VALSARTAN/HYDROCHLOROTHIAZIDE AUROVITAS 80 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan/Hydrochlorothiazide Aurovitas 80 mg/12.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Valsartan/Hydrochlorothiazide Aurovitas and what is it used for
2. What you need to know before you take Valsartan/Hydrochlorothiazide Aurovitas
3. How to take Valsartan/Hydrochlorothiazide Aurovitas
4. Possible side effects
5. Storage of Valsartan/Hydrochlorothiazide Aurovitas
6. Contents of the pack and other information

1. What is Valsartan/Hydrochlorothiazide Aurovitas and what is it used for

Valsartan/Hydrochlorothiazide Aurovitas film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in 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 class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also decreases blood pressure.

Valsartan/hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders.

2. What you need to know before you take Valsartan/Hydrochlorothiazide Aurovitas

Do not take Valsartan/Hydrochlorothiazide Aurovitas

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances 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 also better to avoid the use of valsartan/hydrochlorothiazide at the start of pregnancy – see section Pregnancy).
• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney disease.
• if you are unable to produce urine (anuria).
• if you are undergoing dialysis.
• if you have low levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment.
• if you have gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of these situations apply to you, inform your doctor and do not take valsartan/hydrochlorothiazide.

Warnings and precautions

Consult your doctor

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its 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 rays while taking valsartan/hydrochlorothiazide.
• if you are using potassium-sparing medications, potassium supplements, salt substitutes that contain potassium, or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels.
• if you have low levels of potassium in your blood.
• if you experience severe diarrhea or vomiting.
• if you are taking high doses of diuretics.
• if you have severe heart disease.
• if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.
• if you have a narrowing of the kidney artery.
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of valsartan/hydrochlorothiazide is not recommended.
• if you have kidney or liver disease.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan/hydrochlorothiazide, stop taking valsartan/hydrochlorothiazide immediately and never take it again. See also the section 4 “Possible side effects”.
• if you have fever, rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, a known autoimmune disease).
• if you have diabetes, gout, high cholesterol or triglyceride levels in your blood.
• if you have previously had allergic reactions with the use of another medication in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur during a period of time ranging from several hours to weeks after taking valsartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be more likely to develop it if you have previously been allergic to penicillin or sulfonamides.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking valsartan/hydrochlorothiazide, see your doctor immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Valsartan/Hydrochlorothiazide Aurovitas”.

Valsartan/hydrochlorothiazide may cause increased sensitivity of the skin to the sun.

The use of valsartan/hydrochlorothiazide is not recommended in children and adolescents (under 18 years of age).

If you suspect that you are pregnant (or might be), you must inform your doctor. Valsartan/hydrochlorothiazide is not recommended for use at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

Other medicines and Valsartan/Hydrochlorothiazide Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of treatment with valsartan/hydrochlorothiazide may be altered if taken with certain medicines. It may be necessary to change the dose, take other precautions, or, in some cases, stop treatment with one of the medicines. This is especially applicable to the following medicines:

• lithium, a medicine used to treat certain types of psychiatric disorders.
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines to urinate), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
• certain antibiotics (of the rifampicin group), a medicine used to protect against rejection after a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of valsartan/hydrochlorothiazide.
• medicines that can induce “torsades de pointes” (irregular heartbeats), such as anti-arrhythmics (medicines used to treat heart problems) and some antipsychotics.
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics.
• medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone.
• therapeutic vitamin D and calcium supplements.
• medicines for treating diabetes (oral antidiabetics such as metformin, or insulin).
• other medicines for lowering blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide Aurovitas” 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 can increase blood sugar levels, such as diazoxide or beta-blockers.
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
• medicines for pain, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in doses above 3 g.
• muscle relaxants, such as tubocurarine.
• anticholinergic medicines (medicines used to treat a wide range of disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia).
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases).
• cholestyramine and colestipol (medicines used primarily to treat high lipid levels in the blood).
• cyclosporin, a medicine used to prevent organ rejection after transplantation.
• alcohol, sleeping pills, and anesthetics (medicines with a sedative or pain-relieving effect used, for example, in case of surgery).
• iodinated contrast media (used for diagnostic imaging examinations).

Taking Valsartan/Hydrochlorothiazide Aurovitas with food, drinks, and alcohol

Avoid taking alcohol until you have consulted your doctor. Alcohol can further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and breastfeeding

• You must inform your doctor if you suspect that you are pregnant (or might be)

Normally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead of valsartan/hydrochlorothiazide. Valsartan/hydrochlorothiazide is not recommended for use at the start of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

• Tell your doctor if you are about to start or are breastfeeding

Valsartan/hydrochlorothiazide is not recommended for use in women during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially to newborns or premature babies.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know how you react to the effects of valsartan/hydrochlorothiazide. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide can, in rare cases, cause dizziness and affect your ability to concentrate.

Valsartan/Hydrochlorothiazide Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Valsartan/Hydrochlorothiazide Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; this is essentially “sodium-free”.

3. How to take Valsartan/Hydrochlorothiazide Aurovitas

Follow the instructions for administration of this medicine exactly as indicated by your doctor. This will help you achieve the best results and reduce the risk of side effects. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any signs of the disease; many feel normal. This makes it very important to attend your appointments with your doctor, even if you feel well.

Your doctor will indicate exactly how many valsartan/hydrochlorothiazide tablets you should take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of valsartan/hydrochlorothiazide is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medicine should be taken at the same time every day, usually in the morning.
• You can take valsartan/hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Aurovitas than you should

If you notice a strong 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartan/Hydrochlorothiazide Aurovitas

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for missed doses.

If you stop taking Valsartan/Hydrochlorothiazide Aurovitas

If you stop your treatment with valsartan/hydrochlorothiazide, your hypertension may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious and require immediate medical attention:

• You should visit your doctor immediately if you notice symptoms of angioedema, such as:
  • swelling in the face, tongue, or pharynx.
  • difficulty swallowing.
  • hives and difficulty breathing.
• Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis).
• Sudden decrease in distant vision (acute myopia), decrease in vision, or eye pain due to high ocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Fever, sore throat, increased frequency of infections (agranulocytosis).

These adverse effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop takingvalsartan/hydrochlorothiazideand contact your doctor immediately (see also section 2 "Warnings and Precautions").

Other adverse effects include:

Uncommon:may affect up to 1 in 100 people

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced urination frequency, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g., ringing or buzzing) in the ears

Rare:may affect up to 1 in 10,000 people

• dizziness
• diarrhea
• joint pain

Frequency not known:cannot be estimated from the available data

• difficulty breathing
• severe decrease in diuresis
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculation, and/or convulsions)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, 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, in severe cases, can cause the skin and eyes to turn yellow)
• increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)
• syncope (fainting)

The following adverse effects have been observed with medicines that contain valsartan or hydrochlorothiazide separately:

Valsartan

Uncommon:may affect up to 1 in 100 people

• feeling of rotation
• abdominal pain

Frequency not known:cannot be estimated from the available data

• skin blisters (sign of bullous dermatitis)
• skin rash with or without itching along with some of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of vasculitis)
• low platelet count in the blood (sometimes with bleeding or unusual bruising)
• high potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling, mainly of the face and throat; skin rash; itching
• increased liver function values
• decrease in hemoglobin levels and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia)
• renal failure
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculation, and/or convulsions)

Hydrochlorothiazide

Very common:may affect more than 1 in 10 people

• low potassium levels in the blood
• increased lipids in the blood

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 rash with itching and other types of rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness when standing up
• inability to achieve or maintain an erection

Rare:may affect up to 1 in 1,000 people

• swelling and blisters on the skin (due to increased sun sensitivity)
• high calcium levels in the blood
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic state
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders that may appear along with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (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 rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitches and spasms, rapid breathing (hypochloremic alkalosis)
• acute breathing difficulties (signs include severe breathing difficulties, fever, weakness, and confusion)

Frequency not known:cannot be estimated from the available data

• weakness, bruising, and frequent infections (aplastic anemia)
• severe decrease in urine production (possible sign of kidney disorder or renal failure)
• rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle spasms
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartan/Hydrochlorothiazide Aurovitas

• The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are:

Core of the tablet:microcrystalline cellulose, lactose monohydrate, crospovidone (type B), anhydrous colloidal silica, hypromellose (5 cps), sodium lauryl sulfate, magnesium stearate, talc.

Tablet coating:hypromellose (6 cps), macrogol 8000, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Package Contents

Light orange film-coated tablets, oval, beveled, biconvex, with the mark "I" on one face and "61" on the other.

Valsartan/hydrochlorothiazide is available in blister packs.

Package sizes:

Blister: 14, 28, 56, and 98 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:February 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).