Product Details

Product Information of Co-Diovan 320/25mg Tablets

What you need to know 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 this
medicine (listed in section 6).
• 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 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 Co-Diovan.
Warnings and precautions
Talk to your doctor
• 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 pressure-lowering 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 fluid
accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in
your eye and can happen within hours to weeks 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.
• 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
• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the
risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun
exposure and UV rays while taking Co-Diovan.
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 Co-Diovan”
Co-Diovan may cause increased sensitivity of the skin to sun.
The use of Co-Diovan in children and adolescents (below the age of 18 years) is not recommended.
You must tell your doctor if you think you are (or might become) pregnant. Co-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 Co-Diovan
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines, or might take
any other medicines.
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, ACE inhibitors (such as
enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “Do not take CoDiovan” and “Warnings and precautions”).
• 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, drink and alcohol
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
• 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. CoDiovan 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
Co-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 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