Package Insert: Information for the User

Valsartán TecniGen 80 mg Film-Coated Tablets

Valsartán

Read this package insert carefully before starting to use the medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Valsartán TecniGen 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 acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán TecniGen 80 mg film-coated tabletscan be usedfor 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 cause damage to blood vessels in the brain, heart, and kidneys and may lead to a stroke, heart failure, or kidney failure. High blood pressureincreases the risk of heart attack. 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” means here between 12 hours and 10 days.

For treating symptomatic heart failure in adult patients.

Valsartán TecniGen 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 may be used added to angiotensin-converting enzyme inhibitors when it is not possible to use other medications for the treatment of heart failure.

The symptoms of heart failure include difficulty breathing, swelling of the feet and legs due to fluid accumulation. This occurs when the heart muscle is unable to pump blood strongly enough to meet the needs of the entire body.

Do not take Valsartán TecniGen

• if you areallergicto the active ingredient or to any of the other components of the medication (listed in section 6)
• if you have asevere liver disease
• if you arepregnantover 3 months(it is also recommended to avoid Valsartán at the beginning of pregnancy; see the pregnancy section).
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskireno.

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

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Valsartán TecniGen

• if you have liver disease,
• if you have a severe 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,
• 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 inflammation of the tongue and face due to an allergic reaction called angioedema while taking another medication (including ACE inhibitors), inform your doctor. If you notice these symptoms while taking Valsartán TecniGen, discontinue treatment immediately and do not take it again. See also section 4 “Adverse Reactions”.
• 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 regularly monitor the amount of potassium in your blood,
• If you are under 18 years of age and taking Valsartán TecniGen in combination with other medications that inhibit the renin-angiotensin-aldosterone system (blood pressure medications), your doctor may check your kidney function and potassium levels in your blood at regular intervals.
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Valsartán.
• 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 suspect you are pregnant (or could be). Valsartán is not recommended for use at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this phase (see Pregnancy section).
• if you are taking any of the following medications used to treat high blood pressure:

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskireno

• - if you are being treated with an ACE inhibitor along with other medications specifically used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

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

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

Use of Valsartán TecniGen with other medications

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

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskireno (see also the information that says “Do not take Valsartán TecniGen” and “Warnings and precautions”).

If you are being treated with an ACE inhibitor along with certain medications used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

The effect of treatment with Valsartán may be altered if taken with certain medications. You may need to change your 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),
• 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 medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (such as rifampicin),ciclosporina (a medication used to prevent transplant rejection) or antiretrovirals used to treat HIV (AIDS) (ritonavir). These medications may increase the effect of valsartan.
• lithium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• if you are being treated aftera heart attack,it is not recommended to combine withACE inhibitors (a medicationfor treating a heart attack)
• if you are being treated forheart failure,it is not recommended to combine withACE inhibitors and beta-blockers (a medicationfor treating a heart attack).

Taking Valsartán TecniGen with food, drinks, and alcohol

You can take Valsartán TecniGen with or without food.

Pregnancy, breastfeeding, and fertility

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 before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Valsartán. Valsartán is not recommended for use at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this phase.
• Inform your doctor if you are breastfeeding or about to start.Valsartán 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 your reactions to the effects of Valsartán. Like many other medications used to treat high blood pressure, Valsartán may cause, in rare cases, dizziness and affect concentration.

To get the best results and reduce the risk of adverse effects, take this medication 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 recommended dose is one 80 mg tablet per day. In some cases, your doctor may prescribe higher doses (for example, 160 mg or 320 mg). Your doctor may also prescribe an additional medication, for example, a diuretic.

Children and adolescents (6 to 18 years) 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 increase to 160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack:

After a recent heart attack, treatment is usually started before 12 hours, usually with a low dose of 20 mg twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase the dose over the next few weeks to a maximum of 160 mg twice a day.

The final dose will depend on your individual tolerance.

Valsartan TecniGen can be taken with other medications for a heart attack, and your doctor will decide which treatment is best for you.

Adult patients with heart failure:The treatment is usually started 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.

Valsartan TecniGen can be taken with other treatments for heart failure, and your doctor will decide which treatment is best for you.

You can take Valsartan with or without food. Swallow the tablet with a glass of water.

Take Valsartan approximately at the same time every day.

The tablet can be divided into two equal doses.

If you take more Valsartan 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 call the Toxicology Information Service, phone 91-562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartan:

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

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.

If you stop taking Valsartan:

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

These side effects may occur at certain frequencies, which are defined as follows:

• Very common: affects more than 1 in 10 patients,
• Common: affects between 1 and 10 in 100 patients,
• Uncommon: affects between 1 and 10 in 1000 patients,
• Rare: affects between 1 and 10 in 10000 patients,
• Very rare: affects less than 1 in 10000 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
• Urticaria (skin rash with itching), pruritus

If you experience any of these symptoms, consult your doctor immediately (see Section 2 “Warnings and precautions”).

Other 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 require immediate medical attention”)
• Sudden loss of consciousness (syncope),
• Sensation of rotation (vertigo),
• Marked reduction in kidney function (signs of acute renal failure),
• 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 bullous dermatitis)
• Allergic reactions with skin rash, itching, and urticaria (skin rash with itching), symptoms of fever, joint inflammation, muscle pain, swelling of the lymph nodes, and/or may occur symptoms similar to the flu (signs of serum sickness),
• Purple spots, fever, itching (signs of inflammation of blood vessels, also known as vasculitis),
• Bleeding or bruising more frequently than usual (signs of thrombocytopenia),
• Muscle pain (myalgia),
• Fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia),
• Reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which, in severe cases, can cause anemia),
• Increased potassium level in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm),
• Elevation of liver function values (which can indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, can cause the skin and eyes to turn yellow),
• Increased urea nitrogen level in the blood and increased serum creatinine level (which can indicate renal anomalies).
• Low sodium level in the blood (which can cause fatigue, confusion, muscle fasciculations, and/or convulsions in severe cases)

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

Side effects in children and adolescents are similar to those seen in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use. Website:www.notificaRAM.es. By 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 Valsartán if you observe that the packaging is damaged or shows signs of deterioration.

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

Composition of Valsartán TecniGen

The active ingredient is Valsartán. Each tablet contains 80 mg of Valsartán.

The other components (excipients) are, in the core: microcrystalline cellulose, crospovidone (Type A), and magnesium stearate. The tablet coating contains hypromellose, titanium dioxide (E171), Macrogol PGE 8000, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

The film-coated Valsartán TecniGen 80 mg tabletsarefilm-coated tablets, pink in color, oval in shape, and scored on one face. The tablet can be divided into two equal halves.

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

Not all packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Tel: 91 383 51 66

Fax: 91 383 51 67

E-mail: [email protected]

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This medicine is authorized in the member states of the European Economic Area with the following names:

Italy: Valsartan Tecnimede 80 mgfilm-coated tablets

Portugal : Valsartan Tecnimede

Romania:Valsartan Tecnimede 80 mg film-coated tablets

Spain: Valsartán Tecnigen 80 mg film-coated tablets

Last reviewed date of this leaflet: June 2015

Further detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es