Valsartan and hydrochlorothiazide Sandoz
Italy
Table of Contents
Package leaflet: Information for the user
Valsartan and Hydrochlorothiazide Sandoz 80 mg / 12.5 mg film-coated tablets, 160 mg / 12.5 mg film-coated tablets, 160 mg / 25 mg film-coated tablets, 320 mg / 12.5 mg film-coated tablets, 320 mg / 25 mg film-coated tablets
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Valsartan and Hydrochlorothiazide Sandoz is and what it is used for
- What you need to know before taking Valsartan and Hydrochlorothiazide Sandoz
- How to take Valsartan and Hydrochlorothiazide Sandoz
- Possible side effects
- How to store Valsartan and Hydrochlorothiazide Sandoz
- Contents of the pack and other information
1. What Valsartan and Hydrochlorothiazide Sandoz is and what it is used for
Valsartan and Hydrochlorothiazide Sandoz film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances 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, thereby increasing 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 group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases the amount of urine produced and, in this way, reduces blood pressure. Valsartan and Hydrochlorothiazide Sandoz is used to treat high blood pressure when it is not adequately controlled by a single medicine alone.
High blood pressure increases the workload on the heart and arteries. Over time, this can damage the blood vessels in the brain, heart, and kidneys, and may lead to heart attack, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
2. What you need to know before taking Valsartan and Hydrochlorothiazide Sandoz
Do not take Valsartan and Hydrochlorothiazide Sandoz:
- if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6)
- if you are more than 3 months pregnant (it is better to avoid taking Valsartan and Hydrochlorothiazide Sandoz even in the early stages of pregnancy – see section on Pregnancy)
- if you have severe liver disorders, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile formation in the liver (cholestasis)
- if you have severe kidney disorders
- if you are unable to produce urine (anuria)
- if you are undergoing treatment with an artificial kidney
- if your blood potassium or sodium levels are lower than normal, or if your blood calcium levels are higher than normal despite treatment
- if you have gout
- if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
If any of these cases apply to you, do not take this medicine and consult your doctor.
Warnings and precautions
Talk to your doctor before taking Valsartan and Hydrochlorothiazide 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 need to regularly monitor your blood potassium levels.
-
if your blood potassium levels are low
-
if you have diarrhoea or severe vomiting
-
if you are taking high doses of medicines that increase fluid elimination (diuretics)
-
if you have serious heart problems
-
if you suffer from heart failure or have previously 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 renal artery
-
if you have recently received a kidney transplant
-
if you suffer from hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of valsartan/hydrochlorothiazide is not recommended.
-
if you have liver or kidney diseases
-
inform your doctor if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema after taking other medicines (including ACE inhibitors). If these symptoms occur while you are taking Valsartan and Hydrochlorothiazide Sandoz, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.
-
if you have fever, skin rashes, and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease)
-
if you have diabetes, gout, high cholesterol or high triglyceride levels in the blood
-
if you have had allergic reactions while using other blood pressure-lowering medicines belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma
-
if you experience vision changes 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 within hours or weeks of taking Valsartan and Hydrochlorothiazide Sandoz. This may lead to permanent vision loss if not treated. If you have had an allergy to penicillin or sulphonamides, your risk of developing this symptom may be higher.
-
may cause increased skin sensitivity to sunlight.
-
if you have previously had skin cancer or develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking Valsartan and Hydrochlorothiazide Sandoz.
-
if you have previously experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If shortness of breath or severe breathing difficulties occur after taking Valsartan and Hydrochlorothiazide Sandoz, consult a doctor immediately.
-
if you are taking any of the following medicines used to treat high blood pressure:
-
an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
-
aliskiren
-
if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).
Your doctor may periodically check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.
See also the section “Do not take Valsartan and Hydrochlorothiazide Sandoz”.
If any of these situations apply to you, consult your doctor.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Sandoz is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section on Pregnancy).
Children and adolescents
The use of Valsartan and Hydrochlorothiazide Sandoz is not recommended in children and adolescents (under 18 years of age).
Other medicines and Valsartan and Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Valsartan and Hydrochlorothiazide Sandoz is taken together with certain other medicines. Your doctor may need to adjust the dose and/or take additional precautions, or in some cases discontinue treatment with one of the medicines. This particularly applies to the following medicines:
- lithium, a medicine used in the treatment of certain psychiatric disorders
- medicines or substances that can increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
- medicines that can decrease blood potassium levels, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
- certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan and Hydrochlorothiazide Sandoz.
- medicines that may cause "torsades de pointes" (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
- medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
- medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
- therapeutic supplements of vitamin D and calcium
- medicines used to treat diabetes (oral such as metformin or insulin)
- other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the sections “Do not take Valsartan and Hydrochlorothiazide Sandoz” 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
- painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (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 abdominal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia)
- amantadine (a medicine used to treat Parkinson’s disease and 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 organ transplant rejection.
- alcohol, sedatives, and anaesthetics (sedatives or painkillers used, for example, during surgery)
- iodinated contrast agents (substances used in X-ray examinations)
- an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprololo).
Valsartan and Hydrochlorothiazide Sandoz with food, drinks, and alcohol
Valsartan and Hydrochlorothiazide Sandoz can be taken with or without food.
Avoid consuming alcohol unless you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
Your doctor will usually advise you to stop taking Valsartan and Hydrochlorothiazide Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan and Hydrochlorothiazide Sandoz is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Inform your doctor if you are breastfeeding or planning to breastfeed.
Valsartan and Hydrochlorothiazide Sandoz is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Before driving, operating machinery, or engaging in other activities requiring concentration, you should be aware of how you react to valsartan/hydrochlorothiazide. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide may occasionally cause dizziness and affect your ability to concentrate.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
3. How to take Valsartan and Hydrochlorothiazide Sandoz
Take this medicine exactly as your doctor has told you. This will help you achieve better results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Sandoz you should take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.
- The recommended dose of Valsartan and Hydrochlorothiazide Sandoz is one tablet daily.
- Do not change the dose and do not stop taking the tablets without first consulting your doctor.
- This medicine should be taken every day at the same time, usually in the morning.
- You may take Valsartan and Hydrochlorothiazide Sandoz with or without food.
- Swallow the tablet with a glass of water.
If you take more Valsartan and 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.
If you forget to take Valsartan and 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 the forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide Sandoz
Stopping treatment with Valsartan/Hydrochlorothiazide Sandoz may cause your high blood pressure to worsen. Do not discontinue use of this medicine unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will get them.
Some side effects may be serious and require immediate medical attention:
Contact your doctor immediately if you experience symptoms of angioedema such as:
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
Contact your doctor immediately if you develop acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion); this is a very rare side effect (may affect up to 1 in 10,000 people).
If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide Sandoz
and contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other side effects are:
Uncommon: may affect from 1 to 10 users in 1,000
- cough
- low blood pressure
- sensation of emptiness in the head
- dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
- muscle pain
- fatigue
- tingling or numbness
- blurred vision
- noises in the ears (e.g. ringing, buzzing)
Very rare: may affect less than 1 user in 10,000
- dizziness
- diarrhoea
- joint pain
Frequency not known, based on available data
- difficulty breathing
- marked decrease in urine output
- low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or seizures in severe cases)
- low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
- 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 may, in severe cases, cause yellowing of the skin and eyes)
- increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
- increased uric acid levels in the blood (which may, in severe cases, cause gout)
- syncope (fainting)
The following side effects have been reported with medicines containing valsartan or hydrochlorothiazide
used alone:
Valsartan
Uncommon: may affect from 1 to 10 users in 1,000
- sensation of dizziness
- abdominal pain
Frequency not known, based on available data
- skin blisters (signs 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 influenza-like symptoms
- skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
- low platelet count in the blood (sometimes with unusual bleeding or bruising)
- increased potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
- allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
- swelling, especially of the face and throat, skin rash, itching
- increased liver function test values
- decreased haemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, may both lead to anaemia)
- kidney failure
- low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or seizures in severe cases)
Hydrochlorothiazide
Very common: may affect more than 1 user in 10
- low potassium levels in the blood
- increased blood lipid levels
Common: may affect from 1 to 10 users in 100
- low sodium levels in the blood
- low magnesium levels in the blood
- high uric acid levels in the blood
- skin rashes with itching or other types of skin rashes
- decreased appetite
- mild nausea and vomiting
- dizziness, fainting when standing up
- inability to achieve or maintain an erection
Rare: may affect from 1 to 10 users in 10,000
- swelling and blistering of 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 disorders, liver disorders which may occur with yellowing of the skin and eyes
- irregular heartbeat
- headache
- sleep disorders
- sadness (depression)
- low platelet count in the blood (sometimes with bleeding or bruising under the skin)
- dizziness
- tingling or numbness
- visual disturbances
Very rare: may affect less than 1 user in 10,000
- inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
- skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
- severe skin disease causing rash, redness of the skin, blistering on 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, shortness of breath, breathlessness (respiratory distress including pneumonia and pulmonary oedema)
- fever, sore throat, more frequent infections (agranulocytosis)
- paleness, fatigue, shortness of breath, dark urine (haemolytic anaemia)
- fever, sore throat or mouth ulcers due to infections (leucopenia)
- confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloraemic alkalosis)
Frequency not known, based on available data
- weakness, bruising and frequent infections (aplastic anaemia)
- excessive reduction in urine production (possible signs of kidney disorder or kidney failure)
- decreased vision 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, skin redness, ulcers on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
- muscle spasms
- fever (pyrexia)
- weakness (asthenia)
- skin and lip cancer (non-melanoma skin cancer)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide
more information on the safety of this medicine.
5. How to store Valsartan and Hydrochlorothiazide Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton. The expiry date refers to the last day of that month.
Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture.
Do not use Valsartan and Hydrochlorothiazide Sandoz if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package Contents and Other Information
What Valsartan and Hydrochlorothiazide Sandoz Contains
The active substances are valsartan and hydrochlorothiazide.
Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
The other components are:
Valsartan and Hydrochlorothiazide Sandoz 80 mg/12.5 mg Film-coated Tablets
Tablet core:
microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica
Tablet coating:
hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Valsartan and Hydrochlorothiazide Sandoz 160 mg/12.5 mg Film-coated Tablets
Tablet core:
microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica
Tablet coating:
hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172).
Valsartan and Hydrochlorothiazide Sandoz 160 mg/25 mg Film-coated Tablets
Tablet core:
microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica
Tablet coating:
hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172).
Valsartan and Hydrochlorothiazide Sandoz 320 mg/12.5 mg Film-coated Tablets
Tablet core:
microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica
Tablet coating:
hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).
Valsartan and Hydrochlorothiazide Sandoz 320 mg/25 mg Film-coated Tablets
Tablet core:
microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica
Tablet coating:
hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Description of the Appearance of Valsartan and Hydrochlorothiazide Sandoz and Package Contents
Valsartan and Hydrochlorothiazide Sandoz 80 mg/12.5 mg Film-coated Tablets
Film-coated tablet, light orange, ovaloid, with slightly convex sides, marked (engraved) with "HGH" on one side and "CG" on the opposite side.
Valsartan and Hydrochlorothiazide Sandoz 160 mg/12.5 mg Film-coated Tablets
Film-coated tablet, dark red, ovaloid, with slightly convex sides, marked (engraved) with "HHH" on one side and "CG" on the opposite side.
Valsartan and Hydrochlorothiazide Sandoz 160 mg/25 mg Film-coated Tablets
Film-coated tablet, brown-orange, ovaloid, with slightly convex sides, marked (engraved) with "HXH" on one side and "NVR" on the opposite side.
Valsartan and Hydrochlorothiazide Sandoz 320 mg/12.5 mg Film-coated Tablets
Film-coated tablet, pink, ovaloid, with beveled edges, marked (engraved) with "NVR" on one side and "HIL" on the opposite side.
Valsartan and Hydrochlorothiazide Sandoz 320 mg/25 mg Film-coated Tablets
Film-coated tablet, yellow, ovaloid, with beveled edges, marked (engraved) with "NVR" on one side and "CTI" on the opposite side.
Valsartan and Hydrochlorothiazide Sandoz 80 mg/12.5 mg Film-coated Tablets
Pack sizes: pack containing 14 or 28 film-coated tablets.
Valsartan and Hydrochlorothiazide Sandoz 160 mg/12.5 mg Film-coated Tablets
Pack sizes: pack containing 28 film-coated tablets.
Valsartan and Hydrochlorothiazide Sandoz 160 mg/25 mg Film-coated Tablets
Pack sizes: pack containing 28 film-coated tablets.
Valsartan and Hydrochlorothiazide Sandoz 320 mg/12.5 mg Film-coated Tablets
Pack sizes: pack containing 28 film-coated tablets.
Valsartan and Hydrochlorothiazide Sandoz 320 mg/25 mg Film-coated Tablets
Pack sizes: pack containing 28 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sandoz S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA)
Italy
Manufacturers Responsible for Batch Release
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
LEK S.A., Ul. Podlipie 16, 95 010 Strykow, Poland
LEK S.A., Ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Lek Pharmaceuticals d.d., Verovskova 57, SI-1526, Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2 D, 9220 Lendava, Slovenia
Novartis Farma S.p.A., Via Provinciale Schito 131, I-800058 Torre Annunziata (NA), Italy
S.C. Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: VALSARTAN E IDROCLOROTIAZIDE SANDOZ 80 mg/12.5 mg film-coated tablets
VALSARTAN E IDROCLOROTIAZIDE SANDOZ 160 mg/12.5 mg film-coated tablets
VALSARTAN E IDROCLOROTIAZIDE SANDOZ 160 mg/25 mg film-coated tablets
VALSARTAN E IDROCLOROTIAZIDE SANDOZ 320 mg/12.5 mg film-coated tablets
VALSARTAN E IDROCLOROTIAZIDE SANDOZ 320 mg/25 mg film-coated tablets