Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide
Consumer Medicine Information
This leaflet answers some common questions about SEVIKAR HCT. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking SEVIKAR HCT against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
SEVIKAR HCT is used to treat high blood pressure which is sometimes called hypertension.
Everyone has blood pressure. This pressure helps push blood all around your body. Your blood pressure changes 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.
There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.
SEVIKAR HCT contains olmesartan medoxomil, which belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which causes blood vessels to tighten. SEVIKAR HCT blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure.
SEVIKAR HCT also contains amlodipine besilate, a calcium channel blocker. This reduces the movement of calcium into the cells of the heart and blood vessels. This also helps to lower blood pressure as it relaxes the blood vessels and increases the supply of blood and oxygen to the heart.
SEVIKAR HCT also contains hydrochlorothiazide, a diuretic which reduces the amount of fluid in the body. This also helps to lower blood pressure.
Your doctor may have prescribed SEVIKAR HCT for another reason. Ask your doctor if you have any questions about why SEVIKAR HCT has been prescribed for you.
This medicine is available only with a doctor's prescription.
The safety and effectiveness of SEVIKAR HCT in children and teenagers under the age of 18 years have not been established.
SEVIKAR HCT is not addictive.
Do not take SEVIKAR HCT if you have an allergy to:
Symptoms of an allergic reaction to SEVIKAR HCT may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint pain.
Do not take SEVIKAR HCT if:
Do not take SEVIKAR HCT if you are pregnant or breastfeeding. SEVIKAR HCT may enter your womb or it may pass into the breast milk and there is the possibility that your baby may be affected.
If pregnancy is discovered SEVIKAR HCT should be discontinued as soon as possible.
Do not take SEVIKAR HCT after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start taking SEVIKAR HCT, talk to your doctor.
Tell your doctor if you have allergies to:
Tell your doctor if you have or have had any medical conditions, especially the following:
You must also tell your doctor if you:
If you have not told your doctor about any of the above, tell him/her before you start taking SEVIKAR HCT.
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and SEVIKAR HCT may interfere with each other. These include:
These medicines may be affected by SEVIKAR HCT, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.
Other medicines not listed above may also interfere with SEVIKAR HCT. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
The safety and effectiveness of SEVIKAR HCT in children have not been established.
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
Your doctor or pharmacist will tell you which SEVIKAR HCT tablet you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
The dose of SEVIKAR HCT is one tablet to be taken once a day.
Swallow SEVIKAR HCT whole with a full glass of water.
Do not chew the tablets.
Take SEVIKAR HCT at about the same time each day, with or without food. Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets. It does not matter whether you take it with or without food.
SEVIKAR HCT helps control your condition, but does not cure it. Therefore you must take SEVIKAR HCT every day. Continue taking your medicine for as long as your doctor tells you.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much SEVIKAR HCT. Do this even if there are no signs of discomfort or poisoning.
Keep telephone numbers for these places handy.
If you take too much SEVIKAR HCT, you may feel light-headed, dizzy or you may faint. You may also have nausea, drowsiness, muscle spasm and a fast heartbeat.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking SEVIKAR HCT.
Make sure you drink enough water during exercise and hot weather when you are taking SEVIKAR HCT, especially if you sweat a lot. If you do not drink enough water while taking SEVIKAR HCT, you may feel light-headed or sick. This is because your blood pressure is dropping suddenly. If you continue to feel unwell, tell your doctor.
If you have excess vomiting and/or diarrhoea while taking SEVIKAR HCT, tell your doctor. You may lose too much water and salt and your blood pressure may drop too much. You may also have dry mouth, weakness, drowsiness, confusion, muscle pain or cramps and seizures. Tell your doctor immediately if you experience any of these symptoms.
If you feel light-headed or dizzy after taking your first dose of SEVIKAR HCT, or when your dose is increased, tell your doctor immediately.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking SEVIKAR HCT. Your blood pressure may drop suddenly.
If you become pregnant while taking SEVIKAR HCT, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking SEVIKAR HCT. SEVIKAR HCT may interfere with the results of some tests.
Tell your doctor if photosensitivity reaction occurs during your treatment.
Tell your doctor immediately in case of acute onset of decreased visual acuity or ocular pain.
Have your blood pressure checked when your doctor says, to make sure SEVIKAR HCT is working.
Go to your doctor regularly for a check-up. Your doctor may occasionally do a blood test to check your potassium levels and see how your kidneys are working.
Do not give SEVIKAR HCT to anyone else, even if they have the same condition as you.
Do not take SEVIKAR HCT to treat any other complaints unless your doctor or pharmacist tells you to.
Do not stop taking SEVIKAR HCT, or lower the dosage, without checking with your doctor.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.
Be careful driving or operating machinery until you know how SEVIKAR HCT affects you. As with other medicines in this class, SEVIKAR HCT may cause dizziness, light-headedness or tiredness in some people. Make sure you know how you react to SEVIKAR HCT before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive. If you drink alcohol, dizziness or light-headedness may be worse.
Some self-help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SEVIKAR HCT. SEVIKAR HCT helps most people with high blood pressure, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Ask your doctor or pharmacist to answer any questions you may have.
The following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
These are common side effects. They are generally mild.
Tell your doctor as soon as possible if you notice any of the following:
These may be serious side effects. You may need medical attention. Serious side effects are rare.
If any of the following happen, stop taking SEVIKAR HCT and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Keep your tablets in the box until it is time to take them. If you take the tablets out of the box they will not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store SEVIKAR HCT or any other medicine in the bathroom or near a sink.
Do not leave it on a windowsill or in the car on hot days. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking SEVIKAR HCT or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
SEVIKAR HCT tablets come in five strengths and each has a different appearance:
The product is presented in blister packs of 10 or 30 film-coated tablets.
SEVIKAR HCT 20/5/12.5 mg tablet contains iron oxide yellow, red and black.
SEVIKAR HCT 40/5/12.5 mg tablet and SEVIKAR HCT 40/5/25 mg tablet contains iron oxide yellow.
SEVIKAR HCT 40/10/12.5 mg tablet and SEVIKAR HCT 40/10/25 mg tablet contains iron oxide red and yellow.
SEVIKAR HCT does not contain sucrose, tartrazine or any other azo dyes.
SEVIKAR HCT is supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road,
Macquarie Park NSW 2113
This leaflet was prepared in July 2014.
® Registered trademark of Daiichi Sankyo Company Ltd
Published by MIMS October 2014