Consumer Medicine Information
Consumer Medicine InformationWhat is in this leaflet
1. What Micardis Plus is used for
2. Before you take Micardis Plus
1. When not to take Micardis Plus
2. Before you start to take Micardis Plus
3. Taking Micardis Plus
1. How much Micardis Plus to take
2. How to take Micardis Plus
3. If you forget to take a dose
4. How long to take Micardis Plus
5. If you take too much Micardis Plus (overdose)
4. While you are taking Micardis Plus
1. Things you must do
2. Ability to drive or operate machinery
5. Side effects
6. After taking Micardis Plus
7. 7.Product description
1. What Micardis Plus is
Micardis® Plus is a registered trademark of Boehringer IngelheimThis leaflet answers some common questions about Micardis Plus. It does not contain all available information.It does not take the place of talking to your doctor or pharmacist.Keep this information with your Micardis Plus tablets. You may need to read it again later.
To find out more about Micardis Plus
Ask your doctor or pharmacist if you have any questions about your medicine or if you have any trouble before, during or after using Micardis Plus.
1. What Micardis Plus is used forMicardis Plus lowers high blood pressure, also called hypertension.Everyone has blood pressure. This pressure helps your blood move 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 when your blood pressure stays higher than normal, even when you are calm or relaxed.There are usually no signs of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. You may feel fine and have no symptoms, but if high blood pressure is not treated, it can lead to serious health problems (such as heart disease).Micardis Plus helps to lower your blood pressure but does not cure hypertension.Micardis Plus contains telmisartan and hydrochlorothiazide. Both medicines reduce blood pressure in different ways. Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. It works by widening the blood vessels of the body, and therefore helping to lower your blood pressure.Hydrochlorothiazide belongs to the group of medicines called diuretics. Diuretics cause an increase in the volume of urine. They also help with lowering blood pressure particularly when combined with other blood pressure reducing medicines.Micardis Plus may be used either alone or in combination with other medicines used to treat high blood pressure.Micardis Plus may have been prescribed for you for another reason.Ask your doctor if you have any questions about why Micardis Plus has been prescribed for you.2. Before you take Micardis Plus 2a) When not to take Micardis Plus
Only take Micardis Plus if it has been prescribed for you by a doctor.
Never give it to someone else even if their symptoms seem to be the same as yours.
Do not take Micardis Plus if you are allergic to telmisartan, hydrochlorothiazide, sulfonamide-derived medicines or to any of the other ingredients in Micardis Plus.
These ingredients are listed in full at the end of this leaflet.If you are uncertain as to whether you have these allergies you should raise those concerns with your doctor.Do not take Micardis Plus if you suffer from:
severe liver disease
severe kidney disease
cholestasis or biliary obstructive disorders (problem with the flow of bile from the gall bladder)
low potassium levels in the blood
high calcium levels in the blood.
Do not take Micardis Plus if you have rare hereditary condition of fructose intolerance.
The maximum recommended daily dose of Micardis Plus contains 169 mg of sorbitol (in the 40/12.5 mg tablets) and approximately 338 mg of sorbitol (in the 80/12.5 mg and 80/25 mg tablets).Do not take Micardis Plus if you have rare hereditary condition of galactose intolerance.
The maximum recommended daily dose of Micardis Plus contains 112 mg of lactose (in the 40/12.5 mg and 80/12.5 mg tablets) and 99 mg of lactose (in the 80/25 mg tablets).If you are uncertain as to whether you have these conditions you should raise those concerns with your doctor.Do not take Micardis Plus if you are pregnant or breastfeeding.Do not take Micardis Plus after the EXPIRY DATE on the carton or blister strips has passed.Do not take Micardis Plus if the packaging is torn or shows signs of tampering.2b) Before you start to take Micardis Plus
It is essential that your doctor knows your medical history before prescribing Micardis Plus.Before taking Micardis Plus, tell your doctor if you have, or have had, any of the following conditions:
a kidney transplant
primary aldosteronism, also known as Conn’s syndrome
a low salt diet
recent severe diarrhoea or vomiting
have a history of allergy or asthma
If you are uncertain as to whether you have, or have had, any of these conditions you should raise those concerns with your doctor.Before taking Micardis Plus it is advisable to tell your doctor if you are taking any other medicines, obtained with or without a doctor's prescription. In particular, tell your doctor if you are taking:
any other medicines used to treat high blood pressure
lithium, a medicine used to treat certain mental illnesses
other diuretics or fluid tablets
potassium tablets (potassium supplements)
potassium containing salt substitutes
medicines or salt substitutes which may increase your potassium levels
heart medicines such as digoxin, a medicine used to treat heart failure or antiarrhythmic medicines
strong pain killing medicines
medicines for diabetes (oral tablets or capsules or insulin)
powder or granules used to help reduce cholesterol
corticosteroid medicines such as prednisolone, cortisone or ACTH
nonsteroidal anti-inflammatory agents (medicines used to relieve pain, swelling and other symptoms of inflammation including arthritis)
medicines used to treat gout
calcium supplements or medicines containing calcium
beta-blockers (a type of medicine used to treat high blood pressure or other heart conditions)
anticholinergic medicines, which can be used to treat Parkinson’s disease, relieve stomach cramps or prevent travel sickness
amantadine, a medicine used to treat Parkinson’s disease or to prevent influenza
medicines used to treat cancer (cytotoxic medicines)
These medicines may be affected by Micardis Plus, or may affect the way it works. Also, other medicines used to treat high blood pressure may have an additive effect with Micardis Plus in lowering your blood pressure. Therefore, you may need different amounts of your medicines.Your doctor or pharmacist will be able to tell you what to do if you are taking Micardis Plus with other medicines.2c) Pregnancy
Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your course of medication.Micardis Plus should not be taken if you are pregnant.2d) Breastfeeding
Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course of your medication.Micardis Plus should not be taken if you are breastfeeding. 2e) Children
Micardis Plus is not recommended for use in children and teenagers up to 18 years of age.3. Taking Micardis Plus 3a) How much Micardis Plus to take
The usual recommended dose for adults is one Micardis Plus 40/12.5 mg tablet once a day. If your blood pressure is still too high after 4-8 weeks of starting treatment, your doctor may increase your dose to one Micardis Plus 80/12.5 mg tablet once a day.If your blood pressure is still not satisfactorily controlled with Micardis Plus 80/12.5 mg, your doctor may increase your dose to one Micardis Plus 80/25 mg tablet once a day.Follow all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet. The amount of Micardis Plus you have to take will depend on your condition and whether or not you are taking any other medicines.
3b) How to take Micardis Plus
Take Micardis Plus at about the same time each day.Micardis Plus should be swallowed with a glass of water.Micardis Plus can be taken with or without food. Do not take extra doses of Micardis Plus without consulting your doctor.3c) If you forget to take a dose
It is important to take Micardis Plus as directed. If you miss a dose, take it as soon as you remember. However, if you remember when it is almost time for your next dose, take only your usual dose at that time. Do not take a double dose of Micardis Plus to make up for a dose that you missed.3d) How long to take Micardis Plus
Micardis Plus helps control your high blood pressure but does not cure it. Therefore Micardis Plus must be taken every day.Continue taking Micardis Plus for as long as your doctor prescribes it.3e) If you have taken too much Micardis Plus (overdose)
Seek medical advice if you have taken more than the recommended or prescribed dose of Micardis Plus.Advice can be provided by a doctor, pharmacist or Poisons Information Centre (telephone 13 11 26).Signs of overdose may include increased or slower heart rate, low blood pressure (dizziness, lightheadedness), dehydration, nausea, drowsiness and muscle spasm.4. While taking Micardis Plus 4a) Things you must do
Tell your doctor immediately if you become pregnant while taking Micardis Plus.Tell your doctor or pharmacist if you begin using any other medicine while you are taking Micardis Plus.If you feel dizzy or lightheaded, and you wish to stand up, you should do so slowly.You may feel dizzy or lightheaded when you begin to take Micardis Plus, especially if you are also taking a diuretic or fluid tablet. If this problem occurs, talk to your doctor.If you exercise, or if you sweat, or if the weather is hot, you should drink plenty of water.If you plan to have surgery or other treatment (even at the dentist) that needs an anaesthetic, make sure you tell your doctor or dentist that you are taking Micardis Plus.4b) Ability to drive or operate machinery
It is advisable to be careful when driving or operating machinery until you know how Micardis Plus affects you. It is always possible that Micardis Plus, like other medicines used to treat high blood pressure, may cause dizziness or drowsiness in some people.
When taken as recommended, and when there are no side effects, Micardis Plus is not known to have any effect on the ability to drive or operate machinery.5. Side effectsYou should be aware that all prescription medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing. Your doctor has weighed the risks of you taking Micardis Plus against the benefits they expect it will have for you.Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of using this medicine.Most side effects of Micardis Plus are mild and temporary. The overall frequency of side effects reported by patients taking Micardis Plus is similar to patients taking a placebo (sugar tablet).The following side effects have been reported by patients taking Micardis Plus. It is not known if these side effects are caused by Micardis Plus:
fainting, dizziness or spinning sensation
a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache (sinusitis)
infections of the air passages
shortness of breath or difficulty breathing
abnormal or blurred vision
changes in heart rhythm or increased heart rate
rash or redness or itchiness of skin
dizziness or lightheadedness when you stand up (postural hypotension)
stomach pain or discomfort (abdominal pain, dyspepsia, gastritis)
wind or excessive gas in the stomach or bowel
diarrhoea or constipation
pins and needles
sleep disturbances or trouble sleeping
leg pain or cramps in legs
aching muscles or aching joints not caused by exercise or muscle spasms
changes in the levels of potassium or sodium or uric acid in your blood (such changes are usually detected by a blood test)
Tell your doctor as soon as possible if you experience any side effects during or after taking Micardis Plus, so that these may be properly treated. Symptoms such as feeling very thirsty, sleepy, sick or vomiting, a dry mouth, general weakness, muscle pain or cramps, a very fast heart rate, may mean that the hydrochlorothiazide part of Micardis Plus is having an excessive effect. You should tell your doctor if you experience any of these symptoms.
If any of the following happens, stop taking Micardis Plus and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettle rash
These are rare but serious side effects and may indicate a severe allergic reaction. You may need urgent medical attention or hospitalisation.In addition, other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything unusual, during or after taking Micardis Plus.6.After taking Micardis Plus 6a) Storage
Leave the tablets in the blister strip until it is time to take a dose. The blister pack protects the tablets.
Micardis Plus should be kept in a cool, dry place where the temperature stays below 25 deg C.Do not store in direct sunlight or heat. For example, do not leave Micardis Plus in the car on hot days.
Keep Micardis Plus where young children cannot reach it.6b) Disposal
If you have been told by your doctor that you will not be needing Micardis Plus anymore, or the tablets have passed their expiry date, the unused medicine should be returned to your pharmacist so that it can be disposed of safely.7. Product Description7a) What Micardis Plus is
Micardis Plus is the brand name of your medicine. Micardis Plus tablets are available in three strengths: 40/12.5 mg, 80/12.5 mg and 80/25 mg tablets.Micardis Plus 40/12.5 mg tablets are red and white oval shaped two layer tablets. The white face is marked with the Boehringer Ingelheim logo and ‘H4’.
Micardis Plus 80/12.5 mg tablets are red and white oval shaped two layer tablets. The white face is marked with the Boehringer Ingelheim logo and ‘H8’.
Micardis Plus 80/25 mg tablets are yellow and white oval shaped two layer tablets. The white face is marked with the Boehringer Ingelheim logo and ‘H9’.
Micardis Plus tablets are available in blister packs of 28 tablets.The following Australian Registration Numbers appear on the carton:
AUST R 82416 for Micardis Plus 40/12.5 mg tablets
AUST R 82418 for Micardis Plus 80/12.5 mg tablets
AUST R 143761 for Micardis Plus 80/25 mg tablets
Each Micardis Plus 40/12.5 mg tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.Each Micardis Plus 80/12.5 mg tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.Each Micardis Plus 80/25 mg tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide. The other ingredients found in the tablets are:
iron oxide red CI77491 (in Micardis Plus 40/12.5 mg tablets and Micardis Plus 80/12.5 mg tablets)
iron oxide yellow CI77492 (in Micardis Plus 80/25 mg tablets)
sodium starch glycollate type A
Micardis Plus tablets are made in Germany and supplied in Australia by:
BOEHRINGER INGELHEIM PTY LIMITED
(ABN 52 000 452 308)
78 Waterloo Road
NORTH RYDE NSW 2113
This leaflet was prepared on 9 May 2002 and updated on 19 August 2008.© Boehringer Ingelheim Pty Limited 2008