Diovan HCT

What Diovan HCT 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.

How to take Diovan HCT

Always take this medicine exactly as your doctor has told you. This will help you to get the best results and lower the risk of side effects. 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 recommended 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 medicine, ask your doctor or pharmacist.

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 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
• Severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Decrease in vision or pain in your eyes due to high pressure (possible signs of acute angleclosure glaucoma)
• Fever, sore throat, more frequent infections (agranulocytosis) These side effects are very rare or of frequency not known. If you get any of these symptoms, stop taking Co-Diovan and contact your doctor straight away (see also section 2 “Warnings and precautions”). Side effects include:

Uncommon (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 10,000 people):
• dizziness
• diarrhoea
• joint pain

Not known (frequency cannot be estimated from the available data):
• 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 (may affect up to 1 in 100 people):
• spinning sensation
• abdominal pain

Not known (frequency cannot be estimated from the available data):
• blistering skin (sign of dermatitis bullous)
• 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
• low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases) Hydrochlorothiazide

Very common (may affect more than 1 in 10 people):
• low level of potassium in the blood
• increase of lipids in the blood

Common (may affect up to 1 in 10 people):
• 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 (may affect up to 1 in 1,000 people):
• 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 (may affect up to 1 in 10,000 people):
• inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• 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)
• 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 (frequency cannot be estimated from the available data):
• weakness, bruising and frequent infections (aplastic anemia)
• severely decreased urine output (possible signs of renal disorder or renal failure)
• rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle spasm
• fever (pyrexia)
• weakness (asthenia)

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.

How to Store Diovan HCT

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 carton. The expiry date refers to the last day of that month.
• Do not store above 30ºC. Store in the original package in order to protect from moisture.
• 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.