Valsartan cardio stada 40 mg comprimidos recubiertos con pelicula efg

Package Insert: Information for the Patient

Valsartán Cardio Stada40 mg Tablets

Coated with EFG Film

Read this package insert carefully before starting to take this 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 or pharmacist.
• This medication 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 Valsartán Cardio Stada and how is it used

2.What you need to know before starting to take Valsartán Cardio Stada

3.How to take Valsartán Cardio Stada

4.Possible adverse effects

5.Storage of Valsartán Cardio Stada

6.Contents of the package and additional information

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

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

• to treat high blood pressure 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 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. Valsartán 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 in addition to ACE inhibitors when it is not possible to use other medications for the treatment of heart failure.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 all the blood needed by the body.

Do not take Valsartán Cardio Stada:

• if you areallergic to valsartán or to any of the other components of this medication (listed in section 6)
• if you havesevere liver disease
• if you havediabetes 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 recommended to avoid valsartán during the first months of pregnancy - see Pregnancy section).

If any of these situations affect 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 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 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 regularly monitor the amount of potassium in your blood
• 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 periodically check your renal function and the amount of potassium in your blood
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, valsartán is not recommended
• 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 experienced 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). Valsartán is not recommended for use at 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 on (see Pregnancy section).

• if you aretaking any of the following medications used to treat high blood pressure:
• • a medication that inhibits the angiotensin-converting enzyme (ACE inhibitor) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskirén

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

Your doctor may regularly monitor your renal function, blood pressure, and electrolyte levels (such as potassium) in the blood.

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

Taking Valsartán Cardio 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 valsartán treatment may be altered if taken with certain medications. Your doctor may need to adjust your dose and/or 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 pain reliefcalled 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 an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartán
• if you aretaking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Valsartán Cardio Stada” and “Warnings and precautions”)
• if you are being treated with an ACE inhibitor along with other medications specifically used to treat your heart failure, known as MRAs (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol)

Additionally:

• if you are beingtreated after a heart attack, the combination with ACE inhibitors (a medication for treating a heart attack) is not recommended

Taking Valsartán Cardio Stada with food and drinks

You can take valsartán with or without food.

Pregnancy and breastfeeding

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

• You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking valsartán before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication in place of valsartán. Valsartán is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

• Inform your doctor if you are breastfeeding or plan to start. Valsartán is not recommended for use during 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 your reactions to the effects of valsartán. Like many other medications used to treat high blood pressure, valsartán may cause dizziness and affect concentration.

Valsartán Cardio Stada contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication 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.

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 can be increased to 160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack: treatment is usually initiated at 12hours, typically at a low dose of 20 mg administered twice a day. The 20mgdose 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 can be administered concurrently with other treatments for a heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:treatment is usually initiated with 40mgtwice 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 can be administered concurrently with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

Administration form

You can take Valsartan Cardio Stada with or without food. The tablet can be divided into equal doses. Swallow Valsartan Cardio Stada with a glass of water.

Take Valsartan Cardio Stada approximately at the same time every day.

If you take more Valsartan Cardio Stada than 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 take Valsartan Cardio 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 doses.

If you interrupt treatment withValsartan Cardio Stada

If you stop taking valsartan, your disease 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, valsartan may 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 renal 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 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 (fatigue)
• weakness (asthenia)

Unknown frequency (frequency cannot be estimated from available data)

• blistering on the skin (sign of dermatitis herpetiformis)
• may occur 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-purple spots, fever, itching (signs of vasculitis, also known as inflammation of the blood vessels)
• 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, 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 may 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 use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.
• Do not use this medication if you observe that the packaging is damaged or shows signs of deterioration.
• Do not store at a temperature above 30°C.
• 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. Askyour pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition ofValsartán Cardio Stada

• The active ingredient is valsartán.

Each Valsartán Cardio Stada 40 mg film-coated tablet contains 40 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)

Appearance of the product and contents of the package

Valsartán Cardio Stada 40 mg film-coated tablets are yellow, round, biconvex tablets with a notch on both sides. The tablet can be divided into equal doses.

Valsartán Cardio Stada 40 mg film-coated tablets are presented in aluminum PVC/PVDC blisters of 10, 14, 28, 30, 50, 56, 90, and 98 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 40 mg filmomhulde tabletten

Bulgaria:Valsavil 40 mg ????????? ????????

Denmark:Valsavil 40 mg, filmovertrukne tabletter

Finland:Valsarstad 40 mg tabletti, kalvopäälllysteinen

Germany:Valsartan STADA 40 mg Filmtabletten

Ireland:Valtan 40 mg film-coated tablets

Luxembourg:Valsartan EG 40 mg comprimés pelliculés

Portugal:Valsartan Ciclum

Spain:Valsartán Cardio Stada 40 mg comprimidos recubiertos con película EFG

Sweden:Valsartore 40 mg filmdragerade tabletter

Netherlands:Valsartan CF 40 mg, filmomhulde tabletten

Last review date of this leaflet:November 2020

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