease the amount of potassium in your blood, 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 increase the effect of valsartan/hydrochlorothiazide,
• medicines that may induce “torsades de pointes” (irregular heart rhythm) such as anti-arrhythmics (medicines used to treat heart problems) and some antipsychotics,
• medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics,
• medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone,
• therapeutic vitamin D and calcium supplements,
• medicines for treating diabetes (oral antidiabetics such as metformin or insulin),
• other medicines for lowering blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information included in “Do not take Valsartan/Hydrochlorothiazide Sandoz” and “Warnings and precautions”),
• medicines that 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 relievers, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and more than 3 grams of acetylsalicylic acid per day,
• muscle relaxants, such as tubocurarine,
• anticholinergic medicines (medicines used to treat a variety of disorders, such as intestinal cramps, bladder spasms, asthma, dizziness, muscle spasms, Parkinson's disease, and as an aid to anesthesia),
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases),
• cholestyramine and colestipol (medicines used primarily to treat high lipid levels in the blood),
• cyclosporine, a medicine used to prevent organ rejection after transplantation,
• alcohol, sedatives, and anesthetics (medicines with a sedative or analgesic effect used, for example, during surgery),
• iodinated contrast media (agents used for imaging examinations).

Valsartan/Hydrochlorothiazide Sandoz with food, drinks, and alcohol.

You can take valsartan/hydrochlorothiazide with or without food.

Avoid drinking alcohol until you have consulted your doctor. Alcohol can 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 have a baby, consult your doctor or pharmacist before using this medicine.

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

Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and will recommend taking another blood pressure-lowering medicine instead of valsartan/hydrochlorothiazide.

Valsartan/hydrochlorothiazide is not recommended for use at the start of pregnancy and should not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby.

Tell your doctor if you are about to start or are breastfeeding.

Valsartan/hydrochlorothiazide is not recommended for administration to women during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially to newborns or premature babies.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how you react to the effects of valsartan/hydrochlorothiazide. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide Sandoz can cause, in rare cases, dizziness and affect your ability to concentrate.

3. How to take Valsartan/Hydrochlorothiazide Sandoz

Always take this medicine exactly as your doctor has told you. This will help you to get the best results and reduce the risk of side effects. If you are not sure, ask your doctor or pharmacist.

People with high blood pressure often do not notice any signs of the disease; many feel 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 valsartan/hydrochlorothiazide tablets to take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of Valsartan/Hydrochlorothiazide Sandoz 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 can 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 notice a strong 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 can also contact the Toxicology Information Service, phone 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 your treatment with Valsartan/Hydrochlorothiazide Sandoz, your hypertension may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on 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 all people suffer from them.

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

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

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

You should contact your doctor immediately if you experience acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion), this is a very rare adverse reaction (it can 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, affects 1 to 10 out of 1,000 patients

• cough,
• low blood pressure,
• dizziness,
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced urination frequency, dark urine, dry skin),
• muscle pain,
• fatigue,
• tingling or numbness,
• blurred vision,
• noises (e.g. ringing or buzzing) in the ears.

Rare, affects less than 1 in 10,000 patients

• dizziness,
• diarrhea,
• joint pain.

Frequency not known, according to available data

• breathing difficulties,
• significant decrease in diuresis,
• low sodium levels in the blood (which can lead to fatigue, confusion, muscle spasms and/or convulsions in severe cases),
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm),
• low white blood cell count in the blood (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, can cause the skin and eyes to turn yellow),
• increased urea and creatinine levels in the blood (which can indicate abnormal kidney function),
• increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack),
• syncope (fainting).

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

Valsartan

Uncommon, affects 1 to 10 out of 1,000 patients

• feeling of rotation,
• abdominal pain.

Very rare, affects less than 1 in 10,000 patients

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known, according to available data

• blisters on the skin (symptom of bullous dermatitis),
• skin rash with or without itching along with some of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation and/or symptoms similar to those of the flu,
• 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 spasms, abnormal heart rhythm),
• 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 values,
• decrease in hemoglobin levels and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia),
• renal failure,
• low sodium levels in the blood (which can lead to fatigue, confusion, muscle spasms and/or convulsions in severe cases).

Hydrochlorothiazide

Very common, affects more than 1 in 10 patients

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

Common, affects 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,
• skin rash with itching and other types of rash,
• decreased appetite,
• mild nausea and vomiting,
• dizziness, dizziness when standing up,
• inability to achieve or maintain an erection.

Rare, affects 1 in 10,000 patients

• swelling and blisters on the skin (due to increased sun sensitivity),
• high calcium levels in the blood,
• high sugar levels in the blood,
• sugar in the urine,
• worsening of diabetic metabolic condition,
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders that can occur along 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, affects less than 1 in 10,000 patients

• inflammation of the blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis),
• rash, itching, skin redness, difficulty breathing or swallowing, dizziness (hypersensitivity reactions),
• severe skin disease that produces rash, skin redness, 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),
• breathing difficulties, 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 (leukopenia),
• 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 decreased urine production (possible signs of renal disorder or renal 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, skin redness, blisters on the lips, eyes, or mouth, fever (possible symptom of erythema multiforme),
• muscle spasms,
• 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 that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Valsartan/Hydrochlorothiazide Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep in the original packaging to protect it from moisture.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartan/Hydrochlorothiazide Sandoz

Valsartan/Hydrochlorothiazide Sandoz 80 mg/12.5 mg

The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other ingredients are:

Core

microcrystalline cellulose, crospovidone, magnesium stearate, and anhydrous colloidal 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 ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other ingredients are:

Core

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

Coating

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

Valsartan/Hydrochlorothiazide Sandoz 160 mg/25 mg

The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.

The other ingredients are:

Core

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

Coating

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

Valsartan/Hydrochlorothiazide Sandoz 320 mg/12.5 mg

The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other ingredients are:

Core

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

Coating

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

Valsartan/Hydrochlorothiazide Sandoz 320 mg/25 mg

The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.

The other ingredients are:

Core

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

Coating

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

Product Appearance and Package Contents

Valsartan/Hydrochlorothiazide Sandoz 80 mg/12.5 mg

Film-coated tablet, light orange in color, oval, slightly convex, and with the imprint (embossing) "HGH" on one side and "CG" on the opposite face.

Valsartan/Hydrochlorothiazide Sandoz 160 mg/12.5 mg

Film-coated tablet, dark red in color, oval, slightly convex, and with the imprint (embossing) "HHH" on one side and "CG" on the opposite face.

Valsartan/Hydrochlorothiazide Sandoz 160 mg/25 mg

Film-coated tablet, dark orange in color, oval, slightly convex, and with the imprint (embossing) "HXH" on one side and "NVR" on the opposite face.

Valsartan/Hydrochlorothiazide Sandoz 320 mg/12.5 mg

Film-coated tablet, pink in color, oval with beveled edges, and with the imprint (embossing) "NVR" on one face and "HIL" on the opposite face.

Valsartan/Hydrochlorothiazide Sandoz 320 mg/25 mg

Film-coated tablet, yellow in color, oval with beveled edges, and with the imprint (embossing) "NVR" on one face and "CTI" on the opposite face.

Package sizes:

They can contain 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100, or 280 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

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 2D9220 Lendava

Slovenia

Or

Sandoz S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures

Romania

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 medicine is authorized in the Member States of the European Economic Area with 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 film-coated tablets

Co-Valsartan Sandoz 160 mg / 12.5 mg film-coated tablets

Co-Valsartan Sandoz 160 mg / 25 mg film-coated tablets

Co-Valsartan Sandoz 320 mg / 12.5 mg film-coated tablets

Co-Valsartan Sandoz 320 mg / 25 mg film-coated tablets

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 Hydrochlorothiazide Sandoz

Estonia: Valsartan HCT Sandoz 80 mg/12.5mg

Valsartan HCT Sandoz 160 mg/12.5mg

Valsartan HCT Sandoz 160 mg/25mg

Valsartan HCT Sandoz 320 mg/12.5mg

Valsartan HCT Sandoz 320 mg/25mg

Greece: Valsartan HCT/Sandoz

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

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

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

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

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

Date of the last revision of this leaflet:February 2025

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