Diovan 3 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diován 3mg/ml oral solution

valsartan

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Diován is and what it is used for
2. What you need to know before taking Diován
3. How to take Diován
4. Possible side effects
5. How to store Diován
6. Contents of the pack and other information

1. What Diován is and what it is used for

Diován contains the active substance valsartan and belongs to a class of medicines 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 narrow, resulting in increased blood pressure. Diován works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Diován 3 mg/ml oral solution can be used to treat high blood pressure in children and adolescents aged 1 to less than 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you need to know before taking Diován

Do not take Diován:

• if you are allergic (hypersensitive) to valsartan or to 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 advisable to avoid Diován during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, inform your doctor and do not take Diován.

Warnings and precautions

Talk to your doctor before taking Diován

• if you have liver disease.
• if you have severe kidney disease or are undergoing dialysis.
• if you have narrowing of the artery to the kidney (renal artery stenosis).
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you experience these symptoms while taking Diován, stop treatment immediately and never take Diován again. See also section 4 “Possible side effects”.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Diován. Your doctor will decide whether to continue treatment. Do not stop taking Diován on your own.
• if you are taking medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, Diován is not recommended.
• if you have lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine output).
• if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., 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 during early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Taking Diován with other medicines

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

The effect of Diován treatment may be altered when taken together with certain medicines. Your doctor may need to adjust your dose and/or take other precautions, or in some cases, discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Diován” and “Warnings and precautions”).
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• certain pain-relief medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (from the rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Diován.
• lithium, a medicine used to treat certain psychiatric conditions.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant (or suspect you may be pregnant). Your doctor will usually advise you to stop taking Diován before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Diován. Diován is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

• Inform your doctor if you are breastfeeding or plan to breastfeed. The use of Diován during breastfeeding is not recommended, and your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, make sure you know how Diován affects you. Like many other medicines used to treat high blood pressure, Diován may cause dizziness and affect your ability to concentrate.

Diován contains sucrose, methylparaben, poloxamer, sodium, and propylene glycol

• Diován solution contains 0.3 g of sucrose per millilitre. Take this into account if you have diabetes mellitus. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking Diován solution. The amount of sucrose in Diován solution may be harmful to teeth.
• Diován solution contains methylparahydroxybenzoate (E218). It may cause allergic reactions that manifest some time after taking the solution. Symptoms may include rash, itching, or hives. If any of these symptoms worsen, consult your doctor.
• Diován solution contains poloxamer (188). It may cause soft stools.
• Diován solution contains 3.72 mg of sodium (a main component of table/cooking salt) in each ml. This corresponds to 0.19% of the maximum daily recommended sodium intake for an adult.

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

3. How to take Diován

Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not notice any signs of the condition and many feel perfectly normal. This makes it very important to keep your doctor appointments, even if you feel well.

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

Dosage

Diován solution should be taken once daily.

Children from 1 to less than 6 years of age

• The usual starting dose is 1 mg/kg once daily. The following table shows the dose and corresponding volume of oral solution to administer:

• Your doctor may prescribe a higher starting dose (2 mg/kg) if you require a rapid reduction in blood pressure.
• The dose may be increased up to a maximum of 4 mg/kg.

Children aged 6 years and older and

• weighing less than 35 kg:

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

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

• weighing 35 kg or more:

• The usual starting dose of Diován oral solution is 40 mg (equivalent to 13 ml of solution).

• The dose may be increased up to a maximum of 80 mg (equivalent to 27 ml of solution).

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

You may take Diován with or without food.

Take Diován at approximately the same time each 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 oral solution than you should, contact your doctor, pharmacist, or hospital. You may also call the Toxicology Information Service at telephone number 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 your next dose, skip the missed dose.

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

If you stop taking Diován

If you stop your treatment with Diován, your condition may worsen. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

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

Some adverse effects may be serious and may require immediate medical attention:

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

• swelling of 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 you start taking Diován”).

Adverse effects include:

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

• dizziness.
• low blood pressure with or without symptoms such as dizziness and fainting upon standing.
• reduced kidney function (signs of kidney impairment).

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 spinning (vertigo).
• marked reduction in kidney function (signs of acute renal failure).
• muscle spasms, irregular heartbeat (signs of hyperkalemia).
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure).
• headache.
• cough.
• abdominal pain.
• nausea.
• diarrhea.
• fatigue.
• weakness.

Rare (may affect up to 1 in 10,000 people):

• intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• blisters on the skin (sign of bullous dermatitis).
• allergic reactions may occur with skin rash, itching, and hives; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (signs of serum sickness).
• purple-red skin spots, fever, itching (signs of inflammation of blood vessels, also called vasculitis).
• bleeding or bruising more than usual (signs of thrombocytopenia).
• muscle pain (myalgia).
• fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia).
• reduction in hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia).
• increased blood potassium levels (which, in severe cases, may cause muscle spasms and irregular heartbeat).
• elevated liver function test values (which may indicate liver injury), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes).
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate kidney function abnormalities).
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle cramps, and/or seizures).

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diován

• Keep out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C.
• After opening, the bottle can be kept for up to 3 months at temperatures below 30°C.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diován

• The active substance is valsartan. Each ml 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 blueberry 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 pack

Diován 3 mg/ml oral solution is a clear, colourless to slightly yellowish solution.

• The solution is supplied 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 press-in adapter for the bottle, a 5 ml polypropylene oral dosing syringe, and a 30 ml polypropylene dosing cup.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Novartis Farmacéutica S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Manufacturer

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

Further information on this medicinal product is available upon request to the Marketing Authorization Holder.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: 11/2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) htpp://www.aemps.es/

INSTRUCTIONS FOR THE USE OF THE ORAL SYRINGE AND DOSING CUP

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

What will you use?

Press the vial adapter firmly into the new medication vial

Prepare the medication dose

1. To clean the oral syringe:

• Wipe the exterior of the oral syringe with a clean, dry cloth.
• Repeat this process each time you use the syringe.

1. To clean the dosing cup:

• Rinse the cup with clean water.
• Dry the cup with a clean cloth and place it back on the bottle cap.