DIOVAN 40MG FILM-COATED TABLETS

Active substance: VALSARTAN

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1959
12.08.14[5]

Diovan® 40 mg Film-Coated Tablets
Valsartan 40 mg Film-Coated Tablets
(valsartan)
PATIENT INFORMATION LEAFLET

Your medicine is available using any one of the above names but will be
referred to as Diovan throughout this leaflet.
Other strengths are also available.
Read all of this leaflet carefully before you start taking this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it to others.
It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Diovan is and what it is used for
2. Before you take Diovan
3. How to take Diovan
4. Possible side effects
5. How to store Diovan
6. Further information
1. WHAT DIOVAN IS AND WHAT IT IS USED FOR
Diovan 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 can be used for three different conditions:
- to treat high blood pressure in children and adolescents 6 to 18
years of age. High blood pressure increases the workload on the heart
and arteries. If not treated it can damage the blood vessels of the brain,
heart, and kidneys, and may result in a stroke, heart failure, or kidney
failure. High blood pressure increases the risk of heart attacks. Lowering
your blood pressure to normal reduces the risk of developing these
disorders.
- to treat adult patients after a recent heart attack (myocardial
infarction). “Recent” here means between 12 hours and 10 days.
- to treat symptomatic heart failure in adult patients. Diovan is used
when a group of medicines called Angiotensin Converting Enzyme
(ACE) inhibitors (a medication to treat heart failure) cannot be used or it
may be used in addition to ACE inhibitors when beta blockers (another
medication to treat heart failure) cannot be used.
Heart failure symptoms include shortness of breath, and swelling of the
feet and legs due to fluid build-up. It is caused when the heart muscle
cannot pump blood strongly enough to supply all the blood needed
throughout the body.
2. BEFORE YOU TAKE DIOVAN
Do not take Diovan:
- if you are allergic (hypersensitive) to valsartan or any of the other
ingredients of Diovan listed at the end of this leaflet.
- 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 any of these apply to you, do not take Diovan
Take special care with 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 are treated after a heart attack or for heart failure, your doctor may
check your kidney function.
- if you have severe heart disease other than heart failure or heart attack.
- 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 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 are below 18 years of age and you take Diovan in combination
with other medicines that inhibit the renin angiotensin aldosterone

system (medicines that lower blood pressure), your doctor may check
your kidney function and 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).
- 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).
If any of these apply to you, tell your doctor before you take Diovan.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
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).
- 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.
In addition:
- if you are being treated after a heart attack, a combination with ACE
inhibitors (a medication to treat heart attack) is not recommended.
- if you are being treated for heart failure, a triple combination with ACE
inhibitors and beta blockers (medications to treat heart failure) is not
recommended.
Taking Diovan with food and drink
You can take Diovan with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
- 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 breastfeeding. Diovan is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you
wish to breast-feed, especially if your baby is newborn, or was born
prematurely.
Driving and using machines
Before you drive a vehicle, use tools or operate machines, or carry out
other activities that require concentration, make sure you know how Diovan
affects you. Like many other medicines used to treat high blood pressure,
Diovan may in rare cases cause dizziness and affect the ability to
concentrate.
3. HOW TO TAKE DIOVAN
Always take Diovan exactly as your doctor has told you in order to get the
best results and reduce the risk of side effects. You should 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.
Children and adolescents (6 to 18 years of age) with high blood
pressure
In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan
once daily.
In patients who weigh 35 kg or more the usual starting dose is 80 mg of
valsartan once daily.
In some cases your doctor may prescribe higher doses (the dose can be
increased to 160 mg and to a maximum of 320 mg).

Adult patients after a recent heart attack: After a heart attack the
treatment is generally started as early as after 12 hours, usually at a low
dose of 20 mg twice daily. You obtain the 20 mg dose by dividing the 40 mg
tablet. Your doctor will increase this dose gradually over several weeks to a
maximum of 160 mg twice daily. The final dose depends on what you as an
individual patient can tolerate.
Diovan can be given together with other treatment for heart attack, and
your doctor will decide which treatment is suitable for you.
Adult patients with heart failure: Treatment starts generally with 40 mg
twice daily. Your doctor will increase the dose gradually over several weeks
to a maximum of 160 mg twice daily. The final dose depends on what you
as an individual patient can tolerate.
Diovan can be given together with other treatment for heart failure, and
your doctor will decide which treatment is suitable for you.
You can take Diovan with or without food. Swallow Diovan with a glass of
water.
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 too many tablets,
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.

Not known
- 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)
The frequency of some side effects may vary depending on your condition.
For example, side effects such as dizziness, and decreased kidney
function, were seen less frequently in adult patients treated with high blood
pressure than in adult patients treated for heart failure or after a recent
heart attack.
Side effects in children and adolescents are similar to those seen in adults.

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 further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Diovan can cause side effects, although not everybody
gets them.
These side effects may occur with certain frequencies, which are defined
as follows:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.
Some symptoms 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
If you get any of these symptoms, stop taking Diovan and contact
your doctor straight away (see also section 2 “Take special care with
Diovan”).
Side effects include:
Common
- dizziness
- low blood pressure with or without symptoms such as dizziness and
fainting when standing up
- decreased kidney function (signs of renal impairment)
Uncommon
- 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

If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE DIOVAN
- Do not store above 30°C. Store in the original package. Protect from
moisture.
- Keep out of the sight and reach of children.
- Do not use Diovan after the expiry date, which is stated on the pack.
The expiry date refers to the last day of that month.
- Do not use Diovan if you notice that the pack is damaged or shows
signs of tampering.
- If the tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
- Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Diovan contains
Each film-coated tablet contains 40mg valsartan.
They also contain the following inactive ingredients: microcrystalline
cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate,
hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide
(E172), yellow iron oxide (E172) and black iron oxide (E172).

What Diovan looks like and contents of the pack
Diovan are yellow, ovaloid, film-coated tablet with bevelled edges, slightly
convex, scored on one side, with debossing “D” on one side of the score
and “O” on the other side of the score and “NVR” on the reverse side of the
tablet.
Supplied in calendar blister packs containing 14 and 28 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Novartis Farma S.p.A., Via Provinciale Schito 131, 80058
Torre Annunziata (NA) , Italy and procured from the EU by Product Licence
holder Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repacked by Servipharm Ltd.
POM

PL 30900/1959

Leaflet revision and issue date: 12.08.14[5]
Diovan is a trademark of Novartis AG.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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