Valsartan: Uses, Dosages, and Side Effects for High Blood Pressure and Heart Failure | Lecture notes Medicine

Package leaflet: Information for the user

Valsartan 40 mg hard capsules

Valsartan 80 mg hard capsules

Valsartan 160 mg hard capsules

valsartan

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Valsartan is and what it is used for

2. What you need to know before you take Valsartan

3. How to take Valsartan

4. Possible side effects

5. How to store Valsartan

6. Contents of the pack and other information

1. What Valsartan is and what it is used for

Valsartan belongs to a class of medicines known as angiotensin II receptor antagonist, which help to

control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten,

thus causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II.

As a result, blood vessels relax and blood pressure is lowered.

Valsartan 40 mg hard capsules can be used for three different conditions:

• to treat high blood pressure in children and adolescents 6 to 18 years of age. High blood

pressure increases the workload on the heart and arteries. If not treated it can damage the

blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or

kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood

pressure to normal reduces the risk of developing 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 to treat

heart failure) cannot be used or it may be used in addition to ACE inhibitors when other

medications to treat heart failure cannot be used.

Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to

fluid build-up. It is caused when the heart muscle cannot pump blood strongly enough to

supply all the blood needed throughout the body.

Valsartan 80 mg and 160 mg hard capsules can be used for three different conditions:

• to treat high blood pressure in adult and in children and adolescents 6 to 18 years of

age. High blood pressure increases the workload on the heart and arteries. If not treated it can

damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart

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Package leaflet: Information for the user

Valsartan 40 mg hard capsules

Valsartan 80 mg hard capsules

Valsartan 160 mg hard capsules

valsartan Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet

What Valsartan is and what it is used for
What you need to know before you take Valsartan
How to take Valsartan
Possible side effects
How to store Valsartan
Contents of the pack and other information 1. What Valsartan is and what it is used for Valsartan belongs to a class of medicines known as angiotensin II receptor antagonist, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Valsartan 40 mg hard capsules can be used for three different conditions:

to treat high blood pressure in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing 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 to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when other medications to treat heart failure cannot be used. Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up. It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Valsartan 80 mg and 160 mg hard capsules can be used for three different conditions :
to treat high blood pressure in adult and in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart

failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing 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 to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when other medications to treat heart failure cannot be used. Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up. It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. 2. What do you need to know before you take Valsartan Do not take Valsartan
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 are more than 3 months pregnant (it is also better to avoid Valsartan in early pregnancy – see pregnancy section).
if you have diabetes or impaired kidney function and you are treated with a blood pressure- lowering medicine containing aliskiren. If any of these apply to you, do not take Valsartan. Warnings and precautions Talk to your doctor or pharmacist before taking Valsartan if any of the following apply to you.
If you have liver disease.
If you have severe kidney disease or if you are undergoing dialysis.
If you are suffering from a narrowing of the kidney artery.
If you have recently undergone kidney transplantation (received a new kidney).
If you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
If you have severe heart disease other than heart failure or heart attack.
If you have ever experienced swelling of the tongue, throat and face caused by an allergic reaction called angioedema when taking another drug (including ‘ACE inhibitors’), tell your doctor. If these symptoms occur when you are taking valsartan, stop taking valsartan immediately and do not take it again. See also section 4 of this leaflet ‘Possible side effects’.
If you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
If you suffer from aldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of Valsartan is not recommended.
If you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).
If you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (for example enalapril, Lisinopril, Ramipril), in particular if you have diabetes-related kidney problems.
aliskiren.

Valsartan with food and drink You can take Valsartan with or without food. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking this medicine.

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan. Valsartan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Valsartan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. Driving and using machines Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Valsartan affects you. Like many other medicines used to treat high blood pressure, Valsartan may in rare cases cause dizziness and affect the ability to concentrate. Valsartan 40 mg hard capsules contain sodium Valsartan 80 mg hard capsules contain sodium Valsartan 160 mg hard capsules contain sodium This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’. 3. How to take Valsartan Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well. Use in children and adolescents (6 to 18 years of age) with high blood pressure : In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily. In patients who weigh 35 kg or more the usual starting dose is 80 mg of valsartan once daily. In some cases your doctor may prescribe higher doses (the dose can be increased to 160 mg and to a maximum of 320 mg). Use in adult patients after a recent heart attack : After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily. It is not possible to obtain the 20 mg dose with Valsartan hard capsules. The 20 mg dose should be obtained by dividing a 40 mg divisible tablet. Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate. Valsartan can be given together with other treatment for 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 doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate. Valsartan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you. Use in adult patients with high blood pressure : The usual dose is 80 mg daily. In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). He may also combine Valsartan with an additional medicine (e.g. a diuretic). You can take Valsartan with or without food. Swallow Valsartan with a glass of water. Take Valsartan at about the same time each day. If you take more Valsartan than you should If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. If you forget to take Valsartan Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed. If you stop taking Valsartan Stopping your treatment with Valsartan may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to. If you have further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows: very common: may affect more than 1 in 10 people common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people rare: may affect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data. Some symptoms need immediate medical attention: You may experience symptoms of angioedema (a specific allergic reaction), such as: - swollen face, lips, tongue or throat - difficulty in swallowing - hives and difficulties in breathing. If you get any of these symptoms, stop taking Valsartan and contact your doctor straight away (see also section 2 ‘What do you need to know before you take Valsartan’).

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan Do not store above 30°C. Store in the original pack to protect from moisture. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not use this medicine if you notice that the pack is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Valsartan contains The active substance is valsartan. One capsule contains 40 mg/ 80 mg/160 mg valsartan. The other ingredients are microcrystalline cellulose, crospovidone (type A), sodium laurilsulfate, povidone, colloidal anhydrous silica, magnesium stearate. In addition the capsule shells contain iron oxide black (E172), titanium dioxide (E171), gelatin, sodium laurilsulfate, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution and potassium hydroxide. What Valsartan looks like and contents of the pack Valsartan 40 mg hard capsules have a hard gelatine light grey cap and light grey body, are imprinted with ‘M40’ on cap and body in black ink and are filled with white to off-white granular powder. Valsartan 80 mg hard capsules have a hard gelatine light grey cap and flesh opaque body, are imprinted with ‘M80’ on cap and body in black ink and are filled with white to off-white granular powder. Valsartan 160 mg hard capsules have a 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 hard capsules come in blister packs of 7, 10 , 14 , 28 , 30 , 56 , 60, 84 , 90 , 98, 100 and 100 (2x50) capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder Generics [UK] Ltd t/a Mylan Station Close Potters Bar Herts EN6 1TL United Kingdom Manufacturer(s) McDermott Laboratories Ltd. t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1, Hungary This medicinal product is authorised in the Member States of the EEA under the following names: Denmark: Valsartan Mylan United Kingdom: Valsartan 40 mg hard capsules, Valsartan 80 mg hard capsules, Valsartan 160 mg hard capsules For any information about this medicine, please contact the Marketing Authorisation Holder.

Valsartan: Uses, Dosages, and Side Effects for High Blood Pressure and Heart Failure, Lecture notes of Medicine

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Download Valsartan: Uses, Dosages, and Side Effects for High Blood Pressure and Heart Failure and more Lecture notes Medicine in PDF only on Docsity!

Valsartan 40 mg hard capsules

Valsartan 80 mg hard capsules

Valsartan 160 mg hard capsules

This leaflet was last revised in 05 / 2021.