Package Insert: Information for the Patient

Valsartan Stada 320 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it 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 or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Valsartan Stada and for what it is used

2.What you need to know before starting to take Valsartan Stada

3.How to take Valsartan Stada

4.Possible adverse effects

5.Storage of Valsartan Stada

6.Contents of the package and additional information

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

Valsartán Stada 320 mg film-coated tabletsmay be used for:

• to treat high blood pressure in adults and in children and adolescents from6 to18 years of age. 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 increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take Valsartán Stada:

• if you are allergic to valsartán or any of the other ingredients of this medication (listed in section 6)
• if you have a severe liver disease
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén
• if you aremore than 3 months pregnant. (It is also best to avoid valsartán during the first months of pregnancy - see Pregnancy section).

If any of these situations apply to you, do not takevalsartán.

Warnings and precautions

Consult your doctor or pharmacist before starting to take valsartán

• if you have liver disease
• if you have 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 (you received a new kidney)
• if you are being treated for a heart attack or heart failure, your doctor may check your renal function
• if you have a severe heart disease other than heart failure or heart attack
• 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 in the blood checked regularly
• if you are under 18 years of age and taking valsartán with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor may check your renal function and potassium levels in the blood periodically
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to takevalsartán
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine production)
• if you have swelling, especially of the face and throat, while taking other medications (including angiotensin-converting enzyme inhibitors). If you develop these symptoms while taking this medication, stop taking it and contact your doctor immediately. You should not take this medication or any other medication containing valsartán again
• inform your doctor if you are pregnant (or if you suspect you may be). It is not recommended to usevalsartánat the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards (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) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes

- aliskirén

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

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

Taking Valsartán Stada 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 withvalsartánmay be altered if taken with certain medications.Your doctor may need to adjust your dose and/or take other precautionsor, in some cases, discontinue treatment with 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)
• litium, a medication used to treat certain types of psychiatric disorders
• some antibiotics (in the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina) or a medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartán.
• ifyou are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskirén (see also the information under the headings “Do not take Valsartán Stada” and “Warnings and precautions”).

Taking Valsartán Stada with food and drinks

You can takevalsartánwith or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be, consult your doctor or pharmacist before using this medication.

• You must inform your doctor if you are pregnant (or if you suspect you may be).Your doctor will usually recommend that you stop takingvalsartánbefore becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead ofvalsartán. It is not recommended to usevalsartánat the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards.

• Inform your doctor if you are breastfeeding or plan to start. It is not recommended to usevalsartánduring breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, 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 you react to the effects ofvalsartán. Like many other medications used to treat high blood pressure,valsartánmay cause dizziness and affect your ability to concentrate.

Valsartán Stada contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Followexactly the administration instructions for this medication as indicated by your doctor. In case of 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 doctor's appointments, even if you feel well.

Patients with high blood pressure: the recommended dose is 80mgper day. In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). Your doctor may also combinevalsartanwith another medication (e.g. a diuretic).

Children and adolescents (6 to18 years old) with high blood pressure

In patients weighing less than35 kg, the recommended dose is 40 mg of valsartan once a day.

In patients weighing35 kgor more, the initial recommended 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).

Administration form

You can takeValsartan Stadawith or without food. The tablet can be divided into equal doses. SwallowValsartan Stadawith a glass of water.

TakeValsartan Stadaapproximately at the same time every day.

If you take moreValsartan Stadathan you should

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

If you forget to takeValsartan Stada

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 compensate for the missed dose.

If you interrupt treatment withValsartan Stada

If you stop takingvalsartan, 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 medication, ask your doctor or pharmacist.

Like all medications,valsartánmay cause side effects, although not everyone will experience them.

Some symptoms 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, consult a doctor immediately.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• reduced kidney function (signs of kidney deterioration)

Rare (may affect up to 1 in 100 people)

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of spinning (vertigo)
• marked reduction in kidney function (signs of acute kidney 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)
• asthenia (weakness)

Unknown frequency (frequency cannot be estimated from available data)

• blistering on the skin (sign of dermatitis herpetiformis)
• may have 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
• red purpuric patches, fever, itching (signs of inflammation of blood vessels, also known as vasculitis)
• more frequent bleeding or bruising 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 percentage of red blood cells in the blood (which, in severe cases, can cause anemia)
• increase in potassium level in the blood (which, in severe cases, can 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, can 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 can cause fatigue, confusion, muscle contractions, and/or seizures in severe cases)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not usethis medicationafter the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.
• Do not usethis medicationif you observe that the packaging is damaged or shows signs of deterioration.
• Do not store at a temperature above 30°C.
• Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE collection pointat the pharmacy. Askyour pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Valsartán Stada

• The active ingredient is valsartán.

Each film-coated tablet ofValsartán Stada 320 mg film-coated tabletscontains 320 mg of valsartán.

• The other components of the core are:

• Lactose monohydrate
• Cellulose, in powder form
• Hydroxypropyl methylcellulose
• Sodium croscarmellose
• Anhydrous colloidal silica
• Magnesium stearate

• The other components of the coating are:

• Hydroxypropyl methylcellulose
• Macrogol 8000
• Titanium dioxide (E171)
• Talc
• Yellow iron oxide (E172)
• Red iron oxide (E172)
• Black iron oxide (E172)

Appearance of the product and contents of the package

Valsartán Stada 320 mg film-coated tabletsare brown, oval, biconvex tablets with a notch on one side. The tablet can be divided into equal doses.

Valsartán Stada 320 mg film-coated tablets are presented in aluminum PVC/PVDC blister packs of10, 14, 28, 30, 50, 56, 90, 98, 100, 112, 126, 154, 168, 182 and 196 tablets.

Only some package sizes may be marketed.

Marketing authorization holder:

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing:

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co.Tipperary

Ireland

or

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

or

Lamp S. Prospero S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

STADA Arzneimittel AG

Stadastraße 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

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

Belgium:Valsartan EG 320 mg filmomhulde tabletten

Denmark:Valsavil 320 mg, filmovertrukne tabletter

Finland:Valsarstad 320 mg tabletti, kalvopäälllysteinen

Germany:Valsartan STADA 320 mg Filmtabletten

Ireland:Valtan 320 mg film-coated tablets

Italy:Valsartan EG 320 mg compresse rivestite con film

Luxembourg:Valsartan EG 320 mg comprimés pelliculés

Portugal:Valsartan Ciclum

Spain:Valsartán Stada320 mg comprimidos recubiertos con película EFG

Sweden:Valsartore320 mg filmdragerade tabletter

Netherlands:Valsartan CF320 mg, filmomhulde tabletten

Last review date of this leaflet:November 2020

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