CO-DIOVAN 160/25MG TABLETS

Active substance: VALSARTAN

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-DIOVAN® 160/25MG TABLETS
(valsartan and hydrochlorothiazide)
This product will be referred to as Co-Diovan throughout this
leaflet.
This product is available in multiple strengths and all strengths will
be referred to throughout this leaflet.
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 on 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 Co-Diovan is and what it is used for
2. Before you take Co-Diovan
3. How to take Co-Diovan
4. Possible side effects
5. How to store Co-Diovan
6. Further information
1.

What Co-Diovan is and what it is used for

Co-Diovan film-coated tablets contain two active substances called
valsartan and hydrochlorothiazide. Both of these substances help to
control high blood pressure (hypertension).
 Valsartan 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. Valsartan works
by blocking the effect of angiotensin II. As a result, blood vessels relax
and blood pressure is lowered.
 Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics (also known as “water tablets”). Hydrochlorothiazide
increases urine output, which also lowers blood pressure.
Co-Diovan is used to treat high blood pressure which is not adequately
controlled by a single substance alone.
High blood pressure increases the workload of 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.

Before you take Co-Diovan

Do not take Co-Diovan:
 if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide,
sulphonamide derivatives (substances chemically related to
hydrochlorothiazide) or to any of the other ingredients of Co-Diovan.
 if you are more than 3 months pregnant (it is also better to avoid
Co-Diovan in early pregnancy – see pregnancy section).
 if you have severe liver disease, destruction of the small bile ducts
within the liver (biliary cirrhosis) leading to the build up of bile in the
liver (cholestasis).
 if you have severe kidney disease.
 if you are unable to produce urine (anuria).
 if you are treated with an artificial kidney.
 if the level of potassium or sodium in your blood is lower than normal,
or if the level of calcium in your blood is higher than normal despite
treatment.
 if you have gout.
If any of the above apply to you, do not take this medicine and speak
to your doctor.
Take special care with Co-Diovan
 if you are taking potassium-sparing medicines, potassium
supplements, salt substitutes containing potassium or other medicines
that increase the amount of potassium in your blood such as heparin.
Your doctor may need to check the amount of potassium in your blood
regularly.
 if you have low levels of potassium in your blood.
 if you have diarrhoea or severe vomiting.
 if you are taking high doses of water tablets (diuretics).
 if you have severe heart disease.
 if you are suffering from heart failure or have experienced a heart
attack. Follow your doctor’s instruction for the starting dose carefully.
Your doctor may also check your kidney function.
 if you suffer from a narrowing of the kidney artery.
 if you have recently received a new kidney.
 if you suffer from hyperaldosteronism. This is a disease in which your
adrenal glands make too much of the hormone aldosterone. If this
applies to you, the use of Co-Diovan is not recommended.
 if you have liver or kidney disease.
 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 Co-Diovan, stop taking Co-Diovan immediately
and never take it again. See also section 4, “Possible side effects”.
 if you have fever, rash and joint pain, which may be signs of systemic
lupus erythematosus (SLE, a so-called autoimmune disease).
 if you have diabetes, gout, high levels of cholesterol or triglycerides in
your blood.
 if you have had allergic reactions with the use of other blood pressurelowering agents of this class (angiotensin II receptor antagonists) or if
you have allergy or asthma.
 if you experience a decrease in vision or eye pain. These could be
symptoms of an increase of pressure in your eye and can happen
within hours to a week of taking Co-Diovan. This can lead to
permanent vision loss, if not treated. If you earlier have had a penicillin
or sulphonamide allergy you can be at higher risk of developing this.
 it may cause increased sensitivity of the skin to sun.
If any of these apply to you, talk to your doctor.
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 Co-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 especially applies to the following medicines:
 lithium, a medicine used to treat some types of psychiatric diseases.
 medicines or substances that may increase the amount of potassium
in your blood. These include potassium supplements or salt
substitutes containing potassium, potassium-sparing medicines and
heparin.
 medicines that may reduce the amount of potassium in your blood,
such as diuretics (water tablets), corticosteroids, laxatives,
carbenoxolone, amphotericin or penicillin G.
 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
Co-Diovan.
 medicines that may induce “torsades de pointes” (irregular heart beat),
such as antiarrhythmics (medicines used to treat heart problems) and
some antipsychotics.
 medicines that may reduce the amount of sodium in your blood, such
as antidepressants, antipsychotics, antiepileptics.
 medicines for the treatment of gout, such as allopurinol, probenecid,
sulfinpyrazone.
 therapeutic vitamin D and calcium supplements.
 medicines for the treatment of diabetes (oral agents such as metformin
or insulins).
 other medicines to lower your blood pressure including methyldopa.
 medicines to increase blood pressure, such as noradrenaline or
adrenaline.
 digoxin or other digitalis glycosides (medicines used to treat heart
problems).
 medicines that may increase blood sugar levels, such as diazoxide or
beta blockers.
 cytotoxic medicines (used to treat cancer), such as methotrexate or
cyclophosphamide.
 pain killers such as non-steroidal anti-inflammatory agents (NSAIDs),
including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors) and
acetylsalicylic acid > 3 g.
 muscle relaxing medicines, such as tubocurarine.
 anti-cholinergic medicines (medicines used to treat a variety of
disorders such as gastrointestinal cramps, urinary bladder spasm,
asthma, motion sickness, muscular spasms, Parkinson's disease and
as an aid to anaesthesia).
 amantadine (medicine used to treat Parkinson’s disease and also
used to treat or prevent certain illnesses caused by viruses).
 cholestyramine and colestipol (medicines used mainly to treat high
levels of lipids in the blood).
 ciclosporin, a medicine used for organ transplant to avoid organ
rejection.
 alcohol, sleeping pills and anaesthetics (medicines with sleeping or
painkilling effect used for example during surgery).
 iodine contrast media (agents used for imaging examinations).
Taking Co-Diovan with food and drink
You can take Co-Diovan with or without food.
Avoid taking alcohol until you have talked to your doctor. Alcohol may
make your blood pressure fall more and/or increase the risk of you
becoming dizzy or feeling faint.
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 Co-Diovan before you
become pregnant or as soon as you know you are pregnant, and will
advise you to take another medicine instead of Co-Diovan. Co-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
Co-Diovan is not recommended for mothers who are breast-feeding, and
your doctor may choose another treatment for you if you wish to breastfeed, 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
Co-Diovan affects you. Like many other medicines used to treat high
blood pressure, Co-Diovan may occasionally cause dizziness and affect
the ability to concentrate.
3.

How to take Co-Diovan

Always take Co-Diovan exactly as your doctor has told you. This will help
you to get the best results and lower 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 your doctor even if you are feeling
well.
Your doctor will tell you exactly how many tablets of Co-Diovan to take.
Depending on how you respond to the treatment, your doctor may suggest
a higher or lower dose.

 The usual dose of Co-Diovan is one tablet per day.
 Do not change the dose or stop taking the tablets without consulting
your doctor.

 The medicine should be taken at the same time each day, usually in
the morning.

 You can take Co-Diovan with or without food.
 Swallow the tablet with a glass of water.

If you take more Co-Diovan than you should
If you experience severe dizziness and/or fainting, lie down and contact
your doctor immediately.
If you have accidentally taken too many tablets, contact your doctor,
pharmacist or hospital.
If you forget to take Co-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 Co-Diovan
Stopping your treatment with Co-Diovan may cause your high blood
pressure 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 product, ask your
doctor or pharmacist.
4.

Possible side effects

Like all medicines, Co-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 side effects can be serious and need immediate medical
attention:
You should see your doctor immediately if you experience symptoms of
angioedema, such as:
 swollen face, tongue or pharynx
 difficulty in swallowing
 hives and difficulties in breathing
If you get any of these symptoms, stop taking Co-Diovan and contact
your doctor straight away (see also section 2 “Take special care with
Co-Diovan”).
Other side effects include:
Uncommon:
 cough
 low blood pressure
 light-headedness
 dehydration (with symptoms of thirst, dry mouth and tongue, infrequent
urination, dark coloured urine, dry skin)
 muscle pain
 tiredness
 tingling or numbness
 blurred vision
 noises (e.g. hissing, buzzing) in ears
Very rare:
 dizziness
 diarrhoea
 joint pain
Not known:
 breathing difficulty
 severely decreased urine output
 low level of sodium in the blood (which can trigger tiredness,
confusion, muscle twitching and / or convulsions in severe cases)
 low level of potassium in the blood (sometimes with muscle weakness,
muscle spasms, abnormal heart rhythm)
 low level of white cells in the blood (with symptoms such as fever, skin
infections, sore throat or mouth ulcers due to infections, weakness)
 the level of bilirubin increased in blood (which can, in severe cases,
trigger yellow skin and eyes)
 the level of blood urea nitrogen and creatinine increased in blood
(which can indicate abnormal kidney function)
 the level of uric acid in blood increased (which can, in severe cases,
trigger gout)
 syncope (fainting)
The following side effects have been reported with products
containing valsartan or hydrochlorothiazide alone:
Valsartan
Uncommon:
 spinning sensation
 abdominal pain
Not known:
 skin rash with or without itching together with some of the following
signs or symptoms: fever, joint pain, muscle pain, swollen lymph
nodes and/or flu-like symptoms
 rash, purplish-red spots, fever, itching (symptoms of inflammation of
blood vessels)
 low level of blood platelets (sometimes with unusual bleeding or
bruising)
 high level of potassium in the blood (sometimes with muscle spasms,
abnormal heart rhythm)
 allergic reactions (with symptoms such as rash, itching, hives, difficulty
breathing or swallowing, dizziness)
 swelling mainly of the face and throat; rash; itching
 elevation of liver function values
 the level of haemoglobin decreased and the percentage of red cells
decreased in the blood (which both can, in severe cases, trigger an
anaemia).
 kidney failure
 low level of sodium in the blood (which can trigger tiredness,
confusion, muscle twitching and/or convulsions in severe cases)

Common:
 low level of sodium in the blood
 low level of magnesium in the blood
 high level of uric acid in the blood
 itchy rash and other types of rash
 reduced appetite
 mild nausea and vomiting
 dizziness, fainting on standing up
 inability to achieve or maintain erection
Rare:
 swelling and blistering of the skin (due to increased sensitivity to sun)
 high level of calcium in the blood
 high level of sugar in the blood
 sugar in the urine
 worsening of diabetic metabolic state
 constipation, diarrhoea, discomfort of the stomach or bowels, liver
disorders which can occur together with yellow skin and eyes
 irregular heart beat
 headache
 sleep disturbances
 sad mood (depression)
 low level of blood platelets (sometimes with bleeding or bruising
underneath the skin)
 dizziness
 tingling or numbness
 vision disorder
Very rare:
 inflammation of blood vessels with symptoms such as rash,
purplish-red spots, fever (vasculitis)
 rash, itching, hives, difficulty breathing or swallowing, dizziness
(hypersensitivity reactions)
 severe skin disease that causes rash, red skin, blistering of the lips,
eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
 facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
 severe upper stomach pain (pancreatitis)
 difficulty breathing with fever, coughing, wheezing, breathlessness
(respiratory distress including pneumonitis and pulmonary oedema)
 fever, sore throat, more frequent infections (agranulocytosis)
 pale skin, tiredness, breathlessness, dark urine (haemolytic anaemia)
 fever, sore throat or mouth ulcers due to infections (leucopenia)
 confusion, tiredness, muscle twitching and spasm, rapid breathing
(hypochloraemic alkalosis)
Not known:
 weakness, bruising and frequent infections (aplastic anemia)
 severely decreased urine output (possible signs of renal disorder or
renal failure)
 decrease in vision or pain in your eyes due to high pressure (possible
signs of acute angle-closure glaucoma)
 rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever
(possible signs of erythema multiforme)
 muscle spasm
 fever (pyrexia)
 weakness (asthenia)
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 Co-Diovan

 KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
 Do not use Co-Diovan after the expiry date which is stated on the
pack. The expiry date refers to the last day of that month.

 Store in the original pack. Do not store above 30ºC. Protect from
moisture.

 Do not use any Co-Diovan pack that is damaged or shows signs of
tampering.

 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 Co-Diovan contains
 Each tablet contains 160mg of valsartan and 25mg of
hydrochlorothiazide as the active ingresient.
 The tablets also contain the following inactive ingredients: Colloidal
anhydrous silica, crospovidone, hypromellose, magnesium stearate,
microcrystalline cellulose, Macrogol 4000, talc, red iron oxide (E172),
yellow iron oxide (E172) black iron oxide (E172) and titanium dioxide
(E171).
What Co-Diovan looks like and contents of the pack
Co-Diovan 160/25 Tablets are brown orange and oval. They are marked
HXH on one side and NVR on the other.
The tablets come in blister packs containing 28 tablets.
Manufacturer
Co-Diovan is manufactured by: Novartis Farma S.p.A., Via Provinciale
Schito 131, 80058 Torre Annunziata NA, Italy. Procured from within the
EU and repackaged by the Product Licence Holder: G Pharma Ltd.,
Salford M50 2PU.
PL NO 16369/1482

POM

Co-Diovan 160/25mg Tablets
Leaflet revision date: 19/11/2013

Hydrochlorothiazide
Very common:
 low level of potassium in the blood
 increase of lipids in the blood

‘Co-Diovan’ is a registered trademark of Novartis

Expand view ⇕

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.

Hide
(web3)