Valsartan and hydrochlorothiazide Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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 they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici is and what it is used for
What you need to know before taking VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici
How to take VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici
Possible side effects
How to store VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici
Contents of the pack and other information

1. What VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generics is and what it is used for

VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generics 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. Hydrochlorothiazide increases the amount of urine produced, thereby reducing blood pressure.

VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generics is used to treat high blood pressure when it is not adequately controlled by a single medicine alone.
When blood pressure is high, the workload on the heart and arteries increases. Over time, this can damage the blood vessels in the brain, heart, and kidneys, potentially leading to heart attack, heart failure, or kidney failure. High blood pressure increases the risk of heart attack.
Bringing blood pressure back to normal levels reduces the risk of developing these conditions.

2. What you should know before taking VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici

Do not take VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici:

if you are allergic to valsartan, hydrochlorothiazide, sulfonamide 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 DOC Generici even in the early stages of pregnancy – see section "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 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 apply to you, do not take this medicine and consult your doctor.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking VALSARTAN and
HYDROCHLOROTHIAZIDE DOC Generici

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 need to check your blood potassium levels regularly
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 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 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 DOC Generici 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 DOC Generici, stop taking it immediately and never take it again. See section 4, "Possible side effects"
if you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease)
if you have diabetes, gout, or elevated cholesterol or blood lipid levels
if you have had allergic reactions when 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 intraocular pressure, which may occur from a few hours to one week after taking VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici. If left untreated, this may lead to permanent vision loss. If you have previously been allergic to penicillins or sulfonamides, you may have a higher risk of developing this condition.
if you are taking any of the following medicines for high blood pressure:
an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), especially 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 monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals
if you have previously 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 radiation while taking VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici.
If you have previously experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici, consult a doctor immediately.

See also the section "Do not take VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici"
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici may cause increased skin sensitivity to sunlight.
The use of VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici is not recommended in children and adolescents (under 18 years of age).
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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 baby if taken during this period (see section "Pregnancy").
Other medicines and VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici
Inform 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 DOC Generici is taken with certain other medicines.
It may be necessary to adjust the dosage, take additional precautions, or, in some cases, stop taking one of the medicines. This particularly applies to the following medicines:

lithium, a medicine used to treat certain psychiatric disorders
medicines or substances that can increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin
medicines that can decrease blood potassium levels, such as diuretics (medicines that increase fluid elimination), corticosteroids, some 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 DOC Generici
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 blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
therapeutic vitamin D and calcium supplements
medicines used to treat diabetes (oral such as metformin or insulin)
other medicines that lower blood pressure, such as methyldopa, ACE inhibitors (e.g., enalapril, lisinopril, etc.), or aliskiren (see also the sections: "Do not take VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici" and "Warnings and precautions")
medicines that 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
medicines for arthritis
muscle relaxants, such as tubocurarine
anticholinergic medicines (used to treat various conditions such as gastrointestinal cramps, bladder spasms, 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 blood lipid levels)
cyclosporine, a medicine used in organ transplantation to prevent organ rejection
alcohol, anaesthetics (medicines with narcotic or painkilling effects used, for example, during surgical procedures), and sedatives
carbamazepine, a medicine used to treat seizures
iodinated contrast agents (used in radiological examinations)

Your doctor may consider it necessary to adjust the dose and/or take other precautions:
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).
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici with food, drinks, and alcohol
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici can be taken with or without food.
Avoid consuming alcohol unless you have discussed it with your doctor. Alcohol may further lower 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 may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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 baby if taken after the third month of pregnancy.
Inform your doctor if you are breastfeeding or planning to breastfeed. VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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 performing other activities requiring concentration, you should be aware of how you react to VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici. Like many other medicines used to treat high blood pressure, VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici may rarely cause dizziness and affect your ability to concentrate.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains lactose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially "sodium-free".
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici contains soybean oil.
If you are allergic to peanuts or soy, do not take this medicine.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 160 mg/12.5 mg also contains Sunset Yellow FCF (E110), which may cause allergic reactions.
If you participate in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms and many feel just 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 DOC Generici you should take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.

The recommended dose 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 DOC Generici with or without food.
Swallow the tablet with a glass of water.

If you take more VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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 DOC Generici
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 DOC Generici
Stopping treatment with VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici may cause your high blood pressure to worsen.
Do not discontinue use of this medicine unless your doctor has instructed you to do so.
If you have any questions 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 experience them.
Some side effects may be serious and require immediate medical attention:
Contact your doctor immediately if you have symptoms of angioedema (an allergic reaction), such as:

swelling of the face, tongue or throat
difficulty swallowing
hives and difficulty breathing
severe skin diseases causing rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling
fever (toxic epidermal necrolysis)
decreased vision or eye pain due to high intraocular pressure (possible sign of acute angle-closure glaucoma)
fever, sore throat, more frequent infections (agranulocytosis)

If you experience any of these symptoms, stop taking VALSARTAN and HYDROCHLOROTHIAZIDE
DOC Generici and contact your doctor immediately (see also section 2 “Warnings and
precautions”).
Other side effects are:
Uncommon (may affect up to 1 in 100 people)

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 up to 1 in 10,000 people)

dizziness
diarrhoea
joint pain

Not known (frequency cannot be estimated from the available data)

difficulty breathing
marked decrease in urine output
low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)
low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, 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 may, in severe cases, cause yellowing of the skin and eyes)
increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
increased blood uric acid levels (which may, in severe cases, cause gout)
syncope (fainting)

The following side effects have been reported with medicines containing valsartan or hydrochlorothiazide
alone:
Valsartan
Uncommon (may affect up to 1 in 100 people)

sensation of dizziness
abdominal pain

Not known (frequency cannot be estimated from the available data)

appearance of blisters on the skin (sign of bullous dermatitis)
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
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 cramps, abnormal heart rhythm)
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
decreased haemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, may both cause anaemia)
renal failure
low sodium levels in the blood (which may cause fatigue, mental 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
skin rashes with itching or other types of skin rashes
decreased appetite
mild nausea and vomiting
feeling of faintness, fainting when standing up
inability to achieve or maintain erection

Rare (may affect up to 1 in 1,000 people)

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 control
constipation, diarrhoea, stomach or intestinal disorders, liver disorders (yellow skin or eyes)
irregular heartbeat
headache
sleep disturbances
sadness (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 skin rashes, red-purple spots, fever (vasculitis)
skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
facial rash, joint pain, muscle disorders, fever (cutaneous lupus erythematosus)
severe upper abdominal pain (pancreatitis)
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty, including pneumonia and pulmonary oedema)
paleness, fatigue, shortness of breath, dark urine (haemolytic anaemia)
fever, sore throat or mouth ulcers due to infections (leucopenia)
confusion, fatigue, tremor and muscle cramp, laboured breathing (hypochloraemic alkalosis)
Acute respiratory distress (signs include severe laboured breathing, fever, weakness and confusion).

Not known (frequency cannot be estimated from the available data)

fatigue, easy bruising and frequent infections (aplastic anaemia)
severe decrease in urine output (possible sign of kidney disorder or renal failure)
rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
muscle cramp
fever (pyrexia)
weakness (asthenia)
skin and lip cancer (non-melanoma skin cancer)
sudden-onset reduction in distance vision (acute myopia), 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).

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: https://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 DOC Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cardboard box or on the blister after
Exp. The expiry date refers to the last day of that month.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generics 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg
film-coated tablets:

PVC/PE/PVDC-Al blisters: Do not store above 30 °C.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generics 320 mg/12.5 mg and 320 mg/25 mg film-coated tablets:
PVC/PE/PVDC-Al blisters: Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 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: Tablet core: Microcrystalline cellulose, Lactose monohydrate, Sodium croscarmellose, Povidone K29-K32, Talc, Magnesium stearate, Anhydrous colloidal silica.
Film coating: [Tablets 80 mg/12.5 mg] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Lecithin (contains soybean oil) (E322), Iron oxide red (E172), Iron oxide yellow (E172), Iron oxide black (E172)
[Tablets 160 mg/12.5 mg] Polyvinyl alcohol, Talc, Macrogol 3350, Titanium dioxide (E171), Iron oxide red (E172), Sunset Yellow FCF Aluminium Lake (E110), Lecithin (contains soybean oil) (E322)
[Tablets 160 mg/25 mg] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Iron oxide yellow (E172), Lecithin (contains soybean oil) (E322), Iron oxide red (E172), Iron oxide black (E172)
[Tablets 320 mg/12.5 mg] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Iron oxide yellow (E172), Lecithin (contains soybean oil) (E322), Iron oxide red (E172)
[Tablets 320 mg/25 mg] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Iron oxide yellow (E172), Lecithin (contains soybean oil) (E322), Iron oxide red (E172)

Description of the appearance of VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici and contents of the
pack
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 80 mg/12.5 mg film-coated tablets:
Pink, oval, biconvex, film-coated tablets, 11 x 5.8 mm in size, engraved with “V” on one side and “H” on the other.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 160 mg/12.5 mg film-coated tablets:
Red, oval, biconvex, film-coated tablets, 15 x 6 mm in size, engraved with “V” on one side and “H” on the other.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 160 mg/25 mg film-coated tablets:
Orange, oval, biconvex, film-coated tablets, 15 x 6 mm in size, engraved with “V” on one side and “H” on the other.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 320 mg/12.5 mg film-coated tablets:
Pink, oval, biconvex, film-coated tablets, 18.9 x 7.5 mm in size, engraved with “V” on one side and “H” on the other.
VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici 320 mg/25 mg film-coated tablets:
Yellow, oval, biconvex, film-coated tablets, 18.9 x 7.5 mm in size, with a breakline on one side and lateral engravings, namely “V” on one side and “H” on the other. The tablet can be divided into two equal parts.
Packaging:
Blister packs: 28 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati, 40
20121 Milan
Italy

Manufacturer responsible for batch release
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy

This medicinal product is authorized in the European Economic Area countries under the following
names:
Italy: VALSARTAN and HYDROCHLOROTHIAZIDE DOC Generici