40 mg film-coated tablets
valsartan
What Valsartan Actavis is and what is it used for
Valsartan Actavis 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 Actavis works by inhibiting the effect of angiotensin II. This leads to vessels dilating and blood pressure falling.
Valsartan Actavis 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 Actavis is used when a class of medicines called ACE inhibitors (a medicine to treat heart failure ) cannot be used or when Valsartan Actavis can be used in 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 Actavis 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 Valsartan Actavis
Do not use Valsartan Actavis
- if you are allergic to valsartan, soya oil, peanut oil, 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 Actavis during the last 6 months of pregnancy. (Even earlier in pregnancy it is good to avoid Valsartan Actavis, 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, talk to your doctor, and do not take Valsartan Actavis.
Warnings and precautions
Talk to your doctor or pharmacist before using Valsartan Actavis
- 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 Actavis, stop taking the medicine immediately and never take it again. See also section 4, “Potential 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 Actavis 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 think you are pregnant or become pregnant during treatment, contact your doctor. Valsartan Actavis is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it can then cause birth defects, see Pregnancy and breastfeeding.
- 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 number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not use Valsartan Actavis”.
If any of these apply to you, tell your doctor before taking Valsartan Actavis.
Other medicines and Valsartan Actavis
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
The treatment effect can be affected if Valsartan Actavis 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 et, especially diuretics.
- medicines that lower 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 ).
- 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 Actavis.
- lithium, a drug used in the treatment of certain types of mental illness.
Your doctor may need to change your dose and/or take other precautions:
- if you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not use Valsartan Actavis” and “Warnings and precautions”).
- 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 ).
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.
Valsartan Actavis with food and drink
You can take Valsartan Actavis regardless of meals.
Pregnancy and breastfeeding
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.
Your doctor will usually suggest that you stop taking Valsartan Actavis before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Valsartan Actavis 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 breastfeeding or intend to start breastfeeding.
Valsartan Actavis 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 Actavis affects you. Like many other medicines for the treatment of high blood pressure, Valsartan Actavis 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 Actavis contains lactose, sodium and soya oil
Valsartan Actavis contains lactose . If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Valsartan Actavis contains sodium . This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is almost ‘sodium-free’.
Valsartan Actavis contains soya oil. If you are allergic to peanuts or soya, you should not use this medicine.
How to use Valsartan Actavis
Always use this medicine according to the doctor’s or pharmacist’s instructions, 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, the recommended starting dose is 40 mg of valsartan once daily.
In patients weighing 35 kg or more, the recommended 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 Actavis 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 Actavis can be given together with other treatments for heart failure and your doctor will decide which treatment is appropriate.
You can take Valsartan Actavis regardless of meals. Swallow Valsartan Actavis with a glass of water.
Take Valsartan Actavis at about the same time each day.
If you use too much Valsartan Actavis
If you have ingested too much medicine or if, for example, If a child has ingested the drug by mistake, 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 Actavis
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 Actavis
If you stop your treatment with Valsartan Actavis, 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 side effects can be serious and require immediate medical attention:
If you get symptoms of angioedema (a specific allergic reaction ), a less common side effect, such as:
- swollen face, lips, tongue, or throat
- difficulty breathing or swallowing
- hives, itching.
If you get any of these, stop taking Valsartan Actavis and contact your doctor immediately (see 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):
- 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
- increased creatinine levels in the blood (which may indicate abnormal kidney function)
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 pain, 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 urea nitrogen in the blood (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 Actavis
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton, and blister pack, and can after EXP. The expiration date is the last day of the specified month.
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.
PVC/PE/PVDC-Al blister pack: Store at a maximum of 30 °C.
Polyethylene (PE) can: This medicinal product does not require special storage conditions.
Contents of the packaging and other information
Contents declaration
- The active substance is valsartan. Each film-coated tablet contains 40 mg of valsartan.
- Other ingredients are tablet core: lactose monohydrate, microcrystalline cellulose, crushed caramel sodium, povidone K29-K32, talc, magnesium stearate, colloidal anhydrous silica; Film coating: polyvinyl alcohol, macrogol 3350, talc, lecithin (contains soybean oil) (E322), titanium dioxide (E171), yellow iron oxide (E172).
Appearance and package sizes of the medicine
Valsartan Actavis 40 mg tablets: yellow, oval, biconvex, film-coated tablets, 9 x 4.5 mm scored on one side and debossed with “V” on the other side.
The tablet can be divided into two equal doses.
Package sizes
PVC/PE/PVDC/aluminium blister: 7, 14, 28, 30, 56, 98 and 280 tablets.
Container (PE): 7, 14, 28, 30, 56, 98 and 280 tablets.
Not all pack sizes may be marketed.
Marketing authorization holder
Actavis Group PTC EHF.
Reykjavikurvegi 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun, ZTN 3000
Malta