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Diovan

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Package leaflet: Information for the user


Diovan 3 mg/ml oral solution

valsartan


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


What is in this leaflet:

1. What Diovan is and what it is used for

2. What you need to know before you take Diovan

3. How to take Diovan

4. Possible side effects

5. How to store Diovan

6. Contents of the pack and other information


1. What Diovan is and what it is used for


Diovan contains the active substance: valsartan and belongs to a class of medicines known as angiotensin II receptor antagonists, 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. Diovan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.


Diovan 3 mg/ml oral solution can be used 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.


2. What you need to know before you take Diovan


Do not take Diovan:

If any of the above apply to you, tell your doctor and do not take Diovan.


Warnings and precautions:

Talk to your doctor before taking Diovan


Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.


See also information under the heading “Do not take Diovan”


You must tell your doctor if you think you are (or might become) pregnant. Diovan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).


Other medicines and Diovan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.


The effect of the treatment can be influenced if Diovan is taken together with certain other medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:


Pregnancy and breast-feeding


You must tell your doctor if you think that you are (or might become) pregnant.

Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan. Diovan 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.

Diovan 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 Diovan affects you. Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.


Diovan contains sucrose, methyl parahydroxybenzoate and poloxamer


3. How to take Diovan


Always take this medicine exactly as your doctor 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.


Please read the instructions at the end of this leaflet before you use the oral syringe or the dosing cup.


How much to take

Diovan solution should be taken once a day

the usual dose is 40 mg of valsartan (corresponding to 13 ml of the solution).


In some cases your doctor may ask you to take


You can take Diovan with or without food.

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 your doctor immediately and lie down. If you have accidentally taken more Diovan solution than you should, contact your doctor, pharmacist, or hospital.


If you forget to take Diovan

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.


Do not take a double dose to make up for a forgotten dose.


If you stop taking Diovan

Stopping your treatment with Diovan may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.


If you have any 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.


Some side effects can be serious and need immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

If you get any of these symptoms, stop taking Diovan and contact your doctor straight away (see also section 2 “What you need to know before you take Diovan”).


Side effects include:


Common (may affect up to 1 in 10 people):


Uncommon (may affect up to 1 in 100 people):


Not known (frequency cannot be estimated from the available data):


The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in adult patients treated with 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.


Reportingof side effects

If you getany side effects, talk to your doctor or pharmacist. This includes any possible side effectsnot listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V.By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Diovan



6. Contents of the pack and other information


What Diovan contains


What Diovan looks like and contents of the pack

Diovan 3 mg/ml oral solution is a clear, colourless to pale yellow solution.

The solution is supplied in a pack containing one 180 ml amber glass bottle with a child-resistant screw cap and a yellow tamper evident ring. The bottle contains 160 ml of solution. It comes with a dispensing kit containing one press in bottle adapter, one 5 ml oral polypropylene dosing syringe and one 30 ml polypropylene dosing cup.


Marketing Authorisation Holder and Manufacturer


<[To be completed nationally>]


{Name and address}

<{tel}>

<{fax}>

<{e-mail}>


For any information about this medicine, please contact the Marketing Authorisation Holder.


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom

Diovan

Belgium, Luxembourg

Diovane

France, Italy

Tareg


This leaflet was last revised in 2016-07-25

INSTRUCTIONS FOR USING THE ORAL SYRINGE AND THE DOSING CUP


Please read these instructions carefully before taking the medicine. This will help you to use the oral syringe and the dosing cup correctly.


What you will be using




A press in bottle adapter:

  • that you insert into the neck of the bottle.

  • Once you have inserted it, do not remove it.


A bottle containing the medicine:

  • that has a child- resistant screw cap.

  • Always screw the cap back on after use.


An oral dosing syringe:

  • that consists of a clear plastic tube with a plunger inside.

  • The oral syringe fits into the bottle adapter and is used to measure out the required amount of medicine from the bottle. Use a new bottle adapter and oral dosing syringe each time you start a new bottle of medicine.


A dosing cup:

  • that can be used if the prescribed dose requires filling the syringe several times.

  • Always put the dosing cup back onto the cap after use and cleaning.


Fitting the press in bottle adapter into a new bottle of medicine


Remove the cap from the bottle by pushing it down firmly and turning it anti-clockwise (as shown on the top of the cap).

Holding the open bottle upright on a table, push the bottle adapter firmly into the neck of the bottle as far as it will go.


Note: You may not be able to push the bottle adapter down fully but this does not matter as it will be forced into the bottle when you screw the cap back on.


Screw the cap back on the bottle.



Preparing a dose of medicine


Remove the cap from the bottle by pushing it down firmly and turning it anti-clockwise (as shown on the top of the cap).


Check that the plunger is pushed fully into the oral syringe.


Keeping the bottle upright, insert the oral syringe firmly into the bottle adapter.


Holding the oral syringe in place, carefully turn the bottle and oral syringe upside down.


Before you measure your dose you need to get rid of any large bubbles that may be trapped in the oral syringe. To do this:

  • slowly pull the plunger all the way out so that the oral syringe fills with medicine.

  • then, push the plunger all the way back in so that it is empty again.

Measuring a dose of medicine

Note: The total amount of solution that can be measured into the oral syringe is 5 ml. Depending on the prescribed dose, it may be necessary to repeat steps 10 to 16 several times. For example, if the prescribed dose is 13 ml, it will be necessary to measure out the solution in three separate stages: 5 ml + 5 ml + 3 ml.






Find the marker on the oral syringe that corresponds to the required amount of medicine.


Slowly pull the plunger out until the top edge of the black ring inside is exactly level with the marker.


Carefully turn the bottle and oral syringe back upright.



Remove the oral syringe from the bottle adapter by gently twisting it out.



Taking the medicine



Sit upright.


Put the end of the oral syringe into the mouth.


Slowly push the plunger in and swallow the medicine directly from the oral syringe.


If the prescribed dose requires filling the syringe several times, you can empty the measured doses of medicine from the syringe into the dosing cup and then check the total volume of solution.


Drink the entire solution right away.

Replace the child-resistant screw cap after use.


To clean the oral syringe:

  • Wipe the outside of the oral syringe with a clean, dry tissue.

  • Do this after each time that you use the oral syringe.


To clean the cup:

Rinse the cup with clean water.

Dry the cup with a clean tissue and place it back over the cap of the bottle.



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