(telmisartan and hydrochlorothiazide) multilayer tablet
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Telmisartan HCT GH.
It does not contain all available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking this medicine against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet. More recent information may be available.
The latest Consumer Medicine Information is available from your pharmacist, doctor, and may contain important information about the medicine and its use of which you should be aware.
Keep this leaflet with the medicine. You may need to read it again.
What Telmisartan HCT GH is used for
Telmisartan HCT GH 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.
If high blood pressure is not treated, it can lead to serious health problems, including stroke, heart disease and kidney failure.
How Telmisartan HCT GH works
Telmisartan HCT GH contains telmisartan and hydrochlorothiazide in one single tablet. These two active ingredients help to reduce blood pressure in different ways:
- Telmisartan belongs to a group of medicines called angiotensin II receptor blockers. 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 Telmisartan HCT GH for another reason.
Ask your doctor if you have any questions about why Telmisartan HCT GH has been prescribed for you.
Telmisartan HCT GH is not addictive. This medicine is available only with a doctor’s prescription.
Before you take Telmisartan HCT GH
When you must not take it
Do not take Telmisartan HCT GH if you have an allergy to:
- any medicine containing telmisartan or hydrochlorothiazide (the two active ingredients in Telmisartan HCT GH);
- other sulfonamide-derived medicines;
- 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 Telmisartan HCT GH if you have a rare hereditary condition of fructose intolerance.
The maximum recommended daily dose of Telmisartan HCT GH 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 Telmisartan HCT GH if you have a rare hereditary condition of galactose intolerance.
The maximum recommended daily dose of Telmisartan HCT GH contains 112 mg of lactose monohydrate (in the 40/12.5 mg and 80/12.5 mg tablets) and 99 mg of lactose monohydrate (in the 80/25 mg tablets).
Do not take Telmisartan HCT GH 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 Telmisartan HCT GH. It is not known if telmisartan or hydrochlorothiazide, the active ingredients in Telmisartan HCT GH, pass into breast milk and there is a possibility that your baby may be affected.
Do not give Telmisartan HCT GH 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.
Do not take Telmisartan HCT GH if you have any of 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).
Do not take Telmisartan HCT GH after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking Telmisartan HCT GH, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
- 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.
Tell your doctor if you are following a very low salt diet.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell your doctor before you start taking Telmisartan HCT GH.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Telmisartan HCT GH may interfere with each other. These include:
- any other medicines used to treat high blood pressure such as beta blockers;
- heart medicines such as digoxin, a medicine used to treat heart failure or antiarrhythmic medicines;
- 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;
- lithium, a medicine used to treat certain mental illnesses;
- medicines used to treat depression;
- antipsychotics, medicines used to treat certain mental and emotional conditions;
- antiepileptic’s, medicines used to treat epilepsy or fits;
- 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 as 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 Telmisartan HCT GH or may affect how well it works.
Other medicines used to treat high blood pressure may have an additive effect with Telmisartan HCT GH in lowering your blood pressure. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Telmisartan HCT GH.
How to take Telmisartan HCT GH
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 how many tablets 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 label, ask your doctor or pharmacist for help.
How much to take
The usual dose for adults is one Telmisartan HCT GH 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 Telmisartan HCT GH 80/12.5 mg tablet once a day.
If your blood pressure is still not satisfactorily controlled with Telmisartan HCT GH 80/12.5 mg, your doctor may increase your dose to one Telmisartan HCT GH 80/25 mg tablet once a day.
It is important to take Telmisartan HCT GH exactly as your doctor or pharmacist has told you.
How to take it
Swallow the tablet whole with a full glass of water.
When to take it
Take Telmisartan HCT GH 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.
You can take Telmisartan HCT GH with or without food.
How long to take it
Continue taking Telmisartan HCT GH for as long as your doctor tells you to. Telmisartan HCT GH helps control your high blood pressure but does not cure it. It is important to keep taking Telmisartan HCT GH 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 take it
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 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 that you missed. This may increase the chance of you getting unwanted side effects.
If you are not sure what to do, ask your doctor or pharmacist.
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 Poisons Information Centre (telephone 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 Telmisartan HCT GH.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too much Telmisartan HCT GH you may feel dizzy, light-headed or faint. Your heartbeat may be faster or slower than usual. You may experience dehydration, nausea, drowsiness and muscle spasm.
While you are taking Telmisartan HCT GH
Things you must do
Tell any other doctors, dentists and pharmacists who are treating you that you are taking Telmisartan HCT GH.
If you are about to be started on any new medicine, tell your doctor or pharmacist that you are taking Telmisartan HCT GH.
If you feel that Telmisartan HCT GH is not helping your condition, tell your doctor or pharmacist.
Tell your doctor if, for any reason, you have not used Telmisartan HCT GH exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor immediately if you become pregnant while taking Telmisartan HCT GH.
If you are going to have surgery, tell your doctor, surgeon and anaesthetist that you are taking Telmisartan HCT GH. Telmisartan HCT GH 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. 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).
Protect your skin from sun exposure and UV rays while taking Telmisartan HCT GH.
Things you must not do
Do not take Telmisartan HCT GH to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as you.
Do not stop taking Telmisartan HCT GH or lower the dosage without checking with your doctor.
Things to be careful of
Be careful when driving or operating machinery until you know how Telmisartan HCT GH affects you.
Like other medicines used to treat high blood pressure, Telmisartan HCT GH may cause sleepiness, dizziness or light-headedness 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 Telmisartan HCT GH, 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.
If you exercise, or if you sweat, or if the weather is hot, you should drink plenty of water.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Telmisartan HCT GH.
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.
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 the following and they worry you:
- ‘flu-like’ symptoms;
- 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;
- eye pain;
- back pain;
- changes in heart rhythm or increased heart rate;
- rash or redness or itchiness of skin;
- increased sweating;
- dizziness or light-headedness when you stand up (postural hypotension);
- stomach pain or discomfort (abdominal pain, dyspepsia, gastritis);
- wind or excessive gas in the stomach or bowel;
- vomiting;
- diarrhoea or constipation;
- dry mouth;
- pins and needles;
- sleep disturbances or trouble sleeping;
- feeling anxious;
- depression;
- impotence;
- leg pain or cramps in legs;
- aching muscles or aching joints not caused by exercise or muscle spasms;
- chest pain;
- pain;
- liver problems;
- changes in the levels of potassium or sodium or uric acid in your blood (such changes are usually detected by a blood test).
- symptoms that may indicate low sodium levels in the blood, such as headache, dizziness, confusion, forgetfulness, weakness, unsteadiness or difficulty concentrating
- decrease in vision or pain in your eyes due to high pressure
(possible signs of fluid accumulation in the vascular layer of the eye or acute angleclosure glaucoma).
Tell your doctor as soon as possible if you experience any side effects during or after taking Telmisartan HCT GH, so that these may be properly treated.
Symptoms such as feeling very thirsty, sleepy, sick or vomiting, a dry mouth, general weakness, restlessness, seizures (fits), confusion, muscle pain or cramps, passing less urine than normal and a very fast heart rate, may mean that the hydrochlorothiazide part of Telmisartan HCT GH 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).
Tell your doctor immediately or go to Emergency at your nearest hospital if you notice any of the following:
- 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;
- developing or worsening of a disease called systemic lupus erythematosus which affects the skin, joints and kidney.
These are serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
After taking Telmisartan HCT GH
Storage
Keep 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 Telmisartan HCT GH in a cool, dry place where the temperature stays below 25°C.
Do not store Telmisartan HCT GH or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sill. Heat and dampness can destroy some medicines.
Keep Telmisartan HCT GH 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.
Disposal
If your doctor tells you to stop using Telmisartan HCT GH or it has passed its expiry date, ask your pharmacist what to do with any that is left over.
Product description
What it looks like
Telmisartan HCT GH is the brand name of your medicine. Telmisartan HCT GH tablets are available in three strengths:
- Telmisartan HCT GH 40/12.5 mg tablets are oblong biconvex bilayered uncoated tablets with one white/off white colour layer and one pink colour mottled layer debossed with L199.
- Telmisartan HCT 80/12.5 mg tablets are oblong biconvex bilayered uncoated tablets one white/off white colour layer and one pink colour mottled layer debossed with L200.
- Telmisartan HCT GH 80/25 mg tablets are oblong shaped biconvex, bilayered, uncoated tablets with one white/off white colour layer and one yellow colour mottled layer debossed with L201.
Telmisartan HCT GH tablets are available in blister packs of 28 tablets.
Ingredients
Active ingredients
Each Telmisartan HCT GH 40/12.5 mg tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Each Telmisartan HCT GH 80/12.5 mg tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Each Telmisartan HCT GH 80/25 mg tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Other ingredients
- povidone;
- lactose monohydrate
- magnesium stearate;
- meglumine;
- sodium hydroxide;
- sodium stearylfumarate;
- purified water;
- mannitol.
Telmisartan HCT GH 40/12.5 mg and Telmisartan HCT GH 80/12.5 mg tablets also contain Pigment Blend PB-24880 Pink as colouring agent.
Telmisartan HCT GH 80/25 mg tablets also contain Pigment Blend PB-52290 Yellow, as colouring agent.
Australian Registration Numbers
Telmisartan HCT GH 40/12.5 tablets: AUST R 208070.
Telmisartan HCT GH 80/12.5 tablets: AUST R 208075.
Telmisartan HCT GH 80/12 tablets: AUST R 208076.
Sponsor
Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia
Email: ghinfo@generichealth.com.au
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au
This leaflet was prepared in September 2022.
Published by MIMS November 2022
