40 mg and 320 mg film-coated tablets
film-coated tablets
What Valsartan Sandoz is and what is it used for
Valsartan Sandoz belongs to a drug class called angiotensin II receptor blockers and is used to lower high blood pressure. Angiotensin II is a substance found in the body that constricts the blood vessels, which increases blood pressure et. Valsartan Sandoz works by inhibiting the effect of angiotensin II. This leads to vessels dilating and blood pressure falling.
Valsartan Sandoz 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.
- for the treatment of adult patients who have recently had a heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.
- for the treatment of symptomatic heart failure in adult patients. Valsartan Sandoz 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 Sandoz 320 mg film-coated tablets can be used
- for the treatment of high blood pressure in adults and 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.
The valsartan contained in Valsartan Sandoz may also be approved to treat other conditions not mentioned in this product 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 Sandoz
Do not take Valsartan Sandoz
- 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.
- if you are more than 3 months pregnant (it is also better to avoid Valsartan Sandoz during early pregnancy – see the section “Pregnancy and breast-feeding”).
- if you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.
If any of these apply to you, you should not take Valsartan Sandoz.
Warnings and precautions
Talk to your doctor before taking Valsartan Sandoz
- 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 are being treated after having a heart attack or if you have heart failure, your doctor may then check your kidney function.
- 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 when taking another medicine (including ACE inhibitors ). If these symptoms occur while taking Valsartan Sandoz, stop taking Valsartan Sandoz 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 are under 18 years of age and you are taking Valsartan Sandoz at the same time as other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure, etc.), your doctor may need to check your kidney function and the amount of potassium in your blood at regular intervals.
- 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 Sandoz 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 ).
- you must tell your doctor if you think you are (or may become) pregnant. Valsartan Sandoz is not recommended in early pregnancy and must not be used if you are more than 3 months pregnant, as the medicine may cause serious harm to the unborn child if used at this stage (see section “Pregnancy and breast-feeding”).
- 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 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 ).
If any of these apply to you, tell your doctor before taking Valsartan Sandoz.
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 take Valsartan Sandoz”.
Other medicines and Valsartan Sandoz
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 Sandoz 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 the information under the headings “Do not take Valsartan Sandoz” 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 Sandoz.
- 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 with an ACE inhibitor together with certain other medicines that you take to treat your heart failure, called mineralocorticoid receptor antagonists (MR antagonists ) (eg spironolactone, eplerenone) or beta-blockers (eg metoprolol ).
Valsartan Sandoz with food, drink, and alcohol
You can take Valsartan Sandoz with or without food.
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.
- You must tell your doctor if you think you are (or may become) pregnant. Your doctor will usually advise you to stop taking Valsartan Sandoz before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Valsartan Sandoz. Valsartan Sandoz is not recommended in early pregnancy and must not be taken when you are more than 3 months pregnant as it may cause serious birth defects if used after the third month of pregnancy
- Tell your doctor if you are breastfeeding or intend to breastfeed. Valsartan Sandoz is not recommended for mothers who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, 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 Sandoz affects you. Like many other medicines for the treatment of high blood pressure, Valsartan Sandoz can rarely 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.
How to use Valsartan Sandoz
Always take this medicine as directed by your doctor, 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.
Adult patients with high blood pressure: The recommended dose is 80 mg daily. In some cases, your doctor may prescribe a higher dose (eg 160 mg or 320 mg) or combine Valsartan Sandoz with another medicine (eg a diuretic).
Children and adolescents (from 6 to 18 years) with high blood pressure: In patients weighing less than 35 kg, the recommended 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 after a recent heart attack: After a heart attack, treatment is generally started after 12 hours, usually with a low dose of 20 mg twice daily. You get a 20 mg dose by dividing the 40 mg tablet. 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 Sandoz can be given together with other heart attack treatments 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 Sandoz may be given together with other treatments for heart failure and your doctor will decide which treatment is appropriate.
You can take Valsartan Sandoz with or without food. Swallow Valsartan Sandoz with a glass of water.
Take Valsartan Sandoz at about the same time each day.
If you have used too much Valsartan Sandoz
If you experience severe dizziness and/or fainting, contact a doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor or hospital.
If you have ingested too much medicine or if, for example, a child has ingested the drug by mistake, contact a doctor, hospital, or the Poisons Information Center (tel. 112) for an assessment of the risk and advice.
If you forget to use Valsartan Sandoz
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.
Do not take a double dose to make up for a missed dose.
If you stop using Valsartan Sandoz
If you stop your treatment with Valsartan Sandoz, your disease may get worse. Do not stop taking your medicine unless your doctor tells you to stop.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention:
If you get symptoms of angioedema (a specific allergic reaction ), such as:
- swelling of the face, lips, tongue, or throat
- difficulty breathing or swallowing
- hives, itching.
If you get any of these symptoms, stop taking Valsartan Sandoz and contact your doctor immediately (see also section 2 “Warnings and precautions”).
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.
Has been reported (occurring in an unknown number of users):
- blistering of the skin (a sign of skin inflammation, also called bullous dermatitis )
- allergic reactions with skin rash, itching, and hives; symptoms such as fever, swollen joints, 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)
- 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)
- low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching, and/or seizures in severe cases).
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.
How to store Valsartan Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging/blister after the Expiration date. or 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.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Medicines must not be thrown into the drain or among the household waste. Question
pharmacists on 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.
Valsartan Sandoz 40 mg film-coated tablets one film-coated tablet contains 40 mg of valsartan.
Valsartan Sandoz 320 mg film-coated tablets one film-coated tablet contains 320 mg of valsartan. - Other ingredients are:
Tablet core: Microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate film coating: Hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172); additionally for Valsartan Sandoz 40 mg/320 mg film-coated tablets: black iron oxide (E172).
Appearance and package sizes of the medicine
Valsartan Sandoz 40 mg film-coated tablets:
Yellow, oval film-coated tablet with beveled edges, slightly convex, scored on one side and marked with “D” on one side of the score and “O” on the other side of the score, and “NVR” on the opposite side of the tablet.
The tablet can be divided into two equal doses.
Valsartan Sandoz 320 mg film-coated tablets:
Dark grey-violet, oval film-coated tablet with beveled edges, slightly convex, scored on one side and marked with “DC” on one side of the score and “DC” on the other side of the score and “NVR” on the opposite side of the tablet.
The break score is not for dividing the tablet into equal doses, but only to facilitate swallowing.
Pack sizes: 7, 10, 14, 15, 20, 28, 30, 50, 50×1, 56, 60, 84, 90, 98, 100 or 280 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, DE-39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Verovskova 57, SI-1526 Ljubljana, Slovenia
or
Lek SA, ul. Domaniewska 50 C, PL-02-672 Warsaw, Poland
or
Lek Pharmaceuticals dd, Trimline 2 D 9220 Lendava, Slovenia
or
LEK SA, Ul. Podlipie 16 C, 95 010 Strykow, Poland
or
Novartis Farmacéutica SA, Ronda de Santa Maria 158, E-08210, Barbéra del Vallés, Barcelona, Spain
or
SC Sandoz SRL, Str. Livezeni no. 7A, 540472 Targo-Mures, Romania.