Package Leaflet: Information for the User

Diován 3mg/ml Oral Solution

valsartán

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Diován is and what it is used for

2.What you need to knowbeforestarting totake Diován

3.How to take Diován

4.Possible side effects

5.Storage of Diován

6.Contents of the pack and additional information

Diován contains the active ingredient valsartán and belongs to a class of medications known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Diován acts by blocking the effect of angiotensin II. As a consequence, blood vessels relax and blood pressure decreases.

Diován3mg/ml oral solutionmay be usedto treat high blood pressure in children and adolescents from 1 toless than18years of age.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take Diován:

• if you areallergic(hypersensitive) to valsartán or any of the other components of this medication (listed in section 6).
• if you have aserious liver disease.
• if you arepregnantover 3 months(it is better to avoid Diovánalso during the first months of pregnancy– see section Pregnancy).
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskireno.

If any of the above situations affect you,inform your doctordo not takeDiován.

Warnings and precautions

Consult your doctor before taking Diován

• if you have liver disease.
• if you have a serious kidney disease or if you are undergoing dialysis.
• if you have a narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including IECAs), inform your doctor. If you have these symptoms when taking Diován, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.
• if you are using medications that increase the amount of potassium in the blood. Among them are potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to regularly control the amount of potassium in the blood.
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Diován.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine elimination).
• if you are taking any of the following medications used to treat high blood pressure:
• • a converting enzyme inhibitor (IECA) (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskireno.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Diován”.

You must inform your doctor if you think you are (or could be) pregnant. Diován is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than3months, as it could cause serious damage to your baby if you use it during this period (see the Pregnancy section).

Use of Diován with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to useany other medication.

The effect of treatment with Diován may be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, stop treatment with one of the medications. This applies to both prescription and non-prescription medications, especially:

• other medications that lower blood pressure,especiallydiuretics(medications to increase urine elimination), IECAs(such as enalapril, lisinopril, etc.) or aliskireno(see also the information under the headings“Do not take Diován” and “Warnings and precautions”).
• medications that increase the amount of potassiumin the blood. Among them are potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (of the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/SIDA infection (ritonavir). These medications may increase the effect of Diován.
• lithium,a medication used to treat certain types of psychiatric disorders.

Pregnancy and breastfeeding

• You must inform your doctor if you are pregnant(or if you suspect you may be).Your doctor will usually recommend that you stop taking Diován before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Diován. Diován is not recommended for use at the beginning of pregnancy, and it should not be administered after the third month of pregnancy as it may cause serious damage to your baby when administered from that point on.

• Inform your doctor if you are breastfeeding or are about to start. Diován is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

Before driving a vehicle, using tools or operating machines, or performing other activities that require concentration, make sure you know how Diován affects you. Like many other medications used to treat high blood pressure, Diován may cause dizziness and affect concentration.

Diován contains saccharose, parahydroxybenzoate of methyl, poloxamer, sodium, and propylene glycol

• Diován solution contains 0.3g ofsaccharoseper milliliter. Take this into account if you have diabetes mellitus. If your doctor has told you that you are intolerant to certain sugars, contact him before taking Diován solution. The amount of saccharose present in the Diován solution may be harmful to your teeth.
• Diován solution containsparahydroxybenzoate of methyl(E218). It may cause allergic reactions that manifest some time after taking the solution. The symptoms may include rash, itching, urticaria. If any of these symptoms worsen, consult your doctor.
• Diován solution containspoloxamer (188). It may cause soft stools.
• Diován solution contains 3.72mg ofsodium(main component of table salt/for cooking) in each ml. This is equivalent to 0.19% of the maximum daily sodium intake recommended for an adult.

Diován solution contains 0.99mg ofpropylene glycol(E 1520)in each ml of oral solution.

Take this medicine exactly as your doctor tells you to.In case of doubt, ask yourdoctor or pharmacist. People with high blood pressure often do not notice any signs of the disease; many feel normal. This makes it very important to attend your doctor's appointments, even if you feel well.

Please read the instructions at the end of this leaflet before using the oral syringe or measuring cup.

How much to take

Diován solution should be taken once a day

Children from 1 to under 6 years of age

• The usual starting dose is1 mg/kg once a day. The following table shows the dose and the corresponding oral solution volume to administer:

• yourdoctor may prescribe a higher starting dose (2mg/kg) if you need a rapid reduction in blood pressure.
• The dose may be increased up to a maximum of4mg/kg.

Children 6 years of age and older and

• who weigh less than 35kg:

• The usual starting dose for Diován oral solutionis 20mg (which is equivalent to 7ml of solution).

• The dose may be increased up to a maximum of 40 mg (which is equivalent to 13ml of solution).

• who weigh 35kg or more:

• The usual starting dose for Diován oral solution is 40mg (which is equivalent to 13ml of solution)
• The dose may be increased up to a maximum of 80 mg (which is equivalent to 27ml of solution).

Children who have started taking Diován before the age of 6years may receive a higher dose of Diován than the maximum dose mentioned above. In certain selected cases, your doctor may choose to maintain that dose.

You can take Diován with or without food.

Take Diován approximately at the same time every day.

If you take more Diován than you should

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken more Diován solution than you should, contact your doctor, pharmacist, or hospital. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Diován

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for the missed doses.

If you interrupt treatment withDiován

If you stop taking Diován, your condition may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious and may require immediate medical attention:

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

• swelling in the face, lips, tongue, or throat.
• difficulty breathing or swallowing.
• hives, itching.

If you experience any of these symptoms, stop taking Diován and contact your doctor immediately (see also section 2 “What you need to know before starting to take Diován”).

Side effects include:

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

• dizziness.
• low blood pressure with or without symptoms such as dizziness and fainting when standing up.
• reduced kidney function (signs of renal deterioration).

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

• angioedema (see section “Some symptoms require immediate medical attention”).
• sudden loss of consciousness (syncope).
• sensation of rotation (vertigo).
• marked reduction in kidney function (signs of acute renal insufficiency).
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia).
• shortness of breath, difficulty breathing while lying down, swelling of the feet or legs (signs of heart failure).
• headache.
• cough.
• abdominal pain.
• nausea.
• diarrhea.
• fatigue.
• weakness.

Frequency not known(cannot be estimated from available data):

• blistering on the skin (sign of dermatitis herpetiformis).
• may occur allergic reactions with skin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu.
• red-purple patches, fever, itching (signs of inflammation of blood vessels, also known as vasculitis).
• more frequent bleeding or bruising than usual (signs of thrombocytopenia)
• muscle pain (myalgia).
• fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia).
• reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which, in severe cases, can cause anemia).
• increase in potassium level in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm).
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, can cause the skin and eyes to turn yellow).
• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may indicate renal anomalies).
• low sodium level in the blood (which, in severe cases, can cause fatigue, confusion, muscle contractions, and/or convulsions).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced kidney function were observed less frequently in patientsadultswith high blood pressure than in patientsadultswith heart failure or after a recent heart attack.

Side effects in children and adolescents are similar to those observed in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep out of sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Do not store at a temperature above30°C.
• Once opened, the bottle can be stored for up to 3months at temperatures below30°C.
• Do not use this medication if you observe that the packaging is damaged or shows signs of deterioration.
• Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at theSIGREcollection pointat the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Diován

• The active ingredient is valsartan. Each milliliter of oral solution contains 3 mg of valsartan.
• The other components are: sucrose, methyl parahydroxybenzoate (E218), potassium sorbate, poloxamer (188), citric acid, sodium citrate, artificial raspberry flavor, propylene glycol (E1520), sodium hydroxide, hydrochloric acid, purified water (see also section 2 "Diován contains sucrose, methyl parahydroxybenzoate, poloxamer, sodium, and propylene glycol").

Appearance of the product and contents of the package

Diován 3 mg/ml oral solution is a transparent, colorless to slightly yellowish solution.

• The solution is presented in a 180 ml amber glass bottle with a child-resistant screw cap and a yellow tamper-evident seal. The bottle contains 160 ml of solution. Several administration devices are included: a pressure adapter for the bottle, a 5 ml polypropylene syringe for oral administration, and a 30 ml polypropylene dosing cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Novartis Farmacéutica SA

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Responsible for manufacturing

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Novartis Poland Sp. z o.o.

ul. Marynarska 15

02-674 Warsaw

Poland

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

You can request more information about this medication by contacting the holder of the marketing authorization.

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 11/2020

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) htpp://www.aemps.es/

INSTRUCTIONS FOR USE OF THE ORAL SYRINGE AND DOSING CUP

Please read these instructions carefully before taking the medication. They will help you use the oral syringe and dosing cup correctly.

What will you use?

Insert the pressure adapter into the new bottle of medication

Prepare the dose of medication

1. To clean the oral syringe:
• Clean the outside of the syringe with a clean, dry cloth.
• Repeat this process each time you use the syringe.
2. To clean the dosing cup:
• Wash the dosing cup with clean water.

Dry the dosing cup with a clean cloth and place it back on the cap of the bottle.