40 mg, 80 mg, 160 mg, 320 mg film-coated tablets
valsartan
1. What Diovan is and what it is used for
Diovan contains the active substance valsartan and belongs to a class of medicines called angiotensin II receptor blockers and is used to lower high blood pressure. Angiotensin II is a substance found in the body that constricts blood vessels, which increases blood pressure. Diovan works by inhibiting the effects of angiotensin II. This causes the blood vessels to dilate and the blood pressure to drop.
Diovan 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 up to 18 years. High blood pressure increases the load on the heart and blood vessels. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and lead to stroke ( stroke ), heart failure, or kidney failure. High blood pressure increases the risk of a heart attack. Lowering blood pressure 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). “Recently” here means between 12 hours and 10 days.
- for the treatment of symptomatic heart failure in adult patients. Diovan is used when a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) (a medicine for the treatment of heart failure ) can not be used or as a supplement to ACE inhibitors when other medicines for the treatment of heart failure can not 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 around the blood enough to supply the whole body with blood.
Diovan 80 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 up to 18 years. High blood pressure increases the load on the heart and blood vessels. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and lead to stroke ( stroke ), heart failure, or kidney failure. High blood pressure increases the risk of a heart attack. Lowering blood pressure 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). “Recently” here means between 12 hours and 10 days.
- for the treatment of symptomatic heart failure in adult patients. Diovan is used when a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) (a medicine for the treatment of heart failure ) can not be used or as a supplement to ACE inhibitors when other medicines for the treatment of heart failure can not 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 around the blood enough to supply the whole body with blood.
Diovan 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 up to 18 years. High blood pressure increases the load on the heart and blood vessels. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and lead to stroke ( stroke ), heart failure, or kidney failure. High blood pressure increases the risk of a heart attack. Lowering blood pressure 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). “Recently” here means between 12 hours and 10 days.
- for the treatment of symptomatic heart failure in adult patients. Diovan is used when a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) (a medicine for the treatment of heart failure ) can not be used or as a supplement to ACE inhibitors when other medicines for the treatment of heart failure can not 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 around the blood enough to supply the whole body with blood.
Diovan 320 mg film-coated tablets can be used
- for the treatment of high blood pressure in adults and in children and adolescents from 6 up to 18 years. High blood pressure increases the load on the heart and blood vessels. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and lead to stroke ( stroke ), heart failure, or kidney failure. High blood pressure increases the risk of a heart attack. Lowering blood pressure to a normal level reduces the risk of these diseases.
Valsartan contained in Diovan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before taking Diovan
Do not take Diovan
- if you are allergic (hypersensitive) 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 Diovan during the last 6 months of pregnancy (even earlier in pregnancy, it is good to avoid Diovan, see pregnancy section).
- if you have diabetes or kidney problems and you are being treated with a blood pressure-lowering medicine containing aliskiren.
If any of these apply to you, talk to your doctor and do not take Diovan.
Warnings and cautions
Talk to your doctor
- 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 have a serious heart condition 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 you are taking Diovan, stop taking Diovan 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 your 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 at regular intervals.
- if you suffer from aldosteronism. This is a disease in which your adrenal glands produce too much of the hormone et alaldosterone. If this applies to you, Diovan should not be used.
- if you have lost a lot of fluid ( dehydration ) due to diarrhea or vomiting or if you take high doses of your diuretics ( diuretics ).
- 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.
- aliskiren
- If you are being treated with an ACE inhibitor together with certain other medicines that you are taking to treat your heart failure, called MR antagonists(mineral corticoid 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 take Diovan”.
Contact your doctor if you think you may be pregnant or become pregnant during treatment. Diovan is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breast-feeding.
Other drugs and Diovan
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines, or might take any other medicines.
The treatment effect may be affected if Diovan is taken with certain other medicines. It may be necessary to change the dose, take other precautions, or in some cases discontinue treatment with one of the drugs. This applies to both prescription and over-the-counter medicines, in particular:
- other drugs that lower blood pressure, et, particularly diuretic agents ( diuretic ), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (also see details under “Do not take Diovan” and “Precautions”).
- drugs 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), a drug used to protect against transplant rejection (cyclosporine), or antiretroviral drugs against HIV – / AIDS infection (ritonavir). These medicines may increase the effect of Diovan.
- lithium, a drug used in the treatment of certain types of mental illness.
Besides:
- if you are being treated after a heart attack, a combination of ACE inhibitors(a medicine used to treat a heart attack) is not recommended.
- if you are being treated for heart failure, a triple combination with ACE inhibitors and other medicines to treat heart failure, called MR antagonists(mineral corticoid receptor antagonists ) (eg spironolactone, eplerenone) or beta-blockers (eg . metoprolol ).
Pregnancy and breastfeeding
- If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor will suggest that you stop taking Diovan before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Diovan 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 planning to start breast-feeding. Diovan is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is newborn or born prematurely.
Driving and using machines
Before driving, using tools or machines, or performing activities that require concentration, make sure you know how Diovan affects you. Like many other medicines used to treat high blood pressure, Diovan can cause dizziness and affect your ability to concentrate.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to take Diovan
Always take this medicine exactly as your doctor has told you 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 feel any symptoms of this. Many feel as usual. It is therefore important that you go to your doctor’s visits as planned even if you feel good.
Adult patients with high blood pressure: The recommended dose is 80 mg daily. In some cases, your doctor may prescribe higher doses (eg 160 mg or 320 mg) or combine Diovan with another medicine (eg a diuretic).
Children and adolescents (from 6 up to 18 years) with high blood pressure:
In patients weighing less than 35 kg, the recommended starting dose of Diovan tablet is 40 mg once daily.
In patients weighing 35 kg or more, the recommended starting dose of Diovan tablet is 80 mg once daily.
In some cases, your doctor may prescribe a higher dose for you ( dose one may be increased to 160 mg and a maximum of 320 mg).
For children who are unable to swallow tablets, the use of Diovan oral solution is recommended.
Adult patients after a recent myocardial infarction: Following a myocardial infarction, treatment is generally started as early as 12 hours, usually with a low dose of 20 mg twice daily. You will receive 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.
Diovan can be given with other treatment for 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 one over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient tolerate.
Diovan can be given with other treatments for heart failure and your doctor will decide which treatment is appropriate.
You can take Diovan regardless of meals. Swallow Diovan with a glass of water.
Take Diovan at about the same time each day.
If you take more Diovan than you should
If you experience severe dizziness and/or fainting, contact a doctor immediately and lie down. If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Diovan
If you forget to take a dose, take it as soon as you remember. If it is soon time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Diovan
If you stop taking Diovan, your disease may get worse. Do not stop taking your medicine unless your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms may be severe and require immediate medical attention:
If you get symptoms of angioedema (a specific 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 Diovan and contact your doctor immediately (see section 2 “Warnings and precautions”).
Other side effects are:
Common (may affect up to 1 in 10 people)
- dizziness
- low blood pressure with or without symptoms such as dizziness and fainting when traveling to standing
- impaired renal function (signs of renal impairment)
Uncommon (may affect up to 1 in 100 people):
- angioedema (see section “Some symptoms require immediate medical attention”)
- sudden unconsciousness ( syncope )
- feeling that it is spinning ( vertigo )
- severely reduced renal function (signs of acute renal failure )
- muscle cramps, abnormal heart rhythm (signs of hyperkalemia )
- shortness of breath, difficulty breathing in a supine position, swollen feet or legs (signs of heart failure )
- headache
- cough
- abdominal pain
- nausea
- diarrhea
- fatigue
- weakness
Has been reported (occurs in an unknown number of users):
- blistering of the skin (signs of dermatitis, 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)
- purple-red dots, fever, itching (signs of inflammation in blood vessels, also called vasculitis )
- unusual bleeding or bruising (signs of thrombocytopenia )
- muscle pain ( myalgia )
- fever, sore throat, or cold sores due to infection (symptoms of low white blood cell count, also called neutropenia )
- decreased hemoglobin level and decreased percentage of red blood cells in the blood (which in severe cases can lead to anemia )
- elevated potassium levels 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 bilirubin level in the blood (which in severe cases may cause yellowing of the skin and eyes)
- elevated levels of urea nitrogen in the blood and elevated levels of serum creatinine (which may indicate abnormal kidney function)
- low levels of sodium in the blood (which can trigger fatigue, confusion, muscle twitching, and/or cramps in severe cases)
The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness and renal impairment occurred less frequently in adult patients treated for hypertension than in adult patients treated for heart failure or after a recent myocardial infarction.
Side effects in children and adolescents are similar to those seen in adults.
5. How to store Diovan
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP” and “EXP”, respectively. The expiration date is the last day of the specified month.
- Do not store above 30 ° C. Store in the original package. Moisture sensitive.
- Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
- The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is valsartan.
- Each film-coated tablet contains 40 mg, 80 mg, 160 mg, or 320 mg of valsartan.
- The other ingredients are microcrystalline cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate.
- The film casing of the tablet contains hypromellose, titanium dioxide (E 171), macrogol 8000, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172, only 40 mg and 160 mg and 320 mg).
What the medicine looks like and the contents of the pack
Diovan 40 mg film-coated tablets are yellow, oval tablets with a scoreline on one side. They have the letters “D” on one side of the breaker and “O” on the other side of the breaker and “NVR” on the other side of the tablet. The tablet can be divided into two equal parts.
Diovan 80 mg film-coated tablets are bright red, round tablets with a scoreline on one side. They have the letters “D” on one side of the breaker and “V” on the other side of the breaker and “NVR” on the other side of the tablet. The breaker is not for dividing the tablet into equal doses, but only to facilitate swallowing.
Diovan 160 mg film-coated tablets are gray-orange, oval tablets with a scoreline on one side. They have the letters “DX” on one side of the breaker notch and “DX” on the other side of the breaker notch and “NVR” on the other side of the tablet. The breaker is not for dividing the tablet into equal doses, but only to facilitate swallowing.
Diovan 320 mg film-coated tablets are dark gray-violet, oval tablets with a scoreline on one side. They have the letters “DC” on one side of the breaker and “DC” on the other side of the breaker and “NVR” on the other side of the tablet. The breaker is not for dividing the tablet into equal doses, but only to facilitate swallowing.
The tablets are supplied in blister packs of 7, 14, 28, 30, 56, 90, or 98 tablets and calendar blister packs of 14, 28, 56, 98, and 280 tablets. Perforated unit dose blister pack of 56×1, 98×1, or 280×1 tablets is also available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Novartis Sverige AB
Box 1218
164 28 Kista
Phone: 08-732 32 00
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder.