Friday 27 July 2012

Co-Diovan 80mg / 12.5mg Tablets





CO-DIOVAN 80/12.5 mg TABLETS





What You Should Know About Co-Diovan (Valsartan And Hydrochlorothiazide) Tablets


Please read this carefully before you start to take this medicine, even if you have already been using CO-DIOVAN for some time. If you have any questions or are not sure about anything ask your doctor or pharmacist (chemist) for advice.





What’S In Your Medicine


The name of your medicine is CO-DIOVAN and the tablets contain the active ingredients valsartan and hydrochlorothiazide. Valsartan is one of a group of medicines called Angiotensin II Antagonists, hydrochlorothiazide is one of a group of medicines called Diuretics (water tablets). These medicines are used together to lower your blood pressure.


Each tablet contains 80mg of valsartan and 12.5mg of hydrochlorothiazide and come in blister packs containing 28, 56 and 98 tablets.


The tablets also contain the following inactive ingredients: Colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, microcrystaline cellulose, macrogol 8000, talc, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171).




CO-DIOVAN 80/12.5 mg Tablets are manufactured by:



Novartis Pharmaceuticals UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB




The product licence holder is



NOVARTIS PHARMACEUTICALS UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR






Why Does Your Doctor Want You To Use Co-Diovan?


CO-DIOVAN is used to treat high blood pressure (also known as hypertension).


Although you may have no symptoms, it is important to treat this condition because high blood pressure can cause damage to the heart and blood vessels. This damage can increase the risk of a stroke, heart attack, heart failure or kidney failure. Medicines such as CO-DIOVAN can lower the blood pressure to a normal level.


Your doctor may also suggest some changes to your lifestyle so that you can help yourself to reduce your blood pressure. These may include losing weight, stopping smoking, reducing the amount of salt in your diet and the amount of alcohol that you drink, taking regular exercise and avoiding stress. You should always follow your doctor’s advice.





Before Taking Your Medicine


Tell your doctor before you start taking CO-DIOVAN if the answer to any of the following questions is yes:


  • Have you ever had an allergic reaction to valsartan, hydrochlorothiazide or any of the other ingredients of CO-DIOVAN (see “What’s in your medicine”)?

  • Are you pregnant, trying to become pregnant or breast feeding?

  • Do you have any problems with your liver or have you had a disease which may have affected your liver?

  • Do you have any problems with your kidneys or have you had a disease which may have affected your kidneys?

  • Do you suffer from low blood levels of potassium or sodium or high blood levels of calcium?

  • Do you suffer from gout or kidney stones?

  • Do you have difficulty in passing urine?

  • Do you suffer from diabetes? Your doctor may need to alter your dose of insulin or the oral medication you take whilst taking CO-DIOVAN.

  • Do you suffer from systemic lupus erythematosus (SLE)?

  • Have you been told you have low levels of magnesium or chloride in your blood?

  • Do you suffer from high cholesterol levels?

  • Do you suffer from Addison’s disease (a disorder affecting the adrenal gland)? If so and you are not treated for this condition, tell your doctor.

Are you taking any other medicines (either bought or prescribed)? Some medicines can interfere with your treatment, so make sure you check with your doctor or pharmacist before taking any other medicines. In particular, tell your doctor if you are taking any of the following:


  • potassium or calcium supplements

  • salt substitutes containing potassium

  • potassium sparing diuretics (“water tablets” - e.g. spironolactone, triamterene, amiloride)

  • mood stabilisers (e.g. lithium)

  • medicines for diabetes (e.g. glibenclamide, insulin)

  • anti-inflammatory drugs (NSAIDs) for painful conditions (e.g. indometacin or salicylates such as aspirin)

  • anti-cholinergic medicines (e.g. atropine, biperiden)

  • medicines for cancer (e.g. methotrexate, cyclophosphamide)

  • steroids

  • antibiotics (e.g. amphotericin, penicillin)

  • medicines to treat ulcers (e.g. carbenoxolone)

  • medicines for heart problems, high blood pressure that your doctor does not know about (e.g. digoxin, methyldopa)

  • muscle relaxants (curare derivatives such as atracurium or pancuronium)

  • vitamin D, diazoxide, amantadine, allopurinol, cholestyramine, cholestipol, adrenaline, heparin or ciclosporin

Tell your doctor if you suffer from severe or prolonged vomiting or diarrhoea.


Take care when drinking alcohol whilst taking CO-DIOVAN. You may feel dizzy or faint as a result.


If you are going to have an operation requiring an anaesthetic, tell the doctor or dentist in charge that you are taking CO-DIOVAN.


CO-DIOVAN is not suitable for children.




Effects On Driving Or Operating Machinery


During the first few days of treatment your reactions may be impaired (i.e. you may feel drowsy or your reactions may be slower than usual, even if you do not feel drowsy).


You should not take charge of vehicles or machinery until the effect of your medicine on your reactions is known.






Using Your Medicine


Follow the instructions given to you by your doctor. He/she will tell you the correct dose and how often to take it. Usually this will be one CO-DIOVAN tablet, once a day.


Follow your doctor’s instructions exactly and never change the dose yourself.


Remove the tablet from the foil and swallow it whole with a glass of water.




Missed Dose


If you forget to take a dose, take one as soon as you remember, unless it is almost time for you to take your next dose. Then go on as before. Do not take a double dose.





Overdose


If you accidentally take too much of your medicine, tell your doctor immediately or go to your nearest casualty department.






After Taking Your Medicine


Co-Diovan is suitable for most people. However, as with all medicines, it may occasionally cause unwanted effects in a few people.


If you experience any of the following, or any other unusual effects, tell your doctor at the earliest opportunity:


  • dizziness

  • dry mouth and thirst

  • tiredness or weakness

  • sore throat

  • cough

  • diarrhoea

  • chest pain

  • infection of upper airways

  • increase in creatinine in the blood

  • rash accompanied by itching

  • sprains or strains

  • skin swellings

  • muscular weakness

  • increase in heartbeat

  • nausea (feeling sick)

  • vomiting

  • a cold or runny nose

  • indigestion

  • abdominal pain

  • muscular pain or cramps

  • pain in the arms or legs

  • sore joints

  • having to pass urine frequently but sometimes in smaller amounts

  • bladder infection

  • problems with vision

  • viral infection

  • increases or reduction of potassium in the blood

  • swelling due to water retention, usually in lower body

  • disturbance in kidney function

  • decreased libido

Other side-effects that have been seen occasionally with hydrochlorothiazide given on its own are rash, loss of appetite, feeling sick or being sick; impotence; dizziness, faintness or headache when getting up from a sitting or lying position (the risk of this occurring is increased if you drink alcohol or if you have been given an anaesthetic); reduced levels of potassium, sodium, magnesium and chloride in the blood; raised levels of calcium in the blood; changes in the way your body deals with carbohydrates (sugary or starchy foods); raised levels of certain kinds of fats and uric acid levels in the blood.


Side-effects that have been seen rarely with hydrochlorothiazide are constipation, increased sensitivity of the skin to light, headache, diarrhoea, abdominal pain, irregular heartbeat, yellowing of the eyes and skin, sleep disturbances, depression, tingling or numbness in the hands and feet, visual disturbance and a decrease in the number of platelets (a blood cell essential for the clotting of the blood).


Side-effects that have been seen very rarely with hydrochlorothiazide include severe inflammation of the blood vessels (known as necrotising vasculitis), severe skin rashes, inflammation of the pancreas, breathing difficulty (caused by fluid in the lungs or inflammation of the lungs), allergic reactions, anaemia, a reduction in the number of certain types of white blood cells, a persistent sore throat or high temperature or both, or pale skin.





Storing Your Medicine


Do not use this medicine after the expiry date printed on the foil/packet.


Leave your tablets in the original packaging to protect from moisture and only remove them when it is time to take your medicine.


Do not store your tablets above 30°C.


Keep all medicines out of the reach and sight of children. Your medicine could harm them.





LEAFLET REVISED


October 2008




Further Information




REMEMBER:
This medicine is for you. Only a doctor can prescribe it for you. Never give it to anyone else. It may harm them, even if their symptoms appear to be the same as yours.


If you have any further questions, or are unsure about any of the advice in this leaflet, ask your doctor or pharmacist.






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