Co-Diovan 80 mg/12.5 mg film-coated tablets
Co-Diovan 160 mg/12.5 mg film-coated tablets
Co-Diovan 160 mg/25 mg film-coated tablets
Valsartan/hydrochlorothiazide
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
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.
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.
- if you have severe kidney disease.
- if you are unable to urinate.
- 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 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 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 fats 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.
- it 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).
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 illness
- medicines that affect or can be affected by potassium blood levels, such as digoxin, a medicine to control the heart rhythm, some antipsychotic medicines
- medicines that may increase the amount of potassium in your blood, such as potassium supplements, potassium-containing salt substitutes, potassium sparing medicines, heparin
- medicines that may reduce the amount of potassium in your blood, such as corticosteroids, some laxatives
- diuretics (water tablets), medicines for the treatment of gout, such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for the treatment of diabetes (oral agents or insulins)
- other medicines to lower your blood pressure, such as beta-blockers or methyldopa, or medicines that tighten your blood vessels or stimulate your heart, such as noradrenaline or adrenaline
- medicines to increase blood sugar levels, such as diazoxide
- medicines to treat cancer, such as methotrexate or cyclophosphamide
- pain killers
- arthritis medicines
- muscle relaxing medicines, such as tubocurarine
- anti-cholinergic medicines, such as atropine or biperiden
- amantadine (a medicine used to prevent influenza)
- cholestyramine and colestipol (medicines used to treat high levels of fats in the blood)
- ciclosporin, a medicine used for organ transplant to avoid organ rejection
- some antibiotics (tetracyclines), anaesthetics and sedatives
- carbamazepine, a medicine used to treat seizure conditions
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 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.
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.
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
Other side effects include:
Uncommon:
- cough
- low blood pressure
- light-headedness
- dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark colored 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 (sometimes with nausea, tiredness, confusion, malaise, convulsions)
- 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)
Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Co-Diovan:
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, purplished-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
Hydrochlorothiazide
Common:
- itchy rash and other types of rash
- reduced appetite
- mild nausea and vomiting
- faintness, fainting on standing up
- impotence.
Rare:
- swelling and blistering of the skin (due to increased sensitivity to sun)
- constipation, discomfort of the stomach or bowels, liver disorders (yellow skin or eyes)
- irregular heart beat
- headache
- sleep disturbances
- sad mood (depression)
- low level of blood platelets (sometimes with bleeding or bruising underneath the skin).
Very rare:
- inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever
- itching or red skin
- blistering of the lips, eyes or mouth
- skin peeling
- fever
- facial rash associated with joint pain
- muscle disorder
- fever (cutaneous lupus erythematosus)
- severe upper stomach pain; lack or low levels of different blood cells
- severe allergic reactions
- difficulty breathing
- lung infection; breathlessness
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.
How To Store Co-Diovan
- Keep out of the reach and sight 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.
- Keep your tablets in their original pack at a temperature below 30ºC.
- 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.
Further Information
What Co-Diovan contains
Co-Diovan 80/12.5 contains 80mg of valsartan and 12.5mg of hydrochlorothiazide. Co-Diovan 160/12.5 contains 160mg of valsartan and 12.5mg of hydrochlorothiazide and Co-Diovan 160/25 contains 160mg of valsartan and 25mg of hydrochlorothiazide.
The tablets also contain the following inactive ingredients: Colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, Macrogol 8000, talc, red iron oxide (E172) and titanium dioxide (E171).
In addition, Co-Diovan 80/12.5 Tablets contain yellow iron oxide (E172), and Co-Diovan 160/25 Tablets contain yellow iron oxide (E172) and black iron oxide (E172).
What Co-Diovan looks like and contents of the pack
Co-Diovan 80/12.5 Tablets are light orange and oval. They are marked HGH on one side and CG on the other. The tablets come in blister packs containing 28, 56 or 98 tablets. Some pack sizes may not be marketed.
Co-Diovan 160/12.5 Tablets are dark red and oval. They are marked HHH on one side and CG on the other. The tablets come in blister packs containing 28, 56 or 98 tablets. Some pack sizes may not be marketed.
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, 56 or 98 tablets. Some pack sizes may not be marketed.
Marketing Authorisation Holder and Manufacturer
The product licence holder is:
Co-Diovan is manufactured by:
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 last approved in December 2009.
Copyright Novartis Pharmaceuticals UK Limited.
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