Valsartan medical valley

Valsartan Medical Valley, 80 mg, film-coated tablets
Valsartan Medical Valley, 160 mg, film-coated tablets
Valsartanum
Please read the entire leaflet carefully before taking this 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 further information.
• This medicine has been prescribed for a specific individual and must not be passed on to others, as it may harm them even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions 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 constrict, thereby increasing blood pressure. Valsartan Medical Valley blocks the action of angiotensin II, resulting in the widening of blood vessels and lowering of blood pressure.

Valsartan Medical Valley 80 mg and 160 mg tablets can be used to treat three different conditions:

• Treatment of high blood pressure in adult patients and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and blood vessels. 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" means within 12 hours to 10 days after the event.
• 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 medicines for treating heart failure cannot be used.

Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. These are caused by the heart muscle being unable to pump blood strongly enough to meet the body's needs.

2. Important information before using Valsartan Medical Valley

When not to use Valsartan Medical Valley:

• if the patient is allergic to valsartan or to any of the other ingredients 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 dysfunction 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 starting treatment with 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 undergone kidney transplantation (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 during treatment with 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, salt substitutes containing potassium, 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 excessive amounts of a hormone called aldosterone) – in such a case, 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 diuretic medicines (diuretics);
• 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, discuss this with the doctor. The doctor will decide whether treatment should
continue. Do not make decisions about stopping Valsartan Medical Valley on your own.
See also the section "When not to use Valsartan Medical Valley".
Inform the doctor if the patient is pregnant (or suspects pregnancy). Use of Valsartan Medical
Valley is not recommended in 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 "Pregnacy and breastfeeding").

If any of the above conditions apply, inform the doctor before using Valsartan Medical Valley.
Valsartan Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines the patient plans to take.
Taking Valsartan Medical Valley with certain other medicines may affect treatment. A dose
adjustment, 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 pills), ACE inhibitors (e.g. enalapril, lisinopril, etc.), or aliskiren;
• medicines that increase blood potassium levels – these include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparins;
• certain painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs);
• some antibiotics (such as rifampicin), medicines used to prevent organ transplant rejection (cyclosporine), 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 psychiatric disorders).

Additionally:

• after myocardial infarction, combination therapy with ACE inhibitors (medicines used to treat heart attack) is not recommended;
• in patients being treated for heart failure, use of Valsartan Medical Valley in triple combination with ACE inhibitors and beta-adrenergic blocking agents (medicines used to treat heart failure) 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 recommend stopping Valsartan Medical Valley before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe an alternative medicine. Use of Valsartan Medical Valley is not recommended in early pregnancy and must not be used in patients beyond
  3 months 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 other tasks 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
Valsartan Medical Valley 80 mg: This medicine contains 9.25 mg of sorbitol per tablet.
Valsartan Medical Valley 160 mg: This medicine contains 18.5 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 contact the doctor before taking this medicine.

3. How to take Valsartan Medical Valley

Valsartan Medical Valley must always be taken exactly as directed by your doctor in order to achieve the best results and minimize the risk of adverse effects. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not notice any symptoms and many feel quite well. For this reason, it is especially important to attend regular check-ups with your doctor, even if you feel well.

Adult patients with high blood pressure
The usual dose is 80 mg once daily. In some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg). Your doctor may also prescribe Valsartan Medical Valley in combination with another medicine (e.g. a diuretic).

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, your doctor may prescribe a higher dose (the dose may be increased up to 160 mg, and a maximum of 320 mg).
For children who cannot 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. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on how well the patient tolerates the medicine.
Valsartan Medical Valley may be given together with other medicines used in the treatment of heart attack, and your doctor will decide which treatment is appropriate in each individual case.

Adult patients with heart failure
Treatment usually starts with a dose of 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on how well the patient tolerates the medicine.
Valsartan Medical Valley may be given together with other medicines used in the treatment of heart failure, and your doctor will decide which treatment is appropriate in each individual case.

Valsartan Medical Valley may be taken with or without food. Swallow the tablets with a glass of water.
Take Valsartan Medical Valley every day at approximately the same time.

Taking more Valsartan Medical Valley than prescribed
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you accidentally take too many tablets, contact your doctor, pharmacist, or go to the nearest hospital immediately.

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

Stopping Valsartan Medical Valley
Stopping treatment with Valsartan Medical Valley may worsen your condition. Do not discontinue the medicine unless instructed by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Valsartan Medical Valley can 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 straight away (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 kidney dysfunction)

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 (vestibular dizziness),
• 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 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
Intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea,
vomiting and diarrhoea.
Not known: frequency cannot be estimated from available data

• blisters on the skin (symptoms of bullous dermatitis),
• allergic reactions 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 hemoglobin concentration and reduced proportion of red blood cells in blood (which may lead to anemia in severe cases),
• increased potassium concentration 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 concentration in blood (which may cause yellowing of the skin and eyes in severe cases),
• increased blood urea nitrogen and increased serum creatinine concentration (which may indicate impaired kidney function),
• low sodium concentration 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 kidney dysfunction 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 observed in adult patients.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 authorization 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 in a place 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 your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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), colloidal anhydrous silica (E 551), sorbitol (E 420), magnesium carbonate (E 504), pregelatinized corn 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. Additionally, Valsartan Medical Valley 80 mg contains red iron oxide (E 172). Valsartan Medical Valley 160 mg additionally contains 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 division line.
Valsartan Medical Valley 160 mg: Ochre-colored, cylindrical film-coated tablets with a division 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
Zentiva k.s
U kabelovny 130
102 37 Prague
Czech Republic

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Valsartan Xiromed 80 mg/160 mg filmomhulde tablet
Bulgaria: Vamadrid 80 mg/160 mg филмирани таблетки
Estonia: Vamadrid
Hungary: Vamadrid 80 mg/160 mg mg bevont tabletta
Ireland: Valsartan Rowa 80 mg/160 mg film-coated tablets
Italy: Vamadrid 80 mg/160 mg compressa rivestita con film
Luxembourg: Vamadrid 80 mg/160 mg comprimé pelliculé
Poland: Valsartan Medical Valley
Portugal: Vamadrid