Co – Diovan ® 25 mg Tablets

Your medicine is called CO - DIOVAN and is available as a film - coated tablet. CO - DIOVAN contains 2 medicines, valsartan (80 mg, 160 mg or 320 mg) and hydrochlorothiazide (12,5 or 25 mg).

WHAT CO - DIOVAN IS USED FOR: CO - DIOVAN contains valsartan which is an angiotensin - II receptor antagonist and hydrochlorothiazide which is a diuretic, both these medicines together help control high blood pressure. CO - DIOVAN is used to treat mild to moderate high blood pressure.

BEFORE YOU TAKE CO - DIOVAN: Follow your doctor’s instructions carefully. They may differ from the general instructions in this leaflet.

Do not take CO - DIOVAN:

• if you have had any unusual or allergic reaction to valsartan or to hydrochlorothiazide or related sulfonamides or to any other component of CO - DIOVAN listed at the beginning of this leaflet. If you are not sure which medicines to avoid, ask your doctor or pharmacist;
• If you have a history of any type of angioedema (is the rapid swelling (oedema) of the skin, face, tongue, lips and throat);
• If you ever had a swelling mainly of the face and throat while taking other medicines (including an ACE - inhibitor). If you get those symptoms, stop taking CO - DIOVAN and contact your doctor straight away. You should never take CO - DIOVAN again;
• If you are suffering from heart failure or have experienced a heart attack.
• if you have too low a level of potassium or sodium in your blood, or if you have too high a level of calcium in your blood despite treatment;
• if you have gout;
• If you are pregnant, planning to become pregnant or breastfeeding your baby;
• If you suffer from severe kidney disease.
• If you suffer from liver disorders or from a severe liver disease with destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the builds up bile in the liver (cholestasis);
• If you have porphyria, (porphyrias are a group of inherited or acquired disorders of certain enzymes or chemicals in the blood product manufacturing system);
• If you have aortic stenosis (valvular heart disease caused by the incomplete opening of the aortic valve) or hypertrophic obstructive cardiomyopathy (a disease of the myocardium (the muscle of the heart) ) in which a portion of the myocardium is hypertrophied (thickened);
• If you use lithium;
• If you use potassium sparing diuretics (any medicine that elevates the rate of urination and thus provides a means of forced diuresis) such as spironolactone, triamterene, amiloride;
• If you are treated with an ACE - inhibitor or another class of medicine e.g. aliskiren;
• If you have Addison’s disease (a rare endocrine (system of glands that secrete hormones that regulate the body) disorder wherein the adrenal glands (triangular shaped glands on top of the kidneys) produce insufficient steroid hormones (glucocorticoids and often mineralocorticoids);
• If you have acute angle - closure glaucoma, or if you are experiencing a decrease in vision or eye pain;
• If you suffer from severe kidney disease with being unable to produce urine (anuria);
• If you have serious kidney impairment and are elderly, do not take CO - DIOVAN with fluoroquinolones.

Take special care with CO - DIOVAN:

• If you have liver or kidney disease;
• If you have diabetes (high blood sugar);
• If you have fever, rash, and joint pain, which may be signs of lupus erythematosus (or a history of this disease);
• If you have low levels of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, convulsions);
• If you have low levels of potassium in your blood;
• If you have high levels of cholesterol in your blood;
• If you are suffering from vomiting or diarrhoea, or taking high doses of a diuretic (water pill);
• If you are treated with an ACE - inhibitor or aliskiren;
• If you have non - melanoma skin cancer (appearance of a lump or discoloured patch on the skin that continues to persist after a few weeks);
• If you are using fluoroquinolones (a type of antibiotic) as this may precipitate acute kidney injury.

If any of the following apply to you, tell your doctor before you take CO - DIOVAN.

Taking CO - DIOVAN with food and drink: CO - DIOVAN can be taken with or without food. Do not crush or chew the tablets, it should be swallowed whole with a glass of water.

Pregnancy and Breastfeeding: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Pregnant women: Do not take CO - DIOVAN if you are pregnant. Use of CO - DIOVAN may cause serious harm to the unborn child. It is therefore important to check with your doctor immediately if you think you are pregnant or are planning to become pregnant.

Breast - feeding mothers: You should not breast feed while taking CO - DIOVAN.

Driving and using machinery: CO - DIOVAN may cause dizziness and affect the ability to concentrate. So before you drive a vehicle, use machinery, or carry out other activities that require concentration, make sure you know how you react to the effects of CO - DIOVAN.

Taking other medicines with CO - DIOVAN (i.e., interactions): Always tell your healthcare professional if you are taking any other medicine. If you are taking medicines on a regular basis (including complementary or traditional medicines), concomitant use of the medicine may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional, for advice. Remember also those not prescribed by a doctor (including complementary or traditional 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 used to lower blood pressure, especially ACE - inhibitors or aliskiren;
• potassium - sparing medicines (water tablets), such as spironolactone, triameterone, amiloride, potassium supplements, or salt substitutes containing potassium;
• cortisone - like medicines, steroids;
• carbenoxolone (a medicine used to treat ulceration and inflammation);
• antibiotics such as penicillin G, amphothericine, antidysrrhythmics (medicines used to treat heart problems);
• allopurinol (medicine used to treat gout);
• amantadine (medicine to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses);
• anticholinergic agents (medicines used to treat symptoms of stomach cramps, bladder spasm, asthma, motion sickness, and muscular spasms);
• ciclosporin (a medicine used in transplantation and in autoimmune disorders);
• lithium, a medicine used to treat some psychological conditions;
• antiepileptics, such as carbamazepine (used to treat convulsions);
• medicines used to relieve pain or inflammation, especially non - steroidal anti - inflammatory drugs (including aspirin);
• digoxin (a heart medicine);
• insulin or antidiabetic medicines taken by mouth;
• cholestyramine and colestipol, resins used mainly to treat high levels of lipids in the blood;
• vitamin D and calcium salts;
• Cytotoxic medicines, methyldopa, ciclosporin, barbituates and narcotics;
• Using medicines known as fluoroquinolones and CO - DIOVAN together, and have moderate to severe renal impairment and are an elderly patient. Use of these medicines together may precipitate acute kidney injury.

Avoid alcohol until you have talked to your doctor. Alcohol may make blood pressure fall more and/or increase the possibility of dizziness or fainting.

Older people (age 65 and over): You can also use CO - DIOVAN if you are 65 years of age or older.

Children and adolescents (below the age of 18 years): There is no experience with CO - DIOVAN in children and adolescents.

Do not share medicines prescribed for you with others. Do not exceed the recommended dosage. CO - DIOVAN is for oral use only.

How much CO - DIOVAN to take: Your doctor will tell you exactly how many tablets of CO - DIOVAN to take. To treat high blood pressure the usual dosage is one CO - DIOVAN (80/12,5 mg) or CO - DIOVAN 160 (160/12,5 mg) or CO - DIOVAN (320/12,5 mg) or CO - DIOVAN (320/25 mg) tablet once a day. Your doctor will tell you exactly how long you will need to take the tablets.

How long to take CO - DIOVAN: Your doctor will tell you exactly how long you will need to take the tablets.

If you take more CO - DIOVAN than you should: If you experience severe dizziness and/or fainting, unusual tiredness, weakness or muscle cramps, or irregular heartbeats, tell your doctor as quickly as possible. In the event of over dosage, consult your doctor or pharmacist. If neither is available, rush the patient to the nearest hospital or poison control centre.

If you forget to take CO - DIOVAN: It is advisable to take your medicine at the same time each day, preferably in the morning. However, if you forget to take a dose of CO - DIOVAN, carry on with the next one at the usual time. Do not take a double dose to make up for the forgotten tablet.

Effects when treatment with CO - DIOVAN is stopped: Stopping your treatment with CO - DIOVAN may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.

CO - DIOVAN can have side effects. Not all side - effects reported for CO - DIOVAN are included in this leaflet. Should your general health worsen while taking CO - DIOVAN, please consult your doctor, pharmacist or other health care professional for advice.

Tell your doctor immediately or go to the nearest casualty department at your nearest hospital if you notice any of the following:

• Breathlessness (possible symptoms of non - cardiogenic pulmonary oedema)
• Sudden loss of consciousness (possible symptoms of syncope)
• Severely decreased urine output (possible symptoms of impaired renal function)
• Fever, sore throat or mouth ulcers due to infections (possible symptoms of neutropenia)
• Muscle weakness, muscle spasms, abnormal heart rhythm (possible symptoms of low level of potassium in blood)
• Tiredness, confusion, muscle twitching, convulsions (possible symptoms of hyponatremia)
• Allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing( angioedema)

These are all serious side effects. If you get any of these, tell your doctor straight away. You may need urgent medical attention.

Some side effects are Less Frequent:

• Non - melanoma skin cancer (appearance of a lump or discoloured patch on the skin that continues to persist after a few weeks)
• Thirst, low urine output, dark urine, dry flushed skin, irritability (possible symptoms of dehydration)
• Tingling or numbness (possible symptoms of paraesthesia)
• Vision disorders
• Tiredness
• Cough
• Muscle pain
• Noises in ears
• Dizziness, light headedness (possible symptoms of hypotension)

Tell your doctor if you notice any of the following:

• Decreased level of hemoglobin and decrease of the percentage of blood cells in the blood (which can, in severe cases lead to anaemia), unusual bleeding or bruising (thrombocytopenia);
• Weakness, bruising and frequent infections (possible signs of pancytopenia, bone marrow depression).
• Pale skin, tiredness, breathlessness and dark urine (possible signs of haemolytic anaemia).
• High levels of sugar in the blood (hyperglycaemia, glycosuria).
• Facial rash, joint pain, muscle disorder, fever (possible signs of Systemic Lupus Erythematosus).
• headache, insomnia, fainting on standing up, drowsiness (somnolence), spinning sensation (vertigo), sleep disorder, depression.
• chest pain, fast heart beat (tachycardia), irregular heartbeat (possible signs of dysrrhythmia).
• cough with phlegm together with chest pain and fever (bronchitis or bronchitis acute), nose bleeds (epistaxis), flu (influenza), blocked nose (nasal congestion), nasopharyngitis, otitis media, palpitations, sore throat (pharyngolaryngal pain), pollakiuria, fever (pyrexia), feeling of pressure pain in the cheeks and forehead (sinusitis), sinus congestion.
• diarrhoea, stomach discomfort after meal (dyspepsia), dry mouth, gastroenteritis, nausea, severe upper stomach pain (possible signs of pancreatitis), decreased appetite.
• yellow eyes and skin (cholestasis or jaundice).
• excessive sweating (hyperhidrosis), decreased skin sensitivity (hypoesthesia), swelling (oedema), swollen hands, ankles or feet (edema peripheral), pain in extremity, purplish - red spots with fever and itching (vasculitis), purple skin patches (possible signs of thrombocytopenia, purpura), itchy rash or other forms of rash (uticuria).
• red skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of Toxic Epidermal Necrolysis, erythema multiforme).
• Joint pain, abdominal pain, abdominal pain upper, anxiety, weakness (asthenia), back pain, ligament sprain, muscle spasms, muscle strain, neck pain.
• Confusion, tiredness, muscle twitching and spasm, rapid breathing (possible signs of hypochloraemic alkalosis).
• High levels of lipids in your blood (hyperlipidaemia), low levels of magnesium in your blood (hypomagnesaemia), high levels of uric acid in your blood (hyperuricaemia).
• inability to achieve or maintain an erection (erectile dysfunction).
• upper respiratory tract infections, urinary tract infections, viral infections.
• fever, sore throat, more frequent infections (possible signs of agranulocytosis).

If any of these affects you severely, tell your doctor.

Also reported (frequency unknown: frequency cannot be estimated from the available data):

• Abnormal kidney function test results (possible symptoms of serum uric acid or creatinine or blood urea nitrogen increased).
• Abnormal liver function test results (possible symptoms of serum bilirubin increased).

If you notice any other effects not mentioned in this leaflet, please inform your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CO - DIOVAN.

Store at or below 30°C. Protect from moisture. Store your tablets in the original package. Do not take CO - DIOVAN after the expiry date shown on the pack. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Do not use any CO - DIOVAN pack that is damaged or shows signs of tampering. Store all medicines out of the reach of children.