Valsartan reddy: detailed information

Package leaflet: 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
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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.

Table of contents:

What Valsartan Reddy is and what it is used for
Important information before taking Valsartan Reddy
How to take Valsartan Reddy
Possible side effects
How to store Valsartan Reddy
Contents of the pack and other information

1. What Valsartan Reddy is and what it is 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 narrow, thereby increasing blood pressure. Valsartan Reddy works by blocking the effects of angiotensin II. As a result, blood vessels widen and blood pressure is lowered.

Valsartan Reddy 40 mg film-coated tablets can be used to treat three different conditions:

Treatment of high blood pressure in children and adolescents aged 6 to below 18 years. High blood pressure increases the strain on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels helps reduce the risk of these complications.
Treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
Treatment of symptomatic heart failure in adult patients. Valsartan Reddy is used when angiotensin-converting enzyme (ACE) inhibitors (medicines used in heart failure treatment) cannot be used, or as add-on therapy to ACE inhibitors when other types of heart failure medicines cannot be used. Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid accumulation. These occur because the heart muscle is unable to pump blood strongly enough to supply sufficient blood to the entire body.

Valsartan Reddy 80 mg film-coated 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 below 18 years. High blood pressure increases the strain on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels helps reduce the risk of these complications.
Treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
Treatment of symptomatic heart failure in adult patients. Valsartan Reddy is used when angiotensin-converting enzyme (ACE) inhibitors (medicines used in heart failure treatment) cannot be used, or as add-on therapy to ACE inhibitors when other types of heart failure medicines cannot be used. Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid accumulation. These occur because the heart muscle is unable to pump blood strongly enough to supply sufficient blood to the entire body.

Valsartan Reddy 120 mg film-coated 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 below 18 years. High blood pressure increases the strain on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels helps reduce the risk of these complications.
Treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
Treatment of symptomatic heart failure in adult patients. Valsartan Reddy is used when angiotensin-converting enzyme (ACE) inhibitors (medicines used in heart failure treatment) cannot be used, or as add-on therapy to ACE inhibitors when other types of heart failure medicines cannot be used. Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid accumulation. These occur because the heart muscle is unable to pump blood strongly enough to supply sufficient blood to the entire body.

Valsartan Reddy 160 mg film-coated 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 below 18 years. High blood pressure increases the strain on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels helps reduce the risk of these complications.
Treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
Treatment of symptomatic heart failure in adult patients. Valsartan Reddy is used when angiotensin-converting enzyme (ACE) inhibitors (medicines used in heart failure treatment) cannot be used, or as add-on therapy to ACE inhibitors when other types of heart failure medicines cannot be used. Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid accumulation. These occur because the heart muscle is unable to pump blood strongly enough to supply sufficient blood to the entire body.

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

For the treatment of high blood pressure in adult patients and in children and adolescents aged 6 to below 18 years. High blood pressure increases the strain on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels helps reduce the risk of these complications.

2. Important information before using Valsartan Reddy

When not to use Valsartan Reddy:

if the patient is allergic to 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 more than 3 months pregnant (use of Valsartan Reddy is also not recommended 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 apply, do not take Valsartan Reddy.
Warnings and precautions
Before taking Valsartan Reddy, discuss with your doctor or pharmacist

if the patient has liver disease.
if severe kidney disease has been diagnosed or if the patient is on dialysis.
in case of renal artery stenosis.
if the patient has recently received a kidney transplant.
if severe heart disease other than heart failure or myocardial infarction has been diagnosed.
if the patient has previously experienced swelling of the tongue and face due to an allergic reaction, called angioedema, after taking another medicine (including ACE inhibitors), this should be reported to the doctor. If such symptoms occur while taking Valsartan Reddy, the treatment must be stopped immediately and the medicine must never be used again. See also section 4, "Possible side effects".
if the patient is taking medicines that increase blood potassium levels, such as potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, or heparin. Regular monitoring of blood potassium levels may be necessary.
if the patient has aldosteronism, a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone. In such cases, use of Valsartan Reddy 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 used to treat 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 other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

The doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading "When not to use Valsartan Reddy".
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Valsartan Reddy, this should be discussed with the doctor. The doctor will decide on further treatment. Do not make independent decisions to stop taking Valsartan Reddy.
Inform the doctor if the patient suspects she is pregnant (or plans pregnancy). Use of Valsartan Reddy 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 at this stage (see section "Pregnancy").

Valsartan Reddy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Taking Valsartan Reddy 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, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings "When not to use Valsartan Reddy" and "Warnings and precautions").
medicines that increase blood potassium levels, including potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, and heparin.
certain types of painkillers, so-called non-steroidal anti-inflammatory drugs (NSAIDs).
certain antibiotics (rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used in the treatment of HIV/AIDS (ritonavir). These medicines may enhance the effect of Valsartan Reddy.
Lithium, a medicine used in the treatment of certain psychiatric disorders.

Additionally:

after myocardial infarction, combined treatment with ACE inhibitors (medicines used to treat heart attack) is not recommended.
in the case of treatment of heart failure, combined triple therapy with ACE inhibitors, other medicines used to treat heart failure known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone), and beta-blockers (e.g. metoprolol) is not recommended.

Pregnancy and breastfeeding

Inform your doctor if you suspect you are pregnant (or plan to become pregnant). The doctor will usually advise stopping Valsartan Reddy before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Valsartan Reddy 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 beyond the third month.
Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Valsartan Reddy is not recommended in breastfeeding mothers; the doctor may choose an alternative treatment for patients planning to breastfeed, especially when 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 Reddy affects them. Like many other medicines used to treat high blood pressure, Valsartan Reddy may cause dizziness and affect the ability to concentrate.

Valsartan Reddy contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Valsartan Reddy

This medicine should always be taken exactly as prescribed 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 experience 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.

High blood pressure in adult patients: The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). Your doctor may also prescribe Valsartan Reddy together with another medicine (e.g. a diuretic).

High blood pressure in children and adolescents (aged 6 to below 18 years): For patients with body weight below 35 kg, the recommended initial dose of Valsartan Reddy tablets is 40 mg once daily. For patients with body weight of 35 kg or more, the recommended initial dose of Valsartan Reddy tablets is 80 mg once daily. In some cases, your doctor may recommend higher doses (the dose may be increased up to 160 mg and 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 following a recent heart attack in adult patients: Treatment usually begins within 12 hours after a heart attack, usually with a low dose of 20 mg twice daily. The patient receives a 20 mg dose, obtained by splitting a 40 mg tablet. Your 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 may be given together with other medicines used in the treatment after a heart attack, and your doctor will decide which treatment is appropriate in each individual case.

Heart failure in adult patients: The usual initial dose is 40 mg twice daily. Your 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 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 Reddy can be taken with or without food. Swallow the tablet with a glass of water. Valsartan Reddy should be taken every day at approximately the same time.

The tablet may be divided into equal doses.

If you take more Valsartan Reddy than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. In case of accidental overdose, contact your doctor, pharmacist, or hospital immediately.

If you forget to take Valsartan Reddy
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 forgotten dose.

Stopping Valsartan Reddy
Stopping treatment with Valsartan Reddy may cause your condition to worsen. Do not discontinue use unless advised by your doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine 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, treatment with Valsartan Reddy must be stopped immediately
and a doctor should be contacted (see also section 2 "Warnings and precautions").
Other adverse reactions include:
Common (may affect up to 1 in 10 people):

dizziness,
low blood pressure with or without symptoms such as dizziness and fainting upon standing.

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

angioedema (see "Some symptoms requiring immediate medical attention"),
sudden loss of consciousness (fainting),
sensation of spinning (dizziness),
kidney function disorders (symptoms of kidney dysfunction),
severe kidney function disorders (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.

Rare (may affect up to 1 in 1,000 people):

Intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Not known (frequency cannot be estimated from the available data)

skin blisters (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 inflammation of blood vessels, also known as vasculitis),
unusual bleeding or bruising (symptoms of thrombocytopenia),
muscle pain (myalgia),
fever, sore throat or mouth ulcers due to infection (symptoms of low white blood cell count, so-called neutropenia),
decreased haemoglobin concentration and reduced number of red blood cells in blood (which may lead to anaemia 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 yellowish 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 patient's condition.
For example, adverse reactions such as dizziness and kidney function disorders 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 heart attack.
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 adverse reactions not listed in
this leaflet, inform your 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
181C, 02-222 Warsaw, tel.: + 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. By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Valsartan Reddy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after: Expiry (EXP). The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Do not use this medicine if you notice that 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. Such measures help protect the environment.

6. Contents of the packaging 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: monohydrate lactose, microcrystalline cellulose, corn starch, crospovidone type A, povidone K30, anhydrous colloidal silicon dioxide, magnesium stearate. The tablet coating contains hypromellose, macrogol 4000, titanium dioxide (E 171).
For 40 mg only: talc, yellow iron oxide (E 172).
For 80 mg, 160 mg and 320 mg only: red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (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 bevelled edges, marked with an embossing of "V" on one side and "4" and "0" on each side of the central dividing groove on the other side.
Valsartan Reddy 80 mg film-coated tablets are pink, round, film-coated tablets with bevelled edges, marked with "V 80" on one side and a central dividing groove on the other side.
Valsartan Reddy 120 mg film-coated tablets are white to off-white, round, film-coated tablets with bevelled edges, marked with "V 120" on one side and a central dividing groove on the other side.
Valsartan Reddy 160 mg film-coated tablets are grey-orange, oval, film-coated tablets with bevelled edges, marked with "V 160" on one side and a central dividing groove on the other side.
Valsartan Reddy 320 mg film-coated tablets are light brown, oval, film-coated tablets with bevelled edges, marked with "V 320" on one side and a central dividing groove on the other side.
The tablet can be divided into equal doses.
The tablets are available in blisters containing 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +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 further information about this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the European Economic Area countries 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