Valsartan and hydrochlorothiazide
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about DILART HCT.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.alphapharm.com.au.
Those updates may contain important information about the medicine and its use of which you should be aware
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What DILART HCT is used for
DILART HCT is used to control high blood pressure, also called hypertension.
Everybody has blood pressure. This pressure helps get your blood all around your body.
Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.
High blood pressure increases the workload of the heart and blood vessels. If it continues for a long time, it can damage the blood vessels in the brain, heart and kidneys. This can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure reduces the chance of these disorders happening.
DILART HCT contains valsartan and hydrochlorothiazide. These medicines reduce blood pressure in two different ways.
Valsartan blocks the effect of angiotensin II, which is a substance in the body that tightens blood vessels and makes your blood pressure rise. When the effect of angiotensin II is blocked, your blood vessels relax and your blood pressure goes down.
Hydrochlorothiazide helps reduce the amount of excess fluid in the body by increasing the amount of urine produced. This helps lower your blood pressure.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another purpose.
There is not enough information to recommend the use of DILART HCT in children.
This medicine is only available with a doctor's prescription. It is not addictive.
Before you take DILART HCT
When you must not take it
Do not take DILART HCT if you have ever had an allergic reaction after taking:
valsartan or hydrochlorothiazide (the active ingredients in DILART HCT) or sulfonamide-derived medicines (such as some antibiotics eg. Bactrim® trimethoprim and sulfamethoxazole)
any of the other ingredients listed at the end of this leaflet
Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Do not take DILART HCT if you are pregnant or intend to become pregnant.
DILART HCT is not recommended for use in pregnancy. Like other similar medicines, it could affect your unborn baby.
Do not take DILART HCT if you have:
severe kidney or liver disease including biliary cirrhosis
cholestasis, which is reduced or stopped bile flow
anuria, which is a condition where you are unable to urinate
high uric acid levels in the blood, which may cause gout
low level of potassium or sodium, or high level of calcium in your blood
Check with your doctor if you are unsure if you have any of the above conditions.
Do not take DILART HCT if you are also taking other blood pressure lowering medicines containing aliskiren and have type 2 diabetes.
Do not take DILART HCT after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Before you start to take it
Tell your doctor if you have/have had any of the following health problems/medical conditions:
kidney problems
liver problems
systemic lupus erythematosus, a disease affecting the skin, joints and kidneys
heart problems, including obstructed blood flow from narrowing of valves (stenosis) or enlarged septum (HOCM)
high cholesterol levels
diabetes
swelling, mainly of the face and throat, while taking other medicines (including an ACE inhibitor or aliskiren)
primary hyperaldosteronism (Conn's syndrome), a hormone disorder causing fluid retention
passing less urine than is normal for you or difficulty passing urine
recent excessive vomiting or diarrhoea
salt restricted diet
Your doctor may want to take special precautions if you have any of the above conditions.
Tell your doctor if you are breast-feeding a baby. Ask your doctor about the risks and benefits of taking DILART HCT in this case.
Hydrochlorothiazide is known to pass into the breast milk, however it is not known if valsartan passes into the breast milk. Therefore DILART HCT is not recommended if you are breast-feeding.
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Your doctor will want to know if you are prone to allergies.
If you have not told your doctor about any of these things, tell them before you take DILART HCT.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and DILART HCT may interfere with each other. These include:
medicines used to treat high blood pressure and some other heart conditions including fluid tablets or diuretic medicines, ACE-inhibitors, aliskireb and beta blockers
non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis
tablets, preparations or supplements which contain potassium
some antibiotics (rifamycins), anti-rejection drugs (cyclosporin), antiretrovirals (ritonavir) which may increase the effect of valsartan
medicines or supplements containing calcium
vitamin D
other medicines that raise blood pressure
medicines used to relax muscles before or during surgery
steroid medicines such as cortisone, prednisone and ACTH
lithium, antidepressants, antipsychotics, medicines used to treat mood swings and some types of depression
medicines used to treat heart problems
cyclophosphamide or methotrexate
penicillin
amphotericin, a medicine used to treat fungal infections
insulin and tablets used to treat diabetes
medicines used to treat gout
cyclosporin
carbamazepine (a drug used to treat epilepsy, bipolar disorders, neuralgia and other conditions)
medicines used to lower cholesterol (e.g. cholestyramine)
amantadine, a medicine used to treat Parkinson's disease or to prevent influenza
anticholinergic medicines, which are used to treat Parkinson's disease, relieve stomach cramps, spasms and prevent travel sickness
carbenoxolone, a medicine used to treat stomach ulcers
antiarrhythmics and digitalis glycosides, medicines used to treat irregular heart beats
tetracycline, a medicine used to treat some infections
alcohol
sleeping tablets
radioactive iodine, used as a medical tracer or diagnosis
Your doctor and pharmacist have a more complete list of medicines to be careful of while taking DILART HCT.
How to take DILART HCT
Follow carefully all directions given to you by your doctor and pharmacist.
These instructions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How much to take
The usual dose is 80/12.5 mg, 160/12.5 mg or 320/12.5 mg once a day. If your blood pressure is still too high after 4 weeks, your doctor may increase the dose to 160/25 mg or 320/25 mg once a day.
When to take it
When you take the first dose from the pack of DILART HCT, take the one marked with the correct day of the week (e.g. if it is Wednesday, take the dose from the section of the foil marked Wednesday).
DILART HCT comes in a calendar pack with the days of the week marked on it to help you remember to take your medicine each day.
Take your DILART HCT dose at the same time each day.
This also helps you remember to take it, especially if you take it as part of your usual routine (e.g. at breakfast time). This medicine will keep working for the whole 24 hours until the next dose is due.
How to take DILART HCT
Swallow the tablet with a full glass of water. Always take DILART HCT the same way in relation to food.
It does not matter if you take DILART HCT after food or on an empty stomach, as long as you take it the same way each day.
If your stomach is upset after taking DILART HCT, always take it after a meal (e.g. breakfast).
How long to take it
Take this medicine until your doctor tells you to stop even if you feel quite well.
People who have high blood pressure often feel well and do not notice any signs of this problem.
It will take at least 4 weeks for this medicine to have its full effect. After that, it can be continued for as long as needed to control your blood pressure.
If you forget to take it
If it is almost time for your next dose, skip the missed dose and take the next one when you are meant to.
Otherwise, take the dose as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone number: 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much DILART HCT. Do this even if there are no signs of discomfort or poisoning.
Keep the telephone numbers for these places handy.
Too much DILART HCT may make you feel dizzy, light headed or faint. You may experience rapid, shallow breathing or cold, clammy skin. Your heartbeat may be faster than usual. This is because your blood pressure is too low.
While you are taking DILART HCT
Things you must do
If you become pregnant while taking DILART HCT, tell your doctor immediately.
You should not take this medicine while you are pregnant.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.
Be sure to keep all of your doctor's appointments so that your progress can be checked. Do this even if you feel well.
People with high blood pressure often do not notice any signs of this problem. But it is important to keep track of your progress. Your doctor will want to check your blood pressure regularly to make sure the medicine is working. Your doctor will also check your kidney and liver function from time to time to prevent unwanted side effects.
If you are going to have surgery, tell your doctor and anaesthetist that you are taking DILART HCT.
DILART HCT may affect some medicines you receive during surgery.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking DILART HCT.
Tell any other doctor, dentist or pharmacist who treats you that you are taking DILART HCT.
Things you must not do
Do not use DILART HCT to treat any other complaints unless your doctor says you can.
Do not give this medicine to anyone else, even if their condition seems to be similar to yours.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert while you are taking DILART HCT until you know how it affects you.
This medicine can cause tiredness, sleepiness or dizziness in some people. If you have these symptoms, do not drive or do anything else that could be dangerous.
If this medicine makes you feel dizzy or light-headed, be careful when getting up from a sitting or lying position.
Dizziness can usually be prevented by getting up slowly and flexing leg muscles and toes to get the blood flowing. When getting out of bed, dangle your legs over the side for a minute or two before standing up.
When you are outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use a sunlamp.
This medicine may cause your skin to be much more sensitive to sunlight than it normally is.
Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If your skin does appear to be burning, tell your doctor.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DILART HCT, even if you do not think it is connected with the medicine.
All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of these side effects and they worry you:
headache
dizziness, spinning sensation, blurred vision
sleepiness, tiredness or weakness
pain in the back or joints
runny or bleeding nose or congested sinuses
dry cough, sore throat or hoarse voice
dry mouth
diarrhoea, constipation or wind
nausea (feeling sick), vomiting, loss of appetite, stomach upset or indigestion
back pain, muscle pain, muscle tenderness or weakness, cramps or joint pain
tingling or numbness in hands or feet
blistering skin
symptoms of sunburn which happens more quickly than normal
difficulty sleeping
feeling anxious or sad
dizziness on standing up, especially when getting up from a sitting or lying position
problems with sexual function
pain when passing urine, frequent urge to urinate
hair loss
facial pain
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or troubled breathing
feeling of fast or irregular heart beat (pounding, racing, skipping beats)
chest pain
tiredness or lack of energy, being short of breath when exercising, dizziness and looking pale
constant "flu-like" symptoms such as chills, fever, sore throat, aching joints, sores in mouth, swollen glands
pain in the stomach, often accompanied by nausea and vomiting
signs of a serious skin reaction such as painful red areas, large blisters, peeling of layers of skin, bleeding in the lips, eyes, mouth, nose or genitals. These signs may be accompanied by fever and chills, aching muscles and feeling generally unwell
unusual bleeding or bruising under the skin
severe dizziness or fainting
passing less urine than normal
liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine
decrease in vision or pain in your eyes
The above side effects are rare, but may be serious. You may need urgent medical attention.
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may get other side effects of DILART HCT.
After taking DILART HCT
Storage
keep your tablets in the original container until it is time to take them.
store them in a cool dry place below 25°C (room temperature).
do not store DILART HCT or any other medicine in the bathroom or near a sink.
do not leave DILART HCT in the car or on window sills.
Heat and dampness can destroy some medicines. DILART HCT will keep well if it is cool and dry.
Keep medicines where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking DILART HCT, or it has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.
Product description
What it looks like
DILART HCT 80/12.5 tablets are a light orange, film-coated, oval, biconvex tablet debossed with VH 1 on one side of the tablet and M on other side.
DILART HCT 160/12.5 tablets are a reddish, film-coated, oval, biconvex tablet debossed with VH 2 on one side of the tablet and M on other side.
DILART HCT 160/25 tablets are a brown, film-coated, oval, biconvex tablet debossed with VH 3 on one side of the tablet and M on other side.
DILART HCT 320/12.5 tablets are a pink, film-coated, oval, biconvex tablet debossed with VH 4 on one side of the tablet and M on other side.
DILART HCT 320/25 tablets are a yellow, film-coated, oval, biconvex tablet debossed with VH 5 on one side of the tablet and M on other side.
Each blister pack contains 28 tablets.
Ingredients
DILART HCT tablets contain 80 mg, 160 mg or 320 mg of valsartan and 12.5 mg or 25 mg of hydrochlorothiazide as the active ingredient.
The tablets contain the following non active ingredients:
colloidal anhydrous silica
sodium lauryl sulphate
crospovidone
povidone
magnesium stearate
microcrystalline cellulose
pregelatinised maize starch
lactose
Opadry II complete film-coating system 03F84793 pink (ARTG no. 107334) [80/12.5 tablets].
Opadry II complete film-coating system 03B57310 brown (ARTG no. 107338) [160/12.5 tablets].
Opadry II complete film-coating system 03F86873 brown (ARTG no. 107335) [160/25 tablets].
Opadry II complete film-coating system 03F84782 pink (ARTG no. 107336) [320/12.5 tablets].
Opadry II complete film-coating system 03F82965 yellow (ARTG no. 107337) [320/25 tablets].
DILART HCT contains lactose.
DILART HCT does not contain gluten, sucrose, tartrazine or any other azo dyes.
