Valsartan Medical Vallei

1. What is Valsartan Medical Valley and what is it used for

Valsartan Medical Valley belongs to a group of medicines called angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan Medical Valley blocks the action of angiotensin II, resulting in the dilation of blood vessels and a decrease in blood pressure.
Valsartan Medical Valley 40 mg can be used to treat the following conditions:

• treatment of high blood pressure in children and adolescents from 6 to 18 years of age.High blood pressure increases the burden on the heart and arteries, and if left untreated, can lead to damage to blood vessels in the brain, heart, and kidneys, as well as cause stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of these disorders.
• treatment of adult patients after a recent heart attack(myocardial infarction). "Recent" means a period of 12 hours to 10 days.
• treatment of symptomatic heart failure in adult patients. Valsartan Medical Valley is used if angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to treat heart failure) cannot be used or Valsartan Medical Valley may be used in combination with ACE inhibitors if other heart failure treatments cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and ankles due to fluid accumulation. They are caused by the heart muscle not being able to pump blood with sufficient force to meet the body's needs.

2. Important information before taking Valsartan Medical Valley

When not to take Valsartan Medical Valley:

• if the patient is allergicto valsartan or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe liver disease.
• if the patient is pregnant more than 3 months(also, Valsartan Medical Valley should be avoided in early pregnancy - see section "Pregnancy and breastfeeding").
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to the patient, Valsartan Medical Valley should not be taken.

Warnings and precautions:

Before taking Valsartan Medical Valley, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver disease;
• if the patient has severe kidney disease or is undergoing dialysis;
• if the patient has narrowing of the renal artery;
• if the patient has recently had a kidney transplant (the patient has received a new kidney);
• if the patient has severe heart disease, other than heart failure or heart attack;
• the patient should inform their doctor if they have ever had swelling of the tongue and face, caused by an allergic reaction (angioedema) when taking other medicines (including ACE inhibitors) - if such symptoms occur while taking Valsartan Medical Valley, the patient should stop taking it immediately and never take it again. See also section 4, "Possible side effects";
• if the patient is taking medicines that increase potassium levels in the blood - these are potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparins; regular monitoring of potassium levels in the blood may be necessary;
• if the patient has hyperaldosteronism (a disease in which the adrenal glands produce too much of a hormone called aldosterone) - in such cases, Valsartan Medical Valley is not recommended;
• in case of significant fluid loss (dehydration) due to diarrhea, vomiting, or the use of high doses of diuretics;
• if the patient is taking any of the following blood pressure-lowering medicines: ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes; aliskiren; if the patient is being treated with an ACE inhibitor in combination with certain other heart failure medicines called mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol). The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Valsartan Medical Valley, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Valsartan Medical Valley on their own.
See also the section "When not to take Valsartan Medical Valley".
The patient should tell their doctor if they are pregnant (or may become pregnant). Valsartan Medical Valley should not be taken in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period (see section "Pregnancy and breastfeeding").

• The patient should inform their doctor if they are breastfeeding or plan to breastfeed.

Valsartan Medical Valley with food and drink

Valsartan Medical Valley can be taken with or without food.

Pregnancy and breastfeeding

Before taking any medicine, the patient should consult their doctor or pharmacist.

• The patient should tell their doctor if they are pregnant, suspect they may be pregnant, or are planning to become pregnant. The doctor will usually recommend stopping Valsartan Medical Valley before becoming pregnant or as soon as pregnancy is confirmed and recommend an alternative medicine instead of Valsartan Medical Valley. Valsartan Medical Valley should not be taken in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period.

3. How to take Valsartan Medical Valley

Valsartan Medical Valley should always be taken exactly as the doctor has instructed to achieve the best results and minimize the risk of side effects. If the patient is unsure, they should ask their doctor or pharmacist. Patients with high blood pressure often do not notice any symptoms. Many of them feel quite well. For this reason, it is especially important to attend doctor's appointments, even if the patient feels well.

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

In patients with a body weight of less than 35 kg, the usual dose of valsartan is 40 mg once daily. In patients with a body weight of 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases, the doctor may recommend a higher dose (the dose of the medicine can be increased to 160 mg, and up to 320 mg).
In the case of children who cannot swallow tablets, an oral solution is recommended.

Adult patients after a recent heart attack

Treatment usually starts 12 hours after the heart attack, usually with a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing a 40 mg tablet. The doctor will gradually increase this dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the patient's tolerance to the medicine.
Valsartan Medical Valley can be given with other medicines used to treat heart attack, and the doctor will decide which treatment is appropriate in each case.

Adult patients with heart failure

Treatment usually starts with a dose of 40 mg twice daily. The doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily.
The final dose depends on the patient's tolerance to the medicine.
Valsartan Medical Valley can be given with other medicines used to treat heart failure, and the doctor will decide which treatment is appropriate in each case.
Valsartan Medical Valley can be taken with or without food. The tablets should be swallowed with a glass of water.
Valsartan Medical Valley should be taken every day at approximately the same time.

Taking a higher dose of Valsartan Medical Valley than recommended

If the patient experiences severe dizziness and/or fainting, they should contact their doctor immediately and lie down. If the patient has taken too many tablets, they should contact their doctor, pharmacist, or go to the nearest hospital.

Missing a dose of Valsartan Medical Valley

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose.
The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Valsartan Medical Valley

Stopping treatment with Valsartan Medical Valley may worsen the disease. The patient should not stop taking the medicine unless their doctor tells them to.
If the patient has any doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Valsartan Medical Valley can cause side effects, although not everybody gets them.

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

There may be symptoms of angioedema (a specific allergic reaction), such as:

• swelling of the face, lips, tongue, or throat,
• difficulty breathing or swallowing,
• hives, itching.

If the patient experiences any of these symptoms, they should stop taking valsartan and contact their doctor immediately (see also section 2 "Warnings and precautions").

Other side effects:

Common:may affect up to 1 in 10 people

• dizziness,
• low blood pressure, with symptoms such as dizziness and fainting when standing up or without such symptoms,
• worsening of kidney function (symptoms of kidney problems).

Uncommon:may affect up to 1 in 100 people

• angioedema (see the section "Some side effects may be serious and may require immediate medical attention"),
• sudden loss of consciousness (fainting),
• feeling of spinning (vertigo),
• significant worsening of kidney function (symptoms of acute kidney failure),
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhea,
• feeling tired,
• weakness.

Rare:may affect up to 1 in 10,000 people
Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown: frequency cannot be estimated from the available data

• blistering of the skin (symptoms of bullous dermatitis),
• allergic reactions with rash, itching, and hives; symptoms such as fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or flu-like symptoms (symptoms of serum sickness),
• purple-red spots, fever, itching (symptoms of vasculitis),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain,
• fever, sore throat, or mouth ulcers due to infection (symptoms of neutropenia),
• decrease in hemoglobin and red blood cell count in the blood (which can lead to anemia in severe cases),
• increase in potassium levels in the blood (which can cause muscle cramps and heart rhythm disturbances in severe cases),
• increase in liver enzyme values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which can cause yellowing of the skin and eyes in severe cases),
• increase in urea and creatinine levels in the blood (which may indicate kidney problems),
• low sodium levels in the blood (which can cause fatigue, disorientation, muscle twitching, and/or seizures in severe cases).

The frequency of some side effects may vary depending on the disease.
For example, such side effects as dizziness and kidney problems are 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.
Side effects observed in children and adolescents are similar to those observed in adult patients.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Valsartan Medical Valley

Do not store above 30°C.
Store in the original package to protect from moisture

• Keep out of the sight and reach of children.
• Do not use Valsartan Medical Valley after the expiry date stated on the packaging.
• The expiry date refers to the last day of the month stated.
• Do not use Valsartan Medical Valley if the packaging is damaged or shows signs of tampering.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Valsartan Medical Valley contains

• The active substance is valsartan. Each film-coated tablet contains 40 mg of valsartan.
• The other ingredients are: microcrystalline cellulose (E 460), colloidal anhydrous silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), maize starch, povidone K25 (E 1201), sodium stearyl fumarate, crospovidone type A (E 1202). Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).

What Valsartan Medical Valley looks like and contents of the pack

Yellow, cylindrical, film-coated tablets with a score line.
Pack sizes: 7, 14, 28, 56, 98, or 280 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
Laboratorios CINFA, S.A.
Olaz Chipi, 10, Polígono Areta
31620 Huarte (Pamplona), SPAIN
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:

Valsartan Xiromed 40 mg filmomhulde tablet

Bulgaria:

Vamadrid 40 mg филмирани таблетки
Estonia:
Vamadrid

Hungary:

Vamadrid 40 mg bevont tabletta

Ireland:

Valsartan Rowa 40 mg film-coated tablets

Italy:

Vamadrid 40 mg compressa rivestita con film

Luxembourg:

Vamadrid 40 mg comprimé pelliculé
Poland:
Valsartan Medical Valley
Portugal:
Vamadrid
Date of last revision of the leaflet:01/2025