40 mg, 80 mg, 160 mg film-coated tablets
valsartan
What Valsartan Krka is and what is it used for
Valsartan Krka belongs to a drug class called angiotensin II receptor blockers and is used to lower elevated blood pressure. Angiotensin II is a substance found in the body that constricts the blood vessels, which increases blood pressure et. Valsartan Krka works by inhibiting the effect of angiotensin II. This causes the blood vessels to widen and blood pressure to drop.
Valsartan Krka 40 mg film-coated tablets can be used in three different conditions:
- for the treatment of high blood pressure in children and adolescents from 6 to 18 years of age. High blood pressure increases the load on the heart and blood vessels. If left untreated, it can damage the blood vessels in the brain, heart, and kidneys, and lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of a heart attack. A lowering of blood pressure et to a normal level reduces the risk of these diseases.
- to treat adult patients who have recently had a heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.
- to treat symptomatic heart failure in adult patients. Valsartan Krka is used when a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) (a medicine to treat heart failure ) cannot be used or as an addition to ACE inhibitors when other medicines to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swollen feet and legs due to fluid retention. Heart failure is caused by the heart muscle not being able to pump enough blood around to supply the whole body with blood.
Valsartan Krka 80 mg and 160 mg film-coated tablets can be used in three different conditions:
- to treat high blood pressure in adults and children and adolescents aged 6 to 18 years. High blood pressure increases the load on the heart and blood vessels. If left untreated, it can damage the blood vessels in the brain, heart, and kidneys, and lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of a heart attack. A lowering of blood pressure et to a normal level reduces the risk of these diseases.
- to treat adult patients who have recently had a heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.
- to treat symptomatic heart failure in adult patients. Valsartan Krka is used when a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) (a medicine to treat heart failure ) cannot be used or as an addition to ACE inhibitors when other medicines to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swollen feet and legs due to fluid retention. Heart failure is caused by the heart muscle not being able to pump enough blood around to supply the whole body with blood.
The valsartan contained in Valsartan Krka may also be approved to treat other conditions not mentioned in this information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Valsartan Krka
Do not use Valsartan Krka
- if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
- if you have severe liver disease.
- pregnant women should not use Valsartan Krka during the last 6 months of pregnancy. (Even earlier in pregnancy it is good to avoid Valsartan Krka, see Pregnancy and breastfeeding).
- if you have diabetes or impaired kidney function and you are being treated with an antihypertensive medicine containing aliskiren.
If any of these apply to you, you should not take Valsartan Krka.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Krka:
- if you have liver disease.
- if you have severe kidney disease or if you are undergoing dialysis.
- if you have a narrowing of the renal arteries.
- if you have recently had a kidney transplant (received a new kidney).
- if you have a serious heart disease other than heart failure or heart attack.
- if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors ), talk to your doctor. If these symptoms occur while taking Valsartan Krka, stop taking Valsartan Krka immediately and never take it again. See also section 4, “Possible side effects”.
- if you are taking medicines that increase the amount of potassium in the blood. These are, for example, potassium supplements or salt substitutes containing potassium, potassium-sparing drugs, and heparin. It may be necessary to check the amount of potassium in your blood periodically.
- if you suffer from aldosteronism. This is a disease in which your adrenal glands produce too much of the hormone aldosterone. If this applies to you, Valsartan Krka should not be used.
- if you have lost a lot of fluid ( dehydration ) due to diarrhea or vomiting or if you are taking high doses of diuretics ( diuretics ).
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems
- the aliskiren
- if you are being treated with an ACE inhibitor together with certain other medicines that you take to treat your heart failure, called MR antagonists (mineralocorticoid receptor antagonists ) (eg spironolactone, eplerenone) or beta-blockers (eg metoprolol ).
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not use Valsartan Krka”.
Contact your doctor if you think you are pregnant or become pregnant during treatment. Valsartan Krka is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may then cause birth defects, see Pregnancy and breastfeeding.
If any of these apply to you, tell your doctor before taking Valsartan Krka.
Other medicines and Valsartan Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The treatment effect can be affected if Valsartan Krka is taken together with certain other medicines. It may be necessary to change the dose, take other precautions or, in some cases, stop treatment with one of the drugs. This applies to both prescription and over-the-counter medicines, in particular:
- other medicines that lower blood pressure, especially diuretics, ACE inhibitors ( such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartan Krka” and “Warnings and precautions”).
- medicines that increase the amount of potassium in the blood. These are, for example, potassium supplements or salt substitutes containing potassium, potassium-sparing drugs, and heparin.
- certain types of painkillers called non-steroidal anti-inflammatory drugs ( NSAIDs ).
- certain antibiotics (rifamycin group), a medicine used to protect against transplant rejection (ciclosporin), or an antiretroviral medicine for HIV /AIDS infection (ritonavir). These medicines can increase the effect of Valsartan Krka.
- lithium, a drug used in the treatment of certain types of mental illness.
In addition:
- if you are being treated after a heart attack, a combination with ACE inhibitors (a medicine to treat a heart attack) is not recommended.
- if you are being treated for heart failure, a triple combination of ACE inhibitors and other medicines to treat heart failure called MR antagonists (mineralocorticoid receptor antagonists ) (eg spironolactone, eplerenone) or beta-blockers (eg metoprolol ).
Valsartan Krka with food, drink, and alcohol
You can take Valsartan Krka regardless of meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
- If you think you are pregnant or become pregnant during treatment, contact your doctor. Usually, your doctor will suggest that you stop taking Valsartan Krka before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Valsartan Krka should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may then cause birth defects.
- Tell your doctor if you are breastfeeding or intend to start breastfeeding. Valsartan Krka is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed your baby, especially if your baby is a newborn or was born prematurely.
Driving ability and use of machinery
Before you drive, use tools or machines, or perform activities that require concentration, make sure you know how Valsartan Krka affects you. Like many other medicines for the treatment of high blood pressure, Valsartan Krka can cause dizziness and affect the ability to concentrate.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Valsartan contains lactose and sodium
Valsartan Krka contains lactose . If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to use Valsartan Krka
Always take this medicine as directed by your doctor or pharmacist, so that you get the best results and reduce the risk of side effects. Ask your doctor or pharmacist if you are unsure. People with high blood pressure often do not experience any symptoms of this. Many feel as usual. It is therefore important that you go to your doctor’s appointments as planned, even if you feel well.
Children and adolescents (from 6 up to 18 years) with high blood pressure
In patients weighing less than 35 kg, a usual dose is 40 mg of valsartan once daily. In 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 ( dose one can be increased to 160 mg and a maximum of 320 mg).
Adult patients with high blood pressure
The usual dose is 80 mg daily. In some cases, your doctor may prescribe a higher dose (eg 160 mg or 320 mg) or combine Valsartan Krka with another medicine (eg a diuretic).
Adult patients after recent myocardial infarction
After a heart attack, treatment is generally started already after 12 hours, usually with a low dose of 20 mg twice daily. You get a 20 mg dose by dividing the tablet into 40 mg. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient tolerate. Valsartan Krka can be given together with other treatments for a heart attack and your doctor will decide which treatment is appropriate.
Adult patients with heart failure
The usual starting dose is 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient tolerate. Valsartan Krka can be given together with other treatments for heart failure and your doctor will decide which treatment is appropriate.
You can take Valsartan Krka regardless of meals. Swallow Valsartan Krka with a glass of water. Take Valsartan Krka at about the same time each day.
If you have used too much Valsartan Krka
If you experience severe dizziness and/or fainting, contact a doctor immediately and lie down.
If you have ingested too much medicine or if, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice. If you experience severe dizziness and/or fainting, lie down and contact a doctor immediately.
If you forget to use Valsartan Krka
Do not take a double dose to make up for a missed dose.
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, then skip the missed dose.
If you stop using Valsartan Krka
If you stop your treatment with Valsartan Krka, your disease may get worse. Do not stop taking your medicine unless your doctor tells you to stop.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Valsartan Krka can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention:
If you get symptoms of angioedema (a particular allergic reaction ), such as:
- swollen face, lips, tongue, or throat
- difficulty breathing or swallowing
- hives, itching.
If you get any of these symptoms, stop taking Valsartan Krka and see a doctor immediately (see also section 2 “Warnings and precautions”).
Other side effects are:
Common (may affect up to 1 in 10 users):
- dizziness
- low blood pressure with or without symptoms such as dizziness and fainting when standing up.
- impaired kidney function (signs of impaired kidney function).
Uncommon (may affect up to 1 in 100 users):
- angioedema (see section “Some symptoms require immediate medical attention”)
- sudden loss of consciousness ( syncope )
- the feeling of spinning ( vertigo )
- severely reduced kidney function (signs of acute kidney failure )
- muscle cramps, abnormal heart rhythm (signs of hyperkalemia )
- shortness of breath, difficulty breathing when lying down, swollen feet or legs (signs of heart failure )
- headache
- cough
- abdominal pain
- nausea
- diarrhea
- fatigue
- weakness
Frequency not known (cannot be estimated from available data):
- blistering of the skin (a sign of skin inflammation, also called bullous dermatitis )allergic reactions with rash, itching, and hives; symptoms such as fever, swollen joints, and joint pain, muscle aches, swollen lymph nodes, and/or flu-like symptoms may occur (signs of serum sickness)
- purplish-red dots, fever, itching (signs of inflammation of blood vessels, also called vasculitis )
- unusual bleeding or bruising (signs of thrombocytopenia )
- muscle pain ( myalgia )
- fever, sore throat, or mouth ulcers due to infection (symptoms of a low level of white blood cells, also called neutropenia )
- lowered hemoglobin level and reduced proportion of red blood cells in the blood (which in severe cases can lead to anemia )
- increased level of potassium in the blood (which in severe cases can cause muscle cramps, and abnormal heart rhythm)
- decreased levels of sodium in the blood (which can trigger tiredness and confusion, muscle twitching, seizures, or coma )
- elevated liver function values (which may indicate liver damage) including an elevated level of bilirubin in the blood (which in severe cases may cause yellowing of the skin and eyes)
- increased level of blood urea nitrogen and increased level of serum creatinine (which may indicate abnormal kidney function)
The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness and decreased kidney function occurred less often in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.
Side effects in children and adolescents are similar to those seen in adults.
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
How to store Valsartan Krka
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30°C.
Store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is valsartan. Each film-coated tablet contains 40 mg, 80 mg, or 160 mg of valsartan.
- Other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate.
- Other ingredients in the film coating on the 40 mg tablets are hypromellose, titanium dioxide (E171), macrogol 4000, and yellow iron oxide (E172).
- Other ingredients in the film coating on the 80 mg tablets are hypromellose, titanium dioxide (E171), macrogol 4000, and red iron oxide (E172).
- Other ingredients in the film coating on the 160 mg tablets are hypromellose, titanium dioxide (E171), macrogol 4000, and yellow and red iron oxide (E172).
- See section 2 “Valsartan Krka contains lactose and sodium”.
Appearance and package sizes of the medicine
The 40 mg tablets are yellow-brown, round, slightly biconvex, film-coated, and scored on one side.
The 80 mg tablets are light red, round, biconvex, film-coated, and scored on one side. The 160 mg tablets are yellow-brown, oval, biconvex, film-coated, and scored on one side.
The tablets for all three strengths can be divided into two equal doses.
For each strength, packs of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 120 and 180 film-coated tablets in blisters are available.
Not all pack sizes may be marketed.
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o. o., ul. Równoległa 5, 02-235 Warsaw, Poland