Valsartan medical valley

Valsartan Medical Valley, 40 mg, film-coated tablets
Valsartanum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you need advice or additional information.
• This medicine has been prescribed for a specific individual and should not be passed on to others, as it may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Valsartan Medical Valley is and what it is used for
2. Important information before taking Valsartan Medical Valley
3. How to take Valsartan Medical Valley
4. Possible side effects
5. How to store Valsartan Medical Valley
6. Contents of the pack and other information

1. What Valsartan Medical Valley is and what it is 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 narrow, thereby increasing blood pressure. Valsartan Medical Valley blocks the effects of angiotensin II, causing blood vessels to widen and blood pressure to decrease.

Valsartan Medical Valley 40 mg may be used in the treatment of the following conditions:

• Treatment of high blood pressure in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, and may cause stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of these complications.
• Treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" refers to the period from 12 hours to 10 days after the heart attack.
• Treatment of symptomatic heart failure in adult patients. Valsartan Medical Valley is used when medicines known as angiotensin-converting enzyme (ACE) inhibitors (medicines used in treating heart failure) cannot be used, or Valsartan Medical Valley may be used in combination with ACE inhibitors when other heart failure treatments cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. These symptoms occur because the heart muscle is unable to pump blood strongly enough to meet the body's needs.

2. Information before using Valsartan Medical Valley

When not to use Valsartan Medical Valley:

• if the patient has hypersensitivity to valsartan or to any of the other components of this medicine (listed in section 6);
• if the patient has severe liver disease;
• if the patient is more than 3 months pregnant (use of Valsartan Medical Valley should also 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, Valsartan Medical Valley must not be used.
Warnings and precautions:
Before taking Valsartan Medical Valley, discuss this with your doctor or
pharmacist:

• if the patient has liver disease;
• if the patient has severe kidney disease or is undergoing dialysis;
• if the patient has renal artery stenosis;
• if the patient has recently received a kidney transplant (the patient has received a new kidney);
• if the patient has severe heart disease other than heart failure or myocardial infarction;
• inform the doctor if the patient has ever experienced swelling of the tongue and face due to an allergic reaction (angioedema) while taking other medicines (including ACE inhibitors) – if such symptoms occur while taking Valsartan Medical Valley, the medicine must be stopped immediately and must never be taken again. See also section 4, "Possible side effects";
• if the patient is taking medicines that increase blood potassium levels – these include potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, and heparins; regular monitoring of blood potassium levels may be necessary;
• if the patient has hyperaldosteronism (a condition in which the adrenal glands produce too much of a hormone called aldosterone) – in such cases, use of Valsartan Medical Valley is not recommended;
• in case of significant fluid loss (dehydration) due to diarrhoea, vomiting, or use of high doses of diuretics (water tablets);
• if the patient is taking any of the following medicines for high blood pressure: ACE inhibitors (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 in heart failure treatment 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 blood electrolyte levels (e.g. potassium).

If the patient experiences abdominal pain, nausea, vomiting,
or diarrhoea after taking Valsartan Medical Valley, this should be discussed with the doctor. The doctor will decide on further treatment. Do not
make independent decisions to stop taking Valsartan Medical Valley.
See also the section "When not to use Valsartan Medical Valley".
Inform the doctor if the patient is pregnant (or suspects she may be pregnant). Use of Valsartan Medical Valley is not recommended during early pregnancy and must not be used after

the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period (see section "Pregnancy and breastfeeding").

If any of the above conditions apply, inform the doctor before using Valsartan Medical Valley.
Valsartan Medical Valley and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Taking Valsartan Medical Valley together with certain other medicines may affect treatment. Dose adjustments, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This applies to both prescription and over-the-counter medicines, particularly:

• other medicines that lower blood pressure, especially diuretics (water tablets), ACE inhibitors (e.g. enalapril, lisinopril, etc.), or aliskiren;
• medicines that increase blood potassium levels – these include potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, and heparins;
• certain painkillers, so-called non-steroidal anti-inflammatory drugs (NSAIDs);
• some antibiotics (rifampicin group), medicines used to prevent rejection of transplanted organs (cyclosporine), or antiretroviral medicines used to treat HIV/AIDS (ritonavir) – these medicines may enhance the effect of Valsartan Medical Valley;
• lithium (a medicine used in the treatment of certain psychiatric disorders).

Additionally:

• after myocardial infarction, combination therapy with ACE inhibitors (medicines used to treat heart attack) is not recommended;
• in the treatment of heart failure, use of Valsartan Medical Valley in triple combination with ACE inhibitors and beta-adrenergic receptor blockers (medicines used in heart failure treatment) is not recommended.

The doctor may recommend dose adjustment and/or additional precautions:

• If the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to use Valsartan Medical Valley" and "Warnings and precautions").
• If the patient is being treated with an ACE inhibitor in combination with certain other medicines used in heart failure treatment 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 may be taken with or without food.
Pregnancy and breastfeeding
Consult a doctor or pharmacist before taking any medicine.

• Inform the doctor if the patient is pregnant, suspects pregnancy, or plans to become pregnant. The doctor will usually advise stopping Valsartan Medical Valley before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Valsartan Medical Valley. Use of Valsartan Medical Valley is not recommended in early pregnancy and must not be used in patients beyond

the 3rd month of pregnancy, as it may seriously harm the unborn child if used beyond the third month of pregnancy.

• Inform the doctor if the patient is breastfeeding or intends to breastfeed. Use of Valsartan Medical Valley is not recommended in breastfeeding mothers; the doctor may choose an alternative treatment for patients who plan to breastfeed. This is particularly important for feeding newborns or preterm infants.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing any activity requiring concentration, each patient should determine how Valsartan Medical Valley affects them. Like many other medicines used to treat high blood pressure, Valsartan Medical Valley may rarely cause dizziness and affect the ability to concentrate.
Valsartan Medical Valley contains sorbitol
This medicine contains 4.6 mg of sorbitol per tablet.
Valsartan Medical Valley contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".
Valsartan Medical Valley contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars (e.g. lactose), the patient should consult a doctor before taking this medicine.

3. How to use Valsartan Medical Valley

Valsartan Medical Valley must always be used as directed by the physician to achieve the best results and minimize the risk of adverse effects. If in doubt, consult a doctor or pharmacist. Patients with high blood pressure often do not experience any symptoms and may feel quite well. For this reason, it is particularly important to attend regular medical check-ups, even if feeling well.

Children and adolescents (aged 6 to 18 years) with high blood pressure
For patients weighing less than 35 kg, the usual dose of valsartan is 40 mg once daily. For patients weighing 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases, the physician may prescribe a higher dose (the dose may be increased up to 160 mg, and a maximum of 320 mg).

For children unable to swallow tablets, an oral solution is recommended.

Adult patients following a recent heart attack
Treatment usually begins within 12 hours after the heart attack, typically starting with a low dose of 20 mg twice daily. The 20 mg dose is obtained by splitting a 40 mg tablet. The physician will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the individual patient's tolerance to the medication.

Valsartan Medical Valley may be administered together with other medications used in the treatment of heart attack. The physician will determine the appropriate treatment regimen for each individual case.

Adult patients with heart failure
Treatment usually begins with a dose of 40 mg twice daily. The physician will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the individual patient's tolerance to the medication.

Valsartan Medical Valley may be administered together with other medications used in the treatment of heart failure. The physician will determine the appropriate treatment regimen for each individual case.

Valsartan Medical Valley may be taken with or without food. Tablets should be swallowed with a glass of water.

Valsartan Medical Valley should be taken every day at approximately the same time.

Taking more Valsartan Medical Valley than prescribed
If severe dizziness and/or fainting occur, contact a physician immediately and lie down. In case of accidental overdose, contact a physician, pharmacist, or go to the nearest hospital immediately.

Missing a dose of Valsartan Medical Valley
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping Valsartan Medical Valley
Discontinuing treatment with Valsartan Medical Valley may lead to worsening of the condition. Do not stop taking the medication unless instructed by a physician.

If you have any questions about the use of this medication, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Valsartan Medical Valley may cause adverse reactions, although not
everyone will experience them.
Some adverse reactions may be serious and may require immediate medical attention:
Symptoms of angioedema (a specific allergic reaction) may occur, such as:

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

If any of these symptoms occur, stop taking valsartan immediately and contact a doctor without delay (see also section 2 "Warnings and precautions").
Other adverse reactions:
Common: may affect less than 1 in 10 people

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

Uncommon: may affect less than 1 in 100 people

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

Very rare: may affect less than 1 in 10,000 people
Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea,
vomiting and diarrhoea.
Unknown frequency: frequency cannot be estimated from the available data

• skin blisters (symptoms of bullous dermatitis),
• allergic reactions presenting with rash, itching and hives; symptoms such as fever, swelling and joint pain, muscle pain, swollen 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 oral mucosal ulceration due to infection (symptoms of low white blood cell count, so-called neutropenia),
• decreased haemoglobin concentration and reduced proportion of red blood cells in blood (which may lead to anaemia in severe cases),
• increased potassium levels in blood (which may cause muscle cramps and heart rhythm disturbances in severe cases),
• increased liver function parameters (which may indicate liver damage), including increased bilirubin levels in blood (which may cause yellowing of the skin and eyes in severe cases),
• increased blood urea nitrogen and increased serum creatinine (which may indicate impaired kidney function),
• low sodium levels in blood (which may cause fatigue, disorientation, muscle twitching and (or) seizures in severe cases).

The frequency of some adverse reactions may vary depending on the disease.
For example, adverse reactions such as dizziness and impaired kidney function have been observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent myocardial infarction.
Adverse reactions observed in children and adolescents are similar to those occurring in adult patients.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Valsartan Medical Valley
Do not store above 30°C.
Keep in the original packaging 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 packaging.
• The expiry date refers to the last day of the stated month.
• 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. Ask a pharmacist how to dispose of medicines no longer in use. 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), pregelatinized corn starch, povidone K25 (E 1201), sodium stearyl fumarate, crospovidone type A (E 1202).
  Coating: monohydrate lactose, 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 contents: 7, 14, 28, 56, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturers
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

For further information, please contact the Marketing Authorisation Holder's representative.

This medicinal product is authorised 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