Valsartan and hydrochlorothiazide Teva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan and Hydrochlorothiazide Teva 160 mg/12.5 mg film-coated tablets

Valsartan and 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, 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 Teva is and what it is used for
What you need to know before taking Valsartan and Hydrochlorothiazide Teva
How to take Valsartan and Hydrochlorothiazide Teva
Possible side effects
How to store Valsartan and Hydrochlorothiazide Teva
Contents of the pack and other information

1. WHAT VALSARTAN AND HYDROCHLOROTHIAZIDE TEVA IS AND WHAT IT IS USED FOR

Valsartan and Hydrochlorothiazide Teva 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.

Valsartan and Hydrochlorothiazide Teva is used for the treatment of 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 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. Bringing blood pressure back to normal reduces the risk of developing these conditions.

2. What you should know before taking Valsartan and Hydrochlorothiazide Teva

Do not take Valsartan and Hydrochlorothiazide Teva:

if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (chemically related substances to hydrochlorothiazide), or to any of the excipients of this medicine (listed in section 6)
if you are more than 3 months pregnant (it is better to avoid taking Valsartan and Hydrochlorothiazide Teva even in the early stages of pregnancy – see section 2: Pregnancy and breastfeeding)
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 apply to you, do not take this medicine and consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan and Hydrochlorothiazide Teva

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 monitor 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 have 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 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, the use of Valsartan and Hydrochlorothiazide Teva 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 while taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan and Hydrochlorothiazide Teva, stop taking it 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 triglyceride levels in the blood
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 decreased vision or eye pain. These may be symptoms of increased intraocular pressure and may occur from a few hours to a week after taking Valsartan and Hydrochlorothiazide Teva. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulphonamides, you have a higher risk of developing this condition.
it may cause increased sensitivity of the skin to sunlight.
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

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Valsartan and Hydrochlorothiazide Teva".
If any of these apply to you, consult your doctor.
You must inform your doctor if you think you may be pregnant (or if there is any possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Teva 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 2: Pregnancy and breastfeeding).
If you are an athlete: using this medicine without a medical need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
The use of Valsartan and Hydrochlorothiazide Teva is not recommended in children and adolescents (under 18 years of age).
Other medicines and Valsartan and Hydrochlorothiazide Teva with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

The effect of treatment may be affected if Valsartan and Hydrochlorothiazide Teva is taken together with certain other medicines. It may be necessary to adjust the dose, 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 potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
medicines that may decrease potassium levels in the blood, 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), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may enhance the effect of Valsartan and Hydrochlorothiazide Teva
medicines that may induce "torsades de pointes" (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart rhythm disorders) and certain antipsychotics
medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics
medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
therapeutic vitamin D and calcium supplements
medicines used to treat diabetes (oral agents such as metformin or insulin)
other blood pressure-lowering medicines, including methyldopa
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 the sections: "Do not take Valsartan and Hydrochlorothiazide Teva" 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 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 prevent or treat Parkinson’s disease and also to treat or prevent certain viral infections)
cholestyramine and colestipol (medicines primarily used to treat high blood lipid levels)
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/Hydrochlorothiazide Teva with food, drinks and alcohol
Valsartan and Hydrochlorothiazide Teva 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, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is any possibility of becoming pregnant)
Your doctor will normally advise you to stop taking Valsartan and Hydrochlorothiazide Teva before becoming pregnant or as soon as you learn you are pregnant, and will recommend an alternative medicine. Valsartan and Hydrochlorothiazide Teva is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed
Valsartan and Hydrochlorothiazide Teva is not recommended for breastfeeding mothers, 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 tasks requiring concentration, you should be aware of how you react to Valsartan and Hydrochlorothiazide Teva. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Teva may rarely cause dizziness and affect your ability to concentrate.

3. HOW TO TAKE VALSARTAN AND HYDROCHLOROTHIAZIDE TEVA

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms and may feel perfectly well. 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 Teva 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 Teva 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 Teva with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide Teva 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 Teva
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 one.
If you stop taking Valsartan and Hydrochlorothiazide Teva
Stopping treatment with Valsartan and Hydrochlorothiazide Teva may cause your high blood pressure to worsen. Do not discontinue use of this medicine unless instructed to do so by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
These adverse reactions may occur with certain frequencies, defined as follows:

very common: may affect more than 1 in 10 people
common: may affect up to 1 in 10 people
uncommon: may affect up to 1 in 100 people
rare: may affect up to 1 in 1,000 people
very rare: may affect up to 1 in 10,000 people
not known: frequency cannot be estimated from the available data.

Some adverse reactions 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

If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide Teva Italia and contact your doctor immediately (see section 2 “Warnings and Precautions”)
Other adverse reactions are:
Uncommon

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

dizziness
diarrhea
joint pain

Not known

difficulty breathing
marked decrease in urine output
low sodium levels in the blood (which may lead to 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 blood uric acid levels (which may, in severe cases, cause gout)
syncope (fainting)

The following adverse reactions have been reported with medicines containing valsartan or
hydrochlorothiazide alone:
Valsartan
Uncommon

sensation of dizziness
abdominal pain

Not known

skin blisters (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
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 hemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, may both lead to anemia)
kidney failure
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases)

Hydrochlorothiazide
Very common

low potassium levels in the blood
increased blood lipid levels

Common

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 faint, dizziness, fainting when standing up
inability to achieve or maintain erection

Rare

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, diarrhea, stomach or intestinal disturbances, liver disorders that may present with yellowing of the skin or eyes
irregular heartbeat
headache
sleep disturbances
depression
low platelet count in the blood (sometimes with bleeding or bruising under the skin)
dizziness
tingling or numbness
vision disturbances

Very rare

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 diseases 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 (cutaneous lupus erythematosus)
severe upper abdominal pain (pancreatitis)
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary edema)
fever, sore throat, frequent infections (agranulocytosis)
pallor, fatigue, shortness of breath, dark urine (hemolytic anemia)
fever, sore throat or mouth ulcers due to infections (leukopenia)
confusion, fatigue, tremor or muscle spasm, rapid breathing (hypochloremic alkalosis)

Not known

fatigue, easy bruising and frequent infections (aplastic anemia)
severe decrease in urine output (possible sign of kidney disorder or kidney failure)
decreased vision or eye pain due to high intraocular pressure (possible sign of acute angle-closure glaucoma)
skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
muscle cramps
fever (pyrexia)
weakness (asthenia)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Hydrochlorothiazide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.
Do not store above 30 °C.
Do not use Valsartan and Hydrochlorothiazide Teva packs that are damaged or show signs of tampering.
Do not dispose of medicines 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 this leaflet and Other information

What Valsartan and Hydrochlorothiazide Teva contains

The active substances are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other components are anhydrous colloidal silica, sodium starch glycolate (type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate, and Opadry 03F25380 red (hypromellose, polyethylene glycol 8000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)).

Description of the appearance of Valsartan and Hydrochlorothiazide Teva and pack contents

Valsartan and Hydrochlorothiazide Teva 160 mg/12.5 mg film-coated tablets are standard round, convex, red film-coated tablets, marked with the code "VH" on one side.
The medicine is available in packs of 1, 14, 15, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets. Hospital pack: 50 (50 x 1) film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milan, Italy
Manufacturers
Teva UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, Netherlands
Teva Santé SAS, Rue Bellocier, 89107 Sens, France
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Czech Industries, s.r.o., Ostravská 29, č.p. 305, 747 70 Opava –Komárov, Czech Republic
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren-Weiler, Germany
This medicinal product is authorised in the Member States under the following names: