40 mg, 80 mg, 160 mg, 320 mg\u00a0film-coated tablets
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Valsartore belongs to a drug class called\u00a0angiotensin\u00a0II receptor blockers and is used to lower high\u00a0blood pressure.\u00a0Angiotensin\u00a0II is a substance found in the body that constricts the blood vessels, which increases\u00a0blood pressure\u00a0et.\u00a0Valsartore works by\u00a0inhibiting\u00a0the effect of\u00a0angiotensin\u00a0II.\u00a0This leads to\u00a0vessels\u00a0dilating and\u00a0blood pressure\u00a0falling.<\/p>\n\n\n\n
Valsartore 40 mg film-coated tablets can be used in three different conditions<\/strong> :<\/p>\n\n\n\n Valsartore 80 mg and 160 mg film-coated tablets can be used in three different conditions<\/strong> :<\/p>\n\n\n\n Valsartore 320 mg film-coated tablets can be used for<\/strong> :<\/p>\n\n\n\n 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. If any of these apply to you, you should not take Valsartore.<\/strong><\/a><\/p>\n\n\n\n Talk to your doctor or pharmacist before taking Valsartore<\/p>\n\n\n\n Your doctor may need to check your kidney function, blood pressure and the amount of electrolytes (eg potassium ) in your blood at regular intervals.<\/p>\n\n\n\n See also the information under the heading “Do not take Valsartore”.<\/a><\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.<\/p>\n\n\n\n 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:<\/p>\n\n\n\n In addition:<\/strong><\/p>\n\n\n\n You can take Valsartore regardless of meals.<\/a><\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/a><\/p>\n\n\n\n If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.<\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”. Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Adult patients after a recent heart attack:<\/strong> 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.<\/p>\n\n\n\n Valsartore can be given together with other treatment for a heart attack and your doctor will decide which treatment is appropriate.<\/p>\n\n\n\n Adult patients with heart failure:<\/strong> 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.<\/p>\n\n\n\n Valsartore can be given together with other treatment for heart failure and the doctor will judge which treatment is appropriate.<\/p>\n\n\n\n Adult patients with high blood pressure<\/strong><\/p>\n\n\n\n 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).<\/p>\n\n\n\n Administration<\/strong><\/p>\n\n\n\n You can take Valsartore regardless of meals. The tablet can be divided into equal doses . Swallow Valsartore with a glass of water.<\/p>\n\n\n\n Take Valsartore at about the same time each day.<\/a><\/p>\n\n\n\n Children and adolescents (from 6 to 18 years) with high blood pressure<\/strong><\/p>\n\n\n\n In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily.<\/p>\n\n\n\n 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).<\/a><\/p>\n\n\n\n If you have ingested too much medicine or if, for example,\u00a0a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n If you experience severe dizziness and\/or fainting, contact a doctor immediately and lie down.<\/a><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Do not take a double dose to make up for a missed dose .<\/a><\/p>\n\n\n\n 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.<\/p>\n\n\n\n If you have further questions about this medicine, contact your doctor or pharmacist.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause side effects , although not everybody gets them.<\/p>\n\n\n\n Some symptoms require immediate medical attention:<\/strong><\/p>\n\n\n\n If you get symptoms of angioedema (a special allergic reaction ), such as:<\/p>\n\n\n\n If you get any of these, see a doctor immediately.<\/strong><\/p>\n\n\n\n Side effects are:<\/strong><\/p>\n\n\n\n Common (may affect up to 1 in 10 users):<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 users):<\/strong><\/p>\n\n\n\n Has been reported (occurring in an unknown number of users)<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Side effects in children and adolescents are similar to those seen in adults.<\/p>\n\n\n\n <\/a><\/p>\n\n\n\n The active substance is valsartan. Each tablet contains 40 mg, 80 mg, 160 mg and 320 mg of valsartan respectively.<\/p>\n\n\n\n Other ingredients are:<\/strong><\/p>\n\n\n\n Tablet core:<\/strong><\/p>\n\n\n\n Lactose monohydrate<\/p>\n\n\n\n Cellulose powder<\/p>\n\n\n\n Hypromellose<\/p>\n\n\n\n Croscarmellose sodium’Silicon dioxide ( colloidal , anhydrous)<\/p>\n\n\n\n Magnesium stearate<\/p>\n\n\n\n Film coating:<\/strong><\/p>\n\n\n\n Hypromellose<\/p>\n\n\n\n Macrogol 8000<\/p>\n\n\n\n Titanium dioxide (E171)<\/p>\n\n\n\n Talc<\/p>\n\n\n\n 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).<\/a><\/p>\n\n\n\n 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 .<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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 .<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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 .<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Valsartore 320 mg film-coated tablets are brown, oblong and biconvex in shape.\u00a0The tablets have a break on one side to be able to divide the tablet into two equal\u00a0doses.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before you use Valsartore<\/h2>\n\n\n\n
Do not use Valsartore<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Other medicines and Valsartore<\/h2>\n\n\n\n
Valsartore with food, drink and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Valsartore contains lactose (lactose) and sodium<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nHow to use Valsartore<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
If you use too much Valsartore <\/h2>\n\n\n\n
If you forget to use Valsartore<\/h2>\n\n\n\n
If you stop using Valsartore<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Valsartore<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n