Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Diovan 3 mg/ml Oral Solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Valsartan may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 1 to less than 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 it
e Diovan
Do not take Diovan: • if you are allergic (hypersensitive) 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 Diovan 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 the above apply to you, tell your doctor and do not take Diovan.
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Warnings and precautions: Talk to your doctor before taking Diovan • 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 have ever experienced swelling of the tongue 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 Diovan, stop taking Diovan immediately and never take it again. See also section 4, "Possible side effects". • if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Diovan. Your doctor will decide on further treatment. Do not stop taking Diovan on your own. • 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. It may be necessary to check the amount of potassium in your blood at regular intervals. • 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 Diovan 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: o an ACE inhibitors (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. o aliskiren 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: • other medicines that lower blood pressure, especially water tablets (diuretics), ACE inhibitors (such as enalapril, lisinopril etc.) or aliskiren (see also information under the headings "Do not take Diovan" and "Warnings and precautions"). • medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. • certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs). • some antibiotics (rifamycin group), a drug used to protect against transplant rejection (ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Diovan. • lithium, a medicine used to treat some types of psychiatric illness.
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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 cause dizziness and affect the ability to concentrate. Diovan contains sucrose, methyl parahydroxybenzoate, poloxamer, sodium and propylene glycol • Diovan solution contains 0.3 g sucrose per millilitre. Take this into account if you have diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Diovan solution. The amount of sucrose in the Diovan solution may be harmful to your teeth. • Diovan solution contains methyl parahydroxybenzoate (E218). This may cause allergic reactions possibly occurring some time after you take the solution. The signs may include rash, itching, hives. If any of the side effects gets serious, please tell your doctor.
- Diovan solution contains poloxamer (188). This may soften your stools.
- Diovan solution contains 3.72 mg of sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.19% of the recommended maximum daily dietary intake of sodium for an adult.
- Diovan solution contains 0.99 mg propylene glycol (E1520) in each ml oral solution. 3.
How to take it
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 Children aged 1 to less than 6 years old
- the usual starting dose is 1 mg/kg once daily. The dose and the corresponding volume of oral solution to be administered is given in the below table: Weight of the child 10 kg 15 kg
Diovan dose (for the usual starting dose 1 mg/kg) 10 mg 15 mg 3
Volume of oral solution 3.5 ml 5.0 ml
20 kg 25 kg 30 kg • •
20 mg 25 mg 30 mg
6.5 ml 8.5 ml 10 ml
your doctor can prescribe a higher starting dose (2 mg/kg) if a faster reduction of the blood pressure is needed. the dose can be increased up to a maximum of 4 mg/kg.
Children aged 6 years and older and
- weighing less than 35 kg: o the usual starting dose for Diovan oral solution is 20 mg (corresponding to 7 ml of the solution). o the dose can be increased up to a maximum of 40 mg (corresponding to 13 ml of the solution). •
weighing 35 kg or more: o the usual starting dose for Diovan oral solution is 40 mg (corresponding to 13 ml of the solution). o the dose can be increased up to a maximum of 80 mg (corresponding to 27 ml of the solution).
Children who started taking Diovan prior to the age of 6 may have a higher Diovan dose than the maximum dose stated above. In selected cases your doctor may choose to retain that dose. 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 • swollen face, lips, tongue or throat • difficulty in breathing or swallowing • hives, itching 4
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): • dizziness • low blood pressure with or without symptoms such as dizziness and fainting when standing up • decreased kidney function (signs of renal impairment) Uncommon (may affect up to 1 in 100 people): • angioedema (see section "Some symptoms need immediate medical attention") • sudden loss of consciousness (syncope) • spinning sensation (vertigo) • severely decreased kidney function (signs of acute renal failure) • muscle spasms, abnormal heart rhythm (signs of hyperkalaemia) • breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure) • headache • cough • abdominal pain • nausea • diarrhoea • tiredness • weakness Very Rare (may affect up to 1 in 10,000 people) •
Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea
Not known (frequency cannot be estimated from the available data): • blistering skin (sign of dermatitis bullous) • allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness) • purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis) • unusual bleeding or bruising (signs of thrombocytopenia) • muscle pain (myalgia) • fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia) • decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases) • increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases) • elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases) • increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function) • low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)
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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.
Possible side effects
in children and adolescents are similar to those seen in adults. 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5.
How to store it
Diovan
• •
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 bottle. The expiry date refers to the last day of that month. Do not store above 30°C. Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C. 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 Diovan contains • The active substance is valsartan. Each ml of oral solution contains 3 mg of valsartan. • The other ingredients are sucrose, methyl parahydroxybenzoate (E218), potassium sorbate, poloxamer (188), citric acid, sodium citrate, artificial blueberry 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, colourless to pale yellow solution. • The solution is supplied in a pack containing one 180 ml amber glass bottle with a childresistant screw cap and a yellow or colourless 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 Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland.
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Manufacturer Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London, W12 7FQ United Kingdom If you would like any more information, or would like this leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd., telephone number 01276 698370 This leaflet was revised on 02 February 2025
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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 1. Remove the cap from the bottle by pushing it down firmly and turning it anti-clockwise (as shown on the top of the cap). 2. 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. 3. Screw the cap back on the bottle.
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Preparing a dose of medicine 4. Remove the cap from the bottle by pushing it down firmly and turning it anti-clockwise (as shown on the top of the cap). 5. Check that the plunger is pushed fully into the oral syringe. 6. Keeping the bottle upright, insert the oral syringe firmly into the bottle adapter.
7. Holding the oral syringe in place, carefully turn the bottle and oral syringe upside down. 8. 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. 9. Find the marker on the oral syringe that corresponds to the required amount of medicine. 10. Slowly pull the plunger out until the top edge of the indicated ring inside is exactly level with the marker. 11. Carefully turn the bottle and oral syringe back upright.
12. Remove the oral syringe from the bottle adapter by gently twisting it out.
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Taking the medicine 13. Sit upright. 14. Put the end of the oral syringe into the mouth. 15. Slowly push the plunger in and swallow the medicine directly from the oral syringe. 16. 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. 17. Drink the entire solution right away. 18. Replace the child-resistant screw cap after use. 19. 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. 20. 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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Frequently asked questions about Diovan 3 mg/ml Oral Solution
How do I take Diovan 3 mg/ml Oral Solution?
Diovan 3 mg/ml Oral Solution comes as oral solution containing 3mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Diovan 3 mg/ml Oral Solution?
The active substance in Diovan 3 mg/ml Oral Solution is valsartan.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Diovan 3 mg/ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Diovan 3 mg/ml Oral Solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: valsartan
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of hypertension in children and adolescents 1 to less than 18 years of age.
4.2. Posology and method of administration
Posology
For children and adolescents who are unable to swallow tablets, the use of the Diovan oral solution is recommended. The systemic exposure and peak plasma concentration of valsartan is about 1.7-fold and 2.2-fold higher with the solution compared to the tablets.
Children 1 to less than 6 years of age
The usual starting dose is 1 mg/kg once daily. The table below shows the corresponding volume of Diovan oral solution to some selected doses.
Weight of the child
Valsartan dose (for the usual starting dose of 1 mg/kg)
Volume of Diovan oral solution
10 kg
10 mg
3.5 ml
15 kg
15 mg
5.0 ml
20 kg
20 mg
6.5 ml
25 kg
25 mg
8.5 ml
30 kg
30 mg
10 ml
A higher starting dose 2 mg/kg may be considered in some selected cases when a faster reduction of blood pressure is needed. The dose should be adjusted based on blood pressure response and tolerability up to a maximum dose of 4 mg/kg once daily. Doses above 4 mg/kg have not been studied in children between 1 and less than 6 years old.
When reaching the age of six years, transition to the posology for children 6-17 years old is recommended. However, some children may have a higher valsartan dose than the highest recommended dose for children 6-17 years of age. If this dose is well-tolerated, the dose may be retained under close monitoring of blood-pressure and tolerability.
Children and adolescents 6 to lessthan 18 years of age
The initial dose for the Diovan oral solution is 20 mg (corresponding to 7 ml of the solution) once daily for children and adolescents below 35 kg of weight and 40 mg (corresponding to 13 ml of the solution) once daily for those weighing 35 kg or more. The dose should be adjusted based on blood pressure response up to a maximum dose of 40 mg valsartan once daily (corresponding to 13 ml of the solution) for children and adolescents with body weight below 35 kg and 80 mg valsartan (corresponding to 27 ml of the solution) for children and adolescents with body weight of 35 kg or more. For children already started on valsartan prior to the age of six years, please refer to the posology for Children 1 to less than 6 years of age.
Switching between Diovan tablets and Diovan Oral Solution
It is not recommended to switch between Diovan tablets and Diovan oral solution unless clinically required.
If switching from Diovan tablets to Diovan oral solution is considered essential on clinical grounds, the valsartan dose should be adjusted as described in the table below and blood pressure should be carefully monitored. The dose should be titrated based on blood pressure response and tolerability.
Tablets
Solution
Valsartan dose
Valsartan dose to provide when switching
Volume to take
40 mg
20 mg
7 ml
80 mg
40 mg
13 ml
160 mg
80 mg
27 ml
320 mg
Due to the high volume of solution that would be necessary, the use of the solution is not recommended
Not applicable
If switching from Diovan oral solution to Diovan tablets is considered clinically essential, initially the same dose in milligrams should be given. Subsequently, frequent blood pressure monitoring should be performed taking into account potential under-dosing and dose should be titrated further based on blood pressure response and tolerability.
Diovan tablets are not suitable for children aged 1 to 5 years of age and for those having difficulties swallowing the tablets.
Children less than 1 year of age
Available data are described in sections 4.8, 5.1 and 5.2. However, the safety and efficacy of Diovan in children aged below 1 year of age have not been established.
Use in paediatric patients aged 1 to less than 18 years with renal impairment
Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients. No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min. Renal function and serum potassium should be closely monitored (see sections 4.4 and 5.2).
Use in paediatric patients aged 1 to less than 18 years with hepatic impairment
As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3, 4.4 and 5.2). There is limited clinical experience with Diovan in paediatric patients with mild to moderate hepatic impairment. The dose of valsartan should not exceed 80 mg in these patients.
Paediatric heart failure and recent myocardial infarction
Diovan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
Method of administration
Diovan may be taken independently of a meal.
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Severe hepatic impairment, biliary cirrhosis and cholestasis.
- Second and third trimester of pregnancy (see sections 4.4 and 4.6).
- Concomitant use of Diovan with aliskiren containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.5 and 5.1).
4.4. Special warnings and precautions for use
Hyperkalaemia
Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended. Monitoring of potassium should be undertaken as appropriate.
Impaired renal function
There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients. No dose adjustment is required for adult patients with creatinine clearance >10 ml/min (see sections 4.2 and 5.2).
Hepatic impairment
In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Sodium- and/or volume-depleted patients
In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan. Sodium and/or volume depletion should be corrected before starting treatment with Diovan, for example by reducing the diuretic dose.
Renal artery stenosis
In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Diovan has not been established.
Short-term administration of Diovan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN). However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Kidney transplantation
There is currently no experience on the safe use of Diovan in patients who have recently undergone kidney transplantation.
Primary hyperaldosteronism
Patients with primary hyperaldosteronism should not be treated with Diovan as their renin-angiotensin system is not activated.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy
As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Diabetes
Diovan oral solution contains 0.3 g sucrose per milliliter. This should be taken into account in patients with diabetes mellitus.
Hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Diovan oral solution as it contains sucrose.
Methyl parahydroxybenzoate
Diovan oral solution contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Poloxamer
Diovan oral solution contains poloxamer (188) which may cause softened stools.
Sodium content
This medicinal product contains 3.72 mg sodium per ml, equivalent to 0.19% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Pregnancy
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
History of angioedema
Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should be immediately discontinued in patients who develop angioedema, and Diovan should not be re-administered (see section 4.8).
Intestinal angioedema
Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including valsartan (see section 4.8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, valsartan should be discontinued, and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.
Other conditions with stimulation of the renin-angiotensin system
In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death. As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Diovan may be associated with impairment of the renal function.
Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS)
There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia, and decreased renal function (including acute renal failure). Dual blockade of the RAAS through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Paediatric population
Change of pharmaceutical form
Diovan oral solution is not bioequivalent to the tablet formulation and patients should not be switched unless clinically essential. For dosing recommendations in this case, see section 4.2.
Impaired renal function
Use in paediatric patients with a creatinine clearance <30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients. No dose adjustment is required for paediatric patients with a creatinine clearance >30 ml/min (see sections 4.2 and 5.2). Renal function and serum potassium should be closely monitored during treatment with valsartan. This applies particularly when valsartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function.
Impaired hepatic function
As in adults, Diovan is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis (see sections 4.3 and 5.2). There is limited clinical experience with Diovan in paediatric patients with mild to moderate hepatic impairment. The dose of valsartan should not exceed 80 mg in these patients.
4.5. Interaction with other medicinal products and other forms of interaction
Dual blockade of the Renin-Angiotensin-Aldosterone System (RAAS) with ARBs, ACEIs, or aliskiren
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Concomitant use not recommended
Lithium
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including with Diovan. If the combination proves necessary, a careful monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may presumably be increased further.
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised.
Caution required with concomitant use
Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs
When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium. Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Transporters In vitro data indicates that valsartan is a substrate of the hepatic uptake transporter OATP1B1/OATP1B3 and the hepatic efflux transporter MRP2. The clinical relevance of this finding is unknown. Co-administration of inhibitors of the uptake transporter (e.g. rifampin, ciclosporin) or efflux transporter (e.g. ritonavir) may increase the systemic exposure to valsartan. Exercise appropriate care when initiating or ending concomitant treatment with such drugs.
Others
In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Paediatric population
In hypertension in children and adolescents, where underlying renal abnormalities are common, caution is recommended with the concomitant use of valsartan and other substances that inhibit the renin angiotensin aldosterone system which may increase serum potassium. Renal function and serum potassium should be closely monitored.
4.6. Fertility, pregnancy and lactation
Pregnancy
The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia); see also section 5.3 “Preclinical safety data”.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Breast-feeding
Because no information is available regarding the use of valsartan during breastfeeding, Diovan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Fertility
Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day. This dose is 6 times the maximum recommended human dose on a mg/m2 basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive have been performed. When driving vehicles or operating machines it should be taken into account that dizziness or weariness may occur.
4.8. Undesirable effects
In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse drug reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan. The incidence of ADRs did not appear to be related to dose or treatment duration and also showed no association with gender, age or race.
The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class.
Adverse Drug Reactions
Adverse drug reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse drug reactions are ranked in order of decreasing seriousness.
For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a "not known" frequency.
- Hypertension
Blood and lymphatic system disorders
Not known
Decrease in haemoglobin, Decrease in haematocrit, Neutropenia, Thrombocytopenia
Immune system disorders
Not known
Hypersensitivity including serum sickness
Metabolism and nutrition disorders
Not known
Increase of serum potassium, Hyponatraemia
Ear and labyrinth disorders
Uncommon
Vertigo
Vascular disorders
Not known
Vasculitis
Respiratory, thoracic and mediastinal disorders
Uncommon
Cough
Gastrointestinal disorders
Uncommon
Abdominal pain
Very Rare
Intestinal angioedema
Hepato-biliary disorders
Not known
Elevation of liver function values including increase of serum bilirubin
Skin and subcutaneous tissue disorders
Not known
Angioedema, Dermatitis bullous, Rash, Pruritus
Musculoskeletal and connective tissue disorders
Not known
Myalgia
Renal and urinary disorders
Not known
Renal failure and impairment, Elevation of serum creatinine
General disorders and administration site conditions
Uncommon
Fatigue
Paediatric population
Hypertension
The antihypertensive effect of valsartan has been evaluated in two randomised, double-blind clinical studies (each followed by an extension period or study) and one open-label study. These studies included 711paediatric patients from 6 to less than 18 years of age with and without chronic kidney disease (CKD), of which 560 patients received valsartan. With the exception of isolated gastrointestinal disorders (such as abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to less than 18 years and that previously reported for adult patients.
Neurocognitive and developmental assessment of paediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with Diovan for up to one year.
A pooled analysis of 560 paediatric hypertensive patients (aged 6-17 years) receiving either valsartan monotherapy [n=483] or combination antihypertensive therapy including valsartan [n=77] was conducted. Of the 560 patients, 85 (15.2%) had CKD (baseline GFR <90 mL/min/1.73m2). Overall, 45 (8.0%) patients discontinued a study due to adverse events. Overall 111 (19.8%) patients experienced an adverse drug reaction (ADR), with headache (5.4%), dizziness (2.3%), and hyperkalaemia (2.3%) being the most frequent. In patients with CKD, the most frequent ADRs were hyperkalaemia (12.9%), headache (7.1%), blood creatinine increased (5.9%), and hypotension (4.7%). In patients without CKD, the most frequent ADRs were headache (5.1%) and dizziness (2.7%). ADRs were observed more frequently in patients receiving valsartan in combination with other antihypertensive medications than valsartan alone.
The antihypertensive effect of valsartan in children 1 to less than 6 years of age has been evaluated in three randomised, double-blind clinical studies (each followed by an extension period). In the first study in 90 children aged 1 to less than 6 years, two deaths and isolated cases of marked liver transaminases elevations were observed. These cases occurred in a population who had significant comorbidities. A causal relationship to Diovan has not been established. In the two subsequent studies in which 202 children aged 1 to less than 6 years were randomised, no significant liver transaminase elevations or death occurred with valsartan treatment.
In a pooled analysis of the two subsequent studies in 202 hypertensive children (aged 1 to less than 6 years), all patients received valsartan monotherapy in the double blind periods (excluding the placebo withdrawal period). Of these, 186 patients continued in either extension study or open label period. Of the 202 patients, 33 (16.3%) had CKD (baseline eGFR <90 ml/min). In the double blind period, two patients (1%) discontinued due to an adverse event and in the open label or extension period four patients (2.1%) discontinued due to an adverse event. In the double blind period, 13 (7.0%) patients experienced at least one ADR. The most frequent ADRs were vomiting n=3 (1.6%) and diarrhoea n=2 (1.1%). There was one ADR (diarrhoea) in the CKD group. In the open label period, 5.4% patients (10/186) had at least one ADR. The most frequent ADR was decreased appetite which was reported by two patients (1.1%). In both the double blind period and the open label periods, hyperkalaemia was reported for one patient in each period. There were no cases of hypotension or dizziness in either double blind or open label periods.
Hyperkalaemia was more frequently observed in children and adolescents aged 1 to less than 18 years with underlying chronic kidney disease (CKD). The risk of hyperkalaemia may be higher in children aged 1 to 5 years compared to children aged 6 to less than 18 years
The safety profile seen in controlled-clinical studies in adult patients with post-myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients. This may relate to the patients underlying disease. ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure are listed below.
- Post-myocardial infarction and/or heart failure (studied in adult patients only)
Blood and lymphatic system disorders
Not known
Thrombocytopenia
Immune system disorders
Not known
Hypersensitivity including serum sickness
Metabolism and nutrition disorders
Uncommon
Hyperkalaemia
Not known
Increase of serum potassium, Hyponatraemia
Nervous system disorders
Common
Dizziness, Postural dizziness
Uncommon
Syncope, Headache
Ear and labyrinth disorders
Uncommon
Vertigo
Cardiac disorders
Uncommon
Cardiac failure
Vascular disorders
Common
Hypotension, Orthostatic hypotension
Not known
Vasculitis
Respiratory, thoracic and mediastinal disorders
Uncommon
Cough
Gastrointestinal disorders
Uncommon
Nausea, Diarrhoea
Very Rare
Intestinal angioedema
Hepato-biliary disorders
Not known
Elevation of liver function values
Skin and subcutaneous tissue disorders
Uncommon
Angioedema
Not known
Dermatitis bullous, Rash, Pruritis
Musculoskeletal and connective tissue disorders
Not known
Myalgia
Renal and urinary disorders
Common
Renal failure and impairment
Uncommon
Acute renal failure, Elevation of serum creatinine
Not known
Increase in Blood Urea Nitrogen
General disorders and administration site conditions
Uncommon
Asthenia, Fatigue
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Overdose with Diovan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock.
Treatment
The therapeutic measures depend on the time of ingestion and the type and severity of the symptoms; stabilisation of the circulatory condition is of prime importance.
If hypotension occurs, the patient should be placed in a supine position and blood volume correction should be undertaken.
Valsartan is unlikely to be removed by haemodialysis.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- VALSACOR 40 mg prescriptionVALSARTANUM · taken by mouth
- VALSACOR 80 mg prescriptionVALSARTANUM · taken by mouth
- VALSACOR 160 mg prescriptionVALSARTANUM · taken by mouth
- VALSACOR 320 mg prescriptionVALSARTANUM · taken by mouth
- DIOVAN 80 mg prescriptionVALSARTANUM · taken by mouth
- DIOVAN 160 mg prescriptionVALSARTANUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- DiovanValsartanum · taken by mouth
- Valsacor 80 mg tabletki powlekaneValsartanum · taken by mouth
- Valsacor 160 mg tabletki powlekaneValsartanum · taken by mouth
- TensartValsartanum · taken by mouth
- BespresValsartanum · taken by mouth
- AvasartValsartanum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Diovan 3 mg/ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.