40 mg, 80 mg, 160 mg, 320 mg film-coated tablets
What Valsartore is and what it is used for
Valsartore 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. Valsartore works by inhibiting the effect of angiotensin II. This leads to vessels dilating and blood pressure falling.
Valsartore 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 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 . Valsartore 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.
Valsartore 80 mg and 160 mg film-coated tablets can be used in three different conditions :
- 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 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 . Valsartore 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.
Valsartore 320 mg film-coated tablets can be used for :
- 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 heart attack. A lowering of blood pressure et to a normal level reduces the risk of these diseases.
The valsartan contained in Valsartore may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Valsartore
Do not use Valsartore
- 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 have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.
- if you are further along in your pregnancy than the 3rd month. (Even earlier in pregnancy it is good to avoid Valsartore, see Pregnancy and breast-feeding).
If any of these apply to you, you should not take Valsartore.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartore
- if you have liver disease.
- if you have severe kidney disease or if you are undergoing dialysis .
- if you have narrowing of the renal arteries.
- if you have recently had a kidney transplant (received a new kidney).
- if you are being treated after a heart attack or because you have heart failure , your doctor may check your kidney function.
- if you have a serious heart disease other than heart failure or heart attack.
- 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 Valsartore 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, Valsartore should not be used.
- if you have lost a lot of fluid ( dehydration ) due to diarrhoea, vomiting or high doses of diuretics ( diuretics ) .
- if you have had swelling, especially of the face and neck, while taking other medicines (including ACE inhibitors ). If you get these symptoms, stop taking this medicine and contact your doctor immediately. You should never take any medicine containing valsartan (such as Valsartore) again.
- if you are taking other medicines used to treat high blood pressure (see section ‘Other medicines and Valsartore’ below).
- if you think you are pregnant or become pregnant during treatment, contact your doctor. Valsartore is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy, as it may then cause birth defects, see Pregnancy and breast-feeding.
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg 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 amount of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Valsartore”.
Other medicines and Valsartore
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 Valsartore is taken together with certain other medicines. Your doctor may need to change your dose and/or take other precautions or, in some cases, stop treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, in particular:
- other medicines that lower blood pressure et , especially diuretics .
- 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 pain relievers called non-steroidal anti-inflammatory drugs ( NSAIDs ).
- lithium , a drug used in the treatment of certain types of mental illness.
- 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 Valsartore.
- If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Valsartore” and “Warnings and precautions”)
- 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 ).”
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.
Valsartore with food, drink and alcohol
You can take Valsartore regardless of meals.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, 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 Valsartore before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Valsartore should not be used in early pregnancy and should not be used during the last 6 months of pregnancy, as it may cause birth defects.
- Tell your doctor if you are breast-feeding or intend to start breast-feeding . Valsartore is not recommended if you are breast-feeding and your doctor may choose another treatment for you if you wish to breast-feed 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 Valsartore affects you. Like many other medicines used to treat high blood pressure , Valsartore can cause dizziness and affect concentration.
You yourself 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 . 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.
Valsartore contains lactose (lactose) and sodium
If you have an intolerance to some 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. is almost “sodium-free”.
How to use Valsartore
Always take this medicine as directed by your doctor. 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 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. The 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.
Valsartore can be given together with other treatment for a heart attack and your doctor will decide which treatment is appropriate.
Adult patients with heart failure: The recommended starting dose is 40 mg twice daily. The 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.
Valsartore can be given together with other treatment for heart failure and the doctor will judge which treatment is appropriate.
Adult patients with high blood pressure
The recommended dose is 80 mg daily. In some cases, the doctor may prescribe a higher dose (eg 160 mg or 320 mg) or combine Valsartore with another medicine (eg a diuretic).
Administration
You can take Valsartore regardless of meals. The tablet can be divided into equal doses . Swallow Valsartore with a glass of water.
Take Valsartore at about the same time each day.
Use for children and adolescents
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 recommended starting dose is 80 mg valsartan once daily. In some cases, the doctor may prescribe a higher dose ( dose one can be increased to 160 mg and to a maximum of 320 mg).
If you use too much Valsartore
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, contact a doctor immediately and lie down.
If you forget to use Valsartore
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 one.
Do not take a double dose to make up for a missed dose .
If you stop using Valsartore
If you stop your treatment with Valsartore, 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, this medicine can cause side effects , although not everybody gets them.
Some symptoms require immediate medical attention:
If you get symptoms of angioedema (a special allergic reaction ), such as:
- swollen face, lips, tongue or throat
- difficulty breathing or swallowing
- hives , itching .
If you get any of these, see a doctor immediately.
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 )
- feeling of spinning ( vertigo )
- severely reduced kidney function (signs of acute kidney failure )
- muscle cramps, abnormal heart rhythm (signs of too high levels of potassium in the blood, also called hyperkalemia )
- shortness of breath, difficulty breathing when lying down, swollen feet or legs (signs of heart failure )
- headache
- cough
- abdominal pain
- nausea
- diarrhea
- fatigue (exhaustion)
- weakness ( asthenia )
Has been reported (occurring in an unknown number of users)
- 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 too low levels of platelets in the blood, also called 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 Valsartore
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
- Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
- Store Valsartore at a maximum of 30 ºC.
- Medicines must not be thrown into the drain or among 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 tablet contains 40 mg, 80 mg, 160 mg and 320 mg of valsartan respectively.
Other ingredients are:
Tablet core:
Lactose monohydrate
Cellulose powder
Hypromellose
Croscarmellose sodium’Silicon dioxide ( colloidal , anhydrous)
Magnesium stearate
Film coating:
Hypromellose
Macrogol 8000
Titanium dioxide (E171)
Talc
In addition, Valsartore 40 mg and 160 mg contain yellow iron oxide (E172), while Valsartore 80 mg contains red iron oxide (E172). Valsartore 320 mg contains yellow, red and black iron oxide (E172).
Appearance and package sizes of the medicine
Valsartore 40 mg film-coated tablets are yellow, round and biconvex in shape. The tablets have a break on both sides to be able to divide the tablet into two equal doses .
Valsartore 40 mg film-coated tablets are packed in PVC/PVDC/aluminium blister packs containing 10, 14, 28, 30, 50, 56, 90 and 98 tablets.
Valsartore 80 mg film-coated tablets are pink, round and biconvex in shape. The tablets have a break on both sides to be able to divide the tablet into two equal doses .
Valsartore 80 mg film-coated tablets are packed in PVC/PVDC/aluminium blister packs containing 10, 14, 28, 30, 50, 56, 90, 98 and 100 tablets.
Valsartore 160 mg film-coated tablets are yellow, oblong and have a biconvex shape. The tablets have a break on both sides to be able to divide the tablet into two equal doses .
Valsartore 160 mg film-coated tablets are packed in PVC/PVDC/aluminium blister packs containing 10, 14, 28, 30, 50, 56, 90, 98 and 100 tablets.
Valsartore 320 mg film-coated tablets are brown, oblong and biconvex in shape. The tablets have a break on one side to be able to divide the tablet into two equal doses.
Valsartore 320 mg film-coated tablets are packed in PVC/PVDC/aluminium blister packs containing 10, 14, 28, 30, 50, 56, 98, 100, 112, 126, 154, 168, 182 and 196 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Centrafarm Services BV
Nieuwe Donk 9
4879 AC Etten Leur
Netherlands
Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland
Eurogenerics NV
Heizel Esplanade Heysel b 22
B-1020 Brussels
Belgium
LAMP S. Prospero SpA
Via della Pace, 25/A
I-41030 San Prospero (Modena)
Italy
STADA Arzneimittel GmbH
Muthgasse 36/2
A-1190 Vienna
Austria
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark