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Leaflet: information for the patient

Valsartán TAD 40mg 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isValsartán TADand what it is used for

2. What you need to know before you start takingValsartán TAD

3. How to takeValsartán TAD

4. Possible side effects

5. Storage ofValsartán TAD

6. Contents of thepack and additional information

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

Valsartán TAD 40mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure inchildren and adolescents aged 6 to less than 18 years.High blood pressure increases the load on 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 increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders,
• to treat adult patients after a recent heart attack(myocardial infarction). “Recent” means here between 12 hours and 10 days,
• to treat symptomatic heart failure in adult patients.ValsartánTADcan be used to treat symptomatic heart failure in adult patients.Valsartán TAD is used when a group of medications called angiotensin-converting enzyme (ACE) inhibitors (a medication for treating heart failure) cannot be used or can be used in combination with ACE inhibitors when another medication for treating heart failure cannot be used).

Among the symptoms of heart failure are difficulty breathing and swelling of feet and legs due to fluid retention. This is because the heart muscle cannot pump blood strongly enough to provide all the blood needed by the body.

Do not take ValsartánTAD.

• If you areallergicto valsartán or 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 better to avoid taking this medication during the first months of pregnancy - see the Pregnancy section).
• If you have diabetes or kidney function impairment and are being treated with a medication used to lower blood pressure that contains aliskirén.

If any of the above situations affect you, inform your doctor and do not take ValsartánTAD.

Warnings and precautions

Consult your doctor or pharmacist before starting to take valsartán:

Your doctor may monitor your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the information under the title "Do not take Valsartán TAD".

You should inform your doctor if you think you are (or could be) pregnant. Valsartán is not recommended 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 you use it during this period (see the Pregnancy section).

If any of these situations affect you, inform your doctor before taking ValsartánTAD.

Other medications and ValsartánTAD

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

• Other medications that lower blood pressure,especiallydiuretics(medications to increase urine elimination), ACE inhibitors (such as enalapril, lisinopril, etc.,) or aliskirén (see also the information under the headings “Do not take Valsartán TAD” and “Warnings and precautions”),
• Medications that increase the amount of potassiumin the blood. Among them are potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin,
• Certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• Some antibiotics (rifampicin group), a medication used to protect against transplant rejection (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán TAD,
• Lithium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• If you are beingtreated after a heart attack,it is not recommended to combine withACE inhibitors(a medication for treating a heart attack),
• If you are beingtreated for heart failure,it is not recommended to combine withACE inhibitors and other medications specifically for treating your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol).

Taking Valsartán TAD with food and drinks

You can take Valsartán TAD regardless of 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 are pregnant, if you suspect you may be, or if you plan to become pregnant.Generally, your doctor will advise you to stop taking Valsartán TAD before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Valsartán is not recommended at the beginning of pregnancy, and it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if used during this period.
• Inform your doctor if you are about to start or are breastfeedingsince it is not recommended to administer Valsartán TAD during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machines

Before driving a vehicle, using tools, or operating machines, or performing other activities that require concentration, make sure you know your reactions to the effects of Valsartán TAD. Like many other medications used to treat high blood pressure, Valsartán TAD may cause dizziness and affect concentration.

Valsartán TAD contains lactose and sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This will help you obtain the best results and reduce the risk of adverse effects. 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 doctor's appointments, even if you feel well.

Children and adolescents (6 to less than 18 years of age) with high blood pressure

In patients weighing less than 35 kg, the recommended starting 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 can 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 is usually started at 12 hours, typically at 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

Valsartan TAD can be taken in combination with other treatments for heart attack, and your doctor will decide what treatment is suitable 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 TAD can be taken in combination with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Valsartan TAD with or without food. Swallow Valsartan TAD with a glass of water. Take Valsartan TAD approximately at the same time every day.

If you take more Valsartan TAD than you should

If you notice a strong dizziness or fainting, contact your doctor immediately and lie down. 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Valsartan TAD

Do not take a double dose to compensate 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 interrupt the treatment with Valsartan TAD

If you stop taking Valsartan TAD, your disease 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 medication, ask your doctor or pharmacist.

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

Some side effects may be serious and may require immediate medical attention:

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

• swelling in the face,lips,tongue or throat,
• difficultybreathing or swallowing,
• urticaria,itching.

If you experience any of these symptoms, stop takingValsartán TADand contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

Frequent(may affect up to 1 in 10 people):

• dizziness,
• low blood pressure with or without symptoms such as dizzinessand fainting when standing up,
• reduction in kidney function (signs of renal deterioration).

Less frequent(may affect up to 1 in 100 people):

• 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 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.

Unknown frequency(cannot be estimated from available data):

• blistering on the skin (sign of dermatitis herpetiformis),

• may occur allergic reactions with skin rash, itching and urticaria: symptoms of serum sickness, such as fever, swelling, muscle pain, swelling of lymph nodes and/or symptoms similar to the flu (signs of serum sickness),
• red purpuric spots, fever, itching (signs of inflammation of blood vessels, also known as vasculitis),
• more frequent bleeding or bruising (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 percentage of red blood cells in the blood (which, in severe cases, may cause anemia),
• increase in 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),
• increase in urea nitrogen level in the blood and increase in 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 kidney function reduction were observed less frequently in adult patients treated for hypertension than in adult patients treated for heart failure or after a recent heart attack.

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

Reporting 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 national notification system:Spanish System for Pharmacovigilance of Medicines for Human Use: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 above 86°F (30°C). Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Valsartán TAD

• The active ingredient is valsartan. Each tablet contains 40 mg of valsartan.

• The other components of the tablet core are lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate.
• The other components of the tablet coating are hypromellose, titanium dioxide (E171), macrogol 4000, and yellow iron oxide (E172).

See section 2 “Valsartán TAD contains lactose and sodium”.

Appearance of the product and contents of the packaging

The film-coated tablets of 40 mg are yellow-brown, round, slightly biconvex, and scored on one of their faces.

The tablets can be divided into equal doses.

The film-coated tablets are presented in blister packs containing 14 tablets.

Marketing Authorization Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany.

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain.

Last revision date of this leaflet: June 2021

“Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”