Validroc

PACKAGE LEAFLET: INFORMATION FOR THE USER

Validroc 80 mg/12.5 mg film-coated tablets, 160 mg/12.5 mg film-coated tablets, 160 mg/25 mg film-coated tablets

Valsartan/hydrochlorothiazide
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 to them.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Validroc is and what it is used for

Validroc 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 and, in this way, helps reduce blood pressure.

Validroc is used to treat high blood pressure when blood pressure is not sufficiently controlled by a single medicine.
When blood pressure is high, the workload on the heart and arteries increases. Over time, this can damage 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 should know before taking Validroc

Do not take Validroc:

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (chemically related substances to hydrochlorothiazide), or to any of the excipients of this medicine (listed in section 6.1)
• if you are more than 3 months pregnant (it is better to avoid taking Validroc even in the early stages of pregnancy – see 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 levels of potassium or sodium 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 situations apply to you, consult your doctor and do not take this medicine.
Warnings and precautions
Consult your doctor before taking VALIDROC:

• if you have previously had skin cancer or if you develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly 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 VALIDROC
• if you are taking potassium-sparing medications, 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 had a heart attack. Follow your doctor’s instructions carefully regarding the starting dose of therapy. Your doctor will also monitor your kidney function
• if you have renal artery stenosis (narrowing of the artery to the kidney)
• if you have recently received a kidney transplant
• if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, use of Validroc is not recommended
• if you have liver or kidney diseases
• 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 Validroc, stop taking Validroc immediately and never take it again. See 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, or elevated cholesterol or blood fat 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 and may occur from hours to weeks after taking Validroc. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulphonamides, 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 regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).
  • if you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If shortness of breath or severe breathing difficulties occur after taking VALIDROC, consult a doctor immediately.

See also information under the heading “Do not take Validroc”
Validroc may increase skin sensitivity to sunlight.
The use of Validroc is not recommended in children and adolescents (under 18 years of age).
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Validroc is not recommended in 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 if taken during this period (see “Pregnancy”).
Other medicines and Validroc
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The effect of treatment may be influenced if Validroc 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 in the treatment of certain psychiatric disorders
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
• medicines that may decrease blood potassium levels, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), and an antiretroviral drug used to treat HIV/AIDS infections (ritonavir). These medicines may enhance the effect of valsartan
• medicines that may induce 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, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also section “Do not take Validroc” 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 in cancer treatment) 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 disorders 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 mainly used to treat high blood fat levels)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcoholic beverages, sedatives, and anaesthetics (medicines with narcotic or pain-relieving effects used, for example, during surgical procedures)
• iodinated contrast agents (used in radiological examinations)

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:

• If you are taking an ACE inhibitor or aliskiren (see also information under: "Do not take Validroc" and "Consult your doctor before taking Validroc").
• 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., metoprololo).

Validroc with food, drinks, and alcohol
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.
Pregnancy
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 Validroc before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine instead of Validroc. Validroc is not recommended in 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 if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to start breastfeeding.
Validroc is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.
Driving and using machines
Before driving a vehicle, operating machinery, or engaging in other activities requiring concentration, you should be aware of how you react to Validroc. Like many other medicines used to treat high blood pressure, Validroc may rarely cause dizziness and affect concentration ability.
Validroc contains lactose.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
If you know you have this intolerance, remember to consult your doctor before taking Validroc.
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Validroc

Always take this medicine exactly as instructed by your doctor. This will help you achieve better results and reduce the risk of unwanted side effects. If you have any doubts, consult your doctor or pharmacist.
People who suffer from high blood pressure often do not notice any signs of this condition 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 Validroc tablets you should take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.

• The recommended dose of Validroc 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 Validroc with or without food.
• Swallow the tablet with a glass of water.

If you take more Validroc 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 Validroc
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next tablet, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Validroc
Stopping treatment with Validroc may cause worsening of high blood pressure. Do not discontinue use of this medicine unless instructed to do so by your doctor.
Use in children and adolescents
Validroc must not be used in children under 18 years of age due to concerns regarding safety and efficacy.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Some adverse effects can be serious and require immediate medical attention:

• Consult your doctor immediately if you have symptoms of angioedema, such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• hives and breathing difficulties
• severe skin disease causing rash, skin redness, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• reduced vision or eye pain due to high intraocular pressure (possible sign of acute angle-closure glaucoma)
• fever, sore throat, more frequent infections (agranulocytosis)

These adverse effects are very rare or their frequency is unknown.
If you experience any of these symptoms, stop taking VALIDROC and contact your doctor immediately (see also section 2 “Warnings and Precautions”).
Other adverse effects are:
Uncommon (may affect up to 1 in 100 people)

• cough
• low blood pressure
• feeling 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 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 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 in the blood (which may indicate kidney dysfunction)
• increased blood uric acid levels (which may, in severe cases, cause gout)
• syncope (fainting)

The following adverse effects have been reported with medicinal products 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 available data)

• appearance of blisters on the skin (sign 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 cramps, irregular heartbeat)
• 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 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 lipid levels

Common (may affect up to 1 in 100 people)

• 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 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
• presence of sugar in the urine
• worsening of diabetic metabolic status
• constipation, diarrhoea, stomach or intestinal disturbances, liver disorders which may present with yellowing of the skin and 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 clouding
• 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 rashes, joint pain, muscle disorders, fever (lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty, 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, laboured breathing (hypochloraemic alkalosis)
• acute respiratory distress (signs include severe laboured breathing, fever, weakness and confusion).

Not known (frequency cannot be estimated from available data)

• fatigue, easy bruising and frequent infections (aplastic anaemia)
• severe decrease in urine output (possible sign of kidney disorder or kidney failure)
• skin 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)
• Rapid-onset reduction in distance vision (acute myopia), decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Validroc

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after . The expiry date refers to the last day of the month.
• Do not store above 30 °C. Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• 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 Validroc contains
The active substances are valsartan and hydrochlorothiazide.
Validroc 80 mg/12.5 mg film-coated tablets: each film-coated tablet contains 80 mg of
valsartan and 12.5 mg of hydrochlorothiazide.
Validroc 160 mg/12.5 mg film-coated tablets: each film-coated tablet contains 160 mg of
valsartan and 12.5 mg of hydrochlorothiazide.
Validroc 160 mg/25 mg film-coated tablets: each film-coated tablet contains 160 mg of
valsartan and 25 mg of hydrochlorothiazide.
The excipients are:
Tablet core:
anhydrous lactose, monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, colloidal silicon dioxide,
and magnesium stearate
Tablet coating:
hypromellose, macrogol 8000, talc, titanium dioxide (E 171);
Validroc 80 mg/12.5 mg also contains red iron oxide (E 172), yellow iron oxide (E 172);
Validroc 160 mg/12.5 mg also contains red iron oxide (E 172);
Validroc 160 mg/25 mg also contains red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172).

Description of the appearance of Validroc and contents of the pack
Validroc tablets are film-coated.
Validroc 80 mg/12.5 mg film-coated tablets are pink, oval-shaped, biconvex tablets.
Validroc 160 mg/12.5 mg film-coated tablets are dark red, oval-shaped, biconvex tablets.
Validroc 160 mg/25 mg film-coated tablets are brown, oval-shaped, biconvex tablets.

Validroc 80 mg/12.5 is available in packs containing 10, 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Validroc 160 mg/12.5 is available in packs containing 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Validroc 160 mg/25 is available in packs containing 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia (RM) - Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) - Italy

This summary of product characteristics was last approved on