Diovan

Patient Information Leaflet

Diovan, 3 mg/ml, oral solution
Valsartanum
Please read all of this leaflet before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Diovan is and what it is used for
2. Important information before taking 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 group of medicines called angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Diovan works by blocking the action of angiotensin II. As a result, blood vessels dilate and blood pressure is lowered.
Diovan oral solution can be used in the treatment of high blood pressure in children and adolescents aged 1 to below 18 years. High blood pressure increases the workload on the heart and blood vessels. Untreated high blood pressure may damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. Important information before using Diovan

When not to use Diovan:

• if the patient has hypersensitivity (allergy) to valsartan or to any of the other ingredients of this medicine (see section 6);
• if the patient has severe liver disease;
• if the patient is pregnant beyond the 3rd month (use of Diovan is also not recommended during early pregnancy – see Pregnancy section);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply, Diovan must not be used.
Warnings and precautions
Before taking Diovan, inform your doctor if:

• the patient has liver disease;
• the patient has severe kidney disease or is on dialysis;
• the patient has renal artery stenosis (narrowing of the artery to the kidney);
• the patient has recently received a kidney transplant;
• the patient has ever previously experienced swelling of the tongue and face due to an allergic reaction called angioedema after taking another medicine (including ACE inhibitors), the patient should inform the doctor. If such symptoms occur while taking Diovan, the patient must stop taking Diovan immediately and must never take it again. See also section 4, "Possible side effects";
• if the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Diovan, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Diovan on your own;
• if the patient is taking medicines that increase blood potassium levels, including potassium supplements or potassium-containing salt substitutes, potassium-sparing agents or heparin. Regular monitoring of blood potassium levels may be necessary;
• if the patient has aldosteronism (a condition in which the adrenal glands produce too much of a hormone called aldosterone), Diovan should not be used;
• in case of significant fluid loss (dehydration) due to diarrhoea, vomiting or use of high doses of diuretics (water tablets);
• if the patient is taking any of the following medicines for high blood pressure:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes;
  • aliskiren.

The treating physician may monitor kidney function, blood pressure and electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading "When not to use Diovan".
The patient should inform the doctor if she suspects she is pregnant (or plans to become pregnant). Use of Diovan is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if taken at this stage (see Pregnancy section).
If any of the above conditions apply, the patient must inform the doctor before using Diovan.
Diovan and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken or planned for use.
Taking Diovan with certain other medicines may affect treatment. Dose adjustments, additional precautions or in some cases discontinuation of one of the medicines may be necessary. This applies to both prescription and over-the-counter medicines, particularly:

• other blood pressure-lowering medicines, especially diuretics (water tablets), angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also information under "When not to use Diovan" and "When to exercise caution with Diovan");
• medicines that increase blood potassium levels, including potassium supplements or potassium-containing salt substitutes, potassium-sparing agents and heparin;
• certain types of painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used in the treatment of HIV/AIDS (ritonavir). These medicines may enhance the effect of Diovan;
• lithium (a medicine used to treat certain types of psychiatric disorders).

Taking Diovan with food and drink
Diovan can be taken with or without food.
Pregnancy and breastfeeding

• Inform your doctor if the patient suspects she is pregnant (or plans to become pregnant). The doctor will usually advise stopping Diovan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Diovan is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if taken beyond the third month of pregnancy.
• Inform your doctor if the patient is breastfeeding or intends to breastfeed. Use of Diovan is not recommended in breastfeeding mothers; the doctor may choose an alternative treatment for a patient who plans to breastfeed. This is particularly important when breastfeeding newborns or premature infants.

Driving and operating machinery
Before driving, using tools or operating machinery, or performing any activity requiring concentration, each patient should be aware of how Diovan affects them. Like many other medicines used to treat high blood pressure, Diovan may cause dizziness and affect the ability to concentrate.
Diovan contains sucrose, methyl parahydroxybenzoate, poloxamer, sodium and propylene glycol

• Diovan oral solution contains 0.3 g of sucrose per millilitre. This should be taken into account in patients with diabetes. If the patient has been informed by the doctor of intolerance to certain sugars, the patient should consult the doctor before taking Diovan oral solution. The amount of sugar in Diovan oral solution may be harmful to teeth.
• Diovan oral solution contains methyl parahydroxybenzoate (E218). It may cause allergic reactions, which may occur some time after starting treatment. Symptoms may include rash, itching, urticaria. If any of these symptoms worsen, inform the doctor.
• Diovan oral solution contains poloxamer (188), which may cause loose stools.
• Diovan contains 3.72 mg of sodium (the main component of table salt) per millilitre. This corresponds to 0.19% of the maximum daily sodium intake recommended in an adult diet.
• This medicine contains 0.99 g of propylene glycol (E1520) per millilitre of oral solution.

3. How to take Diovan

This medicine should always be taken exactly as directed by your doctor. If in doubt,
you should contact your doctor or pharmacist again. People with high blood pressure often
do not notice any signs of this condition. Many of them feel quite well. For this reason,
it is especially important to attend regular check-ups with your doctor, even if you feel well.
Before using the oral syringe or dosing container, read the instructions
provided at the end of the leaflet.
How much medicine to take
Diovan oral solution should be taken once daily.
Children aged 1 year to below 6 years

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

• The doctor may recommend a higher initial dose (2 mg/kg body weight) if a faster reduction in blood pressure is required.
• The dose may be increased up to a maximum of 4 mg/kg body weight.

Children and adolescents aged 6 years and older

• With body weight below 35 kg:
• The usual recommended starting dose of Diovan oral solution is 20 mg (corresponding to 7 ml of solution).
• The dose may be increased up to a maximum of 40 mg (corresponding to 13 ml of solution).
• With body weight of 35 kg and above:
• The usual recommended starting dose of Diovan oral solution is 40 mg (corresponding to 13 ml of solution).
• The dose may be increased up to a maximum of 80 mg (corresponding to 27 ml of solution).

Children who started treatment with Diovan before completing 6 years of age may receive a higher dose than the maximum dose stated above. In certain cases, the doctor may decide to continue such a dose.
Diovan may be taken regardless of meals.
Diovan should be taken every day at approximately the same time.
Taking more Diovan than prescribed
If severe dizziness and/or fainting occurs, contact a doctor immediately and lie down. In case of accidental overdose with Diovan oral solution, contact a doctor, pharmacist, or hospital immediately.
Missing a dose of Diovan
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped.
Do not take a double dose to make up for a missed dose.
Stopping Diovan treatment
Discontinuing treatment with Diovan may lead to worsening of the condition. Do not stop taking the medicine unless advised by a doctor.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious and require immediate medical attention:
Symptoms of angioedema (a specific allergic reaction) may occur, such as:

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

If any of these symptoms occur, stop taking Diovan immediately and contact your doctor
(see also section 2 "Important information before taking Diovan").
Adverse reactions:
Common (may affect up to 1 in 10 people):

• dizziness,
• low blood pressure with or without symptoms such as dizziness and fainting upon standing,
• kidney function disorders (symptoms of impaired kidney function).

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

• angioedema (see "Some symptoms requiring immediate medical attention"),
• sudden loss of consciousness (fainting),
• sensation of spinning (dizziness),
• severe kidney function disorders (symptoms of acute kidney failure),
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhea,
• feeling of fatigue,
• weakness.

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

• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Unknown (frequency cannot be estimated from available data):

• blisters on the skin (symptoms of bullous dermatitis),
• allergic reactions with rash, itching and hives; symptoms such as fever, swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (symptoms of serum sickness),
• purple-red spots, fever, itching (symptoms of inflammation of blood vessels, also known as vasculitis),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat or mouth ulcers due to infection (symptoms of low white blood cell count, so-called neutropenia),
• decreased hemoglobin levels and reduced proportion of red blood cells in blood (which may lead to anemia in severe cases),
• increased potassium levels in blood (which may cause muscle cramps and heart rhythm disturbances in severe cases),
• increased liver function test values (which may indicate liver damage), including increased bilirubin levels in blood (which may cause yellowing of skin and eyes in severe cases),
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate impaired kidney function),
• low sodium levels in blood (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases).

The frequency of some adverse reactions may vary depending on the disease.
For example, adverse reactions such as dizziness and kidney function disorders have been 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 reactions observed in children and adolescents are similar to those observed in adult patients.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diovan

• Keep this medicine out of the sight and reach of children.
• Do not store at temperatures above 30°C. After opening, the bottle can be stored for up to 3 months at temperatures below 30°C.
• Do not use Diovan after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• Do not use this medicine if the packaging is damaged or shows any signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Diovan contains

• The active substance is valsartan.
• 1 ml of oral solution contains 3 mg of valsartan.
• Other ingredients of the medicine are sucrose, methyl parahydroxybenzoate (E218), potassium sorbate, poloxamer (188), citric acid, sodium citrate, berry flavour, propylene glycol (E1520), sodium hydroxide, hydrochloric acid, purified water (see also section 2 "Diovan contains sucrose, methyl parahydroxybenzoate, poloxamer, sodium and propylene glycol").

What Diovan looks like and contents of the pack
Diovan 3 mg/ml oral solution is a clear solution ranging in colour from colourless to pale yellow.

• The solution is available in packs containing one amber glass bottle with a capacity of 180 ml, equipped with a child-resistant cap and a yellow or colourless tamper-evident ring. The bottle contains 160 ml of solution. A dosing set is supplied with the bottle, consisting of one press-in bottle adapter, one 5 ml oral polypropylene syringe and one polypropylene dosing container with a capacity of 30 ml.

Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel. (22) 375 48 88

Manufacturer / Importer
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

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

INSTRUCTIONS FOR USE OF ORAL SYRINGE AND DOSING CONTAINER
Before taking the medicine, carefully read these instructions. They will help you to use the oral syringe and dosing container correctly.
The kit contains:
Press-on cap for the bottle mouth:

• Which is placed onto the neck of the bottle.
• Once the cap is fitted onto the bottle, do not remove it.

Bottle with medicine:

• Equipped with a child-resistant closure cap.
• After taking the medicine, always recap the bottle.

Oral dosing syringe:

• Consisting of a transparent plastic cylinder with a plunger.
• The tip of the oral syringe fits into the bottle cap adapter and is used to draw the required amount of medicine from the bottle. For each new medicine bottle, use a new adapter and a new dosing syringe.

Dosing container:

• Which may be used if the prescribed

dose requires multiple fillings
of the syringe.

• After administering the medicine and washing the container, always place it back onto the bottle cap.

Fitting the press-on cap onto a new medicine bottle

1. Remove the cap by pressing down firmly and then turning it counterclockwise (as shown in the illustration on the top of the cap).
2. Place the bottle upright on a flat surface and then firmly press the cap onto the neck of the bottle until resistance is felt or as far as possible.

Note: It may not be possible to fully press the cap in completely, but this is not critical, as it will be fully secured by the closure cap when the bottle is capped.

3. Recap the bottle.

Preparing the medicine dose

4. Remove the cap from the bottle by pressing down firmly and turning it

counterclockwise (as shown
in the illustration on the top of the cap).

5. Ensure that the plunger of the syringe is fully depressed to the end.

6. Holding the bottle upright, firmly and decisively insert the syringe into the adapter on the bottle neck.

7. Carefully turn the bottle upside down, keeping the syringe inserted.

8. Before measuring the dose, remove any large air bubbles that may have entered the syringe. To do this:

   • Slowly pull the plunger back fully so that the syringe fills with medicine.
   • Then push the plunger back in to empty the syringe.

Measuring the medicine dose
Note: The maximum volume of solution that can be measured using the oral syringe is
5 mL. Depending on the prescribed dose, it may be necessary to repeat the steps described
in points 10–16 several times. For example, if the prescribed dose is 13 mL, the solution must be measured three times: 5 mL + 5 mL + 3 mL.

9. Locate on the syringe the marking corresponding to the prescribed dose.
10. Slowly pull back the plunger until the top edge of the plunger aligns exactly with the appropriate graduation mark.
11. Carefully turn the bottle with the syringe attached so that the bottom faces downward.

12. Remove the syringe from the adapter by gently rotating it.

Taking the medicine

13. Sit in an upright position.
14. Place the tip of the syringe into the mouth.

15. Slowly depress the plunger to administer the medicine directly from the syringe.
16. If the prescribed dose requires multiple syringe fillings, the measured medicine dose may be transferred from the syringe into the dosing container, and finally, verify that the total measured volume matches the prescribed dose.
17. Drink the entire solution at once.
18. After taking the medicine, recap the bottle.
19. Cleaning the oral syringe:

• Wipe the external parts of the syringe with a clean, dry tissue.
• The syringe should be cleaned after each use.

20. Cleaning the dosing container:

• Rinse the container with clean water.
• Dry it with a clean tissue and then place it back onto the bottle cap.