Valsartan premium pharm… – інструкція – Іспанія

Інструкція із застосування Valsartan premium pharma 160 mg comprimidos recubiertos con pelicula efg

Introduction

Package Insert: Information for the Patient

Valsartan

Premium Pharma 160 mg Film-Coated Tablets

valsartan

Read this package insert carefully before taking 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 Premium Pharma and what is it used for

Valsartán Premium Pharma belongs to a class of medications known as angiotensin II receptor antagonists, which 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 Premium Pharma acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Premium Pharma 160 mg film-coated tabletscan be used to treat three different conditions:

to treat 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 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 patientsValsartan Premium Pharma is used when it is not possible to use a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication to treat 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.

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 is not able to pump blood with sufficient force to provide all the blood needed by the body.

2. What you need to know before starting Valsartán Premium Pharma

Do not take Valsartán Premium Pharma:

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 better to avoid Valsartán Premium Pharma 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 the above situations apply to you, inform your doctor and do not take Valsartán Premium Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán Premium Pharmaif you have a 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 (you received a new kidney),
if you have a serious 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 have these symptoms when taking Valsartan Premium Pharma, 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 regularly control the amount of potassium in the blood,
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 Premium Pharma,
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 are taking any of the following medications used to treat high blood pressure:
- a medication that inhibits the angiotensin-converting enzyme (ACEI) (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
- aliskirén

if you are being treated with an ACEI along 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).

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

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

You should inform your doctor if you think you are or may be pregnant. Valsartán Premium Pharma is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartán. Your doctor will decide whether to continue treatment. Do not stop taking valsartán in monotherapy.

Other medications and Valsartán Premium Pharma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The effect of treatment with Valsartán Premium Pharma 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, stop 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 production),ACEIs(such as enalapril, lisinopril, etc.,) oraliskirén(see also the information under the headings “Do not take Valsartán Premium Pharma” and “Warnings and precautions”).
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 (in the group of rifampicin), 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 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 withACEIs(a medication for treating a heart attack),
if you are being treated forheart failure,it is not recommended to take a triple combination withACEIs and other medications specifically used to treat yourheart failure,known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Pregnancy and breastfeeding

Pregnancy

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 Premium Pharma before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Valsartán Premium Pharma. Valsartán Premium Pharma is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding.It is not recommended to use Valsartán Premium Pharma during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

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

3. How to Take Valsartán Premium Pharma

To get the best results and reduce the risk of adverse effects, take this medication exactly as your doctor tells you to. If you are unsure, ask your doctor or pharmacist. People with high blood pressure often do not notice any symptoms of the disease; many feel normal. This makes it very important to attend your doctor's appointments, 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 Premium Pharma with another medication (e.g. a diuretic).

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

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

In patients weighing 35 kg or more, the initial usual 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, usually 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 Premium Pharma can be taken with other treatments for heart attack, and your doctor will decide what 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 Premium Pharma can be taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

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

Take valsartan approximately at the same time every day.

Uncovered dosage with the available presentations of Valsartán Premium Pharma

The available presentations of Valsartán Premium Pharma (80 mg, 160 mg, and 320 mg) do not allow for the administration of the recommended starting dose for the treatment of recent myocardial infarction or heart failure in adults, nor for the treatment of hypertension in children <35>

If you take more Valsartán Premium Pharma 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 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 Valsartán Premium Pharma

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

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

If you interrupt treatment with Valsartán Premium Pharma

If you stop taking Valsartán Premium Pharma, 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.

4. Possible Adverse Effects

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,
difficulty breathing or swallowing,
hives, itching.

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

The 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,
reduction in 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 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.

Very rare(may affect up to 1 in 10,000 people)

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known(cannot be estimated from available data):

blistering on the skin (sign of dermatitis bullosa)
may occur allergic reactions with skin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and joint pain, muscle pain, swelling of 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, 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 high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

The side effects in children and adolescents are similar to those observed 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Valsartán Premium Pharma

Store below 30°C. Store in the original packaging to protect it from moisture.
Keep out of the reach and sight of children.
Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
Do not use Valsartán Premium Pharma if you observe that the packaging is damaged or shows signs of manipulation.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and unused medicines at the SIGRE collection point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Additional Information

Composition of Valsartán Premium Pharma

The active ingredient is valsartan.
A film-coated tablet contains 160 mg of valsartan.
The other components are microcrystalline cellulose, crospovidone, and magnesium stearate.
The tablet coating contains hypromellose, titanium dioxide (E171), Macrogol PGE 8000, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172)..

Appearance of the product and contents of the package

Valsartán Premium Pharma 160 mg film-coated tablets are yellow-orange, oblong, and scored on one side. The tablet can be divided into two equal halves.

The tablets are presented in blister packs containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Premium Pharma SL

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet:February 2025

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

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