Patient Information Leaflet

Valsartan and Hydrochlorothiazide Aurobindo 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

Equivalent medicine
Please read all of 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Valsartan and Hydrochlorothiazide Aurobindo is and what it is used for
What you need to know before taking Valsartan and Hydrochlorothiazide Aurobindo
How to take Valsartan and Hydrochlorothiazide Aurobindo
Possible side effects
How to store Valsartan and Hydrochlorothiazide Aurobindo
Contents of the pack and other information
What Valsartan and Hydrochlorothiazide Aurobindo is and what it is used for
Valsartan and Hydrochlorothiazide Aurobindo 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 is lowered.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases urine production, which also helps lower blood pressure.
Valsartan and Hydrochlorothiazide Aurobindo is used to treat high blood pressure that is not adequately controlled by a single active substance alone.

High blood pressure 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 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 Valsartan and Hydrochlorothiazide Aurobindo

Do not take Valsartan and Hydrochlorothiazide Aurobindo
if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances
to hydrochlorothiazide), or any of the excipients of this medicine (listed in section 6);
if you are more than 3 months pregnant (it is also better to avoid Valsartan and Hydrochlorothiazide Aurobindo
in early pregnancy – see the section on pregnancy);
if you have severe liver problems, destruction of the small bile ducts within the liver (biliary cirrhosis)
leading to bile accumulation in the liver (cholestasis);
if you have severe kidney problems;
if you are unable to urinate (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 level is 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 apply to you, speak with your doctor and do not take this medicine.
Warnings and precautions
Contact your doctor or pharmacist before taking Valsartan and Hydrochlorothiazide Aurobindo:
if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt
substitutes, or other medicines that increase potassium levels in the blood, such as heparin. Your doctor
may wish to check your blood potassium levels regularly;
if you have low levels of potassium in your blood;
if you have diarrhoea or severe vomiting;
if you are taking high doses of diuretics;
if you have a serious heart condition;
if you suffer from heart failure or have had a heart attack. Follow your doctor’s instructions carefully
regarding the starting dose of treatment. Your doctor will also monitor your kidney function;
if you have narrowing of the renal artery;
if you have recently received a new 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 and Hydrochlorothiazide Aurobindo is not
recommended;
if you have liver or kidney disease;
if you have previously experienced swelling of the tongue and face due to an allergic reaction called
angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these
symptoms occur while taking Valsartan and Hydrochlorothiazide Aurobindo, stop taking it immediately and
never take it again. See also section 4 “Possible side effects”;
if you have fever, rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called
autoimmune disease);
if you have diabetes, gout, high cholesterol or triglyceride levels in the blood;
if you have had allergic reactions with other antihypertensive agents of the same class (angiotensin II
receptor antagonists), or if you have allergies or asthma;
if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the
vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few
hours to weeks after taking Valsartan and Hydrochlorothiazide Aurobindo. If untreated, this may lead to
permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher
risk of developing this condition;
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 have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking
Valsartan and Hydrochlorothiazide Aurobindo.
Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in
your blood at regular intervals.
See also the information in the section “Do not take Valsartan and Hydrochlorothiazide Aurobindo”.
Valsartan and Hydrochlorothiazide Aurobindo may cause increased skin sensitivity to sunlight.
The use of Valsartan and Hydrochlorothiazide Aurobindo is not recommended in children and adolescents (under
18 years of age).
You must inform your doctor if you think you are (or might be) pregnant. Valsartan and Hydrochlorothiazide
Aurobindo is not recommended during early pregnancy and must not be taken if you are more than 3 months
pregnant, as it may cause severe harm to the unborn child (see the pregnancy section).
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may
nonetheless result in a positive anti-doping test.
Other medicines and Valsartan and Hydrochlorothiazide Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The effect of treatment may be affected if Valsartan and Hydrochlorothiazide Aurobindo is taken together with
certain other medicines. It may be necessary to adjust the dose, take additional precautions, or in some
cases, discontinue one of the medicines. This particularly applies to the following medicines:
lithium, a medicine used to treat certain psychiatric disorders;
medicines or substances that may increase potassium levels in the blood. These include potassium
supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
medicines that may reduce potassium levels in the blood, such as diuretics (medicines that increase fluid
excretion), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
certain antibiotics (belonging to the rifampicin group), a medicine used to prevent transplant rejection
(cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These
medicines may enhance the effect of Valsartan and Hydrochlorothiazide Aurobindo;
medicines that may cause torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines
used to treat heart problems) and certain antipsychotics;
medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics,
antiepileptics;
medicines used to treat gout such as allopurinol, probenecid, sulfinpyrazone;
therapeutic supplements of vitamin D and calcium;
medicines used to treat diabetes (oral agents such as metformin or insulin);
other medicines that lower blood pressure such as methyldopa, ACE inhibitors (such as enalapril, lisinopril,
etc.) or aliskiren (see also the sections “Do not take Valsartan and Hydrochlorothiazide Aurobindo” 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 selective cyclooxygenase-2
(Cox-2) inhibitors and acetylsalicylic acid > 3 g;
muscle relaxants such as tubocurarine;
anticholinergic medicines (used to treat various conditions such as gastrointestinal cramps, bladder
spasm, asthma, motion sickness, muscle spasms, Parkinson’s disease, and to facilitate anaesthesia);
amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral
infections);
cholestyramine and colestipol (medicines used to treat high lipid levels in the blood);
cyclosporine, a medicine used in organ transplantation to prevent organ rejection;
alcohol, sedatives, and anaesthetics (medicines with narcotic or pain-relieving effects used, for example,
during surgical procedures);
iodinated contrast agents (used in radiological examinations).
Valsartan and Hydrochlorothiazide Aurobindo with food, drinks and alcohol
You may take Valsartan and Hydrochlorothiazide Aurobindo with or without food.
Avoid consuming alcohol until 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, are planning a pregnancy, or are breastfeeding, consult
your doctor or pharmacist before taking this medicine.
You must inform your doctor if you think you are (or might be) pregnant
Normally, your doctor will advise you to stop taking Valsartan and Hydrochlorothiazide Aurobindo before
becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
Valsartan and Hydrochlorothiazide Aurobindo is not recommended during early pregnancy and must not be
taken after the third month of pregnancy, as it may cause severe harm to your unborn child if used after the
third month of pregnancy.
Inform your doctor if you are breastfeeding or starting to breastfeed.
Valsartan and Hydrochlorothiazide Aurobindo is not recommended for women who are breastfeeding and
wish to continue breastfeeding; your doctor may choose an alternative treatment for you, especially if your
baby is a newborn or was born prematurely.
Driving and using machines
Before driving, operating tools or machinery, or performing activities requiring concentration, ensure you
understand how Valsartan and Hydrochlorothiazide Aurobindo affects you. Like many other medicines used
to treat high blood pressure, Valsartan and Hydrochlorothiazide Aurobindo may occasionally cause dizziness
and affect your ability to concentrate.
Valsartan and Hydrochlorothiazide Aurobindo contains lactose. If your doctor has diagnosed you with an
intolerance to certain sugars, contact him before taking this medicine.
Valsartan and Hydrochlorothiazide Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially ‘sodium-free’.

3. How to take Valsartan and Hydrochlorothiazide Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. This
will help you achieve the best 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 signs of this condition. Many may feel quite normal.
Therefore, it is important that you attend all your doctor's appointments, even if you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Aurobindo 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 Aurobindo is one tablet daily.
Do not change the dose and do not stop taking the tablets without consulting your doctor.
The medicine should be taken every day at the same time, usually in the morning.
You may take Valsartan and Hydrochlorothiazide Aurobindo with or without food.
Swallow the tablet with a glass of water.
If you take more Valsartan and Hydrochlorothiazide Aurobindo 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 Aurobindo
If you miss 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 a forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide Aurobindo
Stopping treatment with Valsartan and Hydrochlorothiazide Aurobindo may cause your high blood pressure to worsen. Do not stop taking the medicine unless your doctor tells you to do so.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention:
You must 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;
severe skin diseases causing rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis);
decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
fever, sore throat, more frequent infections (agranulocytosis).
These side effects are very rare or their frequency is unknown.
If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide Aurobindo
and contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other side effects include:
Uncommon (may affect up to 1 in 100 people):
cough;
low blood pressure;
dizziness;
dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark-coloured urine, dry skin);
muscle pain;
fatigue;
tingling or numbness;
blurred vision;
noises (e.g. ringing or buzzing) in the ears.
Very rare (may affect up to 1 in 10,000 people):
dizziness;
diarrhoea;
joint pain.
Frequency not known (cannot be estimated from the available data):
difficulty breathing;
greatly reduced urine production;
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, 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 may, in severe cases, lead to 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 gout);
syncope (fainting).
The following side effects have been reported with medicines containing valsartan or hydrochlorothiazide
used alone:
Valsartan
Uncommon (may affect up to 1 in 100 people):
dizziness;
abdominal pain.
Frequency not known (cannot be estimated from the available data):
blisters on the skin (sign of bullous dermatitis);
rash with or without itching, together with one or more of the following signs and symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms;
rash, red-purple spots, fever, itching (signs of inflammation of blood vessels);
low platelet count in the blood (sometimes with unusual bleeding or bruising);
increased potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat);
allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness);
swelling, especially of the face and throat; rash; itching;
increased liver function test values;
reduction in haemoglobin levels and percentage of red blood cells in the blood (which may, in severe cases, 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 in 10 people):
low potassium levels in the blood;
increased blood lipids.
Common (may affect up to 1 in 10 people):
low sodium levels in the blood;
low magnesium levels in the blood;
high uric acid levels in the blood;
rash with itching and other types of rashes;
reduced appetite;
mild nausea and vomiting;
feeling faint, fainting when standing;
inability to achieve or maintain erection.
Rare (may affect up to 1 in 1,000 people):
skin swelling and pustules (due to increased sensitivity to sunlight);
high calcium levels in the blood;
high blood sugar levels;
sugar in the urine;
worsening of diabetic metabolic control;
constipation, diarrhoea, gastrointestinal discomfort, liver disorders which may occur together with yellowing of the skin or eyes;
irregular heartbeat;
headache;
sleep disorders;
low mood (depression);
low platelet count in the blood (sometimes with bleeding or bruising under the skin);
dizziness;
tingling or numbness;
vision disturbances.
Very rare (may affect up to 1 in 10,000 people):
inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis);
rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions);
facial rash, joint pain, muscle disorders, fever (lupus erythematosus);
severe upper abdominal pain (pancreatitis);
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary oedema);
pallor, fatigue, shortness of breath, dark urine (haemolytic anaemia);
fever, sore throat or mouth ulcers due to infections (leucopenia);
confusion, fatigue, tremor and muscle cramps, rapid breathing (hypochloraemic alkalosis).
Frequency not known (cannot be estimated from the available data):
fatigue, easy bruising and frequent infections (aplastic anaemia);
severe reduction in urine output (possible sign of kidney disorder or kidney failure);
rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme);
muscle cramps;
fever (pyrexia);
weakness (asthenia);
skin and lip cancer (non-melanoma skin cancer).
Reporting of side effects
If you get any side effects, including ones 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Valsartan and Hydrochlorothiazide Aurobindo contains
The active substances are valsartan and hydrochlorothiazide.
Valsartan and Hydrochlorothiazide Aurobindo 80 mg/12.5 mg tablets contain 80 mg of valsartan and 12.5 mg of
hydrochlorothiazide (HCTZ) as active substances.
Valsartan and Hydrochlorothiazide Aurobindo 160 mg/12.5 mg tablets contain 160 mg of valsartan and 12.5 mg
of hydrochlorothiazide (HCTZ) as active substances.
Valsartan and Hydrochlorothiazide Aurobindo 160 mg/25 mg tablets contain 160 mg of valsartan and 25 mg of
hydrochlorothiazide (HCTZ) as active substances.
Valsartan and Hydrochlorothiazide Aurobindo 320 mg/12.5 mg tablets contain 320 mg of valsartan and 12.5 mg
of hydrochlorothiazide (HCTZ) as active substances.
Valsartan and Hydrochlorothiazide Aurobindo 320 mg/25 mg tablets contain 320 mg of valsartan and 25 mg of
hydrochlorothiazide (HCTZ) as active substances.

The other components are:
Tablet core
Microcrystalline cellulose, lactose monohydrate, crospovidone, anhydrous colloidal silica, hypromellose, sodium
lauryl sulfate, magnesium stearate, talc.

Film coating
80 mg/12.5 mg and 160 mg/12.5 mg:
Hypromellose, polyethylene glycol 8000, talc, titanium dioxide (E171), iron oxide yellow, iron oxide red.
160 mg/25 mg:
Hypromellose, polyethylene glycol 4000, talc, titanium dioxide (E171), iron oxide yellow, iron oxide black, iron oxide red.
320 mg/12.5 mg:
Hypromellose, polyethylene glycol 4000, talc, titanium dioxide (E171), iron oxide red, iron oxide black.
320 mg/25 mg:
Hypromellose, polyethylene glycol 4000, talc, titanium dioxide (E171), iron oxide yellow.

Description of the appearance of Valsartan and Hydrochlorothiazide Aurobindo and contents of the pack
Film-coated tablet.
80 mg/12.5 mg
Light orange, ovaloid, bevelled-edged, biconvex film-coated tablets, with "I" engraved on one side and "61" on the other.
160 mg/12.5 mg
Dark red, ovaloid, bevelled-edged, biconvex film-coated tablets, with "I" engraved on one side and "62" on the other.
160 mg/25 mg
Brown-orange, ovaloid, bevelled-edged, biconvex film-coated tablets, with "I" engraved on one side and "63" on the other.
320 mg/12.5 mg
Pink, oval, bevelled-edged, biconvex film-coated tablets, with "I" engraved on one side and "64" on the other.
320 mg/25 mg
Yellow, oval, bevelled-edged, biconvex film-coated tablets, with "I" engraved on one side and "65" on the other.

Valsartan and Hydrochlorothiazide tablets are available in colourless PVC/Aclar-aluminium blister packs.

Packs:
Blister: 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD.
United Kingdom

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Valsartan e Idroclorotiazide Aurobindo
Netherlands: Valsartan/Hydrochloorthiazide Auro 80 mg/12.5 mg; 160 mg/12.5 mg; 160 mg/25 mg; 320 mg/12.5 mg; 320 mg/25 mg, filmomhulde tabletten