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 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 80 mg and 160 mg can be used to treat three different diseases:

• to treat high blood pressure in adult patients and in children and adolescents from 6 to 18 years of age.High blood pressure increases the strain 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.
• to treat adult patients after a recent heart attack(myocardial infarction). "Recent" means a period from 12 hours to 10 days.
• to treat symptomatic heart failure in adult patients.Valsartan Medical Valley is used if ACE inhibitors (medicines used to treat heart failure) cannot be used or Valsartan Medical Valley may be used in combination with ACE inhibitors if other medicines used to treat heart failure cannot be used.

Symptoms of heart failure are: shortness of breath and swelling of the feet and ankles due to fluid accumulation. They are caused by the fact that the heart muscle is not able to pump blood with sufficient force to supply 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 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 this case, 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 medicines used to treat high blood pressure: 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 medicines used to treat heart failure, 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 this 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").

• 3. If the patient is pregnant, the doctor will normally advise stopping Valsartan Medical Valley before becoming pregnant or as soon as pregnancy is confirmed, and will advise taking a different medicine instead of Valsartan Medical Valley.

If any of the above conditions apply to the patient, they should inform their doctor before taking Valsartan Medical Valley.

Valsartan Medical Valley and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Taking Valsartan Medical Valley with certain other medicines may affect treatment. A dose change, other precautions, or discontinuation of one of the medicines may be necessary. This applies to both prescription and non-prescription medicines, in particular:

• other blood pressure-lowering medicines, especially diuretics, ACE inhibitors (e.g., enalapril, lisinopril, etc.), or aliskiren;
• medicines that increase potassium levels in the blood- these are potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparins;
• certain painkillerscalled non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics(from the rifampicin group), medicines to prevent organ rejection (cyclosporin), or antiretroviral medicines used to treat HIV/AIDS (ritonavir) - these medicines may enhance the effect of Valsartan Medical Valley;
• lithium(a medicine used to treat certain mental illnesses).

In addition:

• after a heart attack, it is not recommended to take Valsartan Medical Valley in combination with ACE inhibitors(medicines used to treat heart attack);
• in the case of heart failure, it is not recommended to take Valsartan Medical Valley in triple combination with ACE inhibitorsand beta-blockers (medicines used to treat heart failure).

The doctor may recommend a dose change and/or take other precautions:

• If the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to take Valsartan Medical Valley" and "Warnings and precautions").
• If the patient is being treated with an ACE inhibitor in combination with certain other medicines used to treat heart failure, called mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

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 about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will normally advise stopping Valsartan Medical Valley before becoming pregnant or as soon as pregnancy is confirmed, and will advise taking a different 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. If the patient is pregnant, the doctor will normally advise stopping Valsartan Medical Valley before becoming pregnant or as soon as pregnancy is confirmed, and will advise taking a different medicine instead of Valsartan Medical Valley.
• The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Valsartan Medical Valley is not recommended for mothers who are breastfeeding; the doctor may choose a different treatment for the patient who plans to breastfeed. This is especially important for breastfeeding newborns or premature babies.

Driving and using machines

Before driving, using tools, operating machines, or performing other activities that require concentration, the patient should make sure how Valsartan Medical Valley affects them. Like many other medicines used to treat high blood pressure, Valsartan Medical Valley may cause dizziness and affect concentration.

Valsartan Medical Valley contains sorbitol

Valsartan Medical Valley 80 mg: This medicine contains 9.25 mg of sorbitol in each tablet.
Valsartan Medical Valley 160 mg: This medicine contains 18.5 mg of sorbitol in each tablet.

Valsartan Medical Valley contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Valsartan Medical Valley contains lactose

If the patient has been diagnosed with intolerance to some sugars (e.g., lactose), they should contact their doctor before taking the medicine.

3. How to take Valsartan Medical Valley

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

Adult patients with high blood pressure

The usual dose is 80 mg once a day. In some cases, the doctor may recommend higher doses (e.g., 160 mg or 320 mg). The doctor may also prescribe Valsartan Medical Valley in combination with another medicine (e.g., a diuretic).

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 a day. In patients with a body weight of 35 kg or more, the usual starting dose is 80 mg of valsartan once a day. 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 a day. 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 a day. 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 a day. The doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice a day.
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 missed dose should be skipped.
The patient should not take a double dose to make up for the missed dose.

Stopping Valsartan Medical Valley

Stopping treatment with Valsartan Medical Valley may worsen the disease. The patient should not stop taking the medicine unless their doctor advises them to do so.
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:

Angioedema (a specific allergic reaction) may occur, with symptoms 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 Medical Valley 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 of tiredness,
• 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

• blisters on the skin (symptoms of bullous dermatitis),
• allergic reactions with rash, itching, and hives; symptoms such as fever, swelling, and pain in the joints, muscle pain, swelling of the 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 a yellow discoloration 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, side effects such as dizziness and kidney problems are less common 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 observed in children and adolescents are similar to those in adult patients.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health:
Al. 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

• Store out of sight and reach of children.
• Do not use Valsartan Medical Valley after the expiry date stated on the package.
• The expiry date refers to the last day of the month.
• Do not use Valsartan Medical Valley if the package 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 80 mg or 160 mg of valsartan.
• The other ingredients are: microcrystalline cellulose (E 460), anhydrous colloidal silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), maize starch, povidone K-25 (E 1201), sodium stearyl fumarate, crospovidone type A (E 1202). Coating: lactose monohydrate, hypromellose (E 464), titanium dioxide (E 171), macrogol 4000, and Valsartan Medical Valley 80 mg, additionally, red iron oxide (E 172). Valsartan Medical Valley 160 mg, additionally, yellow iron oxide (E 172) and brown iron oxide (E 172)

What Valsartan Medical Valley looks like and contents of the pack

Valsartan Medical Valley 80 mg: Pink, cylindrical, film-coated tablets with a dividing line.
Valsartan Medical Valley 160 mg: Cylindrical, film-coated tablets, ochre in color, with a dividing line
Pack contents: 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
Zentiva k.s
U kabelovny 130
102 37 Prague
Czech Republic
For 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 80 mg/160 mg film-coated tablets

Bulgaria:

Vamadrid 80 mg/160 mg film-coated tablets

Estonia:

Vamadrid

Hungary:

Vamadrid 80 mg/160 mg film-coated tablets

Ireland:

Valsartan Rowa 80 mg/160 mg film-coated tablets

Italy:

Vamadrid 80 mg/160 mg film-coated tablets

Luxembourg:

Vamadrid 80 mg/160 mg film-coated tablets

Poland:

Valsartan Medical Valley

Portugal:

Vamadrid

Date of last revision of the leaflet: 01/2025