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CO-VALSARTAN 80/12.5MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

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Co-Diovan® 80/12.5mg Tablets

1346
27.04.16[15]

(valsartan/hydrochlorothiazide)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Co-Diovan 80/12.5mg Tablets but will be
referred to as Co-Diovan throughout this leaflet.
What is in this leaflet:
1. What Co-Diovan is and what it is used for
2. What you need to know before you take Co-Diovan
3. How to take Co-Diovan
4. Possible side effects
5. How to store Co-Diovan
6. Contents of the pack and other information
1. 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.
2. 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 CoDiovan 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 called aliskiren.
If any of the above apply to you, tell your doctor and do not take CoDiovan.
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 pressurelowering 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 an increase of pressure in your eye and can happen within
hours to a week 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:
- an ACE inhibitors (for example enalapril, lisinopril, Ramipril), in
particular if you have diabetes-related kidney problems.
- aliskiren
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 CoDiovan.
- 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 Co-Diovan” 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.
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 breastfeeding
Co-Diovan is not recommended for mothers who are breast-feeding, and
your doctor may choose another treatment for you if you wish to breastfeed, 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.
3. 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. 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.
4. 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 angle-closure 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 coloured 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

- 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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE CO-DIOVAN
- Keep out of the sight and reach 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.
- Do not store above 30°C. Store in the original package to protect from
moisture.
- 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-Diovan contains
Each Co-Diovan film-coated tablet contains 80mg of valsartan and 12.5mg
of hydrochlorothiazide.
Co-Diovan also contains the following inactive ingredients: colloidal
anhydrous silica, crospovidone, hypromellose, magnesium stearate,
microcrystalline cellulose, talc, macrogol 8000, red iron oxide (E 172),
yellow iron oxide (E 172) and titanium dioxide (E 171).
What Co-Diovan looks like and contents of the pack
Co-Diovan tablets are oval, non-divisible, film-coated tablets, coloured light
orange and imprinted with ‘HGH’ on one side and ‘CG’ on the other side.
Co-Diovan comes in calendar blister packs of 28 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Novartis Farma S.p.A., Via Proviniciale Schito 131, 80058
Torre Annunziata (NA), Italy and is procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/1346

Leaflet revision and issue date (Ref) 27.04.16[15]
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

Co-Diovan is registered trademark of Novartis AG.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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