Valsartan and hydrochlorothiazide Teva Italia: detailed information

Package leaflet: Information for the user

Valsartan and Hydrochlorothiazide Teva Italia 80 mg/12.5 mg film-coated tablets, 160 mg/25 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
:

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

1. What Valsartan and Hydrochlorothiazide Teva Italia is and what it is used for

Valsartan and Hydrochlorothiazide Teva Italia film-coated tablets contain two active substances: 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 Italia is used to treat high blood pressure when it is not sufficiently controlled by a single medicine alone.
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, potentially leading 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 Valsartan and Hydrochlorothiazide Teva Italia

Do not take Valsartan and Hydrochlorothiazide Teva Italia:

if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide), or to 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 Teva Italia even during early pregnancy – see section 2: Pregnancy and breastfeeding)
if you have severe liver disorders, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis)
if you have severe kidney disorders
if you are unable to pass urine (anuria)
if you are undergoing treatment with an artificial kidney
if your blood potassium or sodium levels are lower than normal, or if your blood calcium levels are higher than normal despite treatment
if you have gout
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these situations 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 Italia.

If you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin. Your doctor may need to regularly monitor your blood potassium levels.
If your blood potassium levels are low.
If you have diarrhoea or severe vomiting.
If you are taking high doses of medicines that increase fluid elimination (diuretics).
If you have serious heart problems.
If you suffer from heart failure or have 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, use of Valsartan and Hydrochlorothiazide Teva Italia is not recommended.
If you have liver or kidney disease.
If you 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 Italia, 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 triglyceride levels in the blood.
If you have had allergic reactions while using other blood pressure-lowering medicines belonging to the same class (angiotensin II receptor antagonists), or if you suffer from allergies or asthma.
If you experience decreased vision or eye pain. These may 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 Teva Italia. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you have a higher risk of developing this condition.
If you have previously had skin cancer or 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 sun exposure and UV radiation while taking Valsartan and Hydrochlorothiazide Teva Italia.
It may cause increased skin sensitivity 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), especially 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 Italia”.
If any of these situations apply to you, consult your doctor.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Teva Italia 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: “Pregnancy and breastfeeding”).
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
The use of Valsartan and Hydrochlorothiazide Teva Italia is not recommended in children and adolescents (under 18 years of age).
Other medicines and Valsartan and Hydrochlorothiazide Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

The effect of treatment may be influenced if Valsartan and Hydrochlorothiazide Teva Italia 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 (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valsartan and Hydrochlorothiazide Teva Italia
medicines that may cause “torsades de pointes” (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart disorders) 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 supplements of vitamin D and calcium
medicines used to treat diabetes (oral agents such as metformin or insulin)
other medicines that lower blood pressure, 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 Italia” 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 at doses above 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 diseases)
cholestyramine and colestipol (medicines mainly used in the treatment of 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 and Hydrochlorothiazide, food, drinks, and alcohol
Valsartan and Hydrochlorothiazide Teva Italia 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you are pregnant (or if there is a possibility of becoming pregnant).
Your doctor will normally advise you to stop taking Valsartan and Hydrochlorothiazide Teva Italia before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan and Hydrochlorothiazide Teva Italia is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Valsartan and Hydrochlorothiazide Teva Italia is not recommended for breastfeeding mothers. 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 Teva Italia. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Teva Italia may rarely cause dizziness and affect your ability to concentrate.
Valsartan and Hydrochlorothiazide Teva Italia 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 Teva Italia 80 mg/12.5 mg contains Sunset Yellow FCF (E110)
Valsartan and Hydrochlorothiazide Teva Italia contains Sunset Yellow FCF (E110), which may cause allergic reactions.

3. How to take Valsartan and Hydrochlorothiazide Teva Italia

Take this medicine exactly as instructed by your doctor. 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. Many feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Teva Italia 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 Italia 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 Italia with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide Teva Italia 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 Italia
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 missed one.
If you stop taking Valsartan and Hydrochlorothiazide Teva Italia
Stopping treatment with Valsartan and Hydrochlorothiazide Teva Italia 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
These side effects 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 side effects may be serious and require immediate medical attention:
Contact your doctor immediately if you experience symptoms of angioedema such as:

swelling of the face, tongue or throat
difficulty swallowing
hives and difficulty breathing

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 side effects include:
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
diarrhoea
joint pain
Frequency not known
difficulty breathing
markedly reduced urine output
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or convulsions in severe cases)
low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, abnormal heart rhythm)
low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
increased uric acid levels in the blood (which may, in severe cases, lead to gout)
syncope (fainting)

The following side effects have been reported with medicines containing valsartan or
hydrochlorothiazide alone:
Valsartan
Uncommon

dizziness
abdominal pain

Frequency 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 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, skin rash, itching
increased liver function test values
decreased haemoglobin levels and red blood cell percentage in the blood (which, in severe cases, may both lead to anaemia)
kidney failure
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or convulsions 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
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 state
constipation, diarrhoea, stomach or intestinal disturbances, liver disorders which may present with yellowing of the 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

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 of the lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
facial rash, joint pain, muscle disorders, fever (cutaneous lupus erythematosus)
severe pain in the upper abdomen (pancreatitis)
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty, including pneumonia and pulmonary oedema)
fever, sore throat, frequent infections (agranulocytosis)
paleness, fatigue, shortness of breath, dark urine (haemolytic anaemia)
fever, sore throat or mouth ulcers due to infections (leucopenia)
confusion, fatigue, tremor or muscle cramps, laboured breathing (hypochloraemic alkalosis)
Frequency not known
fatigue, easy bruising and frequent infections (aplastic anaemia)
severe reduction in urine output (possible sign of kidney disorder or kidney failure)
decreased vision or eye pain due to high eye pressure (possible sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
skin rash, redness of the skin, blistering of the lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
skin and lip cancer (non-melanoma skin cancer)
muscle cramps
fever (pyrexia)
weakness (asthenia)

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

5. How to store Valsartan and Hydrochlorothiazide Teva Italia

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 any pack of Valsartan and Hydrochlorothiazide Teva Italia that 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. Contents of this leaflet and other information

What Valsartan and Hydrochlorothiazide Teva Italia contains
The active substances are valsartan and hydrochlorothiazide. Each tablet contains 80 or 160 mg of
valsartan and 12.5 or 25 mg of hydrochlorothiazide.
The excipients are: anhydrous colloidal silica, sodium starch glycolate (type A), crospovidone, microcrystalline
cellulose, maize starch, and magnesium stearate.
The coating contains:
Valsartan and Hydrochlorothiazide Teva Italia 80 mg/12.5 mg: Opadry 03F24039 (hypromellose, polyethylene glycol
8000, talc, titanium dioxide (E171), sunset yellow FCF (E110), iron oxide red (E172))
Valsartan and Hydrochlorothiazide Teva Italia 160 mg/25 mg: Opadry 03F26816 (hypromellose, polyethylene glycol
8000, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172)).

Description of the appearance of Valsartan and Hydrochlorothiazide Teva Italia and pack contents
Valsartan and Hydrochlorothiazide Teva Italia 80 mg/12.5 mg
Round, film-coated tablets, pink in colour, with the code "93" imprinted on one side and "7428" on the other side of the tablet.

Valsartan and Hydrochlorothiazide Teva Italia 160 mg/25 mg
Round, film-coated tablets, brown in colour, with the code "93" imprinted on one side and "7430" on the other side of the tablet.

The medicine is available in transparent blisters made of Aluminium/PVC/PE/PVdC.
Pack sizes of 1, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 280 film-coated tablets.
Hospital packs: 30, 50, 56 x 1, 98 x 1, and 280 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 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, The Netherlands
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 medicine is authorized in member states under the following names:
Belgium Co-Valsartan Teva 80 mg/12.5 mg film-coated tablets
Co-Valsartan Teva 160 mg/25 mg film-coated tablets
Denmark Tevavaltan comp.
France VALSARTAN/HYDROCHLOROTHIAZIDE TEVA 80 mg/12.5 mg
film-coated tablet
VALSARTAN/HYDROCHLOROTHIAZIDE TEVA 160 mg/25 mg
film-coated tablet
Italy Valsartan and Hydrochlorothiazide Teva Italia
Valsartan and Hydrochlorothiazide Teva Italia
Netherlands Valsartan/Hydrochloorthiazide 80 mg/12.5 mg PCH, film-coated tablets
Valsartan/Hydrochloorthiazide 160 mg/25 mg PCH, film-coated tablets
United Kingdom Valsartan and Hydrochlorothiazide 160 mg/25 mg Film-coated Tablets