Valsartan Reddi

Leaflet attached to the packaging: information for the user

Valsartan Reddy, 40 mg, film-coated tablets

Valsartan Reddy, 80 mg, film-coated tablets

Valsartan Reddy, 120 mg, film-coated tablets

Valsartan Reddy, 160 mg, film-coated tablets

Valsartan Reddy, 320 mg, film-coated tablets

Valsartanum

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Valsartan Reddy and what is it used for

Valsartan Reddy contains the active substance: valsartan and 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 Reddy works by blocking the action of angiotensin II. As a result, blood vessels dilate and blood pressure decreases. Valsartan Reddy 40 mg film-coated tablets can be used to treat three different diseases:

• to treat high blood pressure in children and adolescents from 6 to less than 18 years of age.High blood pressure increases the burden on the heart and blood vessels. If left untreated, it can lead to damage to blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to a normal level can help reduce 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 Reddy is used if ACE inhibitors (medicines used to treat heart failure) cannot be used or as additional treatment to ACE inhibitors if other types of medicines used to treat heart failure 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 supply the necessary amount of blood to the entire body.

Valsartan Reddy 80 mg film-coated tablets can be used to treat three different diseases:

• to treat high blood pressure in adult patients and children and adolescents from 6 to less than 18 years of age.High blood pressure increases the burden on the heart and blood vessels. If left untreated, it can lead to damage to blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to a normal level can help reduce 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 Reddy is used if ACE inhibitors (medicines used to treat heart failure) cannot be used or as additional treatment to ACE inhibitors if other types of medicines used to treat heart failure 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 supply the necessary amount of blood to the entire body.

Valsartan Reddy 120 mg film-coated tablets can be used to treat three different diseases:

• to treat high blood pressure in adult patients and children and adolescents from 6 to less than 18 years of age.High blood pressure increases the burden on the heart and blood vessels. If left untreated, it can lead to damage to blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to a normal level can help reduce 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 Reddy is used if ACE inhibitors (medicines used to treat heart failure) cannot be used or as additional treatment to ACE inhibitors if other types of medicines used to treat heart failure 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 supply the necessary amount of blood to the entire body.

Valsartan Reddy 160 mg film-coated tablets can be used to treat three different diseases:

• to treat high blood pressure in adult patients and children and adolescents from 6 to less than 18 years of age.High blood pressure increases the burden on the heart and blood vessels. If left untreated, it can lead to damage to blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to a normal level can help reduce 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 Reddy is used if ACE inhibitors (medicines used to treat heart failure) cannot be used or as additional treatment to ACE inhibitors if other types of medicines used to treat heart failure 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 supply the necessary amount of blood to the entire body.

Valsartan Reddy 320 mg film-coated tablets can be used:

• to treat high blood pressure in adult patients and in children and adolescents from 6 to less than 18 years of age.High blood pressure increases the burden on the heart and blood vessels. If left untreated, it can lead to damage to blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to a normal level can help reduce the risk of these disorders.

2. Important information before taking Valsartan Reddy

When not to take Valsartan Reddy:

• 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 for more than 3 months(it is also not recommended to take Valsartan Reddy during early pregnancy - see section on pregnancy).
• 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 are met, Valsartan Reddy should not be taken.

Warnings and precautions

Before starting treatment with Valsartan Reddy, 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 on dialysis.
• in case of narrowing of the renal artery.
• 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 heart attack.
• if the patient has ever had swelling of the tongue and face caused by an allergic reaction, known as angioedema, after taking another medicine (including ACE inhibitors), they should tell their doctor. If such symptoms occur while taking Valsartan Reddy, the patient should stop taking Valsartan Reddy immediately and never take it again. See also section 4, "Possible side effects".
• if the patient is taking medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. Regular monitoring of potassium levels in the blood may be necessary.
• if the patient has aldosteronism. This is a disease in which the adrenal glands produce too much of a hormone called aldosterone. In this case, taking Valsartan Reddy is not recommended.
• in case of significant fluid loss (dehydration) due to diarrhea, vomiting, or the use of high doses of diuretics (diuretics).
• if the patient is taking any of the following medicines used to treat high blood pressure: an ACE inhibitor (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under "When not to take Valsartan Reddy" and "Warnings and precautions").

The doctor may monitor kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals. See also the information under "When not to take Valsartan Reddy". If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Valsartan Reddy, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Valsartan Reddy on their own. If the patient suspects that they are pregnant (or plan to become pregnant), they should tell their doctor. It is not recommended to take Valsartan Reddy during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken at this stage (see section on pregnancy).

Valsartan Reddy and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Taking Valsartan Reddy 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(diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under "When not to take Valsartan Reddy" and "Warnings and precautions").
• medicines that increase the amount of potassium in the blood, including potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• certain types of painkillerscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (from the rifamycin group), a medicine used to prevent transplant rejection (cyclosporin) or an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may enhance the effect of Valsartan Reddy.
• Lithium, a medicine used to treat certain types of mental illnesses.

In addition:

• after a heart attackit is not recommended to treat with ACE inhibitors(medicines used to treat heart attack);
• in the case of heart failure treatmentit is not recommended to use a combination of three medicines, namely ACE inhibitors, other heart failure medicines known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) and beta-blockers(such as metoprolol).

Pregnancy and breastfeeding

• The patient should tell their doctor if they suspect that they are pregnant (or plan to become pregnant).The doctor will usually advise to stop taking Valsartan Reddy before becoming pregnant or as soon as pregnancy is confirmed and recommend taking another medicine instead of Valsartan Reddy. It is not recommended to take Valsartan Reddy during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken at this stage.
• The patient should inform their doctor if they are breastfeeding or plan to breastfeed.It is not recommended to take Valsartan Reddy while breastfeeding; the doctor may choose another treatment for the patient who plans to breastfeed. This applies especially to breastfeeding newborns or premature babies.

Driving and using machines

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

Valsartan Reddy contains lactose

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

3. How to take Valsartan Reddy

This medicine should always be taken as directed by the doctor to achieve the best results and minimize the risk of side effects. If in doubt, the patient should consult their doctor or pharmacist. People with high blood pressure often do not notice any symptoms of this problem. Many of them feel quite well. Therefore, it is especially important to attend doctor's appointments, even if the patient feels well. High blood pressure in adult patients:The recommended dose is 80 mg once daily. In some cases, the doctor may prescribe higher doses (e.g., 160 mg or 320 mg). The doctor may also use Valsartan Reddy in combination with another medicine (e.g., a diuretic). High blood pressure in children and adolescents (from 6 to less than 18 years of age):The recommended initial dose of Valsartan Reddy is 40 mg once daily for patients with a body weight below 35 kg. For patients with a body weight of 35 kg or more, the recommended initial dose of Valsartan Reddy is 80 mg once daily. In some cases, the doctor may recommend higher doses (the dose can be increased to 160 mg, and up to a maximum of 320 mg). For children who cannot swallow tablets, it is recommended to use valsartan in the form of an oral solution. Condition after a recent heart attack in adult patients:Treatment usually starts 12 hours after the heart attack, usually with a low dose of 20 mg twice daily. The patient receives a dose of 20 mg, 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 Reddy can be given with other medicines used to treat heart attack, and the doctor will decide which treatment is appropriate in a given case. Heart failure in adult patients:The usual starting dose is 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 Reddy can be given with other medicines used to treat heart failure, and the doctor will decide which treatment is appropriate in a given case. Valsartan Reddy can be taken with or without food. Valsartan Reddy should be swallowed with a glass of water. Valsartan Reddy should be taken every day at approximately the same time. The tablet can be divided into equal doses.

Taking a higher dose of Valsartan Reddy than recommended

In case of severe dizziness and/or fainting, the patient should contact their doctor immediately and lie down. In case of accidental ingestion of too many tablets, the patient should contact their doctor, pharmacist, or hospital.

Missing a dose of Valsartan Reddy

If a dose is missed, the patient 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 Reddy

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

4. Possible side effects

Like all medicines, Valsartan Reddy 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 any of these symptoms occur, the patient should stop taking Valsartan Reddy immediately and contact their doctor (see also section 2 "Warnings and precautions").

Other side effects include:

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 these symptoms,
• kidney problems (symptoms of kidney problems).

Uncommon (may affect up to 1 in 100 people):

• angioedema (see "Some side effects may be serious and may require immediate medical attention"),
• sudden loss of consciousness (fainting),
• feeling of spinning (vertigo),
• severe kidney problems (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 due to fluid accumulation (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhea,
• feeling of tiredness,
• weakness.

Rare (may affect up to 1 in 1,000 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 joint or muscle pain, swollen lymph nodes, and/or flu-like symptoms (symptoms of serum sickness),
• purple-red spots, fever, itching (symptoms of vasculitis, also known as inflammation of the blood vessels),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat, or mouth ulcers due to infection (symptoms of neutropenia),
• decreased hemoglobin and red blood cell count in the blood (which can lead to anemia in severe cases),
• increased potassium levels in the blood (which can cause muscle cramps and heart rhythm disturbances in severe cases),
• increased liver enzyme values (which may indicate liver damage), including increased bilirubin levels in the blood (which can cause a yellow discoloration of the skin and eyes in severe cases),
• increased urea and creatinine levels in the blood (which may indicate kidney problems),
• low sodium levels in the blood (which can cause fatigue, disorientation, muscle tremors, and/or seizures in severe cases).

The frequency of some side effects may vary depending on the patient's condition. 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 side effects 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: Al. Jerozolimskie 181C, 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Valsartan Reddy

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
• There are no special precautions for storing the medicine.
• Do not use this medicine 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 Reddy contains

• The active substance is valsartan. Each film-coated tablet contains 40 mg, 80 mg, 120 mg, 160 mg, or 320 mg of valsartan.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, crospovidone, type A, povidone K30, colloidal anhydrous silica, magnesium stearate. The tablet coating contains hypromellose, macrogol 4000, titanium dioxide (E 171), only 40 mg: talc, iron oxide yellow (E 172) only 80 mg, 160 mg, and 320 mg: iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172).

What Valsartan Reddy looks like and contents of the pack

Valsartan Reddy 40 mg film-coated tablets are yellow, oval, film-coated tablets with a beveled edge, with the imprint "V" on one side and the imprint "4" and "0" on either side of the score line on the other side. Valsartan Reddy 80 mg film-coated tablets are pink, round, film-coated tablets with a beveled edge, with the imprint "V 80" on one side and a score line on the other side. Valsartan Reddy 120 mg film-coated tablets are white to off-white, round, film-coated tablets with a beveled edge, with the imprint "V 120" on one side and a score line on the other side. Valsartan Reddy 160 mg film-coated tablets are grey-orange, oval, film-coated tablets with a beveled edge, with the imprint "V 160" on one side and a score line on the other side. Valsartan Reddy 320 mg film-coated tablets are light brown, oval, film-coated tablets with a beveled edge, with the imprint "V 320" on one side and a score line on the other side. The tablet can be divided into equal doses. The tablets are available in blisters of 28 tablets (Valsartan Reddy 40 mg, 80 mg, 120 mg, 160 mg, 320 mg) or 56, 98 tablets (Valsartan Reddy 160 mg). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reddy Holding GmbH Kobelweg 95 86156 Augsburg Germany Phone: +49 821 74881 0

Manufacturer/Importer

betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany Rual Laboratories S.R.L. Splaiul Unirii 313, Building H, 1st Floor, Sector 3 030138 Bucharest Romania For more detailed information on this medicine, the patient should contact the marketing authorization holder.

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

Austria Valsartan Reddy 40 mg Filmtabletten, Valsartan Reddy 80 mg Filmtabletten, Valsartan Reddy 120 mg Filmtabletten, Valsartan Reddy 160 mg Filmtabletten, Valsartan Reddy 320 mg Filmtabletten, Czech Republic Valsartan Reddy Germany Valsartan beta 40 mg Filmtabletten, Valsartan beta 80 mg Filmtabletten, Valsartan beta 120 mg Filmtabletten, Valsartan beta 160 mg Filmtabletten, Valsartan beta 320 mg Filmtabletten Netherlands Valsartan Reddy 40 mg filmomhulde tabletten, Valsartan Reddy 80 mg filmomhulde tabletten, Valsartan Reddy 120 mg filmomhulde tabletten, Valsartan Reddy 160 mg filmomhulde tabletten, Valsartan Reddy 320 mg filmomhulde tabletten Poland Valsartan Reddy Slovakia Valsartan Reddy

Date of last revision of the leaflet: 12/2024