PATIENT INFORMATION LEAFLET

Valsartán Tarbis 80 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you:

• Keep this leaflet, as 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Valsartán Tarbis belongs to a group of medications 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 constrict, resulting in increased blood pressure. Valsartán Tarbis acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Tarbiscan be used to treat three different conditions:

-For treating high blood pressure in adults and in children and adolescents aged 6 to 18 years.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

-For treating adult patients after a recent heart attack (myocardial infarction)“Recent” here means between 12 hours and 10 days.

-For treating symptomatic heart failure in adult patients.Valsartán Tarbis is used when it is not possible to use a group of medications called Angiotensin-Converting Enzyme Inhibitors (ACE inhibitors) (a medication for treating heart failure), or it can be used in addition to ACE inhibitors when it is not possible to use other medications for heart failure treatment.Among the symptoms of heart failure are shortness of breath and swelling of feet and legs due to fluid retention. This is because the heart muscle is not able to pump blood with sufficient force to provide the necessary blood supply to the body.

Do not take Valsartán Tarbis

-if you areallergic(hypersensitive) to valsartán or to any of the other components of this medication (listed in section 6).

-if you have aserious liver disease

-if you aremore than 3 months pregnant(it is also recommended to avoid Valsartán Tarbis during the first months of pregnancy; see Pregnancy section).

-if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén

If any of these situations apply to you, do not take Valsartán Tarbis.

Warnings and precautions:

Be especially careful with Valsartán Tarbis:

-if you have liver disease.

-if you have a serious kidney disease or if you are undergoing dialysis.

-if you have a narrowing of the kidney artery.

-if you have recently undergone a kidney transplant (received a new kidney).

-if you are being treated for a heart attack or heart failure, your doctor may check your kidney function.

-if you have a severe heart disease other than heart failure or heart attack.

-if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACEIs), inform your doctor. If you experience these symptoms when taking Valsartán Tarbis, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.

-if you are using medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to have your potassium levels checked regularly.

-if you are under 18 years of age and taking Valsartán Tarbis in combination with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor may check your kidney function and potassium levels regularly.

-if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Valsartán Tarbis.

-if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine production).

-you should inform your doctor if you think you are (or could be) pregnant. Valsartán Tarbis is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if used during this period (see Pregnancy section).

-if you are taking any of the following medications used to treat high blood pressure:

- “an angiotensin-converting enzyme inhibitor (ACEI)” (such as enalapril, lisinopril, etc.), especially if you have kidney problems related to diabetes.

- aliskirén.

-if you are being treated with an ACEI in combination with other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

If any of these information applies to you, inform your doctor before taking Valsartán Tarbis.

Your doctor may check your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Valsartán”

Use of Valsartán Tarbis with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The effect of treatment with Valsartán Tarbis may be altered if taken with certain medications. You may need to change the dose, take other precautions, or, in some cases, discontinue one of the medications. This applies to both prescription and over-the-counter medications, especially:

-other medications that lower blood pressure, especiallydiuretics(medications to increase urine production), ACEIs (such as enalapril, lisinopril, etc.), or aliskirén.

-medications that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.

-certain pain medicationscalled nonsteroidal anti-inflammatory drugs (NSAIDs).

-some antibiotics (in the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán Tarbis.

-lithium, a medication used to treat certain types of psychiatric disorders.

-if you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Valsartán” and “Warnings and precautions”).

-if you are being treated with an ACEI in combination with other medications specifically used to treat your heart failure, known as MRAs (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Additionally:

-if you are being treated aftera heart attack, it is not recommended to combine withACEIs(a medicationfor treating a heart attack)

-if you are being treated forheart failure, it is not recommended to take a triple combination withACEIs and beta-blockers(a medicationfor treating a heart attack).

Taking Valsartán Tarbis with food and drinks

You can take Valsartán Tarbis with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

-You should inform your doctor if you suspect you are pregnant or could be.Generally, your doctor will advise you to stop taking Valsartán Tarbis before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Valsartán Tarbis. Valsartán Tarbis is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if used during this period.

-Inform your doctor if you are breastfeeding or plan to start.Valsartán Tarbis is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to start breastfeeding, especially if your baby is newborn or premature.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know how Valsartán Tarbis affects you. Like many other medications used to treat high blood pressure, Valsartán Tarbis may cause, in rare cases, dizziness and affect concentration.

To get the best results and reduce the risk of adverse effects, take Valsartán Tarbis exactly as your doctor tells you to. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not notice any signs of the disease, and many feel normal. This makes it very important to keep your appointments with your doctor even if you feel well.

Adult patients with high blood pressure:

The usual dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). You may also take Valsartán Tarbis with another medication (e.g., a diuretic).

Use in children and adolescents (6 to 18 years old) with high blood pressure:

In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once a day.

In patients weighing 35 kg or more, the recommended starting dose is 80 mg of valsartan once a day.

In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack:

After a heart attack, treatment usually starts at 12 hours, typically with a low dose of 20 mg, administered twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartán Tarbis can be taken with other treatments for a heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure:

Treatment usually starts with 40 mg twice a day. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartán Tarbis can be taken with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

You can take Valsartán Tarbis with or without food. Swallow Valsartán Tarbis with a glass of water.

Take Valsartán Tarbis approximately at the same time every day.

If you take more Valsartán Tarbis than you should:

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or call the Toxicological Information Service, phone 91-562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartán Tarbis:

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

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

If you interrupt treatment with Valsartán Tarbis:

If you stop taking the medication, your condition may worsen. Do not stop taking the medication unless your doctor tells you to.

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

These side effects may occur with certain frequencies, which are defined below:

-Very common: may affect more than 1 in 10 patients.

-Common: may affect between 1 and 10 in 100 patients.

-Uncommon: may affect between 1 and 10 in 1000 patients.

-Rare: may affect between 1 and 10 in 10,000 patients.

-Very rare: may affect less than 1 in 10,000 patients.

-Frequency not known: the frequency cannot be estimated from the available data.

Some symptoms that require immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

-Swelling in the face, lips, tongue, or throat

-Difficulty breathing or swallowing

-Hives, itching

If you experience any of these symptoms,stop taking Valsartán Tarbis and contact your doctor immediately (see also section 2 “Be careful with Valsartán Tarbis”).

The side effects include:

Common

-Dizziness

-Low blood pressure with or without symptoms such as dizziness and fainting when standing up

-Reduction in kidney function (signs of renal deterioration)

Uncommon

-Angioedema (see section “Some symptoms that require immediate medical attention”)

-Sudden loss of consciousness (syncope)

-Sensation of rotation (vertigo)

-Marked reduction in kidney function (signs of acute renal insufficiency)

-Muscle spasms, abnormal heart rhythm (signs of hyperkalemia)

-Shortness of breath, difficulty breathing while lying down, swelling of the feet or legs (signs of heart failure)

-Headache

-Cough

-Abdominal pain

-Nausea

-Diarrhea

-Fatigue

-Weakness

Frequency not known

-Blisters on the skin (sign of dermatitis herpetiformis)

-You may experience allergic reactions with skin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to the flu

-Reddish-purple spots, fever, itching (signs of inflammation of the blood vessels, also known as vasculitis)

-Bleeding or bruising more frequently than usual (signs of thrombocytopenia),

-Muscle pain (myalgia)

-Fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia)

-Reduction in hemoglobin level and reduction in the percentage of red blood cells in the blood (which, in severe cases, may cause anemia)

-Increased potassium level in the blood (which, in severe cases, may cause muscle spasms and abnormal heart rhythm)

-Elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, may cause the skin and eyes to turn yellow)

-Increased urea nitrogen level in the blood and increased serum creatinine level (which may indicate renal anomalies)

-Low sodium level in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduction in kidney function were observed less frequently in adult patients treated for hypertension than in adult patients treated for heart failure and after a recent heart attack.

The side effects in children and adolescents are similar to those observed in adults.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from light.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Valsartán Tarbis

The active ingredient is valsartan. Each film-coated tablet contains 80 mg of valsartan.

The other components are: microcrystalline cellulose, powdered cellulose, crospovidone, and magnesium stearate.

The coating of the tablet contains hypromellose, titanium dioxide (E171), Macrogol 8000, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the Product and Contents of the Package

Valsartán Tarbis 80 mg film-coated tablets are pink, round, and scored on one face.

They are presented in packages of 14, 28, 30, 56, and 90 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the Marketing Authorization and Responsible Manufacturer

Holder of the Marketing Authorization:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible Manufacturer:

Laboratorios Lesvi, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

This Medicinal Product is Authorized in the Member States of the European Economic Area with the Following Names:

Portugal: Valsartan Qualigen

Spain: Valsartán Tarbis 80 mg film-coated tablets EFG

Last Review Date of this Leaflet: November 2015

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.