SUMMARY CMI
TELTARTAN HCT
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using TELTARTAN HCT?
TELTARTAN HCT contains the active ingredients telmisartan and hydrochlorothiazide. TELTARTAN HCT is used to lower high blood pressure (hypertension).
For more information, see Section 1. Why am I using TELTARTAN HCT? in the full CMI.
2. What should I know before I use TELTARTAN HCT?
Do not use if you have ever had an allergic reaction to telmisartan, hydrochlorothiazide or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use TELTARTAN HCT? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with TELTARTAN HCT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use TELTARTAN HCT?
- It is important to take TELTARTAN HCT exactly as your doctor or pharmacist has told you.
- Swallow the tablet whole with a full glass of water.
More instructions can be found in Section 4. How do I use TELTARTAN HCT? in the full CMI.
5. What should I know while using TELTARTAN HCT?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using TELTARTAN HCT? in the full CMI.
6. Are there any side effects?
There are a number of side effects associated with this medicine. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TELTARTAN HCT, even if you do not think it is connected with this medicine.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
TELTARTAN HCT
Active ingredient(s): Telmisartan and hydrochlorothiazide
Consumer Medicine Information (CMI)
This leaflet provides important information about using TELTARTAN HCT. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using TELTARTAN HCT.
Where to find information in this leaflet:
1. Why am I using TELTARTAN HCT?
2. What should I know before I use TELTARTAN HCT?
3. What if I am taking other medicines?
4. How do I use TELTARTAN HCT?
5. What should I know while using TELTARTAN HCT?
6. Are there any side effects?
7. Product details
1. Why am I using TELTARTAN HCT?
TELTARTAN HCT contains the active ingredients telmisartan and hydrochlorothiazide. TELTARTAN HCT is used to lower high blood pressure (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 (high blood pressure) when your blood pressure stays higher than is needed, 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.
These two active ingredients help to reduce blood pressure in different ways:
- Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. When the effect of angiotensin II is blocked, your blood vessels relax and your blood pressure goes down.
- Hydrochlorothiazide belongs to the group of medicines called diuretics. Diuretics help to reduce the amount of excess fluid in the body by increasing the amount of urine produced. They help with lowering blood pressure particularly when used with other blood pressure lowering medicines. Your doctor may have prescribed.
If high blood pressure is not treated, it can lead to serious health problems, including stroke, heart disease and kidney failure.
2. What should I know before I use TELTARTAN HCT?
Warnings
Do not use TELTARTAN HCT if:
- You are allergic to Telmisartan or hydrochlorothiazide (the two active ingredients in TELTARTAN HCT), or any of the ingredients listed at the end of this leaflet.
- You had an allergic reaction to other sulfonamide-derived medicines.
- You have a rare hereditary condition of fructose intolerance.
- You have a rare hereditary condition of galactose intolerance.
- You are pregnant or breastfeeding.
- You are under the age of 18 years.
- You have the following medical conditions:
- 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.
- low sodium levels that is treatment resistant
- low blood volume causing very low blood pressure
- gout
- diabetes or kidney problems and you are taking aliskiren (a medicine used to treat high blood pressure). - Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
- have any other medical conditions, including:
- kidney problems
- liver problems
- heart problems
- diabetes
- a condition known as primary hyperaldosteronism (raised aldosterone levels, also known as Conn's syndrome)
- fructose intolerance
- galactose intolerance
- recent severe diarrhoea or vomiting
- asthma
- systemic lupus erythematosus (a disease affecting the skin, joints and kidney)
- eye problems
- skin cancer. - experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past.
- are following a very low salt diet
- take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Do not take TELTARTAN HCT if you are pregnant.
Like other similar medicines, it may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking TELTARTAN HCT.
It is not known if telmisartan or hydrochlorothiazide, the active ingredients in TELTARTAN HCT, pass into breast milk and there is a possibility that your baby may be affected.
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Children
- Do not give TELTARTAN HCT to a child under the age of 18 years.
- Safety and effectiveness in children and teenagers up to 18 years of age have not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and TELTARTAN HCT may interfere with each other. These include:
- any other medicines used to treat high blood pressure such as betablockers
- heart medicines such as digoxin, a medicine used to treat heart failure or antiarrhythmic medicines
- lithium, a medicine used to treat certain mental illnesses
- medicine used to treat depression
- antipsychotics, medicines used to treat certain mental and emotional conditions
- antiepileptics, medicines used to treat epilepsy or fits
- other diuretics or fluid tablets medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced
- laxatives
- potassium supplements or potassium-containing salt substitutes
- medicines or salt substitutes which may increase your potassium levels
- amphotericin B, a medicine used to treat fungal infections
- penicillin antibiotics used to treat bacterial infections
- alcohol
- sleeping tablets
- 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 (a hormone)
- aspirin
- nonsteroidal anti-inflammatory agents (medicines used to relieve pain, swelling and other symptoms of inflammation including arthritis)
- medicines used to treat gout
- medicines used to increase blood pressure, such a noradrenaline
- ciclosporin, a medicine used to help prevent organ transplant rejection or to treat certain problems with the immune system
- calcium supplements or medicines containing calcium
- vitamin D supplements
- 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 TELTARTAN HCT, or may affect the way it works. Other medicines used to treat high blood pressure may have an additive effect with TELTARTAN HCT in lowering your blood pressure. Therefore, you may need different amounts of your medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TELTARTAN HCT.
4. How do I use TELTARTAN HCT?
How much to take
- The usual dose for adults is one TELTARTAN HCT 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 TELTARTAN HCT 80/12.5 mg tablet once a day.
- If your blood pressure is still not satisfactorily controlled with TELTARTAN HCT 80/12.5 mg, your doctor may increase your dose to one TELTARTAN HCT 80/25 mg tablet once a day.
- It is important to take TELTARTAN HCT exactly as your doctor or pharmacist has told you.
When to take TELTARTAN HCT
- TELTARTAN HCT should be taken at about the same time each day, either morning or evening.
- Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
- It does not matter if you take TELTARTAN HCT before or after food.
- You can take TELTARTAN HCT with or without food.
How to take TELTARTAN HCT
- Swallow the tablet whole with a full glass of water.
- It does not matter if you take TELTARTAN HCT before or after food.
- You can take TELTARTAN HCT with or without food.
How long to take TELTARTAN HCT
Take TELTARTAN HCT every day until your doctor tells you to stop.
TELTARTAN HCT helps control your high blood pressure but does not cure it. It is important to keep taking TELTARTAN HCT every day even if you feel well.
People who have high blood pressure often feel well and do not notice any signs of this problem.
If you forget to use TELTARTAN HCT
TELTARTAN HCT should be used regularly at the same time each day. If you miss your dose at the usual time, take the dose as soon as you remember and then go back to taking it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting unwanted side effects.
If you use too much TELTARTAN HCT
If you think that you have used too much TELTARTAN HCT, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using TELTARTAN HCT?
Things you should do
Tell any other doctors, dentists and pharmacists who are treating you that you are taking TELTARTAN HCT.
If you are about to be started on any new medicine, tell your doctor or pharmacist that you are taking TELTARTAN HCT.
If you feel that TELTARTAN HCT is not helping your condition, tell your doctor or pharmacist.
Tell your doctor if, for any reason, you have not used TELTARTAN HCT exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
If you are going to have surgery, tell your doctor and anaesthetist that you are taking TELTARTAN HCT.
TELTARTAN HCT may affect some medicines you receive during surgery.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Tell your doctor if you develop an unexpected abnormal lump, bump, ulcer, sore or coloured area on the skin (skin lesion) during the treatment.
Protect your skin from sun exposure and UV rays while TELTARTAN HCT.
If you develop any severe shortness of breath or difficulty breathing after taking TELTARTAN HCT, seek medical attention immediately.
Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer (nonmelanoma skin cancer).
Call your doctor straight away if you:
- Become pregnant while taking TELTARTAN HCT
Remind any doctor, dentist or pharmacist you visit that you are using TELTARTAN HCT.
Things you should not do
- Do not use TELTARTAN HCT to treat other complaints unless your doctor or pharmacist tells you to.
- Do not give this medicine to anyone else, even if they have the same symptoms as you.
- Do not stop taking TELTARTAN HCT or lower the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TELTARTAN HCT affects you.
Like other medicines used to treat high blood pressure, TELTARTAN HCT may cause sleepiness, dizziness or lightheadedness in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
You may feel dizzy or light-headed when you begin to take TELTARTAN HCT, especially if you are also taking a diuretic (or fluid tablet) or if you are dehydrated.
If you feel dizzy or light-headed, and you wish to stand up, you should do so slowly.
Standing up slowly, especially when you get up from a bed or chair, 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may interfere with TELMISARTAN HCT
Looking after your medicine
- Leave the tablets in the blister strip until it is time to take a dose.
The blister pack protects the tablets from light and moisture. - Keep TELTARTAN HCT in a cool, dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
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 TELTARTAN HCT is having an excessive effect.
You should tell your doctor if you experience any of these symptoms.
Tell your doctor as soon as possible if you notice any unexpected changes to your skin, including your lips.
This could be a type of skin or lip cancer (non-melanoma skin cancer).
Serious side effects
Serious side effects | What to do |
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TELTARTAN HCT contains
Active ingredient (main ingredient) |
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Other ingredients (inactive ingredients) |
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Potential allergens | Contains sugars as lactose. |
Do not take this medicine if you are allergic to any of these ingredients.
What TELTARTAN HCT looks like
TELTARTAN HCT 40/12.5 mg tablets are pink mottled and white to off-white biconvex, oval shaped, two layer tablets. The white to off-white layer may contain pink specks. The pink mottled face of TELTARTAN HCT 40/12.5 mg tablets are marked with L199. (AUST R 208068)
TELTARTAN HCT 80/12.5 mg tablets are pink mottled and white to off-white biconvex, oval shaped, two layer tablets. The white to off-white layer may contain pink specks. The pink mottled face of TELTARTAN HCT 80/12.5 mg tablets are marked with L200. (AUST R 208067)
TELTARTAN HCT 80/25 mg tablets are yellow mottled and white to off-white biconvex, oval shaped, two layer tablets. The white to off-white layer may contain yellow specks. The white face of TELTARTAN HCT 80/25 mg tablets are marked with L201. (AUST R 208074)
Who distributes TELTARTAN HCT
Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121 Australia
This leaflet was prepared in August 2024.
Published by MIMS October 2024