Valsartan 80mg Capsules
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VALSARTAN 40 mg CAPSULES VALSARTAN 80 mg CAPSULES VALSARTAN 160 mg CAPSULES
(valsartan)
Read all ofthis leaflet carefully beforeyou start taking this medicine because it contains important information foryou.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, askyour doctor or pharmacist.
• This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even iftheir signs ofillnessarethe sameas
• Ifyou get any sideeffects, talktoyour doctor or pharmacist.This includesany possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. WhatValsartan is and what it is used for.
2. What you need to know beforeyou takeValsartan.
3. HowtotakeValsartan.
4. Possibleside effects.
5. HowtostoieValsartan.
6. Contents ofthe packand other information.
1. WHATVALSARTAN ISAND WHAT IT IS USED FOR
Valsartan belongsto a class of medicines known asangiotensin IIreceptorantagonist, which help to control high blood pressure. Angiotensin Ilisa substance in the bodythat causesvesselstotighten, thus causing your blood pressureto increase.
Valsartan works by blocking the effect ofangiotensin II.
As a result, blood vessels relaxand blood pressure is lowered.
Valsartan 40 mg capsules can be used for three differentconditions:
• to treat high blood pressure in children and adolescents 6 to18 years ofage. High blood pressure increasestheworkload on the heart and arteries. Ifnot treated it can damage the blood vessels ofthe brain, heart, and kidneys,and may result in a stroke, heart failure, or kidney failure.
High blood pressure increasesthe riskofheart attacks. Lowering your blood pressureto normal reducesthe risk ofdeveloping these disorders.
• to treat adult patients after a recent heart attack (myocardial infarction). 'Recent' here means between 12 hours and 10 days.
• to treat symptomatic heart failure in adult patients. Valsartan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication totreat heart failure) cannot be used or it may be used in addition to ACE inhibitorswhen beta blockers (anothermedication totreat heart failure) cannot be used.
Heart failure symptoms include shortness of breath, and swelling ofthe feet and legs duetofluid build-up. It is caused when the heart muscle cannot pump blood stronglyenough to supplyall the blood needed throughout the body.
Valsartan 80 mg and 160 mg capsules can be used For three different conditions:
• to treat high blood pressure in adult and in children and adolescents 6 to 18years ofage.
High blood pressure increases theworkload on the heart and arteries. If not treated it can damage the blood vessels ofthe brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increasesthe riskofheart attacks. Lowering your blood pressureto normal reducesthe risk ofdeveloping these disorders.
• to treat adult patients after a recent heart attack (myocardial infarction). 'Recent' here means between 12 hours and 10 days.
• to treat symptomatic heart failure in adult patients. Valsartan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication totreat heart failure) cannot be used or it may be used in addition to ACE inhibitorswhen beta blockers (anothermedication totreat heart failure) cannot be used.
Heart failure symptoms include shortness of breath, and swelling ofthe feet and legs duetofluid build-up. It is caused when the heart muscle cannot pump blood stronglyenough to supplyall the blood needed throughout the body.
2. WHAT DOYOU NEEDTO KNOWBEFOREYOU TAKEVALSARTAN
Do not takeValsartan:
• ifyou are allergic tovalsartan orany of the other ingredients ofthis medicine (listed in section 6)
• ifyou have severe liver disease
• ifyou are more than 3 months pregnant (it is also bettertoavoid Valsartan in early pregnancy -see pregnancy section)
• ifyou have diabetes mellitus orimpaired kidney function and you are treated with aliskiren (a renin inhibitorwhich is used totreat blood pressure).
If any of these apply to you, do not takeValsartan.
Warnings and precautions
Talk toyour doctor or pharmacist before taking
Valsartan ifany ofthe following apply to you:
• Ifyou have liver disease.
• Ifyou have severe kidney disease orif you are undergoing dialysis.
• Ifyou are suffering froma narrowing ofthe kidney artery.
• Ifyou have recently undergone kidney transplantation (received a newkidney).
• Ifyou aretreated aftera heart attackorfor heart failure, yourdoctormay checkyourkidney function.
• Ifyou have severe heart disease otherthan heart failureor heart attack.
• Ifyou haveeverexperienced swelling ofthe tongue,throat and face caused by an allergic reaction called angioedemawhen taking another drug (including 'ACE inhibitors'), tell your doctor. Ifthese symptoms occurwhen you aretaking valsartan, stoptaking valsartan immediately and do not take it again. Seealso section4ofthis leaflet 'Possibleside effects'.
• Ifyou aretaking medicines that increasethe amount ofpotassium in your blood.These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicinesand heparin. It may be necessaryto checkthe amount ofpotassium in your blood at regular intervals.
• Ifyou sufferfromaldosteronism.This is a disease in which your adrenal glands make too much ofthe hormonealdosterone. Ifthisappliestoyou, theuse ofValsartan is not recommended.
• Ifyou have lost a lot offluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets(diuretics).
• You must tell yourdoctor ifyou thinkyou are (or might become) pregnant.Valsartan is not recommended in early pregnancy, and must not be taken ifyou are morethan 3 months pregnant, as it may cause serious harmtoyour baby ifused at that stage (see pregnancy section).
Children and adolescents
Ifyou are below 18years ofageand you take Valsartan in combination with other medicinesthat inhibit the renin angiotensin aldosterone system (medicinesthat lower blood pressure), your doctor may checkyour kidneyfunction and theamount of potassium in your blood at regular intervals.
Othermedicines and Valsartan
Tell your doctor or pharmacist ifyou are taking, have
recently taken or might takeany other medicines.
Theeffect ofthe treatment can be influenced if Valsartan istaken togetherwith certain other medicines. It may be necessary to change the dose, totake other precautions, or in some cases to stop taking one ofthe medicines. This appliesto both prescription and non-prescription medicines, especially:
• othermedicines that lower blood pressure,
especially watertablets (diuretics), ACE inhibitors or aliskiren
• medicines that increase the amount of potassium in your blood.These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines
and heparin.
• certain type ofpain killers called non-steroidal anti-inflammatory medicines (NSAIDs)
• someantibiotics (rifamycin group), a drug used to protect against transplant rejection (ciclosporin) oran antiretroviral drug used totreat HIV/AIDS infection (ritonavir).These drugs may increase the effect ofValsartan.
• lithium,a medicine used totreat sometypes of psychiatric illness.
In addition:
• ifyou are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) isnot recommended.
• ifyou are being treated for heart failure, atriple combination with ACE inhibitors and beta blockers (medicationstotreat heart failure) is not recommended.
Valsartan with food and drink
You can takeValsartan with orwithout food.
Pregnancyand breast-feeding
Askyour doctor or pharmacist foradvice before taking any medicine:
• You must tell your doctor ifyou think that you are (ormight become) pregnant. Your doctorwill normally adviseyou to stoptakingValsartan before you become pregnant oras soon asyou knowyou are pregnant,and will advise you totake another medicine instead ofValsartan.Valsartan is not recommended in early pregnancy, and must not betaken when morethan 3 months pregnant,as
it may cause serious harm to your baby if it is used afterthethird month of pregnancy.
• Tell your doctor ifyou are breast-feeding or about to start breast-feeding. Valsartan is not recommended formotherswhoarebreast-feeding, and your doctor may chooseanothertreatment foryou ifyou wish tobreast-feed,especially ifyour baby is newborn, or was born prematurely.
Driving and using machines
Beforeyou driveavehicle, usetools or operate machines, or carry out other activities that require concentration, make sure you know howValsartan affects you. Like many other medicines used totreat high blood pressure,Valsartan may in rare cases cause dizzinessand affect theability to concentrate.
3. HOWTOTAKEVALSARTAN
Alwaystakethismedicineexactly asyourdoctoror pharmacist hastold you. Checkwith your doctor or pharmacist ifyou are not sure. Peoplewith high blood pressure often do not noticeany signs of this problem. Many mayfeel quite normal.This makes it all the more important foryou to keep yourappointmentswith the doctoreven ifyou are feeling well.
Use in children and adolescents (6 to18 years of age) with high blood pressure
In patientswhoweigh less than 35 kg the usual dose is 40 mg ofvalsartan once daily. In patients who weigh 35 kg or more the usual starting dose is 80 mg ofvalsartan once daily. In some casesyour doctor may prescribe higher doses (the dose can be increased to 160 mg and toa maximum of320 mg).
Jse in adult patients after a recent heart attack
Aftera heart attackthetreatment is generally started asearlyasafter 12 hours, usuallyat a low dose of 20 mg twice daily. It is not possibleto obtain the 20 mg dosewith Valsartan Capsules.The20 mg dose should be obtained by dividing a 40 mg divisible ablet.Yourdoctorwill increasethis dosegradually over several weekstoa maximum of160 mg twice daily.Thefinal dosedependson what you asan individual patient can tolerate.
Valsartan can be given togetherwith othertreatment ror heart attack, and your doctor will decide which treatment is suitable for you.
Use in adult patients with heart failure
Treatment starts generally with 40 mg twice daily. Your doctorwill increasethe dose gradually over several weekstoa maximum of 160 mg twice daily. Thefinal dose depends on what you asan individual patient can tolerate.Valsartan can be given together with othertreatment forheart failure, and your doctorwill decidewhich treatment is suitable ror you.
Use in adult patients with high blood pressure
The usual dose is 80 mg daily. In some casesyour doctor may prescribe higher doses (e.g. 160 mg or 320 mg). He may also combineValsartan with an additional medicine (e.g. a diuretic).
You can takeValsartan with or without food. Swallow Valsartan with a glass ofwater.
TakeValsartan at about the same timeeach day.
fyou take moreValsartan than you should
Ifyou experience severe dizziness and/or fainting, lie downand contactyourdoctor immediately. If you lave accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
Ifyou forgettotakeValsartan
Do not takea double dose to make up fora 'orgotten dose.
fyou forget to take a dose, take it as soon asyou remember. However, ifit isalmost timeforyour next dose, skip the doseyou missed.
fyou stop taking Valsartan
Stopping yourtreatment withValsartan may cause your diseaseto get worse. Do not stop taking your medicine unless your doctor tellsyou to.
fyou havefurther questions on the use ofthis medicine, ask your doctor or pharmacist.
1. POSSIBLESIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These sideeffects may occurwith certain frequencies, which are defined asfollows: very common: may affect morethan 1 in 10 people
common: may affect upto1 in 10 people uncommon: may affect upto1 in100 people rare: mayaffect upto1 in 1,000 people very rare: mayaffect upto1 in 10,000 people not known: frequency cannot be estimated from theavailable data.
Some symptoms need immediate medical attention: You may experience symptoms ofangioedema a specific allergic reaction), such as:
• swollenface,lips,tongueor throat
• difficulty in swallowing
• hivesand difficulties in breathing.
Ifyou get any ofthese symptoms, stop taking Valsartan and contactyour doctor straight away (see also section 2 'What doyou need to know seforeyou takeValsartan').
Other side effects include:
• dizziness
• low blood pressurewith orwithout symptoms such as dizzinessand fainting when standing up
• decreased kidney function (signs of renal impairment).
Uncommon:
• angioedema (see section 'Some symptoms need immediate medical attention')
• sudden loss of consciousness (syncope)
• spinning sensation (vertigo)
• severely decreased kidney function (signs ofacute renal failure)
• muscle spasms,abnormal heart rhythm (signs ofhyperkalaemia)
• breathlessness, difficulty breathing when lying down, swelling ofthefeet or legs (signs of cardiac failure)
• headache
• abdominal pain
• nausea
• diarrhoea
• tiredness
• weakness.
• increase of level of potassium in the blood (which can, in severe cases,trigger muscle spasms, abnormal heart rhythm)
• elevation of liverfunction values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, in severe cases, triggeryellow skin and eyes)
• increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicateabnormal kidneyfunction)
• low level ofsodium in the blood (which can trigger tiredness, confusion, muscletwitching and/or convulsions in severe cases).
The frequency of some side effects may vary depending on your condition. Forexample, side effects such as dizziness,and decreased kidney function,were seen lessfrequently in patients treated with high blood pressurethan in patients treated for heart failure oraftera recent heart attack.
Side effects in children and adolescents are similar to those seen in adults.
Reporting ofsideeffects
Ifyou get any side effects, talk to your doctor
or pharmacist. Thisincludesanypossibleside
effects not listed in this leaflet. You can also report
sideeffectsdirectlyviatheYellow Card Schemeat:
By reporting sideeffects you can help provide more information on the safety ofthis medicine.
5. HOWTOSTOREVALSARTAN
Do not store above 30°C. Store in the original pack to protect from moisture.
Keep out ofthesight and reach ofchildren.
Do not use this medicine aftertheexpiry datewhich is stated on the carton.Theexpiry date referstothe last day ofthat month.
Do not use this medicine ifyou noticethat the pack is damaged orshowssignsoftampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicinesyou no longer use.These measures will help protect the environment.
6. CONTENTSOFTHEPACKANDOTHER INFORMATION
WhatValsartan contains
Theactive substance isvalsartan.
One capsule contains40 mg/80 mg/160 mg/ valsartan.
The other ingredientsare microcrystalline cellulose, crospovidone (type A), sodium laurilsulfate, povidone, silica colloidal anhydrous, magnesium stearate.
In addition the capsule shells contain iron oxide black,titaniumdioxide, gelatin,sodiumlaurilsulfate, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution concentrated and potassiumhydroxide.
WhatValsartan looks likeand contents ofthe pack
Valsartan 40 mg Capsules havea hard gelatine light grey capand light grey body,are imprinted with 'M40' on cap and body in blackinkand arefilled with white to off-white granular powder.
Valsartan 80 mg Capsules havea hard gelatine light grey cap and flesh opaque body, are imprinted with 'M80' on cap and body in blackinkand arefilled with white to off-white granular powder.
Valsartan 160 mg Capsules havea hard gelatine dark grey cap and flesh opaque body, are imprinted with 'M160' on cap and body in black ink and are filled with white to off-white granular powder.
Valsartan Capsules come in blisterpacks of7,10,14, 28,30,56,60, 84, 90, 98,100 and 100 (2x50) capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,Potters Bar, Hertfordshire, EN61TL,
United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd., Potters Bar, Herts., EN6 1TL,
United Kingdom.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.
Not known:
• allergic reactionswith rash, itching and hives; symptoms offever, swollenjoint andjoint pain, muscle pain, swollen lymph nodes and/orflu-like symptoms may occur (signs of serum sickness)
• purplished-red spots, fever, itching (signs of inflammation ofblood vesselsalso called vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sorethroat or mouth ulcers dueto infections (symptoms of low level ofwhite blood cells also called neutropenia)
• decrease of level of haemoglobin and decrease
ofthe percentage ofred blood cells in the blood This leafletwas last revised in: 10005138
(which can, in severe cases, lead toanaemia) 07-2013 0000000Y